(405 days)
Not Found
No
The description focuses on isothermal nucleic acid amplification technology and fluorescence detection, with no mention of AI or ML for data analysis or interpretation.
No.
The device is an in vitro diagnostic test intended for the qualitative detection of nucleic acid from SARS-CoV-2 to aid in the diagnosis of COVID-19. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a rapid molecular in vitro diagnostic test" and "is intended for use as an aid in the diagnosis of COVID-19."
No
The device description explicitly lists multiple hardware components including a Sample Receiver, Test Base, Transfer Cartridge, Patient Swabs, Positive Control Swab, and the ID NOW Instrument itself, which performs heating, mixing, and detection by fluorescence. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the ID NOW COVID-19 2.0 is a "rapid molecular in vitro diagnostic test".
- Purpose: The test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in human specimens (nasal or nasopharyngeal swabs) to aid in the diagnosis of COVID-19. This is a classic definition of an in vitro diagnostic test.
- Method: It utilizes an isothermal nucleic acid amplification technology (NAAT), which is a laboratory technique performed outside of the body on a biological sample.
- Specimen Type: It is performed on biological specimens (swabs) collected from individuals.
- Regulatory Language: The document uses language common to IVD submissions, such as "prescription use only" and "Point-of-Care settings," indicating it's a regulated medical device for diagnostic purposes.
N/A
Intended Use / Indications for Use
ID NOW COVID-19 2.0 performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection. ID NOW COVID-19 2.0 performed on the ID NOW Instrument is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection.
Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not preclude co-infection with bacteria or other viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
A negative test result is presumptive, and it is recommended these results be confirmed by another molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Point-of-Care settings.
Product codes (comma separated list FDA assigned to the subject device)
QWR
Device Description
ID NOW COVID-19 2.0 is a rapid, instrument-based isothermal test for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA in direct nasal or nasopharyngeal swabs. The ID NOW COVID-19 2.0 System utilizes isothermal nucleic acid amplification technology and is comprised of:
- Sample Receiver single use, disposable containing the elution buffer .
- Test Base single use, disposable comprising two sealed reaction tubes, each containing a . lyophilized pellet
- . Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base
- Patient Swabs sterile anterior nasal swabs (foam) for anterior nasal swab collection and for use . as a Negative Control Swab
- . Positive Control Swab - single use, to ensure that test reagents are working properly and that the test is correctly performed, and
- ID NOW Instrument ●
The reaction tubes in the Test Base contain lyophilized reagents required for amplification of the target nucleic acid and an internal control. ID NOW COVID-19 2.outilizes a pair of templates (similar to primers) for the specific amplification of RNA from SARS-CoV-2 and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid targets. ID NOW COVID-19 2.0 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.
To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating viral lysis and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.
Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW Instrument by the operator either manually or using barcode scanner . Data can be retrieved and downloaded by the operator at any time after testing. An external Universal Printer can be attached via USB to the ID NOW Instrument to print test results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
direct anterior nasal (nasal) or nasopharyngeal swabs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This test is intended for prescription use only and can be used in Point-of-Care settings.
Professional use, in a medical laboratory or point-of-care
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
The clinical performance of ID NOW COVID-19 2.0 was established in a multi-center, prospective clinical study conducted at twenty-one (21) US sites in 2020/2021.
A total of 60 different operators, across the sites tested subjects with ID NOW COVID-19 2.0. The study sites and the test operators used in this clinical study were representative of the CLIA waived setting.
To be enrolled in the study at the participating study centers, patients had to be presenting at the participating study centers showing signs and symptoms of upper respiratory infection.
Two nasal or nasopharyngeal swabs were collected from each patient and tested using ID NOW COVID-19 2.0 at all study sites.
Three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for the detection of SARS-CoV-2 were utilized in a composite comparator method.
At all sites, one nasal or nasopharyngeal swab was tested directly in ID NOW COVID-19 2.0 according to product instructions and the other swab was eluted in Universal Transport Media (UTM). All sites shipped the UTM sample to a central testing laboratory for RT-PCR testing with the composite comparator.
