Cleared Traditional

K780475 - DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT

K780475 is the FDA 510(k) clearance for DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT by Burroughs Wellcome Co.. It is a Class 2 Toxicology device (product code DON) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K780475 · Burroughs Wellcome Co. · Toxicology device
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Apr 1978
Decision
31d
Days
Class 2
Risk

K780475 is an FDA 510(k) clearance for the DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (product code DON), Class II - Special Controls.

Submitted by Burroughs Wellcome Co. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1978 after a review of 31 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 Burroughs Wellcome Co. devices

Submission Details

510(k) Number K780475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1978
Decision Date April 24, 1978
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 87d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DON Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.
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 - DON Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep.

All 11
Devices cleared under the same product code (DON) and FDA review panel - the closest regulatory comparables to K780475.
DIGOXIN RIABEAD DIAGNOSTIC KIT
K803075 · Abbott Laboratories · Dec 1980
TECHNICON STAR SYSTEM
K791549 · Technicon Instruments Corp. · Sep 1979
RIA, DIGOXIN
K781660 · E. R. Squibb & Sons, Inc. · Oct 1978
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA
K772422 · Bio-Rad · Feb 1978
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS
K772098 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1977
CEBTRIA DIGOXIN RIA
K771255 · Union Carbide Corp. · Aug 1977