Cleared Traditional

K971418 - CHIRON DIAGNOSTICS AUTOMATED CHEMILUMIN...

K971418 is an FDA 510(k) clearance for CHIRON DIAGNOSTICS AUTOMATED CHEMILUMIN..., manufactured by Chiron Diagnostics Corp.. The device is a Class 2 Chemistry device with product code MOI cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K971418 · Chiron Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
92d
Days
Class 2
Risk

K971418 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER. 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 July 17, 1997 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.6010 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Chiron Diagnostics Corp. devices

FDA 510(k) Submission Details - K971418

510(k) Number K971418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1997
Decision Date July 17, 1997
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
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 Chemistry devices follow this clearance model.