ORION DIAGNOSTICA UNIQ PINP RIA

K043125 · Orion Diagnostica, OY · CIN · May 4, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043125
• Device Name: ORION DIAGNOSTICA UNIQ PINP RIA
• Applicant: Orion Diagnostica, OY
• Product Code: CIN · Clinical Chemistry
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

Orion Diagnostica UniQ™ PINP RIA is a quantitiative radioimmunoassay designed for the measurement of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum. The test is intended to be used as an aid in the management of postmenopausal osteoporosis. For in vitro diagnostic use.

Device Story

UniQ PINP RIA is an in vitro diagnostic radioimmunoassay (RIA) used to measure intact aminoterminal propeptide of type I procollagen in human serum. It serves as a biomarker for osteoblastic activity. The device is intended for use by laboratory professionals to assist clinicians in managing postmenopausal osteoporosis. The assay quantifies the propeptide concentration, providing data that clinicians use to assess bone turnover and monitor therapeutic response in patients. The device operates within a clinical laboratory setting.

Clinical Evidence

Retrospective analysis of two clinical studies. Study 1 (n=124) compared PINP and BAP response to BMD in postmenopausal women treated with alendronate vs. placebo over 12 months. Study 2 (n=44) evaluated PINP and BAP response to hormone replacement therapy over 12 months. Both studies demonstrated that PINP and BAP show similar decreases in response to treatment, correlating with increases in BMD. Analytical performance included precision (intra-assay CV 6.5-19.8%, inter-assay CV 6.0-10.1%), linearity (recovery 96-112%), and detection limit (2 µg/L).

Technological Characteristics

Radioimmunoassay (RIA) for the quantitative measurement of intact aminoterminal propeptide of type I procollagen in human serum. Classified under 21 CFR 862.1050 (Alkaline phosphatase or isoenzymes test system).

Indications for Use

Indicated for the quantitative measurement of intact aminoterminal propeptide of type I procollagen (PINP) in human serum to aid in the management of postmenopausal osteoporosis.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 4 2005

Ms. Annikka Rantama Assistant Vice President Quality Assurance and Regulatory Affairs Orion Diagnostica Oy Koivu- Mankkaantie 6 B Espoo, Finland 02200

k043125 Re:

Trade/Device Name: Orion Diagnostica UniQTMPINP RIA Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CIN Dated: April 7, 2005 Received: April 11, 2005

Dear Ms. Rantama:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o no re ro row a your we 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 or uny I 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) I mis lotter will and my are 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 information about the application of labeling requirements to your device, rr you don's on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, 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): K043125

Device Name: Orion Diagnostica UniQ™ PINP RIA

Indications For Use:

Orion Diagnostica UniQ™ PINP RIA is a quantitiative radioimmunoassay
of type l Orion Diagnostica UniQ FINF INA is a quantitions conseptide of type I
designed for the measurement of intect aminoterminal propendent. The test designed for the measurement of thate antirity, in human serum. The test
procollagen, an indicator of osted in the mensagement of postmenopausal procollagen, an Indicator of osteibiastic dolling, in ham.
is intended to be used an aid in the management of postmenopausal is interided to be in vitro diagnostic use.

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

Over-The-Counter Use _ (21 CFR 807 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)

Albert
Division Sign-Off

Office of In Vitro Diagnostic Device Onloo tion and Safety

510(k) K043125