Cleared Traditional

AST ASPARTATE AMINOTRANSFERASE REAGENT (K851994) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851994 · Alpkem Corp. · Chemistry device
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Jun 1985
Decision
27d
Days
Class 2
Risk

K851994 is an FDA 510(k) clearance for the AST ASPARTATE AMINOTRANSFERASE REAGENT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on June 3, 1985 after a review of 27 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 Alpkem Corp. devices

Submission Details

510(k) Number K851994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date June 03, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 36
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K851994.
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094 · Em Diagnostic Systems, Inc. · Aug 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465 · Abbott Laboratories · May 1986
VISION SGOT (AST)
K854982 · Abbott Laboratories · Jan 1986
ROCHE REAGENT FOR AST
K843109 · Roche Diagnostic Systems, Inc. · Nov 1984
SYSTEMATE GOT 67208
K843333 · Em Diagnostic Systems, Inc. · Sep 1984
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
K842411 · Sigma Chemical Co. · Aug 1984