Cleared Traditional

(AST) OR (ALT) UV DETERM. PHY. PHOS. (K781020) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K781020 · The Dow Chemical Co. · Chemistry device
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Jul 1978
Decision
42d
Days
Class 2
Risk

K781020 is an FDA 510(k) clearance for the (AST) OR (ALT) UV DETERM. PHY. PHOS.. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 42 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 The Dow Chemical Co. devices

Submission Details

510(k) Number K781020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1978
Decision Date July 27, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 35
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K781020.
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS
K842411 · Sigma Chemical Co. · Aug 1984
BECKMAN LIQUID-STAT AST-UV LIQUID
K821433 · Beckman Instruments, Inc. · Jun 1982
AST (UV) TEST
K810390 · Boehringer Mannheim Corp. · Feb 1981
SINGLE VIAL 10 SGOT-TRIS
K780634 · Boehringer Mannheim Corp. · May 1978
ASPARTATE TRANSAMINASE
K780039 · Beckman Instruments, Inc. · Jan 1978