Cleared Traditional

K770991 - SERUM GLUTAMIC PYRUVIC TRANSAMINASE

K770991 is the FDA 510(k) clearance for SERUM GLUTAMIC PYRUVIC TRANSAMINASE by Macomb Chemical Co.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K770991 · Macomb Chemical Co. · Chemistry device
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Aug 1977
Decision
62d
Days
Class 1
Risk

K770991 is an FDA 510(k) clearance for the SERUM GLUTAMIC PYRUVIC TRANSAMINASE. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977 after a review of 62 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 Macomb Chemical Co. devices

Submission Details

510(k) Number K770991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1977
Decision Date August 02, 1977
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 102
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K770991.
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030 · Harleco · Nov 1977
DYNAZYME II GPT 340
K771152 · J.T. Baker Chemical Co. · Nov 1977
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466 · Instrumentation Laboratory CO · Sep 1977
ULTRAZYME PLUS GPT
K770882 · Harleco · Jul 1977
REAGENT GPT, ENZYME
K770314 · Icn Pharmaceuticals, Inc. · Mar 1977
GEMENI GPT (ALT) ASSAY
K761269 · Electro-Nucleonics Laboratories, Inc. · Dec 1976