The performance of ID NOW COVID-19 2.0 was established with 914 specimens. including 460 anterior nasal swabs and 4.54 nasopharyngeal swabs collected from individuals showing signs and symptoms of upper respiratory infection.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL STUDY
The clinical performance of ID NOW COVID-19 2.0 was established in a multi-center, prospective clinical study conducted at twenty-one (21) US sites in 2020/2021.
A total of 914 specimens (460 anterior nasal swabs and 454 nasopharyngeal swabs) were collected from individuals showing signs and symptoms of upper respiratory infection.
Performance against the composite comparator (three FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for the detection of SARS-CoV-2):
Positive Agreement: 254/277 = 91.7% (95% CI: 87.8% - 94.4%)
Negative Agreement: 627/637 = 98.4% (95% CI: 97.1% - 99.1%)
ANALYTICAL STUDIES
Analytical Sensitivity (Limit of Detection)
LoD in natural nasal swab matrix: 500 copies/swab (20 copies/reaction)
LoD in nasopharyngeal swab matrix: 500 copies/swab (20 copies/reaction)
Analytical Reactivity (Inclusivity)
ID NOW COVID-19 2.0 detected all SARS-CoV-2 strains tested at specified concentrations. In-silico analysis showed 99.58% homology with available genomic sequences from NCBI GenBank and GISAID databases (4,466,800 sequences analyzed between Dec 1, 2019 and Dec 3-4, 2021). An additional alignment with sequences from the US (Oct 17, 2022 - Apr 17, 2023) showed 100% sequence homology across 99.51% of 382,309 sequences.
Analytical Specificity (Cross Reactivity)
38 commensal and pathogenic microorganisms (24 viruses, 12 bacteria, and 2 yeasts) were tested and showed no cross-reactivity at specified concentrations. In silico analysis also predicted no cross-reactivity with 34 other upper respiratory tract microorganisms.
Microbial Interference
Performance was evaluated in the presence of 23 non-SARS-CoV-2 viruses, 12 bacteria, and 2 yeasts. All were found not to affect test performance.
Interfering Substances
23 substances naturally present or artificially introduced into the nasal cavity/nasopharynx were evaluated and found not to affect test performance at specified concentrations.
Reproducibility/Near the Cut Off
Study conducted by nine operators at three sites over five days using panels of four contrived samples.
Percent agreement for moderate positive samples: 98.1% (263/268).
Percent agreement for low positive samples: 96.3% (260/270).
Percent agreement for high negative samples: 80.6% (240/268).
Percent agreement for true negative samples: 99.6% (267/268).
Positive Control: 100% (137/137)
Negative Control: 100% (137/137)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement: 91.7% (95% CI: 87.8% - 94.4%)
Negative Agreement: 98.4% (95% CI: 97.1% - 99.1%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sofia 2 SARS Antigen+ FIA, DEN220039
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Abbott Diagnostics Scarborough, Inc. Jessica Stahle Regulatory Affairs Manager 10 Southgate Road Scarborough, Maine 04074
Re: K221925
Trade/Device Name: ID NOW COVID-19 2.0 Regulation Number: 21 CFR 866.3982 Regulation Name: Simple Point-Of-Care Device To Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens In Near-Patient Settings Regulatory Class: Class II Product Code: QWR Dated: April 29, 2023 Received: May 1, 2023
August 10, 2023
Dear Jessica Stahle:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Kristian M. Roth -S
For: Himani Bisht, Ph.D. Assistant Director Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Products Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221925
Device Name ID NOW COVID-19 2.0
Indications for Use (Describe)
ID NOW COVID-19 2.0 performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection. ID NOW COVID-19 2.0 performed on the ID NOW Instrument is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection.
Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not preclude co-infection with bacteria or other viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
A negative test result is presumptive, and it is recommended these results be confirmed by another molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Pointof-Care settings.
| 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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3
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K221925
SUBMITTER
Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, Maine 04074 USA Establishment Registration Number: 1221359
PRIMARY CONTACT PERSON
Jessica E. Stahle (207) 730-6353 (phone) jessica.stahle@abbott.com (email)
SECONDARY CONTACT PERSON
Angela Drysdale (207) 415-1393 (phone) angela.drysdale@abbott.com (email)
DATE PREPARED June 30, 2022
TRADE NAME ID NOW COVID-19 2.0
COMMON NAME ID NOW COVID, ID NOW COVID-19
CLASSIFICATION NAME
21 CFR 866.3982 Simple Point-Of-Care Device To Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens In Near-Patient Settings
CLASSIFICATION
Class II
PRODUCT CODE QWR
4
PANEL Microbiology (83)
PREDICATE DEVICE
Sofia 2 SARS Antigen+ FIA, DEN220039
DEVICE DESCRIPTION
ID NOW COVID-19 2.0 is a rapid, instrument-based isothermal test for the qualitative detection of nucleic acid from SARS-CoV-2 viral RNA in direct nasal or nasopharyngeal swabs. The ID NOW COVID-19 2.0 System utilizes isothermal nucleic acid amplification technology and is comprised of:
- Sample Receiver single use, disposable containing the elution buffer .
- Test Base single use, disposable comprising two sealed reaction tubes, each containing a . lyophilized pellet
- . Transfer Cartridge - single use, disposable for transfer of the eluted sample to the Test Base
- Patient Swabs sterile anterior nasal swabs (foam) for anterior nasal swab collection and for use . as a Negative Control Swab
- . Positive Control Swab - single use, to ensure that test reagents are working properly and that the test is correctly performed, and
- ID NOW Instrument ●
The reaction tubes in the Test Base contain lyophilized reagents required for amplification of the target nucleic acid and an internal control. ID NOW COVID-19 2.outilizes a pair of templates (similar to primers) for the specific amplification of RNA from SARS-CoV-2 and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid targets. ID NOW COVID-19 2.0 is performed within the confinement of the Test Base, and no other part of the ID NOW Instrument has contact with the sample during the amplification process. This minimizes the risk of instrument contamination and sample carry-over between measurements.
To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base and initiating viral lysis and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.
Results are displayed by the ID NOW Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the ID NOW Instrument by the operator either manually or using barcode scanner . Data can be retrieved and downloaded by the operator at any time after testing. An external Universal Printer can be attached via USB to the ID NOW Instrument to print test results.
INTENDED USE
ID NOW COVID-19 2.0 performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyneeal swabs from individuals with signs and symptoms of respiratory tract infection. ID NOW COVID-19 2.0 performed on the ID NOW Instrument is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection.
5
Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not preclude co-infection with bacteria or other viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
A negative test result is presumptive, and it is recommended these results be confirmed by another molecular SARS-COV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Point-of-Care settings.
TECHNOLOGICAL CHARACTERISTICS
ID NOW COVID-19 2.0 and the predicate device, Sofia 2 SARS Antigen+ FIA, have the same intended use and indications for use. They are both assays for the qualitative detection of SARS-CoV-2 in point of care patient settings.
DEVICE COMPARISON
ID NOW COVID-19 2.0 was compared to the legally marketed predicate device, the Sofia 2 SARS Antigen+ FIA assay.
| Parameter | ID NOW COVID-19 2.0 | Sofia 2 SARS Antigen+ FIA
(DEN220039) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product Code | QWR | QVF |
| Regulation Number/Name | 21 CFR 866.3982 - Simple Point-Of-
Care Device To Directly Detect SARS-
CoV-2 Viral Targets From Clinical
Specimens In Near-Patient Settings | Same |
| Assay Target | SARS-CoV-2 viral RNA | SARS-CoV-2 nucleocapsid protein |
| Intended Use | ID NOW COVID-19 2.0 performed on
the ID NOW Instrument is a rapid
molecular in vitro diagnostic test
utilizing an isothermal nucleic acid
amplification technology (NAAT)
intended for the qualitative detection of
nucleic acid from SARS-CoV-2 in direct
anterior nasal (nasal) or nasopharyngeal
swabs from individuals with signs and
symptoms of respiratory tract infection.
