BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

K032525 · Bayer Healthcare, LLC · NBC · Sep 9, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032525
• Device Name: BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
• Applicant: Bayer Healthcare, LLC
• Product Code: NBC · Clinical Chemistry
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1117
• Device Class: Class 2

Indications for Use

The Bayer ADVIA Centaur is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.

Device Story

Bayer ADVIA Centaur (formerly ACS Centaur Analyzer); automated clinical chemistry analyzer. Modification notification following Bayer Healthcare acquisition of Chiron Diagnostics. Enhancements include: LIS software features; QC program updates; foreign language support; diagnostic tools; maintenance/event log/reagent tracking reports; screen saver; exit queue; new UI module with increased sample capacity; high-resolution barcode scanner. Operated by laboratory personnel in clinical settings. Output used for diagnostic testing and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation of software and hardware modifications.

Technological Characteristics

Automated immunoassay analyzer; chemiluminescent detection using acridinium ester label and paramagnetic particles; PMT optical system; 37°C reaction temperature; random access/batch processing; barcode-based sample/reagent tracking; Unix-based software; bi-directional LIS interface; dimensions/form factor: floor-standing analyzer.

Indications for Use

Indicated for in vitro diagnostic immunochemical analysis of clinical specimens (serum or plasma) for endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease markers. For prescription use only.

Regulatory Classification

Identification

The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

Special Controls

*Classification.* Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”

Predicate Devices

• ACS: Centaur Analyzer (K971418)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K032525 "Special"

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):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
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.
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 notification of the acquisition of Chiron Diagnostics along with the ACS Centaur Analyzer by Bayer Healthcare LLC-Diagnostics Division. Through this submission Bayer intends to provide additional information on the device and its subsequent enhancements as well as summarize some of the control activities that have been done to validate the changes that the instrument has undergone. The name of the instrument was changed to the Bayer ADVIA Centaur. This submission also describes the addition of features in the LIS software, additional features in the QC program, the addition of foreign language support, additional diagnostic tools, new reports for maintenance, the event log and reagent tracking. Also added to the instrument are the following: a screen saver, new exit queue, new User Interface (UI) module with a higher sample capacity and a high resolution barcode screen.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

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
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.