PYRILINKS-D ASSAY KIT

K974260 · Metra Biosystems, Inc. · JMM · Jan 26, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974260
• Device Name: PYRILINKS-D ASSAY KIT
• Applicant: Metra Biosystems, Inc.
• Product Code: JMM · Clinical Chemistry
• Decision Date: Jan 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1400
• Device Class: Class 1

Intended Use

Pyrilinks-D is a urinary assay that provides a quantitative measure of the excretion of deoxypyridinoline (Dpd) crosslinks as an indicator of bone resorption. Elevated levels of urinary Dpd indicate elevated bone resorption in individuals. Measurement of Dpd is intended for use in monitoring bone resorption changes in postmenopausal women receiving antiresorptive therapies and in individuals diagnosed with osteoporosis.

Device Story

Pyrilinks-D is a urinary assay for quantitative measurement of deoxypyridinoline (Dpd) crosslinks; serves as biomarker for bone resorption. Used in clinical laboratory settings by trained personnel. Input is urine sample; assay quantifies Dpd levels to assess bone turnover. Output provides clinicians with objective data on bone resorption status; assists in monitoring efficacy of antiresorptive therapies in postmenopausal women and osteoporosis patients. Facilitates clinical decision-making regarding treatment adjustments based on changes in bone resorption rates.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

In vitro diagnostic urinary assay; quantitative measurement of deoxypyridinoline (Dpd) crosslinks. Class I device.

Indications for Use

Indicated for monitoring bone resorption changes in postmenopausal women receiving antiresorptive therapies and in individuals diagnosed with osteoporosis. Used as an indicator of bone resorption via quantitative measurement of urinary deoxypyridinoline (Dpd) crosslinks.

Regulatory Classification

Identification

A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 26 1998

David Casal, Ph.D. · Senior Director, Clinical, Regulatory, and Quality Affairs Metra Biosystems, Inc. 265 North Whisman Road Mountain View, California 94043-3911

Re: K974260 Pyrilinks® -D Assay Requlatory Class: I Product Code: JMM Dated: August 29, 1997 November 13, 1997 Received:

Dear Dr. Casal:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਪ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 requlation (21 CFR Part 801 and 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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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510(k) Number (if known): K974260 Device Name: Pyrilinks -D Assay Indications For Use:

Pyrilinks-D is a urinary assay that provides a quantitative measure of the excretion of deoxypyridinoline (Dpd) crosslinks as an indicator of bone resorption. Elevated levels of urinary Dpd indicate elevated bone resorption in individuals. Measurement of Dpd is intended for use in monitoring bone resorption changes in postmenopausal women receiving antiresorptive therapies and in individuals diagnosed with osteoporosis.

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number L J

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use_

(Per 21 CFR 801.109)

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