ID NOW COVID-19 2.0 performed on
the ID NOW Instrument is intended for
use as an aid in the diagnosis of COVID-
19 if used in conjunction with other
clinical, epidemiologic, and laboratory
findings. SARS-CoV-2 RNA is generally
detectable in nasal and nasopharyngeal
swab specimens during the acute phase
of infection.
Positive results are indicative of the
presence of SARS-CoV-2 RNA. Positive
results do not preclude co-infection with
bacteria or other viruses and should not
be used as the sole basis for diagnosis, | The Sofia 2 SARS Antigen+ FIA is a lateral
flow immunofluorescent sandwich assay
that is used with the Sofia 2 instrument for
the rapid, qualitative detection of SARS-
CoV-2 nucleocapsid protein antigens
directly in anterior nasal swab specimens
from individuals with signs and symptoms
of upper respiratory infection (i.e.,
symptomatic) when testing is started
within 6 days of symptom onset. The test is
intended for use as an aid in the diagnosis
of SARS-CoV-2 infections (COVID-19) in
symptomatic individuals when tested at
least twice over three days with at least 48
hours between tests.
The test does not differentiate between
SARS-CoV and SARS-CoV-2.
A negative test result is presumptive, and it
is recommended these results be confirmed
by a molecular SARS-CoV-2 assay. |
| Parameter | ID NOW COVID-19 2.0 | Sofia 2 SARS Antigen+ FIA
(DEN220039) |
| | treatment, or other patient management
decisions.
A negative test result is presumptive, and
it is recommended these results be
confirmed by another molecular SARS-
CoV-2 assay. Negative results do not
preclude SARS-CoV-2 infection and
should not be used as the sole basis for
diagnosis, treatment, or other patient
management decisions. This test is
intended for prescription use only and
can be used in Point-of-Care settings. | Negative results do not preclude SARS-
CoV-2 infections and should not be used as
the sole basis for treatment or other patient
management decisions.
Positive results do not rule out co-infection
with other respiratory pathogens.
Performance characteristics for SARS-CoV-
2 were established during the 2021-2022
SARS-CoV-2 pandemic when SARS-CoV-2
Omicron was the predominant SARS-CoV-
2 variant in circulation. When other SARS-
CoV-2 virus variant are emerging,
performance characteristics may vary. |
| | | This test is intended for prescription use
only and can be used in Point-of-Care
settings. |
| Intended Environment for
Use | Professional use, in a medical laboratory
or point-of-care | Same |
| Instrumentation | ID NOW Instrument | Sofia Q, Sofia 2, Sofia |
| Automated Assay | Yes, Sample preparation, amplification,
detection and result interpretation | Automated test interpretation and report
generation |
| Assay Information | | |
| Sample Type | Direct anterior nasal or nasopharyngeal
swabs | Direct anterior nasal swabs |
| SARS-CoV-2 Target | RdRp gene | Nucleocapsid Protein Antigen |
| Technology | Isothermal nucleic acid amplification
for detecting the presence/absence of
viral RNA in clinical specimens | lateral flow immunofluorescent sandwich
assay for detecting the presence/absence of
the nucleocapsid protein antigen in clinical
specimens |
| Internal Control | Yes | Same |
| Result Interpretation | Automated | Same |
| Assay Result | Qualitative | Same |
| Time to Result | Viruses | Bacteria | Yeast |
|------------------------|--------------------------------------|------------------------------|
| Human Adenovirus 1 | Bordetella pertussis | Candida albicans |
| Human Adenovirus 7 | Chlamydia pneumoniae | Pneumocystis jirovecii (PJP) |
| Human Coronavirus 229E | Haemophilus influenzae | |
| Human Coronavirus HKU1 | Legionella pneumophila | |
