Cleared Traditional

K896241 - COBAS READY LDH REAGENT

K896241 is an FDA 510(k) clearance for COBAS READY LDH REAGENT, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CFJ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K896241 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K896241

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.

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 K896241.
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
COULTER LD (LDH-L) REAGENT
K897164 · Coulter Electronics, Inc. · Mar 1990
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
K894482 · Em Diagnostic Systems, Inc. · Sep 1989
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · Em Diagnostic Systems, Inc. · Nov 1988
VISION(R) LDH (LACTATE DEHYDROGENASE)
K881474 · Abbott Laboratories · Jun 1988