Cleared Traditional

K903198 - ALANINE AMINOTRANSFERASE TEST

K903198 is the FDA 510(k) clearance for ALANINE AMINOTRANSFERASE TEST by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K903198 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1990
Decision
55d
Days
Class 1
Risk

K903198 is an FDA 510(k) clearance for the ALANINE AMINOTRANSFERASE TEST. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 12, 1990 after a review of 55 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K903198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1990
Decision Date September 12, 1990
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 97
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K903198.
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464 · Em Diagnostic Systems, Inc. · Nov 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
K913846 · Em Diagnostic Systems, Inc. · Sep 1991
COULTER DART ALT (GPT) REAGENT
K905767 · Coulter Electronics, Inc. · Jan 1991
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K901702 · American Research Products Co. · Apr 1990
TECHNICON AXON SYSTEM REAGENT METHODS
K900905 · Technicon Instruments Corp. · Apr 1990
PARAMAX ALANINE AMINOTRANSFERASE REAGENT
K901105 · Baxter Healthcare Corp · Mar 1990