Cleared Traditional

K843109 - ROCHE REAGENT FOR AST

K843109 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 90-day FDA review.

K843109 · Roche Diagnostic Systems, Inc. · Chemistry device
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Nov 1984
Decision
90d
Days
Class 2
Risk

K843109 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. (Nutley, US). The FDA issued a Cleared decision on November 5, 1984 after a review of 90 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 K843109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1984
Decision Date November 05, 1984
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
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 K843109.
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K860725 · Trace Scientific , Ltd. · Apr 1986
VISION SGOT (AST)
K854982 · Abbott Laboratories · Jan 1986
AST(OPTIMIZED) REAGENT
K854503 · Sigma Diagnostics, Inc. · Nov 1985
SYSTEMATE GOT 67208
K843333 · Em Diagnostic Systems, Inc. · Sep 1984
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
K842411 · Sigma Chemical Co. · Aug 1984
ASPARTATE AMINOTRANSFERASE ASSAY KIT
K842245 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984