Cleared Traditional

RIA, DIGNXIN-125-I (K790602) - FDA 510(k) Clearance

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

K790602 · Endocrine-Metabolic Center · Chemistry device
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Jul 1979
Decision
125d
Days
Class 2
Risk

K790602 is an FDA 510(k) clearance for the RIA, DIGNXIN-125-I. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (product code DPB), Class II - Special Controls.

Submitted by Endocrine-Metabolic Center (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K790602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1979
Decision Date July 30, 1979
Days to Decision 125 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 88d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.