Cleared Traditional

COBAS READY LDH REAGENT (K896241) - FDA 510(k) Clearance

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

K896241 · Roche Diagnostic Systems, Inc. · Chemistry device
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Feb 1990
Decision
109d
Days
Class 2
Risk

K896241 is an FDA 510(k) clearance for the COBAS READY LDH REAGENT. 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 February 16, 1990 after a review of 109 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K896241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date February 16, 1990
Days to Decision 109 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
21d slower than avg
Panel avg: 88d · This submission: 109d
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 K896241.
ROCHE REAGENT FOR LDH
K900121 · Roche Diagnostic Systems, Inc. · Mar 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