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Assay:

ZEUS IFA™ ANA HEp-2 Test System is an indirect immunofluorescence assay for the qualitative detection and semiquantitative determination of IgG anti-nuclear antibodies in human serum by manual fluorescence microscopy or with ZEUS dlFine®. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. All suggested results obtained with ZEUS dIFine® must be confirmed by a trained operator.

Instrument:

ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides. ZEUS dlFine can only be used with FDA cleared or approved ZEUS in vitro diagnostic assays that are indicated for use on this instrument. All suggested results obtained with ZEUS dIFine must be confirmed by a trained operator

ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides.

The provided text is an FDA 510(k) clearance letter for the Zeus IFA ANA HEp-2 Test System and Zeus dIFine. While it states the device is "substantially equivalent" and outlines its indications for use, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and performance data.

The FDA 510(k) summary, often referred to as the 510(k) "Premarket Notification Summary" or "Special 510(k) Notification Summary," would contain the information you are seeking regarding acceptance criteria and performance data. This document is typically publicly available on the FDA's website alongside the 510(k) clearance letter.

Therefore, I cannot provide the requested information based solely on the text you provided. To answer your questions, I would need access to the 510(k) summary document for K201956.

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ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System: The ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease. Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays: - ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System - ZEUS ELISA Borrelia burgdorferi IgM Test System - ZEUS ELISA Borrelia burgdorferi IgG Test System Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

Zeus ELISA Borrelia burgdorferi IgG/IgM Test System: The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

Not Found

This document is an FDA 510(k) clearance letter for two ELISA Borrelia test systems. While it outlines the intended use and regulatory classifications, it does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) summary or the full submission data, which would typically contain the results of performance studies.

The document primarily focuses on regulatory approval and equivalence to predicate devices, not the detailed scientific performance data from the clinical studies.

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ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System: The ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease. Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays: - ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System - ZEUS ELISA Borrelia burgdorferi IgM Test System - ZEUS ELISA Borrelia burgdorferi IgG Test System Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

ZEUS ELISA Borrelia burgdorferi IgG Test System: The ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibody to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgG Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches: (1) Standard two-tier test methodology (STTT) using IgG Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

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The provided FDA 510(k) clearance letter and Indications for Use statement do not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a specific study proving device performance. This document primarily focuses on the regulatory clearance process and the intended use of the devices, rather than the raw performance data from clinical or analytical studies.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Details about standalone (algorithm-only) performance studies.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states one of the devices is "ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System." ELISA is an Enzyme-Linked Immunosorbent Assay, which is a laboratory assay for detecting antibodies, not an AI or digital imaging device. Therefore, questions related to "human readers improving with AI" or "standalone algorithm performance" are not applicable to these specific devices as described.

The document indicates the following regarding ground truth:

• Type of Ground Truth: The device is intended to detect IgG and IgM class antibodies. Positive and equivocal results "must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays..." This implies that the 'ground truth' or confirmatory standard is based on established laboratory diagnostic protocols (Western blot or other ELISA assays), rather than expert consensus on images, pathology, or direct outcome data in the context of an AI device.

To obtain the specific performance data, acceptance criteria, and study details you're looking for, you would typically need to consult the full 510(k) submission, clinical study reports, or peer-reviewed publications related to these specific devices, which are not included in the provided text. The FDA clearance letter summarizes the regulatory decision and the intended use, but not the detailed underlying performance data.

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The ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease.

Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:

(1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines;

or

(2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays:

• ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
• · ZEUS ELISA Borrelia burgdorferi IgM Test System
• ZEUS ELISA Borrelia burgdorferi IgG Test System

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data.

ZEUS ELISA Borrelia burgdorferi IgM Test System

The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease.

Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches:

(3) Standard two-tier test methodology (STTT) using IgM Western blot testing following current interpretation guidelines; or

(4) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System.

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter does not contain the specific information required to complete your request. The document is primarily a formal notification of substantial equivalence for a medical device (ELISA test systems for Lyme disease) and outlines its intended use and regulatory details.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about the sample size used for a test set, data provenance, or information about training sets.
• Mention of experts establishing ground truth, adjudication methods, or multi-reader multi-case (MRMC) studies.
• Information on standalone algorithm performance or the type of ground truth used in validation studies.

To get this information, you would typically need to refer to the actual 510(k) submission document or the device's Instructions For Use (IFU), which would contain the detailed studies and performance data submitted to the FDA for clearance. The provided text is merely the FDA's decision letter based on that submission.

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The ZEUS ELISA Borrelia VLSe-1/PepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This kit is for in vitro diagnostic use.

Not Found

This FDA 510(k) clearance letter pertains to the ZEUS ELISA Borrelia VlsE-1/pepC10 IgG/IgM Test System. However, the provided document does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a 510(k) summary (which is a separate document). The letter primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.

Therefore, I cannot fulfill most of your request directly from the provided text. To answer your questions, I would need access to the 510(k) summary for K113397.

