FDA.reportPublic FDA data

Access Hybritech free PSA

Primary DI
H628372101
Brand
Access Hybritech free PSA
Company
Beckman Coulter, Inc.
Model
37210
Catalog number
37210
Device description
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Published
2014-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MTGTest,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign ConditionsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970038004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970038004TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.1998-03-10MTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H628372101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) 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
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590701680Access Hybritech free PSABeckman Coulter, Inc.MTG2025-05-30
00380740130305AlinityAbbott Ireland DiagnosticsMTG2020-11-18
00380740130312AlinityAbbott Ireland DiagnosticsMTG2020-11-18
00380740158330AlinityAbbott Ireland DiagnosticsMTG2020-11-18
00380740158347AlinityAbbott Ireland DiagnosticsMTG2020-11-18
07613336166673Elecsys free PSARoche Diagnostics GmbHMTG2020-08-27
07613336166628Elecsys free PSARoche Diagnostics GmbHMTG2020-08-26
07613336168134free PSA CalSetRoche Diagnostics GmbHMTG2020-08-26
04015630940011Elecsys free PSARoche Diagnostics GmbHMTG2018-08-23
07613336154403free PSA CalCheckRoche Diagnostics GmbHMTG2018-06-29
07613336154397Elecsys free PSARoche Diagnostics GmbHMTG2017-09-29
07613336155400free PSA CalsetRoche Diagnostics GmbHMTG2017-09-29
04015630997053Elecsys Free PSA CalCheckRoche Diagnostics GmbHMTG2014-12-18
00380740009007ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00380740009014ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00380740009021ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00842768013751Dimension® clinical chemistry system T/F PSA CalibratorSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00842768013881Dimension® clinical chemistry system FPSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00842768016677Dimension Vista® System FPSA Flex® Reagent CartridgeSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00842768024214Dimension Vista® System PSA CALSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00630414971575IMMULITE®/IMMULITE®1000 Systems fPS Free PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTG2014-09-24
00630414977478IMMULITE® 2000 Systems fPS Free PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTG2014-09-24
H628372151Access Hyritech free PSA CalibratorsBeckman Coulter, Inc.MTG2014-09-16
04015630919338Elecsys Free PSA CalSetRoche Diagnostics GmbHMTG2014-09-10
04015630919321Elecsys Free PSA ImmunoassayRoche Diagnostics GmbHMTG2014-09-09