FDA.reportPublic FDA data

Access Ostase

Primary DI
15099590232313
Brand
Access Ostase
Company
Beckman Coulter, Inc.
Model
37300
Catalog number
37300
Device description
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), and 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.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CINElectrophoretic Separation, Alkaline Phosphatase IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994278000ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.2000-03-28CIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590232313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023231315099590232313

GMDN Terms#

Term, Definition table
TermDefinition
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of bone alkaline phosphatase (BALP) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060169695801IDS-iSYS Ostase® BAPIMMUNODIAGNOSTIC SYSTEMS LIMITEDCIN2021-03-08
30014613333920MicroVueQUIDEL CORPORATIONCIN2016-09-15
M52530580TITAN GEL Alkaline Phosphatase KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M52533480SPIFE ALP Separation EnhancerHELENA LABORATORIES CORPORATIONCIN2016-09-07
M52551020Alkaline Phosphatase Indolyl Blue Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255510310TITAN GEL Alkaline Phosphatase Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255520550SPIFE Alkaline Phosphatase Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255523950SPIFE Alkaline Phosphatase-20,40 Gel KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255526040SPIFE Alkaline Phosphatase Gel KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
06438115000082UniQ® PINP RIAAidian OyCIN2016-04-13
05060169690059Ostase®+ BAP EIA IMMUNODIAGNOSTIC SYSTEMS LIMITEDCIN2016-04-01