Cleared Traditional

K113382 - ACE ALT REAGENT

K113382 is an FDA 510(k) clearance for ACE ALT REAGENT, manufactured by Alfa Wassermann. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K113382 · Alfa Wassermann · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
246d
Days
Class 1
Risk

K113382 is an FDA 510(k) clearance for the ACE ALT REAGENT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Alfa Wassermann (West Caldwell, US). The FDA issued a Cleared decision on July 19, 2012 after a review of 246 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Wassermann devices

FDA 510(k) Submission Details - K113382

510(k) Number K113382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2011
Decision Date July 19, 2012
Days to Decision 246 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 88d · This submission: 246d
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 K113382.
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CARESIDE ALT
K020487 · Careside, Inc. · Jun 2002
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K980028 · Trace America, Inc. · Feb 1998
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K973869 · Trace America, Inc. · Jan 1998
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
K974003 · Diagnostic Chemicals , Ltd. · Dec 1997