Cleared Traditional

K982680 - CHIRON DIAGNOSTICS CORPORATION ACS: CEN...

K982680 is the FDA 510(k) clearance for CHIRON DIAGNOSTICS CORPORATION ACS: CEN... by Chiron Diagnostics Corp.. It is a Class 2 Immunology device (product code MOI) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K982680 · Chiron Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
76d
Days
Class 2
Risk

K982680 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on October 15, 1998 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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 Chiron Diagnostics Corp. devices

Submission Details

510(k) Number K982680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1998
Decision Date October 15, 1998
Days to Decision 76 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 104d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOI System, Test, Immunological, Antigen, Tumor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - MOI System, Test, Immunological, Antigen, Tumor

All 19
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K982680.
ELECSYSCA 15-3 II ASSAY
K010588 · Roche Diagnostics Corp. · Mar 2001
ELECSYS CA 15-3 TEST SYSTEM
K001468 · Roche Diagnostics Corp. · Oct 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
K983690 · Ortho-Clinical Diagnostics, Inc. · Feb 1999
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703 · Bayer Corp. · Dec 1997
IMX CA 15-3
K964407 · Abbott Laboratories · Nov 1997
AXSYM CA 15-3
K963926 · Abbott Laboratories · Sep 1997