Cleared Traditional

K863068 - LDH S.C.E.

K863068 is an FDA 510(k) clearance for LDH S.C.E., manufactured by J. D. Assoc.. The device is a Class 2 Chemistry device with product code CFJ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K863068 · J. D. Assoc. · Chemistry device
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Dec 1986
Decision
120d
Days
Class 2
Risk

K863068 is an FDA 510(k) clearance for the LDH S.C.E.. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 10, 1986 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all J. D. Assoc. devices

FDA 510(k) Submission Details - K863068

510(k) Number K863068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date December 10, 1986
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFJ Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K863068.
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET
K871781 · Biochemical Trade, Inc. · Jun 1987
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
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
K863477 · Em Diagnostic Systems, Inc. · Sep 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · Em Diagnostic Systems, Inc. · Sep 1986