K Number
K241915
Device Name
CareSuperb™ COVID-19 Antigen Home Test
Manufacturer
Date Cleared
2025-01-29

(212 days)

Product Code
Regulation Number
866.3984
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The device description and performance studies focus on a traditional lateral flow immunoassay, which relies on chemical reactions and visual interpretation, not AI/ML for result determination. There is no mention of AI, ML, or image processing in the summary.

No.
The device is an in-vitro diagnostic test intended for the detection of SARS-CoV-2 antigens, providing diagnostic information, but it is explicitly stated that it "should not be used to determine any treatments without provider supervision" and is "not a substitute for visits to a healthcare provider or appropriate follow-up." This indicates it does not directly provide therapy or treatment.

Yes

Explanation: The device is intended for the "rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen" to identify individuals with COVID-19, which is a diagnostic purpose.

No

The device is a lateral flow immunoassay, which is a physical test kit that uses chemical reactions to detect the presence of an antigen. It is not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's for the "rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens". This is a diagnostic purpose, aiming to identify the presence of a specific substance (SARS-CoV-2 antigen) in a biological sample (nasal swab) to aid in the diagnosis of COVID-19.
  • Device Description: The description details a "lateral flow immunoassay device intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein in anterior nasal samples." This describes a test performed in vitro (outside the body) on a biological specimen.
  • Mechanism of Action: The description explains how the test works by detecting antigens in the sample through an immunoassay process, which is a common method used in IVD tests.
  • Clinical Performance Studies: The document includes details about clinical performance studies where the device was evaluated against a comparator method using human samples. This is a standard requirement for demonstrating the performance of an IVD.
  • Key Metrics: The document provides key metrics like Positive Percent Agreement and Negative Percent Agreement, which are used to assess the performance of diagnostic tests.

All these elements align with the definition and characteristics of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes

QYT

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 guardian), 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior nasal swab specimens

Indicated Patient Age Range

individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

Intended User / Care Setting

non-prescription home use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Analytical Performance

  1. Precision (Repeatability/Reproducibility) Study:

    • Study Type: Precision/Repeatability/Reproducibility study.
    • Sample Size: Total 1620 true negative, 540 high negative, 540 low positive (1X LoD), 540 low positive (1.5X LoD), 540 low positive (2X LoD), 540 moderate positive (4X LoD) samples tested across 3 operators and 3 product lots.
    • Description: Conducted with gamma-irradiated SARS-CoV-2 Omicron B.1.1.529 diluted into negative nasal swab matrix. Involved testing across multiple operators, sample types, and product lots. Samples were blinded and randomized.
    • Key Results:
      • 100% agreement with expected results for 1.5X, 2X, and 4X LoD.
      • 99.8% positivity agreement at 1X LoD.
      • 92.6% positivity agreement at 0.75X LoD.
      • No significant variability observed between the three independently manufactured lots.
  2. Limit of Detection (LoD):

    • Study Type: LoD determination study.
    • Description: Evaluated different dilutions of gamma-irradiated SARS-CoV-2 isolates USA-WA1/2020 and Omicron B.1.1.529 in natural negative swab matrix (NSM). Preliminary LoD determined by 10-fold dilution series, 5 replicates. Confirmed by testing at least 19 out of 20 replicates for each lot. Also tested with 1st WHO International Standard for SARS-CoV-2 Antigen (NIBSC 21/368).
    • Key Results:
      • 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)
  3. Hook Effect Study:

    • Study Type: Hook effect study.
    • Description: Tested SARS-CoV-2 WA1/2020 and Omicron B.1.1.529 at high concentrations.
    • Key Results: No hook effect observed up to 4.0 x 10^5 TCID50/mL for WA1/2020 and 7.5 x 10^5 TCID50/mL for Omicron B.1.1.529.
  4. Cross Reactivity/Microbial Interference Study:

    • Study Type: Cross-reactivity and microbial interference study.
    • Description: Tested 18 non-SARS-CoV-2 viruses and 10 other microorganisms diluted into negative NSM at high concentrations, in the absence or presence of gamma-irradiated SARS-CoV-2 (WA 1/2020 and Omicron B.1.1.529) at 2x LoD. Nasal wash tested as representative of normal respiratory microbial flora.
    • Key Results: None of the organisms and viruses tested showed cross-reactivity or interference with the device at the concentrations tested.
  5. Interfering Substances Effect Study:

