Cleared Traditional

LACTATE DEHYDROGENASE (K771836) - FDA 510(k) Clearance

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

K771836 · Gamma Enterprises, Inc. · Chemistry device
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Nov 1977
Decision
62d
Days
Class 2
Risk

K771836 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Gamma Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1977 after a review of 62 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 Gamma Enterprises, Inc. devices

Submission Details

510(k) Number K771836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1977
Decision Date November 22, 1977
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
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 23
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K771836.
SINGLE VIAL LDH-L TRIS
K781538 · Boehringer Mannheim Corp. · Oct 1978
SINGLE VIAL LACTATE
K780563 · Boehringer Mannheim Corp. · Apr 1978
LACTATE DEHYDROGENASE
K780041 · Beckman Instruments, Inc. · Feb 1978
MULTISTAT III LACTIC DEHYDROGENASE
K771465 · Instrumentation Laboratory CO · Sep 1977