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The BinaxNOW COVID-19 Ag Card is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the BinaxNOW COVID-19 Ag Card and followed up with a molecular test.

A negative test is presumptive and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.

Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

The BinaxNOW COVID-19 Ag Card is an immunochromatographic membrane assay that uses antibodies to detect SARS-CoV-2 nucleocapsid protein from anterior nasal swab specimens. SARS-CoV-2 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card.

To perform the test, an anterior nasal swab specimen is collected from the patient, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.

The provided document is a 510(k) summary for the BinaxNOW COVID-19 Ag Card. It does not describe a study proving a device meets acceptance criteria in the manner typically associated with AI/ML-driven medical devices, which would involve measures like sensitivity, specificity, or AUC against a ground truth, often with human readers involved (MRMC studies).

Instead, this document describes the validation of an immunochromatographic assay (a rapid antigen test) for COVID-19. The "acceptance criteria" here are typically performance targets for analytical and clinical characteristics (e.g., Limit of Detection, cross-reactivity, Positive Percent Agreement, Negative Percent Agreement). The "study" refers to the analytical and clinical studies conducted to demonstrate these performance characteristics.

Therefore, the following response will interpret "acceptance criteria" as the performance benchmarks for a diagnostic assay and describe the validation studies for the BinaxNOW COVID-19 Ag Card based on the provided text.

Here's a breakdown of the information requested, interpreted in the context of a rapid antigen test (not an AI/ML device):

Acceptance Criteria and Device Performance for BinaxNOW COVID-19 Ag Card

The BinaxNOW COVID-19 Ag Card is a lateral flow immunochromatographic assay, not an AI/ML diagnostic device. Therefore, the "acceptance criteria" are based on the analytical and clinical performance characteristics typical for such an in-vitro diagnostic (IVD) device, rather than metrics like AUC, sensitivity/specificity of an AI algorithm, or human reader improvement with AI assistance.

1. Table of Acceptance Criteria and Reported Device Performance

• Day 0: 69.23% (Omicron Study)
• Day 1: 94.12% (Original), 88.24% (Omicron)
• Day 2: 73.33% (Original), 97.22% (Omicron)
• Day 3: 76.00% (Original), 100.00% (Omicron)
• Day 4: 88.89% (Original), 66.67% (Omicron)
• Day 5: 100.00% (Original), 100.00% (Omicron) |
  | | Invalid Rate | Low invalid rate. | 0.68% overall (5/730). |
  | User/Environmental Factors | Flex Studies (Robustness) | Device performs accurately under various usage and environmental conditions. | Demonstrated robustness to usage variation and environmental factors. Identified that direct exposure of test strip to wet cleaning solutions or excessive glove powder may cause erroneous results, leading to specific instructions for use. |

2. Sample Sizes and Data Provenance (Clinical Studies)

• Clinical Test Set Sample Size:
  • Study 1 (Original): 295 evaluable subjects.
  • Study 2 (Omicron): 309 evaluable subjects.
  • Combined Clinical Data: 604 evaluable nasal swabs from symptomatic patients (within 5 days of symptom onset).
• Data Provenance: Clinical studies were conducted within the United States.
  • Study 1: November 2020 through March 2021 (when Delta and Omicron were dominant).
  • Study 2: February 2022 to July 2022 (when Omicron and its variants were prevalent).
• Retrospective/Prospective: Both clinical studies were prospective.

3. Number of Experts and Qualifications for Ground Truth for Test Set

This type of diagnostic device (lateral flow immunoassay) does not typically utilize human experts in the same way an AI/ML device would for image interpretation or clinical diagnosis. For the BinaxNOW COVID-19 Ag Card, the ground truth for the clinical studies was established by a comparator molecular test (RT-PCR). The experts involved would be the laboratory personnel performing and interpreting the RT-PCR assays. Their specific qualifications are not detailed in this summary but are implicitly assumed to be standard for clinical laboratory professionals performing EUA-authorized RT-PCR tests.

4. Adjudication Method for the Test Set

Not applicable in the typical sense for an AI/ML study involving human interpretation. The comparator method (RT-PCR) serves as the reference standard. The document mentions for the serial testing study's composite comparator method that in cases of discordant RT-PCR results, a third RT-PCR test was performed, and the final result based on majority rule.

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

No. This is a rapid antigen test, not an AI/ML system where human readers would interpret results "with vs. without AI assistance." The test is visually read by the user, and its performance is assessed against a molecular gold standard.

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

This question is not applicable in the context of this device. The BinaxNOW COVID-19 Ag Card is a manually read, qualitative visual assay. There is no AI algorithm to evaluate for standalone performance. The "performance" tables provided in the document (PPA and NPA) essentially represent the "standalone" performance of the rapid antigen test itself when interpreted visually.

