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 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 from influenza A, influenza B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), from nasopharyngeal samples.

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 required 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.

The FINDER Flu A&B/SARS-CoV-2 Test commences with the collection of a nasopharyngeal swab 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. The second droplet is mixed with reagents to amplify and detect influenza A and influenza B. 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 an annealing zone and 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.

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

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - FINDER Flu A&B/SARS-CoV-2 Test

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.04

March 30, 2026

Baebies Inc
Vijay Srinivasan
Official Correspondent
25 Alexandria Way
Durham, North Carolina 27519

Re: K252269
Trade/Device Name: FINDER Flu A&B/SARS-CoV-2 Test
Regulation Number: 21 CFR 866.3981
Regulation Name: 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
Regulatory Class: Class II
Product Code: QOF
Dated: July 21, 2025
Received: July 21, 2025

Dear Vijay Srinivasan:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K252269 - Vijay Srinivasan Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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K252269 - Vijay Srinivasan Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

JOSEPH BRIGGS -S

Joseph Briggs, Ph.D
Deputy Division Director
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252269
Device Name: FINDER Flu A&B/SARS-CoV-2 Test

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

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

510(k) Summary

DHF00005239 Rev 02 Page 1 of 20

1. Administrative Information

A. Applicant: Baebies Inc
B. Address: 25 Alexandria Way, Durham NC 27703
C. Phone Number: 919-891-0432
D. Contact Person: Vijay Srinivasan
E. Date Prepared: March 23, 2026

2. Submission/Device Overview

A. Name of Device: FINDER Flu A&B/SARS-CoV-2 Test
B. Common Name: Same
C. Classification name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
D. Regulatory Classification: Class II
E. Regulation: 21 CFR 866.3981
F. Primary Product Code: QOF

3. Intended Use/Indications for Use

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.

4. Device/System Characteristics

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

5. Substantial Equivalence Information

A. Predicate Device Name(s): DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct
B. Predicate 510(k) Number(s): K220963
C. Comparison with Predicate(s):

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Device & Predicate Device	Subject Device	K220963
Device Trade Name	FINDER Flu A&B/SARS-CoV-2 Test	Simplexa COVID-19 & Flu A/B Direct

General Device Characteristic Similarities

Subject Device	K220963
Product Code	Same
Regulation Number	Same
Prescription Use Only	Same
Device Technology	Same
Detection	Same

Intended Use/Indications For Use

Subject Device:
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.

Positive results do not rule out co-infection with other organisms. The agent(s) detected by the FINDER Flu

K220963:
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 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

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A&B/SARS-CoV-2 Test may not be the definite cause of disease.

PCR and in vitro diagnostic procedures.

General Device Characteristic Differences

Subject Device	(K220963)
Instrumentation	FINDER Instrument
Time to Result	Approximately 20 minutes
Sample Preparation	Uses magnetic-bead based solid-phase extraction chemistry for sample preparation

6. Performance Characteristics

6.1. Expected Values

Performance evaluation of the FINDER Flu A&B/SARS-CoV-2 included 527 prospectively collected nasopharyngeal specimens. The number and percentages of cases positive for influenza A, influenza B, and SARS-CoV-2 as determined by an FDA cleared molecular diagnostic comparator device are shown by age in Table 1 and by site in Table 2 below.

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Table 1: Positivity by Age

Age	N (%)	Positivity Rate (Number Positive / Number Tested)
		Influenza A
1– 5	24 (4.6%)	12.5% (3/24)
6 – 21	112 (21.2%)	14.3% (16/112)
22 – 59	353 (67.0%)	11.3% (40/353)
≥ 60	38 (7.2%)	15.8% (6/38)
Total	527 (100%)	12.3% (65/527)

[1] – one sample did not have a valid SARS-COV-2 result on the comparator device

Table 2: Positivity by Site

Site	Influenza A	Influenza B	SARS-CoV-2
	# of positives	% positivity	# of positives
AL	10	9.2% (10/109)	4
CT	4	6.9% (4/58)	7
OH Site 1	15	17.2% (15/87)	5
TX	7	8.4% (7/83)	3
LA	16	16.2% (16/99)	2
OH Site 2	13	14.3% (13/91)	4
TOTAL	65	12.3% (65/528)	25

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6.2. Clinical Performance

Performance of the FINDER Flu A&B/SARS-CoV-2 Test was characterized during the 2024–2025 respiratory virus season. The study was conducted across 6 geographically diverse POC investigational sites within the United States with testing performed by CLIA Waived operators. Specimens were collected from subjects exhibiting signs and symptoms associated with respiratory infection. The performance of the FINDER Flu A&B/SARS-CoV-2 Test was compared to FDA cleared molecular diagnostic tests.

