Cleared Traditional

K896585 - MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT

K896585 is an FDA 510(k) clearance for MODIFIED FERRITIN ENZYME IMMUNOASSAY TE..., manufactured by Medix Biotech, Inc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K896585 · Medix Biotech, Inc. · Immunology device
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Dec 1989
Decision
13d
Days
Class 2
Risk

K896585 is an FDA 510(k) clearance for the MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on December 4, 1989 after a review of 13 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 Medix Biotech, Inc. devices

FDA 510(k) Submission Details - K896585

510(k) Number K896585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date December 04, 1989
Days to Decision 13 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
92d faster than avg
Panel avg: 105d · This submission: 13d
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 74
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K896585.
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
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SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
K911175 · Serono-Baker Diagnostics, Inc. · Apr 1991
CIBA CORNING ACS FERRITIN IMMUNOASSAY
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LAN.0800Q/2800Q
K895872 · Amersham Corp. · Oct 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · Amersham Corp. · May 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989