Cleared Traditional

K812590 - ULTRA ZYME PLUS LDH #64950

K812590 is the FDA 510(k) clearance for ULTRA ZYME PLUS LDH #64950 by Harleco. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K812590 · Harleco · Chemistry device
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Sep 1981
Decision
13d
Days
Class 2
Risk

K812590 is an FDA 510(k) clearance for the ULTRA ZYME PLUS LDH #64950, 65038 & 39. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981 after a review of 13 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 Harleco devices

Submission Details

510(k) Number K812590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1981
Decision Date September 24, 1981
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
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 K812590.
ULTRAZYME PLUS LDH, #64950,65038&65039
K821466 · Emd Chemicals, Inc. · Jun 1982
LD-L TRIS SYSTEM PACK TEST
K820378 · Boehringer Mannheim Corp. · Mar 1982
LDH-L
K813496 · Pointe Scientific, Inc., · Dec 1981
SPIN-CHEM LD-L REAGENT
K812472 · Smithkline Diagnostics, Inc. · Sep 1981
SERALYZER LDH REAGENT STRIPS, CALIBR
K803019 · Miles Laboratories, Inc. · Dec 1980
BECKMAN LIQUID-STAT LD-L-UV ENZYME
K802572 · Beckman Instruments, Inc. · Nov 1980