    • Study Type: Interfering substances effect study.
    • Description: Tested 42 interfering substances diluted into negative NSM, in the absence or presence of two gamma-irradiated SARS-CoV-2 strains (WA1/2020 and Omicron B.1.1.529) at their 2x LoD concentration.
    • Key Results: None of the endogenous substances tested showed cross-reactivity or interference with the assay at the concentrations tested.
  6. Biotin Interference Study:

    • Study Type: Biotin interference study.
    • Key Results: False negative results obtained when biotin concentration in positive samples exceeded 2,500 ng/mL.
  7. Inclusivity (Analytical Reactivity) Study:

    • Study Type: Analytical reactivity study.
    • Description: Tested 7 additional strains of SARS-CoV-2 variants in a dilution series using contrived samples.
    • Key Results: Determined the lowest concentration for 100% positive results for each variant (e.g., SARS-CoV-2, hCoV-19/USA/CA; CDC_5574/2020; Alpha variant at 4.00 x 10^2 TCID50/mL).
  8. Flex Studies:

    • Study Type: Robustness flex studies.
    • Description: Assessed major aspects of the test procedure for potential sources of error during test performance (e.g., reading times, buffer volume, swab handling delays) and environmental conditions (temperature, humidity, non-level surface, light sources). Tested with positive nasal swabs (WA1/2020 and Omicron B.1.1.529 at 2X LoD) and negative samples.
    • Key Results: Studies support that the test is robust in the intended use condition with insignificant risk of erroneous results.

Clinical Performance

  • Study Type: Clinical performance evaluation against an FDA-cleared molecular assay.
  • Sample Size: 646 symptomatic subjects within 4 days post symptom onset.
  • Data Source: 10 clinical sites in the U.S. between October 2023 and April 2024.
  • Description: Subjects self-sampled and self-tested in a simulated home setting using only the provided labeling. All discrepant results were investigated by an alternative FDA-cleared molecular assay.
  • Key Results: The CareSuperb™ COVID-19 Antigen Home Test correctly identified 97.2% of positive samples and 98.8% of negative samples.
    • 146 Positive results (140 true positives, 6 false positives).
    • 500 Negative results (4 false negatives, 496 true negatives).
    • 6/6 False Positive specimens were detected as COVID-19 using the alternative RT-PCR assay.
    • 0/4 False Negative specimens were not detected as COVID-19 using the alternative RT-PCR assay.
  • Results by Days Post Symptom Onset (DPSO):
    • DPSO 0: Positive Percent Agreement 100.0% (1/1), Negative Percent Agreement 88.9% (8/9)
    • DPSO 1: Positive Percent Agreement 100.0% (21/21), Negative Percent Agreement 99.1% (110/111)
    • DPSO 2: Positive Percent Agreement 98.0% (49/50), Negative Percent Agreement 100.0% (196/196)
    • DPSO 3: Positive Percent Agreement 100.0% (48/48), Negative Percent Agreement 99.2% (131/132)
    • DPSO 4: Positive Percent Agreement 87.5% (21/24), Negative Percent Agreement 94.4% (51/54)

Usability Study

  • Study Type: Usability study.
  • Sample Size: 50 users.
  • Description: Assessed lay user's ability to understand the IFU and perform testing in a simulated setting.
  • Key Results: Overall success rate for all critical tasks was ≥ 80%.

Readability Study

  • Study Type: Readability study.
  • Sample Size: 50 users.
  • Description: Assessed users' comprehension of positive, negative, and invalid test results using two panels of mock devices.
  • Key Results: Overall success rate for both panels was 95.0%.

Key Metrics

  • 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%)

Predicate Device(s)

K230828

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

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"

1

(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).

2

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

3

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.

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.

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)
------------------------------------------------------------------------------

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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.

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.

4.1. Kit Components:

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

5

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".

| Component

NameQuantity (in a kit)Description
Catalog/Product Reference No. ( REF )
RCTM-00171RCTM-00271RCTM-02071
Test Device1220Individually foil pouched test cassette.
Dropper Vial1220Vial containing the extraction reagent.
Nasal Swab1220Sterile swab for anterior nasal
specimen collection.
Quick Reference
Instructions (QRI)1Paper-printed instruction

00171, RCTM-00271 and RCTM-02071).

5. Indications for Use / Intended Use

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 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.

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.

