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Trinity Biotech Uni-Gold™ Giardia is a single use rapid immunoassay for the qualitative detection of Giardia lamblia ( G. lamblia ) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Giardia gastrointestinal infections. As with other Giardia tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

The Trinity Biotech Uni-Gold™ Giardia was designed as a single use, rapid, lateral flow immunoassay test device to detect the presence of Giardia lamblia antigen in unpreserved (fresh & frozen), preserved and media containing human stool specimens.

The Trinity Biotech Uni-Gold™ Giardia test strip (5mm x 60mm) combines a Nitrocellulose Membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.

The Giardia Nitrocellulose Membrane Test Strip - above consist of

• A) Mouse anti-Giardia lamblia antibody is coated onto the Test Line region of the test strip.
• B) Rabbit anti-Goat IgG antibody is coated onto the Control Line region of the Test Strip.
• C) Goat anti- Giardia lamblia antibodies and Goat IgG antibodies are conjugated to red latex particles and dried onto the inert glass fiber (Conjugate Pad) which is inserted into the test strip below the nitrocellulose zone.

When Giardia antigens are present in the sample they combine with the antibody/red latex complex. As the complex migrates it binds to the antibodies in the test region forming a visible pink/red band. (Picture B) This forms the basis for the double antibody sandwich assay. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device. This internal control line is to ensure and indicate that the test device is functioning correctly.

The plastic housing device contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes.

The test concept:

Mouse anti-Giardia lamblia is coated onto the test line region of the nitrocellulose zone of the test strip. Rabbit anti- Goat IgG is coated onto the control line region.

Goat anti-Giardia lamblia antibodies are conjugated to red latex particles and dried onto inert glass fiber. This is inserted into the test strip below the nitrocellulose zone.

A buffered solution is added to a dilution tube followed by the addition of the stool specimen (2 drops) via a disposable pipette. This mixture is then dispensed in total into the sample well of the lateral flow cartridge device with a dropper pipette and migrates through a pad containing red microspheres that have been coated with a antibody specific for the Giardia antigen. If the antigen is present, an immune complex forms. The migration continues along the membrane, which contains a striped down anti Giardia capture antibody. If Giardia antigen is present, the immune complex reacts with the anti-Giardia antibody at the test line on the membrane.

Thus Giardia antigens present in the sample combine with the antibody/red latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band.

Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly.

Here's a summary of the acceptance criteria and the study details for the Uni-Gold™ Giardia device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative format (e.g., "Sensitivity must be >90%"). However, based on the studies presented, the implicit acceptance criteria are 100% agreement/sensitivity/specificity in the evaluated studies.

2. Sample Sizes and Data Provenance

• Test Set for Agreement vs. Comparator Device:

  • Total Samples: 267 retrospective samples.
  • Matrix types: unpreserved frozen (42), C&S (15), SAF (139), and formalin (71).
  • Country of Origin: Not explicitly stated, but the studies were conducted at 3 external laboratories. Given the "US and Canada" mention for overall sample collection, it's likely from these regions.
  • Retrospective/Prospective: Retrospective.

• Test Set for Sensitivity/Specificity vs. DFA Microscopy (Retrospective):

  • Total Samples: 241 (91 positive, 150 negative).
  • Positive matrix types: formalin (48), SAF (13), unpreserved frozen (17), Cary Blair (3), and C&S (10).
  • Negative matrix types: formalin (42), SAF (70), unpreserved frozen (25), Cary Blair (3), and C&S (10).
  • Country of Origin: Not explicitly stated, but collected from "Hospitals throughout the US and Canada."
  • Retrospective/Prospective: Retrospective.

• Test Set for Additional Retrospective Studies (Non-Fluorescent Microscopy):

  • Site 2 (Wheatley's Stain): 67 retrospective samples (22 positive, 45 negative).
  • Site 3 (Iron Hematoxylin Stain): 259 retrospective samples (60 positive, 199 negative).
  • Country of Origin: Not explicitly stated, but likely from "US and Canada."
  • Retrospective/Prospective: Retrospective.

