Cleared Traditional

K803075 - DIGOXIN RIABEAD DIAGNOSTIC KIT

K803075 is an FDA 510(k) clearance for DIGOXIN RIABEAD DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DON cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K803075 · Abbott Laboratories · Toxicology device
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Dec 1980
Decision
17d
Days
Class 2
Risk

K803075 is an FDA 510(k) clearance for the DIGOXIN RIABEAD DIAGNOSTIC KIT. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (product code DON), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 17 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K803075

510(k) Number K803075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1980
Decision Date December 22, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 87d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DON Device Classification - Class 2, Special Controls

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 10
Devices cleared under the same product code (DON) and FDA review panel - the closest regulatory comparables to K803075.
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
K881679 · Ciba Corning Diagnostics Corp. · Jul 1988
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
K840461 · Corning Medical & Scientific · Mar 1984
ENZYMUNE-TEST DIGOXIN
K821000 · Icl Scientific · Apr 1982
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