Skip to content

CardioChek Plus Test System, CardioChek Home Test System

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

510(k) K162282

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK162282 Date22 Dec 2016ClearedStatusActive

Recalls

2 recalls · FDA

    • Completed Z-1741-2022 FDA Class III initiated 16 Aug 2022

    Incorrect instructions for use were packaged into the final product.

    • Terminated Z-0741-2020 FDA Class II initiated 15 Mar 2016 on shared 510(k) K162282

    This lot of test strips is showing an under-recovery when tested against a reference method.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CardioChek Plus Test System and CardioChek Home Test System are point-of-care diagnostic analyzers designed for measuring blood chemistry values, including glucose, cholesterol, and HDL. These devices utilize glucose oxidase chemistry to provide quantitative results from small blood samples, enabling rapid clinical assessments in non-laboratory settings.

These systems are intended for single-use or reusable configurations, depending on the model, and are supplied with test strips, quality controls, and optional communication tools for data management. They are classified as Class II devices under FDA regulations (21 CFR 862.1345) and require FDA 510(k) clearance for use in clinical chemistry applications. The CardioChek Plus Test System is designed for professional settings, while the CardioChek Home Test System is intended for home use, with both adhering to regulatory standards for accuracy and safety.

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

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CardioChek Plus Test System used for?

    The CardioChek Plus Test System is a point-of-care diagnostic analyzer designed for measuring blood chemistry values, including glucose, cholesterol, and HDL, using glucose oxidase chemistry to provide quantitative results from small blood samples in non-laboratory settings.

  • Is the CardioChek Test System single-use or reusable?

    The CardioChek Test System is available in both single-use and reusable configurations depending on the model, with the CardioChek Plus designed for professional settings and the CardioChek Home Test System intended for home use.

  • What is included with the CardioChek Test System?

    The CardioChek Test System is supplied with test strips, quality controls, and optional communication tools for data management, providing a complete solution for blood chemistry analysis in various settings.

  • How is the CardioChek Test System classified for regulatory purposes?

    The CardioChek Test System is classified as a Class II device under FDA regulations (21 CFR 862.1345) and requires FDA 510(k) clearance for use in clinical chemistry applications, ensuring it meets regulatory standards for accuracy and safety.