Cleared Traditional

K820274 - DIGOXIN RADIOIMMUNOASSAY

K820274 is an FDA 510(k) clearance for DIGOXIN RADIOIMMUNOASSAY, manufactured by American Diagnostic Corp.. The device is a Class 2 Toxicology device with product code DPB cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K820274 · American Diagnostic Corp. · Toxicology device
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Feb 1982
Decision
21d
Days
Class 2
Risk

K820274 is an FDA 510(k) clearance for the DIGOXIN RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (product code DPB), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1982 after a review of 21 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 American Diagnostic Corp. devices

FDA 510(k) Submission Details - K820274

510(k) Number K820274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1982
Decision Date February 23, 1982
Days to Decision 21 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
66d faster than avg
Panel avg: 87d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPB Device Classification - Class 2, Special Controls

Product Code DPB Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal 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 - DPB Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep.

Devices cleared under the same product code (DPB) and FDA review panel - the closest regulatory comparables to K820274.
OPTIMATE DIGOXIN TEST
K853021 · Miles Laboratories, Inc. · Aug 1985
DIGOXIN KIT
K823014 · Pcl-Ria, Inc. · Nov 1982
RIA TEST KIT, CENTRIA DIGOXIN
K790540 · Ventrex Laboratories, Inc. · Apr 1979
125 I DIGOXIN RIA KIT
K771525 · Diagnostic Products Corp. · Oct 1977
DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY
K760883 · Nuclear Medical Laboratories, Inc. · Nov 1976