• Test Set for Prospective Study (DFA Microscopy):

  • Total Samples: 378 negative samples.
  • Matrix types: unpreserved fresh (153), unpreserved frozen (45), formalin (45), SAF (45), C&S (45), and Cary Blair (45).
  • Country of Origin: Not explicitly stated, but collected from "Hospitals throughout the US and Canada."
  • Retrospective/Prospective: Prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the "number of experts" used to establish ground truth or their specific qualifications (e.g., "Radiologist with 10 years of experience"). However, the ground truth methods (DFA microscopy, Wheatley's Stain, Iron Hematoxylin Stain) are laboratory diagnostic techniques typically performed by trained medical technologists or laboratory personnel. It implies that these established methods served as the expert-level reference.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by the reference methods (DFA microscopy, Wheatley's Stain, Iron Hematoxylin Stain). In cases where the Uni-Gold device and the initial comparator device disagreed (e.g., in the "Agreement vs. Comparator Device" study), further resolution was sought through DFA microscopy or Iron Hematoxylin Stain, which effectively acted as an adjudicator to determine the true positive/negative status for those discrepant samples.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. The study compares the device performance to established laboratory methods or an existing comparator device, not the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was evaluated. The studies directly compare the Uni-Gold™ Giardia device's results (algorithm only, as it's a rapid immunoassay) against the chosen established ground truth methods (DFA microscopy, non-fluorescent microscopy, or a comparator device). There is no "human-in-the-loop" aspect to the device's reading mechanism described.

7. Type of Ground Truth Used

The types of ground truth used were primarily:

• DFA Microscopy: Direct Fluorescent Antibody microscopy.
• Non-Fluorescent Microscopy: Specifically, Wheatley's Stain and Iron Hematoxylin Stain.
• Comparator Device: Remel Xpect™ Giardia Lateral Flow Assay (510K #: K031942) for initial agreement studies, with discrepant results often adjudicated by DFA or Iron Hematoxylin Stain.

8. Sample Size for the Training Set

The document describes a rapid immunoassay device. It does not mention a "training set" in the context of machine learning. The device is a chemical/immunological test, not an algorithm that requires a training set in the AI sense. The development of the assay itself would have involved internal validation and optimization, but not a distinct "training set" as understood in AI studies.

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

As there is no "training set" for an AI algorithm, this question is not applicable to the Uni-Gold™ Giardia immunoassay device.

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The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antiqen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.

The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane immunoassay for the simultaneous detection of Giardia cyst antigen and Cryptosporidium occyst antigen in a single test device. It is performed with a 25 to 30-minute total incubation time. The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test uses monoclonal and polyclonal antibodies to cell-surface antigens of the device contains a Reaction Window with three vertical lines of immobilized antibodies. The Giardia test line ("Giar") contains mouse monoclonal antibodies against Giardia. The Crypto test line ("Cryp") contains mouse monoclonal antibodies against Cryptosporidium. The control line ("C") is a dotted line that contains anti-horseradish peroxidase (HRP) antibodies. The Conjugate consists of polyclonal antibodies coupled to horseradish peroxidase. To perform the test, the sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, cyst antigens in the sample bind the antibody-peroxidase conjuqates. The antigen-antibody-conjugate complexes migrate through a filter pad to a membrane where they are captured by the immobilized Giardia and/or Cryptosporidium-specific antibodies in the test lines. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10 minute incubation period, the reaction is examined visually for the appearance of a vertical blue line on either side of the Reaction Window. A blue line indicates a positive "control" reaction, indicated by a vertical dotted blue line under the "C" portion of the Reaction Window. confirms that the test is working properly and the results are valid.

Here's a breakdown of the acceptance criteria and study information for the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ device, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a diagnostic test like this are typically defined by performance metrics such as sensitivity, specificity, and agreement with a predicate device or gold standard. The reported performance for the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test against the Microscopy - IFA gold standard is as follows:

The reported performance against Commercial ELISA Predicate Devices is as follows:

The regulatory acceptance of the device (K103673) by the FDA suggests that these reported performance metrics met their criteria for substantial equivalence to legally marketed predicate devices.

