(179 days)
Not Found
No
The device description and performance studies focus on lateral flow immunoassay technology and visual interpretation of results, with no mention of AI, ML, or image processing.
No
The device is strictly for diagnostic purposes (detection of SARS-CoV-2 antigen) and the text explicitly states it should not be used to determine any treatments.
Yes
The iHealth COVID-19 Antigen Rapid Test is intended for the "rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen," 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 analyte (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" that uses a "reagent" to interact with a "specimen" to detect "viral antigens". This is a classic description of an in vitro diagnostic test that analyzes a sample outside of the body.
- Performance Studies: The document includes detailed performance studies (Precision/Reproducibility, Limit of Detection, Cross Reactivity, Endogenous Interfering Substances, Hook Effect, Inclusivity, Flex Studies, and Clinical Testing) which are standard for evaluating the performance of an IVD.
- Key Metrics: The document provides key metrics like Positive Agreement and Negative Agreement, which are used to assess the accuracy of a diagnostic test.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device fits that definition perfectly by testing a nasal swab specimen to detect the presence of SARS-CoV-2 antigen.
N/A
Intended Use / Indications for Use
The iHealth COVID-19 Antigen Rapid Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 6 days from symptom onset. This test is for nonprescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.
The iHealth COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.
All negative results are presumptive. Symptomatic individuals with an initial neqative 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. 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 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from October 2022 to June 2023 when the COVID-19 variant Omicron 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 iHealth COVID-19 Antigen Rapid Test employs lateral flow immunoassay technology. Using this test allows for the rapid detection of nucleocapsid protein from SARS-CoV-2.
To begin the test, a self-collected anterior nares swab sample in individuals aged 15 and older or individuals between the age of 2 to 14 with a swab collected by a parent or quardian is inserted into a tube that has been pre-filled with reagent. The reagent in the tube interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The liguid in the tube, now containing the specimen, is added to the Sample Port of the COVID-19 Test Card.
If the extracted specimen contains SARS-CoV-2 antigens, a pink-to-purple T Line, along with a pink-to-purple C Line will appear on the COVID-19 Test Card indicating a positive result. If SARS-CoV-2 antigens are not present at very low levels, only a pinkto-purple C Line will appear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior nasal (nares) swab specimens
Indicated Patient Age Range
individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.
Intended User / Care Setting
nonprescription home use / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility Study:
- Sample Size: 405 (135/site x 3 sites) for each of 3 levels (Negative, Low positive, Positive).
- Data Source: Contrived samples using heat-inactivated SARS-CoV-2 spiked in negative clinical matrix (NCM).
- Annotation Protocol: Not specified beyond "agreement of obtained results with expected results."
- Key Results: 100% agreement for all samples across all lots, operators, and days. No variability observed between the three independently manufactured lots.
Limit of Detection (LOD) Study:
- Sample Size: Initial 5 replicates per concentration, followed by 20 replicates for confirmation.
- Data Source: Heat-inactivated SARS-CoV-2 virus (BA.5. Omicron Variant) spiked into negative clinical matrix (raw nasal fluid in saline) and 1st WHO International Standard for SARS-CoV-2 Antigen (NIBSC 21/368).
- Annotation Protocol: Testing was performed through the full assay workflow, from processing in the extraction reagent to reading the test result. LoD was determined as the lowest virus concentration detected ≥ 95% of the time (at least 19 out of 20 replicates tested positive).
- Key Results:
- LOD in natural nasal swab matrix: 1.33 x 10^4 TCID50/mL (665 TCID50/swab).
- LOD with WHO Standard (NIBSC 21/368): 4.00 x 10^2 IU/mL (20 IU/swab).
Cross Reactivity (Analytical Specificity) and Microbial Interference Study:
- Sample Size: 5 replicates for each organism/virus.
- Data Source: 53 commensal and pathogenic microorganisms (22 bacteria and 31 viruses) tested in the absence or presence of heat-inactivated SARS-CoV-2 virus (BA.5. Omicron Variant) at approximately 2x LoD.
- Annotation Protocol: Not explicitly detailed, but involved testing and observation for cross-reactivity or interference.
