Cleared Traditional

K922035 - GLUCOSE 3

K922035 is an FDA 510(k) clearance for GLUCOSE 3, manufactured by Caro Med, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K922035 · Caro Med, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
145d
Days
Class 2
Risk

K922035 is an FDA 510(k) clearance for the GLUCOSE 3. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Caro Med, Inc. (Chester, US). The FDA issued a Cleared decision on September 23, 1992 after a review of 145 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Caro Med, Inc. devices

FDA 510(k) Submission Details - K922035

510(k) Number K922035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date September 23, 1992
Days to Decision 145 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 88d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
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 - CGA Glucose Oxidase, Glucose

All 313
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K922035.
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
K923048 · Boehringer Mannheim Corp. · Oct 1992
ACCUDATA GLUCOSE TEST STATION
K924475 · Boehringer Mannheim Corp. · Oct 1992
IL TEST GLUCOSE, PN 181633-80
K922532 · Instrumentation Laboratory CO · Sep 1992
ONE TOUCH IIB BLOOD GLUCOSE METER
K922888 · Lifescan, Inc. · Sep 1992
QUICK-CHECK II REAGENT STRIP
K921825 · Diagnostic Solutions, Inc. · Aug 1992
ULTRA+ BLOOD GLUCOSE TEST STRIP
K915770 · Home Diagnostics, Inc. · Apr 1992