Cleared Traditional

BECKMAN EPSILON(TM) FERRITIN TEST KIT (K864437) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864437 · Beckman Instruments, Inc. · Immunology device
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Jan 1987
Decision
65d
Days
Class 2
Risk

K864437 is an FDA 510(k) clearance for the BECKMAN EPSILON(TM) FERRITIN TEST KIT. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on January 16, 1987 after a review of 65 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K864437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date January 16, 1987
Days to Decision 65 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
39d faster than avg
Panel avg: 104d · This submission: 65d
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 27
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K864437.
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031 · Diagnostic Products Corp. · Nov 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
QUANTIMUNE(R) FERRITIN IRMA
K863487 · Bio-Rad · Oct 1986
ENZYMUN-TEST FERRITIN
K860137 · Boehringer Mannheim Corp. · Mar 1986
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K844158 · American Dade · Nov 1984