FERRITIN CALIBRATOR

K983548 · Dade Behring, Inc. · JIT · Oct 27, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983548
• Device Name: FERRITIN CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.

Device Story

Ferritin Calibrator is a liquid, bovine albumin-based product used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system. The kit consists of ten vials across five levels; Level 1 contains no detectable ferritin, while Levels 2 through 5 contain human liver ferritin. The device is used in clinical laboratory settings by trained laboratory personnel. By establishing a calibration curve for the Dimension® RxL system, the calibrator ensures the accuracy of ferritin measurements in patient samples, which aids healthcare providers in assessing iron status and diagnosing conditions related to iron deficiency or overload.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid bovine albumin-based matrix; contains human liver ferritin (Levels 2-5); 1.0 mL per vial; 5 levels; calibrated against WHO 3rd International Standard.

Indications for Use

Indicated for use as a calibrator for the ferritin (FERR) method on the Dimension® RxL clinical chemistry system. No specific patient population, age, or gender restrictions are defined.

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

• Dimension® Ferritin Calibrator (K963493)

Submission Summary (Full Text)

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KG83548

# Dade Behring

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

### 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: | Cathy P. Craft<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | October 5, 1998 |
| Name of Product: | Ferritin Calibrator |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Dimension® Ferritin Calibrator, K963493 |

Device Description: The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.

Intended use: The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.

#### Comparison to Predicate Device:

| Item | Cleared Ferritin Calibrator | Modified Ferritin Calibrator |
|--------------|--------------------------------|------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analytes | ferritin | ferritin |
| Matrix | bovine albumin base | bovine albumin base |
| Form | lyophilized | liquid |
| Volume | 2.0 mL per vial, reconstituted | 1.0 mL per vial |
| Levels | 5 levels | 5 levels |
| Reference | WHO standard, 2nd IS | WHO standard, 3rd IS |

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#### Comments on Substantial

Equivalence: Both the cleared Ferritin Calibrator and the modified Ferritin Calibrator are intended to be used as calibrators for the Dimension® Ferritin (FERR) method.

Conclusion: The modified Ferritin Calibrator is substantially equivalent to the cleared Ferritin Calibrator based on the comparison discussed above.

> Cathy P. Craft Regulatory Affairs and Compliance Manager Date: October 5, 1998

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 2 7 1998

Ms. Cathy P. Craft Regualtory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delware 19714-6101

K983548 Re : Trade Name: Ferritin Calibrator Requlatory Class: II Product Code: JIT Dated: October 5, 1998 Received: October 9, 1998

Dear Ms. Craft:

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 Requlations, 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 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 regulations.

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Page 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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Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known) K983548

Device Name: Ferritin Calibrator

Indications for Use:

The Ferritin Calibrator is intended to be used to calibrate the Ferritin (FERR) Method on the Dimension® RxL clinical chemistry system.

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Cathy P. Craft Regulatory Affairs and Compliance Manager

October 5, 1998

(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 | Medical Laboratory Devices |
| 510(k) Number | KG8354 |

Image /page/4/Picture/10 description: The image shows the words "Prescription Use" with a check mark next to it. Below that, it says "(Per 21 CFR 801.109)". The text is in a simple, sans-serif font and is likely part of a form or document.

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Over-The-Counter Use