Cleared Traditional

K925551 - HI CHEM GLUCOSE REAGENT KIT

K925551 is the FDA 510(k) clearance for HI CHEM GLUCOSE REAGENT KIT by Hichem Diagnostics. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K925551 · Hichem Diagnostics · Chemistry device
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Apr 1993
Decision
168d
Days
Class 2
Risk

K925551 is an FDA 510(k) clearance for the HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 168 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.

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Submission Details

510(k) Number K925551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date April 20, 1993
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 196
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K925551.
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GLUCOMETER M+ BLOOD GLUCOSE METER
K931310 · Heraeus Kulzer, Inc. · Jun 1993
ELITE TEST STRIPS GLUCOMETER
K924499 · Heraeus Kulzer, Inc. · Dec 1992
ONE TOUCH TEST STRIPS
K923544 · Lifescan, Inc. · Dec 1992
NOVA 12 ANALYZER, MODIFICATION
K924743 · Nova Biomedical Corp. · Nov 1992