ELECSYS CALLCHECK DIGOXIN

K973973 · Boehringer Mannheim Corp. · DMP · Nov 4, 1997 · Clinical Toxicology

Device Facts

• Record ID: K973973
• Device Name: ELECSYS CALLCHECK DIGOXIN
• Applicant: Boehringer Mannheim Corp.
• Product Code: DMP · Clinical Toxicology
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The Boehringer Mannheim Elecsys CalCheck DIGOXIN is used to verify the calibration assignment for the Boehringer Mannheim Elecsys DIGOXIN assay.

Device Story

Elecsys CalCheck DIGOXIN is a set of three-level, stable, bovine-based liquid materials used to verify calibration of the Elecsys DIGOXIN assay. Device is used in clinical laboratory settings by laboratory personnel. The user assays the materials in triplicate and compares results to target values to confirm the accuracy of the reagent calibration. This verification process ensures the Elecsys DIGOXIN assay maintains performance within its measuring range, supporting accurate clinical decision-making for patients undergoing digoxin therapy.

Clinical Evidence

No clinical data. Bench testing only; performance data incorporated into draft labeling.

Technological Characteristics

Three-level (low, mid, high) single analyte calibration verification material. Matrix: bovine serum. Form: stable liquid. Intended for use with Elecsys DIGOXIN assay.

Indications for Use

Indicated for use in periodic verification of the calibration of the Elecsys DIGOXIN reagent. Solutions comprise three levels (low, mid, high) with defined DIGOXIN concentrations spanning the assay measuring range.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Elecsys® CalCheck™ TSH (K963147)

Submission Summary (Full Text)

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NOV 트'4 1997

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| 510(k) Summary |
|----------------|
|----------------|

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. Submitter name, address, contact | Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>Pleasanton, CA 94588-2722<br>(510) 730 - 8415<br>Fax number: (510) 225 - 0654 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Jody J. Savage<br>Date Prepared: October 17, 1997 |
| 2. Device Name | Proprietary name: Elecsys® CalCheck™ DIGOXIN<br>Common name: Calibration Verification Material<br>Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3. Predicate device | The Elecsys® CalCheck™ DIGOXIN is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147). |
| 4. Device Description | The Elecsys® CalCheck™ DIGOXIN is a three level single analyte set of stable liquid, bovine based materials. They are assayed in triplicate and the results compared to the target values. |

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## 510(k) Summary, Continued

| 5.<br>Intended use | The Boehringer Mannheim Elecsys CalCheck DIGOXIN is used to verify the<br>calibration assignment for the Boehringer Mannheim Elecsys DIGOXIN assay. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.<br>Comparison to<br>predicate device | The Elecsys® CalCheck™ DIGOXIN is substantially equivalent to the<br>currently marketed Elecsys® CalCheck™ TSH (K963147).<br>The following table compares the Elecsys® CalCheck™ DIGOXIN with the<br>predicate devices, Elecsys® CalCheck™ TSH. Specific data on the<br>performance of the test have been incorporated into the draft labeling in<br>attachment 5. Labeling for the predicate devices is provided in attachment 6. |
| | Similarities: |
| | • Configuration: Three CalCheck levels: low, mid, and high |
| | • Intended use: To verify calibration |
| | Differences: |

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| Feature | CalCheck DIGOXIN | CalCheck TSH |
|-------------|------------------|--------------|
| Matrix type | Bovine serum | Horse serum |
| Analyte | DIGOXIN | TSH |

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, overlaid with three horizontal lines that suggest movement or energy. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure, indicating the organization's name and country.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jody J. Savage .Consultant, Regulatory Affairs Boehringer Mannheim 4300 Hacienda Drive 94588-2722 Pleasanton, California

NOV - 4 1997

Re : K973973 Elecsys® CalCheck™ DIGOXIN Requlatory Class: I Product Code: DMP October 17, 1997 Dated: Received: October 20, 1997

Dear Ms. Savage:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ 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 (chin oo), chip device maj uquifical 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 asborized in 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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510(k) Number (if known): N/A

Device Name: Elecsys® CalCheck™ DIGOXIN

Indications For Use:

Elecsys® CalCheck™ DIGOXIN calibration verification solutions comprise three levels - low, mid, and high - each with a defined DIGOXIN 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™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K973973 |
|---------------|---------|
|---------------|---------|

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

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