A total of 559 prospectively collected nasopharyngeal specimens were collected. Demographic data from the individuals from whom specimens were collected are presented in Table 3. Specimens were excluded from the data analysis due to delay in FINDER testing (n=6), lack of a valid comparator result (n=1 only for SARS-CoV-2), a lack of a valid FINDER Flu A&B/SARS-CoV-2 Test result (n=19), improper specimen collection (n=4), and inadequate sample for the comparator (due to tube leakage, n=3). This yielded 527 specimens for influenza A and influenza B performance evaluation & 526 specimens for SARS-CoV-2 performance evaluation.

The initial invalid rate for FINDER Flu A&B/SARS-CoV-2 was 10.8% and the final invalid rate was 3.5% after retesting.

The positive percent agreement (PPA) and negative percent agreement (NPA) are shown in Table 4 below.

Table 3: Demographic summary for prospective clinical evaluation

Prospectively Collected Clinical Samples	N=559
Gender
Female	343
Male	216
Age Group (Years)
≤5 years	24
6-21 years	118
22-59 years	377
60+ years	40
Race
Asian	7
Black or African American	137
Black or African American, American Indian or Alaska Native	1
Black or African American, Hispanic	6
Hispanic	36

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| 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 4: FINDER Flu A&B/SARS-CoV-2 Performance Results - PPA and NPA

	TP	FP	TN	FN	PPA (95% CI)	NPA (95% CI)
Influenza A	62	13[1]	449	3[2]	95.4% (87.3%-98.4%)	97.2% (95.2%-98.3%)
Influenza B	24	3[3]	499	1[4]	96% (80.5%-99.3%)	99.4% (98.3%-99.8%)
SARS-CoV-2	40	1[6]	484	1[5]	97.6% (87.4%-99.6%)	99.8% (98.8%-100%)

[1] – Discrepant testing results: 9/13 were positive; 4/13 were negative.
[2] – Discrepant testing results: 3/3 were positive.
[3] – Discrepant testing results: 2/3 were positive; 1/3 was negative.
[4] – Discrepant testing results: 1/1 was positive.
[5] – Discrepant testing results: 1/1 was negative.
[6] – Discrepant testing results: 1/1 was negative.

6.3. Within-Laboratory Precision Testing

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 LOD, a positive sample co-spiked with viral materials at 5x LOD, and a negative sample. Specimens were prepared in pooled negative nasopharyngeal 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). A total of 6 instruments were used for the testing.

Table 5 below summarizes the qualitative run results (percent agreement with expected results).

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Table 5: Within-Laboratory Precision - Qualitative Results

Sample	Target	Calls	% Agreement	95% CI
Negative	Flu A	0/96	100	96.2 – 100%
	Flu B	0/96	100	96.2 – 100%
	SC2	1/96	99.0	94.3 – 99.8%
Low Positive (2x LOD)	Flu A	95/96	99.0	94.3 – 99.8%
	Flu B	95/96	99.0	94.3 – 99.8%
	SC2	96/96	100	96.2 – 100%
Moderate Positive (5x LOD)	Flu A	96/96	100	96.2 – 100%
	Flu B	96/96	100	96.2 – 100%
	SC2	96/96	100	96.2 – 100%

All moderate positive (5x LOD) runs were 100% positive for all assay targets. All low positive (2x LOD) runs were ≥99% positive for all assay targets. All negative sample runs were ≤1% positive, with one false positive for SARS-CoV-2.

Table 6 below summarizes the quantitative run results of the within-laboratory precision study (Ct signal variability analysis).

