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The Flowflex® Plus Strep A Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

The Flowflex® Plus Strep A Rapid Test Strip is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

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The Flowflex Plus RSV + Flu A/B + COVID Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to RSV, influenza, and SARS-CoV-2 can be similar.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with RSV, influenza, SARS-CoV-2 or other pathogens.

Individuals who test negative and/or experience continued or worsening symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

The Flowflex Plus RSV + Flu A/B + COVID Home Test is a lateral flow immunoassay.

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The On Call® Sure GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips.

The On Call® Sure GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The system is for in vitro diagnostic use. It should only be used by a single patient and should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure Sync GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips.

The On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The system is for in vitro diagnostic use. It should only be used by a single patient and should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

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The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar.

This test is for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens.

Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay.

This FDA 510(k) clearance letter pertains to a lateral flow immunoassay (a type of rapid diagnostic test), not an AI/computer-aided detection (CAD) device. Therefore, many of the requested criteria (like ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set information) are not directly applicable or would be established differently for an in-vitro diagnostic (IVD) device.

However, I can extract the relevant information regarding acceptance criteria and performance as presented for this type of device.

Key takeaway for this document: This is a clearance for a physical diagnostic test (Flowflex Plus COVID-19 + Flu A/B Home Test), not a software or AI-based medical device. Therefore, the concepts of "ground truth for test set," "adjudication methods," "MRMC studies," "standalone algorithm performance," and "training set details" are not applicable in the typical AI/CAD sense. Instead, the "ground truth" for an IVD device like this is typically established by a gold standard laboratory method (e.g., PCR), and the performance metrics are sensitivity and specificity against that gold standard.

Here's the breakdown based on the provided document and the nature of the device:

Device: Flowflex Plus COVID-19 + Flu A/B Home Test (Lateral flow immunoassay)

1. Table of Acceptance Criteria and Reported Device Performance:

The document itself does not contain the specific performance data (sensitivity, specificity) or the exact acceptance criteria that were used for clearance. Instead, it is the clearance letter stating that the device has been reviewed and found substantially equivalent. To find the actual performance data and acceptance criteria, one would typically need to refer to the full 510(k) submission summary or associated clinical study reports, which are not included here.

For a lateral flow immunoassay like this, the acceptance criteria would typically be defined as minimum acceptable sensitivity and specificity values for each analyte (SARS-CoV-2, Flu A, Flu B) compared to a gold standard molecular test (e.g., RT-PCR).

Hypothetical Example Table (based on typical IVD clearance expectations, not from this document):

Study Proving Device Meets Acceptance Criteria:

The document implicitly states that such a study was conducted and reviewed by the FDA, leading to the substantial equivalence determination. This would be a clinical performance study comparing the results of the Flowflex Plus test to a gold standard laboratory test (e.g., RT-PCR).

Details not explicitly in the document, but standard for IVD tests:

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

• Sample Size: Not specified in this clearance letter. For a multi-analyte home test, the sample size would likely be in the hundreds to low thousands of patient samples, ensuring sufficient numbers of positive and negative cases for each analyte.
• Data Provenance: Not specified. For home tests, clinical studies typically involve both prospective collection of samples and sometimes the use of banked, de-identified retrospective samples, often from diverse geographical locations to ensure generalizability. It would likely be from symptomatic individuals, mirroring the intended use.

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

• Not applicable in the sense of human image readers for AI. For an in-vitro diagnostic test, the "ground truth" is established by a reference laboratory method, almost always a highly sensitive and specific molecular test (e.g., RT-PCR for SARS-CoV-2 and Influenza). The experts involved would be laboratory professionals performing and interpreting these reference tests, following validated protocols.

4. Adjudication Method for the Test Set:

• Not applicable in the sense of imaging adjudication. For IVD tests, if there are discrepancies between the investigational device and the reference method, these are typically investigated by retesting, re-sampling, or sequence analysis, rather than human "adjudication" of a readout in the way one would for an imaging study.

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

• No, not applicable. MRMC studies are specific to evaluating the impact of AI/CAD on human reader performance, typically in imaging diagnostics. This device is a direct patient-use diagnostic test.

