Cleared Traditional

K803216 - CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT

K803216 is an FDA 510(k) clearance for CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT, manufactured by Union Carbide Corp.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K803216 · Union Carbide Corp. · Chemistry device
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Jan 1981
Decision
22d
Days
Class 2
Risk

K803216 is an FDA 510(k) clearance for the CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981 after a review of 22 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K803216

510(k) Number K803216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1980
Decision Date January 09, 1981
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 110
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K803216.
ULTRA ZYME PLUS GOT #64953, 65033 & 34
K812592 · Harleco · Sep 1981
GOT ISOENZYME ASSAY EIKEN KIT
K802447 · Syn-Kit, Inc. · Apr 1981
AST (UV) TEST
K810390 · Boehringer Mannheim Corp. · Feb 1981
DATA-ZYME AST(GOT) PROCEDURE
K801856 · Data Medical Associates, Inc. · Sep 1980
CENTRIFI CHEM AST/SGOT
K800641 · Union Carbide Corp. · Apr 1980
DURAZYME GOT/AST
K800116 · American Monitor Corp. · Feb 1980