The CareSuperb™ COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.

Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

Performance characteristics for SARS-CoV-2 were established from October 2023 to April 2024 when SARS-CoV-2 Omicron variant was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

Device Description

The CareSuperb™ COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein in anterior nasal samples.

To begin the test, a self-collected anterior nasal swab sample (in individuals between the age of 2 to 14 a swab collected by a parent or quardian), or a heathcare-provider collected anterior nasal swab sample is inserted into the sample port and the extraction reagent in the dropper vial is added to the extraction to occur exposing the viral nucleocapsid antigens The SARS-CoV-2 antigens present in the sample bind with anti-SARS-CoV-2 antibodies dispensed in the conjuqate wick filter. These antigen-antibody complexes migrate to the the plastic cassette and travel across the membrane through capillary action. The complexes are captured at the tegion, causing a colored line to appear on the membrane.

If the sample contains SARS-CoV-2 antigen, a visible line at the test line ("T") and a procedural control line at the control line ("C") will appear in the result window indicating a positive result. If SARS-CoV 2 viral nucleocapsid antigens are not present, or are present at very low levels, only the procedural control line will appear.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device (CareSuperb™ COVID-19 Antigen Home Test) meets them, based on the provided FDA 510(k) summary:

Summary of Acceptance Criteria and Device Performance

The acceptance criteria for this device are primarily centered around its clinical performance (accuracy) and usability for lay users, as well as robust analytical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implied by FDA Review)	Reported Device Performance
Clinical Performance
Positive Percent Agreement (PPA) with RT-PCR (within 4 days of symptom onset)	High agreement (e.g., generally > ~80-90% for antigen tests, with higher expectations for devices for home use) to correctly identify positive samples.	97.2% (140/144) (95% CI: 93.1%-98.9%)
Negative Percent Agreement (NPA) with RT-PCR (within 4 days of symptom onset)	High agreement (e.g., generally > ~95-98% for antigen tests for home use) to correctly identify negative samples.	98.8% (496/502) (95% CI: 97.4%-99.5%)
Analytical Performance
Precision (Repeatability/Reproducibility)	Consistent results across operators, sample types, lots, and varying concentrations (especially around LoD).	True Negative: 100% agreement (1620/1620). High Negative (0.75X LoD): 92.6% agreement (500/540). Low Positive (1X LoD): 99.8% agreement (539/540). Low Positive (1.5X LoD, 2X LoD, 4X LoD): 100% agreement. Demonstrated precision with no significant variability between lots.
Limit of Detection (LoD)	Ability to detect SARS-CoV-2 at low concentrations.	WA1/2020: 2.63 x 10^2 TCID50/mL (1.32 x 10^1 TCID50/Swab). Omicron B.1.1.529: 1.5 x 10^2 TCID50/mL (7.5 x 10^1 TCID50/Swab). WHO Standard (NIBSC 21/368): 32 IU/mL (1.6 IU/swab).
Hook Effect	No false negatives at very high concentrations of analyte.	No hook effect observed up to 4.0 x 10^5 TCID50/mL (WA1/2020) and 7.5 x 10^5 TCID50/mL (Omicron B.1.1.529).
Cross-Reactivity/Microbial Interference	No false positives or interference from common respiratory microorganisms or viruses.	None of 18 non-SARS-CoV-2 viruses and 10 other microorganisms showed cross-reactivity or interference. Pooled human nasal wash also showed no cross-reactivity or interference.
Interfering Substances Effect	No interference from common medications or endogenous substances.	None of 42 tested interfering substances (common medications, endogenous substances like blood, mucin) showed cross-reactivity or interference, except biotin at high concentrations. (False negative results observed when biotin concentration exceeded 2,500 ng/mL in positive samples). This is a known limitation for biotin-sensitive assays.
Inclusivity (Analytical Reactivity)	Ability to detect various SARS-CoV-2 variants.	Demonstrated reactivity with 7 additional SARS-CoV-2 variants (Alpha, Delta, Omicron BA.2.12.1, BA.2.3, BA.2.75.5, BA.4.6, JN.1.4) at specific low concentrations.
Flex Studies	Robustness to minor variations in user technique and environmental conditions.	Studies support that the test is robust with an insignificant risk of erroneous results under various tested conditions (e.g., reading times, buffer volume, swab handling, environmental stress).
Usability & Readability
Usability Study	Lay users can competently perform critical tasks with the device using provided instructions.	Overall success rate for all critical tasks was ≥ 80% among 50 users.
Readability Study	Lay users can correctly interpret test results (positive, negative, invalid).	Overall success rate for both tested panels (negative and positive interpretations) was 95.0% among 50 users.