- Key Results: No cross-reactivity or interference was observed with the microorganisms tested.
Endogenous Interfering Substances Study:
- Sample Size: 5 replicates per substance.
- Data Source: 31 potentially interfering substances, some naturally present in respiratory specimens or artificially introduced, evaluated with SARS-CoV-2 target at approximately 2x LoD.
- Annotation Protocol: Not explicitly detailed, but involved testing and demonstration of performance not being affected.
- Key Results: The device performance was not affected by any of the 31 potentially interfering substances at the tested concentrations; all samples produced expected results.
Hook Effect Study:
- Sample Size: Not specified.
- Data Source: SARS-CoV-2 target at 3.98 x 10^6 TCID50/mL (300x LoD).
- Annotation Protocol: Not specified.
- Key Results: No Hook effect observed at 300x LoD, which was the highest concentration tested.
Inclusivity (Analytical Reactivity) Study:
- Sample Size: Not specified, but "5/5 positive replicates" mentioned for lowest concentration.
- Data Source: 14 strains of SARS-CoV-2 representing temporal, geographic, and genetic diversity (e.g., USA-WA1/2020, Alpha, Beta, Gamma, Delta, various Omicron variants).
- Annotation Protocol: Not specified.
- Key Results: The lowest variant concentrations with 5/5 positive replicates were determined for each of the 14 SARS-CoV-2 variants, confirming inclusivity.
Flex Studies:
- Sample Size: Not specified.
- Data Source: Contrived positive nasal swabs prepared by diluting heat-inactivated SARS-CoV-2 virus into negative clinical nasal swab matrix at 2x LoD.
- Annotation Protocol: Assessed major aspects of the test procedure (swab extraction time, drops, development time, delay in analysis, agitation) and environmental conditions (temperature, humidity, cassette disturbance, sample/reagent temperature, lighting).
- Key Results: Studies support the test is robust in the intended use condition with an insignificant risk of erroneous results.
Clinical Testing Summary:
- Study Type: Clinical performance evaluation.
- Sample Size: 915 individuals with signs and symptoms of COVID-19 within the first 6 days of symptom onset.
- Data Source: Real-world anterior nasal swab samples, self-collected by individuals >=15 years old or collected by parents for individuals 2-14 years old.
- Annotation Protocol: Test results compared to a highly sensitive molecular FDA EUA Authorized SARS-CoV-2 assay (comparator method).
- Key Results:
- Positive Agreement (Sensitivity): (104/117) 88.9% (95% CI: 81.9% to 93.4%)
- Negative Agreement (Specificity): (797/798) 99.9% (95% CI: 99.3% to 100.0%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement: (104/117) 88.9% 95% Confidence Interval: 81.9% to 93.4%
Negative Agreement: (797/798) 99.9%; 95% Confidence Interval: 99.3% to 100.0%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
May 31, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a circular seal with an abstract image of an eagle or a similar bird-like figure, surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA". To the right of the seal, there is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue, with "ADMINISTRATION" appearing in a smaller font size below "FOOD & DRUG".
Tianyang Liu Director of Regulatory and Policy 880 W Maude Ave Sunnyvale, California 94085
Re: K233842
Trade/Device Name: iHealth COVID-19 Antigen Rapid 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: December 4, 2023 Received: December 4, 2023
Dear Tianyang Liu:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 QS 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.
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).
Sincerely,
Digitally signed by Silke Silke Schlottmann -S Schlottmann -S Date: 2024.05.31 15:51:47
Silke Schlottmann, 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
2
3
Indications for Use
510(k) Number (if known) K233842
Device Name iHealth COVID-19 Antigen Rapid Test
Indications for Use (Describe)
The iHealth COVID-19 Antigen Rapid 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. This test is for nonprescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.
The iHealth COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV-2.