7. Type of Ground Truth Used

• For Clinical Studies: The primary ground truth for clinical performance (PPA, NPA) was an FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assay for the detection of SARS-CoV-2.
• For Serial Testing Study: A composite comparator method was used, involving at least two highly sensitive EUA RT-PCRs. If discordant, a third RT-PCR was performed, and the final result was based on majority rule.
• For Analytical Studies: Ground truth was established by known concentrations of heat-inactivated SARS-CoV-2 virus or WHO International Standard for SARS-CoV-2 Antigen (NIBSC 21/368) for LoD and inclusivity studies, and known presence/absence of specific microorganisms for cross-reactivity.

8. Sample Size for the Training Set

This information is not applicable for this type of IVD device. The BinaxNOW COVID-19 Ag Card is a laboratory-developed lateral flow assay, not an AI/ML model that is 'trained' on data. Its 'training' is the fundamental assay development and optimization process, not a computational training set.

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

Not applicable for this device type. The manufacturing process and quality control of the reagents and test strip govern its 'performance' characteristics, which are then analytically and clinically validated.

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The BinaxNOW COVID-19 Antigen Self Test is a visually read lateral flow immunoassay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.

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 from November, 2020 to July, 2022, when SARS-CoV-2 Delta and Omicron were 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 BinaxNOW COVID-19 Antigen Self Test is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab specimens. SARS-COV-2 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card.

To perform the test, a nasal swab specimen is collected from the patient, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into ugh the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for BinaxNOW COVID-19 Antigen Self Test

The document outlines acceptance criteria generally through reported performance metrics for various analytical and clinical studies. Explicit "acceptance criteria" are not given as pass/fail thresholds in the same way that a test specification would be. Instead, the reported performance serves to demonstrate the device's capabilities.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

2. Sample Sizes and Data Provenance

Test Set (Clinical Studies):

• Total for Clinical Performance: 604 nasal swabs from symptomatic patients within 5 days of symptom onset.
• Study 1 (Original Study): 295 subjects (resulting in 295 evaluable samples).
• Study 2 (Omicron Study): 309 subjects (resulting in 309 evaluable samples).
• Serial Testing Study: 5,600 eligible participants for analysis, out of 7,361 enrolled. 154 tested positive for SARS-CoV-2 infection by RT-PCR.
• Provenance: All subjects were from the United States.
  • Study 1: Prospective, conducted from November 2020 through March 2021 across five investigational sites (when Delta and Omicron were dominant).
  • Study 2 (Omicron Study): Prospective, "all comers, real world," conducted from March 2022 to July 2022 at a high-volume COVID community testing site (when Omicron and its variants were prevalent). Led by Johns Hopkins Medicine in collaboration with the University of Maryland Medical Center and Maryland Department of Health.
  • Serial Testing Study: Prospective, decentralized clinical study conducted between January 2021 and May 2022 as part of the Rapid Acceleration of Diagnostics (RADx) initiative from NIH, with broad geographical representation in the U.S.

Test Set (Usability Studies):

• Lay User Readability Study: 30 users across various age ranges and with and without vision impairments.

3. Number of Experts and Qualifications for Ground Truth

• The document does not explicitly state the number of experts used to establish the ground truth for the test set in the clinical studies.
• The ground truth in the clinical studies was established using FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for the detection of SARS-CoV-2. These are laboratory-based molecular tests, implying the involvement of qualified laboratory personnel (e.g., medical technologists, molecular diagnosticians) experienced in performing and interpreting these assays, but specific qualifications are not detailed. In the serial testing study, the composite comparator method involved "at least two highly sensitive EUA RT-PCRs" and a third if discordant, performed by presumably qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Clinical Studies (Primary Performance): No explicit adjudication method is described for discrepancies between the BinaxNOW test and the comparator RT-PCR. The RT-PCR is considered the gold standard (comparator method).
• Serial Testing Study (Composite Comparator): A form of adjudication was used for the molecular comparator itself: "If results of the first two molecular tests were discordant a third highly sensitive EUA RT-PCR test was performed, and the final test result was based upon the majority rule." This is a 2+1 adjudication method for establishing the RT-PCR ground truth.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted to evaluate human readers with and without AI assistance. The BinaxNOW COVID-19 Antigen Self Test is a visually read lateral flow immunoassay, interpreted directly by the user, and does not involve AI assistance for result interpretation.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) performance study was conducted. As a visually read immunoassay, the device relies on human interpretation. The "lay user readability study" specifically evaluates human interpretation, not an automated algorithm.