2. Sample Size and Data Provenance

Test Set (Clinical Performance):
- Sample Size: A total of 646 symptomatic subjects were evaluated in the clinical study.
- Data Provenance: Data was collected from 10 clinical sites in the U.S. between October 2023 and April 2024. This was a prospective study, as subjects self-sampled and self-tested in a simulated home setting.
Analytical Performance Studies: Sample sizes for these studies vary, but are explicitly stated for each (e.g., 540 replicates per lot for precision, 20 replicates for LoD confirmation, 3 replicates for cross-reactivity/interference studies). The document does not specify a country of origin for these lab-based studies, but for a US FDA submission, it implicitly means the studies adhere to US regulatory standards.

3. Number of Experts and Qualifications for Ground Truth

For the clinical performance study, the ground truth was established by an FDA-cleared molecular assay (RT-PCR). This is a scientific, objective standard, not dependent on human expert interpretation in the same way imaging studies might be.
For the adjudication of discrepant results in the clinical study, it states: "All discrepant results were investigated by testing using an alternative FDA-cleared molecular assay at the central laboratory." This further reinforces the objective, lab-based ground truth.
For analytical studies (LoD, cross-reactivity, etc.), ground truth is established by the known concentrations of spiked analytes and the inherent characteristics of the reference materials. These are objective measures rather than expert consensus.

4. Adjudication Method for the Test Set

For the clinical performance study, the primary ground truth was an FDA-cleared molecular assay.
Any discrepant results between the CareSuperb™ test and the primary molecular assay were adjudicated by testing with an alternative FDA-cleared molecular assay at a central laboratory. This acts as a robust, independent verification method for discrepancy resolution. There isn't a "2+1" or "3+1" human reader adjudication since the ground truth is objective molecular testing.

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

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This is because the device is a visually read lateral flow immunoassay for COVID-19 antigen detection. It is a standalone diagnostic test performed by lay users, not an AI-assisted interpretation tool for images or complex data that would involve human readers and their performance improvement.

6. Standalone Performance (Algorithm Only)

Yes, the primary clinical performance data (PPA and NPA) represents the standalone performance of the device when used by lay users, as it is a visually read test. There is no "algorithm" in the sense of a software-based AI interpreting results; the interpretation is visual by the user. The performance metrics (PPA, NPA) directly reflect the device's accuracy in identifying positive and negative cases compared to the molecular reference standard.

7. Type of Ground Truth Used

Clinical Performance Ground Truth: The primary ground truth for the clinical study was an FDA-cleared molecular assay (RT-PCR) result. Discrepant results were further confirmed by an alternative FDA-cleared molecular assay. This is considered a highly reliable and objective gold standard for SARS-CoV-2 detection.
Analytical Performance Ground Truth: For the analytical studies (LoD, precision, cross-reactivity, inclusivity), the ground truth was established by using known concentrations of purified or inactivated SARS-CoV-2 strains/variants/reference materials and other microorganisms/substances, diluted into a negative clinical matrix (nasal swab matrix).

8. Sample Size for the Training Set

The document primarily describes a diagnostic test kit (lateral flow immunoassay), not an AI/ML-based algorithm that requires a "training set" in the computational sense.
The closest equivalent to a "training set" for physical test development would involve extensive R&D and optimization studies during the design phase to establish reagent concentrations, membrane properties, and other manufacturing parameters. This type of "training" isn't quantified by a sample size of patient data in the same way an AI model's training set would be. The clinical and analytical studies presented are validation studies to prove the device works as intended, not data used for "training" the device itself.

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

As noted above, there isn't a "training set" and associated ground truth in the AI/ML context for this type of device. The development and optimization of the physical components (e.g., antibody selection, membrane type, buffer formulation) are based on robust analytical chemistry and immunology principles, often using characterized biological materials (like specific viral concentrations) as internal benchmarks during the R&D process. The performance of these optimized components is then validated in the extensive analytical and clinical studies detailed in the 510(k) submission.

Summary

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January 29, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Access Bio, Inc. Sung Jang Senior Manager of Regulatory Affairs 65 Clyde Road Suite A Somerset, New Jersey 08873

Re: K241915

Trade/Device Name: CareSuperb COVID-19 Antigen Home Test Regulation Number: 21 CFR 866.3984 Regulation Name: Over-The-Counter Test To Detect SARS-Cov-2 From Clinical Specimens Regulatory Class: Class II Product Code: QYT Dated: June 29, 2024 July 1, 2024 Received:

Dear Sung Jang:

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 (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.