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 preclude SARS-CoV-2 infections or other pathogens and should not be used as 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 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from October 2022 to June 2023 when the COVID-19 variant Omicron 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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4
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | iHealth Labs, Inc. |
|---|---|
| Address: | 880W Maude Ave Sunnyvale, CA 94085 USA |
| Phone number: | (408) 398 0318 |
| Contact: | Tianyang Liu |
| Contact email: | policy@ihealthlabs.com |
| Date Prepared: | May 31, 2024 |
2.0 Device Information
Device trade name: iHealth COVID-19 Antigen Rapid Test Device Common Name: Coronavirus Antigen Detection Test
3.0 Classification
| Product code: | QYT |
|---|---|
| Classification Regulation: | 21 CFR 866.3984 - Over-The-Counter Test To Detect |
| SARS-Cov-2 From Clinical Specimens | |
| Classification: | Class II |
| Review Panel: | Microbiology |
4.0 Predicate Device Information
| 510(k) number | K230828 |
|---|---|
| Manufacturer | ACON Laboratories,Inc |
| Trade/Proprietary Name | Flowflex COVID-19 Antigen Home Test |
| Classification | |
| Regulation | 21 CFR 866.3984 - Over-The-Counter Test To |
| Detect SARS-CoV-2 From Clinical Specimens | |
| Classification | Class II |
| Product Code | QYT |
5
5.0 Device Description
The iHealth COVID-19 Antigen Rapid Test employs lateral flow immunoassay technology. Using this test allows for the rapid detection of nucleocapsid protein from SARS-CoV-2.
To begin the test, a self-collected anterior nares swab sample in individuals aged 15 and older or individuals between the age of 2 to 14 with a swab collected by a parent or quardian is inserted into a tube that has been pre-filled with reagent. The reagent in the tube interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The liguid in the tube, now containing the specimen, is added to the Sample Port of the COVID-19 Test Card.
If the extracted specimen contains SARS-CoV-2 antigens, a pink-to-purple T Line, along with a pink-to-purple C Line will appear on the COVID-19 Test Card indicating a positive result. If SARS-CoV-2 antigens are not present at very low levels, only a pinkto-purple C Line will appear.
6.0 Intended Use
The iHealth COVID-19 Antigen Rapid Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 6 days from symptom onset. This test is for nonprescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.
The iHealth COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.
All negative results are presumptive. Symptomatic individuals with an initial neqative 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. 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 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from October 2022 to June 2023 when the COVID-19 variant Omicron 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.
6
7.0 Comparison with Predicate Device
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Product Name | iHealth COVID-19 Antigen Rapid Test | Flowflex COVID-19 Antigen Home Test |
| 510(K) Number | K233842 | K230828 |
| Product Code | QYT | QYT |
| Regulation Number | 21 CFR 866.3984 | 21 CFR 866.3984 |
| Regulatory Class | Class II | Class II |
| Assay Target | COVID-19 nucleocapsid protein antigen | COVID-19 nucleocapsid protein antigen |
| Intended Use | The iHealth COVID-19 Antigen Rapid Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 6 days from symptom onset. This test is for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older. | 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. 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 iHealth COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. | The Flowflex COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS CoV-2. | |
| 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 preclude 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. | 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-CoV2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out coinfection 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 | 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 | |
| Characteristics | Subject Device | Predicate Device |
| test negative and experience | ||
| continued or worsening COVID-19 | ||
| like symptoms, such as fever, cough | ||
| and/or shortness of breath, should | ||
| seek follow up care from their | ||
| healthcare provider. | provider supervision. Individuals who | |
| test negative and experience | ||
