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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.

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This document is a 510(k) clearance letter from the FDA for the CAPTIA™ Syphilis-G device. While it states that the device is substantially equivalent to legally marketed predicate devices and is subject to general and special controls, it does not contain the detailed study information required to answer your request. Specifically, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number and qualifications of experts, adjudication methods for the test set.
• Information on MRMC comparative effectiveness studies or standalone performance studies.
• Type of ground truth used.
• Sample size for the training set or how its ground truth was established.

To obtain this information, you would typically need to refer to the original 510(k) submission document itself, which contains the detailed premarket data and studies conducted by the manufacturer, Trinity Biotech, plc. The clearance letter only summarizes the FDA's decision based on that submission.

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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.

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.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

   • Accuracy Study (Test Set 1): 501 fresh throat samples. Data provenance is not explicitly stated regarding country of origin, but it is a retrospective or concurrent collection as it was tested "both in the immunoassay and by routine culture."
   • Comparison to Predicate Device (Test Set 2): 501 total specimens tested. Data provenance is not explicitly stated.
   • Culture Confirmation Study (Test Set 3):
     • Initial: 109 samples visually positive for Strep A on blood agar plates.
     • Second part (non-Strep A confirmation): 224 samples, of which 117 were identified as non-Strep A.
     • Third part (blinded and duplicate testing): 6 samples (2 Group A beta-haemolytic, 4 non-Group A beta-haemolytic).
   • All these studies appear to be "test sets" as they are used to evaluate the device's performance directly.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

   • For the core clinical accuracy and comparison studies, the "routine culture" is considered the ground truth. There is no specific mention of "experts" adjudicating these results, as routine culture itself serves as the reference standard in these diagnostic tests.
   • For the Culture Confirmation Study (third part), "2 independent physicians" conducted blinded, duplicate testing. Their qualifications are not further specified beyond "physicians."

4. Adjudication Method for Test Set:

   • In the primary clinical accuracy study, the Uni-Gold™ Strep A results were compared directly against "routine culture." There isn't an explicit adjudication method described beyond this direct comparison.
   • For the comparison between Uni-Gold™ Strep A and the predicate device, discordant results were later "resolved against culture" when calculating relative sensitivity/specificity/agreement. This implies that if the two devices disagreed, a third reference (culture) was used to determine the true positive/negative status for performance calculation. This is a form of an adjudication process, likely a 2+1 type (two devices, one gold standard for resolution).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The device is an immunoassay, not an imaging device that would typically involve human readers interpreting results with or without AI assistance. The studies performed compare the device's performance against a reference standard (culture) and a predicate device.

6. Standalone (Algorithm Only) Performance:

   • Yes, the performance values presented (sensitivity, specificity, agreement, concordance) are for the Uni-Gold™ Strep A test kit operating as a standalone device, without human-in-the-loop assistance in its core detection mechanism. The human interaction is usually limited to performing the test and reading the results, which is inherent to the use of such a diagnostic kit.

7. Type of Ground Truth Used:

   • Primary Ground Truth: Routine culture (specifically for Group A Streptococcus). This is a well-established laboratory method for identifying bacterial presence and is considered a high-quality reference standard for infectious disease diagnostics.
   • Secondary Ground Truth (for Culture Confirmation): Initial culture results confirmed by "Beta-haemolysis and morphology" and "Streptococcal latex grouping test" for further confirmation.

8. Sample Size for Training Set:

   • The document does not provide information about a separate "training set" for the Uni-Gold™ Strep A test kit. As an immunoassay (lateral flow assay), it is a biochemical test, not a machine learning algorithm that typically requires a distinct training phase with a dedicated dataset. The device's components and assays are developed and validated during the manufacturing process, rather than "trained" on data.

9. How Ground Truth for Training Set Was Established:

   • Not applicable, as there is no explicit "training set" in the context of this immunoassay device. The scientific principles and reagents are developed based on known biological interactions and established laboratory methods. Analytical studies (sensitivity, specificity) ensure the components function as intended.

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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.

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.

This document describes the Uni-Gold™ H. pylori test kit, a rapid in-vitro qualitative immunoassay for detecting IgG antibodies to Helicobacter pylori in adult human serum, plasma, or whole blood.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

While explicit acceptance criteria are not stated as numerical thresholds (e.g., "sensitivity must be >X%"), the study's goal was to demonstrate "substantial equivalence" and "accuracy." Given the results, it can be inferred that performance around these reported accuracy metrics was deemed acceptable by the FDA for substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 348 clinical samples (164 positive and 184 negative based on biopsy results).
• Data Provenance: The clinical trials were performed at three independent sites in the USA, Canada, and Sweden. This indicates a prospective and multi-site collection with a mixed population (race, sex, age) of patients presenting with gastrointestinal symptoms.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used to establish the ground truth for the test set, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the ground truth was established by "gastric biopsy for culture and histology for the detection of H. pylori infection." This implies medical professionals (pathologists, microbiologists) involved in the analysis of these biopsy samples.

