COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

K122722 · Roche Diagnostics · DFC · Nov 29, 2012 · Immunology

Device Facts

• Record ID: K122722
• Device Name: COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
• Applicant: Roche Diagnostics
• Product Code: DFC · Immunology
• Decision Date: Nov 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. The Preciset Lp(a) calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Device Story

Device is particle-enhanced immunoturbidimetric assay for quantitative Lp(a) measurement. Input: human serum or plasma samples. Principle: Lp(a) in sample binds to latex particles coated with polyclonal anti-human Lp(a) antibodies (rabbit); agglutination measured turbidimetrically; signal proportional to Lp(a) concentration. Used in clinical laboratories on Roche/Hitachi cobas c 501 analyzers. Output: quantitative Lp(a) concentration (mg/dL). Healthcare providers use results alongside clinical evaluation to assess lipid metabolism and cardiovascular disease risk. Benefits: provides standardized, automated measurement of Lp(a) to aid in identifying patients at increased cardiovascular risk.

Clinical Evidence

Bench testing only. Evaluated precision (repeatability and intermediate precision), LoB, LoD, LoQ, high-dose hook effect, cross-reactivity, interfering substances (bilirubin, hemolysis, lipemia, plasminogen, ApoB, Rheumatoid Factor), linearity, and reagent stability. Method comparison performed against predicate device.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents: glycine buffer, BSA, rabbit serum, latex particles coated with polyclonal anti-human Lp(a) antibodies. Calibrators/controls: lyophilized human plasma matrix. Instrument: cobas c 501 analyzer. Software: automated processing on clinical chemistry analyzer. Standards: CLSI EP05-A2, EP6-A, EP07-A2, EP17-A.

Indications for Use

Indicated for quantitative determination of lipoprotein(a) in human serum and plasma to evaluate lipid metabolism disorders and assess atherosclerotic cardiovascular disease risk in specific populations. Used in conjunction with clinical evaluation and other lipoprotein tests.

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

• Lp(a)-Latex SEIKEN assay, Denka Seiken Co., Ltd. (k013359)
• Diazyme Lp(a) calibrator set, General Atomics (k082488)
• Diazyme Lp(a) control set, General Atomics (k082488)

Submission Summary (Full Text)

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K122722

# NDV 2 9 2012

1

| Section 4 - 510(k) Summary: cobas c Tina-quant Lipoprotein (a)<br>Gen.2 Test System | | |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose | In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits<br>official notification as required by Section 510(k) of the Federal Food, Drug<br>and Cosmetics Act of our intention to market the device described in this<br>Premarket Notification [510(k)]. | |
| | The purpose of this premarket notification is to obtain FDA review and<br>clearance for the cobas c Tina-quant Lipoprotein (a) Gen.2 assay, Preciset<br>Lp(a) Gen.2 calibrator set, and PreciControl Lp(a) Gen.2 control set. | |
| Device name | Proprietary name: | (1) cobas c Tina-quant Lipoprotein (a) Gen.2 assay<br>(2) Preciset Lp(a) Gen.2 calibrator set<br>(3) PreciControl Lp(a) Gen.2 control set |
| | Common name: | (1) TQ Lp(a) Gen.2<br>(2) Preciset Lp(a) Gen.2 calibrator set<br>(3) PreciControl Lp(a) Gen.2 control set |
| | Classification: | (1) Low-Density Lipoprotein Immunological Test System<br>(2) Calibrator, secondary<br>(3) Single (specified) analyte controls (assayed and<br>unassayed) |
| Establishment<br>registration | For the cobas c Tina-quant Lipoprotein (a) Gen.2 assay, Preciset Lp(a) Gen.2<br>calibrator set, and PreciControl Lp(a) Gen.2 control set, the establishment<br>registration number for Roche Diagnostics GmbH in Mannheim, Germany is<br>9610126. The establishment registration number for Roche Diagnostics<br>United States is 1823260. | |

