BAYER SPECIFIC PROTEIN REFERENCE SERUM

K033791 · Bayer Healthcare, LLC · JIX · Feb 13, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033791
• Device Name: BAYER SPECIFIC PROTEIN REFERENCE SERUM
• Applicant: Bayer Healthcare, LLC
• Product Code: JIX · Clinical Chemistry
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For in vitro diagnostic use in the calibration of the ADVIA 1650 Technicon RA-500, Technicon RA-1000, Technicon RA-XT, Technicon RA-2000, opeRA chemistry systems specific protein methods.

Device Story

Specific Protein Reference Serum is a human serum-based calibrator material containing specific protein analytes (C4, IgA, IgG, IgM, Transferrin, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Haptoglobin, Ceruloplasmin). It is used in clinical laboratory settings to calibrate Bayer chemistry analyzers. The product is supplied as a concentrate requiring dilution with a provided sample diluent. By establishing assigned values for specific proteins, the calibrator enables the analyzer to accurately quantify patient sample concentrations, supporting clinical diagnostic decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Human serum-based calibrator material; requires dilution with provided sample diluent; intended for use on specific Bayer chemistry analyzers; no electronic or software components.

Indications for Use

Indicated for in vitro diagnostic calibration of specific protein methods on Bayer ADVIA 1650, Technicon RA-500, RA-1000, RA-XT, RA-2000, and opeRA 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

• Specific Protein Reference Serum (K833402)

Submission Summary (Full Text)

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## 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:________________________________________________________________________________________________________________________________________________

# 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

Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645-0307 Establishment Registration: 1181121

| Device Name: | Specific Protein Reference Serum |
|------------------------|----------------------------------------------------------------------------|
| Proprietary/Trade Name | Specific Protein Reference Serum |
| Common Name: | Calibrator Material |
| Classification Name: | Calibrator |
| Classification: | Class II |
| Regulation Number: | 21 CFR 862.1150 |
| Panel: | Chemistry (75) |
| Product Code: | JIX |
| Predicate Device: | Specific Protein Reference Serum<br>Premarket Notification Number: K833402 |

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### Device Description:

The Bayer Specific Protein Reference Serum 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: ੍ਰਤ C4 IgA IgG IgM Transferrin Alpha-1-Acid Glycoprotein Alpha-1-Antitrypsin Haptoglobin

The intention of this submission is to add the assigned values to the labeling claims for use in the US for: Haptoglobin

#### Intended Use:

For in vitro diagnostic use in the calibration of the ADVIA 1650 Technicon RA-500, Technicon RA-1000, Technicon RA-XT, Technicon RA-2000, opeRA chemistry systems specific protein methods.

### Substantial Equivalence:

Ceruloplasmin

The Specific Protein Reference Serum are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Specific Protein Reference Serum. The only difference in these calibrators is the addition of the assigned values in the labeling of one new analyte: Haptoglobin.

As with the predicate device, the calibrator materials are a human serum concentrate and dilution is needed with the Specific Protein Sample Diluent provided. These calibrators are for use on the Bayer ADVIA 1650, Technicon RA-1000, Technicon RA-XT, Technicon RA-500, Technicon RA-2000, opeRA chemistry analyzers.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and tail.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 3 2004

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

Re: k033791

> Trade/Device Name: Specific Protein Reference Serum Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: November 17, 2003 Received: December 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 (QS) regulation (21 CFR Part 820).

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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). You may obtain other general information on your responsibilities under the Act 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.

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K033991 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Specific Protein Reference Serum

## Indications for Use:

For in vitro diagnostic use in the calibration of the ADVIA 1650 Technicon RA-500, Technicon RA-1000, Technicon RA-XT, Technicon RA-2000, opeRA chemistry systems specific protein methods.

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

(ODE) Concurrence of CDRH, Office of Device Evaluation

| Prescription Use | <div> <span>✓</span> </div> | OR | Over-The-Counter |
|----------------------|-----------------------------|----|------------------|
| Use | | | |
| (Per 21 CFR 801.109) | | | (Optional Format |
| 1-2-96) | | | |

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k053741