FINDER Flu A&B/SARS-CoV-2 Test

K252269 · Baebies, Inc. · QOF · Mar 30, 2026 · Microbiology

Device Facts

• Record ID: K252269
• Device Name: FINDER Flu A&B/SARS-CoV-2 Test
• Applicant: Baebies, Inc.
• Product Code: QOF · Microbiology
• Decision Date: Mar 30, 2026
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 866.3981
• Device Class: Class 2

Indications for Use

The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test performed on the FINDER instrument and is intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B viral nucleic acid in nasopharyngeal swab (NPS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar. The FINDER Flu A&B/SARS-CoV-2 Test is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in NPS specimens during the acute phase of infection. Positive results do not rule out co-infection with other organisms. The agent(s) detected by the FINDER Flu A&B/SARS-CoV-2 Test may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Device Story

The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR assay performed on the FINDER instrument. It utilizes a single-use test cartridge containing all necessary reagents. The system employs electrowetting-based digital microfluidics to automate sample preparation, including lysis, nucleic acid precipitation onto paramagnetic beads, washing, and elution. The eluate is split into two droplets for parallel amplification and detection of SARS-CoV-2 and influenza A/B targets, with RPP30 as an internal control. The instrument performs thermal cycling and multicolor fluorescence detection. Results are generated in approximately 20 minutes. The device is intended for use in clinical settings (e.g., urgent care, outpatient clinics) by trained operators. The software automatically calculates cycle threshold (Ct) values to report qualitative results. The test aids in differential diagnosis by providing rapid detection of viral nucleic acids, supporting clinical decision-making when combined with patient history and epidemiological data.

Clinical Evidence

Prospective clinical study of 559 NPS specimens across six US CLIA-waived sites. Performance compared to an FDA-cleared RT-PCR assay. After excluding invalid results, 527 evaluable specimens were analyzed. Positive Percent Agreement (PPA) was 97.6% (SARS-CoV-2), 95.4% (Flu A), and 96.0% (Flu B). Negative Percent Agreement (NPA) was 99.8% (SARS-CoV-2), 97.2% (Flu A), and 99.4% (Flu B).

Technological Characteristics

Automated, multiplexed, real-time RT-PCR system. Uses electrowetting-based digital microfluidics for sample preparation and reagent handling. Employs paramagnetic beads for solid-phase nucleic acid extraction. Features multicolor fluorescence detection. Instrument includes thermal control, touch-screen interface, and integrated software. Single-use test cartridge format. Operates on AC power. Software performs automated Ct calculation and result reporting.

Indications for Use

Indicated for individuals with signs and symptoms of respiratory tract infection to qualitatively detect and differentiate SARS-CoV-2, influenza A, and influenza B viral nucleic acid in nasopharyngeal swab (NPS) specimens.

Regulatory Classification

Identification

A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes and targets the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device. (3) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens; (ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies including the following, as applicable: Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, precision, reproducibility, and clinical studies; (iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing; (iv) A warning statement that viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety ( *e.g.,* BSL 3 and BSL 3+, etc.) is available to receive and culture specimens; and(v) A prominent statement that device performance has not been established for specimens collected from individuals not identified in the intended use population ( *e.g.,* when applicable, that device performance has not been established in individuals without signs or symptoms of respiratory infection).(vi) Limiting statements that indicate that: (A) A negative test result does not preclude the possibility of infection; (B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician; (C) There is a risk of incorrect results due to the presence of nucleic acid sequence variants in the targeted pathogens; (D) That positive and negative predictive values are highly dependent on prevalence; (E) Accurate results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and (F) When applicable ( *e.g.,* recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed literature), that the clinical performance may be affected by testing a specific clinical subpopulation or for a specific claimed specimen type.(4) Design verification and validation must include: (i) Detailed documentation, including performance results, from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, as appropriate, additional characterized clinical samples. The clinical study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses. (ii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as Failure Modes Effects Analysis and/or Hazard Analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains ( *e.g.,* regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request. Results that are reasonably interpreted to support the conclusion that novel respiratory pathogen strains or isolates impact the stated expected performance of the device must be sent to FDA immediately.(iii) A detailed description of the identity, phylogenetic relationship, and other recognized characterization of the respiratory pathogen(s) that the device is designed to detect. In addition, detailed documentation describing how to interpret the device results and other measures that might be needed for a laboratory diagnosis of respiratory infection. (iv) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device ( *e.g.,* saturation level of hybridization and maximum amplification and detection cycle number, etc.), internal and external controls, and computational path from collected raw data to reported result (*e.g.,* how collected raw signals are converted into a reported signal and result), as applicable.(v) A detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review. (vi) For devices intended for the detection and identification of microbial agents for which an FDA recommended reference panel is available, design verification and validation must include the performance results of an analytical study testing the FDA recommended reference panel of characterized samples. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses. (vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens, the design verification and validation must include a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses. (5) When applicable, performance results of the analytical study testing the FDA recommended reference panel described in paragraph (b)(4)(vi) of this section must be included in the device's labeling under § 809.10(b) of this chapter. (6) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens in addition to detection of SARS-CoV-2 and similar microbial agents, the required labeling under § 809.10(b) of this chapter must include the following: (i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation. (ii) Where applicable, a warning statement that reads if infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to State or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. (iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required followup actions or retesting in the case of an unusual or unexpected device result. (iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated ( *i.e.,* H1-2009 and H3), this result requires notification of appropriate local, State, or Federal public health authorities to determine necessary measures for verification and to further determine whether the specimen represents a novel strain of Influenza A.(7) If one of the actions listed at section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain: (i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those influenza viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. (ii) Within 60 days from the date that FDA notifies manufacturers that characterized influenza viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by: (A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or (B) In a section of the device's label or in other labeling that accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's website, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the website containing this information and must allow unrestricted viewing access.