Study Information

1. Sample size used for the test set and the data provenance:

   • Test set for comparison to Microscopy (IFA): N = 791 (combined from Study Sites #1 and #3). This included 220 fresh, 140 frozen, 216 preserved-formalin, and 215 preserved-SAF fecal specimens.
   • Test set for comparison to Commercial ELISAs (predicate devices): N = 849 (combined from Study Sites #1 and #2). This included 349 fresh, 322 frozen, 36 preserved-formalin, and 142 preserved-SAF fecal specimens.
   • Data Provenance: The studies were conducted at "3 geographically diverse sites" within the US. The data is prospective in the sense that the test samples were collected and then tested with the new device, but the text doesn't specify if these were newly collected for the study or a collection of existing samples. Given the various preservation methods, it's likely a mix of prospective collection and retrospective analysis of stored samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical specimens. It refers to "Microscopy - IFA (considered the gold standard)" and "two commercially available ELISAs (predicate devices)" as the comparators, implying the expertise lies in the performance of those established methods.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies in the test set. The comparisons are presented as direct comparisons between the new device's results and the results from the gold standard/predicate devices.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. This device is a rapid membrane enzyme immunoassay (a lab test), not an AI-assisted imaging device that would involve human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this was a standalone performance study of the diagnostic device itself. The "device performance" metrics (sensitivity, specificity, agreement) directly reflect the algorithm's (immunoassay's) ability to detect the antigens in the samples. There is no human-in-the-loop scenario described for the device's main function, as it's a qualitative visual membrane assay. The reading of the lines by a technician would be part of the standard operation of this type of IVD, but the fundamental detection is by the assay itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For clinical performance, the primary ground truth reference was Microscopy - IFA (Immunofluorescence Assay), which is explicitly stated as "considered the gold standard" for detecting Giardia cysts and Cryptosporidium oocysts in fecal specimens.
   • Additionally, two commercially available ELISA predicate devices were used as comparators for agreement in other parts of the study.
   • For analytical sensitivity (LOD) and cross-reactivity studies, the ground truth involved purified Giardia cysts or Cryptosporidium oocysts quantified by immunofluorescent antibody microscopy (IFA) or documented positive specimens for other organisms by microscopy.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional immunoassay. Therefore, there's no training set as understood in AI/ML development. The development of the assay (e.g., antibody selection, reagent concentrations) would be an iterative process, but not in the "training set" paradigm.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no specific "training set" mentioned in the context of an AI/ML algorithm for this immunoassay device. The assay development would rely on internal validation and optimization against known positive and negative samples, similar to how the analytical studies for sensitivity and cross-reactivity were performed.

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The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is a qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved human fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections. For in vitro diagnostic use.

The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is an immunochromatographic assay for the detection of Giardia lamblia antigen in human fecal samples. The test uses sample wicking to capture Giardia antigen on a discrete test line containing antibodies specific for Giardia antigen. A specimen is added to a dilution tube and mixed with a buffer solution. The mixture is dispensed into the sample well of the device which resolubilizes the Giardia specific mouse monoclonal antibody that has been conjugated to colored microparticles. This solution wicks along a membrane containing capture antibodies bound to the membrane at the Test and Control lines. The Giardia immune complex, if present, reacts with antibody at the Test line. Unbound conjugate not captured at the test line is captured at the Control line containing anti-mouse antibody. If Giardia antigens are present in the fecal sample, two pink-to-purple bands (one at the Sample line and one at the Control line) will appear in the test window. If no Giardia antigen is present, or if the level of antigen is below the detection limit of the assay, only one pink-to-purple band at the Control line will appear in the test window. For the test to be valid, a pink-to-purple band must always appear at the Control line position of the device test window regardless of whether the sample is positive or negative. This Control line indicates that the test is working properly.

Acceptance Criteria and Study for IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit

This response will detail the acceptance criteria and the study performance for the Giardia Fecal Antigen Detection Lateral Flow Kit, as extracted from the provided 510(k) Pre-market Notification.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity and specificity. Instead, the "acceptance" is implied through a comparison to a predicate device and a reference method, aiming for "substantial equivalence" and acceptable clinical performance.

