Cleared Traditional

K780505 - SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE

K780505 is the FDA 510(k) clearance for SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE by Gamma Enterprises, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K780505 · Gamma Enterprises, Inc. · Chemistry device
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May 1978
Decision
34d
Days
Class 2
Risk

K780505 is an FDA 510(k) clearance for the SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Gamma Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978 after a review of 34 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 Gamma Enterprises, Inc. devices

Submission Details

510(k) Number K780505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1978
Decision Date May 03, 1978
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 110
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K780505.
REAGENT SET, U.V. ENZMATIC KINETIC, SGOT
K781725 · Medical Analysis Systems, Inc. · Nov 1978
SINGLE VIAL 10 SGOT-TRIS
K780634 · Boehringer Mannheim Corp. · May 1978
AST(GOT) UNI-UV, SGOT
K780463 · Sclavo, Inc. · May 1978
SGOT/AST REAGENT SYSTEM
K780443 · American Monitor Corp. · Apr 1978
ULTRAZYME PLUS GOT
K780103 · Harleco · Feb 1978
ASPARTATE TRANSAMINASE
K780039 · Beckman Instruments, Inc. · Jan 1978