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510(k) Data Aggregation
K Number
K014233Device Name
CAPTIAM SYPHILIS-G ASSAY
Manufacturer
TRINITY BIOTECH, PLC
Date Cleared
2002-01-24
(29 days)
Product Code
LIP
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
TRINITY BIOTECH, PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CAPTIA™ Syphilis (T. pallidum )-G is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis)
CAPTIA™ Syphilis (T. pallidum )-G is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
Warning: A positive result is not useful for establishing a diagnosis of syphilis. In most situations, such a result may reflect a prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
Device Description
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K Number
K011709Device Name
UNI-GOLD STREP A TEST KIT
Manufacturer
TRINITY BIOTECH, PLC
Date Cleared
2001-11-08
(157 days)
Product Code
GTZ, GTY
Regulation Number
866.3740Why did this record match?
Applicant Name (Manufacturer) :
TRINITY BIOTECH, PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinity Biotech Uni-Gold™ Strep A test kit is intended for the rapid, in vitro qualitative detection of group A Streptococcal antigen from human throat swabs. It can also be used as a confirmation test of beta-haemolytic colonies obtained from blood agar plates. The test is intended for professional use in physicians offices as an aid in the rapid diagnosis of group A Streptococcal pharyngitis. The test may also be used in hospital laboratories as an aid in the rapid diagnosis of group A Streptococcal pharyngitis and the confirmation of group A Streptococcus from culture.
Device Description
The extracted sample flows through an absorbent pad containing anti-Strep A antibody conjugated to colloidal gold which binds group A Streptoccal antigen if present, forming an antigen-antibody complex. As this complex travels along the membrane, it becomes immobilised at the test region, which is impregnated with a rabbit polyclonal anti-Strep A antibody, resulting in the formation of a pink/red line. A pink/red line will also appear in the control region of the test indicating proper functioning of the test. In the absence of group A Streptococcal antigen, a pink/red line will only appear in the control line.
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K Number
K001525Device Name
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
Manufacturer
TRINITY BIOTECH, PLC
Date Cleared
2000-11-29
(197 days)
Product Code
LIP
Regulation Number
866.3830Why did this record match?
Applicant Name (Manufacturer) :
TRINITY BIOTECH, PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991697Device Name
UNI-GOLD H. PYLORI
Manufacturer
TRINITY BIOTECH, PLC
Date Cleared
1999-12-21
(217 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
TRINITY BIOTECH, PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.
Device Description
As the sample flows laterally through the membrane, the specific antibody bindingprotein dye conjugate binds to the human immunoglobulins in the sample. If the sample contains IgG antibodies to H. pylori, the complex binds to the antigens on the solid phase of the device's test region producing a red/pink (red) line. In the absence of H. pylori antibodies, no line appears in the test region of the device. A procedural-functional control is built in to each device. As the sample migrates across the control region, the appearance of a red line at the control region indicates correct procedure and a functional device.
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K Number
K982373Device Name
UNI-GOLD STREP A TEST KIT
Manufacturer
TRINITY BIOTECH, PLC
Date Cleared
1999-02-11
(219 days)
Product Code
GTY
Regulation Number
866.3740Why did this record match?
Applicant Name (Manufacturer) :
TRINITY BIOTECH, PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinity Biotech Uni-Gold™ Strep A Test Kit is a rapid immunoassay for the qualitative detection of Streptococcal A antigen from throat swabs, or the confirmation of beta-hemolytic colonies obtained from blood agar plates.
The Trinity Biotech Uni-Gold™ Strep A Test Kit is intended for use in hospital laboratories and physicians' offices as an aid in the diagnosis of Group A Streptococcal pharyngitis.
Device Description
Immunoassay: Strep A antigen, when present, binds to the anti-Strep A antibody conjugated to a gold dye. As this complex travels along the membrane, it becomes immobilized at the test region, resulting in the formation of a red line. Excess antibodygold conjugate further migrates along the membrane and binds to the control region, forming another red line. In the absence of Strep A antigen, a red line will only be formed at the control region.
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