ADVIA CHEMISTRY MICROALBUMIN CONTROLS

K052242 · Bayer Healthcare, LLC · JJW · Oct 3, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052242
• Device Name: ADVIA CHEMISTRY MICROALBUMIN CONTROLS
• Applicant: Bayer Healthcare, LLC
• Product Code: JJW · Clinical Chemistry
• Decision Date: Oct 3, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of ADVIA® Chemistry systems for the microalbumin method. For Prescription Use Only

Device Story

ADVIA® Chemistry Microalbumin Controls are human urine-based solutions used as quality control material for the ADVIA® Chemistry systems. The device consists of two levels of control material to monitor the performance of the Microalbumin assay. It is used in clinical laboratory settings by laboratory professionals to verify the accuracy and precision of the analytical system. By comparing the measured values of the control against established target ranges, clinicians ensure the reliability of patient test results, facilitating accurate diagnosis and monitoring of conditions related to microalbuminuria.

Clinical Evidence

No clinical data. Performance was validated through bench testing of stability and control value consistency.

Technological Characteristics

Lyophilized human urine-based solution; two-level control format; intended for use with ADVIA® Chemistry systems. Stability: 28 days at 2-8°C when reconstituted; 24-month shelf life.

Indications for Use

Indicated for in vitro diagnostic use as a quality control material to monitor the precision of ADVIA Chemistry system microalbumin testing procedures.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Urine Controls (K043266)

Submission Summary (Full Text)

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OCT 3 - 2005

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ADVIA® Chemistry Microalbumin Controls

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

The assigned 510(k) number is:

The assigned 510(k) number is: K052242

### 1. Submitter's name, address and telephone number:

Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC A subsidiary of Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591 TEL: [phone] FAX: [phone] Email: [e-mail]

#### 2. Name of the device:

- a) Classification Names: Quality Control Material, §862.1660 Classification: Class I Product Code: 75 JJW
- b) Common name: Assayed Quality Control Material
- c) Proprietary name: ADVIA® Chemistry Microalbumin Controls
- d) The device:

| Product Name | Part Number |
|-------------------------------------------|-------------|
| ADVIA® Chemistry<br>Microalbumin Controls | 02185464 |

- e) Contract Manufacturing Site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK

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#### 3. Predicate Device:

| Product Name | Part Numbers |
|----------------|----------------|
| Urine Controls | AU2352, AU2353 |

Contract Manufacturing Site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK

510(k) Number: K043266

#### 4. Description of the device:

The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.

#### 5. Statement of Intended Use

ADVIA® Chemistry Microalbumin Controls is intended for in vitro diagnostic use in the control of ADVIA® Chemistry systems for the Microalbumin method.

#### 6. Product Performance

The stability of the ADVIA® Chemistry Microalbumin Control values have been validated according to established procedures at the manufacturing site. The performance of the control is similar to other products in commercial distribution intended for similar use.

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# 7. Substantial Equivalence:

| Feature | Predicate Urine Controls<br>(K043266) | ADVIA® Chemistry<br>Microalbumin Control |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Format | Lyophilized mixture of human<br>urine base to which<br>appropriate constituents have<br>been added to achieve<br>specific concentrations. | Same |
| Constituent Analytes | • Multiple analytes | • Microalbumin values<br>only |
| Stability | • Reconstituted urine<br>controls are stable for 8<br>hours at 25°C and 5 days<br>at 4°C if kept capped in<br>original container and free<br>from contamination or 14<br>days at -20°C. | • Reconstituted, capped<br>and stored at 2-8°C<br>stable for 28 days<br>• 24 month shelf life |
| Levels | • Two levels | Same |

Andrea Halle

Andres Holle Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

8/12/2005
Date

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

OCT 3 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k052242

> Trade/Device Name: ADVIA® Chemistry Microalbumin Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 12, 2005 Received: August 18, 2005

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/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting 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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# Indications for Use

510(k) Number (if known): K052242

Device Name: ADVIA® Chemistry Microalbumin Control

Indications For Use:

The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.

Prescription Use X (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

Division S

Office of In Vitro Diagnostic Device Evaluation and Safety

052142

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