Cleared Traditional

K855159 - LACTIC DEHYDROGENASE REAGENT SET

K855159 is an FDA 510(k) clearance for LACTIC DEHYDROGENASE REAGENT SET, manufactured by Technostics Intl.. The device is a Class 2 Chemistry device with product code CFJ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K855159 · Technostics Intl. · Chemistry device
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Jan 1986
Decision
19d
Days
Class 2
Risk

K855159 is an FDA 510(k) clearance for the LACTIC DEHYDROGENASE REAGENT SET. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 19 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 Technostics Intl. devices

FDA 510(k) Submission Details - K855159

510(k) Number K855159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 14, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFJ Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K855159.
LDH-P (LACTIC DEHYDROGENASE) REAGENT
K860729 · Trace Scientific , Ltd. · Apr 1986
LDH (OPTIMIZED) REAGENT
K860029 · Sigma Chemical Co. · Feb 1986
LACTIC DEHYDROGENASE (VV) REAGENT SET
K855157 · Technostics Intl. · Jan 1986
ULTRAZYME PLUS & SYSTEMATE LDH
K854585 · Em Diagnostic Systems, Inc. · Dec 1985
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
K852948 · Amresco, Inc. · Aug 1985
LD-L REAGENT
K851996 · Alpkem Corp. · May 1985