TINA-QUANT APOLIPOPROTEIN B VER.2
Device Facts
| Record ID | K013207 |
|---|---|
| Device Name | TINA-QUANT APOLIPOPROTEIN B VER.2 |
| Applicant | Roche Diagnostics Corp. |
| Product Code | DFC · Immunology |
| Decision Date | Nov 13, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5600 |
| Device Class | Class 2 |
Intended Use
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human 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.
Device Story
Tina-quant Apolipoprotein B ver.2 is an in vitro diagnostic reagent system for use on COBAS INTEGRA clinical chemistry analyzers. It measures human apolipoprotein B in serum and plasma samples via immunoturbidimetric assay. The device utilizes a specific sheep anti-apolipoprotein B antibody that forms a precipitate with human apolipoprotein B in the sample; this precipitate is measured turbidimetrically at 340 nm. The system is operated by laboratory professionals in clinical settings. Output is a quantitative concentration of apolipoprotein B (g/L), which healthcare providers use to assess lipid disorders and atherosclerosis. The device provides a standardized measurement traceable to the IFCC reference preparation SP3-07, assisting in clinical decision-making regarding patient lipid management.
Clinical Evidence
Bench testing only. Performance evaluated via precision studies (within-run CV 1.1-1.2%, between-day CV 2.9-3.2%) and method comparison against the predicate device (n=not specified, r=0.954). Interference testing confirmed no significant impact from icterus, hemolysis, lipemia (up to 1000 mg/dL Intralipid), or rheumatoid factors. Measuring range established at 0.20-4.0 g/L (extendable to 0.10-4.0 g/L with rerun).
Technological Characteristics
Immunoturbidimetric assay. Reagents: TRIS buffer, polyethylene glycol, detergent, preservative, and sheep anti-apolipoprotein B antibody. Form factor: Liquid reagent system for automated clinical chemistry analyzers. Connectivity: Integrated with COBAS INTEGRA system. Standardization: IFCC reference preparation SP3-07.
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
- COBAS Integra Tina-quant Apolipoprotein B (K990595)
Related Devices
- K013278 — TINA-QUANT APOLIPOPROTEIN A-1 VER.2 · Roche Diagnostics Corp. · Nov 15, 2001
- K990595 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B · Roche Diagnostics Corp. · Apr 14, 1999
- K013206 — TINA-QUANT APOLIPOPROTEIN B VER.2 · Roche Diagnostics Corp. · Nov 16, 2001
- K013249 — TINA-QUANT APOLIPOPROTEIN VER.2 · Roche Diagnostics Corp. · Nov 16, 2001
- K983281 — APOB · Abbott Laboratories · Jan 26, 1999
Submission Summary (Full Text)
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# NOV 1 3 2001
: :
| 510(k) Summary | K013207 |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 | Human apolipoprotein B forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm. |
| Intended use | In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human apolipoprotein B in serum and plasma. |
| Indications for Use | 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. |
:
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#### 510(k) Summary, Continued
#### The Tina-quant Apolipoprotein B ver.2 is substantially equivalent to other Substantial devices legally marketed in the United States. We claim equivalence to the Equivalence COBAS Integra Tina-quant Apolipoprotein B (K990595).
