Cleared Traditional

IMMULITE DIGOXIN (K914833) - FDA 510(k) Clearance

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

K914833 · Cirrus Diagnostics, Inc. · Toxicology device
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Nov 1991
Decision
28d
Days
Class 2
Risk

K914833 is an FDA 510(k) clearance for the IMMULITE DIGOXIN. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (product code DPO), Class II - Special Controls.

Submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 28 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 Cirrus Diagnostics, Inc. devices

Submission Details

510(k) Number K914833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1991
Decision Date November 22, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 87d · This submission: 28d
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 K914833.
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