Cleared Traditional

K021535 - ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR

K021535 is an FDA 510(k) clearance for ADVIA CANTAUR AND ACS:180 INSULIN CALIB..., manufactured by Bayer Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K021535 · Bayer Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
48d
Days
Class 2
Risk

K021535 is an FDA 510(k) clearance for the ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 27, 2002 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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

FDA 510(k) Submission Details - K021535

510(k) Number K021535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date June 27, 2002
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 215
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K021535.
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