Cleared Traditional

K954839 - ASPARTATE AMINOTRANSFERASE PROCEDURE NO...

K954839 is the FDA 510(k) clearance for ASPARTATE AMINOTRANSFERASE PROCEDURE NO... by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K954839 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
77d
Days
Class 2
Risk

K954839 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 77 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K954839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1995
Decision Date January 05, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
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 104
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K954839.
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
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AST INCORPORATING DST
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ROCHE COBAS INTEGRA REAGENT CASSETTES
K954992 · Roche Diagnostic Systems, Inc. · Jan 1996
ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
K952743 · Medical Diagnostic Technologies, Inc. · Sep 1995
HICHEM AST REAGENT KIT
K951751 · Hichem Diagnostics · Aug 1995
LIQUID AST (SGOT)REAGENT SET
K941132 · Pointe Scientific, Inc., · May 1994