B2-MICROGLOBULIN CONTROL SET SERUM

K982471 · Boehringer Mannheim Corp. · JJX · Aug 6, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982471
• Device Name: B2-MICROGLOBULIN CONTROL SET SERUM
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Boehringer Mannheim β2-microglobulin Control Set Serum is used for the quality control of the Boehringer Mannheim Tinaquant β2-microglobulin assay.

Device Story

The β2-microglobulin Control Set Serum is an in vitro diagnostic control product used in clinical laboratory settings to monitor the performance of the Tinaquant β2-microglobulin assay. The device consists of human serum albumin, β2-microglobulin, and stabilizers, provided in a lyophilized form that requires reconstitution with distilled water. During manufacturing, the analyte is spiked into the control matrix to achieve specific concentration levels (2.50 mg/L and 5.50 mg/L). Value assignment is performed by comparing the control to an analyte-specific and chemistry-specific calibrator. Laboratory professionals use the control to verify the accuracy and precision of the assay system, ensuring reliable patient test results.

Clinical Evidence

No clinical data. Performance characteristics were established through bench testing, including dose assignment and stability studies, to verify the control's ability to monitor the accuracy and precision of the Tinaquant β2-microglobulin assay.

Technological Characteristics

Lyophilized human serum-based control; contains human serum albumin, β2-microglobulin, and stabilizers. Requires reconstitution with distilled water. Value assignment via comparison to analyte-specific calibrators. No electronic components or software algorithms.

Indications for Use

Indicated for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant β2-microglobulin assay.

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

• Abbott Imx β2-microglobulin assay (K890421)

Submission Summary (Full Text)

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510(k) Summary

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K982471

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.<br>Submitter<br>name,<br>address,<br>contact | Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA 94588-2722<br>[phone]<br>Fax number: [phone] |
| | Contact Person: Julie A. Smith |
| | Date Prepared: July 13, 1998 |
| 2.<br>Device Name | Proprietary name: β2-microglobulin Control Set Serum |
| | Common name: Controls |
| | Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.<br>Predicate<br>device | The Boehringer Mannheim β2-microglobulin Control Set Serum is a new<br>product. |
| | The Boehringer Mannheim β2-microglobulin Control Set Serum is<br>substantially equivalent to other products in commercial distribution intended<br>for similar use. Most notably it is substantially equivalent to the β2-<br>microglobulin controls contained in the Abbott Imx β2-microglobulin assay<br>(K890421). |
| 4.<br>Device<br>Description | The Boehringer Mannheim β2-microglobulin Control Set Serum is<br>manufactured using human serum albumin, β2-microglobulin, and stabilizers.<br>The analyte is appropriately spiked into the control matrix to the correct<br>control concentration levels. The controls are in process checked, and a value<br>assignment process is done via a comparison to an analyte specific (and<br>chemistry specific) calibrator. |
| 5.<br>Intended use | Boehringer Mannheim β2-microglobulin Control Set Serum is used for the<br>quality control of the Boehringer Mannheim Tinaquant β2-microglobulin<br>assay. |
| 6.<br>Comparison<br>to predicate<br>device | The Boehringer Mannheim β2-microglobulin Control Set Serum is substantially<br>equivalent to other products in commercial distribution intended for similar use.<br>Most notably it is substantially equivalent to the β2-microglobulin controls<br>contained in the Abbott Imx β2-microglobulin assay (K890421).<br>The following table compares the Boehringer Mannheim β2-microglobulin<br>Controls Set Serum with Abbott β2-microglobulin controls. Specific data on<br>the performance of the controls have been incorporated into the draft labeling in<br>attachment 5. Labeling for the predicate device is provided in attachment 6. |
| | Similarities:<br>• Similar intended use<br>• Same analyte |

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# 510(k) Summary, Continued

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# 510(k) Summary, Continued

## Differences:

| Feature | β2-microglobulin Control Set<br>Serum | Abbott β2-microglobulin control |
|----------------|---------------------------------------------------------------------------|---------------------------------|
| Control levels | 2.50 mg/L | 0.2 mg/L |
| | 5.50 mg/L | 0.6 mg/L |
| | | 2 mg/L |
| Matrix | Human Serum | Buffer with protein stabilizers |
| Preparation | Lyophilized calibrators requiring<br>reconstitution with distilled water. | Ready to use liquid calibrators |

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| Comparison<br>to predicate | Performance Characteristics: | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| device, (cont.) | .<br>Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children C | |

- Dose assignment and stability

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 6 1638

Julie A. Smith Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

Re : K982471 ß2-microglobulin Control Set Requlatory Class: I Product Code: JJX Dated: July 13, 1998 Received: July 16, 1998

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ਼ੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements; as setforth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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## K982471 510(k) Number (if known): NA

Device Name: ß2-microglobulin Control Set Serum

Indications For Use:

The ß2-microglobulin Control Set Serum is used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant ß2-microglobulin assay.

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------|--------------------------------------------------------|--|--|
| Prescription Use | | | |
| (Per 21 CFR 801.109) | | | |
| OR | | | |
| Over-The-Counter Use | | | |
| (Optional Format 1-2-96) | | | |

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K982471

Boehringer Mannheim page 23 B2-Microglobulin Control Set Serum