| continued or worsening COVID-19 | ||
| like symptoms, such as fever, cough | ||
| and/or shortness of breath, should | ||
| seek follow up care from their | ||
| healthcare provider. | ||
| The performance characteristics for | ||
| SARS-CoV-2 were established from | ||
| October 2022 to June 2023 when the | ||
| COVID-19 variant Omicron 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 | The performance characteristics for | |
| SARS-CoV-2 were established from | ||
| December 2022 to March 2023 when | ||
| SARSCOV-2 Omicron was dominant. | ||
| Test accuracy may change as new | ||
| SARS-CoV-2 viruses emerge. | ||
| Additional testing with a | ||
| considered in situations where a new | ||
| virus or variant is suspected. | lab-based molecular test (e.g., PCR) | |
| should be considered in situations | ||
| where a new virus or variant is | ||
| suspected. | ||
| Analyte | SARS-CoV-2 nucleocapsid protein | |
| antigen | SARS-CoV-2 nucleocapsid protein | |
| antigen | ||
| Intended Use | ||
| Population | Individuals with symptoms of COVID- | |
| 19 | Individuals with symptoms of COVID- | |
| 19 | ||
| Prescription or | ||
| OTC | OTC | OTC |
| Usage | Single use test | Single use test |
| Specimen Type | Anterior nasal swab specimens | Anterior nasal swab specimens |
| Assay Result | Qualitative | Qualitative |
| Technology | Lateral flow immunoassay | Lateral flow immunoassay |
| Rapid Test | Yes | Yes |
| Result | ||
| Interpretation | Visually read | Visually read |
| Instrument | No | No |
| Time to Result | 15-30 min | 15-30 min |
| Storage | ||
| Condition | 2-30°C | 2-30°C |
7
8.0 Performance Summary
8.1 Precision/Reproducibility
The purpose of the study was to assess between-site and between-lot variability of three different lots of the iHealth COVID-19 Antigen Rapid Test. Three (3) levels of heatinactivated SARS-CoV-2 were spiked in negative clinical matrix (NCM, Nasal fluid diluted in 1:3 Saline) as follows:
8
- A. Negative, NCM
- B. Low positive (1x LoD)
- C. Positive (3x LoD)
The lot-to-lot precision of the iHealth COVID-19 Antigen Rapid Test was evaluated by using three (3) product lots. A series of coded, contrived samples were prepared as negative, low positive (1xLoD), and moderate positive (3xLoD) using heat inactivated SARS-CoV-2. Each sample level was tested in triplicate in each run per day with three (3) operators at three (3) CLIA waived sites for 5 non-consecutive days. The agreement of obtained results with expected results was 100% for all samples across all lots, operators, and days. Variability in results was not observed between the three independently manufactured lots.
| Precision/Reproducibility Study - Summary Results | |||
|---|---|---|---|
| Site | True Negative | Low Positive | |
| (1x LoD) | Positive | ||
| (3x LoD) | |||
| Site 1 | |||
| (External, 3 operators) | 135/135 | 135/135 | 135/135 |
| Site 2 | |||
| (External, 3 operators) | 135/135 | 135/135 | 135/135 |
| Site 3 | |||
| (External, 3 operators) | 135/135 | 135/135 | 135/135 |
| Total | 405/405 | 405/405 | 405/405 |
| % Agreement | 100% | 100% | 100% |
| 95% CI | 99.1-100% | 99.1-100% | 99.1-100% |
8.2 Limit of Detection (LOD)
The LoD of the iHealth COVID-19 Antigen Rapid Test was established by using limiting dilutions of heat inactivated SARS-CoV-2 virus (BA.5. Omicron Variant). The virus was spiked into negative clinical matrix prepared by mixing raw nasal fluid in saline (1:2) that was confirmed as SARS-CoV-2 negative by RT-PCR.
At each dilution, 50 µL of sample was added to swabs and then tested through the full assay workflow, from processing in the extraction reagent to reading the test result. Testing was performed with 5 replicates per concentration. The estimated LoD was found from testing the initial 5 different concentrations. Using this preliminary concentration, the LoD was confirmed with a 3-fold dilution series, using three test lots tested on consecutive davs The LoD was determined as the lowest virus concentration that was detected ≥ 95% of the time (concentration at which at least 19 out of 20 replicates tested positive) for each lot.
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The iHealth COVID-19 Antigen Rapid Test LOD in natural nasal swab matrix is 1.33×104 TCIDso/mL. Based upon the testing procedure for this study, the LoD of iHealth COVID-19 Antigen Rapid Test TCID50/mL equates to 665 TCID50/swab.
The 1st WHO International Standard for SARS-CoV-2 Antigen (NIBSC 21/368) was also tested to determine the LoD of the iHealth COVID-19 Antigen Rapid Test with a standardized material for SARS-CoV-2.
