BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL

K974733 · Boehringer Mannheim Corp. · LBR · Jan 26, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974733
• Device Name: BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
• Applicant: Boehringer Mannheim Corp.
• Product Code: LBR · Clinical Chemistry
• Decision Date: Jan 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Boehringer Mannheim Direct LDL-Cholesterol test is intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.

Device Story

The Boehringer Mannheim Direct LDL-Cholesterol test is an in vitro diagnostic assay used to measure LDL-C levels in human serum or plasma samples. The device utilizes a chemical inhibition approach where detergent and a sugar compound are added to the sample to selectively inhibit the reaction of VLDL, HDL, and chylomicrons. The remaining LDL-cholesterol is then quantitatively measured via an enzymatic reaction involving cholesterol esterase, cholesterol oxidase, and 4-aminoantipyrin. The test is performed on clinical laboratory instrumentation. Healthcare providers use the resulting quantitative LDL-C values to assess lipid profiles and inform clinical decision-making regarding cardiovascular health and lipid-lowering therapy.

Clinical Evidence

No clinical data provided. Performance characteristics were established via bench testing comparing the subject device to the predicate device, including measuring range and analytical methodology.

Technological Characteristics

In vitro diagnostic assay; liquid reagents; enzymatic measurement (cholesterol esterase, cholesterol oxidase, 4-aminoantipyrin); inhibition via detergent and sugar compound; requires clinical laboratory instrumentation; measuring range 3.0 - 550 mg/dL.

Indications for Use

Indicated for the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• Equal Diagnostics LDL Direct Liquid Select™ Cholesterol Test

Submission Summary (Full Text)

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# 510(k) Summary

JAN 26 1998

1974733

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Boehringer Mannheim Corporation<br>9115 Hague Rd<br>Indianapolis, IN 46250<br>[phone] |
| | Contact person: Ed Kimmelman |
| | Date prepared: Dec. 17, 1997 |
| 2) Device name | Proprietary name: Boehringer Mannheim Direct LDL-Cholesterol |
| | Common name: LDL test |
| | Classification name: LDL and VLDL precipitation, cholesterol via esterase-<br>oxidase, HDL |
| 3) Predicate<br>device | We claim substantial equivalence to the Equal Diagnostics LDL Direct<br>Liquid Select™ Cholesterol Test. |
| 4) Device<br>description | The Boehringer Mannheim Direct LDL-Cholesterol test uses detergent and a<br>sugar compound to inhibit reaction of VLDL, HDL and chylomicrons. The<br>remaining LDL-Cholesterol is quantitatively measured with cholesterol<br>esterase, cholesterol oxidase, and 4-aminoantipyrin. |
| 5) Intended use | The Boehringer Mannheim Direct LDL-Cholesterol test is intended for the<br>quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in<br>serum and plasma. |
| | Continued on next page |

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### 510(k) Summary, Continued

6) Comparison to the predicate device

The Boehringer Mannheim Direct LDL-Cholesterol test is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Equal Diagnostics LDL Direct Liquid Select™ Cholesterol Test.

The following table compares the Boehringer Manneheim Direct LDL-Cholesterol test with the predicate device. Specific data on the performance of the test have been incorporated into the draft labeling in Attachment 5. Labeling for the predicate device is provided in Attachment 6.

| Feature | BM Direct LDL | Equal Direct LDL |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Same | Same |
| Sample type | Serum, plasma | Serum, plasma |
| Formulation | liquid reagents | liquid reagents |
| Instrument required | yes | yes |
| Inhibition approach | Uses detergent and a sugar compound to inhibit reaction of VLDL, HDL, and chylomicrons | Uses detergent to inhibit reaction of non-LDL lipoproteins |
| Measurement approach | Resulting cholesterol after inhibition is measured with cholesterol esterase, cholesterol oxidase, peroxidase, and 4-aminoantipyrin. | Resulting cholesterol after inhibition is measured with cholesterol esterase, cholesterol oxidase, peroxidase, and 4-aminoantipyrin. |
| Measuring range | 3.0 - 550 mg/dL | 6.6 mg/dL - 992 mg/dL |

#### Similarities:

Differences: There are no significant differences between the BM Direct LDL and the predicate device for purposes of determining substantial equivalence.

Continued on next page

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## Summary, Continued

Performance characteristics: The performance of the Boehringer 6) Comparison Mannheim Direct LDL-Cholesterol method is substantially equivalent to to predicate device (cont.) other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Equal Direct LDL system.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### JAN 26 1998

Edward R. Kimmelman . Program Director, Regulatory Affairs and Compliance Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250

Re: K974733 Boehringer Mannheim Direct LDL Cholesterol Requlatory Class: I Product Code: LBR Dated: December 15, 1997 Received: December 18, 1997

Dear Mr. Kimmelman:

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 aqainst 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. ਸੇ 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 requlation (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 Reqister. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, 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 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/dsmamain.html".

sincerely yours,
Steven Gutman

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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974733 510(k) Number (if known):

Device Name: Boehringer Mannheim Direct LDL - Cholesterol

Indications for Use: For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) ****************************************************************************************************************************************************************************** Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number 974733

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