Cleared Traditional

K163658 - ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay

K163658 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 151-day FDA review.

K163658 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
151d
Days
Class 2
Risk

K163658 is an FDA 510(k) clearance for the ADVIA Centaur Intact Parathyroid Hormone (PTH) 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 May 23, 2017 after a review of 151 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, Inc. devices

FDA 510(k) Submission Details - K163658

510(k) Number K163658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date May 23, 2017
Days to Decision 151 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
63d slower than avg
Panel avg: 88d · This submission: 151d
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 74
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K163658.
Access Intact PTH
K232791 · Beckman Coulter, Inc. · Mar 2024
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197 · Ortho-Clinical Diagnostics · Sep 2023
Lumipulse G whole PTH
K190702 · Fujirebio Diagnostics,Inc. · Aug 2019
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
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601 · Siemens Healthcare Diagnostics, Inc. · Feb 2014