Cleared Traditional

K905770 - CIBA CORNING ACS FERRITIN IMMUNOASSAY

K905770 is an FDA 510(k) clearance for CIBA CORNING ACS FERRITIN IMMUNOASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K905770 · Ciba Corning Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
75d
Days
Class 2
Risk

K905770 is an FDA 510(k) clearance for the CIBA CORNING ACS FERRITIN IMMUNOASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on March 12, 1991 after a review of 75 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K905770

510(k) Number K905770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date March 12, 1991
Days to Decision 75 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
29d faster than avg
Panel avg: 104d · This submission: 75d
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 64
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K905770.
AIA-PACK FER CALIBRATION VERIFICATION TEST SET
K924858 · Tosoh Medics, Inc. · Dec 1992
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
K920952 · Vitek Systems, Inc. · Apr 1992
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
K920046 · Medix Biotech, Inc. · Jan 1992
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
K896585 · Medix Biotech, Inc. · Dec 1989
LAN.0800Q/2800Q
K895872 · Amersham Corp. · Oct 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · Amersham Corp. · May 1989