Cleared Traditional

K854585 - ULTRAZYME PLUS & SYSTEMATE LDH

K854585 is the FDA 510(k) clearance for ULTRAZYME PLUS & SYSTEMATE LDH by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K854585 · Em Diagnostic Systems, Inc. · Chemistry device
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Dec 1985
Decision
17d
Days
Class 2
Risk

K854585 is an FDA 510(k) clearance for the ULTRAZYME PLUS & SYSTEMATE LDH. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 5, 1985 after a review of 17 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K854585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date December 05, 1985
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
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 83
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K854585.
L D H-L (LACTIC DEHYDROGENASE) REAGENT
K860728 · Trace Scientific , Ltd. · Apr 1986
LDH-P (LACTIC DEHYDROGENASE) REAGENT
K860729 · Trace Scientific , Ltd. · Apr 1986
LDH (OPTIMIZED) REAGENT
K860029 · Sigma Chemical Co. · Feb 1986
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
K852948 · Amresco, Inc. · Aug 1985
SYSTEMATE LDH, 67210
K843269 · Em Diagnostic Systems, Inc. · Sep 1984
LACTATE DEHYDROGENASE ASSAY KIT
K842507 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984