Cleared Traditional

K894482 - LACTATE DEHYDROGENASE TEST (LD) ITEM #6...

K894482 is the FDA 510(k) clearance for LACTATE DEHYDROGENASE TEST (LD) ITEM #6... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K894482 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1989
Decision
51d
Days
Class 2
Risk

K894482 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE TEST (LD) ITEM #65418. 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 September 7, 1989 after a review of 51 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 K894482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date September 07, 1989
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
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 82
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K894482.
ROCHE REAGENT FOR LDH
K900121 · Roche Diagnostic Systems, Inc. · Mar 1990
COULTER LD (LDH-L) REAGENT
K897164 · Coulter Electronics, Inc. · Mar 1990
COBAS READY LDH REAGENT
K896241 · Roche Diagnostic Systems, Inc. · Feb 1990
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · Em Diagnostic Systems, Inc. · Nov 1988
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · Abbott Laboratories · Jun 1988
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
K875206 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988