DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR

K984193 · Dade Behring, Inc. · JIT · Dec 14, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984193
• Device Name: DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Dimension® RxL Myoglobin (MYO) Calibrator is intended to be used to calibrate the Myoglobin Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Device Story

The Dimension® RxL Myoglobin (MYO) Calibrator is a liquid, bovine serum albumin-based product used to calibrate the Myoglobin assay on the Dimension® RxL clinical chemistry system. The kit consists of ten vials across five levels with target concentrations of 0, 35, 100, 500, and 1060 ng/ml. Level 1 is a blank; levels 2-5 contain human heart myoglobin. The device is used in a clinical laboratory setting by trained technicians to ensure the accuracy of the Dimension® RxL heterogeneous immunoassay module. By establishing a calibration curve, the device enables the system to accurately quantify myoglobin levels in patient samples, aiding clinicians in the assessment of cardiac conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, bovine serum albumin-based matrix. Contains human heart myoglobin. Five-level calibrator set (0, 35, 100, 500, 1060 ng/ml). Designed for use with the Dimension® RxL clinical chemistry system heterogeneous immunoassay module.

Indications for Use

Indicated for use as a calibrator for the Myoglobin Method on the Dimension® RxL clinical chemistry system. No specific patient population, age, or gender is defined as this is an in vitro diagnostic accessory used by laboratory professionals.

Regulatory Classification

Identification

A 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. (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

• Stratus® Myoglobin Calibrator

Submission Summary (Full Text)

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DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

## DADE BEHRING K984193

## Summary of Safety and Effectiveness Information

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

| Submitter's Name: | Rebecca S. Ayash |
|-------------------|---------------------------|
| | Dade Behring Inc. |
| | Building 500, Mailbox 514 |
| | P.O. Box 6101 |
| | Newark, DE 19714-6101 |
| Phone: | [phone] |
| FAX: | [phone] |

Date of Preparation: 11/20/98

Device Name: Dimension® RxL Myoglobin (MYO) Calibrator

Classification Name: Calibrator, secondary

Dade Behring Stratus® Myoglobin Calibrator Predicate Device:

Device Description: MYO Calibrator is a five level liquid bovine serum albumin-based product with target concentrations of 0, 35, 100, 500, and 1060 ng/ml. Level 1 contains no detectable myoglobin. Levels 2 through 5 contain human heart myoglobin. The kit consists of ten vials; two at each level

Intended Use: The MYO Calibrator is intended to be used to calibrate the MYO Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

## Comparison to Predicate Device:

| | Dimension® RxL MYO Calibrator | Stratus® Myoglobin Calibrator |
|-------------------------------------|-------------------------------|-------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analyte | Human heart myoglobin | Human heart myoglobin |
| Matrix | Bovine serum albumin | Bovine serum albumin |
| Form | Liquid | Liquid |
| Target<br>Concentrations<br>(ng/mL) | 0, 35, 100, 500, 1060 | 0, 35, 100, 300, 500, 1000 |
| Levels | Five | Six |

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a symbol that resembles a stylized caduceus, with three lines representing snakes intertwined around a staff. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 4 1998 Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade Behring Buildinq 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re: K984193 Dimension® RxL Myoglobin (MYO) Calibrator Trade Name: Requlatory Class: II Product Code: JIT Dated: November 20, 1998 Received: November 23, 1998

Dear Ms. Ayash:

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 leqally 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation 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 regulations.

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Paqe 2

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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## Indications Statement

Device Name: Dimension® RxL Myoglobin (MYO) Calibrator

Indications for Use: The Dimension® RxL Myoglobin (MYO) Calibrator is intended to be used to calibrate the Myoglobin Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Rebecca Suysh
Rebecca S. Ayash

Rebecca S. Ayast Regulatory Affairs and Compliance Manager Date: 11/20/98

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K984193
510(k) Number

0(k) Number

Division Sign-Off

Office of Device Evatuation

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