Predicate Devices

• Simplexa COVID-19 & Flu A/B Direct (K220963)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K252269

B Applicant

Baebies Inc

C Proprietary and Established Names

FINDER Flu A&B/SARS-CoV-2 Test

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QOF | Class II | 21 CFR 866.3981 - Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The SARS-Cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-Target Test | MI - Microbiology |

## II Submission/Device Overview:

### A Purpose for Submission:

The purpose of this submission is to show that the FINDER Flu A&B/SARS-CoV-2 Test on the FINDER Instrument is substantially equivalent to the DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct (K220963) and to obtain clearance for the FINDER Flu A&B/SARS-CoV-2 Test.

### B Measurand:

- Influenza A RNA

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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Influenza B RNA
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA

## C Type of Test:
Qualitative reverse transcriptase polymerase chain reaction (RT-PCR)

## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for Use:
The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test performed on the FINDER instrument and is intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B viral nucleic acid in nasopharyngeal swab (NPS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.

The FINDER Flu A&B/SARS-CoV-2 Test is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in NPS specimens during the acute phase of infection.

Positive results do not rule out co-infection with other organisms. The agent(s) detected by the FINDER Flu A&B/SARS-CoV-2 Test may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
For In Vitro Diagnostic Use Only

### D Special Instrument Requirements:
For use with the FINDER Instrument.

## IV Device/System Characteristics:

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# A Device Description:

The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test intended for the qualitative detection of viral RNA of influenza A, influenza B, and SARS-CoV-2 viruses in NPS samples collected from individuals with signs and symptoms of respiratory tract infection.

The FINDER Flu A&B/SARS-CoV-2 Test is performed using a single-use test cartridge that contains all the reagents necessary to perform the test. The cartridge uses electrowetting-based digital microfluidics to integrate and automate all the sample and reagent handling steps required to perform the multiplexed, real-time RT-PCR test. The time to result is approximately 20 minutes from sample introduction.

The FINDER Flu A&B/SARS-CoV-2 Test is run on the FINDER Instrument. The instrument is supplied with all the hardware and software required for the electrowetting control, thermal control, and multicolor fluorescence detection capabilities that are needed to perform the test. The instrument also features a touch-screen user interface and the software application that performs the test and reports the results.

# B Principle of Operation:

The FINDER Flu A&B/SARS-CoV-2 Test is performed on the FINDER instrument. NPS samples are collected in a sample collection media (FINDER RVP Buffer) provided by Baebies. To perform a test, the operator inserts the test cartridge into the instrument, follows the onscreen instructions to setup a test and then loads a 200μL sample using the provided exact-volume transfer pipette.

The instrument automatically performs all sample preparation steps once the sample is introduced on the test cartridge. The sample is lysed in a chaotropic (guanidine) lysis reagent in the FINDER RVP Buffer and is further lysed using proteinase K on the cartridge. Paramagnetic beads and a binding buffer (with ethyl alcohol) are added to the lysed sample to precipitate the nucleic acid onto the beads. The beads are then washed and eluted in a buffer.

The eluate is split into two droplets. One droplet is mixed with reagents to amplify and detect SARS-CoV-2 nucleic acid. The second droplet is mixed with reagents to amplify and detect influenza A and influenza B nucleic acid. An internal control (RPP30) is also amplified and detected in each droplet to verify that the test system is working as expected and that sufficient specimen was added.

Reverse transcription (RT) is performed on both droplets. This is followed by Polymerase Chain Reaction (PCR) by shuttling the droplets between the annealing zone and the denaturing zone on the cartridge. Reactions are performed in parallel on both droplets under the two multicolor detectors. The fluorescence is measured at each cycle and the cycle threshold (Ct) is automatically calculated for each target using software algorithms. Within droplets, multiple target reactions produce fluorescence at different wavelengths, allowing analysis of multiple viral targets in parallel.

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After the test is complete, the software computes test results which are then displayed to the user and optionally printed.

## C Instrument Description Information:

1. **Instrument Name:**
FINDER Instrument
2. **Specimen Identification:**
Specimen identification is either entered manually or via barcode
3. **Specimen Sampling and Handling:**
Nasopharyngeal swab collected in FINDER RVP Buffer
4. **Calibration:**
Not applicable
5. **Quality Control:**

### Internal Controls

The FINDER Flu A&B/SARS-CoV-2 Test includes an internal control, which utilizes primers and probes for the human RPP30 gene. Amplification of the RPP30 control indicates that adequate sample collection and the reaction steps were completed successfully on the cartridge.

### External Controls

External Positive and Negative controls are packaged and sold separately from the assay kit. The positive control contains non-infectious intact viral particles representative of multiple pathogens included in the respiratory panel (e.g., influenza A, influenza B, SARS-CoV-2 viruses) dried on a swab. The negative control contains human A-549 cells dried on a swab and is free from target nucleic acids. External controls may be performed to conform with internal Quality Control procedures, or with local, state, or federal regulations. The external controls were evaluated in the analytical, clinical, and flex studies.

## V Substantial Equivalence Information:

### A Predicate Device Name(s):

Simplexa COVID-19 & Flu A/B Direct

### B Predicate 510(k) Number(s):

K220963

### C Comparison with Predicate(s):

| Device & Predicate Device(s): | K252269 | K220963 |
| --- | --- | --- |
| Device Trade Name | FINDER Flu A&B/SARS-CoV-2 | Simplexa COVID-19 & Flu A/B Direct |

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| General Device Characteristic Similarities | Test | |
| --- | --- | --- |
| Intended Use/Indications For Use | The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test performed on the FINDER instrument and is intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B viral nucleic acid in nasopharyngeal swab (NPS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.

