Cleared Traditional

MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD (K920335) - FDA 510(k) Clearance

Class I Chemistry device.

K920335 · Heraeus Kulzer, Inc. · Chemistry device
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Mar 1992
Decision
60d
Days
Class 1
Risk

K920335 is an FDA 510(k) clearance for the MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 24, 1992 after a review of 60 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K920335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1992
Decision Date March 24, 1992
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
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 42
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K920335.
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ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464 · Em Diagnostic Systems, Inc. · Nov 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
K913846 · Em Diagnostic Systems, Inc. · Sep 1991
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K903198 · Em Diagnostic Systems, Inc. · Sep 1990