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"

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(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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).

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Sincerely,

Silke Schlottmann -S

Digitally signed by Silke Schlottmann -S Date: 2025.01.29 14:12:50 -05'00'

Silke Schlottman, Ph.D. Deputy Assistant Director Bacteriology Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241915

Device Name CareSuperb COVID-19 Antigen Home Test

Indications for Use (Describe)

The CareSuperb COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

Positive results do not rule out co-infection with other respiratory pathogens.

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)	区
---------------------------------------------	---------------------------------

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Image /page/4/Picture/0 description: The image contains a logo and some text. The logo is a blue square with a green stem and a flower-like design inside. The text reads "Access Bio," in a large, bold font, followed by "65 Clyde Rd. Suite" in a smaller font. The text is positioned to the right of the logo.

Access Bio, Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 || Tel: (732)-873-4040 || Fax: (732)-873-4043 || info@accessbio.net

510(k) Summary

Date Prepared: Jan. 27, 2025

Submitter Information 1.

1.1. Name: Access Bio, Inc.
1.2. Address: 65 Clyde Road, Suite A, Somerset, NJ 08873
1.3. Telephone Number: +1-732-873-4040
1.4. Contact Person: Sung Jang, Senior Manager of Requlatory Affairs Email: sajang@accessbio.net

2. Device Information

2.1. Trade or Proprietary Name: CareSuperb™ COVID-19 Antigen Home Test
2.2. Common Name: COVID-19 Antigen Detection Test
2.3. Classification: Class II
2.4. Classification Name: Over-the-counter Covid-19 Antigen Test
2.5. Product Code: QYT
2.6. Requlation Number: 21 CFR 866.3984
2.7. Review Panel: Microbiology

Legally Marketed Predicate Device ဒ်.

3.1. Trade Name: Flowflex COVID-19 Antigen Home Test
3.2. Manufacturer: ACON Laboratories, Inc.
3.3. 510(k) Number: K230828
3.4. Product Code: QYT
3.5. Review Panel: Microbiology

4. Device Description

The CareSuperb™ COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein in anterior nasal samples.

4.1. Kit Components:

The CareSuperb™ COVID-19 Antigen Home Test is available in three package sizes (Catalog/Reference Number: RCTM-

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Image /page/5/Picture/0 description: The image shows the logo of Access Bio, Inc. The logo features a blue square with a flower-like design inside, and a green leaf on top. Next to the logo is the text "Access Bio, Inc." followed by the address "65 Clyde Rd. Suite A. Somerset, NJ 08873".

ComponentName	Quantity (in a kit)			Description
	Catalog/Product Reference No. ( REF )
	RCTM-00171	RCTM-00271	RCTM-02071
Test Device	1	2	20	Individually foil pouched test cassette.
Dropper Vial	1	2	20	Vial containing the extraction reagent.
Nasal Swab	1	2	20	Sterile swab for anterior nasalspecimen collection.
Quick ReferenceInstructions (QRI)		1		Paper-printed instruction

00171, RCTM-00271 and RCTM-02071).

5. Indications for Use / Intended Use

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All neqative results are presumptive. Symptomatic indivial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test for SARS-CoV-2. Negative results do not rule out SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.

Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or and should not be used to determine any treatments without provider supervision. Individuals who test negative continued or worsening COVID-19 symptoms, such as fever, cough and/or shorthess of breath, should seek follow up care from their healthcare provider.

Contents	Predicate Device	Subject Device
Manufacturer	ACON Laboratories, Inc.	Access Bio, Inc.
Proprietary name	Flowflex COVID-19 Antigen Home Test	CareSuperb™ COVID-19 Antigen Home Test
K Number	K230828	K241915
Product Code	QYT	QYT
Regulation Number	21 CFR 866.3984	21 CFR 866.3984
Regulatory Class	Class II	Class II
Test Principle	Lateral flow immunoassay	Lateral flow immunoassay
Qualitative/Quantitative	Qualitative	Qualitative
Analyte/Assay Target	SARS-CoV-2 nucleocapsid protein antigen	SARS-CoV-2 nucleocapsid protein antigen