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

• Not applicable. This isn't an algorithm; it's a physical test. The "standalone performance" is simply the test's sensitivity and specificity when read according to its instructions for use, whether by a lay user or healthcare professional.

7. The type of ground truth used:

• Molecular Reference Method (e.g., RT-PCR): This would be the gold standard for confirming the presence or absence of SARS-CoV-2, influenza A, and influenza B in the patient samples.

8. The sample size for the training set:

• Not applicable in the AI sense. For an IVD like this, there isn't a "training set" for an algorithm. The "training" or development of the immunoassay involves chemical and biological optimization, not machine learning on a dataset. The validation happens through analytical and clinical studies.

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

• Not applicable for this type of device.

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The Distinct® Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid for the early detection of pregnancy. This test can help determine if you are pregnant as early as 6 days before the day of the missed period (5 days before the day of your expected period).

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This letter is an FDA clearance letter and does not contain the detailed information necessary to answer all the questions about the acceptance criteria and the study proving the device meets them. The letter confirms that the Distinct® Digital Pregnancy Test has been found substantially equivalent to predicate devices and can be marketed.

However, based on the provided text, here's what can be extracted and what cannot:

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

The clearance letter does not provide a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, accuracy, etc. These details would typically be found in the 510(k) submission summary or the device's labeling (instructions for use).

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

This information is not present in the FDA clearance letter.

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)

This information is not present in the FDA clearance letter. Since this is an over-the-counter diagnostic test for hCG in urine, the "ground truth" for a pregnancy test is typically established by laboratory methods that accurately quantify hCG levels, rather than interpretation by a panel of medical experts.

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

This information is not present in the FDA clearance letter.

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 information is not present in the FDA clearance letter. This device is a "Distinct® Digital Pregnancy Test," implying it's a test that gives a digital readout (e.g., "Pregnant" or "Not Pregnant"). It's unlikely to be an AI-assisted diagnostic tool that requires human reader interpretation in the context of an MRMC study.

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

This information is not explicitly stated as an "algorithm only" study. However, as an over-the-counter digital pregnancy test, its performance is inherently standalone, meaning the user follows instructions and the device provides the result without further human interpretation beyond reading the digital display. The device itself is the "algorithm" in this context.

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

The ground truth for a pregnancy test like this would be established by quantitative laboratory analysis of human chorionic gonadotropin (hCG) levels in urine or blood, which is the gold standard for confirming pregnancy. The letter mentions the test is for "qualitative detection of human chorionic gonadotropin (hCG) in urine."

8. The sample size for the training set

This information is not present in the FDA clearance letter.

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

This information is not present in the FDA clearance letter. However, similar to the test set, the ground truth for the training set (if applicable for a digital test that might use some internal calibration or digital processing) would also be established through reference methods for detecting and quantifying hCG.

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The Flowflex Plus COVID-19 Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID 19 within the first 6 days of symptom onset.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

The Flowflex Plus COVID-19 Home Test does not differentiate between SARS-CoV and SARS-CoV-2.

All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as for treatment. Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

The performance characteristics for SARS-CoV-2 were established during June 2022 to April 2023 when COVID-19 variant Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

The Flowflex Plus COVID-19 Home Test is a visually read lateral flow immunoassay device.

The provided document is an FDA 510(k) clearance letter for the Flowflex Plus COVID-19 Home Test. This document does not contain the acceptance criteria or a detailed study report that proves the device meets the acceptance criteria.

The 510(k) clearance letter acknowledges the device's substantial equivalence to a predicate device based on the information submitted by the manufacturer. It states the indications for use and lists general regulatory provisions. However, it does not provide the specific performance data, such as sensitivity, specificity, or positive/negative predictive values, that were generated during the device's validation studies, nor the pre-defined acceptance criteria for those metrics.

Therefore, I cannot provide the requested information from the given text. A typical 510(k) summary or premarket submission would contain the detailed study results and acceptance criteria. This document is merely the FDA's clearance letter.

