Cleared Traditional

K883746 - MICROMEDIC FERRITIN IRMA KIT

K883746 is an FDA 510(k) clearance for MICROMEDIC FERRITIN IRMA KIT, manufactured by Icn Micromedic Systems. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K883746 · Icn Micromedic Systems · Immunology device
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Oct 1988
Decision
56d
Days
Class 2
Risk

K883746 is an FDA 510(k) clearance for the MICROMEDIC FERRITIN IRMA KIT. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Icn Micromedic Systems (Horsham, US). The FDA issued a Cleared decision on October 27, 1988 after a review of 56 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 Icn Micromedic Systems devices

FDA 510(k) Submission Details - K883746

510(k) Number K883746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1988
Decision Date October 27, 1988
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 105d · This submission: 56d
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 76
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K883746.
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K874203 · Amersham Corp. · Jan 1988
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
K874572 · Nichols Institute Diagnostics · Dec 1987
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031 · Diagnostic Products Corp. · Nov 1987