Search Results
Found 10 results
510(k) Data Aggregation
K Number
K232904Device Name
Access Ostase
Manufacturer
Beckman Coulter
Date Cleared
2024-04-15
(210 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Device Description
The Access Ostase assay is a one-step sandwich immunoenzymatic assay. The Access Ostase assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access Ostase assay reagent pack, Access Ostase assay calibrators, Access Ostase QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
Ask a Question
K Number
K200475Device Name
IDS-iSYS Ostase BAP
Manufacturer
Immunodiagnostic Systems Ltd.
Date Cleared
2020-09-30
(217 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.
Device Description
The IDS-iSYS Ostase® BAP assay consists of one reagent cartridge and one set of calibrators (CAL A & CAL B).
The reagent cartridge contains multiple reagents:
- MPM1 (Magnetic particles coated with streptavidin in a phosphate buffer with sodium azide as preservative);
- Ab-BIOT Monoclonal anti-BAP labelled with biotin, in buffer containing horse serum with bovine and mouse proteins and sodium azide as a preservative (<0.1 %)
- -SUBS (p-nitrophenyl phosphate in a stabilising buffer containing preservatives).
Calibrators A and B are buffered bovine protein matrix containing human BAP with sodium azide as preservative (<0.1 %).
Ask a Question
K Number
K043125Device Name
ORION DIAGNOSTICA UNIQ PINP RIA
Manufacturer
ORION DIAGNOSTICA OY
Date Cleared
2005-05-04
(173 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orion Diagnostica UniQ™ PINP RIA is a quantitative radioimmunoassay designed for the measurement of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum. The test is intended to be used an aid in the management of postmenopausal osteoporosis. For in vitro diagnostic use.
Device Description
Not Found
Ask a Question
K Number
K020625Device Name
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
Manufacturer
HELENA LABORATORIES
Date Cleared
2002-05-06
(69 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The test system will be used in laboratories to separate serum ALP isoenzymes. Elevated bone isoenzyme can be found in conditions of physiologic bone growth, metastatic carcinoma and as rickets. Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver. Intestinal isoenzymes can be seen in patients with intestinal disease in particular after a meal. Intestinal Isoenzymes occur in blood type O or B after a meal.
Device Description
Not Found
Ask a Question
K Number
K011113Device Name
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
Manufacturer
SEBIA
Date Cleared
2001-06-13
(63 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K994278Device Name
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2000-03-28
(99 days)
Product Code
CIN, JIS
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Device Description
The Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma.
Ask a Question
K Number
K981373Device Name
ALKPHASE-B ASSAY KIT
Manufacturer
METRA BIOSYSTEMS, INC.
Date Cleared
1998-05-27
(41 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
Not Found
Ask a Question
K Number
K972666Device Name
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
Manufacturer
HYBRITECH, INC.
Date Cleared
1997-09-11
(57 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tandem-MP Ostase Immunoenzymetric Assay is an in vitro device indicated for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Device Description
Tandem-MP Ostase is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, immunoenzymetric assay. Serum samples containing sALP are reacted in a microwell with the biotinylated capture antibody. Following binding of the biotinylated antibody/antigen complex to the streptavidin coated wells, the microwells are washed and incubated with an enzyme substrate. The captured sALP enzyme turns over the substrate and the amount of sALP bound to the microwell is determined colorimetrically by measuring the absorbance of the quenched reaction at 405 nm in a microplate reader. The calculation of the sALP concentration in the sample is based on concurrent testing of the Ostase Calibrators and Zero/Diluent.
Ask a Question
K Number
K964764Device Name
OPUS BONE ALP
Manufacturer
BEHRING DIAGNOSTICS, INC.
Date Cleared
1997-01-24
(58 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum as an aid in the management of patients with diagnosed Paget's disease. OPUS Bone ALP is intended for use with the OPUS analyzers.
Device Description
OPUS Bone ALP is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum.
Ask a Question
K Number
K961573Device Name
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
Manufacturer
HYBRITECH, INC.
Date Cleared
1996-08-19
(118 days)
Product Code
CIN
Regulation Number
862.1050Why did this record match?
Product Code :
CIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
an indicator of osteoblastic activity which is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease
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.
Ask a Question
Page 1 of 1