7. Type of Ground Truth Used

• Clinical Studies: The primary ground truth for clinical performance was established using FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for SARS-CoV-2.
• Analytical Studies (LoD, Reactivity, Specificity): The ground truth was based on defined concentrations of inactivated SARS-CoV-2 virus strains, international standards, or specific microbial/substance concentrations, as prepared by qualified laboratory personnel.

8. Sample Size for the Training Set

• The document describes performance evaluation studies (test sets) for the BinaxNOW device. It does not provide information about a "training set" in the context of machine learning, as this is a traditional in-vitro diagnostic device that relies on chemical reactions and visual interpretation, not an AI/ML-based device.

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

• As there is no mention of an AI/ML training set, this information is not applicable and not provided in the document.

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The ID NOW™ Influenza A & B 2 assay performed on the ID NOW™ Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2016-2017 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

ID NOW Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

All ID NOW™ assays utilize isothermal nucleic acid amplification technology and are comprised of:

• Sample Receiver single use, disposable containing the elution buffer .
• Test Base single use, disposable comprising two sealed reaction tubes, each . containing a lyophilized pellet
• Transfer Cartridge single use, disposable for transfer of the eluted sample to the Test . Base, and
• ID NOW™ Instrument repeat use reader .

The reaction tubes in the ID NOW Influenza A & B 2 Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. ID NOW Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

ID NOW Influenza A & B 2 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW™ Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument. with results automatically reported.

Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW Instrument by the operator. and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Universal Printer can be attached via USB to the ID NOW Instrument to print test results.

The provided text describes a 510(k) submission for the ID NOW™ Influenza A & B 2 assay, specifically focusing on a software modification to mitigate potential false positive Influenza B test results during sequential workflow testing. The submission is a "Special 510(k)," indicating that the changes are minor and do not significantly alter the device's fundamental technology or safety/effectiveness.

The document emphasizes the equivalence to a legally marketed predicate device (ID NOW Influenza A & B 2, K220801). Therefore, the study presented here is primarily a comparative study to demonstrate that the modified device performs equivalently to the predicate, rather than establishing de novo performance characteristics against a clinical ground truth for a novel device.

Here's an analysis of the provided information, framed by your request for acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this Special 510(k) are implicitly tied to demonstrating non-inferiority or equivalence of the modified device's performance to the predicate device, particularly concerning the reduction of false positives for Influenza B. The document states:

• "A modification of the ID NOW Influenza A & B 2 algorithm was made, as a preventive measure, to mitigate the potential occurrence of false positive Influenza B test results during sequential workflow testing."
• "ID NOW Influenza A & B 2 incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared ID NOW Influenza A & B 2."

While the document states the purpose and the comparison, it does not explicitly list quantitative acceptance criteria (e.g., a specific percentage reduction in false positives, or a non-inferiority margin for sensitivity/specificity) or the reported device performance in a table format as you requested. The provided text is a summary letter and general description, not a detailed study report. For a device like this, the performance data (sensitivity, specificity, positive predictive value, negative predictive value) for both the modified and predicate devices would typically be presented in the detailed 510(k) submission, but this information is not included in the provided excerpt.

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

The provided text does not explicitly state the sample size used for the test set. It mentions the study compares the modified device to the predicate, implying a test set was used for this comparison.

Regarding data provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. These details would be crucial for a full understanding of the study's design.

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

For a molecular diagnostic test like ID NOW Influenza A & B 2, the "ground truth" is typically established by a highly sensitive and specific reference method, such as RT-PCR (Reverse Transcription Polymerase Chain Reaction), which is considered the gold standard for viral detection. The document does not mention the use of human experts (e.g., radiologists) to establish ground truth because this is a laboratory diagnostic assay, not an imaging device. Therefore, no information is provided on expert qualifications or the number of experts.

4. Adjudication Method for the Test Set

Since the ground truth for molecular diagnostics is typically established by a reference laboratory method (e.g., RT-PCR), an "adjudication method" involving human readers (like 2+1 or 3+1 for imaging studies) is not applicable in this context and is therefore not mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable and therefore not done. MRMC studies are typically used for evaluating diagnostic imaging systems where human interpretation plays a critical role, and the impact of AI assistance on human reader performance is being assessed. The ID NOW Influenza A & B 2 is an automated molecular diagnostic test; human "readers" do not interpret results in the same way as in imaging.

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

Yes, the very nature of this device (an automated molecular diagnostic test) means that the performance is standalone (algorithm only without human-in-the-loop performance). The ID NOW Instrument performs the test, processes the sample, and reports results automatically. The software modification described directly impacts this automated process. The comparison to the predicate device would inherently evaluate the standalone performance of the modified algorithm against the predicate algorithm.

