Cleared Traditional

K925802 - ACCESS DIGOXIN ASSAY

K925802 is the FDA 510(k) clearance for ACCESS DIGOXIN ASSAY by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code KXT) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K925802 · Bio-Rad Laboratories, Inc. · Chemistry device
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Jan 1993
Decision
58d
Days
Class 2
Risk

K925802 is an FDA 510(k) clearance for the ACCESS DIGOXIN ASSAY. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on January 13, 1993 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K925802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date January 13, 1993
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXT Enzyme Immunoassay, Digoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - KXT Enzyme Immunoassay, Digoxin

All 64
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K925802.
DIGOXIN TEST SYSTEM, KXT TX
K931123 · Syva Co. · Aug 1993
ACS DIGOXIN IMMUNOASSAY
K931213 · Ciba Corning Diagnostics Corp. · Jun 1993
ACA DIGOXIN ANALYTICAL TEST PACK
K930162 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1993
CEDIA DIGOXIN PLUS ASSAY
K923853 · Microgenics Corp. · Sep 1992
CEDIA DIGOXIN ASSAY (MODIFICATION)
K920214 · Microgenics Corp. · Mar 1992
IL TEST(TM DIGOXIN
K914151 · Instrumentation Laboratory CO · Nov 1991