A preliminary LoD concentration with the WHO standard material was determined for the iHealth COVID-19 Antigen Rapid Test by testing a series of two-fold dilutions starting at 4000 IU/mL. Three replicates using three test kit lots were tested for this two-fold dilution series, flowed by an additional series of two-fold dilutions to refine the preliminary LoD. The preliminary LoD was then confirmed by testing an additional twenty (20) replicates with each of 3 test lots.
| Limit of Detection - Summary Results | ||||
|---|---|---|---|---|
| Virus Strain | LoD in NCM | LoD per Swab | #Positive/#total Tested | Percent Detected (%) |
| Omicron Variant | $1.33\times10^4$ TCID50/mL | 665 TCID50/swab | 60/60 | 100% |
| WHO Standard (NIBSC 21/368) | $4.00\times10^2$ IU/mL | 20 IU/swab | 59/60 | 98.3% |
8.3 Cross Reactivity (Analytical Specificity) and Microbial Interference
The potential cross-reactivity (exclusivity) of a panel of common organisms was evaluated with SARS-CoV-2 negative samples using the iHealth COVID-19 Antigen Rapid Test. Potential microbial interference was evaluated with samples containing heat inactivated SARS-CoV-2 virus (BA.5. Omicron Variant) sample at approximately 2 x LoD.
A total of 53 commensal and pathogenic microorganisms (22 bacteria and 31 viruses) that may be present in the nasal cavity were evaluated in this study. Each of the organism and virus were tested in five replicates in the absence or presence of heat inactivated SARS-CoV-2 virus.
No cross-reactivity or interference was observed with the microorganisms.
| Cross Reactivity (Analytical Specificity) and Microbial Interference - Summary
| Results | ||||
|---|---|---|---|---|
| List of Organism | Concentration | |||
| tested | Cross-reactivity | |||
| results | Microbial | |||
| interference | ||||
| results | ||||
| Human coronavirus 229E | $4.50\times10^4$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Human coronavirus OC43 | $1.36\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Human coronavirus NL63 | $2.84\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| MERS-coronavirus | 27.1( Ct value) | No cross-reactivity | No interference | |
| SARS-coronavirus | $1\times10^5$ PFU/mL | No cross-reactivity | No interference | |
| Human coronavirus HKU1 | 33.8 (Ct value)* | No cross-reactivity | No interference | |
| Adenovirus) | Adenovirus Type 1 | $2.82\times10^6$ | ||
| TCID50/mL | No cross-reactivity | No interference | ||
| Adenovirus Type 4 | $2.84\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Adenovirus Type 7A | $3.16\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Adenovirus Type 8 | $1.13\times10^5$ U/mL | No cross-reactivity | No interference | |
| Adenovirus Type 31 | $1.13\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Adenovirus Type 41 | $3.80\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Human | ||||
| Metapneumovirus | ||||
| us (hMPV) | Human | |||
| Metapneumovirus 3 | ||||
| (hMPV-3) Type B1 | $0.94\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Human | ||||
| Metapneumovirus 4 | ||||
| (hMPV-4) Type B2 | $3.33\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Human | ||||
| Metapneumovirus 9 | ||||
| (hMPV-9) Type A1 | $1.13\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Parainfluenza | ||||
| virus | Parainfluenza Virus | |||
| Type 1 | $3.80\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Parainfluenza Virus | ||||
| Type 2 | $3.39\times10^6$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Parainfluenza Virus | ||||
| Type 3 | $1.15\times10^6$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Parainfluenza Virus | ||||
| Type 4A | $1.13\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Parainfluenza Virus | ||||
| Type 4B | $9.55\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Influenza A & B | Influenza A H3N2 | $1.13\times10^5$ | ||
| TCID50/mL | No cross-reactivity | No interference | ||
| Influenza B Victoria | $1.26\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Enterovirus | Enterovirus Type 68 | $2.84\times10^5$ | ||
| TCID50/mL | No cross-reactivity | No interference | ||
| Enterovirus Type 71 | $1.13\times10^5$ | |||
| TCID50/mL | No cross-reactivity | No interference | ||
