Cleared Traditional

AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI (K852948) - FDA 510(k) Clearance

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

K852948 · Amresco, Inc. · Chemistry device
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Aug 1985
Decision
27d
Days
Class 2
Risk

K852948 is an FDA 510(k) clearance for the AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Amresco, Inc. (South Euclid, US). The FDA issued a Cleared decision on August 7, 1985 after a review of 27 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 Amresco, Inc. devices

Submission Details

510(k) Number K852948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1985
Decision Date August 07, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 K852948.
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
TDX REA LDH
K841703 · Abbott Laboratories · Jun 1984
ASTRA SYSTEMS ENZYME MODULE LD-P
K832048 · Beckman Instruments, Inc. · Jul 1983