Cleared Traditional

K770314 - REAGENT GPT, ENZYME

K770314 is an FDA 510(k) clearance for REAGENT GPT, manufactured by Icn Pharmaceuticals, Inc.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K770314 · Icn Pharmaceuticals, Inc. · Chemistry device
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Mar 1977
Decision
42d
Days
Class 1
Risk

K770314 is an FDA 510(k) clearance for the REAGENT GPT, ENZYME. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Icn Pharmaceuticals, Inc. (Orangeburg, US). The FDA issued a Cleared decision on March 30, 1977 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icn Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K770314

510(k) Number K770314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1977
Decision Date March 30, 1977
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

CKA Device Classification - Class 1, General Controls

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 116
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K770314.
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466 · Instrumentation Laboratory CO · Sep 1977
SERUM GLUTAMIC PYRUVIC TRANSAMINASE
K770991 · Macomb Chemical Co. · Aug 1977
ULTRAZYME PLUS GPT
K770882 · Harleco · Jul 1977
GEMENI GPT (ALT) ASSAY
K761269 · Electro-Nucleonics Laboratories, Inc. · Dec 1976
NDC#12739-0010-1 C-ZYME GPT
K760194 · Coulter Electronics, Inc. · Aug 1976