Cleared Traditional

K896238 - COBAS READY AST REAGENT

K896238 is an FDA 510(k) clearance for COBAS READY AST REAGENT, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIS cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K896238 · Roche Diagnostic Systems, Inc. · Chemistry device
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Feb 1990
Decision
109d
Days
Class 2
Risk

K896238 is an FDA 510(k) clearance for the COBAS READY AST REAGENT. Classified as Hydrazone Colorimetry, Ast/sgot (product code CIS), 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 - K896238

510(k) Number K896238 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.

CIS Device Classification - Class 2, Special Controls

Product Code CIS Hydrazone Colorimetry, 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 - CIS Hydrazone Colorimetry, Ast/sgot

Devices cleared under the same product code (CIS) and FDA review panel - the closest regulatory comparables to K896238.
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
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K854187 · Clinical Data, Inc. · Nov 1985
OPTIONAL TOTAL CA-MODULE FOR IL 504/508
K812872 · Instrumentation Laboratory CO · Oct 1981
ELVI SGOT & SGPT TRANSAMINASE
K792410 · Volu Sol Medical Industries · Dec 1979