Cleared Traditional

K801580 - FERRITIN RIA KIT

K801580 is the FDA 510(k) clearance for FERRITIN RIA KIT by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K801580 · Diagnostic Products Corp. · Immunology device
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Aug 1980
Decision
34d
Days
Class 2
Risk

K801580 is an FDA 510(k) clearance for the FERRITIN RIA KIT. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - the FDA immunology 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K801580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1980
Decision Date August 13, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 104d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 Immunology devices follow this clearance model.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 51
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K801580.
LEECO FERRITIN-QUANT DIAG. TEST KIT
K811880 · Leeco Diagnostics, Inc. · Jul 1981
FERRITIN RIA KIT
K811804 · Amersham Corp. · Jul 1981
FERRIZYME FERRITIN ENZYME IMMUNOASSAY
K801676 · Abbott Laboratories · Aug 1980
FERRITIN CONTROLS CODE QAS.104
K800657 · Amersham Corp. · Apr 1980
FERRITIN RIA KIT
K800299 · Amersham Corp. · Mar 1980
CENTRIA FERRITIN RIA
K792449 · Union Carbide Corp. · Dec 1979