Cleared Traditional

K873573 - CIBA CORNING MAGIC LITE FERRITIN

K873573 is an FDA 510(k) clearance for CIBA CORNING MAGIC LITE FERRITIN, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K873573 · Ciba Corning Diagnostics Corp. · Immunology device
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Oct 1987
Decision
35d
Days
Class 2
Risk

K873573 is an FDA 510(k) clearance for the CIBA CORNING MAGIC LITE FERRITIN. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on October 7, 1987 after a review of 35 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K873573

510(k) Number K873573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1987
Decision Date October 07, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K873573.
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IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
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DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
K871489 · Diagnostic Systems Laboratories, Inc. · Jun 1987
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
K870570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS
K870107 · Diagnostic Products Corp. · Feb 1987