Cleared Traditional

UNI-CHECK REAGENT STRIP (K924398) - FDA 510(k) Clearance

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

K924398 · Diagnostic Solutions, Inc. · Chemistry device
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Dec 1992
Decision
114d
Days
Class 2
Risk

K924398 is an FDA 510(k) clearance for the UNI-CHECK REAGENT STRIP. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Diagnostic Solutions, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 114 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 Diagnostic Solutions, Inc. devices

Submission Details

510(k) Number K924398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date December 23, 1992
Days to Decision 114 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
26d slower than avg
Panel avg: 88d · This submission: 114d
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 59
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K924398.
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
K952875 · Boehringer Mannheim Corp. · Nov 1995
SIGMA GLUCOSE REAGENT
K933694 · Sigma Chemical Co. · Nov 1994
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979 · Boehringer Mannheim Corp. · Sep 1993
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