(49 days)
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No
The device description details a standard ELISA assay, which is a biochemical method for measuring substances. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis relies on a standard calibration curve and biochemical reactions, not algorithmic learning.
No.
The device is a diagnostic assay used to measure bone resorption, not to treat a condition.
Yes
The device measures NTx levels as an indicator of human bone resorption, which is used for predicting skeletal response to therapy, therapeutic monitoring, and assessing relative risk for bone loss – all diagnostic purposes.
No
The device is a laboratory assay kit comprised of chemical reagents and a microwell plate, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "urinary assay that provides a quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption." This involves testing a sample (urine) taken from the human body to provide information about a physiological state (bone resorption).
- Device Description: The description details a "competitive enzyme-linked immunosorbent assay (ELISA)" which is a common laboratory technique used to measure substances in biological samples. It also lists reagents and components typically found in an in vitro diagnostic kit.
- Sample Type: The device uses "urine specimens," which are biological samples taken from the human body.
- Clinical Application: The intended uses (predicting skeletal response, therapeutic monitoring, assessing risk) are all clinical applications that rely on the results of the in vitro test to inform medical decisions.
- Intended User/Care Setting: The intended user is a "Clinical Laboratory," which is where in vitro diagnostic tests are typically performed.
Based on these points, the Osteomark device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Osteomark® is a urinary assay that provides a quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in:
A. Predicting skeletal response (bone mineral density) to hormonal antiresorptive therapy in postmenopausal women.
B. Therapeutic monitoring of:
- antiresorptive therapies in postmenopausal women
- antiresorptive therapies in individuals diagnosed with osteoporosis
- antiresorptive therapies in individuals diagnosed with Paget's disease of bone
- estrogen-suppressing therapies
C. Assessing the relative risk for loss of spinal bone mass after one year if not treated with hormonal antiresorptive therapy
Product codes (comma separated list FDA assigned to the subject device)
JMM
Device Description
Osteomark is a competitive enzyme-linked immunosorbent assay (ELISA) which utilizes a horseradish peroxidase labeled monoclonal antibody directed against the cross-linked N-telopeptides (NTx) present in urine specimens. An Osteomark® kit is comprised of the following reagents:
Antigen Coated 96-Well Plate Calibrators: 1 nM BCE 30 nM BCE 100 nM BCE 300 nM BCE 1000 nM BCE 3000 nM BCE Antibody Conjugate Concentrate Antibody Conjugate Diluent Level I and Level II Urine Controls 30X Wash Concentrate Buffered Substrate Chromogen Reagent Stopping Reagent
The solid phase utilizes microwells onto which NTx has been adsorbed. NTx in the specimen or Calibrator competes with the solid phase NTx for antibody binding sites. The resulting amount of Antibody Conjugate bound to the solid phase is indirectly proportional to the amount of NTx in the specimen or Calibrator. The quantity of NTx in the specimen is determined from a standard calibration curve using reagents supplied in the kit. Assay values are standardized to an equivalent amount of bone collagen, and are expressed in nanomole bone collagen equivalents per liter (nM BCE). BCE reflects the amount of immunoreactive NTx, as measured by Osteomark, liberated from human bone collagen following digestion with bacterial collagenase, as measured by hydroxyproline by high performance liquid chromatography (HPLC).
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
Human Bone (specifically spinal bone mass)
Indicated Patient Age Range
Postmenopausal women, premenopausal women, individuals diagnosed with osteoporosis, individuals diagnosed with Paget's disease of bone. Specific age ranges for studies provided: premenopausal women (mean 36 years, range 25-49), postmenopausal women (
§ 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.
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SECTION 1: REGULATORY INFORMATION SUMMARY OF SAFETY AND EFFECTIVENESS
MAR - 6 1998
280518
Osteomark® is a urinary assay that provides a quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in:
A. Predicting skeletal response (bone mineral density) to hormonal antiresorptive therapy in postmenopausal women.
B. Therapeutic monitoring of:
-
- antiresorptive therapies in postmenopausal women
-
- antiresorptive therapies in individuals diagnosed with osteoporosis
-
- antiresorptive therapies in individuals diagnosed with Paget's disease of bone
- estrogen-suppressing therapies
C. Assessing the relative risk for loss of spinal bone mass after one year if not treated with hormonal antiresorptive therapy
Osteomark is a competitive enzyme-linked immunosorbent assay (ELISA) which utilizes a horseradish peroxidase labeled monoclonal antibody directed against the cross-linked N-telopeptides (NTx) present in urine specimens. An Osteomark® kit is comprised of the following reagents:
Antigen Coated 96-Well Plate Calibrators: 1 nM BCE 30 nM BCE 100 nM BCE 300 nM BCE 1000 nM BCE 3000 nM BCE Antibody Conjugate Concentrate Antibody Conjugate Diluent Level I and Level II Urine Controls
1
30X Wash Concentrate Buffered Substrate Chromogen Reagent Stopping Reagent
The solid phase utilizes microwells onto which NTx has been adsorbed. NTx in the specimen or Calibrator competes with the solid phase NTx for antibody binding sites. The resulting amount of Antibody Conjugate bound to the solid phase is indirectly proportional to the amount of NTx in the specimen or Calibrator. The quantity of NTx in the specimen is determined from a standard calibration curve using reagents supplied in the kit. Assay values are standardized to an equivalent amount of bone collagen, and are expressed in nanomole bone collagen equivalents per liter (nM BCE). BCE reflects the amount of immunoreactive NTx, as measured by Osteomark, liberated from human bone collagen following digestion with bacterial collagenase, as measured by hydroxyproline by high performance liquid chromatography (HPLC).
Expected Values
Urine Collection:
A multi-center, cross-sectional study was conducted in order to compare the results obtained with either a second morning void (SMV) spot urine collection or a 24 hour urine collection in Osteomark®. The population tested represented 186 normal premenopausal women without diseases, disorders, or currently taking medications which may affect bone metabolism or creatinine excretion.
The SMV mean was 35 (+/- 15) nanomoles BCE/millimole creatinine. The 24 hour urine specimens, normalized for urinary creatinine, had a mean of 26 (+/- 13) nanomoles BCE/millimole creatinine.
Reference Range Data:
In the same study discussed above, the expected values for premenopausal women with the Osteomark® assay were determined. An additional multi-center, cross-sectional
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2
study involving subjects without diseases, disorders, or currently taking medications known to affect bone metabolism or creatinine excretion was conducted to establish the expected values for postmenopausal women. The comparative results are presented in Table 1 below.
| Study Group | Mean* | Std Dev | Range* | N |
|---|---|---|---|---|
| Premenopausal Women | ||||
| (mean 36 years, range 25-49) | 35 | 15 | 9-84 | 186 |
| Postmenopausal Women | ||||
| ( |