Cleared Traditional

OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT (K922885) - FDA 510(k) Clearance

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

K922885 · Olympus Corp. · Chemistry device
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Jul 1992
Decision
42d
Days
Class 2
Risk

K922885 is an FDA 510(k) clearance for the OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on July 28, 1992 after a review of 42 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 Olympus Corp. devices

Submission Details

510(k) Number K922885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1992
Decision Date July 28, 1992
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 44
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K922885.
ROCHE REAGENT FOR AST
K924244 · Roche Diagnostic Systems, Inc. · Jan 1993
IL TEST AST, PN 35312
K923641 · Instrumentation Laboratory CO · Oct 1992
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
K922857 · Em Diagnostic Systems, Inc. · Sep 1992
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
K920336 · Heraeus Kulzer, Inc. · Mar 1992
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
K914463 · Em Diagnostic Systems, Inc. · Jan 1992
TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
K914025 · Technicon Instruments Corp. · Nov 1991