Table 6 - Within-Laboratory Precision Study - Ct Variability Results

Panel Member	Target	n	Mean Ct	Repeatability	Between Instruments	Between Days	Between Cartridge Lots	Reproducibility
				SD	CV (%)	SD	CV (%)	SD
Low Positive (2x LOD)	Flu A	95	29.7	1.74	5.9	0.16	0.5	0.35
	Flu B	95	28.5	1.64	5.7	0.53	1.9	0.38
	SARS-CoV-2	96	30.5	0.89	2.9	0	0	0.10
Moderate Positive (5x LOD)	Flu A	96	27.9	1.15	4.1	0.28	1.0	0
	Flu B	96	27.6	1.2	4.4	0.25	0.9	0
	SARS-CoV-2	96	28.9	1.05	3.6	0.14	0.5	0

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6.4. Reproducibility

A study was performed to evaluate the Reproducibility of the FINDER Flu A&B/SARS-CoV-2 Test. The study was conducted at 3 POC investigational sites within the United States across five non-consecutive days. Each site had 2 CLIA Waived operators who tested each panel 3 times each testing day. Results are shown in Table 7 below. Three instruments were tested at each site.

Table 7: Reproducibility

Sample	Site 1	Site 2	Site 3	Total Agreement
	% Agreement (Count)	% Agreement (Count)	% Agreement (Count)	% Agreement (Count)
Negative	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
Influenza A Low Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
Influenza A Moderate Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
Influenza B Low Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
Influenza B Moderate Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
SARS-CoV-2 Low Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)
SARS-CoV-2 Moderate Positive	100% (30/30)	100% (30/30)	100% (30/30)	100% (90/90)

6.5. Analytical Sensitivity

The sensitivity of the FINDER Flu A&B/SARS-CoV-2 Test was evaluated using virus spiked into pooled negative nasopharyngeal matrix collected in FINDER RVP Buffer. An initial estimate of the Limit of Detection (LoD) was determined during a range-finding study in which 3-fold dilutions of the sample were tested in triplicate. The estimated LoD was the lowest concentration in which 100% of the samples were detected. The LoD was verified by detecting at least 19 out of 20 replicates at the estimated LoD in 3 independent test lots. The verified LoD results are summarized in Table 8 below.

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Table 8: LoD Results

Target	Strain	Confirmed LoD
Influenza A	A/Switzerland/9715293/13	3.024 TCID50/mL
	H1N1, Brisbane/02/18	0.670 TCID50/mL
Influenza B	Victoria, B/Brisbane/33/08	0.050 TCID50/mL
	Phuket/3073/13	0.150 TCID50/mL
SARS-CoV-2	USA/MD-HP24556/2022	0.038 TCID50/mL
	First WHO Int. Std. for SC2	2.31E+06 IU/mL
	2006 Isolate	0.059 TCID50/mL

6.6. Analytical Reactivity (Inclusivity)

The reactivity of FINDER Flu A&B/SARS-CoV-2 Test was evaluated with clinically relevant strains of influenza A, influenza B, and SARS-CoV-2. In total 28 strains of influenza A, 12 strains of influenza B, and 12 strains of SARS-CoV-2 were evaluated. The virus under evaluation was spiked into pooled negative nasopharyngeal matrix collected in FINDER RVP Buffer at levels near the analytical LoD. The samples were tested in triplicate for each strain. All strains tested positive for all 3 replicates at the concentrations summarized in Table 9 below.

Table 9: Inclusivity Test Concentrations

Viral Target	Subtype	Strain	Titer (TCID50/mL)
SARS-CoV2	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	3.0375
	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
Influenza A	H1N1	A/New Caledonia/20/1999	2.01
		A/New Jersey/8/76	18.09 (CEID50/mL)
		Brisbane/59/2007	2.01

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| | | 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 |
| | H5N1 | A/white-tailed eagle/Japan/OU-1/2022 | 5400 cp/mL |
| | H7N9 | 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 |

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| | | B/New York/1056/2003 | 1.35 |
| | Yamagata | Florida/07/04 | 0.45 |
| | | Florida/04/06 | 0.45 |
| | | Wisconsin/1/10 | 0.45 |
| | | Massachusetts/2/12 | 1.35 |
| | | Utah/9/14 | 0.45 |

6.7. In Silico Reactivity (Inclusivity) Analysis

The FINDER Flu A&B/SARS-CoV-2 Test was evaluated for SARS-CoV-2, influenza A and influenza B inclusivity.

