Cleared Traditional

LACTATE DEHYDROGENASE REAGENT SET (K961431) - FDA 510(k) Clearance

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

K961431 · Pointe Scientific, Inc., · Chemistry device
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Jun 1996
Decision
49d
Days
Class 2
Risk

K961431 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE REAGENT SET. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on June 3, 1996 after a review of 49 days - a notably fast clearance cycle.

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: 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K961431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date June 03, 1996
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 K961431.
LACTATE DEHYDROGENASE (LD)
K935175 · Em Diagnostic Systems, Inc. · Dec 1993
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
K924703 · Em Diagnostic Systems, Inc. · Feb 1993
ABBOTT QUICKSTART LDH,#5A31
K914262 · Em Diagnostic Systems, Inc. · Oct 1991
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
K910640 · Em Diagnostic Systems, Inc. · Apr 1991
ROCHE REAGENT FOR LDH
K900121 · Roche Diagnostic Systems, Inc. · Mar 1990
COBAS READY LDH REAGENT
K896241 · Roche Diagnostic Systems, Inc. · Feb 1990