7. The Type of Ground Truth Used

As mentioned in point 3, the ground truth for molecular diagnostic tests like this is almost universally established by a highly sensitive and specific reference laboratory method, typically RT-PCR. While the document does not explicitly state "RT-PCR was used as ground truth," this is the industry standard for validating such devices. "Expert consensus," "pathology," or "outcomes data" are generally not the primary ground truth methods for direct viral detection assays.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is a software modification to an existing, cleared device, implying the original device would have undergone substantial training and validation. For a Special 510(k) focusing on a specific bug fix (false positives in sequential workflow), the emphasis is on a targeted verification and validation of the change, rather than retraining a comprehensive model. If a machine learning model were involved, reporting training set size would be crucial, but the description here suggests a more rule-based or algorithmic adjustment.

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

Since no information on a specific "training set" for the software modification is provided, there is also no information on how the ground truth for such a training set (if it existed) was established.

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Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (1c, HbA1c) in venous and capillary human whole blood. The measurement of % HbA1c is recommended as a marker of longterm metabolic control in persons with diabetes mellitus.

Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ test cartridges is for in vitro diagnostic use only.

Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system.

Alere Afinion™ AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only,

The Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus.

The Afinion™ HbA1c assay is designed to be used with the Afinion™ AS100 Analyzer and the Afinion™ 2 analyzer which are compact multi-assay analyzers for point-of-care testing. Quality control using the Afinion™ HbA1c Control is recommended to confirm that the system is working properly and provides reliable results.

The provided text is a 510(k) premarket notification for a medical device, specifically an in-vitro diagnostic test. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical performance study for an AI/ML-based medical device.

The document discusses analytical performance characteristics but does not present clinical performance data with a test set, ground truth established by experts, or MRMC studies. The core of this submission is about demonstrating equivalence to existing, cleared devices rather than providing novel clinical efficacy data for a new type of device or an AI algorithm.

Therefore, I cannot provide all the requested information for an AI/ML device study. I can extract the analytical performance characteristics that serve as "acceptance criteria" for this IVD and the reported device performance within the scope of this regulatory submission.

Here's an attempt to answer the questions based on the provided document, noting the limitations of the document's content for AI/ML specific criteria:

Device: Afinion™ HbA1c, Afinion™ 2, Alere Afinion™ AS100 Analyzer

The device is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used as a marker for long-term metabolic control in persons with diabetes mellitus. This is a chemical assay, not an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to analytical performance specifications, not clinical performance for an AI/ML algorithm. The document presents a comparison of the "Candidate Device" (Modified Afinion™ HbA1c) with predicate devices, highlighting improvements or more detailed specifications for analytical specificity and interference.

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ID NOW COVID-19 2.0 performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection. ID NOW COVID-19 2.0 performed on the ID NOW Instrument is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection.

Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not preclude co-infection with bacteria or other viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

A negative test result is presumptive, and it is recommended these results be confirmed by another molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Pointof-Care settings.

ID NOW COVID-19 2.0 is a rapid, instrument-based isothermal test for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA in direct nasal or nasopharyngeal swabs. The ID NOW COVID-19 2.0 System utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver single use, disposable containing the elution buffer.
• Test Base single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet.
• Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base
• Patient Swabs sterile anterior nasal swabs (foam) for anterior nasal swab collection and for use as a Negative Control Swab
• Positive Control Swab - single use, to ensure that test reagents are working properly and that the test is correctly performed, and
• ID NOW Instrument

The reaction tubes in the Test Base contain lyophilized reagents required for amplification of the target nucleic acid and an internal control. ID NOW COVID-19 2.outilizes a pair of templates (similar to primers) for the specific amplification of RNA from SARS-CoV-2 and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid targets. ID NOW COVID-19 2.0 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating viral lysis and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW Instrument by the operator either manually or using barcode scanner. Data can be retrieved and downloaded by the operator at any time after testing. An external Universal Printer can be attached via USB to the ID NOW Instrument to print test results.

The provided text describes the performance of the ID NOW COVID-19 2.0 device, which is an in vitro diagnostic test for SARS-CoV-2.

Here's an analysis addressing your questions, keeping in mind that this is a diagnostic test and not an AI-assisted imaging device, so some questions (like MRMC studies) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For diagnostic tests, "acceptance criteria" are typically defined by performance targets for sensitivity (Positive Agreement) and specificity (Negative Agreement). These are assessed against a highly accurate comparator method (Ground Truth).