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The Flowflex COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first 6 days of symptom onset.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

The Flowflex COVID-19 Antigen Home Test does not differentiate between SARS-CoV-2.

All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as for treatment. Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

The performance characteristics for SARS-CoV-2 were established from December 2022 to March 2023 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

The Flowflex COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device.

The provided text describes the FDA's clearance of the Flowflex COVID-19 Antigen Home Test but does not contain the detailed performance study information required to answer all aspects of your request. Specifically, it lacks a table of acceptance criteria, the full study details, sample sizes for the test set and training set, and details about expert involvement or adjudication methods.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a table format, nor does it provide a direct table of reported device performance metrics like sensitivity and specificity from a clinical study. It only mentions that the performance characteristics were established.

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

• Sample Size: Not explicitly stated in the document.
• Data Provenance:
  • Country of Origin: Not explicitly stated.
  • Retrospective or Prospective: Not explicitly stated, but clinical studies for antigen tests are typically prospective.
  • Period: "established from December 2022 to March 2023 when SARS-CoV-2 Omicron was dominant."

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

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

This is a standalone test (home use, visually read by individuals). Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and not mentioned. The device itself is an at-home diagnostic, not an AI-assisted diagnostic.

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

Yes, this is essentially a standalone test in the context of being a self-read, visually interpreted immunoassay. There is no AI algorithm involved; the "performance" refers to the test's ability to detect the antigen itself. The document describes it as "a visually read lateral flow immunoassay device."

7. The Type of Ground Truth Used:

The document states the test is for "qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen." Clinical studies for such devices typically use a highly sensitive and specific laboratory-based molecular test (e.g., RT-PCR) as the gold standard (ground truth) for comparison. The phrase "Additional testing with a lab-based molecular test (e.g., PCR) should be considered..." implies PCR is the reference standard.

8. The Sample Size for the Training Set:

This information is not provided in the document. (Note: For a simple lateral flow immunoassay, there may not be a "training set" in the machine learning sense, but rather an optimization/development set).

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

This information is not provided in the document.

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The Distinct® Early Detection Pregnancy Test is an aid for the early detection of pregnancy intended for home use. The device is a chromatographic immunoassay that performs qualitative detection of human chorionic gonadotropin (hCG) in urine. This test can help determine pregnancy as early as 6 days before the day of the missed period (5 days before the day of the expected period).

The Distinct® Early Detection Pregnancy Test is a rapid chromatographic immunoassay for in vitro qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. It is for self-testing. The test strip and absorbent tip are assembled in a plastic housing. The test strip contains monoclonal anti-hCG antibodies and goat anti-mouse polyclonal antibodies. The test result is shown in the result window and read visually after 3 minutes of urine application.

A blue sign of plus (+) at the test window indicates that hCG has been detected (pregnant). Absence of the plus (+) and only a blue line (-) in the Test Window suggests no hCG has been detected. To serve as a procedural control, a blue line will always appear in the Control Window indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided information describes the validation study for the "Distinct® Early Detection Pregnancy Test." Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with specific thresholds. However, based on the studies performed, the implied performance criteria for this qualitative immunoassay are high agreement with a predicate device and high sensitivity (low detection limit for hCG).

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

• Precision/Reproducibility Study:
  • Sample Size: 30 negative urine specimens spiked with hCG at various concentrations (3, 5, 6, 7.5, 8, 8.5, 10, 12, 15, and 25 mIU/mL).
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared samples. Retrospective (spiked samples).
• User Performance Study:
  • Sample Size: 205 laypersons.
  • Data Provenance: Not explicitly stated, but implies U.S. or similar country where FDA approval is sought. Prospective (lay users testing their own urine).
• Device Performance in Different Age Groups:
  • Sample Size: 300 subjects (100 for each age group: 18-40, 41-45, and 55+).
  • Data Provenance: Not explicitly stated. Prospective (subjects providing samples).
• Detection of hCG in Early Pregnancy Clinical Samples:
  • Sample Size: 65 non-pregnant women expecting to become pregnant.
  • Data Provenance: Not explicitly stated. Prospective (daily urine collection from women).

