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510(k) Data Aggregation
(177 days)
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(179 days)
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(179 days)
The LIAISON NES FLU A/B, RSV & COVID-19 assay is a real-time RT-PCR assay intended for use on the LIAISON NES instrument for the simultaneous in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A) virus, influenza B (Flu B) virus, and respiratory syncytial virus (RSV) in anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B, and RSV can be similar.
The LIAISON NES FLU A/B, RSV & COVID-19 assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and RSV infections when used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, influenza B, and RSV viral RNA are generally detectable in anterior nasal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections.
Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent(s) detected by the LIAISON NES FLU A/B, RSV & COVID-19 assay may not be the definite cause of the disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B or RSV infection and should not be used as the sole basis for patient management decisions.
The LIAISON NES Instrument (NES1001) is capable of analysis of a single cartridge containing a single specimen. A set of parameters specific to the assay is included in the instrument software to name target molecules, assign dyes to probes, specify cycling conditions, and to analyze data from runs. Fluorescence intensity is monitored at each PCR cycle by detection modules within the instrument. The instrument software controls the thermocycling and, upon completion of the run, automatically interprets and displays results for the specimen.
The LIAISON NES Instrument is comprised of the following:
- Touchscreen User Interface
- Status LED Indicator
- Audio Speaker
- Barcode Scanner
The LIAISON NES software is a graphical user interface (GUI) application that is the end-user interface to the LIAISON NES Instrument. The software is installed in an embedded computer. The LIAISON NES software is responsible for providing the environment in which a user runs assays and obtains results.
The LIAISON NES instrument is intended to accept a cartridge, containing either a quality control (QC) or patient sample, to process and detect for the target nucleic acid.
The LIAISON NES FLU A/B, RSV & COVID-19 assay used on the LIAISON NES instrument is a real-time RT-PCR system that enables the direct amplification, detection, and differentiation of influenza A viral RNA, influenza B viral RNA, RSV RNA, and SARS-CoV-2 RNA directly from nasal swabs. Nasal swabs can be professionally collected by a healthcare provider or self-collected under the healthcare provider's supervision.
The LIAISON NES FLU A/B, RSV & COVID-19 assay consists of the LIAISON NES instrument, the LIAISON NES FLU A/B, RSV & COVID-19 Cartridge containing all the required PCR reagents, the NES Sample Vial containing sample release buffer, and the NES Swab for sample collection.
In the LIAISON NES FLU A/B, RSV & COVID-19 assay, fluorescent probes are used with corresponding forward and reverse primers to amplify influenza A, influenza B, RSV, and SARS-CoV-2, and internal control (IC) RNA. Conserved regions of influenza A viral RNA, influenza B viral RNA, RSV RNA, and SARS-CoV-2 RNA are targeted to identify the viruses in the specimen, while the internal control (IC) RNA is used to detect any PCR failures and/or inhibition.
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(177 days)
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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(350 days)
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).
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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
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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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(179 days)
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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(180 days)
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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(139 days)
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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(272 days)
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).
| SPOTFIRE R/ST Panel Mini R Menu Analyte | Performance Metric | Reported Performance (Prospective Study) |
|---|---|---|
| Coronavirus SARS-CoV-2 | Positive Percent Agreement (PPA) | 96.2% (95% CI: 87.0-98.9%) |
| Negative Percent Agreement (NPA) | 99.6% (95% CI: 98.8-99.9%) | |
| Human rhinovirus | Positive Percent Agreement (PPA) | 95.7% (95% CI: 92.2-97.6%) |
| Negative Percent Agreement (NPA) | 95.0% (95% CI: 92.9-96.5%) | |
| Influenza A virus | Positive Percent Agreement (PPA) | 94.3% (95% CI: 84.6-98.1%) |
| Negative Percent Agreement (NPA) | 100% (95% CI: 99.5-100%) | |
| Influenza B virus | Positive Percent Agreement (PPA) | 100% (95% CI: 77.2-100%) |
| Negative Percent Agreement (NPA) | 100% (95% CI: 99.5-100%) | |
| Respiratory syncytial virus | Positive Percent Agreement (PPA) | 95.0% (95% CI: 83.5-98.6%) |
| Negative Percent Agreement (NPA) | 99.9% (95% CI: 99.3-100%) |
Archived Specimen Performance for Influenza B virus:
| Analyte | Performance Metric | Reported Performance (Archived Study) |
|---|---|---|
| Influenza B virus | Positive Percent Agreement (PPA) | 100% (95% CI: 90.1-100%) |
| Negative Percent Agreement (NPA) | 100% (95% CI: 98.2-100%) |
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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(211 days)
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.
