Cleared Traditional

K926360 - GLUCOFILM TEST STRIPS

K926360 is an FDA 510(k) clearance for GLUCOFILM TEST 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 261-day FDA review.

K926360 · Heraeus Kulzer, Inc. · Chemistry device
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Sep 1993
Decision
261d
Days
Class 2
Risk

K926360 is an FDA 510(k) clearance for the GLUCOFILM TEST 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 September 8, 1993 after a review of 261 days - an extended review cycle.

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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K926360

510(k) Number K926360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date September 08, 1993
Days to Decision 261 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
173d slower than avg
Panel avg: 88d · This submission: 261d
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 K926360.
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
K934898 · Heraeus Kulzer, Inc. · Dec 1993
GLUCOSTIX REAGENT STRIPS
K926362 · Heraeus Kulzer, Inc. · Nov 1993
CHOLESTECH L.D.X. SYSTEM
K932727 · Cholestech Corp. · Nov 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979 · Boehringer Mannheim Corp. · Sep 1993
ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP
K922136 · Home Diagnostics, Inc. · Aug 1993
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K922137 · Home Diagnostics, Inc. · Aug 1993