Cleared Traditional

K842411 - SIGMA 58-UV ASPARTATE AMINOTRANSFERAS

K842411 is the FDA 510(k) clearance for SIGMA 58-UV ASPARTATE AMINOTRANSFERAS by Sigma Chemical Co.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K842411 · Sigma Chemical Co. · Chemistry device
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Aug 1984
Decision
54d
Days
Class 2
Risk

K842411 is an FDA 510(k) clearance for the SIGMA 58-UV ASPARTATE AMINOTRANSFERAS. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1984 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sigma Chemical Co. devices

Submission Details

510(k) Number K842411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date August 12, 1984
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
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 104
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K842411.
GEMENI AST-LTS REAGENTS
K851267 · Electro-Nucleonics Laboratories, Inc. · Apr 1985
ROCHE REAGENT FOR AST
K843109 · Roche Diagnostic Systems, Inc. · Nov 1984
SYSTEMATE GOT 67208
K843333 · Em Diagnostic Systems, Inc. · Sep 1984
ASPARTATE AMINOTRANSFERASE ASSAY KIT
K842245 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
SGOT-UV REAGENT SET
K841066 · Medical Specialties, Inc. · May 1984
ASPARTATE AMINOTRANSFERASE REAGENT
K840706 · American Dade · Apr 1984