Nova Biomedical Corp.
Medical device manufacturer in Waltham, MA.
129510(k) clearances
0PMA approvals
31recalls
Device types
- CHL Electrode Measurement, Blood-Gases (Pco2… 28
- JGS Electrode, Ion Specific, Sodium 21
- PZI Prescription Use Blood Glucose Meter For… 10
- JJY Multi-Analyte Controls, All Kinds (Assayed) 8
- CGA Glucose Oxidase, Glucose 7
- JFP Electrode, Ion Specific, Calcium 6
- NBW System, Test, Blood Glucose, Over The Counter 6
- CEM Electrode, Ion Specific, Potassium 4
- GKF Instrument, Hematocrit, Automated 3
- CGL Electrode, Ion Based, Enzymatic, Creatinine 3
- KHP Acid, Lactic, Enzymatic Method 3
- CGZ Electrode, Ion-Specific, Chloride 2
- CGX Alkaline Picrate, Colorimetry, Creatinine 2
- LFR Glucose Dehydrogenase, Glucose 2
- GGZ Oxyhemoglobin 2
- JIX Calibrator, Multi-Analyte Mixture 2
- JJX Single (Specified) Analyte Controls… 2
- GLY Oximeter To Measure Hemoglobin 2
- JJF Analyzer, Chemistry, Micro, For Clinical Use 2
- JFL Ph Rate Measurement, Carbon-Dioxide 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251281 | Nova Max Creat eGFR Monitoring SystemSHB · Traditional | 01/21/2026SE |
| K252206 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | 01/09/2026SE |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | 11/22/2024SE |
| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | 11/19/2024SE |
| K232075 | StatStrip Glucose Hospital Meter SystemPZI · Dual Track | 02/23/2024SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 09/29/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | 10/18/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | 04/14/2020SE |
| K200204 | Stat Profile Prime Plus Analyzer SystemGGZ · Traditional | 04/06/2020SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | 03/13/2020SE |
| K193246 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 01/24/2020SE |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer SystemJFP · Traditional | 08/16/2019SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | 07/19/2019SE |
| K182552 | StatStrip Xpress Glucose Hospital Meter SystemPZI · Dual Track | 12/13/2018SE |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter SystemPZI · Dual Track | 12/13/2018SE |
| K180340 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | 09/26/2018SE |
| K180186 | Stat Profile Prime Plus Analyzer SystemGGZ · Traditional | 08/23/2018SE |
| K180428 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | 08/15/2018SE |
| K173797 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 07/17/2018SE |
| K181043 | StatStrip Glucose Hospital Meter SystemPZI · Dual Track | 07/12/2018SE |
| K170464 | StatStrip Xpress Blood Glucose Monitoring SystemNBW · Traditional | 11/07/2017SE |
| K171059 | Nova StatSensor Creatinine Hospital Meter SystemCGL · Special | 05/26/2017SE |
| K160990 | Nova Max Uric Acid Monitoring SystemPTC · Traditional | 04/11/2017SE |
| K163490 | StatStrip Xpress 2 Glucose Hospital Meter SystemPZI · Special | 01/06/2017SE |
| K161856 | StatStrip Xpress Glucose Hospital Meter SystemPZI · Special | 11/15/2016SE |
| K160156 | StatStrip Xpress Blood Glucose Monitoring SystemNBW · Traditional | 06/23/2016SE |
| K152986 | StatStrip Xpress 2 Glucose Hospital Meter SystemPZI · Special | 01/27/2016SE |
| K151982 | Stat Profile Prime ABG Analyzer SystemCHL · Traditional | 09/10/2015SE |
| K141907 | Stat Profile Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat…CHL · Traditional | 05/29/2015SE |
| K150461 | StatStrip Xpress Glucose Hospital Meter SystemPZI · Traditional | 05/20/2015SE |
| K150281 | StatStrip Glucose Hospital MeterPZI · Traditional | 05/06/2015SE |
| K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)CHL · Traditional | 10/17/2014SE |
| K132121 | Statstrip Glucose Hospital Meter SystemPZI · Traditional | 09/24/2014SE |
| K131703 | Nova Stat Profile Prime CCS Analyzer SystemCHL · Traditional | 03/25/2014SE |
| K131013 | Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNBW · Traditional | 10/17/2013SE |
