Cleared Traditional

K790602 - RIA, DIGNXIN-125-I

K790602 is an FDA 510(k) clearance for RIA, manufactured by Endocrine-Metabolic Center. The device is a Class 2 Chemistry device with product code DPB cleared through the Traditional 510(k) pathway after a 125-day FDA review.

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.

View all Endocrine-Metabolic Center devices

FDA 510(k) Submission Details - K790602

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.

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 Chemistry 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 K790602.
OPTIMATE DIGOXIN TEST
K853021 · Miles Laboratories, Inc. · Aug 1985
DIGOXIN KIT
K823014 · Pcl-Ria, Inc. · Nov 1982
DIGOXIN RADIOIMMUNOASSAY
K820274 · American Diagnostic Corp. · Feb 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