Contents	Predicate Device	Subject Device
	The Flowflex COVID-19 Antigen HomeTest is a visually read lateral flowimmunoassay device intended for therapid, qualitative detection of SARS-CoV-2 virus nucleocapsid proteinantigen directly in anterior nasal swabspecimens from individuals with signsand symptoms of COVID-19 within thefirst 6 days of symptom onset.	The CareSuperb™ COVID-19 Antigen HomeTest is a visually read lateral flow immunoassaydevice intended for the rapid, qualitativedetection of SARS-CoV-2 virus nucleocapsidprotein antigen directly in anterior nasal swabspecimens from individuals with signs andsymptoms of COVID-19.
	This test is for non-prescription homeuse by individuals aged 14 years or oldertesting themselves, or adults testingindividuals aged 2 years or older.	This test is for non-prescription home use byindividuals aged 14 years or older testingthemselves, or adults testing individuals aged2 years or older.
	The Flowflex COVID-19 Antigen HomeTest does not differentiate betweenSARS-CoV and SARS-CoV-2.
Intended Use/Indications for Use	All negative results are presumptive.Symptomatic individuals with an initialnegative test result must be re-testedonce between 48 and 72 hours after thefirst test using either an antigen test or amolecular test for SARS-CoV-2.Negative results do not preclude SARS-CoV-2 infections or other pathogens andshould not be used as the sole basis fortreatment.	All negative results are presumptive.Symptomatic individuals with an initialnegative test result must be re-tested oncebetween 48 and 72 hours after the first testusing either an antigen test or a molecular testfor SARS-CoV-2. Negative results do not ruleout SARS-CoV-2 infections or otherpathogens and should not be used as the solebasis for treatment.
	Positive results do not rule out co-infection withother respiratorypathogens.	Positive results do not rule out co-infectionwith other respiratory pathogens.
	Performance characteristics for SARS-CoV-2 were established from December2022 to March 2023 of the SARS-CoV-2 pandemic when SARS-CoV-2 Omicronwas the predominant SARS-CoV-2variant in circulation. When other SARS-CoV-2 virus variants are emerging,performance characteristics may vary.	This test is not a substitute for visits to ahealthcare provider or appropriate follow-upand should not be used to determine anytreatments without provider supervision.Individuals who test negative and experiencecontinued or worsening COVID-19 symptoms,such as fever, cough and/or shortness ofbreath, should seek follow up care from theirhealthcare provider.
	This test is not a substitute for visits to ahealthcare provider or appropriatefollow-up and should not be used todetermine any treatments withoutprovider supervision. Individuals whotest negative and experience continued	Performance characteristics for SARS-CoV-2were established from October 2023 to April2024 when SARS-CoV-2 Omicron variant wasdominant. Test accuracy may change as newSARS-CoV-2 viruses emerge. Additionaltesting with a lab-based molecular test (e.g.,
Contents	Predicate Device	Subject Device
	or worsening COVID-19 like symptoms,such as fever, cough and/or shortness ofbreath, should seek follow up care fromtheir healthcare provider.	PCR) should be considered in situations wherea new virus or variant is suspected.
Intended Use Settings	Over-the-counter use/self-testing	Over-the-counter use/self-testing
Intended Use Population	Individuals with symptoms of COVID-19	Individuals with symptoms of COVID-19
Specimen Type	Direct anterior nasal swab specimen	Direct anterior nasal swab specimen
Development Time	15-30 min	15-30 min
Result Interpretation	Visually Read	Visually Read
Storage Condition	2-30°C	2-30°C
Device Type	Test cartridge (cassette)	Test cartridge (cassette with a sample port)
Extraction Buffer VolumeUsed	4 drops	~250 μL

Comparison with Predicate Device 6.

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Image /page/6/Picture/0 description: The image shows a blue square with a flower design on it. The flower has a pink center and white petals. A green stem and leaf are attached to the top of the square. The image is slightly blurred.

Access Bio, Inc.

65 Clyde Rd. Somerset, NJ 08873 || Tel: (732)-873-4040 || Fax: (732)-873-4043 || info@accessbio.net

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Image /page/7/Picture/0 description: The image shows a blue square with rounded corners, tilted slightly to the left. Inside the square is a stylized flower design with a pink center and white petals. Above the square is a green stem with a leaf, suggesting the flower is attached to it. The overall design appears to be a logo or emblem.

7. Performance Data

7.1. Analytical Performance

Precision (Repeatability/Reproducibility) Study 1)

The precision study was conducted with gamma-irradiated SARS-CoV-2 Omicron B.1.1.529 (hCoV-19/USA/GA-EHC-2811C/2021) diluted into neqative nasal swab matrix and involved testing across multiple operators, sample types, and product lots. Samples were blinded and randomized for testing. The results yielded 100% agreement with the expected results when tested with contrived negative and positive samples at 1.5X, 2X and 4X LoD, 99.8% positivity agreement at 1X LoD, and 92.6% positivity agreement when tested with 0.75X LoD. The results demonstrated that the precision of the device across the operators, runs and days and no significant variability was observed between three independently manufactured lots.

