Cleared Traditional

K770318 - REAGENT GOT, ENZYME

K770318 is an FDA 510(k) clearance for REAGENT GOT, manufactured by Icn Pharmaceuticals, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K770318 · Icn Pharmaceuticals, Inc. · Chemistry device
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Apr 1977
Decision
48d
Days
Class 2
Risk

K770318 is an FDA 510(k) clearance for the REAGENT GOT, ENZYME. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Icn Pharmaceuticals, Inc. (Orangeburg, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 - K770318

510(k) Number K770318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1977
Decision Date April 05, 1977
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 130
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K770318.
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE
K780013 · Macomb Chemical Co. · Jan 1978
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
K772029 · Harleco · Nov 1977
DYNA ZYME II GOT 340
K771153 · J.T. Baker Chemical Co. · Nov 1977
NDC#12739-0011-1 C-ZYME GOT
K760193 · Coulter Electronics, Inc. · Aug 1976
COLORIMETRIC DETERMINATION (SGOT/SGPT)
K760010 · The Dow Chemical Co. · Jul 1976