Cleared Traditional

ULTRAZYME PLUS LDH, #64950,65038&65039 (K821466) - FDA 510(k) Clearance

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

K821466 · Emd Chemicals, Inc. · Chemistry device
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Jun 1982
Decision
14d
Days
Class 2
Risk

K821466 is an FDA 510(k) clearance for the ULTRAZYME PLUS LDH, #64950,65038&65039. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1982 after a review of 14 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K821466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 01, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 110
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K821466.
LACTATE DEHYDROGENASE (LD)
K935175 · Em Diagnostic Systems, Inc. · Dec 1993
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
K924703 · Em Diagnostic Systems, Inc. · Feb 1993
ABBOTT QUICKSTART LDH,#5A31
K914262 · Em Diagnostic Systems, Inc. · Oct 1991
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
K910640 · Em Diagnostic Systems, Inc. · Apr 1991
ROCHE REAGENT FOR LDH
K900121 · Roche Diagnostic Systems, Inc. · Mar 1990
COBAS READY LDH REAGENT
K896241 · Roche Diagnostic Systems, Inc. · Feb 1990