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| Classification | The FDA has classified the Low-Density Lipoprotein Immunological Test<br>System (TQ Lp(a) Gen.2) and the calibrator (Preciset Lp(a)) as Class II<br>devices.<br>The FDA has classified the single (specified) analyte controls (assayed and<br>unassayed) (PreciControl Lp(a)) as a Class 1 (reserved) device. | | | | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------------|------------------------|--|--|
| | Panel | Product<br>Code | Classification Name | Regulation | | |
| | Clinical<br>Chemistry | DFC | Low-Density Lipoprotein<br>Immunological Test System | 21 CFR<br>866.5600 | | |
| | Clinical<br>Chemistry | الا | Calibrator, secondary | 21 CFR<br>862.1150 | | |
| | Clinical<br>Chemistry | الا ال | Single (specified) analyte controls<br>(assayed and unassayed) | 21 CFR<br>862.1660 | | |
| | | | | | | |
| Performance<br>standards | To date, no performance standards that affect this device have been finalized<br>under Section 514 of the Act.<br>Draft labeling sufficient to describe the device, its intended use, and the<br>directions for use on the cobas c 501 analyzer is attached. We believe the<br>draft version of the device labeling presented in Section 8 contains all of the<br>technical information required per 21 CFR 809.10 for the cobas c Tina-quant<br>Lipoprotein (a) Gen.2 test system. | | | | | |
| Proposed<br>labeling | | | | | | |
| | | | | Continued on next page | | |

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The TQ Lp(a) Gen.2 test principle is a particle-enhanced Device description immunoturbidimetric assay. Human lipoprotein (a) agglutinates with latex particles coated with anti-Lp(a) antibodies. The precipitate is determined turbidimetrically. The Preciset Lp(a) Gen.2 calibrator set consists of five lyophilized calibrators based on a stabilized and lyophilized pool of human plasma. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. The PreciControl Lp(a) Gen.2 control set contains two lyophilized controls based on a human plasma matrix. Intended cobas c Tina-quant Lipoprotein (a) Gen.2 assay: use/indications The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test for use intended for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma the Roche/Hitachi cobas c 501 analyzer. The measurement of Lp(a) is useful in evaluation of lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests. Preciset Lp(a) Gen.2 calibrator set: The Preciset Lp(a) Gen.2 calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. PreciControl Lp(a) Gen.2 control set: The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. Continued on next page

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| Substantial<br>equivalence | The cobas c Tina-quant Lipoprotein (a) Gen.2 Test System is substantially<br>equivalent to other devices legally marketed in the United States. |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (1) cobas c Tina-quant Lipoprotein (a) Gen.2 assay is equivalent to Lp(a)-<br>Latex SEIKEN assay, Denka Seiken Co., Ltd. (k013359). |
| | (2) Preciset Lp(a) Gen.2 calibrator set is equivalent to the Diazyme Lp(a)<br>calibrator set, General Atomics (k082488). |
| | (3) PreciControl Lp(a) Gen.2 control set is equivalent to the Diazyme<br>Lp(a) control set, General Atomics (k082488). |
| Substantial<br>equivalence -<br>comparison | The following tables compare the cobas c Tina-quant Lipoprotein (a) Gen.2<br>assay, Preciset Lp(a) Gen.2 calibrator set, and PreciControl Lp(a) Gen.2<br>control set with their respective predicate devices. |
| | Continued on next page |

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#### Comparison of assays similarities and differences

| Feature | Assay Comparison | TQ Lp(a) Gen.2 assay |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Lp(a)-Latex Seiken assay<br>(predicate device: k013359) | (candidate device) |
| Intended<br>Use/Indications<br>for Use | The Lp(a)-Latex Seiken Assay<br>kit is an in vitro diagnostic test<br>for the quantitative<br>determination of lipoprotein(a)<br>[Lp(a)] in huma serum and<br>plasma samples using Hitachi<br>917 analyzer. The measurement<br>of Lp(a) is useful in evaluating<br>lipid metabolism disorders and<br>assessing atherosclerotic<br>cardiovascular disease in specific<br>populations, when used in<br>conjunction with clinical<br>evaluation and other lipoprotein<br>tests. | The cobas c Tina-quant<br>Lipoprotein (a) Gen.2 assay is<br>an in vitro test intended for the<br>quantitative determination of<br>lipoprotein(a) [Lp(a)] in<br>human serum and plasma the<br>Roche/Hitachi cobas c 501<br>analyzer. The measurement of<br>Lp(a) is useful in evaluation of<br>lipid metabolism disorders and<br>assessing atherosclerotic<br>cardiovascular disease in<br>specific populations, when<br>used in conjunction with<br>clinical evaluation and other<br>lipoprotein tests. |
| Assay principle | immunoturbidimetric | same |
| Sample types | Human serum and Na2-EDTA,<br>K2-EDTA, Na-heparin, Li-<br>Heparin, and Citric acid plasma | Human serum and K2-EDTA,<br>K3-EDTA, and Li-Heparin |
| Instrument<br>Platform | Roche/Hitachi 917 analzyer | cobas c 501 analyzer |
| Calibrator | Lp(a)-Latex Seiken Assay Kit<br>Calibrators | Preciset Lp(a) Gen.2 calibrator<br>set |
| Calibration<br>Frequency | After reagent lot change and as<br>required following quality<br>control procedures. | same |
| Calibration<br>mode | Six point; spline | same |
| Controls | commercially available controls | PreciControl Lp(a) control set<br>(2 levels) |
| Reagent active<br>ingredients | R1: glycine buffer solution<br><br>R2: latex particles with anti- | R1: glycine buffer solution<br><br>R3: latex particles with anti- |

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| Comparison of<br>assays –<br>similarities and<br>differences<br>(continued) | Assay Comparison | | |
|-----------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | Feature | Lp(a)-Latex Seiken assay<br>(predicate device: k013359) | TQ Lp(a) Gen.2 assay<br>(candidate device) |
| | Reagent<br>Stability | Unopened:<br>2-10°C until expiration date | Unopened:<br>2-8°C until expiration date |
| | | On-board in use:<br>N/A | On-board in use:<br>6 weeks |
| | Measuring<br>range | 2.0 – 80.0 mg/dL | 6.0 – 80.0 mg/dL |
| | Lower<br>Limits of<br>Measure | LDL: 2.0 mg/dL<br><br>LoB, LoD, and LoQ not tested | LDL: not tested<br><br>LoB: 3 mg/dL<br>LoD: 4 mg/dL<br>LoQ: 6 mg/dL |
| | Hook Effect | Not tested | No hook effect up to 190<br>mg/dL |
| | Expected<br>Values | cutoff point: 30 mg/dL<br><br>Reference ranges have not been<br>established for this assay for<br>different ethnic populations or<br>disease states. Since Lp(a)<br>levels are largely influenced by<br>hereditary factors and vary with<br>ethnic populations, it is<br>recommended that each<br>laboratory establish its own<br>expected values. | same |

