510(k) Report

FDA applicant

Polymer Technology Systems, Inc.

Indianapolis, IN27 decisions1998–201619 recalls

FDA records 27 decisions for Polymer Technology Systems, Inc. (Indianapolis, IN) from 1998 to 2016: 27 510(k) clearances. Most are in product codes CHH (Enzymatic Esterase--Oxidase, Cholesterol) and NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 40 predicates, 34 of them its own earlier devices. 19 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Polymer Technology Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 32014: 12015: 22016: 1
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

9in 2019

2008: 12009: 42010: 12012: 12013: 12016: 12018: 12019: 9
2007high 9 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Polymer Technology Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Polymer Technology Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CHHEnzymatic Esterase--Oxidase, Cholesterol7decisions
  • NBWSystem, Test, Blood Glucose, Over The Counter6decisions
  • CGAGlucose Oxidase, Glucose4decisions
  • NAQLipoprotein, High Density, Hdl, Over The Counter2decisions
  • JGYColorimetric Method, Triglycerides2decisions
  • JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase2decisions

Also: JJY (1), JFY (1), LBR (1), MRR (1).

Whose devices does it build on?

Its devices cite 40 predicates; 34 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 45 times; 34 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 20155cite it
  • K981493MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220Polymer Technology Systems, Inc. · 19984cite it
  • K023558PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 20024cite it
  • K013068Bioscanner 2000Polymer Technology Systems, Inc. · 20013cite it
  • K990688MTM Bioscanner C Test StripsPolymer Technology Systems, Inc. · 19993cite it
  • K972669MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner G Test Strip, Norman…Polymer Technology Systems, Inc. · 19983cite it

What has FDA decided for it lately?

  • K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test…Polymer Technology Systems, Inc. · 20162 recalls
  • K151530CardioChek Plus Test SystemPolymer Technology Systems, Inc. · 2015
  • K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 20154 recalls
  • K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test…Polymer Technology Systems, Inc. · 2014
  • K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 20071 recall
  • K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 20074 recalls
  • K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc. · 2007
  • K060617PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2006

All 27 as Polymer Technology Systems, Inc. →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K140068PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box…Dec 2, 2019Class II
  • K140068Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying…Dec 2, 2019Class II
  • K140068PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with…Dec 2, 2019Class II
  • K140068Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036Dec 2, 2019Class II
  • K151545PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product…Jun 7, 2019Class III
  • K151545Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number…Jun 7, 2019Class III

Other applicant names beginning “Polymer”

FDA records each applicant name separately; these may or may not be the same firm.

Polymer Technology Corp. 28Polymer Technology Intl. 6Polymer Technology Systems, Inc. D/B/A Pts Diagnostics 3Polymer Technology Div. Wilmington Partners, L.P. 3Polymer Technologies 1