SARS-CoV-2
Based on analysis of 5,740,183 SARS-CoV-2 genomes in the GISAID Database submitted between November 2019 and June 2024, 100,101 SARS-CoV-2 genomes in the NCBI repository submitted between July 2024 and May 2025, it is predicted that the FINDER Flu A&B/SARS-CoV-2 Test will detect >99.9% of the SARS-CoV-2 genome sequences.

Influenza A
Based on analysis of 399,012 influenza A genomes in the GISAID Database submitted between January 1997 and June 2025, it is predicted that the FINDER Flu A&B/SARS-CoV-2 Test will detect ~99.8% of the influenza A genome sequences.

Influenza B
Based on analysis of 103,792 influenza B genomes in the GISAID Database submitted between January 1997 and June 2025, it is predicted that the FINDER Flu A&B/SARS-CoV-2 Test will detect >99.1% of the influenza B genome sequences.

6.8. Cross-Reactivity and Microbial Interference

The FINDER Flu A&B/SARS-CoV-2 Test was evaluated for potential interference from related pathogens, high prevalence disease agents, and normal or pathogenic flora reasonably likely to be encountered in a clinical sample. Potential cross-reactivity was evaluated by adding organisms into a pooled negative nasopharyngeal matrix collected in FINDER RVP Buffer. Similarly, microbial interference was evaluated by adding the same organisms into the same sample pool, with each viral target added at 3x the Limit of Detection. No cross-reactivity or microbial interference was observed at the concentrations tested in Table 10 below.

Table 10: Cross-reactivity and Microbial interference

Pool	Microorganism	Concentration	Category	Cross Reactivity	Microbial Interference
1	Adenovirus type 1	1x105 TCID50/mL	Virus	0/3	3/3
	Adenovirus type 7	1x105 TCID50/mL	Virus
2	Adenovirus type 4	1x105 TCID50/mL	Virus	0/3	3/3
3	Cytomegalovirus	4.21x104 TCID50/mL	Virus	0/3	3/3

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| 4 | Herpes simplex virus Type 1 | 1x105 TCID50/mL | Virus | 0/3 | 3/3 |
| | Varicella-zoster virus | 1x105 cp/mL | Virus | | |
| 5 | Epstein Barr Virus | 1x105 cp/mL | Virus | 0/3 | 3/3 |
| 6 | Enterovirus (Coxsackie) | 1x105 TCID50/mL | Virus | 0/3 | 3/3 |
| | Enterovirus (echovirus) | 1x105 TCID50/mL | Virus | | |
| 7 | Human parainfluenza 1 | 1x105 TCID50/mL | Virus | 0/3 | 3/3 |
| | Human parainfluenza 3 | 1x105 TCID50/mL | Virus | | |
| 8 | Human parainfluenza 2 | 1x105 TCID50/mL | Virus | 0/3 | 3/3 |
| 9 | Human parainfluenza 4 | 1x105 TCID50/mL | Virus | 0/3 | 3/3 |
| 10 | Coronavirus HKU1 | 1x106 cp/mL | Virus | 0/3 | 3/3 |
| 11 | Coronavirus 229E | 4.17x104 TCID50/mL | Virus | 0/3 | 3/3 |
| 12 | Coronavirus OC43 | 4.17x104 TCID50/mL | Virus | 0/3 | 3/3 |
| 13 | Coronavirus NL63 | 3.55x104 TCID50/mL | Virus | 0/3 | 3/3 |
| 14 | Measles | 1x105 TCID50/mL | Virus | 0/3 | 3/3 |
| | Mumps virus | 1x105 TCID50/mL | Virus | | |
| 15 | Human metapneumovirus A1 | 1.41x104 TCID50/mL | Virus | 0/3 | 3/3 |
| 16 | Human metapneumovirus A2 | 3.55x104 TCID50/mL | Virus | 0/3 | 3/3 |
| 17 | Rhinovirus Type 1A | 1.41x104 TCID50/mL | Virus | 0/3 | 3/3 |
| 18 | Aspergillus flavus | 1x106 CFU/mL | Fungi | 0/3 | 3/3 |
| | Bordetella pertussis | 1x106 CFU/mL | Bacteria | | |
| | Bordetella parapertussis | 1x106 CFU/mL | Bacteria | | |
| 19 | Chlamydia pneumoniae | 1x106 CFU/mL | Bacteria | 0/3 | 3/3 |
| | Corynebacterium amycolatum | 1x106 CFU/mL | Bacteria | | |
| | Escherichia coli | 1x106 CFU/mL | Bacteria | | |
| 20 | Fusobacterium necrophorum | 1x106 CFU/mL | Bacteria | 0/3 | 3/3 |
| 21 | Hemophilus influenzae | 1x106 CFU/mL | Bacteria | 0/3 | 3/3 |
| 22 | Lactobacillus oris | 1x106 CFU/mL | Bacteria | 0/3 | 3/3 |
| 23 | Legionella pneumophila | 1x106 CFU/mL | Bacteria | 0/3 | 3/3 |
| 24 | Moraxella catarrhalis | 1x106 CFU/mL | Bacteria | 0/3 | 3/3 |
| 25 | Mycobacterium tuberculosis avirulent | 1x104 cp/mL | Bacteria | 0/3 | 3/3 |
| 26 | Mycoplasma pneumoniae | 1x106 CCU/mL | Bacteria | 0/3 | 3/3 |

