TINA-QUANT APOLIPOPROTEIN B VER.2

K013206 · Roche Diagnostics Corp. · DFC · Nov 16, 2001 · Immunology

Device Facts

• Record ID: K013206
• Device Name: TINA-QUANT APOLIPOPROTEIN B VER.2
• Applicant: Roche Diagnostics Corp.
• Product Code: DFC · Immunology
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma on automated clinical chemistry analyzers. 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

In vitro diagnostic assay; measures human apolipoprotein B in serum or plasma samples. Principle: immunoturbidimetric; anti-apolipoprotein B antibodies react with antigen in sample to form antigen/antibody complexes; agglutination measured turbidimetrically. Used on automated clinical chemistry analyzers in clinical laboratory settings by trained laboratory personnel. Output: quantitative concentration of apolipoprotein B (mg/dL). Healthcare providers use results to assess lipid disorders and atherosclerosis risk; informs clinical management and treatment decisions. Benefits: provides standardized, automated measurement of apolipoprotein B for patient monitoring.

Clinical Evidence

Bench testing only. Performance evaluated via precision (within-run CV 0.5-1.5%, between-day CV 1.0-2.5%), method comparison (Bablok/Passing regression vs. nephelometric method, r=0.884), and interference studies (icterus, hemolysis, lipemia). No significant cross-reactivity with Apo A-I or A-II. Hook effect absent up to 600 mg/dL.

Technological Characteristics

Immunoturbidimetric assay; utilizes anti-human apolipoprotein B antibodies (sheep origin). Formatted for automated clinical chemistry analyzers. Standardized to IFCC reference preparation SP3-07. Reagent storage 2-8°C. No specific material standards or software algorithm class provided.

Indications for Use

Indicated for the quantitative determination of apolipoprotein B in human serum and plasma to aid in the diagnosis and treatment of lipid disorders and atherosclerosis.

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

• Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay (K860894)

Submission Summary (Full Text)

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| NOV | 1 6 2001 |
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K013206

# 510(k) Summary

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| 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. |
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| Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 (317) 521 - 3544 |
| | Contact Person: Kay A. Taylor |
| | Date Prepared: September 24, 2001 |
| Device Name | Proprietary name: Tina-quant Apolipoprotein ver.2 |
| | Common name: Apolipoprotein B |
| | Classification name: Low-density lipoprotein immunological test system |
| Device Description | A device for the measurement of human apolipoprotein B in serum or plasma. Anti-apolipoprotein B antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically. |
| Intended use | Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma on automated clinical chemistry analyzers. |
| Indications for Use | 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. |

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Substantial Equivalence

The Tina-quant Apolipoprotein B ver.2 is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Dade Behring N Antisera to Human Apolipoprotein A-1 and Apolipoprotein B assay (K860894).

Substantial equivalence similarities

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

| Feature | Tina-quant<br>Apolipoprotein B ver.2 | Apolipoprotein B (predicate) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidmetric assay<br>for the in vitro quantitative<br>determination of<br>apolipoprotein B in human<br>serum and plasma on<br>automated clinical<br>chemistry analyzers. | In vitro diagnostic reagent for<br>the quantitative determination<br>of apolipoprotein B in human<br>serum with the Behring<br>nephelometers. |
| Indication for Use | For the quantitative<br>determination of<br>apolipoprotein B in serum<br>and plasma. A lipoprotein<br>test system is a device<br>intended to measure<br>lipoprotein in serum and<br>plasma. Lipoprotein<br>measurements are used in<br>the diagnosis and treatment<br>of lipid disorders and<br>atherosclerosis. | For the quantitative<br>determination of<br>apolipoprotein B in serum<br>and plasma. A lipoprotein<br>test system is a device<br>intended to measure<br>lipoprotein in serum and<br>plasma. Lipoprotein<br>measurements are used in<br>the diagnosis and treatment<br>of lipid disorders and<br>atherosclerosis. |
| Assay Protocol | Immunoturbidometric | Immunoturbidometric |
| Traceability /<br>Standardization | Standardized with regard to<br>the IFCC reference<br>preparation SP3-07. | Not provided in insert |
| Calibration<br>Interval | • After each lot<br>• as required by QC<br>procedures | • After each lot<br>• as required by QC<br>procedures |

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### 510(k) Summary, Continued