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

• Clinical Performance Study:
  • Sample Size: A total of 210 human fecal specimens were used.
  • Data Provenance: Retrospective. The samples were "well-characterized, archived samples" collected in 10% formalin or SAF. They were submitted to an independent laboratory for testing. The country of origin is not specified but is implicitly the US given the FDA submission.
• Unpreserved Fecal Specimens Study:
  • Sample Size: 42 unpreserved fecal samples (15 positive, 27 negative)
  • Data Provenance: Retrospective. These samples were from IVD Research's frozen sample bank, stored at -15℃ or lower. The country of origin is implicitly the US.
• Reproducibility Study:
  • Sample Size: A masked panel of ten samples (number of positive/negative not specified, but 6 positive and 4 negative in the summary table). These were tested repeatedly.
  • Data Provenance: Not explicitly stated, but performed at three sites (one internal, two external), suggesting a multi-center study, likely within the US.
• Predicate Device Comparison Study:
  • Sample Size: Total of 110 samples (49 positive by predicate, 61 negative by predicate).
  • Data Provenance: Not explicitly stated, but implies existing samples were used for comparison.

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

• Clinical Performance Study (Reference Method: Microscopy or Direct Immunofluorescence Assay): The document does not specify the number of experts or their qualifications for establishing the ground truth using microscopy or direct immunofluorescence assay. It states that the specimens were "submitted to an independent laboratory for testing," implying expertise within that laboratory. For the 4 false positives, these were "re-tested using a direct immunofluorescence assay and shown to be positive," suggesting a re-evaluation by an expert or a highly sensitive method.
• Unpreserved Fecal Specimens Study (Reference Method: Giardia lamblia Antigen Detection Microwell ELISA): The ground truth was established by another IVD Research, Inc. product, the Giardia lamblia Antigen Detection Microwell ELISA. No human experts are explicitly mentioned for this ground truth establishment, as it is an automated assay.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for reconciling discrepancies for the primary clinical performance test set. For the "false positive" samples identified with the Giardia LF test (4 cases), they were "re-tested using a direct immunofluorescence assay and shown to be positive," which implies a secondary, definitive reference method was used to adjudicate these discrepancies and re-classify them as true positives. For the comparison with the predicate device, the agreement was calculated directly, without mention of an adjudication process for discordant results.

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

No MRMC comparative effectiveness study was mentioned. The device is a Lateral Flow Kit, which generally involves visual interpretation by a single user, not an AI or human reader improvement scenario.

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

This information is not applicable. The device is a Lateral Flow Kit, which is a diagnostic assay that provides a visual result (bands) requiring human interpretation, not an algorithm running independently.

7. Type of Ground Truth Used for Clinical Performance

• Clinical Performance Study: The ground truth was established by "Microscopy or Direct Immunofluorescence Assay." This represents an expert-determined or highly sensitive laboratory reference method, likely considered the gold standard for clinical diagnosis of Giardia at the time.
• Unpreserved Fecal Specimens Study: The ground truth was established by a Giardia lamblia Antigen Detection Microwell ELISA (IVD Research, Inc.). This is a laboratory assay serving as the reference.

8. Sample Size for the Training Set

The document does not provide information about a "training set" in the context of an algorithm or machine learning model. The studies described are performance evaluations of the completed device. For IVD diagnostic kits, development typically involves internal analytical studies and optimization, rather than a distinct "training set" as understood in AI/ML.

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

As there is no explicit mention of a "training set" or a machine learning algorithm, this question is not applicable to the provided information.

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REMEL's Xpect™ Giardia kit is an in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia infections.

The Xpect™ Giardia Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia antigen. The test utilizes sample wicking to capture Giardia antigen on a discrete test line containing antigen-specific antibodies for Giardia. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to murine monoclonal antibody specific for Giardia is added. The mixture is dispensed into the sample well of the device and wicks along a membrane containing capture antibody stripes. The Giardia immune complex, if present, reacts with anti- Giardia antibody at the test line. Antibody-labeled microparticles not bound at the test line are later captured at the control line containing anti-mouse antibody. A blue line of any intensity (light blue to black) will appear at the Giardia test position if Giardia antigen is present. A complete line at the Control position indicates that the test is working properly.