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| 27 | Mycoplasma genitalium | 1.85x105 Bacteria/mL | Bacteria | 0/3 | 3/3 |
| | Neisseria meningitides | 1x106 CFU/mL | Bacteria | | |
| | Neisseria cinerea | 1x106 CFU/mL | Bacteria | | |
| 28 | Pneumocystis jirovecii | 1x106 CFU/mL | Fungi | 0/3 | 3/3 |
| | Pseudomonas aeruginosa | 1x106 CFU/mL | Bacteria | | |
| 29 | Staphylococcus aureus | 1x106 CFU/mL | Bacteria | 0/3 | 3/3 |
| | Staphylococcus epidermis | 1x106 CFU/mL | Bacteria | | |
| 30 | Streptococcus pneumoniae | 1x106 CFU/mL | Bacteria | 0/3 | 3/3 |
| | Streptococcus pyogenes | 1x106 CFU/mL | Bacteria | | |
| | Streptococcus salivarius | 1x106 CFU/mL | Bacteria | | |
| 31 | SARS-CoV-1 | 1x104 cp/mL | Virus | 0/3 | 3/3 |
| 32 | Candida albicans | 1x106 CFU/mL | Fungi | 0/3 | 3/3 |
| 33 | MERS-coronavirus | 10% v/v | Virus | 0/3 | 3/3 |
| 34 | Human genomic DNA | 3.71x106 cp/mL | n/a | 0/3 | 3/3 |
| 35 | Pooled human nasal wash | 10% v/v | n/a | 0/3 | 3/3 |
| n/a | Respiratory syncytial virus | 1x105 TCID50/mL | Virus | 0/3 | 3/3 |

6.9. In Silico Specificity (Exclusivity) Analysis

In addition to the cross-reactivity testing above, the FINDER Flu A&B/SARS-CoV-2 Test was evaluated for potential cross-reactivity of eleven additional microorganisms reasonably likely to be encountered in a clinical sample using in silico analysis. Each oligonucleotide used in the assay was compared against the reference genome for each organism. No significant homology was found with any of the analyzed organisms listed below that are predicted to cause false positive results on the FINDER Flu A&B/SARS-CoV-2 Test.

Human Adenovirus Type 2
Human Adenovirus Type 3
Human Adenovirus Type 5
Human Adenovirus Type 11
Human Adenovirus Type 14
Human Adenovirus Type 22
Human Adenovirus Type 35
Human Adenovirus Type 41
Human Meta-pneumovirus B1
Human Meta-pneumovirus B2
Human Cytomegalovirus (taxid:10359)

6.10. Interfering Substances

The FINDER Flu A&B/SARS-CoV-2 Test was evaluated for potential interference from exogenous/endogenous interferents that may be found in clinical samples. Negative samples were

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prepared by adding potentially interfering substances to pooled negative nasopharyngeal matrix collected in FINDER RVP Buffer. Positive samples were created in the same manner but included a virus spiked at 3x the established Limit of Detection. All samples were tested in triplicate. Table 11 below shows the highest concentration for each substance at which no interference was observed. Interference was observed at higher concentrations for Zicam (5%), budesonide (1%), Nasacort (2.5%), Fluticasone (2.5%) and Nasonex (2.5%).

