Cleared Traditional

K781834 - TEST SET, 125 I-DIGOXIN

K781834 is an FDA 510(k) clearance for TEST SET, manufactured by Wien Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DNL cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K781834 · Wien Laboratories, Inc. · Toxicology device
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Jan 1979
Decision
65d
Days
Class 2
Risk

K781834 is an FDA 510(k) clearance for the TEST SET, 125 I-DIGOXIN. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. (product code DNL), Class II - Special Controls.

Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1979 after a review of 65 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 Wien Laboratories, Inc. devices

FDA 510(k) Submission Details - K781834

510(k) Number K781834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1978
Decision Date January 03, 1979
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DNL Device Classification - Class 2, Special Controls

Product Code DNL Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody 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 - DNL Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep.

Devices cleared under the same product code (DNL) and FDA review panel - the closest regulatory comparables to K781834.
TIPSEP DIGOXIN RIA
K852291 · Nuclear Diagnostics, Inc. · Jun 1985
DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT
K810966 · E. R. Squibb & Sons, Inc. · Apr 1981
DIGOXIN RADIOIMMUNOASSAY KIT
K802841 · American Diagnostic Corp. · Dec 1980
RIANEN ASSAY SYSTEM, 125I KIT
K781495 · New England Nuclear · Sep 1978
IN VITRO DIGOXIN RIA TEST
K772110 · Clinical Assays, Inc. · Nov 1977