Cleared Traditional

ROCHE COBAS INTEGRA REAGENT CASSETTES (K954992) - FDA 510(k) Clearance

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

K954992 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
86d
Days
Class 2
Risk

K954992 is an FDA 510(k) clearance for the ROCHE COBAS INTEGRA REAGENT CASSETTES. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 K954992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1995
Decision Date January 25, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 138
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K954992.
ACTIVATED ASPARTATE AMINOTRANSFERASE
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AST
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AST
K981843 · Abbott Laboratories · Jun 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221 · Abbott Laboratories · Apr 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225 · Abbott Laboratories · Apr 1998
ROCHE REAGENT FOR AST
K924244 · Roche Diagnostic Systems, Inc. · Jan 1993