Here's a breakdown of the acceptance criteria and study information for the Xpect™ Giardia Lateral Flow Assay, based on the provided 510(k) notification:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Clinical Performance Study (compared to microscopy):
     • Total samples with Giardia present by microscopy: 97
     • Total samples with Giardia absent by microscopy: 478
     • Total samples in this comparison: 575 (97 positive + 478 negative)
     • Data Provenance: The study was evaluated at "six geographically diverse laboratories," indicating a multi-center, likely prospective collection of clinical samples. The country of origin is not explicitly stated but can be inferred to be within the US given the submission to the FDA.
   • Comparison to Predicate Device:
     • Total samples: 147 (26 positive by predicate, 121 negative by predicate).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • The primary ground truth for the clinical performance study was microscopy. The document does not specify the number of experts (e.g., medical technologists, parasitologists) involved, nor their specific qualifications (e.g., years of experience). It simply states the comparison was "compared to microscopy."

3. Adjudication Method for the Test Set:

   • The document does not explicitly state an adjudication method (like 2+1, 3+1). It implies that the microscopy results served as the definitive ground truth for the comparison.

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

   • No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test (lateral flow immunoassay), not an AI-powered diagnostic imaging or interpretation tool designed to assist human readers.

5. Standalone (Algorithm Only) Performance:

   • Yes, the performance presented in the "Sensitivity/Specificity" table is the standalone performance of the Xpect™ Giardia Lateral Flow Assay, as it directly compares the device's results to the microscopy ground truth. It operates independently of human interpretation beyond reading the positive/negative line.

6. Type of Ground Truth Used:

   • The primary ground truth used for the clinical performance evaluation was microscopy, which involves expert examination of fecal specimens for the presence of Giardia parasites.

7. Sample Size for the Training Set:

   • The document does not specify a separate "training set" or its size. As this is a lateral flow immunoassay, the development process would involve analytical studies and optimization rather than machine learning training on a distinct dataset. The studies described are performance validation studies.

8. How the Ground Truth for the Training Set Was Established:

   • Since a separate training set, in the context of machine learning, is not applicable or described for this device, the method for establishing its ground truth is not provided. The ground truth for the validation test set was established by microscopy.

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REMEL's Xpect™ Giardia/Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Giardia and Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia and Cryptosporidium infections.

The Xpect™ Giardia/Cryptosporidium Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia and Cryptosporidium antigens. The test utilizes sample wicking to capture Giardia and Cryptosporidium antigens on discrete test lines containing antigen-specific antibodies for each organism. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to monoclonal antibodies specific for Giardia and Cryptosporidium is added. The mixture is dispensed into the sample well of the device and wicks across a membrane containing capture antibody stripes. The Giardia/Cryptosporidium immune complexes if present react with anti-Giardia antibody and/or anti-Cryptosporidium antibody at the test line. Conjugates not bound at the test lines are later captured at the control line containing anti-mouse antibody. A blue line will appear at the Giardia test position if Giardia antigen is present and a pink line will appear at the Cryptosporidium test position if Cryptosporidium antigen is present. A line in the Control position indicates that the test is working properly.

Here's a breakdown of the acceptance criteria and study details for the Remel Xpect™ Giardia/Cryptosporidium Lateral Flow Assay, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

2. Sample size used for the test set and the data provenance:

• Giardia Test Set Sample Size:
  • Sensitivity/Specificity vs. Microscopy: 577 total specimens (96 positive, 481 negative by microscopy).
  • Percent Agreement vs. Microscopy: 146 specimens (21 positive, 125 negative by microscopy).
• Cryptosporidium Test Set Sample Size:
  • Sensitivity/Specificity vs. Microscopy: 577 total specimens (112 positive, 465 negative by microscopy).
  • Percent Agreement vs. Microscopy: 146 specimens (30 positive, 116 negative by microscopy).
• Data Provenance: The studies were conducted at "six geographically diverse laboratories" for the primary sensitivity/specificity comparison and in a side-by-side comparison with a predicate device. The text does not specify the country of origin but implies a multi-site clinical evaluation. The studies appear to be retrospective as they involve analyzing collected fecal specimens.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The ground truth for the test set was established by microscopy. The document does not specify the number of experts or their qualifications (e.g., years of experience for the microscopists).