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<br>(predicate) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro diagnostic reagent<br>system intended for use on<br>COBAS INTEGRA system<br>for the quantitative<br>immunological<br>determination of human<br>apolipoprotein B in serum<br>and plasma. | In vitro diagnostic reagent<br>system intended for use on<br>COBAS Integra (analyzer<br>model) for the quantitative<br>immunological determination<br>of human apolipoprotein B in<br>serum and plasma. |
| Indication for<br>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 the<br>diagnosis and treatment of<br>lipid disorders and<br>atherosclerosis. |
| Assay Protocol | Immunoturbidometric | Immunoturbidometric |
| Instrument | COBAS Integra Clinical<br>Chemistry Analyzers | COBAS Integra Clinical<br>Chemistry Analyzers |
| Traceability /<br>Standardization | Standardized with regard to<br>the IFCC reference<br>preparation SP3-07. | Standardized with regard to<br>the IFCC reference<br>preparation SP3-07. |
| Sample Type | Serum and plasma | Serum and plasma |
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# 510(k) Summary, Continued
| Feature | Tina-quant Apolipoprotein<br>B ver.2 | Apolipoprotein B<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 B<br>antibody (sheep) specific for<br>human Apo B, TRIS buffer,<br>preservative (liquid). | R: Anti-apolipoprotein B T<br>antiserum (rabbit) specific for<br>human Apo B, in phosphate<br>buffer stabilized with 0.09%<br>sodium azide in vial A<br>(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>B ver.2 | Apolipoprotein B<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<br>Values | Females: 0.60 - 1.17 g/L<br>Males: 0.66 - 1.33 g/L | Females: 0.50 - 1.30 g/L<br>Males: 0.60 - 1.40 g/L |
| Measuring<br>Range | 0.20 - 4.0 g/L<br>(0.10 - 4.0 g/L with rerun) | 0.26 - 3.9 g/L<br>(0.09 - 7.8 g/L with rerun) |
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#### 510(k) Summary, Continued
Substantial equivalence performance characteristics The performance characteristics of the Tina-quant Apolipoprotein B ver.2 The performance dicate device are compared in the table below.
| Feature | Tina-quant Apolipoprotein B ver.2 | Apolipoprotein B (predicate) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within run CV<br>1.2% @ 0.8 g/L<br>1.1% @ 1.5 g/L<br>Between Day CV<br>2.9% @ 0.8 g/L<br>3.2% @ 1.5 g/L | Within run CV<br>0.66% @ 1.30 g/L<br>0.50% @ 2.22 g/L<br>Total CV<br>2.1% @ 1.30 g/L<br>0.98% @ 2.22 g/L |
| Method Comparison | Bablok/Passing:<br>Tina-quant Apolipoprotein B ver.2 (Y) / COBAS Integra Apolipoprotein B (X).<br>y = 1.02x + 0.03 g/L<br>r = 0.954 | Bablok/Passing:<br>Apolipoprotein B (Y)/ commercially available system (X).<br>y = 1.06x + 0.10 g/L<br>r = 0.983 |
| Prozone Effect | No effect up to 6 g/L | No effect up to 19.8 g/L |
| Analytical sensitivity (LDL) | 0.046 g/L | Determined by the lower limit of the standard curve which varies with the Apo B concentration of the calibrator. Typical concentration approximately 0.26 g/L |
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#### Premarket Notification, 510(k) for Tina-quant Apolipoprotein B ver. 2 Test System on COBAS Integra Clinical Chemistry Analyzers, 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<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>Levels of rheumatoid<br>factors higher than<br>300 IU/ml increase<br>the apparent<br>apolipoprotein B<br>concentration slightly. |
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
#### NOV 1 3 2001
Ms. Kay A. Taylor Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
k013207 Re:
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
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use Stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce provided to May 20, 1978, as condance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmette Act (rear the device, subject to the general controls provisions of the Act. The T ou may, therefore, mains of the Act include requirements for annual registration, listing of general controll pro resuring 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 If your device is classined (600 a00 rols. Existing major regulations affecting your device can may be subject to success reculations, Title 21, Parts 800 to 898. In addition, FDA may or found in the Outsting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc ac now that i Dr over device complies with other requirements of the Act that I Dri has intass and regulations administered by other Federal agencies. You must of any I cacial stututes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I all 6077, laoomig (21 CFR Part 820); and if applicable, the electronic form in the quality by sections (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 noalicate 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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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NOV 1 3 2001
#### Indications for Use Statement
K013207 510(k) Number (if known): N/A
Device Name: Tina-quant Apolipoprotein B ver.2
Indications For Use:
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the In vitro diagnostic rougent by ecommination of human apolipoprotein B in serum and plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and A npoprotein 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)
e un Cooper
. vices ion of Clinical Lal 510(k) Number