Lot	True Negative	High Negative(0.75X LoD)	Low Positive(1X LoD)	Low Positive(1.5X LoD)	Low Positive(2X LoD)	Moderative Positive(4X LoD)
Lot 1(3 operators)	540/540	167/180	180/180	180/180	180/180	180/180
Lot 2(3 operators)	540/540	164/180	180/180	180/180	180/180	180/180
Lot 3(3 operators)	540/540	169/180	179/180	180/180	180/180	180/180
Total	1620/1620	500/540	539/540	540/540	540/540	540/540
% Agreement	100%	92.6%	99.8%	100%	100%	100%
95% CI	99.8-100.0%	90.1 - 94.5%	99.0 - 100.0%	99.5-100.0%	99.5-100.0%	99.5-100.0%

2) Limit of Detection (LoD)

The LoD of the CareSuperb™ COVID-19 Antigen Home Test was determined by evaluating different dilutions of qamma-irradiated SARS-CoV-2 isolates USA-WA1/2020 and Omicron B.1.1.529 in natural negative swab matrix (NSM).

To determine the preliminary LoD, a 10-fold dilution series was established. 50 µL of each dilution was added to swabs and tested in 5 replicates per the test's instructions for use. The lowest concentration that yielded a positive

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Image /page/8/Picture/1 description: The image shows a logo with a blue square tilted at an angle. Inside the square, there is a stylized flower-like design with white petals and a purple center. A green stem with a leaf extends from the top of the square, adding a natural element to the design. The logo appears to be for a brand or organization, possibly related to nature, flowers, or a product with a floral theme.

Access Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 || Tel: (732)-873-4040 || Fax: (732)-873-4043 || info@accessbio.net

result in all 5 tests from each of 3 product lots tested was the preliminary LoD. The LoD was confirmed by testing the preliminary LoD concentration and additional higher concentrations in 20 replicates using kits from 3 product lots. The lowest concentration resulting in positive detection of ≥ 95% of the replicates (at least 19 out of 20 replicates for each lot) for each strain was confirmed as the LoD.

The 1* WHO International Standard for SARS-CoV-2 Antigen (NIBSC 21/368) was also tested to determine the LoD of the CareSuperb™ COVID-19 Antiqen Home Test. The preliminary LoD was determined by testing a series of 5fold dilutions starting from 4000 IU/mL. 50 µL of each dilution was added to swabs and tested in 5 replicates using a test kit from 1 lot. The LoD was confirmed by testing the preliminary LoD concentration and additional concentrations above and below the preliminary LoD in 20 replicates.

The confirmed LoD concentration is summarized in the table below.

Analyte Strain	LoD Concentration	LoD Concentration per Swab
WA1/2020	2.63 x 102 TCID50/mL	1.32 x 101 TCID50/Swab
Omicron B.1.1.529	1.5 x 102 TCID50/mL	7.5 x 101 TCID50/Swab
WHO Standard (NIBSC 21/368)	32 IU/mL	1.6 IU/swab

3) Hook Effect Study

No hook effect was observed when SARS-CoV-2 WA1/2020 and Omicron B.1.1.529 were tested at concentrations up to 4.0 x 105 and 7.5 x 105 TCID50/mL, respectively.

4) Cross Reactivity/Microbial Interference Study

To evaluate the potential cross-reactivity and microbial interference of the CareSuperb™ COVID-19 Antigen Home Test, 18 non-SARS-CoV-2 viruses and 10 other microorganisms were diluted into negative NSM at high concentrations. Nasal wash was tested as representative of normal respiratory microbial flora. Organisms and viruses were each tested in three replicates in the absence or presence of gamma-irradiated SARS-CoV-2. Both, WA 1/2020 and Omicron B.1.1.529 were tested, each at their respective 2x LoD concentration (5.2 x 102 and 3.0 x 103 TCIDgo mL). Based on the test results summarized in table below, none of the organisms and viruses tested showed cross-reactivity or interference with the device at the concentrations tested.