| Human Coronavirus OC43 | Mycobacterium tuberculosis avirulent | |
| Human Coronavirus NL63 | Mycoplasma pneumoniae | |
| MERS-coronavirus | Pseudomonas aeruginosa | |
10
| Viruses | Bacteria | Yeast |
|---|---|---|
| Enterovirus 70 | Staphylococcus aureus | |
| Human Echovirus 7 | Staphylococcus epidermidis | |
| Human Metapneumovirus (hMPV) | Streptococcus salivarius | |
| Human Parainfluenza virus 1 | Streptococcus pneumoniae | |
| Human Parainfluenza virus 2 | Streptococcus pyogenes | |
| Human Parainfluenza virus 3 | ||
| Human Parainfluenza virus 4a | ||
| Human Influenza A/California/7/2009 | ||
| Human Influenza A/Texas/50/2012 | ||
| Human Influenza B/Wisconsin/1/2010 | ||
| Human Influenza B/Malaysia/2506/04 | ||
| Mumps virus | ||
| Respiratory Syncytial Virus (RSV) A | ||
| Respiratory Syncytial Virus (RSV) B | ||
| Rhinovirus 1 | ||
| Rhinovirus 2 | ||
| SARS-Coronavirus |
In addition, in silico analysis was performed to determine whether there is any significant overlap between ID NOW COVID-19 2.0 target nucleic acid sequence and the genomes of the following upper respiratory tract microorganisms. Based on this analysis, none of the evaluated microorganisms are predicted/expected to crossreact with the ID NOW COVID-19 2.0.
| Viruses | Bacteria | Yeast |
|---|---|---|
| Human coronavirus 229E | Bordetella pertussis | Candida Albicans |
| Human coronavirus OC43 | Bordetella bronchiseptica | Pneumocystis jirovecii (PJP) |
| Human coronavirus HKU1 | Chlamydia pneumoniae | |
| Human coronavirus NL63 | Chlamydia trachomatis | |
| SARS-coronavirus | Corynebacterium diphtheriae | |
| MERS-coronavirus | Escherichia coli | |
| Human adenovirus 1 | Haemophilus influenzae | |
| Human adenovirus 2 | Klebsiella pneumoniae | |
| Human adenovirus 3 | Lactobacillus plantarum | |
| Human adenovirus 4 | Legionella pneumophila | |
| Human adenovirus 5 | Moraxella catarrhalis | |
| Human adenovirus 7 | Mycobacterium tuberculosis | |
| Human adenovirus 11 | Mycoplasma pneumoniae | |
| Human adenovirus 14 | Neisseria gonorrhoeae | |
| Human adenovirus 31 | Neisseria meningitidis | |
| Cytomegalovirus | Neisseria mucosa | |
| Echovirus E6 | ||
| Echovirus E7 | Proteus mirabilis |
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| Viruses | Bacteria | Yeast |
|---|---|---|
| Echovirus E9 | Proteus vulgaris | |
| Echovirus E11 | Pseudomonas aeruginosa | |
| Epstein Barr virus | Staphylococcus aureus | |
| Human Metapneumovirus (hMPV) | Staphylococcus epidermidis | |
| Influenza A | Streptococcus pneumoniae | |
| Influenza B | Streptococcus pyogenes | |
| Measles virus | Streptococcus salivarius | |
| Mumps virus | ||
| Parainfluenza Type 1 | ||
| Parainfluenza Type 2 | ||
| Parainfluenza Type 3 | ||
| Parainfluenza Type 4a and 4b | ||
| RSV A | ||
| RSV B | ||
| Rhinovirus: | ||
| Coxsackievirus B4 | ||
| Human rhinovirus B35 | ||
| Enterovirus 70 (VR-836) | ||
| Other rhinoviruses |
Microbial Interference
ID NOW COVID-19 2.0 test performance in the presence of non-SARS-CoV-2 respiratory pathogens was evaluated. Vendor provided stocks of SARS-CoV-2 virus were diluted in clinical matrix to 1.74 times the limit of detection and tested in the presence of RSV A, RSV B, Flu A/California, Flu A/Texas, Flu B/Wisconsin, and Flu B/Malaysia at concentrations shown below; all others were tested with SARS-CoV-2 virus diluted in clinical matrix to 3 times the limit of detection. Contrived SARS-CoV-2 positive swab specimens were prepared by coating 50 microliters of virus dilution onto each swab. The following panel of non-SARS-CoV-2 viruses, bacteria, and yeast were tested at the concentration provided in the table below and were found not to affect test performance.
