OSTEOMARK NTX POC

K992997 · Metrika, Inc. · JMM · Nov 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992997
• Device Name: OSTEOMARK NTX POC
• Applicant: Metrika, Inc.
• Product Code: JMM · Clinical Chemistry
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1400
• Device Class: Class 1

Intended Use

Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The test is used to monitor bone resorption changes following initiation of antiresorptive therapy (e.g., hormone replacement therapy).

Device Story

Osteomark NTx POC is a urinary assay for quantitative measurement of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine. Device used to monitor bone resorption changes in patients initiating antiresorptive therapy, such as hormone replacement therapy. Intended for point-of-care use by healthcare professionals. Provides quantitative results (nM Bone Collagen Equivalents/mM creatinine) to assist clinicians in assessing therapeutic response to bone resorption inhibitors. Helps evaluate efficacy of antiresorptive treatments.

Technological Characteristics

Urinary assay for quantitative measurement of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine. Results expressed in nM Bone Collagen Equivalents/mM creatinine.

Indications for Use

Indicated for patients undergoing antiresorptive therapy (e.g., hormone replacement therapy) to monitor changes in bone resorption via quantitative measurement of urinary cross-linked N-telopeptides of type I collagen (NTx) normalized to creatinine.

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

NOV - 9 1999

Ms. Erika B. Ammirati, R.A.C., MT (ASCP) Clinical/Regulatory Consultant Metrika. Inc. 510 Oakmead Parkway Sunnyvale, California 94086

Re: K992997

> Trade Name: OSTEOMARK® NTx Point of Care (POC) Regulatory Class: I reserved Product Code: JMM Dated: September 3, 1999 Received: September 7, 1999

Dear Ms. Ammirati:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulation 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 regulations.

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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 regulation (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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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): K99 2997

Devicc Name:

## Indications For Use:

Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The test is used to monitor bone resorption changes following initiation of antiresorptive therapy (e.g., hormone replacement therapy).

Dean Cooper

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(Division Sign-Off)

Ston of Climeal Laboratory Devices 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)