ContentsPredicate DeviceSubject Device
ManufacturerACON Laboratories, Inc.Access Bio, Inc.
Proprietary nameFlowflex COVID-19 Antigen Home TestCareSuperb™ COVID-19 Antigen Home Test
K NumberK230828K241915
Product CodeQYTQYT
Regulation Number21 CFR 866.398421 CFR 866.3984
Regulatory ClassClass IIClass II
Test PrincipleLateral flow immunoassayLateral flow immunoassay
Qualitative/QuantitativeQualitativeQualitative
Analyte/Assay TargetSARS-CoV-2 nucleocapsid protein antigenSARS-CoV-2 nucleocapsid protein antigen
ContentsPredicate DeviceSubject Device
The Flowflex 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 within the
first 6 days of symptom onset.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.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.
The Flowflex COVID-19 Antigen Home
Test does not differentiate between
SARS-CoV and SARS-CoV-2.
Intended Use/
Indications for UseAll 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 preclude SARS-
CoV-2 infections or other pathogens and
should not be used as the sole basis for
treatment.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.Positive results do not rule out co-infection
with other respiratory pathogens.
Performance characteristics for SARS-
CoV-2 were established from December
2022 to March 2023 of the SARS-CoV-
2 pandemic when SARS-CoV-2 Omicron
was the predominant SARS-CoV-2
variant in circulation. When other SARS-
CoV-2 virus variants are emerging,
performance characteristics may vary.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.
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 continuedPerformance 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.,
ContentsPredicate DeviceSubject Device
or worsening COVID-19 like symptoms,
such as fever, cough and/or shortness of
breath, should seek follow up care from
their healthcare provider.PCR) should be considered in situations where
a new virus or variant is suspected.
Intended Use SettingsOver-the-counter use/self-testingOver-the-counter use/self-testing
Intended Use PopulationIndividuals with symptoms of COVID-19Individuals with symptoms of COVID-19
Specimen TypeDirect anterior nasal swab specimenDirect anterior nasal swab specimen
Development Time15-30 min15-30 min
Result InterpretationVisually ReadVisually Read
Storage Condition2-30°C2-30°C
Device TypeTest cartridge (cassette)Test cartridge (cassette with a sample port)
Extraction Buffer Volume
Used4 drops~250 μL

Comparison with Predicate Device 6.

6

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Access Bio, Inc.

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

7

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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

8

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 StrainLoD ConcentrationLoD Concentration per Swab
WA1/20202.63 x 102 TCID50/mL1.32 x 101 TCID50/Swab
Omicron B.1.1.5291.5 x 102 TCID50/mL7.5 x 101 TCID50/Swab
WHO Standard (NIBSC 21/368)32 IU/mL1.6 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, Zincum
gluconicum) | 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, Luffa
operculate, Sabadilla) | 15 % v/v | No | No |
| Zicam Allergy Relief (Galphimia glauca, Histaminum
hydrochloricum, 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, Fir
Needle, Cinnamon & Preservatives) | 15 % v/v | No | No |
| Leukocytes | 5.0 x 106 cells/ml | No | No |

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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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| 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-19

Antigen Home TestFDA-cleared Molecular Assay
PositiveNegativeTotal
Positive1406a146
Negative4b496500
Total144502646c
Positive Percent Agreement97.2% (140/144) (95% CI:93.1%-98.9%)
Negative Percent Agreement98.8% (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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Image /page/12/Picture/0 description: The image shows a logo with a blue square containing a stylized flower with a pink center and blue petals. To the left of the square is a green leaf. To the right of the logo is the letter 'A' underlined, followed by the number '65'.

CareSuperb™ COVID-19 Antigen Home Test
Age GroupFemaleMalePositivity Rate %
2 - 13 Years of Age34317.7% (5/65)
14 - 21 Years of Age221825.0% (10/40)
22 - 64 Years of Age28219923.7% (114/481)
≥65 Years of Age372328.3% (17/60)
Total37527122.6% (146/646)

Patient Demographics

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

DPSOPositive Percent AgreementNegative Percent Agreement
0100.0% (1/1) (95% CI:20.7% - 100.0%)88.9% (8/9) (95% CI:56.5% - 98.0%)
1100.0% (21/21) (95% CI:84.5% - 100.0%)99.1% (110/111) (95% CI:95.1% - 99.8%)
298.0% (49/50) (95% CI:89.5% - 99.6%)100.0% (196/196) (95% CI:98.1% - 100.0%)
3100.0% (48/48) (95% CI:92.6% - 100.0%)99.2% (131/132) (95% CI:95.8% - 99.9%)
487.5% (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).