Cleared Traditional

K860029 - LDH (OPTIMIZED) REAGENT

K860029 is the FDA 510(k) clearance for LDH (OPTIMIZED) REAGENT by Sigma Chemical Co.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K860029 · Sigma Chemical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
31d
Days
Class 2
Risk

K860029 is an FDA 510(k) clearance for the LDH (OPTIMIZED) REAGENT. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on February 6, 1986 after a review of 31 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K860029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date February 06, 1986
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K860029.
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.
K860713 · Catachem, Inc. · Apr 1986
L D H-L (LACTIC DEHYDROGENASE) REAGENT
K860728 · Trace Scientific , Ltd. · Apr 1986
LDH-P (LACTIC DEHYDROGENASE) REAGENT
K860729 · Trace Scientific , Ltd. · Apr 1986
ULTRAZYME PLUS & SYSTEMATE LDH
K854585 · Em Diagnostic Systems, Inc. · Dec 1985
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
K852948 · Amresco, Inc. · Aug 1985
SYSTEMATE LDH, 67210
K843269 · Em Diagnostic Systems, Inc. · Sep 1984