| Panel | Concentration |
|---|---|
| Viruses | |
| Human Adenovirus 1 | 1.0 x 105 TCID50/mL |
| Human Adenovirus 7 | 1.0 x 105 TCID50/mL |
| Human Coronavirus 229E | 1.0 x 105 TCID50/mL |
| Human Coronavirus NL63 | 1.17 x 105 TCID50/mL |
| Human Coronavirus OC43 | 1.0 x 105 TCID50/mL |
| Human Coronavirus HKU1 | 1.0 x 108 copies/mL |
| MERS-Coronavirus | 1.0 x 105 GE/mL |
| SARS-Coronavirus | 2.0 x 105 copies/mL |
| Enterovirus 70 | 1.0 x 105 TCID50/mL |
| Human Echovirus 7 | 1.0 x 105 TCID50/mL |
| Human Metapneumovirus (hMPV) | 1.0 x 105 U/mL |
| Human Parainfluenza Virus 1 | 2.0 x 105 TCID50/mL |
| Human Parainfluenza Virus 2 | 1.0 x 105 TCID50/mL |
| Human Parainfluenza Virus 3 | 1.0 x 105 TCID50/mL |
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| Human Parainfluenza Virus 4a | 1.0 x 105 TCID50/mL |
|---|---|
| Human Influenza A/California/7/2009 | 1.0 x 105 IU/mL |
| Human Influenza A/Texas/50/2012 | 1.0 x 105 IU/mL |
| Human Influenza B/Wisconsin/1/2010 | 1.0 x 105 IU/mL |
| Human Influenza B/Malaysia/2506/04 | 1.0 x 105 IU/mL |
| Mumps virus | 1.0 x 105 TCID50/mL |
| Respiratory Syncytial Virus (RSV) A | 1.0 x 105 IU/mL |
| Respiratory Syncytial Virus (RSV) B | 1.0 x 105 IU/mL |
| Rhinovirus 1 | 1.0 x 105 TCID50/mL |
| Rhinovirus 2 | 1.0 x 105 TCID50/mL |
| Bacteria | |
| Bordetella pertussis | 1.0 x 106 CFU/mL |
| Chlamydia pneumoniae | 1.0 x 106 IFU/mL |
| Haemophilus influenzae | 1.0 x 106 CFU/mL |
| Legionella pneumophila | 1.0 x 106 cells/mL |
| Mycobacterium tuberculosis | 1.0 x 106 CFU/mL |
| Mycoplasma pneumoniae | 1.0 x 106 CFU/mL |
| Pseudomonas aeruginosa | 1.0 x 106 CFU/mL |
| Staphylococcus aureus | 1.0 x 106 CFU/mL |
| Staphylococcus epidermidis | 1.0 x 106 CFU/mL |
| Streptococcus salivarius | 1.0 x 106 CFU/mL |
| Streptococcus pneumoniae | 1.0 x 106 CFU/mL |
| Streptococcus pyogenes | 1.0 x 106 CFU/mL |
| Yeast | |
| Candida albicans | 1.0 x 106 cells/mL |
| Pneumocystis jirovecii (PJP) | 1.0 x 106 CFU/mL |
Interfering Substances
The following substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated with ID NOW COVID-19 2.0 at the concentrations listed below in a negative sample and in a positive sample with SARS-CoV-2 concentrations at 3 times the limit of detection and were found not to affect test performance.