Based only on the provided document, here's what can be inferred or stated about what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Information in document: Not present.
• Missing: The specific clinical performance acceptance criteria (e.g., sensitivity, specificity thresholds) and the actual performance metrics achieved by the ZEUS ELISA Borrelia VlsE-1/pepC10 IgG/IgM Test System are not provided in this regulatory letter.

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

• Information in document: Not present.
• Missing: The number of samples used in the clinical studies to evaluate the device and details about their origin (e.g., country, retrospective/prospective collection) are not included.

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

• Information in document: Not present.
• Missing: This document does not describe the methodology for establishing ground truth, including the number or qualifications of experts involved.

4. Adjudication Method for the Test Set

• Information in document: Not present.
• Missing: Details on how discrepancies in ground truth establishment (if applicable) were resolved are not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• Information in document: Not present.
• Missing: This type of study is more common for imaging devices where human interpretation is a key component. For an ELISA diagnostic kit, a MRMC study involving human readers comparing performance with and without AI assistance is generally not applicable, as the device output is typically quantitative or qualitative (positive/negative) and does not involve human interpretation of complex images or data fields that an AI might augment. Therefore, no effect size of human readers improving with AI vs. without AI assistance would be relevant or found for this type of device.

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

• Information in document: The device is a "Test System" (ELISA kit), implying it functions as a standalone diagnostic tool.
• Implied: Yes, the performance of an ELISA kit is inherently standalone, as it produces a result based on the chemical reaction, not on human interpretation or an "algorithm" in the AI sense. Its "performance" refers to its analytical and clinical accuracy in detecting antibodies.

7. The Type of Ground Truth Used

• Information in document: The "Indications for Use" section states: "All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi." Also, "Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data."
• Inferred based on typical Lyme disease diagnostics: For validating a Lyme disease ELISA, the ground truth for patient samples would typically be established by a combination of:
  • Clinical diagnosis: Based on patient history, symptoms (e.g., erythema migrans), and other clinical findings.
  • Confirmatory laboratory tests: Often a 2-tier testing algorithm as described, where initial screening (like this ELISA) is followed by a Western Blot (which is a more specific confirmatory test) and potentially other specialized tests.
  • Seroprevalence in endemic vs. non-endemic populations: Using panels from confirmed Lyme patients and healthy controls from both endemic and non-endemic areas.
  • Reference standard panels: From organizations like the CDC or NIBSC that provide well-characterized samples.
• Missing: The specific "ground truth" definition used for the clinical study that supported this 510(k) is not detailed.

8. The Sample Size for the Training Set

• Information in document: Not present.
• Missing: ELISA kits do not typically have a "training set" in the same way machine learning algorithms do. However, during the development of the kit, a large number of characterized samples would be used to optimize the assay's cutoff values and ensure robust performance. The size of this internal optimization/development set is not mentioned.

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

• Information in document: Not present.
• Missing: As explained above, the concept of a "training set" doesn't directly apply in the AI sense. For the samples used in the development and optimization of the ELISA, the ground truth would have been established through a similar combination of clinical diagnosis and confirmatory laboratory testing as described for the test set.

To obtain the specific details requested, you would need to access the 510(k) Summary (K113397) for this device, which the FDA generally makes publicly available. That document typically contains the detailed clinical and analytical study results used to support the substantial equivalence claim.

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The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings.

Not Found

I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and the study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the "ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System," describing its intended use and regulatory classification. It does not include specific study details such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for test sets.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This information would typically be found in a more detailed submission document, such as the 510(k) summary or a clinical study report, which is not provided here.

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The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection.

The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing.

The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

Not Found

This document describes the FDA's decision to clear the Zeus ELISA HSV gG-2 IgG Test System, not a study report detailing its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided text.

However, I can extract what is implied about the regulatory context and intended use, which informs the type of studies typically required for such devices.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided as the document is an FDA clearance letter, not a study report. It does not contain specific acceptance criteria values (e.g., sensitivity, specificity thresholds) or the reported performance data from a clinical study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not describe the test set size, its provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Cannot be provided. The document does not describe how ground truth was established, nor the number or qualifications of experts. Given that this is an in-vitro diagnostic device for serological testing, the "ground truth" would likely be established through a combination of other established testing methods rather than expert consensus on images.

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

• Cannot be provided. The document does not discuss adjudication methods.

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

• Not applicable and cannot be provided. This is an in-vitro diagnostic device (ELISA test) for detecting antibodies, not an imaging device intended for interpretation by human readers, nor does it involve AI assistance for human interpretation.

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

• Implied as 'yes' for the device itself. The device, an ELISA test system, operates as a standalone diagnostic tool to detect antibodies. It's a laboratory test, not an AI algorithm. Its performance is measured directly, not in conjunction with human interpretation for improvement.

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

• Cannot be provided explicitly, but typically for serological tests: Ground truth for serological assays like this often involves a composite reference standard, which can include multiple established laboratory tests (e.g., Western Blot, viral culture, PCR, or other highly sensitive and specific serological assays).

8. The sample size for the training set

• Cannot be provided. The document does not mention a training set, as it's an ELISA assay, not a machine learning algorithm that requires supervised training data.

