Cleared Traditional

K931123 - DIGOXIN TEST SYSTEM

K931123 is the FDA 510(k) clearance for DIGOXIN TEST SYSTEM by Syva Co.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K931123 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
154d
Days
Class 2
Risk

K931123 is an FDA 510(k) clearance for the DIGOXIN TEST SYSTEM, KXT TX. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on August 5, 1993 after a review of 154 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K931123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1993
Decision Date August 05, 1993
Days to Decision 154 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 87d · This submission: 154d
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 Toxicology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 69
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K931123.
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · Syva Co. · Apr 1994
CEDIA DIGOXIN PLUS ASSAY
K934168 · Microgenics Corp. · Dec 1993
VIDAS DIGOXIN (DIG)
K932250 · Biomerieux Vitek, Inc. · Sep 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
ACCESS DIGOXIN ASSAY
K925802 · Bio-Rad Laboratories, Inc. · Jan 1993