Cleared Traditional

K980902 - N-ASSAY L AST/GOT

K980902 is the FDA 510(k) clearance for N-ASSAY L AST/GOT by Crestat Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K980902 · Crestat Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
16d
Days
Class 2
Risk

K980902 is an FDA 510(k) clearance for the N-ASSAY L AST/GOT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Seattle, US). The FDA issued a Cleared decision on March 26, 1998 after a review of 16 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 Crestat Diagnostics, Inc. devices

Submission Details

510(k) Number K980902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1998
Decision Date March 26, 1998
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
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 105
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K980902.
AST
K981843 · Abbott Laboratories · Jun 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221 · Abbott Laboratories · Apr 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225 · Abbott Laboratories · Apr 1998
INFINITY AST REAGENT (PROCEDURE NO. 51)
K980666 · Sigma Diagnostics, Inc. · Mar 1998
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
K974001 · Diagnostic Chemicals , Ltd. · Nov 1997
AST INCORPORATING DST
K961114 · Trace Scientific , Ltd. · May 1996