Cleared Traditional

K973331 - VITROS IMMUNODIAGNOSTIC PRODUCTS FERRIT...

K973331 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS FERRIT... by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K973331 · Ortho-Clinical Diagnostics, Inc. · Immunology device
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Oct 1997
Decision
48d
Days
Class 2
Risk

K973331 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN C.... Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 22, 1997 after a review of 48 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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K973331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1997
Decision Date October 22, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 104d · This submission: 48d
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 K973331.
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
K983340 · Beckman Coulter, Inc. · Dec 1998
ABBOTT ARCHITECT FERRITIN
K983759 · Abbott Laboratories · Dec 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
K982714 · Bayer Corp. · Oct 1998
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202 · Behring Diagnostics, Inc. · Sep 1997
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170 · Olympus America, Inc. · Dec 1996
N LATEX FERRITIN
K950707 · Behring Diagnostics, Inc. · Mar 1995