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An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with ß2-glycoprotein I (ß2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The IgG Anti-AtherOx Test Kit is an indirect ELISA detecting IgG anti-oxLDL/B2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL-ß2GPI complex. Incubation allows the IgG anti-oxLDL-B2GPI antibody present in the samples to react with the immobilized antigen complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added forming complexes with the bound IgG anti-oxLDL-B2GPI antibody. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-B2GPI antibody. Results are obtained by reading the OD (optical density or absorbance) of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-B2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean ODs. Controls and patient results are determined from the calibration curve.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets those criteria:

The document provided does not contain explicit "acceptance criteria" for clinical performance in the typical sense of metrics like sensitivity, specificity, or agreement thresholds against an established reference standard. Instead, the clinical testing section focuses on demonstrating agreement with a legally marketed predicate device (REAADS IgG Anti-Cardiolipin Test Kit) across various patient populations. Therefore, the "acceptance criteria" are implied by the observed agreement rates with the predicate, rather than set a-priori.

Acceptance Criteria and Reported Device Performance

Given the nature of the submission (demonstrating substantial equivalence to a predicate device), the primary "acceptance criterion" appears to be sufficient agreement with the predicate device across different patient populations.

Study Information:

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

   • Test Set Sample Size: A total of 448 serum samples were tested:
     • 205 from healthy control patients.
     • 99 from patients with rheumatoid arthritis.
     • 143 from patients with systemic lupus erythematosus (SLE).
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it uses "serum samples from" patients, implying they were collected prior to the study for testing.

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

   • The document does not state that experts were used to establish a "ground truth" for the test set. Instead, the device's performance is compared to a legally marketed predicate device (REAADS IgG Anti-Cardiolipin Test Kit). The predicate device itself serves as the reference for comparison, not an independent expert consensus.

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

   • There is no mention of an adjudication method in the context of expert review or ground truth establishment. The comparison is directly between the new device and the predicate device.

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:

   • This is an in vitro diagnostic (IVD) device (ELISA test kit) for detecting antibodies in serum. It is not an AI-powered diagnostic imaging device or a device involving human readers/interpreters in the presented study. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable to this submission.

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

   • This is an IVD test kit. The "standalone" performance is essentially what is presented in the study: the direct comparison of the assay's results against the predicate device. There is no human-in-the-loop component in the interpretation of the test results described here beyond the laboratory technician performing the assay and reading the ODs.

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

   • The "ground truth" (or reference standard for comparison) in this 510(k) submission is the performance of the REAADS IgG Anti-Cardiolipin Test Kit, a legally marketed predicate device. The clinical diagnoses of the patients (healthy controls, RA, SLE, APS) serve as classification for the samples, but the direct comparison is test-vs-test.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" for the purpose of machine learning or algorithm development. This is a traditional ELISA assay kit. The provided clinical study data (448 samples) represent the "test set" for performance evaluation, not a training set. Development and optimization of the assay would typically involve internal validation, but those details are not part of this summary in terms of a "training set" as understood in AI/ML contexts.

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

   • As there's no mention of a "training set" in the context of algorithm development, this question is not applicable. The development of the assay itself would have involved establishing specific assay parameters, but the mechanism for doing so isn't detailed as "ground truth establishment" for a training set.

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The AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only. The AspirinWorks® Test Kit is intended for use in clinical (hospital and reference) laboratories.

An ELISA for the detection of urinary 11-Dehydro Thromboxane B2 (11dhTxB2). Goat anti-mouse IgG polyclonal antibody (Jackson ImmunoResearch Laboratories, Inc, West Grove, PA) is coated onto 96microwell plates. Reference, control, and patient samples are diluted in a Tris-based sample diluent (pH 9.0) and added to the microwells. An 11dhTxB2 tracer (11dhTxB2 linked to alkaline phosphatase, (AP); Cayman Chemical Company, Ann Arbor, MI) is then added to all wells except assay blanks, followed by the addition of an anti-11dhTxB2 murine monoclonal antibody (Cayman Chemical Company) to all wells except assay blanks. The maximum binding wells (Bo) contain sample diluent, tracer, and monoclonal antibody, but no unlabeled 11dhTxB2. The plate is then covered with the plastic sheet provided in the kit, and incubated at room temperature on a rotary shaker at 300-600 pm for two hours. The AP-Tracer and unlabeled 11dhTxB2 from the reference curve/controls/samples compete for binding to the anti-11dhTxB2 monoclonal antibody, which is bound to the plate by the goat anti-mouse polyclonal antibody. After incubation, the reaction solution is removed from the wells followed by five washes with TBS/Tween 20. The pNPP substrate is then added and the plate is covered and incubated with shaking for 30 minutes. The reaction is stopped by the addition of Stop Solution (0.1M EDTA) to the wells, and the plate is read at 405-420 mm. Results are compared to the reference curve and expressed in pg/ml. Patient results are then normalized using the creatinine concentration of the sample, as measured by a separate assay.

