(74 days)
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.
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The provided text is a 510(k) clearance letter from the FDA for the Pyrilinks®-D Assay, a urinary assay for deoxypyridinoline (Dpd) crosslinks. This document does not contain information regarding detailed acceptance criteria, specific study designs, or performance metrics in the format requested. It primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence.
Therefore, I cannot extract the information required to populate the table and answer the study-related questions from this document. The letter states that 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," implying that its performance was assessed against predicate devices, but the specifics of that assessment are not detailed here.
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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 (770) 488-7655.
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 (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" (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 (800) 638-2041 or (301) 443-6597 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 862.1400 Hydroxyproline test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.