Cleared Traditional

CardioChek Plus Test System (K193406) - FDA 510(k) Clearance

Also marketed or referenced as:
CardioChek Plus Home Test System

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193406 · Polymer Technology Systems, Inc. D/B/A Pts Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
810d
Days
Class 2
Risk

K193406 is an FDA 510(k) clearance for the CardioChek Plus Test System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics (Whitestown, US). The FDA issued a Cleared decision on February 26, 2022 after a review of 810 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

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

Submission Details

510(k) Number K193406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2019
Decision Date February 26, 2022
Days to Decision 810 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
722d slower than avg
Panel avg: 88d · This submission: 810d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 165
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K193406.
IWL2020 Blood Glucose Monitoring System
K203711 · Roche Diabetes Care, Inc. · May 2022
MTM301 Blood Glucose and Ketone Monitoring System
K202534 · Apex BioTechnology Corp. · Apr 2022
GAL-1A Plus Blood Glucose Monitoring System
K213887 · Apex BioTechnology Corp. · Mar 2022
Contour® next GEN Blood Glucose Monitoring System
K193407 · Ascensia Diabetes Care · Dec 2021
MultiSure GK Link Blood Glucose and Ketone Monitoring System
K201880 · Apex BioTechnology Corp. · Oct 2021
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
K201394 · I-Sens, Inc. · Oct 2021