Cleared Traditional

K924244 - ROCHE REAGENT FOR AST

K924244 is the FDA 510(k) clearance for ROCHE REAGENT FOR AST by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K924244 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jan 1993
Decision
133d
Days
Class 2
Risk

K924244 is an FDA 510(k) clearance for the ROCHE REAGENT FOR AST. 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 4, 1993 after a review of 133 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 K924244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date January 04, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
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 K924244.
ASPARTATE AMINOTRANSFERASE (AST) TEST
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STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
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OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
K925155 · Olympus Corp. · Jan 1993
AST (GOT) - ASPARTATE AMINOTRANSFERASE
K923505 · Randox Laboratories, Ltd. · Nov 1992
IL TEST AST, PN 35312
K923641 · Instrumentation Laboratory CO · Oct 1992
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
K922857 · Em Diagnostic Systems, Inc. · Sep 1992