Acceptance Criteria (Implied by High Performance and Clinical Utility for a Molecular Test) and Reported Device Performance:

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

• Sample Size for Clinical Test Set: 914 specimens (460 anterior nasal swabs and 454 nasopharyngeal swabs).
• Data Provenance:
  • Country of Origin: United States (US). The study was conducted at twenty-one (21) US sites.
  • Retrospective or Prospective: Prospective clinical study. Specimens were collected from individuals showing signs and symptoms of upper respiratory infection at the time of enrollment.

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

This is a diagnostic test based on molecular detection, not an imaging device requiring expert reader interpretation for ground truth.

• Number of "Experts": Not applicable in the context of human readers for establishing ground truth for individual cases. The ground truth was established by a composite comparator method using three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays. This method is considered the "gold standard" for SARS-CoV-2 detection.
• Qualifications of Experts: N/A for individual case ground truth. The RT-PCR assays are performed by laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

The ground truth was established by a composite comparator method using three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays. This implies that the consensus or outcome of these highly sensitive and specific molecular tests served as the ground truth. The document does not describe a human adjudication process, as the ground truth is derived from objective molecular testing results.

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

• Was it done?: No, an MRMC study was not conducted for this device.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: This question is not applicable as the ID NOW COVID-19 2.0 is a standalone molecular diagnostic test, not an AI-assisted diagnostic tool for human readers.

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

• Was it done?: Yes, the clinical performance study evaluated the standalone performance of the ID NOW COVID-19 2.0 device. The results are automatically reported by the ID NOW Instrument (see Device Description), meaning there is no human interpretation of the raw signal or algorithm output before a result is given. Results are "Positive," "Negative," or "Invalid."

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was established using a composite comparator method consisting of three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for the detection of SARS-CoV-2. This is considered a molecular gold standard or definitive diagnostic method.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set" in the context of machine learning model development. This is a traditional IVD device, not an AI/ML diagnostic. The analytical studies (LoD, Inclusivity, Cross-Reactivity, Interference) and clinical study are part of the validation process, not "training" of an AI model.

• Training Set Size: Not applicable/not explicitly stated as this is not an AI/ML device that undergoes a discrete training phase with labeled data in the same way. The development and optimization of the assay itself would involve iterative testing, but this is different from an AI "training set."

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

• How Ground Truth for Training was Established: Not applicable as this is a molecular diagnostic test, not an AI/ML device requiring a distinct training set with established ground truth labels in the typical AI sense. The assay's analytical characteristics and performance are established through experiments and clinical trials.

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The ID NOW™ Influenza A & B 2 assay performed on the ID NOW™ Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2016-2017 influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

ID NOW™ Influenza A & B 2 is a rapid. instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

ID NOW™ Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens.

All ID NOW™ assays utilize isothermal nucleic acid amplification technology and are comprised of:

• Sample Receiver single use, disposable containing the elution buffer
• Test Base single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• . Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base, and
• ID NOW™ Instrument repeat use reader

The reaction tubes in the ID NOW™ Influenza A & B 2 Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. ID NOW™ Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

The reaction tubes in the ID NOW™ Strep A 2 Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. ID NOW™ Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target.

All ID NOW™ assays are performed within the confinement of the Test Base, and no other part of the ID NOW™ Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW™ Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating bacterial lysis (for ID NOW™ Strep A 2) and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the ID NOW™ Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW™ Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Universal Printer can be attached via USB to the ID NOW™ Instrument to print test results.

The document describes the modified software for the ID Now Instrument, encompassing ID NOW Influenza A & B 2 and ID NOW Strep A 2 assays. The modification specifically addresses false invalid results caused by baseline values being lower than allowed by the original algorithm, leading to incorrect identification as "Empty Tube Values." This is an algorithm update only, with no changes made to the chemistry of the assays.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified software address the reduction of false invalid results. The document implies that the "performance" here relates to the analytical performance characteristics of the assays (e.g., sensitivity, specificity) remaining equivalent to the predicate devices despite the software change. While explicit numerical acceptance criteria for reduction in false invalid rate are not provided in this excerpt, the study aims to demonstrate that the new algorithm resolves the "false invalid" issue without compromising the core analytical performance.

For ID NOW™ Influenza A & B 2 (with software modification):

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The ID NOW Influenza A & B 2 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

ID NOW Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

The ID NOW Influenza & B 2 system utilizes isothermal nucleic acid amplification technology and is comprised of:

• Sample Receiver - single use, disposable containing the elution buffer
• . Test Base – single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
• . Transfer Cartridge – single use, disposable for transfer of the eluted sample to the Test Base, and
• ID NOW Instrument – repeat use reader

The reaction tubes in the Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. ID NOW Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

ID NOW Influenza A & B 2 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument and the elution buffer is automatically heated by the instrument. The sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered the ID NOW Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the ID NOW Instrument to print test results.