4. Adjudication Method for the Test Set

The adjudication method for the biopsy results (ground truth) was defined as follows:

• Biopsy "positive": Culture and histology positive OR culture positive.
• Biopsy "negative": Negative for both culture and histology OR negative for culture.

This is a specific rule-based adjudication method rather than an expert consensus voting method (like 2+1 or 3+1). It establishes a clear hierarchy and condition for positivity and negativity based on multiple diagnostic tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was mentioned. This device is a rapid diagnostic test kit, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting images. Therefore, the concept of human readers improving with or without AI assistance does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The Uni-Gold™ H. pylori test kit is a physical diagnostic device, and its performance (sensitivity, specificity, accuracy) was evaluated independently against the biopsy gold standard. There is no "human-in-the-loop" once the sample is applied and the test runs; the interpretation is visual (presence/absence of a red line) and inherent to the device's design.

7. The Type of Ground Truth Used

The primary ground truth used was biopsy results, specifically defined as:

• Biopsy positive: Culture and histology positive OR culture positive.
• Biopsy negative: Negative for both culture and histology OR negative for culture.

Additionally, an ELISA assay was used to evaluate 60 discrepant results between the Uni-Gold™ test and the biopsy, indicating a secondary, corroborative ground truth in ambiguous cases, although the primary ground truth remained the biopsy.

8. The Sample Size for the Training Set

The document does not provide information on a separate training set. For rapid diagnostic test kits like this, the development process typically involves internal optimization and validation with various panels of known positive and negative samples, rather than a distinct "training set" in the machine learning sense. The 348 clinical samples tested are referred to as the "clinical data" used to determine the device's accuracy, essentially serving as a validation or test set.

9. How the Ground Truth for the Training Set Was Established

As no explicit training set is identified, the method for establishing its ground truth is not described. However, it can be inferred that any samples used during the development and optimization phases would have had their H. pylori status confirmed by established laboratory methods, likely similar to or including culture, histology, or reference serological tests.

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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.

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.

Here's an analysis of the provided text to extract the acceptance criteria and study information:

Acceptance Criteria and Device Performance Study for Uni-Gold™ Strep A Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or percentage format. Instead, it describes analytical performance parameters that the device demonstrated. The primary "acceptance" for this 510(k) submission is substantial equivalence to the predicate device, which implies comparable performance in key areas.

2. Sample Size Used for the Test Set and Data Provenance

The document focuses on analytical studies rather than clinical studies with patient samples for the test set.

• Analytical Sensitivity Test Set: Serial dilutions of S. pyogenes cultures. The exact number of dilutions or individual tests performed is not specified, only that testing continued until interpretations became "negative."
• Analytical Specificity Test Set: The sample size for the analytical specificity (cross-reactivity) test set includes 19 different organisms. For each organism, testing was performed at a concentration of approximately 1 x 10^6 (or 1 x 10^6 for Staphylococcus aureus).
• Data Provenance: The studies are described as "Laboratory studies" and did not involve human subjects. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical clinical sense. These are in-house, non-clinical evaluations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable. The studies described are analytical (laboratory-based) and do not involve human interpretation of results for establishing ground truth. The "ground truth" for analytical sensitivity was known concentrations of S. pyogenes, and for analytical specificity, the known identity and concentration of non-Strep A organisms.

4. Adjudication Method for the Test Set

This section is not applicable as the studies are analytical and do not involve human adjudication of results in the way clinical studies often do. The results (positive/negative) would be determined by the visual presence or absence of a red line.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory analytical performance, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described are standalone in the sense that they evaluate the performance of the device itself (the immunoassay) without human-in-the-loop performance being a variable. The test results (red line present/absent) are interpreted directly from the device's output.

7. Type of Ground Truth Used

• Analytical Sensitivity: Known concentrations of Streptococcus pyogenes (Strep A) cultures.
• Analytical Specificity: Known identities and concentrations of various non-Strep A organisms.

8. Sample Size for the Training Set

This information is not applicable. The Uni-Gold™ Strep A Test Kit is an immunoassay (a rapid diagnostic test), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of AI development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI algorithm.

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