Cleared Traditional

K832163 - SOPHEIA DIGOXIN EIA KIT

K832163 is the FDA 510(k) clearance for SOPHEIA DIGOXIN EIA KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code DPO) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K832163 · Diagnostic Products Corp. · Chemistry device
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Aug 1983
Decision
38d
Days
Class 2
Risk

K832163 is an FDA 510(k) clearance for the SOPHEIA DIGOXIN EIA KIT. Classified as Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (product code DPO), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K832163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1983
Decision Date August 12, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DPO Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.

Devices cleared under the same product code (DPO) and FDA review panel - the closest regulatory comparables to K832163.
COAT-A-COUNT DIGOXIN RIA
K811932 · Diagnostic Products Corp. · Jul 1981
KALLESTAD QUANTICOAT 125 DIGOXIN
K811776 · Kallestad Laboratories, Inc. · Jul 1981
RIA PHASE DIGOXIN
K800205 · Boehringer Mannheim Corp. · Mar 1980
VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT
K791355 · Ventrex Laboratories, Inc. · Aug 1979
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