CO2 CALIBRATOR/DILUENT

K033643 · Bayer Healthcare, Diagnostics Division · JIT · Jan 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033643
• Device Name: CO2 CALIBRATOR/DILUENT
• Applicant: Bayer Healthcare, Diagnostics Division
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jan 8, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The CO2 Calibrator/Diluent is intended for in vitro diagnostic use to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product.

Device Story

The CO2 Calibrator/Diluent is an aqueous liquid solution containing bicarbonate at a defined concentration. It is used in clinical laboratory settings to calibrate enzymatic CO2 assays on Bayer diagnostic instruments. For Technicon RA, opeRA, and ADVIA IMS systems, it is used with the Bayer Chemistry Calibrator; for ADVIA Chemistry systems, it is used as a stand-alone product. The calibrator ensures the accuracy of CO2 measurements, which are critical for assessing patient acid-base status and metabolic function. Healthcare professionals use the resulting instrument calibration to ensure reliable diagnostic test outputs.

Clinical Evidence

Bench testing only. Stability of the CO2 Calibrator/Diluent value was validated using three separate lots of calibrator material. No clinical data provided.

Technological Characteristics

Aqueous liquid solution containing bicarbonate. Stable at 2-8°C until the expiration date printed on the label; stable for 30 days once opened and stored at 2-8°C. Designed for use with Bayer diagnostic instruments.

Indications for Use

Indicated for in vitro diagnostic calibration of enzymatic CO2 determination on Bayer diagnostic instruments (Technicon RA, opeRA, ADVIA IMS, and ADVIA Chemistry systems).

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

• Calibrator for automated systems (K990460)

Submission Summary (Full Text)

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JAN - 8 2004

# Assigned 510(k) number: Ko3 3643

# Bayer Healthcare CO2 Calibrator/Diluent 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 Healthcare Diagnostics Division 511 Benedict Ave. Tarrytown, NY 10591

| Phone: | [phone] |
|---------|-----------------------|
| FAX: | [phone] |
| e-mail: | [e-mail] |

Date Summary Prepared:

November 17, 2003

## 2. Device Information

Proprietary Name: Common Name:

Classification Name: Class: CFR: Product Code:

CO2 Calibrator/Diluent Calibrator

Calibrator Class II 862.1150 75 JITT

#### Predicate Device Information 3.

Name:

Manufacturer:

Calibrator for automated systems

Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IN 46250

510(k) Number:

### K990460

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#### Device Description 4.

The CO2 Calibrator/Diluent is an aqueous liquid solution containing bicarbonate at a defined concentration.

#### క. Statement of Intended Use

The CO2 Calibrator/Diluent is intended for in vitro diagnostic use to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product.

#### Product Performance 6.

The stability of the CO2 Calibrator/Diluent value has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material. The performance of the calibrator is similar to other products in commercial distribution intended for similar use.

#### Roche Calibrator for Automatic CO2 Calibrator/Diluent Characteristic System The CO2 Calibrator/Diluent is intended for For use as a calibrator of clinical Intended use chemistry assays for automated in vitro diagnostic use to calibrate the analytical procedures. enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product. Lyophilized pooled human Liquid - aqueous solution Format serum with constituents added as required to obtain desired component levels. Stable at 2-8ºC until Stable at 2-8 ℃ until last day of the . Stability . month (expiration date) printed on label. expiration date. Stable for thirty (30) days when properly Stable 2 days when . . capped once the diluent vial is opened reconstituted, stoppered, protected from light and and stored at 2-8°C. stored at 2-8ºC, with exception noted in labeling. Single level Single level Level

#### 7. Product Characteristics

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| Bayer SETpoint CO2 calibrator/Diluent | Roche Calibrator for Automated Systems |
|---------------------------------------|----------------------------------------|
| Bicarbonate | Bicarbonate |
| | ALBUMIN |
| | BILIRUBIN, DIRECT |
| | BILIRUBIN, TOTAL |
| | CALCIUM |
| | CHOLESTEROL |
| | CREATININE |
| | GLUCOSE |
| | IRON |
| | MAGNESIUM |
| | PHOSPHORUS. INORGANIC |
| | TOTAL PROTEIN |
| | TRIGLYCERIDES |
| | UREA NITROGEN |
| | URIC ACID |
| | SODIUM |
| | POTASSIUM |
| | CHLORIDE |
| | LACTATE |
| | PHOSPHOLIPIDS |
| | SALICYLATE |
| | UNSATURATED IRON-BINDING CAPACITY |
| | ACID PHOSPHATASE |
| | ALKALINE PHOSPHATASE |
| | ALANINE AMINOTRANSFERASE |
| | CHOLINESTERASE |
| | CREATINE KINASE |
| | GAMMA-G:UTAMYLTRANSFERase |
| | GLUTAMATE DEHYDROGENASE |
| | ALPHA-HYDROXYBUTRATE DEHYDROGENASE |
| | LACTATE DEHYDROGENASE |
| | LIPASE |
| | UIBC |
| | LDI |

:

## Constituent Analytes

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 8 2004

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

k033643 Re:

Trade/Device Name: Calibrator/diluent for CO2 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 19, 2003 Received: November 20, 2003

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 for use sunce in the encreases 776 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 r ou may, dicrorore, mains of the Act include requirements for annual registration, listing of general of the profice, 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 it may or bund in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Tear announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that + DT Has Intactions and regulations administered by other Federal agencies. You must or un+ x with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

KO33643 510(k) Number (if known):

Device Name: Calibrator/diluent for CO2

## Indications for Use:

The CO2 Calibrator/Diluent is intended for in vitro diagnostic use to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product.

## (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

(Optional Format 1-2-

(Per 21 CFR 801.109) 96)

Nleets L

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**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k033643