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510(k) Data Aggregation
K Number
K011052Device Name
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
Manufacturer
OSTEX INTL., INC.
Date Cleared
2001-07-30
(115 days)
Product Code
JMM
Regulation Number
862.1400Why did this record match?
Applicant Name (Manufacturer) :
OSTEX INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983457Device Name
OSTEOMARK NTX SERUM EIA
Manufacturer
OSTEX INTL., INC.
Date Cleared
1999-02-02
(125 days)
Product Code
JMM
Regulation Number
862.1400Why did this record match?
Applicant Name (Manufacturer) :
OSTEX INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Osteomark® NTx Serum EIA provides a quantitative measure of cross-linked Ntelopeptides of type I collagen (NTx) in serum as an indicator of human bone resorption. Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Prior to initiating antiresorptive therapy, serum NTx level is used to determine the probability for a decrease in bone mineral density after one year in postmenopausal women treated with hormonal antiresorptive therapy relative to those treated with calcium supplement.
Device Description
The Osteomark NTx Serum EIA is a competitive-inhibition enzyme-linked immunosorbent assay (ELISA/EIA) for quantitative determination of NTx present in human serum. NTx is adsorbed to a 96-well microplate: Diluted samples are added to the microplate wells, followed by a horseradish peroxidase labeled monoclonal antibody. NTx in the specimen competes with the NTx epitope on the microtiter plate for antibody binding sites. Following a wash step, the amount of labeled antibody bound is measured by colorimetric generation of a peroxide substrate. NTx concentration is determined spectrophotometrically and calculated using a standard calibration curve. Assay values are reported in nanomoles Bone Collagen Equivalents per liter (nM BCE).
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K Number
K980518Device Name
OSTEOMARK
Manufacturer
OSTEX INTL., INC.
Date Cleared
1998-03-06
(49 days)
Product Code
JMM
Regulation Number
862.1400Why did this record match?
Applicant Name (Manufacturer) :
OSTEX INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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:
- 1. antiresorptive therapies in postmenopausal women
- 2. antiresorptive therapies in individuals diagnosed with osteoporosis
- 3. antiresorptive therapies in individuals diagnosed with Paget's disease of bone
4. estrogen-suppressing therapies
C. Assessing the relative risk for loss of spinal bone mass after one year if not treated with hormonal antiresorptive therapy
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).
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K Number
K961562Device Name
OSTEOMARK
Manufacturer
OSTEX INTL., INC.
Date Cleared
1996-07-11
(80 days)
Product Code
JMM
Regulation Number
862.1400Why did this record match?
Applicant Name (Manufacturer) :
OSTEX INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Osteomark® is a urinary assay that provides a quantitative measure of the excretion of crosslinked 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:
- 1. anti-resorptive therapies in postmenopausal women
- 2. anti-resorptive therapies in individuals diagnosed with osteoporosis
- 3. anti-resorptive therapies in individuals diagnosed with Paget's disease of bone
- 4. estrogen-suppressing therapies
The measurement range of Osteomark is 20 to 3000 nM Bone Collagen Equivalents (BCE) of NTx.
Device Description
Osteomark is a competitive enzyme-linked immunosorbent assay (ELISA) which utilizes a horseradish peroxidase labeled monoclonal antibody directed against the cross-linked Ntelopeptides (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 Ostcomark, liberated from human bone collagen following digestion with bacterial collagenase, as measured by hydroxyproline by high performance liquid chromatography (HPLC).
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