Cleared Traditional

KALLESTAD QUANTICOAT 125 DIGOXIN (K811776) - FDA 510(k) Clearance

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

K811776 · Kallestad Laboratories, Inc. · Toxicology device
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Jul 1981
Decision
17d
Days
Class 2
Risk

K811776 is an FDA 510(k) clearance for the KALLESTAD QUANTICOAT 125 DIGOXIN. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (product code DPO), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 17 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K811776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1981
Decision Date July 10, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 87d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPO Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube 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 - DPO Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.

All 13
Devices cleared under the same product code (DPO) and FDA review panel - the closest regulatory comparables to K811776.
SOPHEIA DIGOXIN EIA KIT
K832163 · Diagnostic Products Corp. · Aug 1983
COAT-A-COUNT DIGOXIN RIA
K811932 · Diagnostic Products Corp. · Jul 1981
RIA PHASE DIGOXIN
K800205 · Boehringer Mannheim Corp. · Mar 1980
IGOXIN SOLID PHASE RIA
K771638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1977
RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO
K770365 · Travenol Laboratories, S.A. · Feb 1977