Search Results

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.

Ask a specific question about this device

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).

Not Found

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

The On Call Sure Blood Glucose Monitoring System is comprised of the On Call Sure Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Blood Glucose Monitoring System is intended to the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Sure Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Blood Glucose Monitoring System is intended for single-patient use and should not be shared.

The On Call Sure Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The On Call Sure Sync Blood Glucose Monitoring System is comprised of the On Call Sure Sync Blood Glucose Meter and On Call Sure Blood Glucose Test Strips. The On Call Sure Sync 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. The On Call Sure Sync Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. The On Call Sure Sync Blood Glucose Monitoring System is intended for single-patient use and should not be shared.

The On Call Sure Sync Blood Glucose Monitoring System is for in vitro diagnostic use. The On Call Sure Sync Blood Glucose Monitoring System is not intended for the diagnosis of or diabetes, nor intended for use on neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System are designed for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm, and/or palm.

Both systems have almost the same meter design and use the same strip and control solution. The only difference is that On Call Sure Sync Blood Glucose meter is embedded with a Bluetooth module which results in an additional Bluetooth data transfer feature for this meter. Thus, the On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System can be considered equivalent for the performance of glucose testing.

Both systems share the same On Call Sure Blood Glucose test strip. It has a reagent system that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample to produce an electrical current signal. This current is measured using an amperometric detection method. The meter then calculates and displays the blood glucose concentration reading, calibrated to plasma reference. The On Call Sure / On Call Sure Sync Blood Glucose Meters are auto-coding.

Both systems consist of the On Call Sure / On Call Sure Sync Blood Glucose Meter, On Call Sure Blood Glucose Test Strips, and On Call Sure Clucose Control Solutions. Kits may be marketed with various combinations and quantities of the system components, or each of the components may be sold separately. All meter kits include a Carrying Case, User's Manual, Ouick Reference Guide, Warranty Card and Logbook. Materials needed but not provided include a single user lancing device and sterile lancets.

The On Call Sure Glucose Control Solutions are used to confirm that the meter and test strips are working properly. Glucose control solution(s) is/are viscosity-adjusted, buffered aqueous control solutions that contain known concentrations of d-glucose. Two control solution levels are available (Level 1 and Level 2). Level 1 is provided with the system. Level 2 is sold separately.

Both meters have a USB data transfer function that is inactive, pending validation with the On Call Diabetes Management Software (K131469). Only the On Call Sure Sync Blood Glucose Meter is equipped with Bluetooth.

The On Call Sure Sync Blood Glucose Meter is designed with a Bluetooth module which can send glucose test results to a mobile device if the glucose meter and the mobile device are paired and within range.

The acceptance criteria and study proving the device meets them are detailed below based on the provided FDA 510(k) summary. The device in question is the ACON Laboratories, Inc. On Call Sure Blood Glucose Monitoring System and On Call Sure Sync Blood Glucose Monitoring System.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against the FDA Guidance for Industry and Food and Drug Administration Staff - Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (2016) regarding accuracy. The acceptance criteria for glucose meters typically follow an established standard, in this case, a combination of ISO 15197:2015 and FDA guidance.

    *   Low Glucose: 88 samples * 3 lots = 264 measurements
    *   High Glucose: 61 samples * 3 lots = 183 measurements

• Data Provenance: The studies were conducted as part of a premarket notification (510(k)) submission to the FDA, implying they were performed for regulatory approval purposes. While the specific country of origin for the study participants is not explicitly stated, the submission is from ACON Laboratories, Inc., located in San Diego, California, USA, and follows FDA guidance, suggesting the studies were likely conducted in the United States or under similar clinical regulatory standards. The studies were prospective in nature, involving active recruitment of subjects to use the device.

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

• The ground truth reference method used was the YSI Model 2300 STAT PLUS Glucose Analyzer (K913806).
• The document states that the YSI 2300 glucose measurement results were obtained by trained technicians. No specific number of experts (technicians) is provided, nor are their detailed qualifications (e.g., years of experience). The YSI 2300 STAT PLUS is a laboratory-grade reference instrument often used for establishing ground truth in glucose monitoring studies.