The FINDER Flu A&B/SARS-CoV-2 Test is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are | The DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct is a real-time RT-PCR assay intended for use on the LIAISON MDX instrument for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus in nasopharyngeal swabs (NPS) from individuals with signs and symptoms of respiratory tract infection. The Simplexa COVID-19 & Flu A/B Direct assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A and influenza B infection. Negative results do not preclude SARS-CoV-2, influenza A or influenza B infection and should not be used as the sole basis for patient management decisions. Positive results do not rule out coinfections with other organisms. Results should be combined with clinical observations, patient history, and epidemiological information. The |

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| | generally detectable in NPS specimens during the acute phase of infection.
Positive results do not rule out co-infection with other organisms. The agent(s) detected by the FINDER Flu A&B/SARS-CoV-2 Test may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. | Simplexa COVID-19 & Flu A/B Direct assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. |
| --- | --- | --- |
| Specimen Type | Same | Nasopharyngeal swab |
| Target Pathogens | Same | Influenza A, Influenza B, SARSCoV-2 |
| Assay Results | Same | Qualitative |
| General Device Characteristic Differences | | |
| Instrumentation | FINDER Instrument | LIAISON MDX |
| Time to Result | Approximately 20 minutes | Approximately 90 minutes |
| Sample Preparation | Uses magnetic-bead based solid-phase extraction chemistry for sample preparation | Extraction free chemistry |

VI Standards/Guidance Documents Referenced:

- Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION
- Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements. IEC 61326-1 Edition 3.0 2020-10

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- Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical electrical equipment. IEC 61326-2-6 Edition 3.0 2020-10
- Medical devices – Application of risk management to medical devices. ISO 14971 Third Edition 2019-12
- Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. ISO 15223-1 Fourth Edition 2021-07
- Evaluation of Precision of Quality Measurement Procedures; Approved Guideline – Third Edition. CLSI EP05-A3 (Reaffirmed: September 2019)
- Evaluation of Stability of In Vitro Medical Laboratory Test Reagents. CLSI EP25 2nd Edition.

## VII Performance Characteristics (if/when applicable):

## A Analytical Performance:

### 1. Precision/Reproducibility:

#### Precision

Within-laboratory precision of the FINDER Flu A&B/SARS-CoV-2 Test was evaluated at a single site using a panel of three samples: a positive sample co-spiked with viral materials at 2x Limit of Detection (LoD), a positive sample co-spiked with viral materials at 5x LoD, and a negative sample. Specimens were prepared in pooled negative NPS media collected in FINDER RVP Buffer. The study was conducted with two operators over the course of 12 non-consecutive days. Two replicates of each panel member were tested in two sessions per testing day, for a total of 96 replicates of each sample (1 site x 2 operators x 12 days x 2 sessions per day x 2 replicates per session). Three cartridge lots were used during the study. Results are summarized in Tables 1-2. All moderate positive (5x LoD) runs were 100% positive for all three assay targets. All low positive (2x LoD) runs were ≥99% positive for all three assay targets. One false positive result for SARS-CoV-2 was observed. The results of the study demonstrate acceptable test variability.

Table 1: Precision Study Results

| Panel Member | Target | Strain | N Positive/N Valid Tested | % Agreement with Expected Results (95% CI) |
| --- | --- | --- | --- | --- |
| Negative | Influenza A | NA | 0/96 | 100.0% (96.2%-100.0%) |
| | Influenza B | NA | 0/96 | 100.0% (96.2%-100.0%) |
| | SARS-COV-2 | NA | 1/96 | 99.0% (94.3%-99.8%) |
| Low Positive (2x LoD) | Influenza A | H3N2/A/Switzerland/9715293/13 | 95/96 | 99.0% (94.3%-99.8%) |
| | Influenza B | B/Brisbane/33/08 | 95/96 | 99.0% (94.3%-99.8%) |
| | SARS-COV-2 | USA/MD-HP24556/2022 | 96/96 | 100.0% (96.2%-100.0%) |
| | Influenza A | H3N2/A/Switzerland/9715293/13 | 96/96 | 100.0% (96.2%-100.0%) |

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Table 2: Precision Study – Ct Analysis Results

| Panel Member | Target | n | Mean Ct | Repeatability | | Between Instruments | | Between Days | | Between Lots | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Low Positive (2x LoD) | Influenza A | 95 | 29.7 | 1.74 | 5.9 | 0.16 | 0.5 | 0.35 | 1.2 | 0.43 | 1.4 | 1.83 | 6.2 |
| | Influenza B | 95 | 28.5 | 1.64 | 5.7 | 0.53 | 1.9 | 0.38 | 1.3 | 0.00 | 0.0 | 1.76 | 6.2 |
| | SARS-COV-2 | 96 | 30.5 | 0.89 | 2.9 | 0.00 | 0.0 | 0.10 | 0.3 | 0.19 | 0.6 | 0.92 | 3.0 |
| Moderate Positive (5x LoD) | Influenza A | 96 | 27.9 | 1.15 | 4.1 | 0.28 | 1.0 | 0.00 | 0.0 | 0.32 | 1.1 | 1.23 | 4.4 |
| | Influenza B | 96 | 27.6 | 1.20 | 4.4 | 0.25 | 0.9 | 0.00 | 0.0 | 0.00 | 0.0 | 1.23 | 4.5 |
| | SARS-COV-2 | 96 | 28.9 | 1.05 | 3.6 | 0.14 | 0.5 | 0.00 | 0.0 | 0.34 | 1.2 | 1.11 | 3.8 |

SD = standard deviation; CV(%) = percent coefficient of variation.; n = total number of samples

## Reproducibility

Assay reproducibility of the FINDER Flu A&B/SARS-CoV-2 Test was evaluated at three US sites using one negative and two positive panel members with one lot of assay reagents and three instruments. Each site tested over five days with two operators, and three replicates for each panel for a total of 90 replicates per panel member. Three instruments at each site were used. A negative panel member was created using pooled negative NPS media (negative NPS specimens collected in FINDER RVP Buffer). Positive panel members were created by spiking inactivated (SARS-CoV-2) and live viral targets at low positive (2x LoD) concentrations and moderate positive (5x LoD) concentrations into pooled negative NPS media. Results are summarized in Table 3 – 4. All low positive (2x LoD) and all moderate positive (5x LoD) sample runs were positive for all assay targets (100% positive agreement). All negative sample runs were negative for all targets (100% negative agreement). The results of the study demonstrate acceptable test reproducibility.

