Cleared Traditional

K980190 - ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)

K980190 is an FDA 510(k) clearance for ACS 180 BR (AUTOMATED CHEMILUMINESCENCE..., manufactured by Chiron Corp.. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K980190 · Chiron Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
45d
Days
Class 2
Risk

K980190 is an FDA 510(k) clearance for the ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM). Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Chiron Corp. (Emeryville, US). The FDA issued a Cleared decision on March 6, 1998 after a review of 45 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 Corp. devices

FDA 510(k) Submission Details - K980190

510(k) Number K980190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date March 06, 1998
Days to Decision 45 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
60d faster than avg
Panel avg: 105d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOI Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K980190.
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
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CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
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ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
K981698 · Chiron Corp. · Jul 1998
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
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IMX CA 15-3
K964407 · Abbott Laboratories · Nov 1997
TRUQUANT BR RIA
K965141 · Biomira USA, Inc. · Oct 1997