The Corgenix AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) designed to measure levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine. This measurement aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion.

1. Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the reported performance that demonstrates the device's ability to detect aspirin effect consistently with established literature. While explicit numerical acceptance criteria for sensitivity/specificity against a definitive gold standard are not provided, the "cutoff" value and the agreement with published aspirin non-responsiveness rates serve as the basis for acceptance.

• 4/38 (10.5%) of the 325 mg/day aspirin users indicated a lack of aspirin effect.
• In total, 11/201 (5.5%) of all aspirin users tested indicated a lack of aspirin effect.
• These percentages are reported as "consistent with those in published literature for aspirin non-responsiveness or lack of aspirin effect." |
  | Detection Range (Non-clinical) | 300 - 4000 pg/mL |
  | Precision (Non-clinical) | Intra- and inter-assay precision %CV's are all

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The HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum. The HEP-ANA Test System is intended for use as an aid in the diagnosis of certain autoimument diseases.

The RhiGene HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate, similar to the predicate device. Diluted serum samples are incubated on substrate slides coated with HEP-2 (human epithelial) cells. Incubation allows the anti-nuclear antibodies (ANA) present in the samples to react with the antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins, labeled with fluorescein isothiocyanate (FITC), are added forming complexes with the nuclear bound antibodies. Following another washing step, coverslips are mounted and then the slides are examined with a fluorescence microscope. The total incubation time (at room temperature in a moist chamber) of the assay is 40 minutes.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the RhiGene HEP-ANA Test System:

Acceptance Criteria and Device Performance

The core of the acceptance criteria is predicated on the new device, the RhiGene HEP-ANA Test System, demonstrating substantial equivalence to a legally marketed predicate device, the RhiGene Titer-Fluor ANA Test System (K872845). While explicit numerical acceptance targets aren't given in the summary, the study's goal was to show comparable performance.

The "reported device performance" refers to the RhiGene HEP-ANA Test System. It's compared directly to the predicate device, with results indicating equivalence rather than specific performance metrics in isolation.

Study Details

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

   • Sample Size: Not explicitly stated as a single number.
     • "a healthy donor serum population"
     • "an autoimmune diseases population"
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "In-house studies," implying they were conducted by RhiGene Inc. The samples appear retrospective as they are described as "populations" rather than detailing a prospective enrollment strategy.

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

   • This information is not provided in the summary. The ground truth for the healthy and autoimmune populations would have been established through clinical diagnosis, but the involvement of specific experts for validating these diagnoses for the study is not mentioned.

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

   • This information is not provided in the summary.

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:

   • An MRMC study was not performed. This device is an in-vitro diagnostic (IVD) assay, not an AI-powered image analysis tool requiring human reader interpretation. The performance is based on the assay's output as interpreted by laboratory personnel.

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

   • A "standalone" study in the typical AI sense (algorithm only) was not performed as this is a traditional laboratory assay. However, the performance metrics (specificity and sensitivity) are representative of the device's inherent capability, with human involvement primarily in performing the assay and interpreting the fluorescent patterns, not the "algorithm" itself. The comparison is between two similar lab assays.

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

   • For specificity, the ground truth was derived from a "healthy donor serum population." This implies individuals diagnosed as healthy, likely through clinical evaluation or self-reported health.
   • For sensitivity, the ground truth was derived from "an autoimmune diseases population." This implies individuals with a clinical diagnosis of an autoimmune disease.
   • The document implies that the ground truth for these populations was established through standard clinical diagnostic practices, rather than a specific expert consensus for this study.

7. The sample size for the training set:

   • This information is not applicable as this is not a machine learning or AI device that requires a "training set." The device is a chemical/biological assay.

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

   • This information is not applicable as this is not a machine learning or AI device.

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The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of von Willebrand Factor Activity (vWF:Act) in citrated human plasma.

The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate formal, similar to the predicate device. Diluted patient plasma is incubated in the wells, allowing any available antigen to bind to the monoclonal antibody on the microwell surface. The plates are washed to remove unbound proteins or other plasma molecules. Bound antigen is quantitated using horseradish peroxidase (HRP) conjugated anti-human von Willebrand Factor antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450mm. Patient von Willebrand Factor Activity in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. The total incubation time (at room temperature) of the assay is 40 minutes.

The provided text describes a 510(k) submission for the REAADS von Willebrand Factor Activity Test Kit. This is an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not directly applicable or reported in the context of an IVD submission.

However, I can extract the information that is available and relevant to an IVD device's acceptance criteria and study.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For IVDs, "acceptance criteria" are typically related to the analytical performance (e.g., correlation, precision, linearity) compared to a predicate device. The primary "performance" reported here is the correlation with the predicate device.

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For the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE).

