Cleared Traditional

K974003 - ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30

K974003 is an FDA 510(k) clearance for ALANINE AMINOTRANSFERASE-SL ASSAY CATAL..., manufactured by Diagnostic Chemicals , Ltd.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K974003 · Diagnostic Chemicals , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
45d
Days
Class 1
Risk

K974003 is an FDA 510(k) clearance for the ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on December 5, 1997 after a review of 45 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 Diagnostic Chemicals , Ltd. devices

FDA 510(k) Submission Details - K974003

510(k) Number K974003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1997
Decision Date December 05, 1997
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

CKA Device Classification - Class 1, General Controls

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 117
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K974003.
CARESIDE ALT
K020487 · Careside, Inc. · Jun 2002
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980028 · Trace America, Inc. · Feb 1998
TRACE REAGENT LINE FOR THE COBAS MIRA
K973869 · Trace America, Inc. · Jan 1998
ALT OR SGPT
K971323 · Carolina Liquid Chemistries Corp. · Apr 1997
ALT/SGPT
K965134 · Derma Media Lab., Inc. · Feb 1997
ALT INCORPORATING DST
K961123 · Trace Scientific , Ltd. · Apr 1996