Cleared Traditional

K010050 - ADVIA CENTAUR AND ACS: 180 FOLATE IMMUN...

K010050 is the FDA 510(k) clearance for ADVIA CENTAUR AND ACS: 180 FOLATE IMMUN... by Bayer Diagnostics Corp.. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K010050 · Bayer Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
31d
Days
Class 2
Risk

K010050 is an FDA 510(k) clearance for the ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on February 5, 2001 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - 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: 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 Bayer Diagnostics Corp. devices

Submission Details

510(k) Number K010050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2001
Decision Date February 05, 2001
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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.

Regulatory Peers - CGN Acid, Folic, Radioimmunoassay

All 51
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K010050.
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