Cleared Traditional

ROCHE REAGENT FOR LDH (K900121) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900121 · Roche Diagnostic Systems, Inc. · Chemistry device
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Mar 1990
Decision
80d
Days
Class 2
Risk

K900121 is an FDA 510(k) clearance for the ROCHE REAGENT FOR LDH. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on March 30, 1990 after a review of 80 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K900121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1990
Decision Date March 30, 1990
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
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 110
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K900121.
COBAS READY LDH REAGENT
K896241 · Roche Diagnostic Systems, Inc. · Feb 1990
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · Abbott Laboratories · Jun 1988
TDX REA LDH
K841703 · Abbott Laboratories · Jun 1984
LD-L TRIS SYSTEM PACK TEST
K820378 · Boehringer Mannheim Corp. · Mar 1982
SINGLE VIAL LDH-L TRIS
K781538 · Boehringer Mannheim Corp. · Oct 1978
SINGLE VIAL LACTATE
K780563 · Boehringer Mannheim Corp. · Apr 1978