Company ยท US
Polymer Technology Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2016. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
25recalls (0 in 12 months)
24recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 14 |
| NBW | System, Test, Blood Glucose, Over The Counter | 14 |
| CGA | Glucose Oxidase, Glucose | 6 |
| LCP | Assay, Glycosylated Hemoglobin | 5 |
| JFY | Enzymatic Method, Creatinine | 2 |
| JGY | Colorimetric Method, Triglycerides | 2 |
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | 2 |
| MRR | System, Test, Low Density, Lipoprotein | 2 |
| NAQ | Lipoprotein, High Density, Hdl, Over The Counter | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
| MRS | Test System, Nicotine, Cotinine, Metabolites | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2016 | K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System Polymer Technology Systems, Inc. | CHH |
| Jul 7, 2015 | K151530 | CardioChek Plus Test System Polymer Technology Systems, Inc. | CGA |
| May 22, 2015 | K140068 | CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM Polymer Technology Systems, Inc. | NBW |
| Oct 2, 2014 | K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANE Polymer Technology Systems, Inc. | CGA |
| Oct 15, 2007 | K071593 | PTS PANELS CHOL+HDL PANEL TEST STRIPS Polymer Technology Systems, Inc. | CHH |
| Sep 10, 2007 | K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS Polymer Technology Systems, Inc. | NBW |
| Jan 31, 2007 | K070017 | PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS Polymer Technology Systems, Inc. | NBW |
| Apr 5, 2006 | K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS Polymer Technology Systems, Inc. | NAQ |
| Jul 23, 2004 | K041750 | PTS PANELS CHOL+GLU TEST PANEL Polymer Technology Systems, Inc. | NBW |
| Jul 6, 2004 | K040693 | PTS PANELS LDL CHOLESTEROL TEST STRIPS Polymer Technology Systems, Inc. | MRR |
| Nov 15, 2002 | K023558 | PTS PANELS LIPID PANEL TEST STRIPS Polymer Technology Systems, Inc. | CHH |
| Sep 24, 2002 | K022898 | PTS PANELS LIPID PANEL TEST STRIPS Polymer Technology Systems, Inc. | CHH |
| Aug 21, 2002 | K022401 | PTS PANELS MULTI-CHEMISTRY CONTROLS Polymer Technology Systems, Inc. | JJY |
| Dec 21, 2001 | K014099 | BIOSCANNER PLUS Polymer Technology Systems, Inc. | NBW |
| Nov 20, 2001 | K013068 | BIOSCANNER 2000 Polymer Technology Systems, Inc. | CGA |
| Nov 16, 2001 | K013203 | BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS Polymer Technology Systems, Inc. | NBW |
| Oct 22, 2001 | K013173 | BIOSCANNER PLUS; LIPID PANEL TEST STRIPS Polymer Technology Systems, Inc. | CHH |
| Jun 20, 2001 | K010456 | BIOSCANNER CREATININE TEST STRIPS Polymer Technology Systems, Inc. | JFY |
| Jul 3, 2000 | K000586 | BIOSCANNER TRIGLYCERIDES TEST STRIPS Polymer Technology Systems, Inc. | JGY |
| May 24, 2000 | K991894 | BIOSCANNER TRIGLYCERIDES TEST STRIPS Polymer Technology Systems, Inc. | JGY |
| Jan 13, 2000 | K993377 | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) Polymer Technology Systems, Inc. | NAQ |
| Dec 27, 1999 | K983860 | MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 Polymer Technology Systems, Inc. | JMK |
| Jun 24, 1999 | K990688 | MTM BIOSCANNER C TEST STRIPS Polymer Technology Systems, Inc. | CHH |
| May 28, 1999 | K990247 | MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 Polymer Technology Systems, Inc. | LBR |
| Feb 26, 1999 | K981865 | MTM BIOSCANNER K TEST STRIPS Polymer Technology Systems, Inc. | JMK |
| Jul 22, 1998 | K981493 | MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 Polymer Technology Systems, Inc. | CHH |
| Jan 22, 1998 | K972669 | MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON Polymer Technology Systems, Inc. | CGA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2020 | Polymer Technology Systems, Inc. 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 n Terminated |
MRS | None listed |
| Dec 2, 2019 | Polymer Technology Systems, Inc. Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411 Terminated |
NBW | K140068 |
| Dec 2, 2019 | Polymer Technology Systems, Inc. Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 Terminated |
NBW | K140068 |
| Dec 2, 2019 | Polymer Technology Systems, Inc. PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702 Terminated |
NBW | K140068 |
| Dec 2, 2019 | Polymer Technology Systems, Inc. PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700 Terminated |
NBW | K140068 |
| Jun 7, 2019 | Polymer Technology Systems, Inc. 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 lipoprote Terminated |
CHH | K151545 |
| Jun 7, 2019 | Polymer Technology Systems, Inc. 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) cholester Terminated |
CHH | K151545 |
| Jan 16, 2019 | Polymer Technology Systems, Inc. CHOL+HDL+GLU test strips, REF 2412 Terminated |
CGA | K071507 K182781 |
| Jan 16, 2019 | Polymer Technology Systems, Inc. Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412 Terminated |
CHH | K023558 |
| Jan 16, 2019 | Polymer Technology Systems, Inc. Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 Terminated |
CHH | K013173 |
| Mar 14, 2018 | Polymer Technology Systems, Inc. PTS Panels CHOL+GLU Test Strips (REF 1765) Terminated |
NBW | K041750 |
| Dec 2, 2016 | Polymer Technology Systems CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 Terminated |
LCP | K090413 |
| Dec 2, 2016 | Polymer Technology Systems ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 Terminated |
LCP | K090413 |
| Dec 2, 2016 | Polymer Technology Systems Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 Terminated |
LCP | K090413 |
| Dec 2, 2016 | Polymer Technology Systems A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062 Terminated |
LCP | K090413 |
| Dec 2, 2016 | Polymer Technology Systems A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024;
EU: 3037, 3038, 3057, 3058 Terminated |
LCP | K090413 |
| Mar 15, 2016 | Polymer Technology Systems, Inc. PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers Terminated |
NBW | K071507 K162282 |
| May 25, 2013 | Polymer Technology Systems, Inc. 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 Terminated |
NBW | K013068 |
| Jun 28, 2012 | Polymer Technology Systems, Inc. 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 (kidne Terminated |
JFY | K010456 |
| Sep 30, 2010 | Polymer Technology Systems, Inc. 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. Terminated |
NBW | K071507 |
| Apr 2, 2010 | Polymer Technology Systems, Inc. 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 meas Terminated |
CHH | K071593 |
| Mar 15, 2010 | Polymer Technology Systems, Inc. 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. Terminated |
CHH | K022898 K023558 |
| Mar 15, 2010 | Polymer Technology Systems, Inc. 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 quantitativ Terminated |
MRR | K040693 |
| Mar 5, 2010 | Polymer Technology Systems, Inc. PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN. Terminated |
CGA | K071507 |
| Mar 1, 2010 | Polymer Technology Systems, Inc. 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 provi Terminated |
CHH | K981493 K990688 |