Cleared Traditional

K903829 - AST REAGENT

K903829 is the FDA 510(k) clearance for AST REAGENT by Amresco, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K903829 · Amresco, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
35d
Days
Class 2
Risk

K903829 is an FDA 510(k) clearance for the AST REAGENT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on September 25, 1990 after a review of 35 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 Amresco, Inc. devices

Submission Details

510(k) Number K903829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date September 25, 1990
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 107
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K903829.
TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
K914025 · Technicon Instruments Corp. · Nov 1991
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
K914068 · Em Diagnostic Systems, Inc. · Oct 1991
COULTER DART AST (GOT) REAGENT
K905771 · Coulter Electronics, Inc. · Feb 1991
ASPARTATE AMINOTRANSFERASE TEST
K903197 · Em Diagnostic Systems, Inc. · Aug 1990
PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT
K901104 · Baxter Healthcare Corp · Mar 1990
COULTER AST (GOT) REAGENT
K897165 · Coulter Electronics, Inc. · Feb 1990