| K122688 | Nova Max Mini Blood Glucose and B-Ketone MonitorLFR · Traditional | 04/04/2013SE |
| K122435 | Nova One Blood Glucose MonitorLFR · Traditional | 12/20/2012SE |
| K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNBW · Traditional | 03/09/2012SE |
| K112955 | Nova Statstrip Lactate Hospital Meter SystemKHP · Traditional | 01/05/2012SE |
| K110648 | Nova Stat Profile Phox Ultra Analyzer SystemCHL · Special | 08/29/2011SE |
| K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsKHP · Traditional | 08/17/2011SE |
| K101633 | Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighJJY · Traditional | 08/27/2010SE |
| K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…NBW · Traditional | 01/15/2010SE |
| K070960 | Nova Statstrip Xpress Glucose Hospital Meter SystemCGA · Special | 07/11/2007SE |
| K070255 | Nova Max Blood Glucose Monitor System, 90001,90002NBW · Traditional | 06/13/2007SE |
| K070068 | Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and…CGL · Traditional | 05/07/2007SE |
| K063821 | Nova Statstrip Glucose Hospital Meter SystemCGA · Traditional | 01/24/2007SE |
| K061830 | Stat Profile Critical Care Xpress (CCX), Model 1+CIG · Traditional | 11/01/2006SE |
| K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsCGA · Traditional | 04/28/2006SE |
| K041016 | Nova Glucose Low/High Level Control SolutionsJJX · Traditional | 05/07/2004SE |
| K033433 | Nova Glucose Control SolutionsJJX · Traditional | 01/02/2004SE |
| K023567 | Stat Profile Phox Plus L AnalyzerCHL · Abbreviated | 12/20/2002SE |
| K022746 | Stat Profile Critical Care Xpress AnalyzerCHL · Traditional | 11/22/2002SE |
| K021713 | Stat Profile Phox Plus C AnalyzerCHL · Traditional | 07/25/2002SE |
| K020297 | Stat Profile Critical Care Xpress AnalyzerCHL · Traditional | 06/10/2002SE |
| K014295 | Stat Profile Phox AnalyzerCHL · Traditional | 02/28/2002SE |
| K013729 | Stat Profile Phox Basic AnalyzerCHL · Traditional | 01/15/2002SE |
| K012058 | Stat Profile Phox Plus L AnalyzerCHL · Traditional | 08/20/2001SE |
| K002613 | Modification to Stat Profile Phox Plus AnalyzerCHL · Traditional | 10/19/2000SE |
| K001761 | Statlyte Na/K/Cl/Li AnalyzerJGS · Traditional | 08/07/2000SE |
| K000895 | Stat Profile Phox Plus AnalyzerJGS · Traditional | 04/17/2000SE |
| K993104 | Stat Profile Phox Co-Oximeter Analyzer, Nova Co-Oximeter Controls, Levels 1 and 2, Nova…GLY · Traditional | 12/02/1999SE |
| K991727 | Stat Profile M7 AnalyzerCGL · Traditional | 07/16/1999SE |
| K982277 | Modification to Stat Profile Phox Blood Gas Analyzer (K980991)CHL · Traditional | 07/22/1998SE |
| K981427 | Stat Profile M AnalyzerGKF · Traditional | 05/12/1998SE |
| K981426 | Stat Profile Ultra F,G,H,I,J,K, and L AnalyzersGKF · Traditional | 05/12/1998SE |
| K981425 | Stat Profile Ultra a, B, C, D, and E AnalyzersGKF · Traditional | 05/12/1998SE |
| K980991 | Nova Stat Profile Phox Blood Gas AnalyzerCHL · Traditional | 04/15/1998SE |
| K970710 | Stat Profile Ultra M AnalyzerCHL · Traditional | 05/09/1997SE |
| K963005 | Nova 16 Analyzer (Modification Point of Care Usage)JFL · Traditional | 08/23/1996SE |
| K962982 | Nova Chemistry Controls, Level 1,2,AND 3 W/O CreatJJY · Traditional | 08/23/1996SE |
| K962997 | Nova Chemistry Controls with Creatinine, Levels (1, 2) and 3JJY · Traditional | 08/15/1996SE |
| K961938 | Stat Profile Ultra L Analyzer Quality Control MaterialsGJS · Traditional | 06/28/1996SE |
| K955013 | Nova Co-Oximeter AnalyzerGLY · Traditional | 04/25/1996SE |
| K960120 | Stat Profile Ultra F,G,H,I,J, and K AnalyzersJFP · Traditional | 03/11/1996SE |
| K955264 | Nova Chemistry Controls, Levels 1 and 2JJY · Traditional | 02/02/1996SE |
| K955260 | Nova Chemistry Performance Check SolutionJJY · Traditional | 02/02/1996SE |
| K955252 | Nova Chemistry Linearity Set F, Levels 1, 2, 3, and 4JJY · Traditional | 02/02/1996SE |
| K954711 | Stat Profile Ultra 11 Analyzer (Modification)CHL · Traditional | 11/30/1995SE |
| K952477 | Stat Profile Ultra Blood Gas ControlsJJS · Traditional | 07/06/1995SE |