Microorganism/Virus	Testing Concentration	Cross-Reactivity(Yes/No)	Interference(Yes/No)
Adenovirus 1	1.58 x 105 TCID50/mL	No	No
Adenovirus 7	1.6 x 105 TCID50/mL	No	No
Enterovirus	1.6 x 106 TCID50/mL	No	No
Human coronavirus (OC43)	1.4 x 105 TCID50/mL	No	No
Human coronavirus (229E)	2.8 x 104 TCID50/mL	No	No
Human coronavirus (NL63)	8.0 x 104 TCID50/mL	No	No
Human metapneumovirus (hMPV)	2.8 x 105 TCID50/mL	No	No
Influenza A Virus (H3N2)	3.5 x 105 FFU/mL	No	No
Influenza B Virus (Yamagata)	7.6 x 105 TCID50/mL	No	No
MERS-CoV	1.78 x 105 TCID50/mL	No	No
Parainfluenza virus type 1	7.4 x 105 TCID50/mL	No	No
Parainfluenza virus type 2	1.58 x 105 TCID50/mL	No	No
Parainfluenza virus type 3	1.58 x 105 TCID50/mL	No	No

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Image /page/9/Picture/0 description: The image shows a blue square with a flower design on it. The flower has a pink center and white petals. A green stem is attached to the top of the square, giving it the appearance of a tag or label. The design is simple and colorful.

Microorganism/Virus	Testing Concentration	Cross-Reactivity(Yes/No)	Interference(Yes/No)
Parainfluenza virus type 4	5.0 x 105 TCID50/mL	No	No
Respiratory syncytial virus Type B	1.58 x 105 TCID50/mL	No	No
Rhinovirus	1.58 x 105 TCID50/mL	No	No
SARS-Coronavirus	1.0 x 105 PFU/mL	No	No
Human coronavirus HKU1	Clinical Samplea	No	No
Bordetella pertussis	1.0 x 107 CFU/mL	No	No
Chlamydophila pneumoniae	1.4 x 106 CFU/mL	No	No
Haemophilus influenzae	1.6 x 106 CFU/mL	No	No
Legionella pneumophila	1.4 x 106 CFU/mL	No	No
Mycoplasma pneumoniae	6.5 x 105 CFU/mL	No	No
Streptococcus pneumoniae	1.0 x 107 CFU/mL	No	No
Streptococcus pyogenes, Group A	1.0 x 107 CFU/mL	No	No
Staphylococcus aureus	1.0 x 107 CFU/mL	No	No
Staphylococcus epidermidis	1.0 x 107 CFU/mL	No	No
Candida albicans	1.0 x 107 CFU/mL	No	No
Pooled human nasal wash	N/A	No	No

ª 10-fold dilution of the stock Human Coronavirus HKU1) clinical sample was tested in triplicates in the presence and absence of SARS-CoV-2. The Ct value of the undiluted sample was 11.7.

5) Interfering Substances Effect Study

To evaluate the potential interfering effect of natural or artificial substances to the CareSuperb™ COVID-19 Antigen Home Test, 42 interfering substances were diluted into negative NSM. Each substance was tested in three replicates in the absence or presence of two gamma-irradiated SARS-CoV-2 strains, WA1/2020 and Omicron B.1.1.529, each at their 2x LoD concentration (5.2 x 102 and 3.0 x 102 TCIDs/mL). Based on the test results summarized in table below, none of the endogenous substances tested showed cross-reactivity or interference with the assay at the concentrations tested.

