← Product Code [CDD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD) · K041133

# MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K041133)

_Bayer Healthcare, LLC · CDD · Jul 2, 2004 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K041133

## Device Facts

- **Applicant:** Bayer Healthcare, LLC
- **Product Code:** [CDD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD.md)
- **Decision Date:** Jul 2, 2004
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1810
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Bayer ADVIA Centaur assay 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 Automated Chemiluminescence Analyzer; modification involves version 3.0 software enhancements. Device performs automated chemiluminescence assays for clinical chemistry analysis. System operates in clinical laboratory settings; used by laboratory technicians/personnel. Software updates address user needs and technological demands. Fundamental scientific technology remains unchanged from predicate. Output used by clinicians for diagnostic decision-making.

## Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, performance features, and software functionality against the predicate device.

## Technological Characteristics

Automated immunoassay analyzer; chemiluminescence sensing principle using acridinium ester label and magnetic-particle solid phase. PMT optical system; 37°C incubation; automated pipetting with air-pressure fluid/tip sensing. Floor-standing unit (60Hx42Dx58L). Connectivity: Serial bi-directional LIS, LAS, and remote diagnostics. Software: Unix-based GUI, distributed real-time computing. Disposables: sample cups, reaction cuvettes, pipette tips.

## Regulatory Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

## Predicate Devices

- Bayer Advia Centaur Automated Chemiluminescence Analyzer ([K032525](/device/K032525.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K041133

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable (delete/add items as necessary) for the MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER:

1. The name and 510(k) number of BAYER HEALTHCARE, LLC's previously cleared device, "Predicate Name", cleared under K032525. (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 version 3.0 software enhancements to meet user needs and future technological demands.

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.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)

revised:3/27/98

March 15, 2013

(Date)

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K041133](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K041133)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com