4. Adjudication method for the test set:

• The document does not specify an adjudication method for disagreements in establishing the ground truth via microscopy. It is simply stated that performance was "compared to microscopy on a single specimen."

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a lateral flow immunoassay not an AI-assisted diagnostic.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, this device is a standalone test. The Xpect™ Giardia/Cryptosporidium Lateral Flow Assay is a qualitative immunoassay designed to provide a direct result (presence or absence of colored lines) without human interpretation beyond reading the lines.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth used was microscopy for the detection of Giardia and Cryptosporidium.

8. The sample size for the training set:

• The document does not explicitly mention a training set sample size. As a lateral flow immunoassay, the device itself is not "trained" in the same way an AI algorithm would be. The development and optimization of such assays involve laboratory work and validation, but not a distinct "training set" in the context of machine learning. The studies described are performance evaluations.

9. How the ground truth for the training set was established:

• As noted above, there is no explicit "training set" for an AI algorithm. The development of the immunoassay would have involved internal validation and optimization to ensure the antibodies and detection system worked as intended. The ground truth for such development would likely rely on known positive and negative control samples, potentially confirmed by gold standard methods like microscopy or PCR, to select optimal reagents and assay conditions. However, the provided text does not detail these developmental activities or their ground truth establishment.

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The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.

The GIARDIA II test is an enzyme immunoassay.

This document does not contain the detailed study information, acceptance criteria, or performance data for the GIARDIA II device. The provided text is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It states the intended use and regulatory classification but does not include the specifics of the performance study that would demonstrate it meets acceptance criteria.

Therefore, I cannot fulfill the request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone performance details.
7. Type of ground truth used for the test set.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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This direct fluorescent antigen (DFA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium oocysts and Giardia Cysts in human feces using fluorescent microscopic visualization. This IVD assay is intended to be used with stools preserved in 10% formalin, SAF or Medical Chemical Corporation's (MCC's) Universal fixative. Such samples may be concentrated or unconcentrated.

This IVD Research, Inc. Cryptosporidium/Giardia Direct Fluorescent Antigen Detection Kit (DFA Assay) is intended for use as an in vitro diagnostic (IVD) fluorescent immunoassay for the qualitative determination of Cryptosporidium oocysts and Giardia cysts in stool feces. This assay may be used with stool samples that are preserved in 10% formalin, SAF, or Medical Chemical Corporation's (MCC's) Universal Fixative.

This DFA Assay corresponds to FDA Classification Name: Entamoeba Histolytica Serological Reagent, a class II (non-exempt) Device, within the Microbiology Classification Panel, having FDA Reg. Citation Number: 21 CFR 866.3220, and FDA Product Codes: MHI and MHJ, and, as such, utilizes the principle of direct immunofluorescence microscopy. The conjugate contains a mixture of FITC-labeled monoclonal antibodies (derived from hybridized mouse B-cells) directed against Cryptosporidium oocysts and Giardia cysts, which, if present, are affixed to a treated slide (provided). The slide with sample material is then rinsed with wash solution to remove unbound conjugate and debris, and air-dried. The prepared slide is then examined using a fluorescent microscope, looking for an apple-green color and the characteristic morphology of the Cryptosporidium oocysts and the Giardia cysts.

The IVD Research, Inc.'s Cryptosporidium/Giardia Direct Fluorescent Antigen (DFA) Detection Kit is intended for use as an in vitro diagnostic (IVD) fluorescent immunoassay for the qualitative determination of Cryptosporidium oocysts and Giardia cysts in stool feces.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the desire to demonstrate substantial equivalence to the gold standard (O&P microscopy) and the predicate device, Meridian Diagnostic's Merifiuor™ Cryptosporidium/Giardia Direct Fluorescent Antigen Detection Kit, with "equivalent sensitivity and specificity." While explicit numerical acceptance criteria (e.g., "sensitivity must be >90%") are not stated, the study results consistently report 100% or near 100% sensitivity and specificity with narrow 95% Confidence Intervals.

