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

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

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The cobas® liat Bordetella panel nucleic acid test (cobas® liat Bordetella panel) is an automated real-time polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of Bordetella pertussis (Bp), Bordetella parapertussis (Bpp), and Bordetella holmesii (Bh) nucleic acid in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.

The test is meant to be used in conjunction with other clinical and epidemiological information and laboratory findings. When clinical factors suggest that B. pertussis, B. parapertussis or B. holmesii may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results do not preclude Bp, Bpp, or Bh infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out co-infection with other bacteria or viruses. The agent detected may not be the definite cause of disease.

The cobas® liat Bordetella panel nucleic acid test (cobas® liat Bordetella panel) is an automated multiplex real-time polymerase chain reaction (PCR) assay for the rapid in vitro qualitative detection and differentiation of B. pertussis (Bp), B. parapertussis (Bpp), and B. holmesii (Bh) DNA in human nasopharyngeal swabs taken from patients with suspected pertussis respiratory infection.

The different fluorescent dye designs enable the specific detection and differentiation of the three microorganisms (Bp, Bpp, and Bh) independently in a multiplex system. The system automates all nucleic acid amplification test sample processing steps, including inhibitor removal, nucleic acid extraction, purification, amplification, real-time detection, and result interpretation in a rapid manner. The test is designed for use in near-patient settings to deliver results in approximately 15 minutes.

The cobas® liat system is comprised of the cobas® liat analyzer (analyzer) hardware with integrated cobas® liat system software (analyzer software + liat assay specific package (script)) for running tests and analyzing the results, and a single-use disposable cobas® liat assay tube (assay tube).

• cobas® liat analyzer is a system component that consists of one software subsystem and three hardware units:

  • Infrastructure unit, which consists of the hardware and embedded software (firmware).
  • Thermal, loading and motion unit: the processing module that interacts physically with the assay tube during the assay execution.
  • Detection unit consisting of the photodetectors that is used for the fluorescence detection during the PCR reaction

• The assay script provides a set of instructions to the analyzer hardware and software for assay tube processing, PCR, result calculation and interpretation and result reporting. The assay script can be installed on the analyzer independently of the analyzer software.

The cobas® liat Bordetella panel nucleic acid test is supported with a Liat Assay Specific Package (Assay Script): cobas® liat Bordetella panel LASP (BPTA).

• The assay tube holds all reagents needed for sample preparation and PCR processes. The assay specific reagents are packaged into a single assay tube in separate segments that are separated by frangible seals. An internal control (IC) is also included. The IC is present to control for adequate processing of the target bacteria through all steps of the assay process and to monitor the presence of inhibitors in the PCR reaction.

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The Status COVID-19/Flu A&B test is a lateral flow immunoassay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from nasopharyngeal (NP) or anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions.

Positive results do not rule out bacterial infection or co-infection with other viruses.

The Status™ COVID-19/Flu A&B test is a lateral flow immuno-chromatographic assay which utilizes the chemical extraction of viral antigens followed by solid-phase immunoassay technology. The Status™ COVID-19/Flu A&B test is designed to detect antigens from SARS-CoV-2, influenza A, and/or influenza B in nasopharyngeal or anterior nasal swab specimens from individuals with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B viral infections. The Status™ COVID-19/Flu A&B test is validated for use with direct specimens without transport media.

In the test procedure, a nasopharyngeal or anterior nasal swab specimen is collected and placed into extraction reagent in the Extraction Well of the test device for one minute. During this time, the antigen is extracted from disrupted virus particles. The test device is then raised, tapped, and laid back down onto a level surface. Through this simple action, the solution of extracted specimen flows onto the test strip and migrates through the pads and membrane of the test strip. The pads contain detector antibodies conjugated to gold dye and the membrane contains immobilized capture antibodies. If SARS-CoV-2, influenza A, and/or influenza B antigens are present in the specimen, they will react with anti-SARS-CoV-2 antibody coupled to gold dye particles and/or anti-influenza antibody coupled to gold dye particles, migrate through the membrane as antigen-antibody-dye complexes, bind to the immobilized capture antibody line(s) on the membrane, and generate a colored line in the specific test line position. The rest of the sample and unbound/bound dye complexes continue to migrate to the Control line position (Ctrl), where immobilized antibodies to the anti-SARS-CoV-2 and anti-influenza antibodies capture the dye complexes and form the Control line. Formation of the Control line serves as an internal control to demonstrate that test reagents are functional, antibody-dye conjugates in the dye pad have been hydrated and released and that sufficient sample has been applied to allow for migration through the Test and Control lines. If the Control line does not appear within the designated incubation time, the result is invalid, and the test should be repeated using a new test device and specimen.