| Respiratory | ||||
| syncytial virus | Respiratory Syncytial | |||
| Virus Type A (RSV-A) | $1.05×10^5$ TCID50/mL | No cross-reactivity | No | |
| interference | ||||
| Respiratory Syncytial | ||||
| Virus Type B (RSV-B) | $1.51×10^5$ TCID50/mL | No cross-reactivity | No | |
| interference | ||||
| Rhinovirus Type 1A | $1.13×10^5$ TCID50/mL | No cross-reactivity | No | |
| interference | ||||
| Haemophilus influenzae | $1.42×10^8$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Streptococcus pneumoniae | $7.22×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Streptococcus pyogenes | $4.60×10^8$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Candida albicans | $1.31×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Pooled human nasal wash – | ||||
| representative of normal respiratory | ||||
| microbial flora | - | No cross-reactivity | No | |
| interference | ||||
| Bordetella pertussis | $1.16×10^9$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Mycoplasma pneumoniae | $2.16×10^8$ CCU/mL | No cross-reactivity | No | |
| interference | ||||
| Chlamydia pneumoniae | $1.33×10^8$ IFU/mL | No cross-reactivity | No | |
| interference | ||||
| Legionella pneumophila | $1.42×10^9$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Staphylococcus aureus | $1.42×10^8$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Staphylococcus epidermidis | $6.84×10^8$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Mycobacterium tuberculosis | $1.21×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Pseudomonas aeruginosa | $7.09×10^8$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Streptococcus salivarius | $1.35×10^8$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Corynebacterium diphtheriae | $3.43×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Escherichia coli | $8.16×10^8$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Lactobacillus Acidophilus | $6.58×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Moraxella catarrhalis | $5.92×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Neisseria elongata | $1.07×10^9$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Neisseria meningitidis serogroup A | $2.04×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Neisseria meningitidis serogroup B | $9.15×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Neisseria meningitidis serogroup C | $7.90×10^7$ CFU/mL | No cross-reactivity | No | |
| interference | ||||
| Epstein-Barr virus | $0.97\times10^7$ cp/mL | No cross-reactivity | No interference | |
| Mumps virus | $9.55\times10^5$ TCID50/mL | No cross-reactivity | No interference | |
| Cytomegalovirus (CMV) | $1.13\times10^5$ TCID50/mL | No cross-reactivity | No interference | |
| Measles virus | $1.23\times10^7$ TCID50/mL | No cross-reactivity | No interference | |
| * Note: one HKU1 NP clinical sample has been tested in 5 replicates |
10
11
12
8.4 Endogenous Interfering Substances
Substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated with the iHealth COVID-19 Antigen Rapid Test.
The SARS-CoV-2 target concentration in the positive samples was approximately 2 x LoD. All samples were tested in 5 replicates and produced expected results, demonstrating that the iHealth COVID-19 Antigen Rapid Test performance was not affected by any of the 31 potentially interfering substances at the tested concentration.
| Endogenous Interfering Substances - Summary Results | |||
|---|---|---|---|
| Substance | Concentration in | ||
| negative/positive | |||
| sample | Cross-reactivity | Interference | |
| Throat lozenges, oral anesthetic | |||
| and analgesic (Benzocaine) | 3mg/mL | No cross-reactivity | No interference |
| Throat lozenges, oral anesthetic | |||
| and analgesic (Menthol) | 3mg/mL | No cross-reactivity | No interference |
| Sore throat spray (Phenol) | 5% w/v | No cross-reactivity | No interference |
| Mucin : bovine submaxillary gland, | |||
| type I-S or pooled mucous | |||
| (Purified mucin protein) | 2.5 mg/mL | No cross-reactivity | No interference |
| Whole Blood (human) | 2.5% | No cross-reactivity | No interference |
| Leukocytes | 4.8×106 cells/mL | No cross-reactivity | No interference |
| Zinc (common ingredient in many | |||
| nasal sprays) | 5% v/v | No cross-reactivity | No interference |
