Cleared Traditional

K854503 - AST(OPTIMIZED) REAGENT

K854503 is the FDA 510(k) clearance for AST(OPTIMIZED) REAGENT by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K854503 · Sigma Diagnostics, Inc. · Chemistry device
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Nov 1985
Decision
13d
Days
Class 2
Risk

K854503 is an FDA 510(k) clearance for the AST(OPTIMIZED) REAGENT. 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 November 25, 1985 after a review of 13 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 K854503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date November 25, 1985
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
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 K854503.
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K860725 · Trace Scientific , Ltd. · Apr 1986
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
K860667 · Sterling Diagnostics, Inc. · Apr 1986
VISION SGOT (AST)
K854982 · Abbott Laboratories · Jan 1986
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851865 · Amresco, Inc. · May 1985
GEMENI AST-LTS REAGENTS
K851267 · Electro-Nucleonics Laboratories, Inc. · Apr 1985
ROCHE REAGENT FOR AST
K843109 · Roche Diagnostic Systems, Inc. · Nov 1984