Table 3: Reproducibility Study Results

| Analyte | Panel Description | % Agreement with Expected Results (n Agreement/N Valid Tested) (95% CI) | | | |
| --- | --- | --- | --- | --- | --- |
| | | Site 1 | Site 2 | Site 3 | Overall |
| Influenza A (H3N2/A/Switzerland/9715293/13) | Moderate Positive (5x LoD) | 100% (30/30) (88.7-100.0) | 100% (30/30) (88.7-100.0) | 100% (30/30) (88.7-100.0) | 100% (90/90) (95.9-100.0) |
| | Low Positive (2x LoD) | 100% (30/30) | 100% (30/30) | 100% (30/30) | 100% (90/90) |

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Table 4: Reproducibility Study - Ct Analysis Results

| Panel Member | Target | n | Mean Ct | Repeatability | | Between Users | | Between Days | | Between Sites | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Low Positive (2x LoD) | Influenza A | 90 | 29.2 | 0.997 | 3.4 | 0.119 | 0.4 | 0.000 | 0.0 | 0.221 | 0.8 | 1.029 | 3.5 |
| | Influenza B | 90 | 28.1 | 0.844 | 3.0 | 0.000 | 0.0 | 0.000 | 0.0 | 0.000 | 0.0 | 0.844 | 3.0 |
| | SARS-COV-2 | 90 | 30.0 | 0.501 | 1.7 | 0.464 | 1.5 | 0.190 | 0.6 | 0.249 | 0.8 | 0.751 | 2.5 |
| Moderate Positive (5x LoD) | Influenza A | 90 | 27.5 | 1.786 | 6.5 | 0.797 | 2.9 | 0.000 | 0.0 | 0.547 | 2.0 | 2.031 | 7.4 |
| | Influenza B | 90 | 27.4 | 0.929 | 3.4 | 0.000 | 0.0 | 0.000 | 0.0 | 0.357 | 1.3 | 0.996 | 3.6 |
| | SARS-COV-2 | 90 | 28.5 | 0.572 | 2.0 | 0.473 | 1.7 | 0.130 | 0.5 | 0.496 | 1.7 | 0.902 | 3.2 |

$\mathrm{SD} =$ standard deviation; $\mathrm{CV}(\%) =$ percent coefficient of variation.; $\mathrm{n} =$ total number of samples

2. Linearity:

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Not applicable.

# 3. Analytical Specificity/Interference:

# Wet Testing

This study was performed to determine the analytical reactivity of the FINDER Flu A&B/SARS-CoV-2 Test with clinically relevant strains of influenza A, influenza B, and SARS-CoV-2 virus. Samples were created by spiking viral strains at concentrations of 3x LoD in pooled negative NPS samples collected in FINDER RVP Buffer. Samples that were not detected in all replicates were tested at higher concentrations, increasing by a factor of 3x until all three replicates were detected. Results from the lowest concentration that achieved $100\%$ detection are shown in Table 5 below. The results from this study demonstrate that the FINDER Flu A&B/SARS-CoV-2 Test is capable of detecting multiple strains of influenza A, influenza B and SARS-CoV-2 virus at the concentrations tested.

Table 5: Inclusivity Wet Testing Results

| Analyte | Subtype | Strain/Isolate Name | Test Concentration (TCID50/mL) |
| --- | --- | --- | --- |
| Influenza A | H1N1 | A/New Caledonia/20/1999 | 2.01 |
| | | A/New Jersey/8/76 | 18.09 (CEID50/mL) |
| | | Brisbane/59/2007 | 2.01 |
| | | Pdm Netherlands/2629/2009 | 2.01 |
| | | pdm NY/01/09 | 2.01 |
| | | Solomon Islands/03/06 | 2.01 |
| | | pdm Victoria/2570/19 | 2.01 |
| | | Michigan/45/15 | 2.01 |
| | | Guangdong-Maonan/SWL1536/19 | 6.03 |
| | | Taiwan/42/06 | 6.03 |
| | | pdm California/07/09 | 2.01 |
| | | pdm Mexico/4108/09 | 54.27 |
| | | Singapore/63/04 | 54.27 |
| | H3N2 | Wisconsin/67/2005 | 9.072 |
| | | Brisbane/10/2007 | 9.072 |
| | | Victoria/3/1975 | 27.216 (CEID50/mL) |
| | | Victoria/361/2011 | 9.072 |
| | | A/Port Chalmers/1/73 | 9.072 (CEID50/mL) |
| | | Texas/50/2012 | 9.072 |
| | | Kansas/14/17 | 9.072 |
| | | Hong Kong/2671/19 | 9.072 |
| | | Singapore/INFIMH-16-0019/16 | 9.072 |
| | | Darwin/6/21 | 9.072 |
| | | Perth/16/09 | 9.072 |
| | | South Australia/55/14 | 9.072 |
| | | Stockholm/6/14 | 9.072 |
| H5N1a | A/white-tailed eagle/Japan/OU-1/2022 | 5400 (cp/mL) | |
| H7N9a | A/Shanghai/4664T/2013 | 59000 (cp/mL) | |
| Influenza B | Victoria | B/Hong Kong/5/72 | 109.35 (CEID50/mL) |
| | | 2506/Malaysia/2004 | 0.15 |
| | | 1/Ohio/2005 | 109.35 (CEID50/mL) |
| | | Alabama/2/17 | 0.45 |
| | | Colorado/06/17 | 0.15 |
| | | Austria/1359417/21 | 0.15 |
| | | B/New York/1056/2003 | 1.35 |

