Cleared Traditional

K885074 - AFFINITY(TM) FERRITIN IMMUNIT(TM)

K885074 is the FDA 510(k) clearance for AFFINITY(TM) FERRITIN IMMUNIT(TM) by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K885074 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
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Jan 1989
Decision
27d
Days
Class 2
Risk

K885074 is an FDA 510(k) clearance for the AFFINITY(TM) FERRITIN IMMUNIT(TM). Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on January 4, 1989 after a review of 27 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K885074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1988
Decision Date January 04, 1989
Days to Decision 27 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
77d faster than avg
Panel avg: 104d · This submission: 27d
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 63
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K885074.
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
K896585 · Medix Biotech, Inc. · Dec 1989
LAN.0800Q/2800Q
K895872 · Amersham Corp. · Oct 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · Amersham Corp. · May 1989
AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
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