(41 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, nor does it describe features or processes typically associated with AI/ML in medical devices (like image processing with AI, training/test sets for algorithms, or performance metrics like AUC which are common in AI/ML evaluations).
No.
The device measures BAP as an aid in management, monitoring, and prediction related to diseases, which are diagnostic or monitoring functions, not therapeutic.
Yes
The device aids in the management, monitoring, and prediction of skeletal response, which indicates it provides information to diagnose or assess a patient's condition.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes any hardware components or relies solely on software for its intended function.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the measurement of BAP (Bone Alkaline Phosphatase) for various clinical purposes related to bone health (management, monitoring, and prediction of response to therapy). This involves analyzing a biological sample (likely blood or serum) to obtain information about a patient's health status.
- Intended User / Care Setting: The intended user is a "Clinical Laboratory," which is the typical setting for performing in vitro diagnostic tests.
The core function of measuring a biomarker (BAP) in a biological sample for clinical decision-making falls squarely within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
CIN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is black and white.
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 (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 regulation (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 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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Page 1 of 1
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
(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
(Optional Format 1-2-96)
(Per 21 CFR 801.109)