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| | Yamagata | Florida/07/04 | 0.45 |
| --- | --- | --- | --- |
| | | Florida/04/06 | 0.45 |
| | | Wisconsin/1/10 | 0.45 |
| | | Massachusetts/2/12 | 1.35 |
| | | Utah/9/14 | 1.45 |
| SARS-CoV-2 | A | Hong Kong/VM20001061/2020 | 0.1125 |
| | A | USA-WA1/2020 | 1.0125 |
| | GISAID Clade O | Italy-INMI1 | 3.0375 |
| | B.1 | USA/NY-Wadsworth-103677-01/2020 | 0.1125 |
| | Beta B.1.351 | South_Africa/KRISP-K005325/2020 | 0.1125 |
| | Delta B.1.617.2 | USA/PHC658/2021 | 0.3375 |
| | Zeta P.2 | NY-Wadsworth-21006055-01/2021 | 0.3375 |
| | Iota B.1.526 | NY-Wadsworth-21018781-01/2021 | 1.0125 |
| | Omicron XBB | USA/CA-Stanford-109_S21/2022 | 1.0125 |
| | Gamma P.1 | Japan/TY7-503/2021 | 0.1125 |
| | Kappa B.1.617.1 | USA/CA-Stanford-15_S02/2021 | 0.3375 |
| | Omicron BQ.1.1 | USA/MD-HP38861/2022 | 0.1125 |

$\mathrm{CEID}_{50} / \mathrm{mL} =$ median chicken embryo infectious dose/mL; $\mathrm{cp} / \mathrm{mL} =$ copies/mL
a Synthetic RNA

# In Silico Assessment

Inclusivity of the FINDER Flu A&B/SARS-CoV-2 Test was also evaluated using in-silico analysis of the assay primer and probes with sequences available in GISAID and NCBI databases. SARS-CoV-2 primer and probes were evaluated against 5,740,183 SARS-CoV-2 genomes in the GISAID database submitted between November 2019 and June 2024 and 100,101 SARS-CoV-2 genomes in the NCBI database submitted between July 2024 and May 2025. Results of the in-silico analysis predict that the FINDER Flu A&B/SARS-CoV-2 Test will detect greater than $99.9\%$ of SARS-CoV-2 variants.

# Cross Reactivity/Microbial Interference

This study evaluated the cross-reactivity and microbial interference for the FINDER Flu A&B/SARS-CoV-2 Test in the presence of related pathogens, high prevalence disease agents, and normal or pathogenic flora reasonably likely to be present in a clinical NPS sample. A total of 35 pools of microorganisms were tested, microorganisms were added to pooled clinical negative NPS matrix in FINDER RVP Buffer, for final concentrations of $10^{5}$ units/mL for viruses and fungi, $10^{6}$ units/mL for bacteria, and $10\%$ v/v of pooled human nasal wash. To evaluate cross-reactivity, each panel member was evaluated in triplicate in the absence of the target organism. To evaluate microbial interference, each panel was tested in triplicate in the presence of 3x LoD of each test analyte. The organisms evaluated are shown below in Table 6. No cross-reactivity or microbial interference was observed at the concentrations tested.

Table 6: Organisms Evaluated in Cross-Reactivity and Microbial Interference Study by Wet-Testing

| Viruses | Concentration1 | Bacteria/Fungi | Concentration1 |
| --- | --- | --- | --- |
| Adenovirus type 1 | 1x105TCID50/mL | Aspergillus flavus | 1x106CFU/mL |
| Adenovirus type 7 | 1x105TCID50/mL | Bordetella parapertussis | 1x106CFU/mL |
| Adenovirus type 4 | 1x105TCID50/mL | Bordetella pertussis | 1x106CFU/mL |
| Cytomegalovirus | 4.21x104TCID50/mLa | Chlamydia pneumoniae | 1x106CFU/mL |

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| Herpes Simplex Virus Type 1 | 1x105TCID50/mL | Corynebacterium amycolatum | 1x106CFU/mL |
| --- | --- | --- | --- |
| Varicella Zoster Virus | 1x105cp/mLb | Escherichia coli | 1x106CFU/mL |
| Epstein Barr Virus | 1x105cp/mLb | Fusobacterium necrophorum | 1x106CFU/mL |
| Enterovirus (Coxsackie) | 1x105TCID50/mL | Haemophilus influenzae | 1x106CFU/mL |
| Enterovirus (echovirus) | 1x105TCID50/mL | Lactobacillus ORIS | 1x106CFU/mL |
| Parainfluenza virus 1 | 1x105TCID50/mL | Legionella pneumophila | 1x106CFU/mL |
| Parainfluenza virus 2 | 1x105TCID50/mL | Moraxella catarrhalis | 1x106CFU/mL |
| Parainfluenza virus 3 | 1x105TCID50/mL | Mycobacterium tuberculosis avirulent | 1x104CFU/mLd |
| Parainfluenza virus 4 | 1x105TCID50/mL | Mycoplasma pneumoniae | 1x106CFU/mL |
| Human coronavirus HKU1 | 1x106cp/mL | Mycoplasma genitalium | 1.85x105CFU/mLa |
| Human coronavirus 229E | 4.17x104TCID50/mLa | Neisseria meningitides | 1x106CFU/mL |
| Human coronavirus OC43 | 4.17x104TCID50/mLa | Neisseria cinerea | 1x106CFU/mL |
| Human coronavirus NL63 | 3.55x104TCID50/mLa | Pneumocystis jirovecii (PJP) | 1x106CFU/mL |
| Mumps | 1x105TCID50/mL | Pseudomonas aeruginosa | 1x106CFU/mL |
| Measles | 1x105TCID50/mL | Staphylococcus aureus | 1x106CFU/mL |
| Human Metapneumovirus A1 | 1.41x104TCID50/mLa | Staphylococcus epidermidis | 1x106CFU/mL |
| Human Metapneumovirus A2 | 3.55x104TCID50/mLa | Streptococcus pneumoniae | 1x106CFU/mL |
| Rhinovirus Type 1A | 1.41x104TCID50/mLa | Streptococcus pyogenes | 1x106CFU/mL |
| SARS-coronavirus2 | 1x104cp/mLd | Streptococcus salivaris | 1x106CFU/mL |
| MERS-coronavirus | 1x104TCID50/mL | Candida albicans | 1x106CFU/mL |
| Respiratory Syncytial Virus | 1x105TCID50/mL | Pooled human nasal wash | 10% v/v |
| Human genomic DNA | 3.71x106cp/mLc | | |

TCID50 = Median Tissue Culture Infectious Dose; cp/mL = copies/mL
a The concentrations of some components were reduced to the values shown in the table to maintain a $\geq 90\%$ concentration of matrix.
b Varicella Zoster Virus and Epstein Barr Virus were inadvertently tested at $1\mathrm{x}10^{5}$ cp/mL rather than $1\mathrm{x}10^{6}$ cp/mL.
Human genomic DNA was inadvertently tested at $3.71 \times 10^{6} \mathrm{cp/mL}$ rather than the intended $10^{4} \mathrm{cp/mL}$ .
d Mycobacterium tuberculosis avirulent and SARS-CoV-1 were inadvertently tested at $1 \times 10^{4} \mathrm{cp/mL}$ rather than the intended $1 \times 10^{6} \mathrm{cp/mL}$ .

