Cleared Traditional

K803045 - IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K803045 · American Dade · Toxicology device
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Dec 1980
Decision
21d
Days
Class 2
Risk

K803045 is an FDA 510(k) clearance for the IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol (product code DOG), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 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 Dade devices

Submission Details

510(k) Number K803045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1980
Decision Date December 22, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code DOG Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol
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.