Cleared Traditional

K800116 - DURAZYME GOT/AST

K800116 is the FDA 510(k) clearance for DURAZYME GOT/AST by American Monitor Corp.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K800116 · American Monitor Corp. · Chemistry device
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Feb 1980
Decision
26d
Days
Class 2
Risk

K800116 is an FDA 510(k) clearance for the DURAZYME GOT/AST. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 26 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 American Monitor Corp. devices

Submission Details

510(k) Number K800116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1980
Decision Date February 13, 1980
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
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 106
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K800116.
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
K803216 · Union Carbide Corp. · Jan 1981
DATA-ZYME AST(GOT) PROCEDURE
K801856 · Data Medical Associates, Inc. · Sep 1980
CENTRIFI CHEM AST/SGOT
K800641 · Union Carbide Corp. · Apr 1980
ASI REAGENT
K800065 · Gilford Diagnostics · Feb 1980
DURAZYME GOT/AST
K792208 · American Monitor Corp. · Nov 1979
NADH OXIDATION, AST/SGOT
K791679 · American Monitor Corp. · Sep 1979