# Interfering Substances

This study evaluated the performance of the FINDER Flu A&B/SARS-CoV-2 Test in the presence of potentially interfering endogenous and exogenous substances that may be commonly found in a NPS sample. The assay was evaluated with potentially interfering substances in the presence and absence of the target analyte. For analyte negative samples, potential interfering substances were added to pooled clinical negative NPS matrix in FINDER RVP Buffer. For analyte positive samples, potentially interfering substances were spiked into analyte positive samples at concentrations of $3\mathrm{x}$ LoD. All samples were tested in triplicate. The concentration of each substance tested can be found in Table 8. Interference was found at the initial testing concentration for the following substances: Zicam,

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Budesonide, Nasacort, Fluticasone, and Nasonex. Testing with these substances were repeated at a lower concentration until 100% detection was obtained.

Table 8: Interfering Substance and Concentrations Tested

| Potentially Interfering Substance Category | Substance/Active Ingredient | Concentration Tested with No Interference |
| --- | --- | --- |
| Biologicals | Mucin | 5 mg/ml |
| | Whole Blood (capillary) | 2% (v/v) |
| | Leukocytes (Human Buffy Coat) | 1% (v/v) |
| Nasal spray/drops | Oxymetazoline (Afrin) | 5% (v/v) |
| | Saline nasal spray | 10% (v/v) |
| | Phenylephrine (1%) | 10% (v/v) |
| | Zinc (Zinc Acetate Dihydrate) | 1 mg/mL |
| Nasal gel | Luffa opperculata, sulfur (Zicam) | 2.5% (v/v)* |
| Throat lozenge | Benzocaine Menthol (Cepacol) | 5% (v/v) |
| Antiviral drugs | Zanamivir | 5 mg/mL |
| | Oseltamivir | 7.5 mg/mL |
| Antimicrobial, systemic | Tobramycin | 4 ug/mL |
| Antibiotic nasal ointment | Mupirocin | 5 mg/mL |
| Nasal corticosteroids | Beclomethasone | 2 mg/mL |
| | Dexamethasone | 1.5 mg/mL |
| | Flunisolide | 2 mg/mL |
| | Budesonide, 32 mcg/spray | 0.5% (v/v)* |
| | Triamcinolone (Nasacort) | 0.63% (v/v)* |
| | Fluticasone | 1.25% (v/v)* |
| | Mometasone (Nasonex) | 1.25% (v/v)* |
| Homeopathic allergy relief | Histaminum hydrochloricum | 10 mg/mL |
| Solvent controls | DMSO | 10% (v/v) |
| | Ethanol | 10% (v/v) |
| | 0.1N NaOH | 10% (v/v) |

* Interference was observed in these substances. The highest concentration at which no interference was observed is presented in this table.

## Competitive Interference

The purpose of this study was to evaluate potential competitive interference between target analytes of the FINDER Flu A&B/SARS-CoV-2 Test. Six panels were used for this study, each consisting of one analyte at low concentrations (3x LoD) and one analyte at high concentrations of 1×10⁵ TCID₅₀/mL added to pooled negative NPS matrix in FINDER RVP Buffer. Each panel was tested in replicates of three. The viral strains used to prepare the panels and the results of the study are shown in Table 9 and Table 10. No competitive interference was observed for all analytes prepared at 3x LoD.

Table 9: Viral Strains and Concentrations Used in the Competitive Interference Study

| Viral Target | Level | Strains Tested | Concentration Tested (TCID₅₀/mL) |
| --- | --- | --- | --- |
| SARS-CoV-2 | Low | USA/MD-HP24556/2022 | 0.113 TCID₅₀/mL |
| | High | USA/CA-Stanford-109_S21/2022 | 1×10⁵ TCID₅₀/mL |
| Influenza A | Low | A/Switzerland/9715293/13 | 9.072 TCID₅₀/mL |
| | High | A/Switzerland/9715293/13 | 1×10⁵ TCID₅₀/mL |
| Influenza B | Low | B/Brisbane/33/08 | 0.150 TCID₅₀/mL |
| | High | B/New York/1056/2003 | 1×10⁵ TCID₅₀/mL |

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Table 10: Competitive Interference of the FINDER Flu A&B/SARS-CoV-2 Test

| Target Analyte | Interferent | Interferent Conc. | Flu A Detection^{a} Rate | Flu A Mean CT | Flu B Detection^{a} Rate | Flu B Mean CT | SARS-CoV-2 Detection^{a} Rate | SARS-CoV-2 Mean CT |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Influenza A | Influenza B | 1x10^{5} TCID_{50}/mL | 3/3 | 29.3 | 3/3 | 17.4 | NA | NA |
| | SARS-CoV-2 | 1x10^{5} TCID_{50}/mL | 3/3 | 29.0 | NA | NA | 3/3 | 13.7 |
| Influenza B | Influenza A | 1x10^{5} TCID_{50}/mL | 3/3 | 14.2 | 3/3 | 30.8 | NA | NA |
| | SARS-CoV-2 | 1x10^{5} TCID_{50}/mL | NA | NA | 3/3 | 28.3 | 3/3 | 14.0 |
| SARS-CoV-2 | Influenza A | 1x10^{5} TCID_{50}/mL | 3/3 | 13.5 | NA | NA | 3/3 | 30.2 |
| | Influenza B | 1x10^{5} TCID_{50}/mL | NA | NA | 3/3 | 17.0 | 3/3 | 28.4 |

a Detection Rate is defined as # of positive tests/# valid tests
NA = Not applicable

