INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1

K990594 · Roche Diagnostics Corp. · DER · Apr 14, 1999 · Immunology

Device Facts

• Record ID: K990594
• Device Name: INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
• Applicant: Roche Diagnostics Corp.
• Product Code: DER · Immunology
• Decision Date: Apr 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5580
• Device Class: Class 2

Intended Use

For in vitro quantitative determination Apolipoprotein A-1 in serum and plasma.

Device Story

The INTEGRA Reagent Cassette for Apolipoprotein A-1 is an in vitro diagnostic test used on the INTEGRA family of clinical chemistry analyzers. It utilizes an immunoturbidimetric, spectrophotometric method to measure Apolipoprotein A-1 levels in serum and plasma samples. The device consists of sheep-derived anti-apolipoprotein A-1 antiserum in a phosphate buffer stabilized with 0.09% sodium azide. The analyzer processes the sample, measures the turbidity resulting from the antigen-antibody reaction, and provides a quantitative output. This output is used by clinicians to assist in the diagnosis and management of lipid disorders, atherosclerosis, and associated liver or renal conditions. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and performance comparisons to the predicate device.

Technological Characteristics

Immunoturbidimetric, spectrophotometric assay. Reagent: Sheep anti-apolipoprotein A-1 antiserum in phosphate buffer with 0.09% sodium azide. Measuring range: 0.37-4.0 g/L (0.12-5.6 g/L with rerun). Form factor: Reagent cassette for use on INTEGRA family of analyzers.

Indications for Use

Indicated for the quantitative determination of apolipoprotein A-1 in serum and plasma. Used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Regulatory Classification

Identification

An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

Predicate Devices

• Roche INTEGRA Reagent Cassette for Apolipoprotein A-1 (K954992)

Submission Summary (Full Text)

{0}------------------------------------------------

长990594

APR 1 4 1999

## 510(k) Summary

| 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. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis, IN 46250<br>[phone] |
| | Contact person: Priscilla A. Hamill |
| | Date prepared: February 23, 1999 |
| Device name | Proprietary name: INTEGRA Reagent Cassette for Apolipoprotein A-1 |
| | Common name: Apolipoprotein A-1 |
| | Classification name: Lipoprotein test system |
| Predicate<br>device | We claim substantial equivalence to currently marketed Roche INTEGRA<br>Reagent Cassette for Apolipoprotein A-1. |
| Device<br>description | The device is an immunoturbidimetric test for the quantitative determination<br>of Apolipoprotein A-1 in serum and plasma for use on the INTEGRA family<br>of analyzers. |
| | Continued on next page |

{1}------------------------------------------------

## 510(k) Summary, Continued

: 代

| Intended use | For in vitro quantitative determination Apolipoprotein A-1 in serum and<br>plasma. |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>equivalence --<br>similarities | The Roche INTEGRA Reagent Cassette for Apolipoprotein A-1 is<br>substantially equivalent to other products in commercial distribution intended<br>for similar use. Most notably, it is substantially equivalent to the currently<br>marketed Roche INTEGRA Reagent Cassette for Apolipoprotein A-1<br>(K954992) |
| | The following table illustrates the similarities between modified INTEGRA<br>Apolipoprotein A-1 and the predicate device. Specific data on the<br>performance of the test have been incorporated into the draft labeling in<br>Section V of this submission. Labeling for the predicate device is provided in<br>Section VI. |
| | Continued on next page. |

のお気になる。

:

,

:

.

{2}------------------------------------------------

K990594

. *

## 510(k) Summary, Continued

Art

。 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

| Feature | Modified Device | Predicate Device |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For the quantitative<br>determination of<br>Apolipoprotein A-1. | For the quantitative<br>determination of<br>Apolipoprotein A-1. |
| Indications<br>for use | Apolipoprotein A-1<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 A-1<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<br>Measure-<br>ment<br>approach | Immunoturbidimetric<br>Spectrophotometric | Immunoturbidimetric<br>Spectrophotometric |
| Instrument<br>required | INTEGRA family of analyzers | INTEGRA family of analyzers |
| Measuring<br>range | 0.37-4.0 g/L<br>0.12-5.6 g/L with rerun | 0.37-4.0 g/L<br>0.12-5.6 g/L with rerun |
| Formulation | Anti-apolipoprotein A-1 T<br>antiserum (sheep) specific for<br>human apolipoprotein A-1 in<br>phosphate buffer stabilized<br>with 0.09% sodium azide. | Anti-apolipoprotein A-1 T<br>antiserum (sheep) specific for<br>human apolipoprotein A-1 in<br>phosphate buffer stabilized<br>with 0.09% sodium azide. |

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines, representing health and well-being.

APR 1 4 1999

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

K990594 Re:

Trade Name: INTEGRA Reagent Cassette for Apolipoprotein A-1 Regulatory Class: II Product Code: DER 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 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

{4}------------------------------------------------

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 Autman

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

{5}------------------------------------------------

K990594 510(k) Number (if known):

Device Name: INTEGRA Reagent Cassette for Apolipoprotein A-1

Indications for Use:

For the quantitative determination of apolipoprotein A-1 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.

han Coogn

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K990594

(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)