DIMENSION AHDL CALIBRATOR

K983850 · Dade Behring, Inc. · JIT · Nov 18, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983850
• Device Name: DIMENSION AHDL CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Dimension® AHDL Calibrator is an in vitro diagnostic product intended to be used to calibrate the Automated High Density Lipoprotein Cholesterol (AHDL) method for the Dimension® clinical chemistry system

Device Story

Dimension® AHDL Calibrator is a liquid, bovine serum albumin-based product used to calibrate the AHDL method on Dimension clinical chemistry systems. The kit consists of six 1 mL vials across three levels. Level 1 contains no detectable HDL cholesterol; Levels 2 and 3 contain human HDL cholesterol. The device is used in clinical laboratory settings by trained laboratory personnel. By establishing a calibration curve for the AHDL assay, the device enables the clinical chemistry system to accurately quantify HDL cholesterol levels in patient samples, supporting the assessment of lipid profiles and cardiovascular risk.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid bovine serum albumin-based matrix; 3-level calibration kit; 1.0 mL per vial; intended for use with Dimension clinical chemistry system.

Indications for Use

Indicated for use as an in vitro diagnostic calibrator for the Automated High Density Lipoprotein Cholesterol (AHDL) method on the Dimension clinical chemistry system.

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® HDL Calibrator (K983850)

Submission Summary (Full Text)

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NOV 1 8 1998

K983850

# 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: | Rebecca S. Ayash<br>Dade Behring Inc.<br>Building 500, Mailbox 514<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 10/29/98 |
| Device Name: | Dimension® AHDL Calibrator |
| Classification Name: | Calibrator, Secondary |
| Predicate Device: | Dimension® HDI Calibrator |

Device Description: The Dimension® AHDL Calibrator is a liquid bovine serum albumin based product. The Level 1 calibrator contains no detectable HDL Cholesterol. Levels 2 and 3 contain human HDL Cholesterol. The kit consists of six vials; two at each of three levels, containing 1 mL each.

Intended Use: The AHDL Calibrator is intended to be used to calibrate the AHDL method for the Dimension® clinical chemistry system.

#### Comparison to Predicate Device:

| | Dimension® AHDL Calibrator | Dimension® HDL Calibrator |
|--------------|-----------------------------------------------|---------------------------|
| Intended Use | Calibrator | Calibrator |
| Analyte | Human high density lipoprotein<br>Cholesterol | Cholesterol |
| Matrix | bovine albumin | Propanol |
| Form | Liquid | liquid |
| Volume | 1.0 mL per vial | 2.0 mL per vial |
| Levels | 3 levels | 3 levels |

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Comments on Substantial Equivalence: Both the Dimension® AHDL Calibrator for the system and the Dimension® HDL Calibrator are similar products. Both products are intended to be used as calibrators for high density lipoprotein cholesterol assays.

Conclusion: The Dimension® AHDL is substantially equivalent to the Dimension® HDL Calibrator based on the comparison summarized above.

Rebecca S. Ayers

Rebecca S. At Regulatory Affairs and Compliance Manager Date: 10/29/98

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract human profiles facing right, stacked on top of each other. The profiles are rendered in black, contrasting with the white background.

# NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark,Delaware 19714-6101

K983850 Re: Dimension® AHDL Calibrator Trade Name: Requlatory Class: II Product Code: JIT Dated: October 29, 1998 Received: October 30, 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 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). 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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#### 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 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 Statement

Device Name: Dimension® AHDL Calibrator

Indications for Use: The Dimension® AHDL Calibrator is an in vitro diagnostic product intended to be used to calibrate the Automated High Density Lipoprotein Cholesterol (AHDL) method for the Dimension® clinical chemistry system

Rebecca S. Ayash

Rebecca S. Ayasb Regulatory Affairs and Compliance Manager Date: 10/29/98

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K983850

510(k) Number

Division Sign-Off Office of Device Evaluation

prescription use

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k98 3880