DIMENSION ALDL CALIBRATOR, MODEL DC131

K020723 · Dade Behring, Inc. · JIT · May 8, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020723
• Device Name: DIMENSION ALDL CALIBRATOR, MODEL DC131
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: May 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Dade Behring Dimension® ALDL Calibrator is an in vitro diagnostic product intended to be used to calibrate low density lipoprotein cholesterol on Dade Behring Dimension® clinical chemistry systems.

Device Story

The Dade Behring Dimension® ALDL Calibrator is a 3-level, lyophilized in vitro diagnostic product; used to calibrate low density lipoprotein (LDL) cholesterol assays on Dade Behring Dimension® clinical chemistry systems. The calibrator consists of bovine serum albumin matrix with added human LDL. It is intended for professional use in clinical laboratory settings. By establishing points of reference, the calibrator enables the clinical chemistry system to accurately quantify LDL cholesterol levels in patient serum and plasma samples. This quantification assists healthcare providers in assessing lipid profiles and managing cardiovascular health.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized 3-level calibrator; matrix consists of bovine serum albumin with added human LDL. Designed for use on Dade Behring Dimension® clinical chemistry systems. Stability testing protocol established for long-term, real-time shelf-life.

Indications for Use

Indicated for use on Dade Behring Dimension® clinical chemistry systems to establish points of reference for the determination of low density lipoprotein cholesterol in human serum and plasma.

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

• Dade Behring Dimension® AHDL Calibrator (K983850)

Submission Summary (Full Text)

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# MAY 0 8 2002

K020723

## Summary of Safety and Effectiveness Information

Dade Behring Dimension® ALDL Calibrator

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

| Submitter's Name: | Richard M. Vaught<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | March 5, 2002 |
| Name of Product: | Dade Behring Dimension® ALDL Calibrator |
| FDA Classification Name: | Calibrator, Secondary; Class II ; 75JIT |
| Predicate Device: | The Dade Behring Dimension® AHDL Calibrator (K983850) |
| Device Description: | The Dade Behring Dimension® ALDL Calibrator is a 3 level,<br>lyophilized product. The carton consists of six vials; two at<br>each of three levels.<br>Lot specific Value Assignment is made according to the process<br>outlined in ATTACHMENT C.<br>The Stability Testing Protocol established for determining long-<br>term, real-time stability is provided in ATTACHMENT D.<br>Shelf-life stability (Expiration Dating) dating reflects the real-<br>time stability data available at commercialization and is on file<br>at Dade Behring. |
| Intended Use: | The Dade Behring Dimension® ALDL Calibrator is an in vitro<br>diagnostic product intended to be used to calibrate low density |

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lipoprotein cholesterol on Dade Behring Dimension® clinical chemistry systems.

### Comparison to Predicate Device:

| Feature | Dimension® ALDL Calibrator | Dimension® AHDL Calibrator |
|---------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Intended Use: | In vitro use.<br>For calibration of human<br>low density lipoprotein<br>cholesterol on Dimension®<br>systems | In vitro use.<br>For calibration of human<br>high density lipoprotein<br>cholesterol on Dimension®<br>systems |
| Levels: | 3 levels; two vials/level | 3 levels; two vials/level |
| Form: | Lyophilized | Liquid |
| Matrix: | bovine serum albumin<br>with added human LDL | bovine serum albumin<br>with added human HDL |

#### Comments on Substantial Equivalence:

The proposed Dade Behring Dimension® ALDL Calibrator and the predicate Dade Behring AHDL Calibrator are similar in vitro diagnostic products. Both are intended be used as cholesterol calibrators for the Dade Behring Dimension® clinical chemistry system analyzer family.

#### Conclusion:

The Dade Behring Dimension® ALDL Calibrator is substantially equivalent to other lipoprotein calibrators such as the Dade Behring Dimension® AHDL Calibrator based on its design and function as summarized above.

Rampart

Richard M. Vaught Regulatory Affairs and Compliance Manager March 5, 2002

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping silhouettes suggesting a sense of community or interconnectedness.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500, M. S. 514 P.O. Box 6101 Newark, DE 19714-6101

MAY 0 8 2002

Re: k020723

Trade/Device Name: Dade Behring Dimension® ALDL Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, secondary Regulatory Class: Class II Product Code: JIT Dated: March 5, 2002 Received: March 6, 2002

Dear Mr. Vaught:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Butman

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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#### INDICATIONS FOR USE STATEMENT

#### Device Name:

Dade Behring Dimension® ALDL Calibrator

Indications for Use:

The Dade Behring Dimension® ALDL Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in determination of low density lipoprotein cholesterol in human serum and plasma

Rmm Vainright

Richard M. Vaught Regulatory Affairs and Compliance Manager

March 5, 2002

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Scan Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K020723

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-counter Use_

(Optional format 1-2-96)

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