Polymer Technology Systems
Whitestown, IN, US
Polymer Technology Systems appears in FDA device records in Whitestown, IN. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 27 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Polymer Technology Systems carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 27 510(k) clearances for Polymer Technology Systems between 1998 and 2016. The busiest year on record is 2001, with 5. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 3 |
| 2001 | 5 |
| 2002 | 3 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 3 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | CHH | Substantially Equivalent | |
| K151530 | CardioChek Plus Test System | CGA | Substantially Equivalent | |
| K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM | NBW | Substantially Equivalent | |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System | CGA | Substantially Equivalent | |
| K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS | CHH | Substantially Equivalent | |
| K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS | NBW | Substantially Equivalent | |
| K070017 | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS | NBW | Substantially Equivalent | |
| K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS | NAQ | Substantially Equivalent | |
| K041750 | PTS PANELS CHOL+GLU TEST PANEL | NBW | Substantially Equivalent | |
| K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS | MRR | Substantially Equivalent | |
| K023558 | PTS PANELS LIPID PANEL TEST STRIPS | CHH | Substantially Equivalent | |
| K022898 | PTS PANELS LIPID PANEL TEST STRIPS | CHH | Substantially Equivalent | |
| K022401 | PTS PANELS MULTI-CHEMISTRY CONTROLS | JJY | Substantially Equivalent | |
| K014099 | BIOSCANNER PLUS | NBW | Substantially Equivalent | |
| K013068 | BIOSCANNER 2000 | CGA | Substantially Equivalent | |
| K013203 | BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS | NBW | Substantially Equivalent | |
| K013173 | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS | CHH | Substantially Equivalent | |
| K010456 | BIOSCANNER CREATININE TEST STRIPS | JFY | Substantially Equivalent | |
| K000586 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | JGY | Substantially Equivalent | |
| K991894 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | JGY | Substantially Equivalent | |
| K993377 | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) | NAQ | Substantially Equivalent | |
| K983860 | MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 | JMK | Substantially Equivalent | |
| K990688 | MTM BIOSCANNER C TEST STRIPS | CHH | Substantially Equivalent | |
| K990247 | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 | LBR | Substantially Equivalent | |
| K981865 | MTM BIOSCANNER K TEST STRIPS | JMK | Substantially Equivalent | |
| K981493 | MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 | CHH | Substantially Equivalent | |
| K972669 | MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON | CGA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015525148 | 3002698769 | Polymer Technology Systems | 4600 Anson Boulevard, Whitestown, IN 46075 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
- LCPAssay, Glycosylated Hemoglobin
- JGYColorimetric Method, Triglycerides
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- CGAGlucose Oxidase, Glucose
- LBRLdl & Vldl Precipitation, Hdl
- NAQLipoprotein, High Density, Hdl, Over The Counter
- OUGMedical Device Data System
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- NBWSystem, Test, Blood Glucose, Over The Counter
- MRRSystem, Test, Low Density, Lipoprotein
- NGOTest, Triglycerides, Over The Counter
- GIOTube, Collection, Capillary Blood
Recall records
Showing 25 of 27| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0223-2025 | 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, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge. | 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 test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy. | Class II | Completed | |
| Z-1741-2022 | PTS Panels CHOL+GLU Test Strips (REF 1765) | Incorrect instructions for use were packaged into the final product. | Class III | Completed | |
| Z-1438-2020 | 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 (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine. | The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-0835-2020 | Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411 | 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. | Class II | Terminated | |
| Z-0834-2020 | Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 | 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. | Class II | Terminated | |
| Z-0833-2020 | PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702 | 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. | Class II | Terminated | |
| Z-0832-2020 | 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. | Class II | Terminated | |
| Z-2158-2019 | Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds. | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | Class III | Terminated | |
| Z-2157-2019 | 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 in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds. | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | Class III | Terminated | |
| Z-1373-2019 | CHOL+HDL+GLU test strips, REF 2412 | 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 | Class II | Terminated | |
| Z-1372-2019 | Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412 | 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 di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412 | Class II | Terminated | |
| Z-1371-2019 | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 | 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. | Class II | Terminated | |
| Z-1543-2018 | 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) | Class II | Terminated | |
| Z-0686-2020 | CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 | 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. | Class II | Terminated | |
| Z-0685-2020 | ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 | 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. | Class II | Terminated | |
| Z-0684-2020 | Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 | 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. | Class II | Terminated | |
| Z-0683-2020 | A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062 | 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. | Class II | Terminated | |
| Z-0682-2020 | 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. | Class II | Terminated | |
| Z-0741-2020 | 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. | Class II | Terminated | |
| Z-1403-2013 | 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. | Class II | Terminated | |
| Z-1903-2012 | 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 the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample | 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. | Class II | Terminated | |
| Z-2641-2010 | 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. | Terminated | ||
| Z-1012-2010 | 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 frequency of occurrence. | Terminated | ||
| Z-1136-2010 | 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. | Terminated | ||
| Z-0871-2010 | 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 measurement of total cholesterol in whole blood. | The memory chip was coded with incorrect product information. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain