LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH

K063838 · Thermo Electron OY · DFC · Sep 27, 2007 · Immunology

Device Facts

• Record ID: K063838
• Device Name: LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
• Applicant: Thermo Electron OY
• Product Code: DFC · Immunology
• Decision Date: Sep 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases. Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy. For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy. For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.

Device Story

Device consists of an immunoturbidimetric assay for quantitative determination of Lipoprotein(a) in human serum and plasma samples. Used on T60 clinical chemistry instruments. Includes associated calibrators and assayed controls (normal and high) to monitor test precision. Operated by laboratory professionals in clinical settings. Input: human serum/plasma samples. Transformation: immunoturbidimetric reaction measured by T60 instrument. Output: quantitative Lipoprotein(a) concentration. Results assist clinicians in diagnosing lipid metabolism disorders and assessing cardiovascular risk.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and performance validation of the immunoturbidimetric assay on T60 instruments.

Technological Characteristics

Immunoturbidimetric assay for use on T60 clinical chemistry instruments. Includes liquid-stable reagents, calibrators, and assayed controls. Operates via light absorbance measurement (turbidimetry) proportional to antigen-antibody complex formation. In vitro diagnostic use.

Indications for Use

Indicated for in vitro quantitative determination of Lipoprotein(a) in human serum, Li-heparin plasma, and EDTA plasma to aid in diagnosing lipid metabolism disorders and identifying cardiovascular disease risk populations.

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Re:

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## SEP 2 7 2007

Thermo Electron Oy c/o Mr. Päivi Sormunen Vice President of Industrial Solutions and QRC Ratastie 2, P.O. Box 100 Vantaa, Finland 01621

> k063838 Trade Name: Lipoprotein(a), Lipoprotein(a) Calibrator, Lipoprotein(a) Control, Lipoprotein(a) Control High Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system. Regulatory Class: Class II Product Code: DFC, JIT, JJY Dated: September 19, 2007 Received: September 21, 2007

Dear Mr. Sormunen:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(x) marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please othe the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree no [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Séan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known): k063838

Device Names:

Lipoprotein(a) Lipoprotein(a) Calibrator Lipoprotein(a) Control Lipoprotein(a) Control High

#### Indications for Use:

For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments.

Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases

Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy

For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy

For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

| Carol C. Benson |
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| Division Sign-Off |

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