Cleared Traditional

K965126 - AST/SGOT

K965126 is an FDA 510(k) clearance for AST/SGOT, manufactured by Derma Media Lab., Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K965126 · Derma Media Lab., Inc. · Chemistry device
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Jan 1997
Decision
25d
Days
Class 2
Risk

K965126 is an FDA 510(k) clearance for the AST/SGOT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 25 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 Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K965126

510(k) Number K965126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1996
Decision Date January 17, 1997
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
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 K965126.
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980030 · Trace America, Inc. · Jan 1998
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
K974001 · Diagnostic Chemicals , Ltd. · Nov 1997
AST OR SGOT
K971344 · Carolina Liquid Chemistries Corp. · Apr 1997
AST INCORPORATING DST
K961114 · Trace Scientific , Ltd. · May 1996
ROCHE COBAS INTEGRA REAGENT CASSETTES
K954992 · Roche Diagnostic Systems, Inc. · Jan 1996
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
K954839 · Sigma Diagnostics, Inc. · Jan 1996