Cleared Traditional

S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (K091544) - FDA 510(k) Clearance

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

K091544 · Alfa Wassermann, Inc. · Chemistry device
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Sep 2009
Decision
105d
Days
Class 2
Risk

K091544 is an FDA 510(k) clearance for the S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Alfa Wassermann, Inc. (West Caldwell, US). The FDA issued a Cleared decision on September 9, 2009 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - 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, Inc. devices

Submission Details

510(k) Number K091544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2009
Decision Date September 09, 2009
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
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 - CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

All 110
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K091544.
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · Abbott Laboratories · Jun 1988
TDX REA LDH
K841703 · Abbott Laboratories · Jun 1984
LD-L TRIS SYSTEM PACK TEST
K820378 · Boehringer Mannheim Corp. · Mar 1982
SINGLE VIAL LDH-L TRIS
K781538 · Boehringer Mannheim Corp. · Oct 1978
SINGLE VIAL LACTATE
K780563 · Boehringer Mannheim Corp. · Apr 1978
MULTISTAT III LACTIC DEHYDROGENASE
K771465 · Instrumentation Laboratory CO · Sep 1977