#### Substantial equivalence differences

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

| Feature | Tina-quant Apolipoprotein<br>B ver.2 | Apolipoprotein B<br>(predicate) |
|----------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | Serum and plasma (heparin,<br>EDTA) | Serum |
| Reagent<br>Stability | Store at 2-8°C,<br>unopened.42 days opened and<br>refrigerated on analyzer. | Store at 2-8°C,<br>unopened.Use within 4 weeks, if<br>directly after use if vials<br>are stopped, capped and<br>stored at 2-8°C.Do not use remaining<br>antiserum if left open on<br>nephelometer for longer<br>than 5 days at 8 hours<br>daily or comparable<br>period of time.Do not freeze. |
| Calibrator | C.f.a.s. Lipids | N Apoliporprotein Standard<br>Serum (human) |
| Controls | Precinorm L, Precipath L | Apolipoprotein Control<br>Serum CHD (human) |
| Expected<br>Values | Females: 60 - 117 mg/dL<br>Males: 66 - 133 mg/dL | Females: 0.66 - 1.25 g/L<br>Males: 0.65 - 1.40 g/L |
| Instrument | Roche/Hitachi Clinical<br>Chemistry Analyzers | Dade Behring<br>Nephelometers |
| Measuring<br>Range | 20 - 400 mg/dL | Not provided in insert |

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### 510(k) Summary, Continued

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

| Feature | Tina-quant Apolipoprotein<br>B ver.2 | Apolipoprotein B<br>(predicate) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within run CV | Inter-assay Precision |
| | 1.5% @ 29 mg/dL (serum) | 1.9% CV @ 1.04 g/L |
| | 0.5% @ 112 mg/dL (serum) | Intra-assay Precision |
| | 0.8% @ 69 mg/dL (control) | |
| | 0.5% @ 152 mg/dL (control) | 2.4% CV @ 1.08 g/L |
| | Between Day CV | |
| | 2.5% @ 26 mg/dL (serum) | |
| | 1.1% @ 127 mg/dL (serum) | |
| | 1.0% @ 80 mg/dL (control) | |
| | 1.9% @ 155 mg/dL (control) | |
| Method<br>Comparison | Bablok/Passing:<br>Tina-quant Apolipoprotein B<br>ver.2 (Y) / Nephelometric<br>method (X).<br>$y = 1.127 - 2.849$ mg/dL<br>$r = 0.884$ | Dade Behring N Antisera<br>Apo B (Y) /<br>radioimmunodiffusion<br>commerical method (X):<br>$y(BN)= 0.94(RID) - 0.004$ g/L<br>$r= 0.99$ |
| Hook Effect | No effect up to 600 mg/dL | NA |
| Analytical<br>sensitivity (LDL) | 1.5 mg/dL | Established by the lower<br>limit of the reference<br>curve and depends<br>therefore upon the<br>concentration of the<br>proteins in the N<br>Apolipoprotein Standard<br>Serum |

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## 510(k) Summary, Continued

Substantial equivalence performance characteristics, cont.

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

| Feature | Tina-quant Apolipoprotein<br>B ver.2 | Apolipoprotein B |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | Icterus: No significant interference up to an I index of 60 mg/dL (conjugated and unconjugated) Hemolysis: No significant interference up to an H index of 1000. Lipemia: No significant interference up to an L index of 1000. Anti-human apolipoprotein B antibodies from sheep show no cross-reactivity with apolipoprotein A-I or A-II. | Turbidity and particles in the sample can interfere with the test. Therefore particulates resulting from incompleted coagulation or denaturation of proteins should be removed prior to assay by centrifugation. In isolated cases excessive concentrations of triglycerides or hyperlipemic samples may disturb the Apo B assay. In such cases the effect of the disturbance can be reduced by retesting the sample in a higher dilution. |

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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 features a stylized eagle with three stripes representing the department's mission. 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

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

Re: k013206

> Trade/Device Name: Tina-quant Apolipoprotein B ver.2 Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC Dated: September 24, 2001 Received: September 25, 2001

NOV 1 6 2001

Dear Ms. Taylor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) regulation (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 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Sutman

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 for Use Statement NOV 1 6 2001

K013206 510(k) Number (if known): N/A

Device Name: Tina-quant Apolipoprotein B ver.2

Indications For Use:

Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein B in human serum and plasma on automated clinical chemistry analyzers.

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)

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013206