ELECSYS CALCHECK CA 125II

K981278 · Roche Diagnostics GmbH · JJX · Apr 23, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981278
• Device Name: ELECSYS CALCHECK CA 125II
• Applicant: Roche Diagnostics GmbH
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ CA 125II is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CA 125II assay.

Device Story

Elecsys® CalCheck™ CA 125II is a calibration verification material used in clinical laboratory settings to ensure the accuracy of the Elecsys® CA 125II immunoassay. The device consists of three levels of solutions (low, mid, high) containing human serum albumin, CA 125 analyte, stabilizers, and preservatives. These solutions are processed and quality-controlled against ID-GC/MS. Laboratory technicians use the product to verify that the analyzer's calibration remains within specified limits across the measuring range. By confirming the calibration, the device helps ensure the reliability of patient test results, which are used by clinicians for clinical decision-making regarding cancer monitoring.

Clinical Evidence

Bench testing only. Evaluation focused on value assignment and stability of the calibration verification solutions.

Technological Characteristics

Calibration verification material consisting of human serum albumin, CA 125 analyte, stabilizers, and preservatives. Quality controlled via ID-GC/MS. Designed for use with automated immunoassay analyzers.

Indications for Use

Indicated for periodic verification of calibration for the Elecsys® CA 125II assay using three concentration levels (low, mid, high) spanning the assay's measuring range.

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

• Elecsys® CalCheck™ TSH

Submission Summary (Full Text)

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APR 23 1998

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## 510(k) Summary

| 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 | Roche Diagnostics/Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA 94566-0900<br>(925) 730 - 8215<br>Fax number: (925) 225 - 0654 |
| | Contact Person: Patricia M. Klimley |
| | Date Prepared: April 7, 1998 |
| 2.<br>Device Name | Proprietary name: Elecsys® CalCheck™ CA 125II<br>Common name: Calibration Verification Material<br>Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.<br>Predicate<br>device | The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys®<br>CalCheck™ CA 125II is substantially equivalent to the currently marketed<br>Elecsys® CalCheck™ TSH. |
| 4.<br>Device<br>Description | The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CalCheck<br>CA 125II is manufactured using human serum albumin, CA 125, stabilizers,<br>and preservatives. The analyte is appropriately spiked into the calcheck<br>matrix to the correct calcheck concentration levels. The calcheck are in<br>process checked and quality controlled against ID-GC/MS. |
| 5.<br>Intended use | The Roche Diagnostics/Boehringer Mannheim CorporationElecsys®<br>CalCheck™<br>CA 125II is used to verify the calibration assignment for the<br>Roche Diagnostics/Boehringer Mannheim CorporationElecsys CA 125II<br>assay. |
| 6.<br>Comparison<br>to predicate<br>device | The Roche Diagnostics/Boehringer Mannheim CorporationElecsys®<br>CalCheck™ CA 125II is substantially euivalent to other products in<br>commercial distribution intended for similar use. Most notably, it is<br>substantially equivalent to the currently marketed Elecsys® CalCheck™<br>TSH. |
| | Both products are intended to be used for the verification of calibration for<br>analytes on automated immunoassay analyzers. |
| 7. Performance<br>Characteristics | The Elecsys® CalCheck™ CA 125II was evaluated for value assignment and<br>stability. |

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## 510(k) Summary, Continued

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 3 1998

Patricia M. Klimley Manager, Elecsys Regulatory Affairs Roche Diaqnostics/Boehringer Manneim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

Re : K981278 Elecsys® CalCheck™ CA 125II Requlatory Class: I Product Code: JJX Dated: April 7, 1998 Received: April 8, 1998

Dear Ms. Klimley:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ನ್ನ substantially equivalent determination assumes compliance with ... the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulation may result in regulatory 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 Bitman

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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510(k) Number (if known):

Device Name: Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ CA 125II

Indications For Use:

Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys® CalCheck™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay. . . . . . . . . . . . . . . . . . . . . . . . .

(Division Sign-off)
Division of Clinical Cancer vices
510(k) Number k98 298

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|----------------------|-------------------------------------------------------------------|
| Prescription Use | <div style="display:inline-block; vertical-align:middle;">✓</div> |
| (Per 21 CFR 801.109) | |
| | OR |
| Over-The-Counter Use | |
| | (Optional Format 1-2-96) |

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