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| Comparison of<br>assays -<br>similarities and<br>differences<br>(continued) | Feature | Assay Comparison | | | | | | | |
|-----------------------------------------------------------------------------|-----------|---------------------------------------------------------|-------------------------------------------------------------------------------------|-------|-------|----------------------------------------------------------------|------------|-----|------|
| | Precision | Lp(a)-Latex Seiken assay<br>(predicate device: k013359) | TQ Lp(a) Gen.2 assay<br>(candidate device)<br>Repeatability = Within-run precision: | | | | | | |
| | | Within-run precision: | Mean | SD | CV | | | | |
| | | Control I | 21.9 mg/dL | 0.438 | 2.00% | Control L | 20.3 mg/dL | 0.3 | 1.4% |
| | | Control II | 54.7 mg/dL | 0.686 | 1.26% | Control H | 61.5 mg/dL | 0.6 | 1.0% |
| | | | | | | Pool 1 | 7.0 mg/dL | 0.4 | 5.4% |
| | | | | | | Pool 2 | 16.1 mg/dL | 1.0 | 6.2% |
| | | | | | | Pool 3 | 30.9 mg/dL | 0.7 | 2.4% |
| | | | | | | Pool 4 | 79.4 mg/dL | 0.7 | 0.9% |
| | | Between-run precision: | | | | Intermediate Precision = Total precision/Between-run precision | | | |
| | | Mean | SD | CV | Mean | SD | CV | | |
| | | Control I | 18.7 mg/dL | 0.40 | 2.12% | Control L | 20.3 mg/dL | 0.3 | 1.6% |
| | | Control II | 41.5 mg/dL | 0.44 | 1.06% | Control H | 61.5 mg/dL | 0.7 | 1.1% |
| | | Pool 1 | 8.4 mg/dL | 0.19 | 2.22% | Pool 1 | 7.0 mg/dL | 0.5 | 7.6% |
| | | Pool 2 | 26.5 mg/dL | 0.29 | 1.11% | Pool 2 | 16.1 mg/dL | 1.0 | 6.4% |
| | | Pool 3 | 66.3 mg/dL | 0.66 | 0.99% | Pool 3 | 30.9 mg/dL | 0.9 | 2.9% |
| | | | | | | Pool 4 | 79.4 mg/dL | 0.9 | 1.1% |

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| Feature | Lp(a)-Latex Seiken assay<br>(predicate device: k013359) | TQ Lp(a) Gen.2 assay<br>(candidate device) |
|------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Interferences<br>and cross<br>reactivity | Icterus (conjugated and<br>unconjugated bilirubin):<br>no significant interference up<br>to 30 mg/dL | Icterus (conjugated and<br>unconjugated bilirubin):<br>no significant interference up<br>to an I index of 60<br>(approximately 60 mg/dL) |
| | Hemolysis:<br>no significant interference up<br>to 500 mg/dL | Hemolysis:<br>no significant interference up<br>to an H index of 1000<br>(approximately 1000 mg/dL) |
| | Triglycerides:<br>no significant interference up<br>to 1500 mg/dL | Lipemia:<br>no significant interference up<br>to an L index of 2000 |
| | Plasminogen:<br>no significant interference up<br>to 200 mg/dL | Plasminogen:<br>no significant cross<br>reactivity up to 150 mg/dL |
| | Apolipoprotein B:<br>no significant interference up<br>to 200 mg/dL | Apolipoprotein B:<br>no significant cross<br>reactivity up to 200 mg/dL |
| | | Rheumatoid Factor:<br>no significant interference up<br>to 1200 IU/mL |
| | | Drugs:<br>No interference was found at<br>therapeutic concentrations<br>using common drug panels |

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Comparison of calibrators – similarities and differences

| Calibrator Comparison | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Diazyme Lp(a) calibrator<br>(predicate device: k082488) | Preciset Lp(a) Gen.2<br>calibrator set<br>(candidate device) |
| Intended<br>use | The Diazyme Lp(a)<br>calibrator set is intended for<br>use in establishing the<br>calibration curve for the<br>Diazyme Lp(a) reagents by<br>turbidimetry. | The Preciset Lp(a) Gen.2<br>calibrator set is intended for use<br>in the calibration of<br>quantitative Roche methods on<br>Roche clinical chemistry<br>analyzers as specified in the<br>value sheets. |
| Analyte | Lipoprotein (a) | same |
| Format &<br>matrix | Consists of 5 lyophilized<br>human serum calibrators | Consists of 5 lyophilized<br>human plasma calibrators |
| Storage | 2-8°C | same |

