Cleared Traditional

ALT (ALANINE AMINO-THRANSFERASE)REAGENT (K851995) - FDA 510(k) Clearance

Class I Chemistry device.

K851995 · Alpkem Corp. · Chemistry device
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May 1985
Decision
23d
Days
Class 1
Risk

K851995 is an FDA 510(k) clearance for the ALT (ALANINE AMINO-THRANSFERASE)REAGENT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on May 30, 1985 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 K851995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date May 30, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 32
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K851995.
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · Em Diagnostic Systems, Inc. · Nov 1986
TWIN GOT-AST IFCC/GPT-ALT IFCC
K861792 · Boehringer Mannheim Corp. · Jul 1986
VISION SGPT (ALT)
K861002 · Abbott Laboratories · Apr 1986
ROCHE REAGENT FOR ALT
K843111 · Roche Diagnostic Systems, Inc. · Oct 1984
SYSTEMATE GPT 67209
K843334 · Em Diagnostic Systems, Inc. · Sep 1984
SIGMA 59-UV FOR ALANINE AMINOTRANSFER
K842564 · Sigma Chemical Co. · Aug 1984