4. Adjudication Method for the Test Set

• For the user evaluation study, the trained technician collected capillary blood samples in microtainer tubes (with heparin anticoagulant) to be measured on the YSI 2300 Stat Plus Glucose Analyzer in duplicate. This duplicate measurement likely served as an internal check for the reference method, but there is no explicit mention of an adjudication method used to resolve discrepancies between device readings and the reference, or between multiple reference measurements, beyond the duplicate testing.

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

• This device is a blood glucose monitoring system intended for self-testing by individuals with diabetes. It is a standalone analytical instrument and does not involve "human readers" interpreting medical images or data assisted by AI for diagnosis. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The studies focused on the accuracy of the device itself when used by lay persons compared to a laboratory reference.

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

• Yes, a standalone performance evaluation (algorithm only, in the sense of the device's internal measurement and calculation) was a core component of the non-clinical testing. This included:
  • Precision/Reproducibility: Repeatability and Intermediate Precision studies were conducted using the device on venous blood samples and control solutions.
  • Linearity/Assay Reportable Range: Evaluated the device's ability to accurately measure glucose across its claimed range using prepared blood samples.
  • Analytical Specificity (Interference): Tested the device's accuracy in the presence of various interfering substances.
  • Stability, Detection Limit, Hematocrit Effect, Temperature Effect, Altitude Effect, Sample Volume, Humidity Effect, etc.: These are all tests of the device's inherent analytical performance without direct human interpretation of results beyond performing the test procedure.
• The "User Evaluation Study" involved lay persons operating the device, but the focus was on the system accuracy (device + user) compared to the reference, rather than an "algorithm-only" performance in isolation from user impact.

7. The Type of Ground Truth Used

• The ground truth used for both the user evaluation study and the accuracy at extreme glucose values study was a laboratory reference method: the YSI Model 2300 STAT PLUS Glucose Analyzer. This is a widely accepted standard for determining glucose concentrations in blood samples.

8. The Sample Size for the Training Set

• This document is a 510(k) summary for a traditional blood glucose meter, not an AI/ML-driven device that typically relies on large "training sets" in the same way. The device's measurement principles are based on established electrochemical enzymatic assays. Any internal calibration or algorithm development would likely have been performed using laboratory data during the device's development phase, but specific "training set" sizes are not applicable/provided in the context of this traditional device submission.

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

• As noted above, a distinct "training set" in the context of AI/ML is not applicable here. For the device's internal calibration and analytical performance development (if a similar term were to be used), the ground truth for establishing values (e.g., for control solutions) was determined by an in-house procedure using the YSI reference method. The On Call Sure and On Call Sure Sync Blood Glucose Monitoring System is also stated to be traceable to the NIST SRM 917b reference material.

Ask a specific question about this device

The Mission® Lipid Panel Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingerin venous whole blood. The Mission® Lipid Panel Monitoring System consisting of the Mission® Lipid Panel Meter, Mission® Lipid Panel Test Cartridges, Mission® Cholesterol Optical Verifier, and Mission® Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto disabling lancing devices. This system is for in vitro diagnostic use only.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders.

An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Pro Meter and is reported only when Triglycerides are ≤400 mg/dL.

Not Found

The document provided (K180504) is a 510(k) premarket notification for the Mission Lipid Panel Monitoring System. Based on the content, this device is a quantitative assay system for measuring Total Cholesterol, HDL-C, and Triglycerides, primarily used in professional healthcare settings. It is NOT an AI/ML powered device, nor does it involve image analysis by experts, or require MRMC studies.

Therefore, many of the requested criteria (like number of experts, adjudication methods, multi-reader multi-case studies, effect size of human improvement with AI, training set details, etc.) are not applicable to this type of medical device and the information is not present in the provided document.

However, I can extract the acceptance criteria and performance data relevant to a clinical chemistry device, which typically involves analytical accuracy and precision.

