Cleared Traditional

K863477 - EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS

K863477 is the FDA 510(k) clearance for EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS 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.

K863477 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1986
Decision
17d
Days
Class 2
Risk

K863477 is an FDA 510(k) clearance for the EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95. 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 26, 1986 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 K863477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date September 26, 1986
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 82
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K863477.
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
K870752 · Miles Laboratories, Inc. · Apr 1987
WAKO(TM) AUTOKIT LDH
K870401 · Wako Chemicals USA, Inc. · Mar 1987
LACTATE DEHYDROGENASE(LD) PROCEDURE
K863255 · Data Medical Associates, Inc. · Oct 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · Em Diagnostic Systems, Inc. · Sep 1986
KING DIAGNOSTICS LDH TEST
K862306 · King Diagnostics, Inc. · Aug 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K862255 · Sterling Diagnostics, Inc. · Jul 1986