Cleared Traditional

K973202 - MODIFICATION OF OPUS FERRITIN TEST SYSTEM

K973202 is an FDA 510(k) clearance for MODIFICATION OF OPUS FERRITIN TEST SYSTEM, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K973202 · Behring Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
66d
Days
Class 2
Risk

K973202 is an FDA 510(k) clearance for the MODIFICATION OF OPUS FERRITIN TEST SYSTEM. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 66 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K973202

510(k) Number K973202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1997
Decision Date September 12, 1997
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
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: 105d · This submission: 66d
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 73
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K973202.
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
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AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
K974505 · Alfa Biotech (Uk) , Ltd. · Feb 1998
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K973331 · Ortho-Clinical Diagnostics, Inc. · Oct 1997
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
K970612 · Sealite Sciences, Inc. · Jun 1997
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170 · Olympus America, Inc. · Dec 1996
UBI MAGIWEL FERRITIN QUANTITATIVE
K951993 · United Biotech, Inc. · Jul 1995