The provided text describes a 510(k) submission for a software modification to the ID NOW Influenza A & B 2 device. The software modification aims to optimize the recognition of partial/non-dispense of samples and prevent false invalids due to system noise. This submission is a "Special 510(k)" because it's an algorithm update only, with no changes to the assay chemistry. Therefore, the study focuses on demonstrating that the modified device performs equivalently to the predicate device (the previously cleared ID NOW Influenza A & B 2, K190204).

Given the nature of a Special 510(k) for a software update to an existing in vitro diagnostic device, the acceptance criteria and study design will be focused on non-inferiority or equivalence to the predicate device, particularly concerning the impact of the software change on invalid rates and overall performance.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

The document does not explicitly state numerical acceptance criteria in the typical format of sensitivity, specificity, and confidence intervals for a new device's de novo clearance. Instead, the acceptance criteria are implicitly defined by demonstrating that the modified device's performance does not degrade compared to the predicate device for relevant metrics impacted by the software change (false invalids, sensitivity, specificity).

The study described is an equivalence study comparing the performance of the ID NOW Influenza A & B 2 (with the new software) against the predicate ID NOW Influenza A & B 2 (K190204).

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a software modification to optimize existing functionality (reducing false invalids and improving baseline recognition), the acceptance criteria would primarily revolve around demonstrating non-inferiority in terms of invalid rates and clinical performance (sensitivity and specificity) when compared to the predicate device. The document does not provide a table with explicit numerical acceptance criteria and reported device performance of the software modified device compared to the predicate in a clinical study. Instead, it emphasizes that the "modified ID NOW Influenza A & B 2 demonstrated performance that was substantially equivalent to the predicate device."

However, we can infer the intent of the acceptance criteria based on the purpose of the software update:

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

The document mentions that "ID NOW Influenza A & B 2 incorporating the software modification was compared to the legally marketed predicate device." However, it does not specify the sample size used for this comparison or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). For a software update to an existing device, a validation might involve re-testing archived samples or conducting a limited prospective study.

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

For an in vitro diagnostic (IVD) device like this, the "ground truth" for influenza detection is typically established by a reference method, not by human expert interpretation of images or clinical findings in the same way as an imaging AI device. The reference method for influenza detection would commonly be RT-PCR (Reverse Transcription Polymerase Chain Reaction), which is a highly sensitive and specific molecular test. Therefore, the concept of "number of experts" for establishing ground truth isn't applicable in this context.

4. Adjudication Method for the Test Set:

Not applicable in the human expert sense for an IVD device. The ground truth is established by a reference laboratory method (e.g., RT-PCR), and the device's results are compared directly to this objective reference.

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

No, an MRMC study was not done. MRMC studies are typically performed for AI-powered diagnostic imaging devices where human readers interpret medical images. This device is an in vitro diagnostic (IVD) test that automates the detection of viral RNA, and its output is a qualitative result (Influenza A positive/negative, Influenza B positive/negative). There are no "human readers" interpreting the device's output in a way that would require an MRMC study.

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

Yes, a standalone study was done. The ID NOW Influenza A & B 2, both the predicate and the modified version, operates as a standalone diagnostic device. It processes the sample, runs the assay, and automatically reports the result ("Automated" Interpretation, "Qualitative" Assay Result, "13 minutes or less" Time to Result). The software modification itself is an algorithm-only change that affects the internal processing of the instrument without requiring human intervention in the result interpretation beyond reading the displayed result. The comparison to the predicate device evaluates this standalone performance.

7. Type of Ground Truth Used:

The ground truth for an influenza diagnostic test is typically established using a highly sensitive and specific molecular reference method, such as Reverse Transcription Polymerase Chain Reaction (RT-PCR). The text states the device is for "qualitative detection and discrimination of influenza A and B viral RNA," implying the ground truth would be based on the presence or absence of this RNA as determined by a gold-standard molecular test.

8. Sample Size for the Training Set:

The document does not specify the sample size used for the training set. Since this is a software update for an existing algorithm focused on optimizing signal processing and invalid interpretation, the "training" might involve internal testing with various scenarios (e.g., partial dispense, low signal) rather than a large, clinical training set as seen in de novo AI model development. If external data was used for refining the algorithm, its size is not mentioned here.

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

The document does not specify how the ground truth for the training set was established. Analogous to the test set, if a training set were used for algorithm refinement (e.g., to teach the algorithm to detect partial dispenses or filter system noise), the ground truth for those scenarios would likely be established through controlled experiments or by expert review of raw signal data, potentially using a reference method (e.g., RT-PCR) to confirm true positive/negative status in various challenging sample conditions.