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

• Precision/Reproducibility Study: The ground truth (hCG concentration) was established by spiking negative urine specimens with known concentrations of WHO 5th International hCG standard. No human experts were explicitly mentioned for interpreting the spiked samples' "true" status, as it's a controlled analytical test.
• User Performance Study: The ground truth for comparative results was established by professional testing with the predicate device using the same samples tested by laypersons. The qualifications of these professionals are not specified beyond "professional" use.
• Device Performance in Different Age Groups: The ground truth for "non-pregnant" status was assumed based on the study design for non-pregnant women. No experts were mentioned for establishing ground truth; it was based on the absence of hCG.
• Detection of hCG in Early Pregnancy Clinical Samples: The ground truth of pregnancy status was inferred from positive hCG results over time relative to the expected menstrual period. It's not explicitly stated that an "expert" individually established the ground truth for each sample. The study assesses the device's ability to detect hCG in early pregnancy, with the "truth" being the presence or absence of a detectable hCG level over time.

4. Adjudication Method for the Test Set:

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth from multiple human readers for any of the studies.
• In the User Performance Study, the comparison was between the layperson's interpretation of the candidate device and a professional's interpretation of the predicate device (or presumably, professional interpretation of the candidate device in parallel, though the wording specifies "compared to results from the same sample performed with the predicate device"). This implies a direct comparison rather than an adjudication process involving multiple readers for consensus.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This device is a rapid chromatographic immunoassay (a traditional dipstick-style pregnancy test) and does not involve AI or digital image analysis by human readers. The "reader" is directly the lay user who visually interprets the test line.

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

• No, a standalone algorithm performance study was not done. The device is a visual qualitative test designed for direct human interpretation. There is no algorithm involved in interpreting the results.

7. The Type of Ground Truth Used:

• Analytical Performance Studies (Precision, Cross-Reactivity, Interference, Hook Effect, etc.): The ground truth was primarily based on known concentrations of spiked hCG and other substances (e.g., WHO 5th International Standard for hCG, known concentrations of interfering substances).
• User Performance Study: The ground truth for comparison was established by professional use of a predicate device on the same samples.
• Device Performance in Different Age Groups: Ground truth was based on the confirmed non-pregnant status of the subjects.
• Detection of hCG in Early Pregnancy Clinical Samples: Ground truth for pregnancy detection over time was based on the presence/absence of hCG in urine samples collected prospectively from women trying to conceive, with "positive" samples validated by the test itself and monitored over time relative to the expected period.

8. The Sample Size for the Training Set:

• This device is a traditional immunoassay, not an AI/ML device. Therefore, the concept of a "training set" for an algorithm is not applicable. The device itself (the physical test strip) is manufactured based on established principles of immunoassay development.

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

• As stated above, there is no training set as this is not an AI/ML device. The "ground truth" in the development of such assays typically comes from established scientific principles, calibrated reference materials (like WHO standards), and extensive R&D to ensure the antibodies and reagents perform as expected for hCG detection.

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The On Call® Express II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steady-state times (when blood glucose level is not changing rapidly).

The On Call® Express II Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call® Express II Blood Glucose Monitoring System is not intended for the diamosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call® Express II Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

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This document is a 510(k) summary for the On Call® Express II Blood Glucose Monitoring System, which primarily describes the device and its indications for use, but does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory clearance letter, not a full study report or technical specification.

To provide the requested details, I would need access to the actual study report or the sections of the 510(k) submission that describe the performance data and acceptance criteria for the On Call® Express II Blood Glucose Monitoring System.

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The On Call® Express Voice Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative site testing should be done only during steadystate times (when blood glucose level is not changing rapidly).

The On Call® Express Voice Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call® Express Voice Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

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The provided text describes the FDA 510(k) clearance for the On Call® Express Voice Blood Glucose Monitoring System but does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.

The document is a clearance letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its intended use. However, it does not include the performance data, study design, or specific thresholds that would typically be found in a study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets them based solely on the provided text. The requested information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth type, training set size, and training set ground truth establishment is not present in this document.

To obtain that information, one would typically need to refer to the full 510(k) submission, which is not provided here.

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