Status™ COVID-19/Flu A&B test has three Test lines, one for SARS-CoV-2 (CoV19), one for influenza A (Flu A), and one for influenza B (Flu B). The three Test lines allow for the differential identification of SARS-CoV-2, influenza A, and/or B from a single specimen. If any Test line appears in the test result window, together with the Control line, the test result is positive for SARS-CoV-2 and/or influenza. The test detects, but does not differentiate, between the SARS-CoV and SARS-CoV-2 viruses.

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The WELLlife COVID-19 Antigen Test Rx is a visually read lateral flow immunoassay test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection. 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 WELLlife COVID-19 Antigen Test Rx and followed with a molecular test.

A negative test result 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 respiratory pathogens and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Performance characteristics for SARS-CoV-2 were established from April 2023 to February 2024 when SARS-CoV-2 Omicron was dominant. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

The WELLlife COVID-19 Antigen Test Rx is a lateral flow immunoassay intended for qualitative detection of nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first five (5) days of symptom onset. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with two lines: a test line (T line) and a control line (C line). The device is for in vitro diagnostic use only. The device is for prescription use only.

The WELLlife COVID-19 Antigen Test Rx consists of the following components:

• Test Cassette
• Tube (pre-filled extraction buffer)
• Swab
• Tube Holder
• Quick Reference Instructions (QRI)
• Instructions for Use (IFU)

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The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with Chlamydia trachomatis and Neisseria gonorrhoeae in males.

The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully automated, rapid, compact device that contains PCR assays for qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA in male urine samples from symptomatic or asymptomatic individuals. The device automatically performs all steps required to complete lysis, PCR amplification, and detection.

The Visby Medical Men's Sexual Health Test is designed to be simple to use. When combined with a user-provided urine collection cup and a Visby power adapter accessory, the test contains all the materials required to perform the test. The patient collects a first catch urine sample in a standard urine collection cup (not provided). The operator starts the test by using a provided fixed-volume disposable transfer pipette to transfer ~ 450 µL of urine from the collection cup into a dropper tube containing ~900 µL of Visby Medical Men's Sexual Health Buffer. The operator transfers the entire volume (~1.35 mL) of the sample (urine in buffer) into the sample port of the device by squeezing the dropper tube to release all of the sample into the device sample port. The operator then slides a purple switch on the front of the device to both close the sample port and initiate the fully automated testing process. At this point, blinking white lights on the front of the device indicate the test is in progress. Test results are available in just under 30 minutes at which time a green "READY" status light will appear at the bottom of the device, and a purple color will appear in the "RESULTS VALID" spot, indicating a valid test. A purple spot adjacent to "CHLAMYDIA" and/or "GONORRHEA" signifies the presence of amplified CT and/or NG DNA in the sample.

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The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini is an automated multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE SPOTFIRE System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) or anterior nasal swab (ANS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19; (Respiratory menu) or in throat swab (TS) specimens from individuals with signs and symptoms of pharyngitis; (Sore Throat menu).

The following analytes are identified and differentiated using the BIOFIRE SPOTFIRE R/ST Panel Mini:

Respiratory Menu
Viruses

• Coronavirus SARS-CoV-2
• Human rhinovirus
• Influenza A virus
• Influenza B virus
• Respiratory syncytial virus

Sore Throat Menu
Viruses

• Human rhinovirus
• Influenza A virus
• Influenza B virus
• Respiratory syncytial virus

Bacteria

• Streptococcus pyogenes (group A Strep)

Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS/ANS/TS specimens during the acute phase of infection. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of respiratory infection and/or pharyngitis is indicative of the presence of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Negative results in the setting of a respiratory illness and/or pharyngitis may be due to infection with pathogens that are not detected by this test, or a respiratory tract infection that may not be detected by an NPS, ANS, or TS specimen. Positive results do not rule out co-infection with other organisms. The agent(s) detected by the BIOFIRE SPOTFIRE R/ST Panel Mini may not be the definite cause of disease.

Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection and/or pharyngitis.

The BIOFIRE SPOTFIRE R/ST Panel Mini (SPOTFIRE R/ST Panel Mini) simultaneously identifies 5 different respiratory viral pathogens in nasopharyngeal swabs (NPS) or anterior nasal swabs (ANS), or 5 different viral and bacterial pharyngitis pathogens in throat swabs (TS) from individuals with signs and symptoms of respiratory tract infections or pharyngitis, respectively, (see Table 1). The SPOTFIRE R/ST Panel Mini is compatible with the BIOFIRE® SPOTFIRE® System, a polymerase chain reaction (PCR)-based in vitro diagnostic system for infectious disease testing. The BIOFIRE SPOTFIRE System Software executes the SPOTFIRE R/ST Panel Mini test and interprets and reports the test results. The SPOTFIRE R/ST Panel Mini was designed to be used in CLIA-waived environments.

A test is initiated by loading Hydration Solution into the hydration solution injection port of the SPOTFIRE R/ST Panel Mini pouch and NPS, ANS, or TS specimen, mixed with the provided Sample Buffer, into the other sample injection port of the SPOTFIRE R/ST Panel Mini pouch and placing it in the SPOTFIRE System. The pouch contains all the reagents required for specimen testing and analysis in a freeze-dried format; the addition of Hydration Solution and Sample/Buffer Mix rehydrates the reagents. After the pouch is prepared, the SPOTFIRE System Software guides the user through the steps of placing the pouch into the instrument, scanning the pouch barcode, entering the sample identification, and initiating the run.

Nucleic acid extraction occurs within the SPOTFIRE R/ST Panel Mini pouch using mechanical and chemical lysis followed by purification using standard magnetic bead technology. After extracting and purifying nucleic acids from the unprocessed sample, the SPOTFIRE System performs a nested multiplex PCR that is executed in two stages. During the first stage, the SPOTFIRE System performs a single, large volume, highly multiplexed reverse transcription PCR (rt-PCR) reaction. The products from first stage PCR are then diluted and combined with a fresh, primer-free master mix and a fluorescent double-stranded DNA binding dye (LC Green® Plus, BioFire Diagnostics). The solution is then distributed to each well of the array. Array wells contain sets of primers designed specifically to amplify sequences internal to the PCR products generated during the first stage PCR reaction. The 2nd stage PCR, or nested PCR, is performed in singleplex fashion in each well of the array. At the conclusion of the 2nd stage PCR, the array is interrogated by melt curve analysis for the detection of signature amplicons denoting the presence of specific targets. A digital camera placed in front of the 2nd stage PCR captures fluorescent images of the PCR reactions and software interprets the data.

The SPOTFIRE System Software automatically interprets the results of each DNA melt curve analysis and combines the data with the results of the internal pouch controls to provide a test result for each organism on the SPOTFIRE R/ST Panel Mini.

The FDA 510(k) clearance letter details the acceptance criteria and study that proves the BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini meets these criteria, specifically for the addition of Anterior Nasal Swabs (ANS) as a sample type for the Respiratory Menu.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics (Positive Percent Agreement - PPA and Negative Percent Agreement - NPA) in the clinical study. The device is deemed to meet these criteria if the lower bound of the 95% Confidence Interval (95% CI) for PPA and NPA is above acceptable thresholds (though specific numerical thresholds for "acceptable" are not explicitly stated as separate criteria, the observed high performance and clearance imply they were met).

Archived Specimen Performance for Influenza B virus:

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

• Test Set Sample Size:
  • Clinical Performance (Prospective Study): 797 specimens (out of 820 initially enrolled, 23 excluded).
  • Archived Specimen Testing: 241 specimens for Influenza B virus (35 positive, 206 negative).
• Data Provenance:
  • Country of Origin: US (prospective multi-center study at five geographically distinct urgent care or emergency department study sites).
  • Retrospective/Prospective: The study was primarily prospective, conducted from March 2024 to February 2025. This was supplemented with archived specimens for Influenza B due to low prevalence in the prospective study.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It states that the performance was evaluated by comparing the test results with those from a "commercially available FDA-cleared multiplexed respiratory pathogen panel." This suggests that the ground truth was established by the results of this comparator method, which themselves would have been validated. No human expert interpretation of the comparator method is described.

