Cleared Traditional

K974505 - AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501

K974505 is an FDA 510(k) clearance for AURAFLEX FERRITIN 200 TEST PACK 80500, manufactured by Alfa Biotech (Uk) , Ltd.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K974505 · Alfa Biotech (Uk) , Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
78d
Days
Class 2
Risk

K974505 is an FDA 510(k) clearance for the AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Alfa Biotech (Uk) , Ltd. (Aldershot Hants, GB). The FDA issued a Cleared decision on February 17, 1998 after a review of 78 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 Alfa Biotech (Uk) , Ltd. devices

FDA 510(k) Submission Details - K974505

510(k) Number K974505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1997
Decision Date February 17, 1998
Days to Decision 78 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
27d faster than avg
Panel avg: 105d · This submission: 78d
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 72
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K974505.
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
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ABBOTT ARCHITECT FERRITIN
K983759 · Abbott Laboratories · Dec 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
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VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
K973331 · Ortho-Clinical Diagnostics, Inc. · Oct 1997
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202 · Behring Diagnostics, Inc. · Sep 1997
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K970612 · Sealite Sciences, Inc. · Jun 1997