Cleared Traditional

LACTIC DEHYDROGENASE (VV) REAGENT SET (K855157) - FDA 510(k) Clearance

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

K855157 · Technostics Intl. · Chemistry device
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Jan 1986
Decision
26d
Days
Class 2
Risk

K855157 is an FDA 510(k) clearance for the LACTIC DEHYDROGENASE (VV) 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 21, 1986 after a review of 26 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

Submission Details

510(k) Number K855157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 21, 1986
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
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 26
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K855157.
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
K863477 · Em Diagnostic Systems, Inc. · Sep 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · Em Diagnostic Systems, Inc. · Sep 1986
LDH (OPTIMIZED) REAGENT
K860029 · Sigma Chemical Co. · Feb 1986
ULTRAZYME PLUS & SYSTEMATE LDH
K854585 · Em Diagnostic Systems, Inc. · Dec 1985
SYSTEMATE LDH, 67210
K843269 · Em Diagnostic Systems, Inc. · Sep 1984
SIGMS PROCED. 228 UV LACTATE DEHYDRO
K841917 · Sigma Diagnostics, Inc. · Jun 1984