510(k) Report

FDA applicant

Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

Indianapolis, IN3 decisions2016–20223 recalls

FDA records 3 decisions for Polymer Technology Systems, Inc. D/B/A Pts Diagnostics (Indianapolis, IN) from 2016 to 2022: 3 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 6 predicates, 0 of them its own earlier devices. 3 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. D/B/A Pts Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 12018: 12022: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2022

2016: 12019: 12022: 1
2016high 1 (2016) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Polymer Technology Systems, Inc. D/B/A Pts Diagnostics by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Polymer Technology Systems, Inc. D/B/A…’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?

  • CGAGlucose Oxidase, Glucose2decisions
  • NBWSystem, Test, Blood Glucose, Over The Counter1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2022
  • K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 20181 recall
  • K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 20162 recalls

All 3 as Polymer Technology Systems, Inc. D/B/A Pts Diagnostics →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K162282PTS Panels CHOL+GLU Test Strips (REF 1765)Aug 16, 2022Class III
  • K182781CHOL+HDL+GLU test strips, REF 2412Jan 16, 2019Class II
  • K162282PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or…Mar 15, 2016Class II

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 Systems, Inc. 27Polymer Technology Intl. 6Polymer Technology Div. Wilmington Partners, L.P. 3Polymer Technologies 1