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An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in serum.

Acid Phosphatase is an in vitro diagnostic assay for the quantitative determination of total and prostatic acid phosphatase in human scrum. The Acid Phosphatase assay is a clinical chemistry assay in which the acid phospliatase in the sample catalyzes the hydrolysis of alpha-naphthylphosphate liberating the alpha-naphthol and phosphate. The alpha-naphthol is then coupled with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form a diazo dye. The absorbances measured at 412 and 660 nm are directly proportional to the amount of acid phosphatase present in the sample. The addition of I .- Tartrate inhibits prostatic acid phosphatase, but does not inhibit other isocnzymes. The difference between the two protocols (Total Acid Phosphatasc and Non-Prostatic Acid Phosphatase) is the level of prostatic acid phosphatase in the sample.

Acceptance Criteria and Device Performance for ACP (Acid Phosphatase) Assay

Study Proving Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria is a comparative performance study demonstrating substantial equivalence to a legally marketed predicate device.

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

   • Test Set Sample Size: Not explicitly stated. The document refers to "comparative performance studies" and "precision studies conducted using two levels of control material," but the precise number of patient samples or runs for method comparison is not provided.
   • Data Provenance: Not explicitly stated. However, given the context of a 510(k) submission for a clinical chemistry assay in the US, the data would likely be from prospective studies conducted in a laboratory setting for regulatory submission in the United States.

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

   • Not applicable in this context. The "ground truth" for this type of in vitro diagnostic assay typically refers to the results obtained from the predicate device (Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer), which itself is a validated and legally marketed device. Expert human interpretation, as found in imaging or pathology studies, is not the primary method for establishing ground truth in clinical chemistry assays measuring analyte concentrations.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement among experts. In this case, the comparison is made between quantitative measurements of two assays.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance, often with and without AI assistance, which is irrelevant for a quantitative clinical chemistry assay where results are generated by an instrument.

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

   • Yes, this was a standalone performance study in the sense that it evaluates the instrument and reagent system (the ACP assay) itself. There isn't a "human-in-the-loop" component in the direct measurement process of a clinical chemistry assay in the same way there might be for an AI-assisted diagnostic tool for image interpretation. The performance characteristics (correlation, precision, linearity, sensitivity) are intrinsic to the assay system.

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

   • The "ground truth" for comparative studies in clinical chemistry is typically established by the legally marketed predicate device's performance results. In this case, the Trace® Acid Phosphatase Assay on the Hitachi® 717 Analyzer served as the comparator or "gold standard" against which the new ACP assay's performance was measured for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This device is an in vitro diagnostic assay, not an AI/ML algorithm that requires a "training set" to learn from data. The performance characteristics are determined by the chemical reagents and instrument design.

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

   • Not applicable, as there is no "training set" for this type of device.

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The IMx® CA 125™ assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 125 assay values in human serum. The IMx® CA 125M assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

IMx CA 125 is a microparticle enzyme immunoassay on the IMx System for the quantitative measurement of CA 125 assay values in human serum. IMx CA 125 employs Abbott Calibrators and Controls.

Here's a breakdown of the acceptance criteria and study details for the IMx® CA 125™ device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in this document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (ABBOTT CA 125 II™ RIA assay) across several performance metrics. Therefore, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" shows how the new device compares.

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

• Linear Regression Analysis: 493 specimens
• Receiver Operating Characteristic (ROC) Analysis: 130 apparently healthy females + 45 patients with benign gynecologic conditions (control groups) + 197 patients with ovarian cancer (disease group). Total: 372 specimens.
• Concordance Analysis: 130 apparently healthy females, 45 patients with benign gynecologic conditions, 197 patients with ovarian cancer, and 542 total subjects (overlaps with ROC and includes other samples not detailed).
• Serial Tracking Data: 55 patients with ovarian cancer.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the context of a 510(k) submission in the US, it's highly likely to be U.S.-based clinical samples. It is not explicitly stated whether the studies were retrospective or prospective.

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

There is no mention of "experts" being used to establish ground truth for the test set in the same way one might assess imaging data. The ground truth for this diagnostic device is based on established clinical diagnoses (e.g., "apparently healthy females," "patients with benign gynecologic conditions," "patients with ovarian cancer," "clinical status of ovarian cancer patients"). Therefore, experts in establishing ground truth (like radiologists for imaging) are not directly applicable in the terms usually used for device performance. The clinical status of the serial tracking patients would have been determined by treating physicians based on standard clinical practices, but the number and qualifications of these individuals are not specified.

