TINA-QUANT APOLIPOPROTEIN A-1 VER.2

K013278 · Roche Diagnostics Corp. · DEL · Nov 15, 2001 · Immunology

Device Facts

• Record ID: K013278
• Device Name: TINA-QUANT APOLIPOPROTEIN A-1 VER.2
• Applicant: Roche Diagnostics Corp.
• Product Code: DEL · Immunology
• Decision Date: Nov 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5590
• Device Class: Class 1

Intended Use

In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein A-1 in serum and plasma. 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.

Device Story

Tina-quant Apolipoprotein A-1 ver.2 is an in vitro diagnostic reagent system for use on COBAS INTEGRA clinical chemistry analyzers. The device measures human apolipoprotein A-1 in serum and plasma samples via an immunoturbidimetric assay. The principle of operation involves the formation of a precipitate between human apolipoprotein A-1 and a specific sheep anti-apolipoprotein A-1 antibody, which is then measured turbidimetrically at 340 nm. The system is operated by laboratory personnel in a clinical setting. The output is a quantitative concentration of apolipoprotein A-1, which healthcare providers use to assist in the diagnosis and management of lipid disorders and atherosclerosis. The device provides standardized results traceable to WHO/IFCC reference material SP1-01.

Clinical Evidence

Bench testing only. Performance characteristics compared to predicate included precision (within-run CV 0.8-1.0%, between-day CV 1.7-2.4%), method comparison (Bablok/Passing regression y = 0.87x + 0.25, r = 0.940), prozone effect (>6 g/L), and analytical sensitivity (0.058 g/L). Interference testing confirmed no significant impact from icterus, hemolysis, lipemia (up to 1000 mg/dL), or rheumatoid factors.

Technological Characteristics

Immunoturbidimetric assay; reagents include TRIS buffer, polyethylene glycol, detergent, and sheep anti-apolipoprotein A-1 antibody. Analyzed on COBAS INTEGRA clinical chemistry analyzers. Standardized to WHO/IFCC SP1-01. Measuring range 0.20-4.0 g/L.

Indications for Use

Indicated for the quantitative determination of human apolipoprotein A-1 in serum and plasma for the diagnosis and treatment of lipid disorders and atherosclerosis in patients.

Regulatory Classification

Identification

A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease.

Predicate Devices

• COBAS Integra Tina-quant Apolipoprotein A-1 (K990594)

Submission Summary (Full Text)

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## NOV 1 5 2001

013278

| 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 Road<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person: Helen T. Torney |
| | Date Prepared: September 27, 2001 |
| Device Name | Proprietary name: Tina-quant Apolipoprotein A-1 ver.2 |
| | Common name: Apolipoprotein A-1 |
| | Classification name: Alpha-1- lipoprotein immunological test system |
| Device<br>Description | Human apolipoprotein A-1 forms a precipitate with a specific antiserum<br>which is determined turbidimetrically at 340 nm. |
| Intended use | In vitro diagnostic reagent system intended for use on COBAS INTEGRA<br>system for the quantitative immunological determination of human<br>apolipoprotein A-1 in serum and plasma. |
| Indications for<br>Use | For the quantitative determination of apolipoprotein A-1 in serum and<br>plasma. A lipoprotein test system is a device intended to measure lipoprotein<br>in serum and plasma. Lipoprotein measurements are used in the diagnosis<br>and treatment of lipid disorders and atherosclerosis. |

510(k) Summary

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### 510(k) Summary, Continued

Substantial Equivalence

The Tina-quant Apolipoprotein A-1 ver.2 is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the COBAS Integra Tina-quant Apolipoprotein A-1 (K990594).

Substantial equivalence similarities

The following table compares the Tina-quant Apolipoprotein A-1 ver.2 Assay with the predicate device.

| Feature | Tina-quant<br>Apolipoprotein A-1 ver.2 | Apolipoprotein A-1<br>(predicate) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein A-1 in serum and plasma. | In vitro diagnostic reagent system intended for use on COBAS Integra (analyzer model) for the quantitative immunological determination of human apolipoprotein A-1 in serum and plasma. |
| Indication 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. | 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. |
| Assay Protocol | Immunoturbidimetric | Immunoturbidimetric |
| Instrument | COBAS Integra Clinical Chemistry Analyzers | COBAS Integra Clinical Chemistry Analyzers |
| Traceability / Standardization | Standardized with regard to the WHO/IFCC reference material SP1-01. | Standardized with regard to the WHO/IFCC reference material SP1-01. |
| Sample Type | Serum and plasma | Serum and plasma |

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### 510(k) Summary, Continued

| Feature | Tina-quant Apolipoprotein<br>A-1 ver.2 | Apolipoprotein A-1<br>(predicate) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibration<br>Interval | After each lot | After each lot |
| Formulation | R: TRIS buffer,<br>polyethylene glycol.<br>detergent, preservative<br>(liquid).<br>SR: Anti-apolipoprotein A-1<br>antibody (sheep) specific for<br>human Apo A-1, TRIS<br>buffer, preservative (liquid). | R: Anti-apolipoprotein A-1<br>T antiserum (rabbit) specific<br>for human Apo A-1, in<br>phosphate buffer stabilized<br>with 0.09% sodium azide in<br>vial A (liquid). |