Comparison of controls – similarities and differences

| Control Comparison | | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Diazyme Lp(a) control set<br>(predicate device: k082488) | PreciControl Lp(a) Gen.2<br>control set<br>(candidate device) |
| Intended<br>use | The Diazyme control set is<br>intended for use in<br>monitoring the quality<br>control of results obtained<br>with the Diazyme Lp(a)<br>reagents by turbidimetry. | The PreciControl Lp(a) Gen.2<br>control set is intended for use<br>in quality control by<br>monitoring accuracy and<br>precision for the quantitative<br>methods as specified in the<br>value sheets. |
| Analyte | Lipoprotein (a) | same |
| Format &<br>matrix | Consists of 2 lyophilized<br>human serum controls | Consists of 2 lyophilized<br>human plasma controls |
| Storage | 2-8°C | same |

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| Evaluations<br>summary | (1) The cobas c Tina-quant Lipoprotein (a) Gen.2 assay was evaluated for<br>several performance characteristics, including precision, LoB, LoD,<br>LoQ, high dose hook effect, cross reactivity, method comparison,<br>interfering substances, anticoagulants, linearity, reagent on-board<br>stability, and reagent shelf life stability. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (2) The Preciset Lp(a) calibrator set was evaluated for value assignment<br>and stability. |
| | (3) The PreciControl Lp(a) control set was evaluated for value assignment<br>and stability. |
| | A summary of the evaluation studies is provided in Section 5-Analytical<br>Performance Characteristics. |
| Confidentiality | Roche Diagnostics requests that the FDA not disclose the nature or existence<br>of the premarket notification until the substantial equivalence decision has<br>been reached. |
| Closing | We trust that the information provided in this Premarket Notification [510(k)]<br>will support a determination of substantial equivalence for the cobas c Tina-<br>quant Lipoprotein (a) Gen.2 test system. |
| | If you should have questions or required further information, please do not<br>hesitate to contact this office. |
| | Lisa K. Klinedinst<br>Roche Diagnostics<br>Regulatory Affairs Consultant<br>Phone: [phone]<br>Fax: [phone] |
| | Date prepared: November 28, 2012 |

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#### DEPARTMENT OF HEALTH & HUM AN SERVICES

Public Health Service .

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 29, 2012

Roche Diagnostics c/o Lisa K. Klinedinst 9115 Hague Road, Building A Indianapolis, IN 46250-0416

Re: k122722

Trade/Device Name: cobas c Tina-quant Lipoprotein (a) Gen.2 Test System

Preciset Lp(a) Gen.2 calibrator set

PreciControl Lp(a) Gen.2 control set

Regulation Number: 21 CFR 866.5600

Regulation Name: Low Density Lipoprotein Immunological Test System Regulatory Class: Class II Product Code: DFC, JIT, JJX Dated: August 31, 2012 Received: September 5, 2012

Dear Ms. Klinedinst:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Lisa Klinedinst

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

#### Carol C. Benson for

Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number (if known): k122722

.Device Name: cobas c Tina-quant Lipoprotein (a) Gen.2 Test System Preciset Lp(a) Gen.2 calibrator set

PreciControl Lp(a) Gen.2 control set

#### Indications for Use:

The cobas c Tina-quant Lipoprotein (a) Gen.2 assay is an in vitro test intended for The countitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma on the Roche/Hitachi cobas c systems. The measurement of Lp(a) is plasma on the Rooms/Filipid metabolism disorders and assessing atherosclerotic useful in evaluation of ifpla metas oppulations, when used in conjunction with clinical evaluation and other lipoprotein tests.

The Preciset Lp(a) calibrator set is intended for use in the calibration of The I reciser Ep(d) canorator books clinical chemistry analyzers as specified in the value sheets.

The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by The I recreonifor Ep(d) Goll:2 com:2 comfor the quantitative methods as specified in the value sheets.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ruth A. Chesler

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

k122722 510(k)