Cleared Traditional

K896233 - COBAS READY LIVER PROFILE REAGENT STRIP

K896233 is the FDA 510(k) clearance for COBAS READY LIVER PROFILE REAGENT STRIP by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K896233 · Roche Diagnostic Systems, Inc. · Chemistry device
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Feb 1990
Decision
109d
Days
Class 2
Risk

K896233 is an FDA 510(k) clearance for the COBAS READY LIVER PROFILE REAGENT STRIP. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), 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 862.1100 - 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: 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 K896233 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 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 93
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K896233.
COULTER AST (GOT) REAGENT
K897165 · Coulter Electronics, Inc. · Feb 1990
COBAS READY CARDIO PROFILE REAGENT STRIP
K896228 · Roche Diagnostic Systems, Inc. · Feb 1990
COBAS READY PROFILE 1 REAGENT STRIP
K896229 · Roche Diagnostic Systems, Inc. · Feb 1990
ASPARTATE AMINOTRANFERASE (AST)
K896000 · American Monitor Corp. · Jan 1990
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
K894180 · Abbott Laboratories · Sep 1989
AST REAGENT (PROCEDURE NUMBER 158)
K892844 · Sigma Chemical Co. · Jun 1989