Cleared Traditional

K790540 - RIA TEST KIT, CENTRIA DIGOXIN

K790540 is an FDA 510(k) clearance for RIA TEST KIT, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DPB cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K790540 · Ventrex Laboratories, Inc. · Toxicology device
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Apr 1979
Decision
34d
Days
Class 2
Risk

K790540 is an FDA 510(k) clearance for the RIA TEST KIT, CENTRIA DIGOXIN. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. (product code DPB), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on April 23, 1979 after a review of 34 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 Ventrex Laboratories, Inc. devices

FDA 510(k) Submission Details - K790540

510(k) Number K790540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1979
Decision Date April 23, 1979
Days to Decision 34 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
53d faster than avg
Panel avg: 87d · This submission: 34d
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 K790540.
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
125 I DIGOXIN RIA KIT
K771525 · Diagnostic Products Corp. · Oct 1977
DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY
K760883 · Nuclear Medical Laboratories, Inc. · Nov 1976