Cleared Traditional

K926362 - GLUCOSTIX REAGENT STRIPS

K926362 is an FDA 510(k) clearance for GLUCOSTIX REAGENT STRIPS, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K926362 · Heraeus Kulzer, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Nov 1993
Decision
324d
Days
Class 2
Risk

K926362 is an FDA 510(k) clearance for the GLUCOSTIX REAGENT STRIPS. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Mishawaka, US). The FDA issued a Cleared decision on November 10, 1993 after a review of 324 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K926362

510(k) Number K926362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date November 10, 1993
Days to Decision 324 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
236d slower than avg
Panel avg: 88d · This submission: 324d
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 K926362.
GLUCOFILM TEST STRIPS
K936212 · Heraeus Kulzer, Inc. · May 1994
RELIEF PLUS ONE REAGENT STRIP MODIFICATION
K934892 · Diagnostic Solutions, Inc. · Jan 1994
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
K934898 · Heraeus Kulzer, Inc. · Dec 1993
CHOLESTECH L.D.X. SYSTEM
K932727 · Cholestech Corp. · Nov 1993
GLUCOFILM TEST STRIPS
K926360 · Heraeus Kulzer, Inc. · Sep 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979 · Boehringer Mannheim Corp. · Sep 1993