Substances	Testing Concentration	Cross-Reactivity(Yes/No)	Interference(Yes/No)
Acetaminophen	10 mg/mL	No	No
Acetyl salicylic acid	15 mg/mL	No	No
Beconase AQ Nasal Spray (Beclomethasone)	5 mg/mL	No	No
Benzocaine	5 mg/mL	No	No
Budesonide	2 mg/mL	No	No
Chlorpheniramine maleate	5 mg/mL	No	No
Dexamethasone	1 mg/mL	No	No
Dextromethorphan HBr	2 mg/mL	No	No
Diphenhydramine HCI	5 mg/mL	No	No
Nasarel Nasal Spray (Flunisolide)	5 mg/mL	No	No
Fluticasone	1 mg/mL	No	No
Guaiacol Glyceryl Ether	20 mg/mL	No	No
Histamine Dihydrochloride	10 mg/mL	No	No
Menthol	10 mg/mL	No	No
Substances	Testing Concentration	Cross-Reactivity(Yes/No)	Interference(Yes/No)
Mometasone	1 mg/mL	No	No
Molnupiravir	1 mg/mL	No	No
Mucin (Bovine submaxillary glands -Type I-S)	2.5 mg/mL	No	No
Mupirocin	1 mg/mL	No	No
Phenylpropanolamine	5 mg/mL	No	No
Remdesivir	1 mg/mL	No	No
Tamiflu (Oseltamivir Phosphate)	5 mg/mL	No	No
Tobramycin	1 mg/mL	No	No
Triamcinolone	1 mg/mL	No	No
Zanamivir	1 mg/mL	No	No
Sore Throat Spray (Phenol)	15 % v/v	No	No
Zicam Oral Mist (Zincum aceticum, Zincumgluconicum)	15 % v/v	No	No
Nasal Spray (Phenylephrine HCI)	15 % v/v	No	No
NasalCrom Nasal Spray (Cromolyn sodium)	15 % v/v	No	No
Vicks Sinex Nasal spray (Oxymetazoline HCI)	15 % v/v	No	No
Alkalol Allergy Relief (Galphimia glauca, Luffaoperculate, Sabadilla)	15 % v/v	No	No
Zicam Allergy Relief (Galphimia glauca, Histaminumhydrochloricum, Luffa operculate, Sulphur)	15 % v/v	No	No
Hand Sanitizer	15 % v/v	No	No
Hand Soap	15 % v/v	No	No
Whole blood	2.5 % v/v	No	No
Buffy coat	2.5 % v/v	No	No
Allergy Spray (Mometasone Furoate)	15 % v/v	No	No
Budesonide Nasal Spray(Budesonide/Glucocorticoid)	15 % v/v	No	No
Nasacort Allergy 24HR (Triamcinolone acetonide)	15 % v/v	No	No
Allergy Relief Nasal Spray (Fluticasone Propionate)	15 % v/v	No	No
Saline Nasal Spray (Sodium Chloride &Preservatives)	15 % v/v	No	No
Alkalol Saline Nasal Spray (Sodium Chloride,Menthol, Thymol, Camphor, Benzoin Resin Extract,Oils of Eucalyptus, Wintergreen, Spearmint, FirNeedle, Cinnamon & Preservatives)	15 % v/v	No	No
Leukocytes	5.0 x 106 cells/ml	No	No

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Image /page/10/Picture/0 description: The image shows a logo with a blue square shape. The square has rounded corners and a white flower design on it. The flower has a purple center and six white petals. The number "23" is written in white on the top left corner of the square. A green stem with a leaf is attached to the top of the square.

6) Biotin Interference Study

A potential interference effect of biotin to the CareSuperb™ COVID-19 Antigen Home Test was tested and false negative results were obtained when the biotin concentration in the positive samples exceeded 2,500 ng/mL.

Inclusivity (Analytical Reactivity) Study 7)

To evaluate the analytical reactivity of the CareSuperb™ COVID-19 Antigen Home Test, additional 7 strains of SARS-CoV-2 variants were tested in a dilution series using contrived samples and the lowest concentration that yielded

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Image /page/11/Picture/0 description: The image shows a blue square with a flower design on it. The flower has white petals and a pink center. A green stem is attached to the top of the square, resembling a tag or label. The design is simple and colorful.

SARS-CoV-2 Variants	Lowest concentration with 5/5 positive replicates(TCID50/mL)
SARS-Co V-2, hCoV-1 9/USA/CA; CDC_5574/2020; Alpha variant	4.00 x $10^2$
SARS-Co V-2, Lineage B.1.617.2; Delta Variant	1.41 x $10^3$
SARS-CoV-2, Lineage BA.2.12.1; Omicron Variant	2.02 x $10^3$
SARS-CoV-2, Lineage BA.2.3; Omicron Variant	1.87 x $10^2$
SARS-CoV-2, Lineage BA.2.75.5; Omicron Variant	2.72 x $10^2$
SARS-Co V-2, Lineage BA.4.6; Omicron Variant	1.84 x $10^3$
SARS-CoV-2 Lineage JN.1.4; Omicron Variant	6.74 x $10^2$

100% positive results for each strain is summarized in table below.

8) Flex Studies

To assess the robustness of the CareSuperb™ COVID-19 Antigen Home Test, flex studies were conducted that assessed all major aspects of the test procedure for potential sources of error that may occur when (1) performing the test (e.g., different reading times, extraction buffer volume variability, delay in swab collection into sample port, delay in addition of extraction buffer after swab insertion into sample port, swab rotation variability after insertion into sample port, delay in removing swab after rotation, delay in initiating testing pouch, variations of swab insertion into sample port) and (2) when environmental test conditions that the test may be subjected to when in use vary (e.q., various temperature and humidity stress, cassette on non-level surface, cassette disturbance, impact of different light sources). Testing was performed positive nasal swabs prepared by diluting gamma-irradiated SARS-CoV-2 virus (WA1/2020 and Omicron B.1.1.529) into NSM at 2X LoD and neqative samples (NSM). The studies support that the test is robust in the intended use condition with an insignificant risk of erroneous results.

