Cleared Traditional

K982935 - SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT

K982935 is the FDA 510(k) clearance for SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT by Beckman Coulter, Inc.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K982935 · Beckman Coulter, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
54d
Days
Class 2
Risk

K982935 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on October 14, 1998 after a review of 54 days - a notably fast clearance 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: 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K982935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1998
Decision Date October 14, 1998
Days to Decision 54 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
33d faster than avg
Panel avg: 87d · This submission: 54d
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 K982935.
RANDOX DIGOXIN
K011302 · Randox Laboratories, Ltd. · Jul 2001
DIGOXIN IMMUNOASSAY
K983323 · Diagnostic Reagents, Inc. · Nov 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
K983151 · Beckman Coulter, Inc. · Nov 1998
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
K980521 · Bayer Corp. · Apr 1998
ELECSYS DIGOXIN
K973112 · Boehringer Mannheim Corp. · Oct 1997
DIGOXIN DG-II FPIA REAGENT SET
K972794 · Sigma Diagnostics, Inc. · Jul 1997