Cleared Traditional

K923257 - EMDS ALANINE AMINOTRANSFER TEST(ALT) TE...

K923257 is the FDA 510(k) clearance for EMDS ALANINE AMINOTRANSFER TEST(ALT) TE... by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K923257 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1992
Decision
88d
Days
Class 1
Risk

K923257 is an FDA 510(k) clearance for the EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000. 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 28, 1992 after a review of 88 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 K923257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1992
Decision Date September 28, 1992
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
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 K923257.
OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT
K925339 · Olympus Corp. · Feb 1993
ALT (GPT) - ALANINE AMINOTRANSFERASE
K923510 · Randox Laboratories, Ltd. · Nov 1992
ROCHE REAGENT FOR ALT
K924245 · Roche Diagnostic Systems, Inc. · Oct 1992
IL TEST ALT, PN 35311
K923623 · Instrumentation Laboratory CO · Sep 1992
OLYMPUS ALANINE AMINOTRANSFERASE REAGENT
K922884 · Olympus Corp. · Jul 1992
KING DIAGNOSTICS ALT (GPT) REAGENT
K922109 · King Diagnostics, Inc. · Jun 1992