#### Substantial equivalence differences

The following table compares the Tina-quant Apolipoprotein B ver.2 Assay with the predicate device.

| Feature | Tina-quant Apolipoprotein<br>A-1 ver.2 | Apolipoprotein A-1<br>(predicate) |
|----------------------|----------------------------------------|-----------------------------------|
| Reagent<br>Stability | On board: 4 weeks | On-board: 12 weeks |
| Calibrator | C.f.a.s. Lipids | Apolipoprotein T Standard |
| Controls | Precinorm L, Precipath L | Apolipoprotein T Control |
| Expected | Females:1.08-2.25 g/L | Females: 1.10-2.05g/L |
| Values | Males: 1.04-2.02 g/L | Males: 1.10-1.80 g/L |
| Measuring | 0.20 - 4.0 g/L | 0.37-4.0 g/L |
| Range | (0.10 - 4.0 g/L with rerun) | (0.12 - 5.6 g/L with rerun) |

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# 510(k) Summary, Continued

Substantial equivalence performance characteristics The performance characteristics of the Tina-quant Apolipoprotein A-1 ver.2 I he performance characterice are compared in the table below.

| Feature | Tina-quant Apolipoprotein<br>A-1 ver.2 | Apolipoprotein A-1<br>(predicate) |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Precision | Within run CV<br>1.0% @ 0.88 g/L<br>0.8% @ 1.64 g/L<br>Between Day CV<br>2.4% @ 0.88 g/L<br>1.7% @ 1.64 g/L | Within run CV<br>1.5% @ 0.68 g/L<br>1.0% @ 2.7 g/L<br>Between Day CV<br>1.2% @ 0.68g/L<br>0.78% @ 2.7 g/L |
| Method<br>Comparison | Bablok/Passing:<br>Tina-quant Apolipoprotein<br>A-1 ver.2 (Y) / COBAS<br>Integra Apolipoprotein A-1<br>(X).<br>y = 0.87x + 0.25 g/L<br>r = 0.940 | Bablok/Passing:<br>Apolipoprotein A-1 (Y)/<br>commercially available<br>system (X).<br>y = 1.19x- 0.2 g/L<br>r = 0.993 |
| Prozone Effect | >6 g/L | >5.8g/L |
| Analytical<br>sensitivity (LDL) | 0.058 g/L (5.8 mg/dL) | 0.37 g/L (37mg/dL) |

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## Premarket Notification, 510(k) for Tina-quant Apolipoprotein A-1 ver. 2 Test System on COBAS Integra Clinical Chemistry

Analyzers, continued

Substantial equivalence performance characteristics, cont.

The performance characteristics of the Tina-quant Apolipoprotein A-1 ver.2 Assay and the predicate device are compared in the table below.

| Feature | Tina-quant Apolipoprotein<br>A-1 ver.2 | Apolipoprotein A-1 |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | • Icterus: No significant<br>interference<br>• Hemolysis: No<br>significant interference<br>• Lipemia: No significant<br>interference up to an<br>Intralipid level of 1000<br>mg/dL<br>• Rheumatoid factors: No<br>significant interference | • Icterus: No significant<br>interference<br>• Hemolysis: No<br>significant<br>interference<br>• Lipemia: No<br>significant<br>interference<br>• Rheumatoid factors:<br>No significant<br>interference |

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three horizontal lines extending from its head, resembling wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Helen Torney Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k013278

Trade/Device Name: Tina-quant Apolipoprotein A-1 ver.2 Regulation Number: 21 CFR 866.5580 Regulation Name: Alpha-1-lipoprotein immunological test system. Regulatory Class: Class II Product Code: DER Dated: September 27, 2001 Received: October 1, 2001

Dear Ms. Torney:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreated of 76 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, de frees that have been require approval of a premarket approval application (PMA). and Costietle Fror (110) that the device, subject to the general controls provisions of the Act. The r ou may ; iferences mixes of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

NOV 1 5 2001

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod (soo as controls. Existing major regulations affecting your device can may be subject to back adder addess, 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 that I Dri has made a and regulations administered by other Federal agencies. You must or any I oderal blacked and st 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 (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 nothleation. The I Dri Imaling of castin 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 1 II you desire specific articles from astic devices), please contact the Office of Compliance at additionally 607.10 for mile ar questions on the promotion and advertising of your device, [phone]. Tracksonally (194-4639. 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 Information on your responsibilities are at its toll-free number [phone] or Manufacturers International met address "http://www.fda.gov/cdrb/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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KD13278

## Indications for Use Statement

NOV 1 5 2001

510(k) Number (if known): N/A

Device Name: Tina-quant Apolipoprotein A-1 ver.2

Indications For Use:

In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein A-1 in serum and plasma.

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.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Looges

(Divisio -Off)
Division: Lanical Laboratory Devices
510(k) Number: K013278