CEDIA DIGOXIN CALIBRATORS

K972433 · Boehringer Mannheim Corp. · DLJ · Jul 24, 1997 · Clinical Toxicology

Device Facts

• Record ID: K972433
• Device Name: CEDIA DIGOXIN CALIBRATORS
• Applicant: Boehringer Mannheim Corp.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Jul 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II assay on the Beckman Synchron. The CEDIA Digoxin Calibrators are used to determine drug concentrations.

Device Story

CEDIA Digoxin Calibrators are liquid-based calibrators containing bovine serum albumin, digoxin, stabilizers, and preservatives. Used in clinical laboratory settings to calibrate the CEDIA Digoxin II assay on Beckman Synchron analyzers. Calibrators are value-assigned by comparison to reference standards to ensure accurate assay calibration. Healthcare providers use the resulting assay output to monitor digoxin levels in patients, facilitating therapeutic drug management. The device provides the necessary reference points for the analyzer to quantify digoxin concentrations in patient serum samples.

Clinical Evidence

Bench testing only. Performance demonstrated via method comparison showing equivalent correlation to the predicate device and equivalent open-vial and shelf-life stability.

Technological Characteristics

Liquid calibrator matrix consisting of bovine serum albumin, digoxin, stabilizers, and preservatives. Designed for use with the CEDIA Digoxin II assay on Beckman Synchron analyzers. No specific ASTM standards or software algorithms described.

Indications for Use

Indicated for use in the calibration of the CEDIA Digoxin II assay to determine digoxin drug concentrations in patient samples.

Regulatory Classification

Identification

A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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

• CEDIA Cardiac TDM Multi-Calibrators (K962269)

Submission Summary (Full Text)

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K972433

| | JUL 24 1997 |
|--|-------------|
|--|-------------|

| <b>BOEHRINGER MANNHEIM CORPORATION</b> | <b>Summary</b> |
|----------------------------------------|----------------|
|----------------------------------------|----------------|

Introduction

According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence.

| 1.<br>Submitter<br>name,<br>address,<br>contact | Boehringer Mannheim Corporation<br>2400 Bisso Lane<br>Concord, CA 94524-4117<br>[phone] extension 8413<br>Fax number: [phone]<br><br>Contact Person: Yvette Lloyd<br><br>Date Prepared: June 27, 1997 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.<br>Device name | Proprietary name: CEDIA Digoxin Calibrators<br><br>Common name: Therapeutic drug monitoring calibrators for use in the calibration of the CEDIA Digoxin II assay.<br><br>Classification name: Calibrators, drug mixture |
| 3.<br>Predicate<br>device | The Boehringer Mannheim CEDIA Digoxin Calibrators are substantially equivalent to the CEDIA Cardiac TDM Multi-Calibrators (K962269). |
| 4.<br>Device<br>Description | The CEDIA Digoxin Calibrators are manufactured using bovine serum albumin, digoxin, stabilizers, and preservatives. The drug is appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by comparison to the predicate device to ensure correct assay calibration. |

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## Summary, Continued

Image /page/1/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo consists of a black square with the word "mannheim" written vertically along the left side. Inside the square is a white circle with the word "boehringer" written horizontally in the center.

| 5.<br>Intended use | The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II<br>assay on the Beckman Synchron. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.<br>Comparison<br>to predicate<br>device | The Boehringer Mannheim CEDIA Digoxin Calibrators are substantially<br>equivalent to the CEDIA Cardiac TDM Multi-Calibrators. |
| | The following table compares the CEDIA Digoxin Calibrators with the<br>predicate device, CEDIA Cardiac TDM Multi-Calibrators. Specific data on<br>the performance of the test have been incorporated into the draft labeling in<br>attachment 5. Labeling for the predicate device in provided in attachment 6. |

## Similarities:

- · Similar concentration of digoxin.
- Similar matrix Differences:

| Feature | CEDIA Digoxin<br>Calibrators | CEDIA Cardiac TDM<br>Multi-Cals |
|---------------|------------------------------|----------------------------------|
| Configuration | sold with reagents in kit | sold separately from<br>reagents |

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## Summary, Continued

Image /page/2/Picture/1 description: The image is a black and white logo. The logo is a black square with the words "mannheim" written vertically along the left side of the square. Inside the square is a white circle with the word "boehringer" written horizontally across the center of the circle.

6. Comparison to predicate device, (cont.)

## Performance Characteristics:

· Method Comparison: equivalent correlation between predicate device Multi-Calibrators and the CEDIA Digoxin Calibrators.

• Stability: equivalent open vial and shelf-life stability performance to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure, emphasizing the department's role within the United States. The logo is presented in black and white, giving it a clean and official appearance.

JUL 2 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

- -

Yvette R. Lloyd Regulatory Affairs Specialist Boehringer Mannheim Corporation 2400 Bisso Lane P.O. Box 4117 Concord, California 94524-4117

K972433 Re : CEDIA Digoxin Calibrators II Requlatory Class: Product Code: DLJ Dated: June 26, 1997 Received: June 30, 1997

Dear Ms. Lloyd:

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 general controls provisions The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Sitman

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): N/A

Device Name: CEDIA® Digoxin Calibrators.

Indications For Use:

ික්ක මෙම විද්‍යාලී

ের পরি

:

The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II assay on the Synchron.

The CEDIA Digoxin Calibrators are used to determine drug concentrations.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number - 1972433