4. Adjudication Method for the Test Set

The document mentions "Investigations of discrepant results are summarized in the footnotes." These footnotes indicate that for discrepant cases (e.g., false positives, false negatives), "additional molecular methods" were used to re-test the specimens. This implies a form of post-hoc adjudication using a more definitive or orthogonal molecular method to resolve discrepancies between the SPOTFIRE R/ST Panel Mini and the initial comparator.

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

No. This study is for a diagnostic PCR test, not an AI-assisted imaging or interpretation device. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not applicable.

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

Yes. The study evaluates the performance of the BIOFIRE SPOTFIRE R/ST Panel Mini as a standalone diagnostic device. The results are automatically interpreted and reported by the system software, with no human interpretation step in the primary analysis flow. The study compares the device's output directly to the comparator method.

7. The Type of Ground Truth Used

The primary ground truth was established by a commercially available FDA-cleared multiplexed respiratory pathogen panel. For discrepant results, "additional molecular methods" were used for confirmatory testing, indicating a molecular gold standard approach.

8. The Sample Size for the Training Set

The document does not provide details about a training set size. This notice is a 510(k) clearance for a PCR-based in vitro diagnostic test, not a machine learning or AI algorithm in the traditional sense that requires distinct training and test sets in the same manner. The "test set" described is the clinical validation cohort for demonstrating performance. PCR assays are generally developed and optimized through laboratory analytical studies, not typically "trained" on large datasets in the way an AI model would be.

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

As noted above, the concept of a "training set ground truth" is not applicable in this context, as the device is a PCR assay. The development and optimization of such assays involve different molecular and analytical validation processes to ensure specificity and sensitivity.

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The Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions.

Positive results do not rule out bacterial infection or co-infection with other viruses.

The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens.

The assay kit consists of 25 test cassette devices, 25 reagent tubes, 25 ampules containing extraction buffer, 25 anterior nasal specimen collection swabs, one positive control swab, one negative control swab, one Instructions for Use, and one Quick Reference Instruction. An external positive control swab contains noninfectious influenza A, influenza B, and SARS-CoV-2 antigens dried onto the swab and an external negative control swab contains noninfectious blank universal viral transport media dried on the swab. The kit should be stored at 2°C - 30°C.

Device Acceptance Criteria and Performance Study: Nano-Check Influenza+COVID-19 Dual Test

The Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay for the qualitative detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens in anterior nasal swab samples. The device's acceptance criteria and performance were established through extensive analytical and clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

The following table summarizes the key acceptance criteria and the performance achieved by the Nano-Check Influenza+COVID-19 Dual Test based on the provided 510(k) summary. Given that this is a qualitative assay, the primary performance metrics are Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) in clinical studies, and various measures of agreement/detection rates in analytical studies.

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

• Clinical Study Test Set Sample Size: A total of 1,969 subjects were enrolled in the clinical study.
• Data Provenance: The data was collected from a multi-center, prospective clinical study in the U.S. between November 2022 and February 2025.

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

The device being reviewed is an in vitro diagnostic (IVD) test for antigen detection. For such devices, the "ground truth" in clinical performance studies is typically established by a highly sensitive and specific molecular assay (RT-PCR), rather than by human experts interpreting images or signals from the test device itself.

• In this case, the ground truth for the clinical test set was established using an FDA-cleared RT-PCR method as the comparator.
• The document does not specify the number of experts directly involved in establishing the RT-PCR ground truth or their qualifications beyond stating it was performed at a "reference laboratory as per the cleared instruction for use." This implies that qualified laboratory personnel, adhering to standardized RT-PCR protocols, established the ground truth.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology reads) where discrepancies between readers need to be resolved. Since the Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunoassay interpreted visually by an operator, and the ground truth was established by an RT-PCR molecular assay, no explicit adjudication method for the test set is described or implied in the provided text. The comparison was directly between the device's visual results and the RT-PCR results.