4. Adjudication Method for the Test Set

Not applicable. The ground truth is based on clinical diagnosis or classification of patient groups, not subjective interpretation requiring adjudication of individual results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a blood-based immunoassay, not an AI-assisted diagnostic imaging device or a device involving human "readers" in the context of MRMC studies.

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

Yes, the studies reported are standalone performance of the IMx® CA 125™ assay. It directly measures the CA 125 assay values in human serum and compares these quantitative results to those of the predicate device and relevant clinical categories. There is no explicit human-in-the-loop component discussed for the performance evaluation itself, although the results are intended to aid clinicians.

7. The Type of Ground Truth Used

The ground truth used is primarily clinical diagnosis/classification and clinical status (for monitoring).

• For ROC analysis, ground truth was "apparently healthy," "benign gynecologic conditions," and "ovarian cancer."
• For serial tracking, ground truth was the "clinical status" of ovarian cancer patients.
• For comparisons with the predicate, the predicate device's results serve as a reference point for correlation, slope, and intercept analysis.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. This immunoassay is a chemical detection system, not an AI/ML algorithm that requires training. The 493 specimens used for linear regression and the 372 specimens for ROC analysis are essentially the test set used to demonstrate performance for substantial equivalence.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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Abbott STREP A Controls are qualitative control materials intended for use in test systems to monitor substantial reagent failure and procedural errors. Specifically, Abbott STREP A Controls are intended for use as external controls in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen.

The Abbott STREP A Controls, K965252 is the same as Abbott STREP A Controls, K922490. The controls are intended for use as external controls to monitor substantial reagent failure and procedural errors in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptoccal antigen.

The provided documents describe the clearance of Abbott STREP A Controls (K972182) as external controls for Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen. The primary study presented focuses on demonstrating substantial equivalence to a predicate device (K922490) and establishing the Relative Limit of Detection for the associated Strep A assays.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the Abbott STREP A Controls (K972182):

• TP+SA & TP+SA OBC: 1:1000 dilution of Strep A Stock consistently produced positive results.
• TP+SA OBC II: 1:500 dilution of Strep A Stock consistently produced positive results.
  (Note: This is not an acceptance criterion for the controls themselves, but rather for the assays they are designed to control. The controls are then designed relative to these limits.) |

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

• Positive Controls: Two lots of Strep A positive control were tested. Each positive control lot was tested with three lots of each of the four Abbott Rapid Immunoassays (TPSA, TP+SA, TP+SA OBC, TP+SA OBC II).
• Negative Controls: Four lots of Strep A negative controls were tested with three lots of TestPack Plus Strep A with OBC.
• Relative Limit of Detection Study: Two lots of Strep A Stock were used. For each dilution level, two replicates were assayed on three lots of reaction discs for each of the four assays. This involves multiple individual test runs (2 stock lots * various dilutions * 2 replicates * 3 assay lots * 4 assays).
• Data Provenance: The documents do not explicitly state the country of origin. Given the Abbott Laboratories address provided (Abbott Park, IL, USA) and the submission to the FDA, it is highly likely the study was conducted in the United States. The studies appear to be prospective in nature, designed specifically to demonstrate the performance of the controls and the assays.

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

Not applicable for this type of device and study. The "ground truth" for these tests is based on the known composition of the positive (containing Strep A antigen) and negative (not containing Strep A antigen) controls, and the established reactivity of the assays to known concentrations of Strep A. The results were "visually read at EOA [End of Assay]" but no mention of expert consensus or qualifications for reading these specific assays is provided, as they are likely standard visual interpretations based on product instructions.

4. Adjudication Method for the Test Set

Not applicable. The results were "visually read at EOA for all assays." There's no mention of a complex adjudication process as the readings are expected to be straightforward positive or negative interpretations, confirming the presence or absence of a visual signal.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a diagnostic control material, not an AI-assisted diagnostic tool.

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

Not applicable. The "device" in question is a control material. The assays it controls still involve a human reading the visual results.

7. The Type of Ground Truth Used

The ground truth used is based on the known concentration and presence/absence of Group A Strep antigen in the prepared Strep A Stock dilutions and the positive/negative control materials. The Strep A Stock itself is defined as a "suspension of phenol-killed Strep A organisms." Thus, it's essentially a reference standard/known concentration approach.

8. The Sample Size for the Training Set

Not applicable in the conventional sense for an AI/algorithm. This device is a control material, and the studies performed are for its validation and the determination of the Relative Limit of Detection of the associated assays. There is no "training set" for an algorithm.

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

Not applicable, as there is no "training set" for an algorithm. The "ground truth" for the performance studies (as described in point 7) was established by the precise formulation of the Strep A Stock and control materials with known concentrations or presence/absence of Strep A antigen.

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