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

• Cannot be provided. Not applicable as explained above.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for the Zeus ELISA HSV gG-2 IgG Test System. It indicates that the device has been found "substantially equivalent" to legally marketed predicate devices, allowing its commercialization. The letter itself does not contain the detailed clinical study data, including acceptance criteria or performance metrics, that would have been submitted by the manufacturer to the FDA for review.

The primary information available is:

• Device Name: Zeus ELISA HSV gG-2 IgG Test System
• Indications for Use: Qualitative detection of type-specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum for aiding in the presumptive diagnosis of HSV-2 infection in sexually active individuals or pregnant women.
• Limitations: Not intended for donor screening or self-testing. Performance not established for pediatric population, neonates, or immunocompromised patients.
• Regulatory Class: Class II
• Product Code: MYF
• Regulatory Pathway: 510(k) (substantial equivalence)

To obtain the specific acceptance criteria and detailed study data, one would typically need to consult the 510(k) summary submitted by Zeus Scientific, Inc. to the FDA, which is usually publicly available on the FDA's website after clearance, or the device's Instructions For Use (IFU)/package insert. These documents would detail the specific studies performed (e.g., sensitivity, specificity, reproducibility, interference studies) and the results that demonstrated substantial equivalence.

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The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical findings to provide serological evidence of infection with T. pallidum. This test is for in vitro diagnostic use only.

This test is not intended for screening blood or plasma donors.

The ZEUS ELISA Treponema pallidum IgG Test System is designed to detect IgG class antibodies in human sera to Treponema pallidum. Wells of plastic microwell strips are sensitized by passive absorption with T. pallidum antigen. The test procedure involves three incubation steps:

1. Test sera are diluted with SAVE Diluent. During sample incubation, any antigen specific lgG antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components.
2. Peroxidase conjugated goat anti-human IgG is added to the wells and the plate is incubated. The conjugate will react with IgG antibody immobilized on the solid phase in step 1. The wells are washed to remove unbound conjugate.
3. The microwells containing immobilized peroxidase conjugate with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After ten minutes have elapsed, the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends on upon the antibody concentration in the original test sample.

The Zeus Scientific Inc. ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non-treponemal testing and clinical findings to provide serological evidence of infection with T. pallidum. It is for in vitro diagnostic use only and not intended for screening blood or plasma donors.

Acceptance Criteria and Device Performance

The acceptance criteria for the ZEUS ELISA Treponema pallidum IgG Test System are implicitly demonstrated by the performance against the predicate device and the specified reproducibility metrics. While explicit quantitative acceptance criteria for clinical performance (e.g., specific sensitivity, specificity thresholds) are not individually listed for each study, the submission aims to demonstrate substantial equivalence to the predicate device.

The internal and external reproducibility studies provide quantitative acceptance criteria for precision (Total CV 1.1 Positive) |
|---|---|---|---|
| Intended Use Populations | | | |
| 500 patients with syphilis test ordered | TPPA (treponemal reference assay) | Phoenix Bio-Tech Trep-Chek | PPA: 80.0% (95% CI: 28.4-99.5%), NPA: 99.2% (95% CI: 97.9-99.8%) |
| 500 pregnant women with syphilis test ordered | TPPA (treponemal reference assay) | Phoenix Bio-Tech Trep-Chek | PPA: 75.0% (95% CI: 19.4-99.4%), NPA: 100.0% (95% CI: 99.4-100%) |
| Other Clinical Performance Studies | | | |
| 1000 unselected hospitalized patients | TPPA (treponemal reference assay) | Phoenix Bio-Tech Trep-Chek | PPA: Not fully reported (21 Positive, 1 Equivocal by predicate resulted in 13 Positive by device), NPA: 97.1% (95% CI: 95.9-98.1%) |
| 223 Retrospective HIV-1 Positive Samples | TPPA (treponemal reference assay) | Phoenix Bio-Tech Trep-Chek | PPA: 85.4% (95% CI: 72.2-93.9%), NPA: 99.4% (95% CI: 96.9-100%) |
| 280 Retrospective TPPA/RPR Positive Samples | TPPA/RPR (reference assays) | Phoenix Bio-Tech Trep-Chek | PPA: 98.5% (95% CI: 96.2-99.6%), NPA: 70.6% (95% CI: 46.9-98.7%) |
| 277 Retrospective TPPA Negative/Positive Pregnant Women | TPPA/RPR (reference assays) | Phoenix Bio-Tech Trep-Chek | PPA: 92.9% (95% CI: 76.5-99.1%), NPA: 99.6% (95% CI: 97.8-100%) |
| 157 CDC Syphilis Panel | Clinical Diagnosis | N/A | % Agreement with Clinical Diagnosis: 93.0% (95% CI: 87.8-96.5%) |
| Precision (Repeatability) | | | |
| 15 samples (Negative, High Negative, Near Cut-off, Low Positive, High Positive) | Internal testing, 48 replicates each | N/A | Total CV for reactive samples: 3.5% to 7.0% (all

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