ADVIA CENTAUR TSH

K141999 · Siemens Healthcare Diagnostics, Inc. · JLW · Apr 22, 2015 · Clinical Chemistry

Device Facts

• Record ID: K141999
• Device Name: ADVIA CENTAUR TSH
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Apr 22, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Indications for Use

The ADVIA Centaur TSH assay is an in vitro diagnostic assay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA, heparin) using the ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems.

Device Story

ADVIA Centaur TSH is an in vitro diagnostic assay for quantitative TSH determination in serum. It utilizes a two-site sandwich immunoassay with direct chemiluminometric technology; monoclonal mouse anti-TSH antibody labeled with acridinium ester (Lite Reagent) and polyclonal sheep anti-TSH antibody coupled to paramagnetic particles (Solid Phase). The assay is performed on ADVIA Centaur, XP, and XPT systems. The system incubates samples at 37°C; uses a Photo Multiplier Tube (PMT) for photon counting. Healthcare providers use the resulting TSH concentration to diagnose thyroid or pituitary disorders. The XPT system introduces updated hardware (Intel Quad processor, ARM 9 real-time CPU) and software (Windows 7, integrated QC) compared to the XP model, while maintaining identical assay chemistry and performance principles.

Clinical Evidence

Bench testing only. Verification and validation activities performed to assess impact of assay measuring range change and system hardware/software modifications. Risk analysis conducted to confirm modifications do not adversely affect device performance.

Technological Characteristics

Two-site sandwich immunoassay; direct chemiluminometric detection using acridinium ester label and paramagnetic particle solid phase. Reaction temperature 37°C. Hardware: Intel Quad processor (UI), ARM 9 CPU (Real-time control). Connectivity: Networked printer support, remote diagnostics, barcode reader (1D/2D). Software: Windows 7 OS, Nucleus OS (real-time). Sterilization: Not applicable (reagent-based).

Indications for Use

Indicated for the quantitative determination of TSH in human serum and plasma to aid in the diagnosis and monitoring of thyroid disorders.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Predicate Devices

• ADVIA Centaur TSH (K910981)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K141999

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): ADVIA Centaur TSH.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. ADVIA Centaur TSH (k910981).
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

A. Changing the measuring range of the TSH assay from 0.01-150 µIU/mL to 0.05 - 150 µIU/mL.
B. Labeling change to the ADVIA Centaur TSH assay to reflect new LoQ result.
C. Modifications in the ADVIA Centaur XPT Immunoassay System, including:

i. Remanufacture of PC boards and cables with RoHS compliant (lead-free) components, and the replacement of fire retardant substances applied to the instrument covers.
ii. Replace the Sun-based PC used for the User Interface and Real-Time application.
iii. Updated User Interface application.
iv. Eliminate monthly cleaning procedure.
v. Change the mounting location of the reagent refrigeration hardware.
vi. Additional 2D barcode capability.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance studies of the ADVIA Centaur TSH assay.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.