Cleared Traditional

K896228 - COBAS READY CARDIO PROFILE REAGENT STRIP

K896228 is an FDA 510(k) clearance for COBAS READY CARDIO PROFILE REAGENT STRIP, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K896228 · Roche Diagnostic Systems, Inc. · Chemistry device
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Feb 1990
Decision
109d
Days
Class 2
Risk

K896228 is an FDA 510(k) clearance for the COBAS READY CARDIO 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

FDA 510(k) Submission Details - K896228

510(k) Number K896228 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.

CIT Device Classification - Class 2, Special Controls

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 130
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K896228.
ASPARTATE AMINOTRANSFERASE TEST
K903197 · Em Diagnostic Systems, Inc. · Aug 1990
PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT
K901104 · Baxter Healthcare Corp · Mar 1990
COULTER AST (GOT) REAGENT
K897165 · Coulter Electronics, Inc. · Feb 1990
COBAS READY PROFILE 1 REAGENT STRIP
K896229 · Roche Diagnostic Systems, Inc. · Feb 1990
COBAS READY LIVER PROFILE REAGENT STRIP
K896233 · Roche Diagnostic Systems, Inc. · Feb 1990
ASPARTATE AMINOTRANFERASE (AST)
K896000 · American Monitor Corp. · Jan 1990