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

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is generally conducted for imaging AI devices to evaluate the impact of AI assistance on human reader performance. The Nano-Check Influenza+COVID-19 Dual Test is an in vitro diagnostic device for antigen detection, not an imaging AI device where human readers interpret complex images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device.

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

Yes, the performance presented for the Nano-Check Influenza+COVID-19 Dual Test in the clinical study is essentially standalone performance in the context of a rapid diagnostic test. While the test is visually interpreted by an operator, the performance metrics (PPA and NPA) are derived from the direct output of the device compared to the RT-PCR reference. There is no complex "algorithm" separate from the physical test strips' chemical reaction and visual readout. The operator simply reads the result displayed by the device. The "human-in-the-loop" here is the visual interpretation of a clear positive/negative line, not a complex decision-making process aided by AI.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical performance study was an FDA-cleared molecular assay (RT-PCR method). This is a highly sensitive and specific laboratory-based test considered the gold standard for detecting viral nucleic acids, making it appropriate for establishing true positive and true negative cases of infection.

8. The Sample Size for the Training Set

The provided document describes the performance data for the test set (clinical study and analytical validation). It does not specify a separate training set sample size. This is expected because the Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunoassay, not a machine learning or AI model that requires a distinct training phase with a labeled dataset. The development and optimization of such assays rely on biochemical and immunological principles, followed by rigorous analytical and clinical validation.

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

As noted above, there isn't a "training set" in the machine learning sense for this type of IVD device. The development of the assay (e.g., selecting antibodies, optimizing reagents) would involve internal R&D studies, using characterized viral samples and clinical specimens, but these are part of the development process rather than a formal "training set" with ground truth establishment for an AI algorithm. The performance data presented is from the validation against established reference methods.

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The BD Veritor™ System for SARS-CoV-2 is a chromatographic digital immunoassay for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory 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 BD Veritor™ System for SARS-CoV-2 and followed up with a molecular test.

A negative test result 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.

Performance characteristics for SARS-CoV-2 were established between April 2024 and August 2024 when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

The BD Veritor™ System for SARS-CoV-2 is a rapid (approximately 15 minutes) chromatographic digital immunoassay for the direct detection of the presence or absence of SARS-CoV-2 antigens in anterior nasal swab specimens taken from patients with signs and symptoms of upper respiratory infection (i.e., symptomatic) who are suspected of COVID-19 by their healthcare provider. The test is intended for use with an opto-electronic interpretation instrument, the BD Veritor™ Plus Analyzer Instrument and is not interpreted visually.

• When specimens are processed and added to the test device, SARS‑CoV‑2 antigens present in the specimen bind to biotinylated antibodies and antibodies conjugated to detector particles in the test strip.
• The biotinylated antibody‑antigen‑conjugate complexes migrate across the test strip to the reaction area and are captured by a line of streptavidin bound on the membrane.
• A positive result is determined by the BD Veritor™ Plus Analyzer when antigen‑conjugate is deposited at the Test "T" position and a control conjugate is deposited at the Control "C" position on the assay device.
• The instrument analyzes and corrects for non‑specific binding and detects positives not recognized by the unaided eye to provide an objective result.

Procedures to evaluate test devices depend on the BD Veritor™ Plus Analyzer workflow configuration chosen. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Additionally, connection of a BD Veritor™ Plus Analyzer to a printer or IT system is possible if desired. Additional result documentation capabilities are possible with the integration of a BD Veritor™ barcode scanning enabled module.

The Analyzer uses a proprietary algorithm that subtracts the nonspecific signal at the negative control line from the signal present at the test line. If the resultant test line signal is above a preselected cutoff, the specimen is scored as positive. If the resultant test line signal is below or equal to the cutoff, the specimen is scored as negative. Use of the active negative control feature allows the BD Veritor™ Plus Analyzer to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal. The Analyzer measures the amount of light reflected from various zones along the assay strip. The measurement of the assay background zone is an important factor during the test interpretation as the reflectance value is compared to that of the control and test zones.

