ALKPHASE-B ASSAY KIT

K981373 · Metra Biosystems, Inc. · CIN · May 27, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981373
• Device Name: ALKPHASE-B ASSAY KIT
• Applicant: Metra Biosystems, Inc.
• Product Code: CIN · Clinical Chemistry
• Decision Date: May 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

Measurement of BAP is intended for use as an aid in the: management of postmenopausal osteoporosis and Paget's disease. monitoring of postmenopausal women on hormonal or bisphosphonate therapy prediction of skeletal response to hormonal therapy in postmenopausal women.

Device Story

Alkphase-B Assay is an in vitro diagnostic kit for measuring bone alkaline phosphatase (BAP). Used in clinical laboratory settings by trained technicians. Input: patient serum/plasma samples. Principle: immunoassay to quantify BAP levels. Output: quantitative BAP concentration. Healthcare providers use results to assess bone turnover, manage osteoporosis/Paget's disease, and monitor therapeutic efficacy of hormonal or bisphosphonate treatments. Benefits include objective assessment of skeletal response to therapy and disease management.

Clinical Evidence

No clinical data provided in the document; 510(k) clearance based on substantial equivalence determination.

Technological Characteristics

In vitro diagnostic immunoassay kit for BAP measurement. Class II device, product code CIN.

Indications for Use

Indicated for postmenopausal women and patients with Paget's disease to manage osteoporosis, monitor hormonal or bisphosphonate therapy, and predict skeletal response to hormonal therapy.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 27 1998

Jill Visor Manager of Clinical Aftairs Metra Biosystems, Inc. 265 North Whisman Road 94043-3911 Mountain View, California

Re : K981373 Alkphase-B® Assay Kit Regulatory Class: II Product Code: CIN Dated: April 14, 1998 Received: April 16, 1998

Dear Ms. Visor:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ರ್ಗ 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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/dsmamain.html".

sincerely yours,
Steven Litman

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):

Device Name: Alkphase-B® Assay

Indications For Use:

Measurement of BAP is intended for use as an aid in the:

management of postmenopausal osteoporosis and Paget's disease.

monitoring of postmenopausal women on hormonal or bisphosphonate therapy

prediction of skeletal response to hormonal therapy in postmenopausal women.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Per 21 CFR 801.109)