Table 11: Interfering substances

Substance/Active Ingredient1	Concentration
Mucin	5 mg/ml
Whole Blood (Capillary)	2% (v/v)
Leukocytes (Human Buffy Coat)	1% (v/v)
Oxymetazoline (Afrin)	5% (v/v)
Saline nasal spray	10% (v/v)
Phenylephrine (1%)	10% (v/v)
Zinc (Zinc Acetate Dihydrate)	1 mg/mL
Luffa opperculata, sulfur (Zicam)	2.5% (v/v)
Benzocaine Menthol (Cepacol)	5% (v/v)
Zanamivir	5 mg/mL
Oseltamivir	7.5 mg/mL
Tobramycin	4 ug/mL
Mupirocin	5 mg/mL
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)
Histaminum hydrochloricum	10 mg/mL
DMSO	10% (v/v)
Ethanol	10% (v/v)
0.1N NaOH	10% (v/v)

1 FluMist was not evaluated.

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6.11. Competitive Interference

Competitive interference of the FINDER Flu A&B/SARS-CoV-2 Test caused by co-infections was evaluated by testing contrived samples of individual SARS-CoV-2, influenza A, or influenza B strains at 3x LoD in the presence of different target strains at a higher concentration (105 TCID50/mL) in nasopharyngeal sample matrix. Three replicates were tested for each combination of target strain and competing strain. Competitive interference was considered absent if 3 of 3 replicates for the target strain were correctly detected in the presence of the competing virus. The results demonstrated no competitive inhibitory effects from co-infecting viruses at the concentrations tested. The results of the competitive interference study are summarized in Table 12.

Table 12: Competitive Interference Samples

Viral Target (3X LOD)	Co-infection target (105 TCID50/mL)	# Calls/Runs
		Flu A
Influenza A (9.072 TCID50/mL)	Influenza B	3/3
	SARS-CoV-2	3/3
Influenza B (0.150 TCID50/mL)	Influenza A	3/3
	SARS-CoV-2	0/3
SARS-CoV-2 (0.113 TCID50/mL)	Influenza A	3/3
	Influenza B	0/3

6.12. Carry-over Contamination

A cross contamination (carry-over) study was conducted to demonstrate that specificity was maintained for runs following positive results. A strongly positive sample was prepared with concentrations per Table 13 below. Runs of the strongly positive sample were directly followed by a negative sample. This cycle was performed 8 times on 5 different FINDER instruments resulting in 40 expected positive and 40 expected negative runs for each virus. No specimen or amplificon contamination was observed.

Table 13: Carry-over Contamination

Viral Target	Strain	Analyte Level
SARS-CoV-2	USA/MD-HP24556/2022	7.5e2 TCID50/mL
Influenza A	H3N2/ A/Switzerland/9715293/13	2.5e4 TCID50/mL
Influenza B	B/Brisbane/33/08	1.0e3 TCID50/mL

7. Specimen Stability

Storage Stability

A study was performed to determine the storage stability of nasopharyngeal swab specimens collected in FINDER RVP Buffer to be analyzed on the FINDER Flu A&B/SARS-CoV-2 Test. Nasopharyngeal swabs were collected in FINDER RVP Buffer and the media were pooled. Storage stability was evaluated at

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refrigerated (2-8°C) and room temperature (30°C) conditions, using both a positive sample (co-spiked with viral materials at 3x LOD) and a negative sample. Eight replicates of each specimen were tested at each timepoint. Results of this testing support that samples collected in FINDER RVP Buffer may be stored:

Up to 5 hours at room temperature (15-30°C)
Up to 72 hours refrigerated (2-8°C)