| Substance | Concentration |
|---|---|
| Mucin1 | 1% w/v |
| Whole Blood | 1% v/v |
| Post nasal lavage discharge | 1% v/v |
| Phenylephrine | 20% v/v |
| Oxymetazoline | 20% v/v |
| Sodium chloride with preservatives | 20% v/v |
| Cromolyn sodium | 20% v/v |
| Alkalol | 20% v/v |
| Phenol | 20% v/v |
| Zincum gluconium, Zincum aceticum² | 10% w/v |
| Galphimia glauca, Histaminum hydrochloricum, Luffa opperculata, Sulfur | 20% v/v |
| Beclomethasone | 0.068 mg/mL |
| Fluticasone propionate | 20% v/v |
| Dexamethasone | 0.48 mg/mL |
| Flunisolide | 0.04 mg/mL |
| Triamcinolone | 0.04 mg/mL |
| Budesonide | 0.051 mg/mL |
| Mometasone | 0.04 mg/mL |
| Zanamivir (Relenza) | 0.284 mg/mL |
| Mupirocin | 4.3 mg/mL |
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| Tobramycin | 1.44 mg/mL |
|---|---|
| Remdesivir (Brand Name: Veklury) | 0.12 mg/mL |
| Throat Lozenge (Benzocaine, Methol) | 0.63 mg/mL |
| Toothpaste (Fluoride) | 1% w/v |
| Tobacco | 0.1% w/v |
| Nicotine | 0.1% w/v |
| Oral Rinse | 10% v/v |
| Leukocytes | 1.1 x 106 cells/mL |
| Fluticasone furoate | 20% v/v |
Mucin at 2% w/v in the absence of SARS-CoV-2 yielded 1/5 invalid result and therefore was tested at a lower concentration. 2When Zincum gluconium, Zincum aceticum was tested at 20% w/v in the presence of SARS-CoV-2, 1/5 invalid result was generated and therefore was tested at a lower concentration.
Reproducibility/Near the Cut Off
A reproducibility/near the cut off study of ID NOW COVID-19 2.0 was conducted by nine operators at three sites over five different days using panels of four samples contrived in clinical matrix. The percent agreement relative to the expected results for the moderate positive samples was 98.1% (263/268). The percent agreement relative to the expected results for the low positive samples was 96.3% (260/270). The percent agreement relative to the expected results for the high negative samples was 80,6% (240/268) and the true negative samples were 99.6% (267/268).
| Sample Category | Site | Overall Agreement and 95% CI | ||||
|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | ||||
| 1.16x LoD | Percent Agreement | 97.8% | 94.4% | 96.7% | 96.3% | 93.3%, 98.0% |
| Count | 88/90 | 85/90 | 87/90 | (260/270) | ||
| 1.74xLoD | Percent Agreement | 98.9% | 96.6% | 98.9% | 98.1% | 95.7%, 99.2% |
| Count | 89/90 | 86/892 | 88/892 | (263/268) | ||
| 0.0235x LoD | ||||||
| (High | ||||||
| Negative) | Percent Agreement | 87.8% | 90.9% | 90.0% | 89.6% | 85.3%, 92.7% |
| Count | 79/90 | 80/882 | 81/90 | (240/268) | ||
| Virus Free | ||||||
| Negative1 | Percent Agreement | 100.0% | 100.0% | 98.9% | 99.6% | 97.9%, 99.9% |
| Count | 90/90 | 89/892 | 88/892 | (267/268) | ||
| Positive | ||||||
| Control | Percent Agreement | 100% | 100% | 100% | 100% | 97.3% - 100% |
| Count | 45/45 | 46/46 | 46/46 | (137/137) | ||
| Negative | ||||||
| Control | Percent Agreement | 100% | 100% | 100% | 100% | 97.3% - 100% |
| Count | 45/45 | 46/46 | 46/46 | (137/137) |
The Reproducibility Study site-to-site qualitative results (agreements relative to the expected results) are presented in the table below:
1Percent Agreement correlates to the percent of negative results.
²Sample(s) excluded due to protocol deviation
Conclusion Drawn from Analytical and Clinical Studies
The results presented in this 510(k) premarket notification demonstrate that the subject device (ID NOW COVID-19 2.0) performance is substantially equivalent to the predicate device (Sofia 2 SARS Antigen+ FIA, DEN220039).
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The similarities and differences between the subject device and the predicate device are presented in the Device Comparison Table. Differences between the subject device and the predicate device shown in the table do not affect the demonstration of substantial equivalence.