Cleared Traditional

K905683 - BIOTROL LACTATE DEHYDROGENASE (L-P)

K905683 is the FDA 510(k) clearance for BIOTROL LACTATE DEHYDROGENASE (L-P) by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K905683 · Biotrol, USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
82d
Days
Class 2
Risk

K905683 is an FDA 510(k) clearance for the BIOTROL LACTATE DEHYDROGENASE (L-P). Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Westchester, US). The FDA issued a Cleared decision on March 11, 1991 after a review of 82 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K905683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1990
Decision Date March 11, 1991
Days to Decision 82 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
6d faster than avg
Panel avg: 88d · This submission: 82d
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 85
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K905683.
DMA LD KINETIC PROCEDURE
K915803 · Data Medical Associates, Inc. · Mar 1992
ABBOTT QUICKSTART LDH,#5A31
K914262 · Em Diagnostic Systems, Inc. · Oct 1991
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
K910640 · Em Diagnostic Systems, Inc. · Apr 1991
SYNERMED LDH REAGENT KIT
K903773 · Synermed, Inc. · Oct 1990
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
K900667 · American Research Products Co. · Apr 1990
ROCHE REAGENT FOR LDH
K900121 · Roche Diagnostic Systems, Inc. · Mar 1990