Freeze/thaw Testing

The equivalency of fresh and frozen specimens on the FINDER Flu A&B/SARS-CoV-2 Test was evaluated. Nasopharyngeal swabs were collected in FINDER RVP Buffer and the media were pooled. A negative sample as well as two positive samples (co-spiked with viral material at either 2x LOD or 5x LOD) were evaluated; ten replicates of the negative and 5x LOD sample were tested and 30 replicates of the 2x LOD sample were tested at each timepoint. All samples were tested fresh and after multiple freeze-thaws following -80°C storage. Results of this testing support that samples collected in FINDER RVP Buffer may be frozen at -80°C and undergo up to 2 freeze/thaw cycles before testing on the FINDER Flu A&B/SARS-CoV-2 Test.

8. Flex Testing

Flex studies were conducted to evaluate the robustness and reliability of the FINDER Flu A&B/SARS-CoV-2 Test when used under conditions that may occur in real-world CLIA-waived settings. These studies are designed to demonstrate that the FINDER system can maintain clinical accuracy and safety despite common user errors and environmental variability.

8.1. Study Design

Flex studies were conducted using both positive and negative samples and with either pooled patient matrix or external run controls. For most testing, presumed negative nasopharyngeal swab media was collected and pooled. The negative pooled matrix was verified as negative for SARS-CoV-2, influenza A, and influenza B by testing on a high sensitivity method. Positive samples were contrived by spiking viral specimens into the above negative pooled matrix at a concentration of 2x the FINDER Flu A&B/SARS-CoV-2 Test Limit of Detection for each viral target. For the test conditions where a swab is required, the recommended external positive and negative control swabs (Cat # 100-000077 and Cat # 100-000078 respectively) were used.

Replicates of 5 positive samples and 5 negative samples were used for each flex condition. Across all studies, a total of 5 trained operators were used. Sample pedigree was blinded to the user.

8.2. Flex Conditions Evaluated

The following flex conditions were selected based on FDA guidance for CLIA waiver submissions, precedent from previously waived molecular diagnostics, and foreseeable user errors as indicated from risk analysis:

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| Environment | a) Vibrations from common lab equipment installed near the instrument. |
| | b) Bumping the instrument during a test. |
| | c) Instrument moved during testing. |
| | d) Temperature and Humidity extremes. |
| | e) High altitude |
| Instrument Installation | a) Instrument installed on a non-level surface. |
| | b) Instrument installed such that airflow is impeded. |
| Specimen Integrity and Handling | a) FINDER RVP Buffer light exposure |
| | b) Insufficient incubation of sample in FINDER RVP Buffer |
| | c) Incorrect Storage of Sample |
| Human Factors/Operator Errors | a) Incorrect handling (equilibration) of sample |
| | b) Incorrect handling (equilibration) of FINDER RVP Buffer |
| | c) Incorrect handling (equilibration) of cartridge |
| | d) Incorrect handling of cartridge preparation (removal from pouch) |
| | e) Incorrect timing of cartridge preparation |
| | f) Incorrect mixing of sample |
| | g) Incorrect sample volume |
| | h) Incorrect pipette technique |
| | i) Incorrect timing of sample introduction |
| | j) Incorrect test steps (closing of sample cap) |
| | k) Interference with test equipment (Power Cycling during test) |

8.3. Flex conditions test results

Condition	NEGATIVE	POSITIVE	INVALID or NO RESULT	Erroneous Results
Control	5/5	5/5	0/10	0/10
Vibration: 9,500 RPM centrifuge within 1'	5/5	5/5	0/10	0/10
Jostling: >1.5g facing instrument	5/5	5/5	0/10	0/10
Instrument moved 1' backwards during test	5/5	5/5	0/10	0/10
Environmental extreme: 15°C / 50% RH	5/5	5/5	0/10	0/10
Environmental extreme: 30°C / 20% RH	5/5	5/5	0/10	0/10
Environmental extreme: 30°C / 80% RH	5/5	5/5	0/10	0/10
Environmental extreme: 10°C / 90-95% RH	5/5	5/5	0/10	0/10