Not Found

The provided text is a 510(k) clearance letter from the FDA for a diagnostic test kit (REAADS® Anti-dsDNA Quantitative Test Kit). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device for the detection and quantitation of anti-dsDNA antibodies in individuals with systemic lupus erythematosus (SLE).

Therefore, I cannot provide the requested information based on the input document.

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The REAADS® II Anti-Cardiolipin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgM antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Cardiolipin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Cardiolipin IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgG antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Cardiolipin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Cardiolipin IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgA antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Cardiolipin IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS II Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine IgG antibodies in human serum or citrated plasma (3.2% sodium citrate). Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidy/serine IgM antibodies in human serum or citrated plasma (3.2% sodium citrate). Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine (aPS) IgA antibodies in human serum and citrated plasma (3.2% sodium citrate). Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (B2GP1) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of anti-ß2GPI IgG antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein l (ß2GPI) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Beta 2 Glycoprotein 1 IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (B2GPI) IgA antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein 1 IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Prothrombin IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-prothrombin (aPT) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of anti-prothrombin (aPT) IgG antibodies with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). The REAADS® II Anti- Prothrombin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Prothrombin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-prothrombin (aPT) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of anti-prothrombin (aPT) IgM antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). The REAADS® II Anti- Prothrombin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The device is an enzyme-linked immunosorbent assay (ELISA) kit for the semi-quantitative determination of specific antibodies in human serum or plasma.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established for "REAADS II anti-Cardiolipin IgG Semi-quantitative Test Kit" or any of the other listed REAADS II test kits.

The document is a 510(k) premarket notification letter from the FDA to Corgenix, Inc., confirming substantial equivalence for a series of REAADS II anti-phospholipid antibody test kits. It primarily lists the device names, regulation numbers, regulatory class, product codes, and indications for use for each kit. While it states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...", it does not provide the details of the studies or data that led to this determination.

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The REAADS IgM Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgG Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for several in vitro diagnostic test kits. It does not contain information about acceptance criteria or specific study details that prove the device meets acceptance criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices and thus can be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG and IgM anti-phosphatidyIserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit." It is primarily a regulatory approval document and does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance studies.

Specifically, the document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device's clearance is based on its substantial equivalence to existing devices, rather than a de novo clinical trial demonstrating its performance against new, specific acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information would typically be detailed in a separate performance study report submitted as part of the 510(k), but it is not present in this clearance letter.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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: This device is an in-vitro diagnostic test kit (likely a lab test for antibodies), not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study in this context is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a test kit.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided document is a regulatory approval letter based on substantial equivalence, not a detailed performance study report. The information you're requesting regarding specific acceptance criteria, study sizes, expert involvement, and ground truth establishment is not available within this text.

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The REAADS IgA Anti-PhosphatidyIserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgA anti-phosphatidylserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

Not Found

The provided text is a 510(k) clearance letter from the FDA for a diagnostic test kit. It does not contain the detailed study information required to answer the questions about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. The document only confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given input.

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An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM anti-cardiolipin antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).

Not Found

This document is a 510(k) clearance letter from the FDA for the REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit. It does not contain the detailed study results, acceptance criteria, or performance data that would answer your specific questions about the device's performance characteristics.

The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device is considered as safe and effective as a device already on the market, but it does not typically involve a new, detailed clinical study with novel acceptance criteria and performance reporting in the same way a PMA (Premarket Approval) might.

Therefore, most of the information you've requested is not available in this document. Here's what can be inferred or explicitly stated:

• Acceptance Criteria and Reported Device Performance: Not provided in this document. The letter only confirms "substantial equivalence."
• Sample size used for the test set and data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and qualifications: Not provided.
• Adjudication method: Not provided.
• MRMC comparative effectiveness study: Not applicable or not mentioned in this type of FDA clearance. This is an in vitro diagnostic device for detecting antibodies, not an AI-assisted diagnostic tool that would typically involve human readers.
• Standalone performance: The letter refers to the "REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit" as the device itself, implying it's a standalone test rather than an AI algorithm assisting a human reader. However, specific performance metrics are not given.
• Type of ground truth used: Not provided in this document. For an in vitro diagnostic device, this would typically involve a reference method or clinical diagnosis in a patient cohort.
• Sample size for the training set: Not applicable for this type of device submission as described. There is no mention of an "algorithm" or "training set" in the context of machine learning. This is a laboratory test kit.
• How the ground truth for the training set was established: Not applicable.

What the document does provide:

• Device Name: REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit
• Regulation Number/Name: 21 CFR 866.5660, Multiple autoantibodies immunological test system
• Regulatory Class: Class II
• Product Code: MID
• Indications for Use:
  • An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM anti-cardiolipin antibodies in human serum or plasma.
  • For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).

To get the information you asked for, one would typically need to review the actual 510(k) submission summary or detailed study reports, which are not included in this FDA clearance letter.

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