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

• Study #1: 170 stools (145 human, 25 bovine). Unconcentrated.
• Study #2: 53 unconcentrated stools.
• Study #3: 74 formalin and SAF preserved stools.
• Study #4: 69 formalin and SAF preserved stools (used for predicate device comparison).
• Data Provenance: The document explicitly states, "Unless otherwise indicated, all fecal samples are derived from humans." The inclusion of 25 bovine stools in Study #1 indicates a mix of human and non-human samples in that specific study; other studies imply human origin. The data is retrospective, as it compares the new DFA assay against existing O&P microscopy results or a predicate device. The country of origin of the data is not specified.

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

The document does not explicitly state the number of experts or their qualifications. However, the ground truth for Studies #1, #2, and #3 was established using "O&P microscopy," which is a standard parasitological examination typically performed by trained medical technologists or clinical microbiologists with expertise in identifying parasites.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). It implies that the O&P microscopy results (the "Micro +" and "Micro -" columns in the tables) were considered the definitive ground truth against which the DFA assay was compared. There is no mention of discrepancies being adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a diagnostic kit (DFA assay) for microscopic visualization, not an AI-powered image analysis tool. Therefore, the concept of human readers improving with AI assistance does not apply here.

6. If a Standalone (Algorithm Only Without Human-in-The-Loop Performance) Was Done

Yes, the studies presented (Studies #1, #2, and #3) represent standalone performance of the IVD Research DFA Assay. The results of the DFA assay were directly compared to O&P microscopy (the ground truth) without human interpretation factors other than the inherent microscopic examination of the DFA slides. Effectively, the "algorithm" here is the DFA assay methodology itself, and its performance is evaluated directly.

7. The Type of Ground Truth Used

The primary ground truth used for Studies #1, #2, and #3 was expert consensus via O&P microscopy (Ova and Parasite microscopy). This is considered the "gold standard for parasitology" as stated in the document. For Study #4, the ground truth was the results obtained from the predicate device.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning or algorithm development. This is a traditional IVD kit validation, not an AI/ML device. The studies described are performance validation studies for the finished product. Therefore, there is no specified training set size for an algorithm.

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

Since there is no explicit training set in the context of an AI/ML algorithm, this question is not applicable. The device relies on chemical reactions and fluorescent microscopy, not machine learning.

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This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in feces.

It is a double antibody (sandwich) ELISA using an anti-Giardia antibody to capture the antigen from the stool supernatant. A second antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Giardia antigens being bound by the anti-Giardia antibodies.

This document is an FDA 510(k) clearance letter for the Giardia Antigen Detection Microwell ELISA Assay. It does not contain information about acceptance criteria, device performance, sample sizes for testing/training, ground truth establishment, or human reader effectiveness studies.

The provided text is purely an FDA clearance letter and an "Indication For Use" statement. It does not include a study description with the requested details. Therefore, I cannot extract the information to complete the table or answer the questions.

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This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens.

It is intended for professional laboratory use.

For In Vitro Diagnostic Use.

Immunoassay for Giardia and Cryptosporidium Antigens

Here's a breakdown of the acceptance criteria and study details for the Genzyme Contrast® Giardia/Cryptosporidium Combo Rapid Assay:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria thresholds like "Sensitivity > 95%". Instead, the performance is presented as the outcome of the study, implying that the observed high sensitivity and specificity values were considered acceptable for demonstrating substantial equivalence. The precision studies explicitly state 100% agreement as the specification.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Retrospective Analysis vs Microscopic Examination:
     • Giardia: 33 positive, 109 negative (total 142)
     • Cryptosporidium: 37 positive, 105 negative (total 142)
   • Prospective Analysis vs Microscopic Examination:
     • Giardia: 50 positive, 452 negative (total 502)
     • Cryptosporidium: 73 positive, 429 negative (total 502)
   • Retrospective Analysis vs Rapid EIA (Predicate):
     • Giardia: 142 samples (agreement reported for 138/142)
     • Cryptosporidium: 142 samples (agreement reported for 142/142)
   • Provenance: The document does not explicitly state the country of origin. Both "Retrospective Analysis" and "Prospective Analysis" are mentioned, indicating a mix of historical and newly collected samples for the microscopic comparison. The comparison against the predicate EIA is stated as "Retrospective Analysis."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the number or qualifications of experts. Ground truth was established by "microscopic examination," which is typically performed by trained laboratory personnel (e.g., medical technologists or microbiologists) but no specific expert details are provided.