The provided FDA 510(k) clearance letter and summary describe the BD Veritor System for SARS-CoV-2. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. However, based on the clinical study results and FDA clearance, the implicit acceptance criteria for clinical performance are related to the confidence intervals for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). The reported device performance is presented below:

Note: The document does not explicitly state numerical acceptance thresholds for PPA and NPA (e.g., "PPA must be > 80%"). Therefore, the "Implicit Acceptance Criteria" are inferred from the demonstrated performance and the fact that the device received clearance. The FDA typically evaluates these metrics within acceptable ranges for diagnostic tests.

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

• Sample Size for Test Set: 1,032 direct anterior nasal swabs.
• Data Provenance: The samples were prospectively collected from individual symptomatic patients across 15 geographically diverse areas across the United States between April and August 2024.

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

The document does not specify the number of experts used to establish the ground truth. The ground truth was established by an FDA-cleared SARS-CoV-2 RT-PCR test. For the false positive/negative re-testing, it broadly states "a second RT-PCR method," implying multiple tests might have been performed to confirm results without specifying expert involvement in interpreting these specific results beyond the RT-PCR outcome itself.

4. Adjudication Method for the Test Set

The primary ground truth for the clinical study was established by an FDA-cleared SARS-CoV-2 RT-PCR test without explicit mention of expert adjudication for every case. However, there was a form of adjudication for discordant results:

• False Positive Adjudication: The three BD Veritor System for SARS-CoV-2 false positive results were retested with a second RT-PCR method and were confirmed negative. This suggests a method where initial discrepancies against the reference method were independently verified.
• False Negative Adjudication: The 23 BD Veritor System for SARS-CoV-2 false negative results were retested with a second RT-PCR method in which 14 were confirmed positive and 9 were negative.

This indicates a process of re-testing or confirmation for discordant results, which serves as a form of adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance (or similar comparative effectiveness of human readers with vs. without the device) was not explicitly mentioned or described in the provided document. The BD Veritor System for SARS-CoV-2 uses an instrument (BD Veritor™ Plus Analyzer) for interpretation, replacing visual interpretation with an automated read. The comparison is between the device's performance and a reference RT-PCR, not between human readers with and without assistance from the device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The entire clinical performance study (Table 9 and 11) is a standalone study, as it evaluates the performance of the BD Veritor System for SARS-CoV-2 (algorithm/device only) compared to a reference RT-PCR without human interpretation of the lateral flow assay itself. The BD Veritor™ Plus Analyzer instrument is explicitly stated to read and interpret the results, and the device "is not interpreted visually."

7. Type of Ground Truth Used

The ground truth used for the clinical study was an FDA-cleared SARS-CoV-2 RT-PCR test (molecular test results).

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This submission is for a device, and the analytical and clinical studies described are for validation of the device's performance, not for developing or training an AI/ML algorithm in the context of a typical AI/ML development pipeline. The device uses a "proprietary algorithm" for signal subtraction and interpretation, but it's not presented as a machine learning model that requires a distinct training set in the typical sense.

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

Since no specific training set and its ground truth establishment are discussed in the context of AI/ML model training, this information is not applicable/provided based on the document. The "proprietary algorithm" for the instrument is described in terms of processing reflectance data and applying a preselected cutoff, and its development process (including any data used for internal calibration or parameter setting) is not detailed here.

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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

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 SQA-iOw Sperm Quality Analyzer is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen:

Measured parameters:

• Sperm Concentration/ Total Sperm Concentration, millions/mL
• Motile Sperm Concentration (MSC), millions/mL
• Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL)
• Normal Forms (% Normal Morphology), %

Derived parameters:

• Total Motility / Total Motile (PR + NP), %
• Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %)
• Non-Progressive (NP), %
• Immotile (IM), %

The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only.

The SQA-iOw Sperm Quality Analyzer is a PC-based analytical medical device that tests human semen samples. The device works with a computer application that manages the device, and information related to the patient, the sample, the test results and the facility.

After collection and preparation, 0.6 mL of semen sample is aspirated into a disposable SQA capillary sample delivery system and inserted into the SQA-iOw measurement chamber. The testing process takes approximately 75 seconds. The system performs an automatic self-test and auto-calibration upon start up, and checks device stability before each sample is run.

The SQA-iOw Sperm Quality Analyzer utilizes proprietary software code to both perform analysis of semen parameters and present those results on the user interface. This software is installed on a PC as a cloud-based application ("app") and is designed to perform all functions and features of the SQA-iO device, controlled by the user through a proprietary graphical user interface (GUI).