| Performance Metric Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| CLINICAL PERFORMANCE | ||
| SARS-CoV-2 | PPA ≥ 80% (typical for antigen tests), NPA ≥ 95% | PPA: 87.6% (95% CI: 83.0% - 91.0%)NPA: 99.8% (95% CI: 99.5% - 99.9%) |
| Influenza A | PPA ≥ 80%, NPA ≥ 95% | PPA: 86.9% (95% CI: 83.6% - 89.6%)NPA: 99.6% (95% CI: 99.1% - 99.8%) |
| Influenza B | PPA ≥ 80%, NPA ≥ 95% | PPA: 86.8% (95% CI: 79.4% - 91.9%)NPA: 99.7% (95% CI: 99.4% - 99.9%) |
| ANALYTICAL PERFORMANCE | ||
| Precision (Within-Lab) | 100% agreement for TN, HN, LP, MP levels across runs/operators | 100% agreement for all levels (SARS-CoV-2, Flu A, Flu B) per operator per run. |
| Precision (Between-Lot) | Consistent results across lots, especially for moderate and high positives | For C90 levels, agreement ranged from 83.3% to 100%. For 3X LOD levels, 100% agreement. |
| Reproducibility (Multi-site, Multi-operator) | High agreement across sites and operators for all sample types (TN, HN, LP, MP) | TN: 100%HN COVID: 100%HN Flu A: 100%HN Flu B: 99.4%LP COVID: 100%LP Flu A: 99.4%LP Flu B: 100%MP COVID: 100%MP Flu A: 100%MP Flu B: 100% |
| Cross-Reactivity/Microbial Interference | No cross-reactivity/interference at tested concentrations | No cross-reactivity/interference observed with 50 pathogens (bacteria, fungi, viruses) and negative matrix. |
| Endogenous/Exogenous Interference | No interference with common substances at tested concentrations | No interference observed with various nasal sprays, pain relievers, hand sanitizers, and other biological substances (except Hand sanitizer lotion, which caused false negative Influenza B when tested at 15% w/v). |
| Limit of Detection (LoD) | Specific LoD values per virus strain | SARS-CoV-2: 1.95×10² TCID₅₀/mL to 1.27×10⁴ TCID₅₀/mL (strain dependent)Influenza A: 2.8×10³ TCID₅₀/mL to 1.4×10⁵ CEID₅₀/mL (strain dependent)Influenza B: 1.04×10² TCID₅₀/mL to 2.25×10⁵ CEID₅₀/mL (strain dependent)WHO Standard SARS-CoV-2: 667 IU/mL |
| Analytical Reactivity (Inclusivity) | 100% detection for various strains at specified concentrations | 100% detection (3/3 replicates) for 14 SARS-CoV-2, 31 Flu A, and 16 Flu B strains at specified concentrations. |
| High Dose Hook Effect | No false negatives at high concentrations | No high-dose hook effect observed for all tested viruses at concentrations up to 3.89×10⁴ TCID₅₀/mL (SARS-CoV-2), 2.8×10⁸ CEID₅₀/mL (Flu A), and 1.8×10⁷ TCID₅₀/mL (Flu B). |
| Competitive Interference | No interference between targets in co-infection scenarios | No competitive interference observed between SARS-CoV-2, Influenza A, and Influenza B at high/low titer combinations. |
| Specimen Stability | Stable results for specified storage conditions/times | Nasal swab samples stable for up to 48 hours at -20°C, 2-8°C, 23.5°C, and 30°C. |
| External Controls | 100% agreement with expected results for positive/negative controls | 100% agreement for all three lots of positive and negative external controls. |
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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