ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR

K021535 · Bayer Diagnostics Corp. · JIT · Jun 27, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021535
• Device Name: ADVIA CANTAUR AND ACS:180 INSULIN 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 Insulin immunoassays on the automated analyzers marketed by Bayer Corporation.

Device Story

Casein-buffered solution containing potassium thiocyanate and sodium azide; used as calibrator for ADVIA Centaur and ACS:180 insulin immunoassays. Device functions as reference standard for automated chemiluminescence immunoassay systems. Used in clinical laboratory settings by trained personnel to establish calibration curves for insulin quantification. Output enables accurate measurement of serum insulin levels, assisting clinicians in diagnosing and managing diabetes mellitus and hypoglycemia.

Clinical Evidence

Bench testing only. Accuracy and precision evaluated by comparing control dose data across three levels (14.63-121.27 mIU/L range) on ADVIA Centaur and ACS:180 systems against the TOSOH predicate. Results showed within-run %CV of 2.6-4.8% and total %CV of 3.1-8.1%. Percent recovery vs. TOSOH ranged from 88.0% to 101.0%.

Technological Characteristics

Casein-buffered solution; contains potassium thiocyanate and sodium azide. Standardized to WHO 66/304. Designed for use with automated chemiluminescence immunoassay analyzers.

Indications for Use

Indicated for calibration of insulin immunoassays used for quantitative determination of insulin in human serum to aid in the diagnosis and treatment of diabetes mellitus and hypoglycemia.

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

• ST AIA-PACK IRI Calibrator Set (K903628)

Submission Summary (Full Text)

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K021535

# Bayer Diagnostics

## ASC:180 and ADVIA Centaur Insulin Calibrator Section 2: Summary of Safety and Effectiveness

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

JUN 2 7 2002

#### 1. Submitter Information

| | Contact person: | Kenneth T. Edds Ph.D. | |
|----|---------------------------------------------------------|-----------------------------------------------------------------------------------------------|--|
| | Address:<br>511 Benedict Ave.<br>Tarrytown, NY 10591 | Bayer Diagnostics Corporation | |
| | Phone:<br>FAX:<br>e-mail: | [phone]<br>[phone]<br>[e-mail] | |
| | Date Summary Prepared: | April 29, 2002 | |
| 2. | Device Information | | |
| | Proprietary Name: | ADVIA Centaur and ACS:180 Insulin<br>Calibrator | |
| | Common Name: | Calibrator for immunoassay analyte | |
| | Classification Name:<br>Class:<br>CFR:<br>Product Code: | Calibrator §862.1150.<br>Class II<br>862.1150<br>75 JIT | |
| 3. | Predicate Device Information | | |
| | Name: | ST AIA-PACK IRI Calibrator Set | |
| | Manufacturer: | TOSOH Corporation<br>TOSOH Kyobashi Building<br>3-2-4 Kyobashi, Chuo-ku, Tokyo 104-0031 Japan | |
| | Japan | Phone: [phone]<br>Fax: [phone] | |
| | 510(k) Number: | K903628 | |

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#### 4. Device Description

The ACS:180 and ADVIA Centaur Insulin Calibrator is a casein buffered solution containing potassium thiocyanate and sodium azide.

#### 5. Statement of Intended Use

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

#### 6. Summary of Technological Characteristics

The ADVIA Centaur and ACS:180 Insulin Calibrators are similar to the TOSOH Corporation AIA-PACK IRI Calibrator Set (K903628) in the indications for use, and reference method for standardization, WHO 66/304. In the ACS:180 and ADVIA Centaur Insulin calibrator a buffer base is used to replace the human serum base used in the TOSOH Corporation AIA-PACK IRI Calibrator Set.

#### 7. Accuracy and Precision

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

Substantial equivalence to the AIA-PACK IRI 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 | 14.63 | 2.7 | 3.6 | |
| AIA TOSOH | Level 2 | 48.71 | 2.1 | 2.9 | |
| AIA TOSOH | Level 3 | 121.27 | 2.1 | 3.0 | |
| ADVIA Centaur | Level 1 | 14.78 | 2.9 | 3.1 | 101.0 |
| ADVIA Centaur | Level 2 | 42.85 | 2.8 | 2.7 | 88.0 |
| ADVIA Centaur | Level 3 | 121.82 | 2.6 | 3.3 | 100.5 |
| ACS:180 | Level 1 | 14.26 | 4.8 | 8.1 | 97.5 |
| ACS:180 | Level 2 | 43.79 | 3.9 | 7.6 | 89.9 |
| ACS:180 | Level 3 | 120.58 | 3.1 | 5.9 | 99.4 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### JN 2 7 2002

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

Re: k021535

> Trade/Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Insulin 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, listing 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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Page 2 -

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 ' 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 Putman

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 of

## 510(k) Number (if known): __ K 0315 35

Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Insulin Calibrator

#### Indications for Use:

The ACS:180 and ADVIA Centaur Insulin calibrators are used for calibrating the ACS:180 and ADVIA Centaur Insulin Immunoassays.

The ACS:180 and ADVIA Centaur Insulin are sandwich, chemiluminescence immunoassay for the quantitative determination of Insulin in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur Insulin Immunoassays can be used to aid in the diagnosis and treatment of diabetes mellitus and hypoglycemia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Dean Cooper

División Sian-Off) Division of Clinical Laborator 510(k) Number .