Acid, Lactic, Enzymatic Method
FDA product code KHP · Class I (low risk) · 21 CFR 862.1450 · Clinical Chemistry
27510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Nova Biomedical Corp. 3
- E.I. Dupont DE Nemours & Co., Inc. 2
- Yellow Springs Instrument Co., Inc. 2
- Eastman Kodak Company 2
- I-Stat Corp. 2
- Abaxis, Inc. 1
- Roche Medical Electronics, Inc. 1
- Siemens Healthcare Diagnostics, Inc. 1
- Abbott Pont of Care, Inc. 1
- Epocal, Inc. 1
- Diametrics Medical, Inc. 1
- Kdk Corp. 1
- Jwt, Inc. 1
- Boehringer Mannheim Corp. 1
- Beckman-Diagnostic Systems Group 1
- Medical Implements, Inc. 1
- Beckman Instruments, Inc. 1
- Sigma Diagnostics, Inc. 1
- Diagnostic Systems 1
- Abbott Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130113 | Piccolo Lactate Test SystemKHP · Traditional | Abaxis, Inc. | 03/11/2013SE |
| K113216 | Rapidpoint 500 Blood Gas AnalyerKHP · Traditional | Siemens Healthcare Diagnostics | 05/03/2012SE |
| K112955 | Nova Statstrip Lactate Hospital Meter SystemKHP · Traditional | Nova Biomedical Corporation | 01/05/2012SE |
| K112430 | I-Stat Lactate Test/I-Sat CG4+CARTRIDGEKHP · Traditional | Abbott Pont of Care, Inc. | 12/20/2011SE |
| K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsKHP · Traditional | Nova Biomedical Corp. | 08/17/2011SE |
| K093297 | Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeKHP · Traditional | Epocal, Inc. | 06/09/2010SE |
| K013938 | Irma SL Blood Analysis System Lactate CartridgeKHP · Traditional | Diametrics Medical, Inc. | 01/28/2002SE |
| K011478 | I-Stat SystemKHP · Traditional | I-Stat Corp. | 07/02/2001SE |
| K980908 | Lactate Pro SystemKHP · Traditional | Kdk Corp. | 09/11/1998SE |
| K982071 | I-Stat Lactate TestKHP · Traditional | I-Stat Corp. | 06/29/1998SE |
| K971944 | Lactest IKHP · Traditional | Jwt, Inc. | 12/17/1997SE |
| K951331 | Accusport Lactate Monitoring System Lactate Test Strips Accusport MonitorKHP · Traditional | Boehringer Mannheim Corp. | 08/11/1995SE |
| K936066 | Stat Profile Plus 9 AnalyzerKHP · Traditional | Nova Biomedical Corp. | 03/09/1995SE |
| K934271 | Beckman Synchron Lactate ReagentKHP · Traditional | Beckman-Diagnostic Systems Group | 11/09/1993SE |
| K914508 | Dimension(R) Lactic Acid MethodKHP · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/27/1991SE |
| K913330 | Urine Collection Kit/DeviceKHP · Traditional | Medical Implements, Inc. | 08/26/1991SE |
| K913197 | Kodak Ektachem DT Slides (Lac)KHP · Traditional | Eastman Kodak Company | 08/26/1991SE |
| K910534 | Synchron Lactate ReagentKHP · Traditional | Beckman Instruments, Inc. | 04/08/1991SE |
| K901131 | Ysi Model 1500 Sport L-Lactate AnalyzerKHP · Traditional | Yellow Springs Instrument Co., Inc. | 08/27/1990SN |
| K897147 | Sigma Procedure No. 735KHP · Traditional | Sigma Diagnostics, Inc. | 04/03/1990SE |
| K884189 | Kodak Ektachem Clinical Chemistry Slides (Lac)KHP · Traditional | Eastman Kodak Company | 01/11/1989SE |
| K880787 | Easy-Test Lactic Acid (la)KHP · Traditional | Diagnostic Systems | 03/15/1988SE |
| K861741 | TDX Rea Lactic AcidKHP · Traditional | Abbott Laboratories | 07/07/1986SE |
| K852261 | Ysi Model 2372 Total Blood Lactate KitKHP · Traditional | Yellow Springs Instrument Co., Inc. | 08/15/1985SE |
| K840778 | Lactate ReagentKHP · Traditional | American Dade | 04/13/1984SE |
| K802064 | Dupont Acalactic Acid (la) TestKHP · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/26/1980SE |
| K790421 | Roche Lactate Analyzer 640KHP · Traditional | Roche Medical Electronics, Inc. | 05/15/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2560-2025 Class II | VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5…VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an… | Ortho-Clinical Diagnostics, Inc. | 07/29/2025Open, Classified |
| Z-2559-2025 Class II | Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5…VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an… | Ortho-Clinical Diagnostics, Inc. | 07/29/2025Open, Classified |
| Z-1263-2020 Class II | i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product…The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA… | Abbott Point Of Care Inc. | 01/15/2020Terminated |
| Z-1146-2019 Class II | Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of…New endogenous interference claims have been established for the following assays used on the cobas c 311… | Roche Diagnostics Corporation | 12/17/2018Terminated |
| Z-0379-2017 Class II | ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the…Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic… | Abbott Laboratories | 10/11/2016Terminated |
| Z-0090-2017 Class II | VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | Ortho-Clinical Diagnostics | 08/11/2016Terminated |
| Z-2601-2016 Class III | Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A…Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States | Siemens Healthcare Diagnostics Inc | 07/05/2016Terminated |
| Z-1931-2016 Class II | Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System…Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the… | Beckman Coulter Inc. | 04/13/2016Terminated |
| Z-0741-2016 Class II | ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in…N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with… | Horiba Instruments Inc | 01/11/2016Terminated |
| Z-2816-2015 Class II | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813…RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on… | Siemens Healthcare Diagnostics Inc | 08/24/2015Terminated |
| Z-2815-2015 Class II | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447…RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on… | Siemens Healthcare Diagnostics Inc | 08/24/2015Terminated |
| Z-2814-2015 Class II | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448…RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on… | Siemens Healthcare Diagnostics Inc | 08/24/2015Terminated |
| Z-2813-2015 Class II | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449…RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on… | Siemens Healthcare Diagnostics Inc | 08/24/2015Terminated |
| Z-2479-2015 Class II | RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855…When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could… | Siemens Healthcare Diagnostics Inc | 07/28/2015Terminated |
| Z-1026-2015 Class II | Beckman Coulter, Lactate Assay, Catalog No. OSR6X93N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen… | Beckman Coulter Inc. | 12/15/2014Terminated |
| Z-2079-2014 Class II | RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement…RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+… | Siemens Healthcare Diagnostics Inc | 05/23/2014Terminated |
| Z-1613-2013 Class II | SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when…Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition… | Beckman Coulter Inc. | 05/28/2013Terminated |
| Z-1400-2013 Class II | Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number:…Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer… | Beckman Coulter Inc. | 04/17/2013Terminated |
| Z-2303-2013 Class II | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is…RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme… | Radiometer America Inc | 10/08/2012Terminated |