| K936203 | Stat Profile Plus 10 AnalyzerCHL · Traditional | 03/09/1995SE |
| K936066 | Stat Profile Plus 9 AnalyzerKHP · Traditional | 03/09/1995SE |
| K945584 | Nova 16 AnalyzerJJC · Traditional | 02/08/1995SE |
| K943643 | Stat Profile Ultra 11 AnalyzerCHL · Traditional | 12/29/1994SE |
| K931373 | Analyzer: Stat Profile Plus 10 AnalyzerJJY · Traditional | 06/15/1993SE |
| K924497 | Stat Profile 9 AnalyzerCHL · Traditional | 02/23/1993SE |
| K924547 | Nova 8 CRT AnalyzerJGS · Traditional | 01/28/1993SE |
| K924864 | Nova 13 Analyzer, ModificationCGZ · Traditional | 11/06/1992SE |
| K924743 | Nova 12 Analyzer, ModificationCGA · Traditional | 11/06/1992SE |
| K922943 | Nova Na/K/Cl/Li ModuleCEM · Traditional | 10/13/1992SE |
| K923806 | Analyzer: Nova 10 CRT Analyzer & Quali Cont MaterJGS · Traditional | 09/29/1992SE |
| K923266 | Nova Total Protein ModuleCEK · Traditional | 08/12/1992SE |
| K921937 | Nova Nucleus Clinical Chemical Syst, ModificationJGS · Traditional | 07/27/1992SE |
| K922215 | Nova 14 Na/K/Cl/Glu/Bun AnalyzerJGS · Traditional | 07/17/1992SE |
| K915178 | Nova 11 Na/K/Li AnalyzerCEM · Traditional | 01/27/1992SE |
| K915177 | Nova 5 NA/K/C1 AlalyzerCEM · Traditional | 01/27/1992SE |
| K915176 | Nova 4 NA/K/C1/TCO2/LI AnalyzerJGS · Traditional | 01/15/1992SE |
| K913259 | Nova Celltrak 12 Auto Multi-Para Hema Analyzer/CalGKZ · Traditional | 10/08/1991SE |
| K912561 | Nova 13 AnalyzerCGZ · Traditional | 09/11/1991SE |
| K912560 | Nova 12 AnalyzerJGS · Traditional | 07/17/1991SE |
| K912559 | Nova 1 Sodium/Potassium/Hematocrit AnalyzerJGS · Traditional | 07/01/1991SE |
| K912321 | Module: Nova Nucleus TMG Module Fluid PackJGJ · Traditional | 06/17/1991SE |
| K905264 | Stat Profile 8 Analyzer,Calibrators and MaterialsJGS · Traditional | 03/05/1991SE |
| K897177 | Calibrators, Control Materials, Electrodes & TubeJIX · Traditional | 03/27/1990SE |
| K894218 | Nova Nucleus Clinical Chemistry SystemJGS · Traditional | 09/07/1989SE |
| K884618 | Nova Celltrak 11 Auto. Hema. Analyzer, CalibratorsGKL · Traditional | 01/24/1989SE |
| K884143 | Nova Stat Profile 7 Analyzer Quality Control MaterCHL · Traditional | 12/02/1988SE |
| K880750 | Nova Stat Profile 6 Analyzer + Quality Control MatJGS · Traditional | 07/01/1988SE |
| K881255 | Nova 12 NA/K/C1/TOTAL Carbon Dioxide/Glucose/UreaJGS · Traditional | 05/16/1988SE |
| K874832 | Nova Stat Profile 5 Analyzer + Quality ControlJGS · Traditional | 02/11/1988SE |
| K872190 | Nova 13 Sodium/Potassium/Chloride/Lithium AnalyzerJGS · Traditional | 06/24/1987SE |
| K871397 | Analyzer: Nova Stat Profile 3 AnalyzerCHL · Traditional | 06/03/1987SE |
| K864445 | Stat Profile 4 Analyzer + Quality Control MaterialCHL · Traditional | 02/04/1987SE |
| K863438 | Nova II Sodium/Potassium/Lithium AnalyzerJJP · Traditional | 09/29/1986SE |
| K854608 | Analyzer Nova Stat Profile 2/QUALITY Control Mat.CHL · Traditional | 12/05/1985SE |
| K852790 | Analyzer: Nova Stat Profile 1 Qua Con Mat: ElectCHL · Traditional | 11/12/1985SE |
| K841464 | Changes in the Chemical Comp. of 5JIX · Traditional | 06/22/1984SE |
| K841452 | Nova Stat Control Levels 1/2/3JJY · Traditional | 06/22/1984SE |
| K833154 | Nova 9 Sodium/Potassium/Total CalciumJJF · Traditional | 12/08/1983SE |
| K833153 | Nova 10 Sodium/Potassium/Total CalciuJJF · Traditional | 11/25/1983SE |
| K830213 | Nova 7 Total Calcium/Ionized CalciumJFP · Traditional | 04/05/1983SE |
| K830502 | Nova 8 Ionized Calcium/Ph AnalyzerJFP · Traditional | 03/24/1983SE |
| K823389 | Sodium/Potassium/Ionized Calcium AnalyzJFP · Traditional | 02/02/1983SE |
| K811289 | Nova 5JGS · Traditional | 05/27/1981SE |
| K801882 | Nova 4 Sodium/Potassium/Chloride/CarbonJGS · Traditional | 09/16/1980SE |
| K792254 | Nova 3+3 Chloride/Total Carbon DioxideJFL · Traditional | 12/06/1979SE |
| K791175 | Analyzer, Sodium/PotassiumCEM · Traditional | 08/10/1979SE |
| K771643 | Nova 2 Ionized Calcium AnalyzerJFP · Traditional | 09/28/1977SE |