| Nasal drops (Phenylephrine) | 15% v/v | No cross-reactivity | No interference |
| Nasal sprays | |||
| (Cromolyn) | 15% v/v | No cross-reactivity | No interference |
| Afrin (Oxymetazoline) | 15% v/v | No cross-reactivity | No interference |
| Saline nasal spray (Sodium | |||
| chloride with preservatives) | 15% v/v | No cross-reactivity | No interference |
| Nasal corticosteroids | |||
| (Beclomethasone dipropionate) | 15% v/v | No cross-reactivity | No interference |
13
| Nasal corticosteroids
| (Dexamethasone) | 15% v/v | No cross-reactivity | No interference |
|---|---|---|---|
| Nasal corticosteroids (Flunisolide) | 15% v/v | No cross-reactivity | No interference |
| Nasocort Allery 24 hour | |||
| (Triamcinolone) | 15% v/v | No cross-reactivity | No interference |
| Rhinocort (Budesonide | |||
| /Glucocorticoid) | 15% v/v | No cross-reactivity | No interference |
| Nasal corticosteroids | |||
| (Mometasone furoate) | 15% v/v | No cross-reactivity | No interference |
| Nasal corticosteroids (Fluticasone | |||
| Propionate) | 15% v/v | No cross-reactivity | No interference |
| (Homeopathic Luffa opperculata | |||
| Galphimia glauce) | 1.25% | No cross-reactivity | No interference |
| Nasal gel (Luffa opperculata | |||
| sulfur) | 1.25% | No cross-reactivity | No interference |
| Homeopathic allergy relief, or | |||
| nasal wash (Galphimia glauca) | 15% v/v | No cross-reactivity | No interference |
| Homeopathic allergy relief, or | |||
| nasal wash (Histaminum | |||
| hydrochloricum) | 15% v/v | No cross-reactivity | No interference |
| Homeopathic allergy relief, or | |||
| nasal wash(Alkalol) | 15% v/v | No cross-reactivity | No interference |
| Homeopathic allergy relief, or | |||
| nasal wash (Zicam) | 15% v/v | No cross-reactivity | No interference |
| Anti-viral drugs (Tamiflu) | 5mg/mL | No cross-reactivity | No interference |
| Anti-viral drugs (Remdesivir) | 5mg/mL | No cross-reactivity | No interference |
| Anti-viral drugs (Molnupiravir) | 5mg/mL | No cross-reactivity | No interference |
| Antibiotic, nasal ointment | |||
| (Mupirocin) | 10mg/mL | No cross-reactivity | No interference |
| Hand sanitizer | 15% v/v | No cross-reactivity | No interference |
| Hand soap | 15% v/v | No cross-reactivity | No interference |
| Biotin* | 200 ng/mL | No cross-reactivity | No interference |
8.5 Hook Effect
There is no Hook effect at 3.98×10 TCIDso/mL corresponding to 300x LoD, which is the highest concentration that have been tested.
8.6 Inclusivity (Analytical Reactivity)
The inclusivity of the iHealth COVID-19 Antigen Rapid Test was evaluated with 14 strains of SARS-CoV-2 representing temporal, geographic, and genetic diversity within the currently circulating subtypes and lineages.
| Inclusivity (Analytical Reactivity) - Summary Results | |
|---|---|
| SARS-CoV-2 Variant | Lowest Variant Concentration |
| with 5/5 positive replicates |
14
| [TCID50/mL] | |
|---|---|
| SARS-CoV-2 virus (USA-WA1/2020) | 4.57 x 103 |
| B.1.1.7 (Alpha) | 9.55x 103 |
| B.1.351 (Beta) | 3.80 x 103 |
| P.1 (Gamma) | 1.7 x 103 |
| B.1.617.2 (Delta) | 1.26 x 104 |
| B.1.1.529 (Omicron) | 5.01 x 102 |
| BA.2. (Omicron) | 1.0 x 103 |
| BA.2.3 (Omicron) | 1.17 x 103 |
| BA.4 (Omicron) | 6.31 x 103 |
| BA.4.6 (Omicron) | 1.00 x 104 |
| BA.5(Omicron) | 3.98 x 103 |
| BQ.1(Omicron) | 2.0 x 103 |
| BQ.1.1(Omicron) | 7.94 x 104 |
| XBB (Omicron) | 1.0 x 103 |
8.7 Flex Studies
To assess the robustness of the iHealth COVID-19 Antigen Rapid Test, flex studies were conducted that assessed all major aspects of the test procedure (e.q., swab extraction time, drops of sample added to test cassette, development time, delay in sample analysis, swab agitation, sample buffer agitation) and variability of environmental test conditions that the test may be subjected to when in use (e.g., various temperature and humidity stress, cassette disturbance, sample/reagent temperature, lighting). Testing was performed with contrived positive nasal swabs prepared by diluting heat inactivated SARS-CoV-2 virus into negative clinical nasal swab matrix at 2x LoD. The studies support that the test is robust in the intended use condition with an insignificant risk of erroneous results.