7.2. Clinical Performance

The clinical performance characteristics of the CareSuperb™ COVID-19 Antigen Home Test using anterior nasal swab specimen were evaluated at 10 clinical sites in the U.S. between October 2023 and April 2024 against an FDA-cleared molecular assay as a comparator method. Subjects self-sampled and self-tested using the CareSuperb™ COVID-19 Antigen Home Test in a simulated home setting utilizing only the labeling provided with the test. A total of 646 symptomatic subjects within 4 days post symptom onset were evaluated in this study. The CareSuperb™ COVID-19 Antigen Home Test when conducted by a lay user correctly identified 97.2% of positive samples and 98.8% of negative samples. All discrepant results were investigated by testing using an alternative FDA-cleared molecular assay at the central laboratory. The overall clinical performance is shown in the following tables.

CareSuperb ™ COVID-19Antigen Home Test	FDA-cleared Molecular Assay
	Positive	Negative	Total
Positive	140	6a	146
Negative	4b	496	500
Total	144	502	646c
Positive Percent Agreement	97.2% (140/144) (95% CI:93.1%-98.9%)
Negative Percent Agreement	98.8% (496/502) (95% CI:97.4%-99.5%)

CareSuperb™ COVID-19 Antigen Home Test clinical performance against the comparator method

COVID-19 was detected in 6 / 6 False Positive specimens using the alternative FDA cleared RT-PCR assay COVID-19 was not detected in 0 / 4 False Negative specimens using the alternative FDA cleared RT-PCR assay One test was invalid and upon repeat testing a valid result was obtained.

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CareSuperb™ COVID-19 Antigen Home Test
Age Group	Female	Male	Positivity Rate %
2 - 13 Years of Age	34	31	7.7% (5/65)
14 - 21 Years of Age	22	18	25.0% (10/40)
22 - 64 Years of Age	282	199	23.7% (114/481)
≥65 Years of Age	37	23	28.3% (17/60)
Total	375	271	22.6% (146/646)

Patient Demographics

Results are broken down by days post symptom onset (DPSO)

DPSO	Positive Percent Agreement	Negative Percent Agreement
0	100.0% (1/1) (95% CI:20.7% - 100.0%)	88.9% (8/9) (95% CI:56.5% - 98.0%)
1	100.0% (21/21) (95% CI:84.5% - 100.0%)	99.1% (110/111) (95% CI:95.1% - 99.8%)
2	98.0% (49/50) (95% CI:89.5% - 99.6%)	100.0% (196/196) (95% CI:98.1% - 100.0%)
3	100.0% (48/48) (95% CI:92.6% - 100.0%)	99.2% (131/132) (95% CI:95.8% - 99.9%)
4	87.5% (21/24) (95% CI:69.0% - 95.7%)	94.4% (51/54) (95% CI:84.9% - 98.1%)

7.3. Usability Study

A usability study was conducted to assess the lay user's ability to understand the IFU of the CareSuperb™ COVID-19 Antigen Home Test and to perform testing using the components provided in the test kit in simulated setting of the intended use. Fifty users participated in the study and the overall success rate for all critical tasks was ≥ 80% demonstrating that the users sufficiently comprehended the test procedure described in the IFU and were able to use the device safely and effectively.

7.4. Readability Study

The purpose of this study was to assess users' comprehension of positive, negative, and invalid test results for the CareSuperb™ COVID-19 Antigen Home Test. Two panels of mock devices with results were prepared, the first panel comprising a negatives (1.5 to 2x LoD) and a positive (5x LoD) and the second one comprising two negatives, one low positive (1.5 to 2x LoD) and a positive (5x LoD). The panels were randomized, and each study participant was given one of the panels and asked to interpret the IFU. Fifty users participated in the study and the overall success rate for both panels was 95.0% demonstrating that the users were able to competently interpret the results for the CareSuperb™ COVID-19 Antigen Home Test with the IFU.

7.5. Conclusion

These studies demonstrated equivalent performance of the CareSuperb™ COVID-19 Antigen Home Test to the predicate device, Flowflex COVID-19 Antigen Home Test (K230828).

Regulation Number and Section

N/A