Cleared Traditional

K914833 - IMMULITE DIGOXIN

K914833 is an FDA 510(k) clearance for IMMULITE DIGOXIN, manufactured by Cirrus Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DPO cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K914833 · Cirrus Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K914833

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
Combination Product No
PCCP Authorized No
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.

DPO Device Classification - Class 2, Special Controls

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.
ECLIPSE ICA DIGOXIN
K905719 · Biotope, Inc. · Jan 1991
DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
K864449 · Canadian Bioclinical, Ltd. · Feb 1987
RIA COAT DIGOXIN
K833842 · Immuno Assay Corp. · Jan 1984
SOPHEIA DIGOXIN EIA KIT
K832163 · Diagnostic Products Corp. · Aug 1983
IMMUCHEM COVALENT-COAT RIA KIT
K830962 · Immuchem Corp. · May 1983
COAT-A-COUNT DIGOXIN RIA
K811932 · Diagnostic Products Corp. · Jul 1981
K914833 · IMMULITE DIGOXIN
Download PDF FDA Summary Cirrus Diagnostics, I…