4. Assay Reportable Range:
Not applicable, this is a qualitative assay.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
a. Controls
See Section IV.C.5.Quality Control.

b. Sample Stability
The purpose of this study was to demonstrate the stability of NPS specimens collected in FINDER RVP Buffer when stored under recommended temperature conditions and durations for the FINDER Flu A&B/SARS-CoV-2 Test. Study results support that NPS samples in FINDER RVP Buffer are stable at 2-8°C for up to 72 hours and at 15-30°C for up to 5 hours.

c. Freeze/Thaw Stability
The purpose of this study was to demonstrate the effects of freeze/thaw cycles on NPS specimens collected in FINDER RVP Buffer. The results of this study support that NPS samples collected in FINDER RVP Buffer are stable when frozen at -80°C and undergo up to two freeze/thaw cycles.

d. Kit Stability
The purpose of this study was to evaluate the storage and in-use stability of the FINDER Flu A&B/SARS-CoV-2 Test. The study data supports the storage and in-use stability storage conditions of the FINDER Flu A&B/SARS-CoV-2 Test which are listed below:
- FINDER Flu A&B/SARS-CoV-2 Test is stable for 6 months when stored at 2-8°C.

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- After removing from refrigerated storage, FINDER Flu A&B/SARS-CoV-2 Test may be stored at room temperature for up to two weeks.

## 6. Detection Limit:

The Limit of Detection (LoD) for the FINDER Flu A&B/SARS-CoV-2 Test was determined by spiking inactivated SARS-CoV-2, and live influenza A and influenza B viruses into pooled negative NPS matrix in FINDER RVP Buffer. To determine the preliminary LoD, three-fold dilutions of each target virus were tested with four replicates each for three reagent lots. The lowest concentration for which all four replicates were detected was considered the preliminary LoD. The LoD was confirmed by testing 20 replicates at the preliminary LoD. If fewer than 19/20 replicates or 20 replicates were detected, three-fold dilutions were prepared above or below the tested concentration until 19/20 positive replicates was detected. The LoD was determined as the lowest concentration at which greater than or equal 95% of all replicates tested positive, as summarized in Table 13.

Table 13: Confirmatory Limit of Detection Study Results

| Target | Strain | LoD (TCID_{50}/mL) | Detection Rate (n Positive/n Tested) | Average Ct |
| --- | --- | --- | --- | --- |
| Influenza A | A/Switzerland/9715293/13 | 1.008 | 16/20 | 34.4 |
| | | 3.024 | 20/20 | 30.5 |
| | H1N1, Brisbane/02/18 | 0.670 | 19/20 | 31.9 |
| Influenza B | Victoria, B/Brisbane/33/08 | 0.050 | 19/20 | 28.9 |
| | Phuket/3073/13 | 0.150 | 19/20 | 28.9 |
| SARS-CoV-2 | USA/MD-HP24556/2022 | 0.013 | 15/20 | 34.2 |
| | | 0.038 | 20/20 | 32.4 |
| | England/02/2020 | 2.57E+05 | 2/20 | 36.4 |
| | | 7.70E+05 | 15/20 | 33.4 |
| | | 2.31E+06 | 19/20 | 32.1 |

The LoD for co-analyte spiked samples was also evaluated and shown to be equivalent to single analyte spiked samples.

## 7. Assay Cut-Off:

The FINDER Instrument has two multi-color fluorescence detectors and an algorithm that is utilized for detection of the targets. The Ct threshold for the test is 42, same as the total number of PCR cycles. If fluorescence signal generated at each PCR cycle satisfied the algorithm criteria before completion of all 42 PCR cycles, a 'Detected' result will be reported. "Not Detected" targets can only be reported after all 42 PCR cycles are completed and analyzed. An invalid result is generated when the assay signals do not meet the predefined quality criteria required for a valid result interpretation.

## 8. Accuracy (Instrument):

Not applicable

## 9. Carry-Over:

The purpose of this study was to determine the carryover contamination rate of the FINDER Flu A&B/SARS-CoV-2 Test. The carryover contamination rate was established by testing

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high titer panels of influenza A, influenza B, and SARS-CoV-2 viruses alternating with negative panels. High titer panels were prepared by spiking inactivated SARS-CoV-2 and live influenza A and influenza B viruses into pooled negative NPS samples collected in FINDER RVP Buffer. Negative panels consisted of pooled negative NPS samples in FINDER RVP Buffer. Testing was conducted on five FINDER instruments with one lot of FINDER Flu A&B/SARS-CoV-2 Test reagents. The high titer positive and negative samples were tested in alternating runs for a total of eight replicates of each per instrument, and 40 runs total per sample. Two instruments started the first round of testing with a positive sample, and three instruments started the first round with a negative sample. All high titer positive panel samples tested positive for all analytes and all negative samples tested negative for all analytes and no carry-over contamination was observed.

## B Comparison Studies:

1. Method Comparison with Predicate Device: Not applicable
2. Matrix Comparison: The FINDER Flu A&B/SARS-CoV-2 Test is to be used with the FINDER RVP Buffer only. No additional collection devices have been evaluated for use with the device.

## C Clinical Studies:

1. Clinical Sensitivity: The clinical performance of the FINDER Flu A&B/SARS-CoV-2 Test was evaluated in a prospective clinical study using NPS in FINDER RVP Buffer collected from individuals with signs and symptoms of upper respiratory viral infection. Testing of clinical samples was performed with the FINDER Flu A&B/SARS-CoV-2 Test in six (6) geographically distinct CLIA waived healthcare facilities (e.g. urgent care centers and primary care/outpatient clinics) located in the US with 12 untrained test operators.