3. Adjudication method for the test set:

   • The document does not specify any adjudication method (e.g., 2+1, 3+1). It simply states "microscopic examination" as the reference method, implying a single definitive read or a standard laboratory process.

4. 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. This study is for an in vitro diagnostic (IVD) assay, not an AI-assisted device for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, effectively. The "Genzyme Giardia/Cryptosporidium Assay" performance (sensitivity and specificity) is reported as a standalone device performance when compared against the reference method (microscopic examination) and the predicate method (Alexon ProSpecT). As an IVD, it is essentially an "algorithm only" in the sense that the assay itself produces the result, without direct human cognitive input to interpret an image or signal beyond reading the immunoassay result.

6. The type of ground truth used:

   • Expert Consensus / Reference Method: "Microscopic examination" is stated as the "Reference method." This implies that microscopic identification of Giardia and Cryptosporidium organisms in fecal samples serves as the gold standard for establishing the ground truth.

7. The sample size for the training set:

   • The document does not provide any information regarding a training set sample size. This is typical for traditional IVD assays, where method development and optimization (analogous to training) involve internal studies and reagent formulation, which are distinct from the formal clinical performance studies presented here.

8. How the ground truth for the training set was established:

   • As no training set is explicitly mentioned or detailed, there is no information provided on how its ground truth was established.

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The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).

The Premier Giardia test utilizes polyclonal anti-Giardia capture antibody adsorbed to microwells.

Here's a breakdown of the acceptance criteria and study information for the Premier Giardia device, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for the Premier Giardia device, as presented in comparison to its predicate device, are focused on its diagnostic performance metrics:

1. Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the Premier Giardia performed at 98% sensitivity and 98% specificity, directly matching the performance of the predicate device, the Alexon ProspecT Giardia Microplate Assay. This direct match implies that these performance metrics of the predicate device serve as the acceptance criteria for the new device.

2. Sample Size and Data Provenance for the Test Set

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number and Qualifications of Experts for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. For an in vitro diagnostic device like this, ground truth would typically be established by culture, microscopy, or other established reference methods interpreted by qualified laboratory personnel.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is more common for imaging devices where human interpretation is a critical component influencing diagnostic accuracy. The Premier Giardia is an in vitro diagnostic assay with a qualitative (positive/negative) output.

6. Standalone (Algorithm Only) Performance

The information provided describes the performance of the Premier Giardia as a standalone device. It's an enzyme immunoassay (EIA) that directly detects Giardia antigens. There is no indication of a human-in-the-loop component or an "algorithm only" performance separate from the assay itself. The "Level of Skill Required" is stated as a "Laboratory Technician," meaning technicians perform the assay according to the specified steps and interpret the results.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the performance evaluation (e.g., expert consensus, pathology, other reference methods, or outcomes data). However, for an in vitro diagnostic for infectious disease, the ground truth is typically established by:

• Microscopy: Direct observation of Giardia cysts or trophozoites in stool samples by a trained microbiologist.
• Culture: Growing the Giardia parasite in a laboratory setting (though this can be challenging for Giardia).
• Reference molecular tests: PCR or other nucleic acid-based tests could also be used as a gold standard.

Given the context of a 510(k) for an EIA, it is highly probable that the reference "Performance vs. Reference Methods" implies comparison against microscopy or another established laboratory method for Giardia detection.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention a training set sample size. For an immunoassay like the Premier Giardia, there isn't typically a "training set" in the machine learning sense. The assay itself is developed and optimized, not "trained" on data. The figures for sensitivity and specificity reflect the performance after development and optimization, assessed against a "test set" (though its size is not specified).

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

Since there is no "training set" in the context of this immunoassay, the question of how its ground truth was established is not applicable. The development of the assay likely involved internal validation and optimization against known positive and negative samples, but these are part of the assay's development, not a separate "training set" with ground truth in the way a machine learning algorithm would have.

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