ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR

K021532 · Bayer Diagnostics Corp. · JIT · Jun 27, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021532
• Device Name: ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
• Applicant: Bayer Diagnostics Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For use in calibrating the ADVIA Centaur and ACS:180 C-peptide immunoassays on the automated analyzers marketed by Bayer Corporation.

Device Story

The device is a calibrator solution consisting of citric acid buffered saline, casein, and preservatives. It is used to calibrate the ADVIA Centaur and ACS:180 automated immunoassay systems. These systems perform sandwich chemiluminescence immunoassays to quantitatively determine C-peptide levels in human serum. The calibrator is used by laboratory professionals in a clinical setting to ensure the accuracy of the immunoassay results. By establishing a reference point for the assay, the calibrator enables the healthcare provider to obtain reliable quantitative measurements of C-peptide, which assists in the clinical assessment and management of patients with insulin secretion disorders, such as diabetes mellitus.

Clinical Evidence

Bench testing only. Accuracy and precision were evaluated by comparing the subject device to the predicate (AIA-PACK C-Peptide Calibrator Set). Performance metrics included within-run and total %CV across three levels of control samples. Recovery rates vs. the predicate were reported, with values ranging from 83.6% to 99.8%.

Technological Characteristics

Citric acid buffered saline with casein and preservatives. Standardized to WHO 84/510. Used as a liquid calibrator for automated chemiluminescence immunoassay systems.

Indications for Use

Indicated for calibration of C-peptide immunoassays used to aid in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus. For use in human serum on automated analyzers.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• AIA-PACK C-Peptide Calibrator Set (K951848)

Reference Devices

• AIA-PACK C-Peptide Calibrator Set (K971998)

Submission Summary (Full Text)

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# Bayer Diagnostics ASC:180 and ADVIA Centaur C-peptide Calibrator Section 2: Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitter Information

| Contact person: | Kenneth T. Edds Ph.D. |
|---------------------------------|-----------------------------------------------------------------------------------------|
| Address: | Bayer Diagnostics Corporation<br>511 Benedict Ave.<br>Tarrytown, NY 10591 |
| Phone: | [phone] |
| FAX: | [phone] |
| e-mail: | [e-mail] |
| Date Summary Prepared: | April 29, 2002 |
| 2. Device Information | |
| Proprietary Name: | ADVIA Centaur and ACS:180 C-peptide<br>Calibrator |
| Common Name: | Calibrator for immunoassay analyte |
| Classification Name: | Calibrator §862.1150. |
| Class: | Class II |
| CFR: | 862.1150 |
| Product Code: | 75 JIT |
| 3. Predicate Device Information | |
| Name: | AIA-PACK C-Peptide Calibrator Set |
| Manufacturer: | TOSOH Corporation<br>TOSOH Kyobashi Building<br>3-2-4 Kyobashi, Chuo-ku, Tokyo 104-0031 |
| Japan | Phone: [phone]<br>Fax: [phone] |

510(k) Number:

K951848

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#### 4. Device Description

The ACS:180 and ADVIA Centaur C-peptide Calibrator is a citric acid buffered saline with casein and preservatives (micro-protect).

#### 5. Statement of Intended Use

For use in calibrating the ADVIA Centaur and ACS:180 C-peptide immunoassays on the automated analyzers marketed by Bayer Corporation.

#### 6. Summary of Technological Characteristics

The ADVIA Centaur and ACS:180 C-peptide Calibrators are similar to the TOSOH Corporation AIA-PACK C-Peptide Calibrator Set (K971998) in the indications for use, and reference method for standardization, WHO 84/510. In the ACS:180 and ADVIA Centaur Cpeptide calibrator a buffer base is used to replace the protein matrix used in the TOSOH Corporation AIA-PACK C-Peptide Calibrator Set.

#### 7. Accuracy and Precision

The commercial control dose data represented in this document was generated using the calibrators for each respective C-peptide immunoassay.

Substantial equivalence to the AIA-PACK C-Peptide Calibrator Set is based on comparison of the control accuracy and precision of the ADVIA Centaur and ACS:180 to the predicate device.

| System | Sample ID | Mean | Within Run<br>%CV | Total<br>%CV | % Recovery<br>vs TOSOH |
|---------------|-----------|-------|-------------------|--------------|------------------------|
| AIA TOSOH | Level 1 | 1.71 | 2.8 | 5.7 | |
| | Level 2 | 5.23 | 2.0 | 5.8 | |
| ACS:180 | Level 1 | 1.63 | 4.3 | 9.8 | 95.3 |
| | Level 2 | 5.22 | 3.2 | 6.1 | 99.8 |
| | Level 3 | 11.72 | 3.6 | 7.6 | NA |
| ADVIA Centaur | Level 1 | 1.43 | 3.7 | 6.1 | 83.6 |
| | Level 2 | 4.88 | 4.0 | 5.1 | 93.3 |
| | Level 3 | 10.60 | 4.1 | 6.2 | NA |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with three heads in profile, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 2 7 2002

Kenneth T. Edds, Ph.D. Manager. Regulatory Affairs Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k021532

> Trade/Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur C-peptide Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: May 3, 2002 Received: May 10, 2002

Dear Dr. Edds:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known):

Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur C-peptide Calibrator

### Indications for Use:

The ACS:180 and ADVIA Centaur C-peptide calibrators are used for calibrating the ACS:180 and ADVIA Centaur C-peptide Immunoassays.

The ACS:180 and ADVIA Centaur C-peptide are sandwich, chemiluminescence immunoassay for the quantitative determination of C-peptide in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur C-peptide Immunoassays can be used to aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

### (PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Clinical Laboratory Devic 510(k) Number