Here's an attempt to answer the request based only on the provided document, acknowledging the limitations for an AI/ML context:

The Mission Lipid Panel Monitoring System is a quantitative in vitro diagnostic device. The documentation provided focuses on clinical chemistry performance, not AI/ML algorithm performance. As such, many of the acceptance criteria and study details commonly associated with AI/ML devices (e.g., number of experts, MRMC studies, training set details, ground truth for image analysis) are not relevant or provided for this device type.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K180504) is a 510(k) clearance letter and an Indications for Use statement. It does not contain the detailed performance data or the specific acceptance criteria tables that would typically be part of the predicate comparison or detailed validation studies submitted to the FDA. The letter only states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

To illustrate what would typically be found for a quantitative diagnostic like this, and based on common regulatory expectations for lipid panels, performance would involve metrics like:

Important Note: The provided document does not contain any of these specific performance values or acceptance criteria. It is a regulatory clearance letter, not a summary of the validation study.

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

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). Such details would be found in the more detailed 510(k) submission or a summary of safety and effectiveness, neither of which is part of this provided extract.

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

Not applicable. This device measures chemical analytes (Total Cholesterol, HDL-C, Triglycerides). The "ground truth" for such measurements is typically established by reference laboratory methods (e.g., enzymatic assays, gas chromatography-mass spectrometry (GC-MS), or high-performance liquid chromatography (HPLC)) traceable to international standards (e.g., CDC Lipid Standardization Program). It does not involve human expert interpretation of images or complex diagnostic reasoning.

4. Adjudication Method for the Test Set

Not applicable, as ground truth is established by objective laboratory methods, not expert consensus requiring adjudication.

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

Not applicable. MRMC studies are relevant for imaging devices where human readers interpret medical images. This device is a quantitative diagnostic instrument that measures chemical concentrations.

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

Not applicable. This device is an analytical instrument; its "performance" is its ability to accurately and precisely measure analytes. While there's an "algorithm" for calculating LDL-C (Friedewald formula), its performance is assessed through the accuracy of the underlying direct measurements (TC, HDL-C, TG) and comparison of the calculated LDL-C to a reference method, not typically in a "standalone algorithm" context as understood for image analysis AI.

7. The Type of Ground Truth Used

The ground truth for a device like the Mission Lipid Panel Monitoring System would be established by:

• Reference Laboratory Methods: Highly accurate and precise laboratory methods (e.g., those traceable to the CDC Lipid Standardization Program or other certified reference methods) for Total Cholesterol, HDL-C, and Triglycerides.
• Certified Reference Materials: Use of materials with known, established concentrations of the analytes.

8. The Sample Size for the Training Set

Not applicable in the context of AI/ML training. This device is likely based on established electrochemical or photometric principles, not on a machine learning model "trained" on a dataset of patient samples in the AI sense. Performance is validated through analytical studies on patient samples and quality control materials.

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

Not applicable. As noted above, this is not an AI/ML device that requires a "training set" in that context. Its analytical method is based on established chemical principles. Validation is done against reference methods and materials, as described in point 7.

Ask a specific question about this device

The On Call® Express Mobile Blood Glucose Monitoring System is intended to be used for the quantitative detection of glucose in fresh capillary whole blood. It allows diabetics to take blood samples from the fingertip, forearm, or palm. It is used by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly)

The On Call® Express Mobile 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 Mobile 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® Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding a blood glucose monitoring system. This type of document does not contain the detailed study information typically found in a clinical study report or a 510(k) summary, which would elaborate on acceptance criteria and performance data.

Therefore, I cannot extract the information required to answer your request about acceptance criteria and study details. The document is primarily a regulatory approval letter stating substantial equivalence to a predicate device.

To address your request, I would need a different type of document, such as:

• A 510(k) Summary: These summaries often contain a section describing the device's performance data and comparison to the predicate.
• A detailed clinical study report or technical file: These would include the specific design of the study, acceptance criteria, sample sizes, ground truth establishment, and adjudicated results.

The current document only provides the following, which is not sufficient for your request:

• Device Name: On Call Express Mobile Blood Glucose Monitoring System
• Regulation Name: Glucose test system
• Regulation Number: 21 CFR 862.1345
• Regulatory Class: Class II
• Product Code: NBW
• Indications for Use: Quantitative detection of glucose in fresh capillary whole blood for diabetics at home, with alternate testing sites (forearm and palm) during steady-state times. Not for diagnosis/screening of diabetes or use on neonates. For in vitro diagnostic use only. For single patient use.

Ask a specific question about this device