FDA.reportPublic FDA data

Elecsys Free PSA CalCheck

Primary DI
04015630997053
Brand
Elecsys Free PSA CalCheck
Company
Roche Diagnostics GmbH
Model
03500373190
Catalog number
03500373190
Published
2014-12-18
Public version status
Update
Distribution status
Not 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
P000027000
P000027001
P000027005
P000027006
P000027012
P000027023
P000027027

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000027000ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKRoche Diagnostics Corp.2000-12-12LTJ
P000027001ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKRoche Diagnostics Corp.2000-12-12LTJ
P000027005ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKRoche Diagnostics Corp.2000-12-12LTJ
P000027006ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKRoche Diagnostics Corp.2000-12-12LTJ
P000027012ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKRoche Diagnostics Corp.2000-12-12LTJ
P000027023ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKRoche Diagnostics Corp.2000-12-12LTJ
P000027027ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECKRoche Diagnostics Corp.2000-12-12LTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630997053PreviousGS10
07613336154403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630997053040156309970534015630997053
07613336154403076133361544037613336154403

GMDN Terms#

Term, Definition table
TermDefinition
Free (unbound) prostate specific antigen (fPSA) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

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
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
H628372101Access Hybritech free PSABeckman Coulter, Inc.MTG2014-09-16
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