INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B

K990595 · Roche Diagnostics Corp. · DFC · Apr 14, 1999 · Immunology

Device Facts

• Record ID: K990595
• Device Name: INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
• Applicant: Roche Diagnostics Corp.
• Product Code: DFC · Immunology
• Decision Date: Apr 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

For in vitro quantitative determination of Apolipoprotein B in serum and plasma

Device Story

The INTEGRA Reagent Cassette for Apolipoprotein B is an in vitro diagnostic reagent used on the Roche INTEGRA family of analyzers. It utilizes an immunoturbidimetric assay to quantitatively measure Apolipoprotein B levels in human serum and plasma samples. The device operates via spectrophotometric measurement of turbidity resulting from the reaction between sheep anti-human apolipoprotein B antiserum and the sample. The system is intended for use by clinical laboratory professionals to assist in the diagnosis and management of lipid disorders, atherosclerosis, and associated metabolic or organ diseases. By providing automated, quantitative results, the device enables clinicians to assess patient lipid profiles, facilitating targeted therapeutic interventions and monitoring of disease progression.

Clinical Evidence

Bench testing only. Performance characteristics, including precision, analytical sensitivity, and calibration intervals, were demonstrated to be equivalent to the predicate device. No clinical trial data was required for this modification.

Technological Characteristics

Immunoturbidimetric assay; spectrophotometric detection. Reagent formulation: sheep anti-apolipoprotein B antiserum in phosphate buffer with 0.09% sodium azide. Measuring range: 0.26-3.9 g/L (0.09-7.8 g/L with rerun). Designed for use on INTEGRA family of analyzers.

Indications for Use

Indicated for quantitative determination of Apolipoprotein B in serum and plasma. Used in diagnosis and treatment of lipid disorders (e.g., diabetes mellitus), atherosclerosis, and liver/renal diseases.

Regulatory Classification

Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Predicate Devices

• Roche INTEGRA Reagent Cassette for Apolipoprotein B (K951595)

Submission Summary (Full Text)

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APR 1 4 1959

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## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis, IN 46250<br>[phone]<br><br>Contact person: Priscilla A. Hamill<br><br>Date prepared: February 23, 1999 |
| Device name | Proprietary name: INTEGRA Reagent Cassette for Apolipoprotein B<br>Common name: Apolipoprotein B<br>Classification name: Lipoprotein Test System |
| Predicate device | We claim substantial equivalence to the currently marketed Roche INTEGRA Reagent Cassette for Apolipoprotein B. |
| Device description | The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein B in serum and plasma for use on the INTEGRA family of analyzers. |

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12990595

## 510(k) Summary, Continued

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| Intended use | For in vitro quantitative determination of Apolipoprotein B in serum and plasma |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial equivalence – similarities | The INTEGRA Reagent Cassette for Apolipoprotein B is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Roche INTEGRA Reagent Cassette for Apolipoprotein B (K951595) |
| | The following table illustrates the similarities between the modified INTEGRA Reagent Cassette for Apolipoprotein B and the predicate device. Specific data on the performance of the test have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI. |

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Continued on next page

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## 510(k) Summary, Continued

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| | Feature | Modified Device | Predicate Device |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended use | For the quantitative<br>determination of<br>Apolipoprotein B. | For the quantitative<br>determination of<br>Apolipoprotein B. |
| | Indications<br>for use | Apolipoprotein B<br>measurements are used in the<br>diagnosis and treatment of<br>lipid disorders (such as<br>diabetes mellitus),<br>atherosclerosis, and various<br>liver and renal diseases. | Apolipoprotein B<br>measurements are used in the<br>diagnosis and treatment of lipid<br>disorders (such as diabetes<br>mellitus), atherosclerosis, and<br>various liver and renal diseases. |
| | Methodology | Immunoturbidimetric | Immunoturbidimetric |
| | Measure-<br>ment<br>approach | Spectrophotometric | Spectrophotometric |
| | Instrument<br>required | INTEGRA family of analyzers | INTEGRA family of analyzers |
| | Measuring<br>range | 0.26-3.9 g/L<br>0.09-7.8 g/L with rerun | 0.26-3.9 g/L<br>0.09-7.8 g/L with rerun |
| | Formulation | Anti-apolipoprotein B T<br>antiserum (sheep) specific for<br>human apolipoprotein B in<br>phosphate buffer stabilized<br>with 0.09% sodium azide. | Anti-apolipoprotein B T<br>antiserum (sheep) specific for<br>human apolipoprotein B in<br>phosphate buffer stabilized<br>with 0.09% sodium azide. |
| Substantial<br>equivalence -<br>differences | The modified device differs from the predicate device in that plasma is now<br>claimed as an acceptable specimen type. | | |
| | The following table illustrates the differences between the INTEGRA Reagent<br>Cassette for Apolipoprotein B and the predicate device. | | |
| | Feature | Modified Device | Predicate Device |
| | Sample type | Serum and plasma | Serum |
| Substantial<br>equivalence -<br>performance<br>characteristics | Performance characteristics, including precision, analytical sensitivity,<br>calibration interval, and limitations statements for the two devices are<br>equivalent. | | |

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are designed to resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

## APR 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Priscilla A. Hamill Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457

Re: K990595 Trade Name: INTEGRA Reagent Cassette for Apolipoprotein B : Regulatory Class: II Product Code: DFC Dated: February 23, 1999 Received: February 24, 1999

Dear Ms. Hamill:

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 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 OS 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

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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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S10(k) Number (if known): ___

K 990593

Device Name: INTEGRA Reagent Cassette for Apolipoprotein B

Indications for Üse:

For the quantitative determination of apolipoprotein B in serum and plasma.

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 and atherosclerosis.

Sean Coogan
(Division Sign-Off)

Division of Clinical Laboratory Devices Knights Hyly 510(k) Number _

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

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-the-Counter Use

(Optional format 1-2-96)