Cleared Traditional

K121981 - ADVIA CENTAUR INACT PARATHYROID HORMONE...

K121981 is an FDA 510(k) clearance for ADVIA CENTAUR INACT PARATHYROID HORMONE..., manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K121981 · Siemens Healthcare Diagnostics · Chemistry device
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Mar 2013
Decision
258d
Days
Class 2
Risk

K121981 is an FDA 510(k) clearance for the ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on March 21, 2013 after a review of 258 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K121981

510(k) Number K121981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2012
Decision Date March 21, 2013
Days to Decision 258 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
170d slower than avg
Panel avg: 88d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEW Device Classification - Class 2, Special Controls

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 - CEW Radioimmunoassay, Parathyroid Hormone

All 60
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K121981.
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