Cleared Traditional

K973202 - MODIFICATION OF OPUS FERRITIN TEST SYSTEM

K973202 is the FDA 510(k) clearance for MODIFICATION OF OPUS FERRITIN TEST SYSTEM by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (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

Submission Details

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
38d faster than avg
Panel avg: 104d · This submission: 66d
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 62
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K973202.
ABBOTT ARCHITECT FERRITIN
K983759 · Abbott Laboratories · Dec 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
K982714 · Bayer Corp. · Oct 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
K973331 · Ortho-Clinical Diagnostics, Inc. · Oct 1997
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170 · Olympus America, Inc. · Dec 1996
N LATEX FERRITIN
K950707 · Behring Diagnostics, Inc. · Mar 1995
AXSYM FERRITIN
K935847 · Abbott Laboratories · Jun 1994