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| Environmental extreme: 13°C / 90-95% RH | 5/5 | 5/5 | 0/10 | 0/10 |
| Environmental extreme: 35°C / 90-95% RH | 5/5 | 5/5 | 0/10 | 0/10 |
| Environmental extreme: 40°C / 90-95% RH | 3/5 | 5/5 | 2/10 | 0/10 |
| Environmental extreme: 8°C / 5-15% RH | 5/5 | 5/5 | 0/10 | 0/10 |
| Environmental extreme: 13°C / 5-15% RH | 5/5 | 5/5 | 0/10 | 0/10 |
| Environmental extreme: 35°C / 5-15% RH | 5/5 | 5/5 | 0/10 | 0/10 |
| Environmental extreme: 40°C / 5-15% RH | 5/5 | 5/5 | 0/10 | 0/10 |
| High altitude: 1500 m | 5/5 | 5/5 | 0/10 | 0/10 |
| High altitude: 1700 m | 5/5 | 5/5 | 0/10 | 0/10 |
| High altitude: 2000 m | 3/5 | 3/5 | 4/10 | 0/10 |
| High altitude: 3000 m | 1/5 | 3/5 | 6/10 | 0/10 |
| Instrument non-level: +2° Pitch, 0° Roll | 5/5 | 5/5 | 0/10 | 0/10 |
| Instrument non-level: -2° Pitch, 0° Roll | 5/5 | 5/5 | 0/10 | 0/10 |
| Instrument non-level: 0° Pitch, -2° Roll | 3/5 | 4/5 | 3/10 | 0/10 |
| Instrument non-level: 0° Pitch, +2° Roll | 5/5 | 4/5 | 1/10 | 0/10 |
| Instrument exhaust blocked | 5/5 | 5/5 | 0/10 | 0/10 |
| RVP buffer left under room light | 5/5 | 5/5 | 0/10 | 0/10 |
| Sample swab incubated for <20s | 5/5 | 5/5 | 0/10 | 0/10 |
| Sample stored at 4C for 7 days | 5/5 | 5/5 | 0/10 | 0/10 |
| Sample stored at 30C for 8 hours | 5/5 | 5/5 | 0/10 | 0/10 |
| Sample stored at 37C for 4 hours | 5/5 | 5/5 | 0/10 | 0/10 |
| Sample not equilibrated after refrigeration | 5/5 | 5/5 | 0/10 | 0/10 |
| RVPB not equilibrated after refrigeration | 5/5 | 5/5 | 0/10 | 0/10 |
| Cartridge not equilibrated after refrigeration | 5/5 | 5/5 | 0/10 | 0/10 |
| Cartridge outside pouch for 2 hours | 5/5 | 5/5 | 0/10 | 0/10 |
| Cartridge idled after initialization for 15 min | 5/5 | 5/5 | 0/10 | 0/10 |
| Sample swab not mixed in RVP | 4/5 | 5/5 | 1/10 | 0/10 |
| 25% of sample loaded (50 uL) | 1/5 | 0/5 | 9/10 | 0/10 |

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Condition	NEGATIVE	POSITIVE	INVALID or NO RESULT	Erroneous Results
50% of sample loaded (100 uL)	5/5	4/5	1/10	0/10
200% of sample loaded (400 uL)	1/5	2/5	7/10	0/10
Pipette action repeated 5x	5/5	5/5	0/10	0/10
Pipette pushed deep, strongly dispensed	5/5	4/5	1/10	0/10
Sample loaded before initialization completes	3/5	3/5	4/10	0/10
Sample loaded after main protocol start	5/5	5/5	0/10	0/10
Sample cap not closed	5/5	5/5	0/10	0/10
Instrument power cycled	0/5	0/5	10/10	0/10
Tablet power cycled	5/5	5/5	0/10	0/10

8.4. Flex Testing Conclusions

Overall, the FINDER FLU A&B/SARS-CoV-2 Test as tested on the FINDER Instrument exhibited strong resilience to a range of flex conditions foreseeably present in a CLIA waived test environment. All conditions either generated expected results or triggered intended fail-safe mechanisms. No incorrect results were reported for any condition tested.

9. Conclusion

The analytical and clinical studies have demonstrated that the FINDER Flu A&B/SARS-CoV-2 Test is substantially equivalent to the predicate device (K220963).

Regulation Number and Section

§ 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.

(a)
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.(b)
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.