Cleared Traditional

K892844 - AST REAGENT (PROCEDURE NUMBER 158)

K892844 is the FDA 510(k) clearance for AST REAGENT (PROCEDURE NUMBER 158) by Sigma Chemical Co.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K892844 · Sigma Chemical Co. · Chemistry device
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Jun 1989
Decision
63d
Days
Class 2
Risk

K892844 is an FDA 510(k) clearance for the AST REAGENT (PROCEDURE NUMBER 158). Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 63 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 Chemical Co. devices

Submission Details

510(k) Number K892844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date June 20, 1989
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 K892844.
COBAS READY LIVER PROFILE REAGENT STRIP
K896233 · Roche Diagnostic Systems, Inc. · Feb 1990
ASPARTATE AMINOTRANFERASE (AST)
K896000 · American Monitor Corp. · Jan 1990
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
K894180 · Abbott Laboratories · Sep 1989
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891468 · Trace Scientific , Ltd. · May 1989
ASPARTATE AMINOTRANSFERASE (AST)
K884724 · Catachem, Inc. · Mar 1989
CLINISTAT SGOT (AST) REAGENT TEST
K885156 · Heraeus Kulzer, Inc. · Feb 1989