(118 days)
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No
The device description details a standard immunoradiometric assay based on chemical reactions and radioactivity measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) device that measures a biomarker (sALP) to aid in the management of diseases; it does not directly treat or alleviate symptoms.
Yes
The device is described as an "in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum," which is used "as an aid in the management of postmenopausal osteoporosis and Paget's disease." This indicates its role in providing information for disease management, which is a diagnostic function.
No
The device description clearly outlines a physical in vitro diagnostic assay involving reagents, plastic beads, and a gamma counter, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "an indicator of osteoblastic activity which is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease." This indicates it's used to provide information about a patient's health status.
- Device Description: The description clearly states it's "an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body. It also specifies that it measures a substance (sALP) in a biological sample (human serum).
- Assay Method: The description details a "solid-phase, two-site immunoradiometric assay," which is a common laboratory technique used for measuring substances in biological fluids.
- Sample Type: The assay is performed on "human serum," which is a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility of any tissue or organ for transplantation.
N/A
Intended Use / Indications for Use
The Tandem-R Ostase Immunoradiometric Assay for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Product codes
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Device Description
Tandem®-R Ostase® is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, two-site immunoradiometric assay. Samples containing sALP are reacted with a plastic bead (solid phase) that is coated with a monoclonal antibody directed toward a specific site on the sALP molecule and, simultaneously, with a second radiolabeled monoclonal antibody directed toward a different antigenic site on the sALP molecule. Following formation of the solidphase/sALP/radiolabeled antibody sandwich, the bead is washed to remove unbound labeled antibody. The radioactivity bound to the solid phase is measured in a gamma counter. The amount of radioactivity measured is directly proportional to the concentration of sALP in the test sample, which is determined from a standard curve. The standard curve is based on the concurrent testing of Tandem-R Ostase calibrators ranging from 0 to 120 µg sALP/L.
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
This premarket notification includes clinical data demonstrating that the Tandem-R Ostase assay provides the clinician with information that is of value in the management of patients with postmenopausal osteoporosis and Paget's disease.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE TANDEM-R V. OSTASE ASSAY
Tandem®-R Ostase® is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, two-site immunoradiometric assay. Samples containing sALP are reacted with a plastic bead (solid phase) that is coated with a monoclonal antibody directed toward a specific site on the sALP molecule and, simultaneously, with a second radiolabeled monoclonal antibody directed toward a different antigenic site on the sALP molecule. Following formation of the solidphase/sALP/radiolabeled antibody sandwich, the bead is washed to remove unbound labeled antibody. The radioactivity bound to the solid phase is measured in a gamma counter. The amount of radioactivity measured is directly proportional to the concentration of sALP in the test sample, which is determined from a standard curve. The standard curve is based on the concurrent testing of Tandem-R Ostase calibrators ranging from 0 to 120 µg sALP/L.
This premarket notification has demonstrated that the Tandem-R Ostase Immunoradiometric Assay for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum is substantially equivalent to the Tandem-R
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Ostase assay that was cleared by FDA in a previous submission (#K930810). This premarket notification includes clinical data demonstrating that the Tandem-R Ostase assay provides the clinician with information that is of value in the management of patients with postmenopausal osteoporosis and Paget's disease.
The Safe Medical Devices Act of 1990 states that a device is substantially equivalent to its predicate if they have the same technological characteristics and intended use. The Tandem-R Ostase device that is the subject of this submission has technological characteristics that are identical to those of the predicate device. The components, manufacture, specifications, and procedure for the Tandem-R Ostase assay remain unchanged from those of the previously-cleared device (#K930810).
The intended use of Tandem-R Ostase remains unchanged from the predicate with respect to the analyte being measured (skeletal alkaline phosphatase) and the specimen matrix (human serum). The only change in the intended use is in the indication for the device. It has been demonstrated in this premarket notification that Paget's disease of bone and postmenopausal osteoporosis are both bone disorders in which patients undergoing therapy can be managed with the aid of Tandem-R Ostase.
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Therefore, it has been demonstrated that the new indication for Tandem-R Ostase, as an indicator of osteoblastic activity which is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease, is substantially equivalent to the indication for the predicate device as an aid in the management of patients with diagnosed Paget's disease. No new issues of safety or effectiveness are raised by the change in indication for use. The Tandem-R Ostase assay remains both safe and effective when used as indicated in the product labeling.