Polymer Technology Systems, Inc.
Medical device manufacturer in Indianapolis, IN.
27510(k) clearances
0PMA approvals
25recalls
Device types
- CHH Enzymatic Esterase--Oxidase, Cholesterol 7
- NBW System, Test, Blood Glucose, Over The Counter 6
- CGA Glucose Oxidase, Glucose 4
- JMK Acid, Alpha-Ketobutyric And Nadh (U.V.)… 2
- NAQ Lipoprotein, High Density, Hdl, Over The… 2
- JGY Colorimetric Method, Triglycerides 2
- LBR Ldl & Vldl Precipitation, Hdl 1
- JFY Enzymatic Method, Creatinine 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- MRR System, Test, Low Density, Lipoprotein 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | 12/22/2016SE |
| K151530 | CardioChek Plus Test SystemCGA · Traditional | 07/07/2015SE |
| K140068 | Cardiochek Plus Test System, Cardiochek Home Test SystemNBW · Special | 05/22/2015SE |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…CGA · Traditional | 10/02/2014SE |
| K071593 | PTS Panels Chol+Hdl Panel Test StripsCHH · Special | 10/15/2007SE |
| K071507 | PTS Panels Chol+Hdl+Glu Panel Test StripsNBW · Special | 09/10/2007SE |
| K070017 | PTS Panels Metabolic Chemistry Panel Test StripsNBW · Special | 01/31/2007SE |
| K060617 | PTS Panels HDL Cholesterol Test StripsNAQ · Special | 04/05/2006SE |
| K041750 | PTS Panels Chol+Glu Test PanelNBW · Special | 07/23/2004SE |
| K040693 | PTS Panels LDL Cholesterol Test StripsMRR · Traditional | 07/06/2004SE |
| K023558 | PTS Panels Lipid Panel Test StripsCHH · Special | 11/15/2002SE |
| K022898 | PTS Panels Lipid Panel Test StripsCHH · Special | 09/24/2002SE |
| K022401 | PTS Panels Multi-Chemistry ControlsJJY · Traditional | 08/21/2002SE |
| K014099 | Bioscanner PlusNBW · Special | 12/21/2001SE |
| K013068 | Bioscanner 2000CGA · Traditional | 11/20/2001SE |
| K013203 | Bioscanner Beyond Glucose Analyzer and Test StripsNBW · Traditional | 11/16/2001SE |
| K013173 | Bioscanner Plus; Lipid Panel Test StripsCHH · Special | 10/22/2001SE |
| K010456 | Bioscanner Creatinine Test StripsJFY · Traditional | 06/20/2001SE |
| K000586 | Bioscanner Triglycerides Test StripsJGY · Traditional | 07/03/2000SE |
| K991894 | Bioscanner Triglycerides Test StripsJGY · Traditional | 05/24/2000SE |
| K993377 | MTM Bioscanner HDL Test Strips, Over the Counter (OTC)NAQ · Traditional | 01/13/2000SE |
| K983860 | MTM Bioscanner K Test Strips, Cat # BSA610JMK · Traditional | 12/27/1999SE |
| K990688 | MTM Bioscanner C Test StripsCHH · Traditional | 06/24/1999SE |
| K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470LBR · Traditional | 05/28/1999SE |
| K981865 | MTM Bioscanner K Test StripsJMK · Traditional | 02/26/1999SE |
| K981493 | MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220CHH · Traditional | 07/22/1998SE |
| K972669 | MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner…CGA · Traditional | 01/22/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1438-2020 Class II | PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product…The firm is removing the product from the market after discussions with the FDA due to lack of 510(k)… | 01/21/2020Terminated |
| Z-0835-2020 Class II | Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying…One brand of batteries have a small dimensional difference in the negative button terminal, which, when the… | 12/02/2019Terminated |
| Z-0834-2020 Class II | Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036One brand of batteries have a small dimensional difference in the negative button terminal, which, when the… | 12/02/2019Terminated |
| Z-0833-2020 Class II | PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box…One brand of batteries have a small dimensional difference in the negative button terminal, which, when the… | 12/02/2019Terminated |
| Z-0832-2020 Class II | PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with…One brand of batteries have a small dimensional difference in the negative button terminal, which, when the… | 12/02/2019Terminated |
| Z-2158-2019 Class III | Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number:…The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD… | 06/07/2019Terminated |
| Z-2157-2019 Class III | PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product…The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD… | 06/07/2019Terminated |
| Z-1373-2019 Class II | CHOL+HDL+GLU test strips, REF 2412Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which… | 01/16/2019Terminated |
| Z-1372-2019 Class II | Lipid Panel test strips (as a component of smart bundles), REF 2729, also private…Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which… | 01/16/2019Terminated |
| Z-1371-2019 Class II | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which… | 01/16/2019Terminated |
| Z-1543-2018 Class II | PTS Panels CHOL+GLU Test Strips (REF 1765)Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life… | 03/14/2018Terminated |
| Z-0686-2020 Class II | CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | 12/02/2016Terminated |
| Z-0685-2020 Class II | ReliOn FastA1C Test, Software Version Revision D, REF Number 3055A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | 12/02/2016Terminated |
| Z-0684-2020 Class II | Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | 12/02/2016Terminated |
| Z-0683-2020 Class II | A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | 12/02/2016Terminated |
| Z-0682-2020 Class II | A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US:…A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13%… | 12/02/2016Terminated |
| Z-0741-2020 Class II | PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or…This lot of test strips is showing an under-recovery when tested against a reference method. | 03/15/2016Terminated |
| Z-1403-2013 Class II | PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage:…Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This… | 04/04/2013Terminated |
| Z-1903-2012 Class II | PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to…During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a… | 05/15/2012Terminated |
| Z-2641-2010 | PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests…The test strips appear to under-recover Cholesterol, HDL and glucose. | 07/06/2010Terminated |
| Z-1012-2010 | PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A…Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL… | 08/04/2009Terminated |
| Z-1136-2010 | PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek…Exhibits under-recovery of all analytes. | 06/05/2009Terminated |
| Z-0871-2010 | PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek…The memory chip was coded with incorrect product information. | 04/02/2009Terminated |
| Z-0975-2010 | PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer…Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009… | 02/20/2009Terminated |
| Z-1132-2010 | PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test…The expiration date was extended by 20 weeks without justification. | 05/29/2008Terminated |