A total of 559 NPS specimens were enrolled in the prospective clinical study from February 2025 to April 2025. Thirty-two (32) specimens were excluded for the performance analysis of influenza A and influenza B virus and 33 specimens were excluded for the performance analysis of SARS-CoV-2 virus. Of the excluded samples, six (6) samples were excluded due to a delay in FINDER testing, one (1) for the lack of a valid comparator result (SARS-CoV-2 only), nineteen (19) for the lack of valid FINDER Flu A&B/SARS-CoV-2 Test results, four (4) for improper specimen collection, and three (3) for inadequate sample volume for comparator testing. The performance of the FINDER Flu A&B/SARS-CoV-2 Test was evaluated by comparing the test results with those from an FDA-cleared RT-PCR assay. The demographics and performance of the FINDER Flu A&B/SARS-CoV-2 Test observed in the clinical study are summarized in Table 14 and Table 15 below.

The initial invalid rate for the FINDER Flu A&B/SARS-CoV-2 Test was 10.8% (59/546), and the final invalid rate was 3.5% (19/546) after retesting.

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Table 14: Demographic Summary for the FINDER Flu A&B/SARS-CoV-2 Test Prospective Clinical Evaluation

| Prospectively Collected Clinical Samples | N=559 | |
| --- | --- | --- |
| Gender | | |
| Female | 343 | 61.4% |
| Male | 216 | 38.6 |
| Age Group (Years) | | |
| ≤5 years | 24 | 4.3% |
| 6-21 years | 118 | 21.1% |
| 22-59 years | 377 | 67.4% |
| 60+ years | 40 | 7.2% |
| Race | | |
| Asian | 7 | 1.3% |
| Black or African American | 137 | 24.5% |
| Black or African American, American Indian or Alaska Native | 1 | 0.2% |
| Black or African American, Hispanic | 6 | 1.1% |
| Hispanic | 36 | 6.4% |
| White | 275 | 49.2% |
| White, Asian | 4 | 0.7% |
| White, Black or African American | 4 | 0.7% |
| While, Black or African American, American Indian or Alaska Native | 1 | 0.2% |
| White, Hispanic | 88 | 15.7% |

Table 15: FINDER Flu A&B/SARS-CoV-2 Test Prospective Clinical Performance Summary for NPS

| Analyte | | | | | Positive Percent Agreement | | | Negative Percent Agreement | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | TP | FP | FN | TN | TP/(TP+FN) | % | 95% CI | TN/(TN+FP) | % | 95% CI |
| SARS-CoV-2 | 40 | 1 | 1 | 484 | 40/41 | 97.6 | 87.4-99.6 | 484/485 | 99.8 | 98.8-100.0 |
| Influenza A | 62 | 13 | 3 | 449 | 62/65 | 95.4 | 87.3-98.4 | 449/462 | 97.2 | 95.2-98.3 |
| Influenza B | 24 | 3 | 1 | 499 | 24/25 | 96.0 | 80.5-99.3 | 499/502 | 99.4 | 98.3-99.8 |

2. Clinical Specificity:
See Clinical Sensitivity above

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable

D Clinical Cut-Off:
Not applicable

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# E Expected Values/Reference Range:

The FINDER Flu A&B/SARS-CoV-2 Test prospective clinical study included a total of 527 evaluable prospectively collected NPS specimens. The number and percentage of cases positive for influenza A, influenza B, and SARS-CoV-2 as determined by the FINDER Flu A&B/SARS-CoV-2 Test are presented below in Tables 16 and 17.

Table 16: FINDER Flu A&B/SARS-CoV-2 Test Expected values for NPS Specimens by Age

| Age | N(%) | Positivity Rate (N Positive/N Tested) | | |
| --- | --- | --- | --- | --- |
| | | Influenza A | Influenza B | SARS-CoV-2 |
| 1-5 | 24 (4.6%) | 12.5% (3/24) | 4.2% (1/24) | 0.0% (0/24) |
| 6-21 | 112 (21.2%) | 14.3% (16/112) | 11.6% (13/112) | 5.4% (6/112) |
| 22-59 | 353 (67.0%) | 11.3% (40/353) | 2.8% (10/353) | 8.8% (31/352)a |
| ≥60 | 38 (7.2%) | 15.8% (6/38) | 2.6% (1/38) | 10.5% (4/38) |
| Total | 527 (100.0%) | 12.3% (65/527) | 4.7% (25/527) | 7.8% (41/526)a |

N = Total number of samples
a one sample did not have a valid SARS-CoV-2 Result on the comparator device.

Table 17: FINDER Flu A&B/SARS-CoV-2 Test Expected values for NPS Specimens by Collection Site

| Site | Influenza A | | Influenza B | | SARS-CoV-2 | |
| --- | --- | --- | --- | --- | --- | --- |
| | # of positives | % positivity | # of positives | % positivity | # of positives | % positivity |
| Site 1 | 10 | 9.2 (10/109) | 4 | 3.7 (4/109) | 19 | 17.4 (19/109) |
| Site 2 | 4 | 6.9 (4/58) | 7 | 12.1 (7/58) | 0 | 0.0 (0/58) |
| Site 3 | 15 | 17.2 (15/87) | 5 | 5.7 (5/87) | 8 | 9.3 (8/86)a |
| Site 4 | 7 | 8.4 (7/83) | 3 | 3.6 (3/83) | 2 | 2.4 (2/83) |
| Site 5 | 16 | 16.2 (16/99) | 2 | 2.0 (2/99) | 4 | 4.0 (4/99) |
| Site 6 | 13 | 14.3 (13/91) | 4 | 4.4 (4/91) | 8 | 8.8 (8/91) |
| Total | 65 | 12.3 (65/528) | 25 | 4.7 (25/528) | 41 | 7.8 (41/527)a |

a one sample did not have a valid SARS-CoV-2 Result on the comparator device.

# F Other Supportive Instrument Performance Characteristics Data:

Not applicable.

# VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

# IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

The submitted information in this CLIA waiver application supports a CLIA waiver approval decision.

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