| K770601 | Analyzer, Sodium/Potassium Nova LJGS · Traditional | 06/14/1977SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3132-2026 | StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | 07/29/2026Open, Classified |
| Z-3131-2026 | StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | 07/29/2026Open, Classified |
| Z-3130-2026 | StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | 07/29/2026Open, Classified |
| Z-3129-2026 | StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | 07/29/2026Open, Classified |
| Z-3128-2026 | StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | 07/29/2026Open, Classified |
| Z-0683-2025 Class I | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910.…A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient… | 11/20/2024Open, Classified |
| Z-0682-2025 Class I | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683.…A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient… | 11/20/2024Open, Classified |
| Z-0681-2025 Class I | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use…A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose… | 11/20/2024Open, Classified |
| Z-0208-2024 Class II | Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in…Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a… | 09/18/2023Open, Classified |
| Z-0207-2024 Class II | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum…Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a… | 09/18/2023Open, Classified |
| Z-2732-2017 Class II | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG…Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator… | 06/19/2017Terminated |
| Z-0650-2014 Class II | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital…Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage | 10/10/2013Terminated |
| Z-1906-2013 Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1905-2013 Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1904-2013 Class I | Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1903-2013 Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage:…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1902-2013 Class I | Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1901-2013 Class I | Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1900-2013 Class I | Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1899-2013 Class I | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1898-2013 Class I | Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1897-2013 Class I | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1154-2013 Class II | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)Glucose test strips reports no result message when tested | 02/25/2013Terminated |
| Z-1153-2013 Class II | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214Glucose test strips reports no result message when tested | 02/25/2013Terminated |
| Z-1783-2010 | Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation.…Glucose strips report low glucose results | 02/12/2010Terminated |
| Z-1328-2009 | Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX…Erroneous, low creatinine results on CCX analyzer | 08/11/2008Terminated |
| Z-1472-2008 | Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova…Lithium batteries may fail if the glucose or creatinine meters have been dropped. | 02/21/2008Terminated |
| Z-0726-2008 | Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454Incorrect Results - Creatinine results were lower than the laboratory reference method. | 11/02/2007Terminated |
| Z-0725-2008 | Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454Incorrect Results - Creatinine results were lower than the laboratory reference method. | 11/02/2007Terminated |
| Z-0724-2008 | Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical…Incorrect Results - Creatinine results were lower than the laboratory reference method. | 11/02/2007Terminated |
| Z-0295-2008 | Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MAElevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on… | 09/17/2007Terminated |