Cleared Traditional

K133601 - ADVIA CENTAUR INTACT PARATHYROID HORMON...

K133601 is an FDA 510(k) clearance for ADVIA CENTAUR INTACT PARATHYROID HORMON..., manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K133601 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
72d
Days
Class 2
Risk

K133601 is an FDA 510(k) clearance for the ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on February 5, 2014 after a review of 72 days - a notably fast clearance 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: 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 Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K133601

510(k) Number K133601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2013
Decision Date February 05, 2014
Days to Decision 72 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
16d faster than avg
Panel avg: 88d · This submission: 72d
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 K133601.
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · Siemens Healthcare Diagnostics, Inc. · May 2017
IDS-iSYS Intact PTHN
K161158 · Immunodiagnostic Systems , Ltd. · Jan 2017
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
K150879 · DiaSorin, Inc. · Jun 2015
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K132515 · DiaSorin, Inc. · Nov 2013
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
K121981 · Siemens Healthcare Diagnostics · Mar 2013
IDS-ISYS INTACT PTH
K103325 · Immunodiagnostic Systems , Ltd. · Feb 2012