The SQA-iOw Sperm Quality Analyzer software analyzes semen parameters using signal processing technology. Sample testing is performed by capturing electrical signals as sperm moves through a light source in the SQA-iO optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iOw software. The SQA-iOw software applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters.

The SQA-iOw Sperm Quality Analyzer package provides the SQA-iOw device and USB cable. SQA disposable capillaries, cleaning kits and related testing supplies and test kits are supplied individually.

Here's a breakdown of the acceptance criteria and the study proving the SQA-iOw Sperm Quality Analyzer meets them, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not explicitly list predefined quantitative acceptance criteria in a dedicated table format. Instead, it describes two precision studies and a method comparison study, concluding that the results "met the acceptance criteria." For the method comparison, it refers to "Passing-Bablok regression" with "Slopes, y-intercepts, and correlation coefficients, along with the 95% confidence intervals, were reported." The implicit acceptance criteria are typically that these statistical measures fall within a pre-specified range demonstrating equivalence to the predicate device.

Given the information provided, we can infer the acceptance criteria for the parameters measured and the reported performance.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • CLIA Waived User Precision Study (Control Material): 270 measurements in total (3 sites x 9 users (3 per site) over 3 days per site x 3 levels x 10 replicates of each level).
  • CLIA Waived User Precision Study (Native Samples): 216 measurements total (9 native semen samples x 2 replicates per sample x 3 users/site x 4 time points).
  • Method Comparison Study: 380 donor semen samples.
• Data Provenance (Country of Origin and Retrospective/Prospective):
  • The Method Comparison Study was conducted across "Three U.S. sites."
  • The Precision studies were also multi-site, with the control material study having "3 sites". The native sample precision study was "across two sites."
  • The data appears to be prospectively collected for the purpose of these studies, as detailed study designs are provided, including number of sites, users, days, replicates, and samples. The samples used in the method comparison were "donor semen samples."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts:
  • For the Method Comparison Study, there were "One or more TRAINED OPERATORS per site" (3 sites) who generated reference SQA-V results.
• Qualifications of Experts:
  • The experts (TRAINED OPERATORS) were described as "fully trained and considered appropriate for generating reference SQA-V results." Their specific professional qualifications (e.g., medical technologists, clinical lab scientists) or years of experience are not explicitly stated.

4. Adjudication Method for the Test Set

• The document implies that the ground truth for the method comparison study was established by the "TRAINED OPERATORS" using the predicate device (SQA-V). There is no mention of an adjudication process (e.g., 2+1, 3+1 consensus) among multiple experts to establish a "true" ground truth beyond the output of the predicate device operated by trained users. The samples were assayed "in singleton and in a blinded fashion" using both methods, suggesting a direct comparison rather than multi-reader adjudication.

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

• No explicit MRMC comparative effectiveness study was described in terms of human readers improving with AI vs. without AI assistance. The study compares the performance of a new device (SQA-iOw operated by waived users) against a predicate device (SQA-V operated by trained users). It's a method comparison for an automated device, not an AI-assisted human reader study.

6. Standalone (Algorithm Only) Performance

• The SQA-iOw is described as an "automated analyzer" that "utilizes proprietary software code to both perform analysis of semen parameters" and "applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters." The performance measurements detailed (precision studies and method comparison) represent the standalone performance of the device/algorithm in processing samples and generating results for the specified semen parameters. There is no human-in-the-loop component in the measurement process itself.

7. Type of Ground Truth Used

• The ground truth for the Method Comparison Study was established using the results from the predicate device (SQA-V) operated by trained users. This serves as a "reference standard" or "comparative method" rather than an absolute ground truth such as pathology or outcomes data.
• For the Precision Studies, the ground truth is statistical variability around the mean measurements of control materials and native samples.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set for the SQA-iOw's algorithms. The studies described are validation (test set) studies, not algorithm development or training data descriptions.

9. How Ground Truth for Training Set was Established

• The document does not provide information on how the ground truth for the training set was established, as it focuses on the validation studies. It only mentions that the device "applies proprietary algorithms" but not how these algorithms were developed or trained.

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