BAYER SPECIAL CHEMISTRY CALIBRATORS

K033380 · Bayer Diagnostics Corp. · JIX · Dec 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033380
• Device Name: BAYER SPECIAL CHEMISTRY CALIBRATORS
• Applicant: Bayer Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Dec 16, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Special Chemistry Calibrators are calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analvzer.

Device Story

Special Chemistry Calibrator is a lyophilized human serum-based material with added non-serum constituents; used to calibrate the ADVIA 1650 Chemistry analyzer. The device requires reconstitution with 5.0 mL distilled water. It provides absolute values for specific analytes—Acid Phosphatase, Lactate, Lipase, and Direct TIBC—to monitor the precision and accuracy of chemistry test procedures. Used in clinical laboratory settings by trained personnel. The output allows healthcare providers to ensure the accuracy of patient test results on the ADVIA 1650 system, supporting reliable clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Traceability established via master lot comparison on the ADVIA 1650 system.

Technological Characteristics

Lyophilized mixture of human and bovine serum base with added nonhuman constituents. Stable at 2-8°C. Reconstituted stability: 7 days for Lactate, Lipase, and Direct TIBC; 2 days for Acid Phosphatase.

Indications for Use

Indicated for in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

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

• Bayer Special Chemistry Calibrator (K030804)

Submission Summary (Full Text)

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# DEC 1 6 2003

# Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number is: K033380

# Submitter's Name and Address

Bayer Healthcare LLC 511 Benedict Avenue Tarrytown, NY 10591 Establishment Registration Number: 2432235

Contact Person: Andres Holle Telephone: [phone] Fax: [phone] e-mail: [e-mail]

# Contract Manufacturer

Randox Laboratories 55 Diamond Road Crumlin, County Antrim, UK Establishment Registration: 8020890

| Device Name: | Special Chemistry Calibrator |
|------------------------|------------------------------------------------------------------------------|
| Proprietary/Trade Name | Bayer ADVIA 1650 Special<br>Chemistry Calibrator |
| Common Name: | Calibrator Material |
| Classification Name: | Calibrator |
| Classification: | Class II |
| Regulation Number: | 21 CFR 862.1150 |
| Panel: | Chemistry (75) |
| Product Code: | JIX |
| Predicate Device: | Bayer Special Chemistry Calibrator<br>Premarket Notification Number: K030804 |

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#### Device Description:

The Bayer Special Chemistry Calibrators are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.

All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Lipase Direct TIBC

The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC

#### Intended Use:

The Special Chemistry Calibrators are calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analvzer.

#### Substantial Equivalence:

The Special Chemistry Calibrators are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrators. The only difference in these calibrators is the addition of the assigned values in the labeling of one new analyte: Direct TIBC.

As with the predicate device, the calibrator materials are lyophilized and require reconstitution with 5.0 mL distilled water. These calibrators are only for use on the Bayer ADVIA 1650 Chemistry Analyzer.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being. The logo is rendered in black and white.

DEC 1 6 2003

Food and Drug Administration 2098 Gaither Road

Public Health Service

Rockville MD 20850

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591

Re: k033380

> Trade/Device Name: Special Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: October 16, 2003 Received: October 23, 2003

Dear Mr. Holle:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 Butman

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

| 510(k) Number (if known): | k033380 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Special Chemistry Calibrator

# Indications for Use:

For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

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

| Concurrence of CDRH, Office of Device Evaluation | |
|--------------------------------------------------|--|
| (ODE) | |

| Prescription Use Use | <div style="text-align:center;">X</div> | OR | Over-The-Counter |
|---------------------------------|-----------------------------------------|----|-------------------|
| (Per 21 CFR 801.109)<br>1-2-96) | | | (Optional Format) |

Carol C Benem for Jean Cooper, DVM

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033380