9.0 Clinical Testing Summary
Clinical performance characteristics of the iHealth COVID-19 Antigen Rapid Test were evaluated in a total of eight (8) investigational sites throughout the U.S. A total of 915 individuals with signs and symptoms of COVID-19 within the first six (6) days of symptom onset completed the study and obtained a valid result. Each subject was provided an iHealth COVID-19 Antigen Rapid Test., Subjects fifteen (15) years and older collected an anterior nasal sample by themselves, conducted the test, interpreted and reported the result. The parents of subjects two (2) to fourteen (14) years of age collected the anterior nasal sample, conducted the test, interpreted and recorded the test result for the child. The iHealth COVID-19 Antigen Rapid Test results were compared to a highly sensitive molecular FDA EUA Authorized SARS-CoV-2 assays to determine test performance. The iHealth COVID-19 Antigen Rapid Test when conducted by a lay user correctly identified 88.9% of positive samples. Additionally, the iHealth COVID-19 Antigen Rapid Test correctly identified 99.9% of negative samples. The performance is shown in the following
15
iHealt
table.
| Comparator Method | |||
|---|---|---|---|
| iHealth COVID-19 Antigen Rapid Test | Positive | Negative | Total |
| Positive | 104 | 1b | 108 |
| Negative | 13a | 797 | 810 |
| Total | 117 | 798 | 915 |
| Positive Agreement: (104/117) 88.9% 95% Confidence Interval: 81.9% to 93.4% |
Negative Agreement: (797/798) 99.9%; 95% Confidence Interval: 99.3% to 100.0%
ª Of the 13 false negative samples, 1 of them was negative on a second FDA EUA high sensitivity molecular SARS-CoV-2 assay, 12 of them was positive on a second FDA EUA high sensitivity molecular SARS-CoV-2 assay.
b Of the 1 false positive sample was positive on a second FDA EUA high sensitivity molecular SARS-CoV-2 assay.
Age and gender distribution and positive rate of symptomatic subjects within first 6 days of symptom onset
| Age Group (years) | Female | Male | Positive | Positivity Rate % (total
positive/total tested) |
|-------------------|--------|------|----------|----------------------------------------------------|
| 2 to 13 | 63 | 66 | 5 | 3.9% (5/129) |
| 14 to 24 | 139 | 94 | 33 | 14.2% (33/233) |
| 25 to 64 | 323 | 206 | 72 | 13.6% (72/529) |
| ≥65 | 16 | 8 | 7 | 29.2% (7/24) |
| Total | 541 | 374 | 117 | 12.8% (117/915) |
| Positive results broken down by days since symptom onset | ||||
|---|---|---|---|---|
| Days Since | ||||
| Symptom Onset | RT-PCR | |||
| Positive (+) | iHealth test | |||
| Positive (+) | PPA | 95 % Confidence Interval | ||
| 1 | 4 | 2 | 50.0% | 15.0% - 85.0% |
| 2 | 32 | 32 | 100.0% | 89.0% - 100.0% |
| 3 | 37 | 34 | 91.9% | 78.7% - 98.2% |
| 4 | 25 | 22 | 88.0% | 70.0% - 95.8% |
| 5 | 12 | 9 | 75.0% | 46.7% - 91.1% |
| 6 | 7 | 5 | 71.4% | 35.9% - 91.7% |
| Total | 117 | 104 | 88.9% | 81.9% - 93.4% |
10.0 Conclusion
Based on the data submitted in this traditional 510(k) submission, the device has been shown to be substantially equivalent in term of intended use, design, technological characteristics and assay performance to the predicate device K230828.