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510(k) Data Aggregation
K Number
K974845Device Name
BTA STAT TEST PRESCRIPTION HOME USE
Manufacturer
BARD DIAGNOSTIC SCIENCES,INC.
Date Cleared
1998-12-08
(355 days)
Product Code
MMW
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
BARD DIAGNOSTIC SCIENCES,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BTA stat test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy. This 510(k) is to expand the same indication to prescription home use of the product. The original 510(k) was K964151.
Device Description
The BTA stat test for bladder tumor associated antigen is an immunochromatographic assay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine. Patient urine is added to the sample well and allowed to react with a colloidal gold-conjugated antibody. If the antigen is present in the sample, an antigen conjugate complex is formed and a line in the patient (P) test zone appears.
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K Number
K971402Device Name
BARD BTA TRAK TEST
Manufacturer
BARD DIAGNOSTIC SCIENCES,INC.
Date Cleared
1998-04-15
(365 days)
Product Code
MMW
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
BARD DIAGNOSTIC SCIENCES,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bard BTA TRAK Test is an in vitro diagnostic assay indicated for the quantitative detection of bladder tumor associated antigen in human urine. This test is intended for use as an aid in management of bladder cancer patients in conjuction with cystoscopy.
Device Description
The BTA TRAK test for bladder tumor associated antigen is an enzyme immunoassay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine.
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K Number
K964151Device Name
BARD AND BTA TEST
Manufacturer
BARD DIAGNOSTIC SCIENCES,INC.
Date Cleared
1997-04-16
(197 days)
Product Code
MMW
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
BARD DIAGNOSTIC SCIENCES,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BTA stat test is an in vitro diagnostic immunoassay indicated for the qualitative detection of bladder turnor associated antigen in urine of persons diagnosed with bladder cancer. This test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.
The BTA stat test is a qualitative test indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.
Device Description
The BTA stat test for bladder tumor associated antigen is an immunochromatographic assay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine. Patient urine is added to the sample well and allowed to react with a colloidal gold-conjugated antibody. If the antigen is present in the sample, an antigen conjugate complex is formed and a line in the patient (P) test zone appears.
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