Data / Medical devices / United States / Polymer Technology Systems
Polymer Technology Systems: FDA-registered device maker in Whitestown, IN, United States, 20 510(k) clearances
Polymer Technology Systems is registered with the FDA (registration 3015525148) in Whitestown, IN, United States. It lists 11 device types. The FDA files 20 510(k) clearances under its listings, the newest dated February 26, 2022. 17 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015525148
- FEI number
- 3002698769
- Address
- 4600 Anson Boulevard, Whitestown, IN, United States, 46075
- Owner or operator
- POLYMER TECHNOLOGY SYSTEMS, INC. (9031081)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 12, 2005
- Registered through
- 2026
- Brand names listed
- A1CNow Self Check, A1CNow+ Professional Use, A1CNow+ Professional Use (A1CNow+ Monitor; A1CNow+ Test Cartridge; A1CNow+ Dilution Kit), CVS Health At Home A1C Test Kit, CardioChek +, CardioChek Analyzer, CardioChek ChekMate, CardioChek ChekMate Strips and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer | accessdata.fda.gov |
| Colorimetric Method, Triglycerides | JGY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer | accessdata.fda.gov |
| Ldl & Vldl Precipitation, Hdl | LBR | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lipoprotein, High Density, Hdl, Over The Counter | NAQ | 1 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Manufacturer | accessdata.fda.gov |
| Test, Triglycerides, Over The Counter | NGO | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Collection, Capillary Blood | GIO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 26, 2022 | K193406 | CardioChek Plus Test System; CardioChek Plus Home Test System | NBW | Substantially Equivalent | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | accessdata.fda.gov |
| December 22, 2016 | K162282 | CardioChek Plus Test System, CardioChek Home Test System | CGA | Substantially Equivalent | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | accessdata.fda.gov |
| December 22, 2016 | K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | CHH | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| July 7, 2015 | K151530 | CardioChek Plus Test System | CGA | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| May 22, 2015 | K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM | NBW | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| May 14, 2009 | K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC | LCP | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| October 15, 2007 | K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | CHH | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| September 10, 2007 | K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS | NBW | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| January 31, 2007 | K070017 | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS | NBW | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| April 5, 2006 | K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS | NAQ | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| July 23, 2004 | K041750 | PTS PANELS CHOL+GLU TEST PANEL | NBW | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| November 15, 2002 | K023558 | PTS PANELS LIPID PANEL TEST STRIPS | CHH | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| September 24, 2002 | K022898 | PTS PANELS LIPID PANEL TEST STRIPS | CHH | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| August 21, 2002 | K022401 | PTS PANELS MULTI-CHEMISTRY CONTROLS | JJY | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| December 21, 2001 | K014099 | BIOSCANNER PLUS | NBW | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| November 20, 2001 | K013068 | BIOSCANNER 2000 | CGA | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| July 3, 2000 | K000586 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | JGY | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| May 24, 2000 | K991894 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | JGY | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| June 24, 1999 | K990688 | MTM BIOSCANNER C TEST STRIPS | CHH | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
| July 22, 1998 | K981493 | MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 | CHH | Substantially Equivalent | Polymer Technology Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 18, 2024 | 95416 | Class II | Completed | A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample | The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the te | accessdata.fda.gov |
| August 16, 2022 | 90791 | Class III | Completed | PTS Panels CHOL+GLU Test Strips (REF 1765) | Incorrect instructions for use were packaged into the final product. | accessdata.fda.gov |
| January 21, 2020 | 84840 | Class II | Terminated | PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary ( | The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. | accessdata.fda.gov |
| December 2, 2019 | 84274 | Class II | Terminated | PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700 | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating. | accessdata.fda.gov |
| June 7, 2019 | 83097 | Class III | Terminated | PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides i | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | accessdata.fda.gov |
| January 16, 2019 | 82331 | Class II | Terminated | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF | Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed. | accessdata.fda.gov |
| March 14, 2018 | 79778 | Class II | Terminated | 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 (August 2018) | accessdata.fda.gov |
| December 2, 2016 | 84231 | Class II | Terminated | A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058 | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. | accessdata.fda.gov |
| March 15, 2016 | 84264 | Class II | Terminated | PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers | This lot of test strips is showing an under-recovery when tested against a reference method. | accessdata.fda.gov |
| April 4, 2013 | 65067 | Class II | Terminated | PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood | Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk. | accessdata.fda.gov |
| May 15, 2012 | 61966 | Class II | Terminated | PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in th | During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay. | accessdata.fda.gov |
| July 6, 2010 | 56188 | Not yet classified | Terminated | PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268. | The test strips appear to under-recover Cholesterol, HDL and glucose. | accessdata.fda.gov |
| August 4, 2009 | 53246 | Not yet classified | Terminated | PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN. | Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the fre | accessdata.fda.gov |
| June 5, 2009 | 53773 | Not yet classified | Terminated | PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710. | Exhibits under-recovery of all analytes. | accessdata.fda.gov |
| April 2, 2009 | 53768 | Not yet classified | Terminated | PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative mea | The memory chip was coded with incorrect product information. | accessdata.fda.gov |
| February 20, 2009 | 53761 | Not yet classified | Terminated | PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol | Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date. | accessdata.fda.gov |
| May 29, 2008 | 53759 | Not yet classified | Terminated | PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL | The expiration date was extended by 20 weeks without justification. | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Enzymatic Esterase--Oxidase, Cholesterol
- All makers of Colorimetric Method, Triglycerides
- All makers of Ldl & Vldl Precipitation, Hdl
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
Updated October 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.