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.

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.

AI/ML Overview

The provided text describes the performance of the ID NOW COVID-19 2.0 device, which is an in vitro diagnostic test for SARS-CoV-2.

Here's an analysis addressing your questions, keeping in mind that this is a diagnostic test and not an AI-assisted imaging device, so some questions (like MRMC studies) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For diagnostic tests, "acceptance criteria" are typically defined by performance targets for sensitivity (Positive Agreement) and specificity (Negative Agreement). These are assessed against a highly accurate comparator method (Ground Truth).

Acceptance Criteria (Implied by High Performance and Clinical Utility for a Molecular Test) and Reported Device Performance:

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Positive Agreement (Sensitivity)	High (e.g., >85-90%)	91.7% (95% CI: 87.8% - 94.4%)
Negative Agreement (Specificity)	Very High (e.g., >95%)	98.4% (95% CI: 97.1% - 99.1%)
Analytical Sensitivity (LoD)	Low (detect SARS-CoV-2 at low concentrations)	500 copies/swab (20 copies/reaction)
Analytical Reactivity (Inclusivity)	Detect a wide range of SARS-CoV-2 strains including variants of concern	All tested strains detected at specified concentrations (various Omicron sub-variants were tested)
Analytical Specificity (Cross-Reactivity)	No cross-reactivity with common respiratory pathogens or commensals	All 38 tested microorganisms (24 viruses, 12 bacteria, 2 yeasts) found negative; In-silico analysis predicted no cross-reactivity
Microbial Interference	No interference from other common respiratory pathogens	No effect on test performance when SARS-CoV-2 was present with other pathogens
Interfering Substances	No interference from common interfering substances (nasal sprays, blood, etc.)	No effect on test performance by specified substances at tested concentrations
Reproducibility	Consistent results across sites, operators, and days	High agreement: Moderate positive 98.1%, Low positive 96.3%, High negative 89.6%, True negative 99.6%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Test Set: 914 specimens (460 anterior nasal swabs and 454 nasopharyngeal swabs).
Data Provenance:
- Country of Origin: United States (US). The study was conducted at twenty-one (21) US sites.
- Retrospective or Prospective: Prospective clinical study. Specimens were collected from individuals showing signs and symptoms of upper respiratory infection at the time of enrollment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is a diagnostic test based on molecular detection, not an imaging device requiring expert reader interpretation for ground truth.

Number of "Experts": Not applicable in the context of human readers for establishing ground truth for individual cases. The ground truth was established by a composite comparator method using three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays. This method is considered the "gold standard" for SARS-CoV-2 detection.
Qualifications of Experts: N/A for individual case ground truth. The RT-PCR assays are performed by laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

The ground truth was established by a composite comparator method using three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays. This implies that the consensus or outcome of these highly sensitive and specific molecular tests served as the ground truth. The document does not describe a human adjudication process, as the ground truth is derived from objective molecular testing results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Was it done?: No, an MRMC study was not conducted for this device.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: This question is not applicable as the ID NOW COVID-19 2.0 is a standalone molecular diagnostic test, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Was it done?: Yes, the clinical performance study evaluated the standalone performance of the ID NOW COVID-19 2.0 device. The results are automatically reported by the ID NOW Instrument (see Device Description), meaning there is no human interpretation of the raw signal or algorithm output before a result is given. Results are "Positive," "Negative," or "Invalid."

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical study was established using a composite comparator method consisting of three (3) FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for the detection of SARS-CoV-2. This is considered a molecular gold standard or definitive diagnostic method.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set" in the context of machine learning model development. This is a traditional IVD device, not an AI/ML diagnostic. The analytical studies (LoD, Inclusivity, Cross-Reactivity, Interference) and clinical study are part of the validation process, not "training" of an AI model.

Training Set Size: Not applicable/not explicitly stated as this is not an AI/ML device that undergoes a discrete training phase with labeled data in the same way. The development and optimization of the assay itself would involve iterative testing, but this is different from an AI "training set."

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

How Ground Truth for Training was Established: Not applicable as this is a molecular diagnostic test, not an AI/ML device requiring a distinct training set with established ground truth labels in the typical AI sense. The assay's analytical characteristics and performance are established through experiments and clinical trials.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K221925

Device Name ID NOW COVID-19 2.0

Indications for Use (Describe)

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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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

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PANEL Microbiology (83)

PREDICATE DEVICE

Sofia 2 SARS Antigen+ FIA, DEN220039

DEVICE DESCRIPTION

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 ●

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.

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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 ClinicalSpecimens 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 onthe ID NOW Instrument is a rapidmolecular in vitro diagnostic testutilizing an isothermal nucleic acidamplification technology (NAAT)intended for the qualitative detection ofnucleic acid from SARS-CoV-2 in directanterior nasal (nasal) or nasopharyngealswabs from individuals with signs andsymptoms of respiratory tract infection.ID NOW COVID-19 2.0 performed onthe ID NOW Instrument is intended foruse as an aid in the diagnosis of COVID-19 if used in conjunction with otherclinical, epidemiologic, and laboratoryfindings. SARS-CoV-2 RNA is generallydetectable in nasal and nasopharyngealswab specimens during the acute phaseof infection.Positive results are indicative of thepresence of SARS-CoV-2 RNA. Positiveresults do not preclude co-infection withbacteria or other viruses and should notbe used as the sole basis for diagnosis,	The Sofia 2 SARS Antigen+ FIA is a lateralflow immunofluorescent sandwich assaythat is used with the Sofia 2 instrument forthe rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigensdirectly in anterior nasal swab specimensfrom individuals with signs and symptomsof upper respiratory infection (i.e.,symptomatic) when testing is startedwithin 6 days of symptom onset. The test isintended for use as an aid in the diagnosisof SARS-CoV-2 infections (COVID-19) insymptomatic individuals when tested atleast twice over three days with at least 48hours between tests.The test does not differentiate betweenSARS-CoV and SARS-CoV-2.A negative test result is presumptive, and itis recommended these results be confirmedby a molecular SARS-CoV-2 assay.
Parameter	ID NOW COVID-19 2.0	Sofia 2 SARS Antigen+ FIA(DEN220039)
	treatment, or other patient managementdecisions.A negative test result is presumptive, andit is recommended these results beconfirmed by another molecular SARS-CoV-2 assay. Negative results do notpreclude SARS-CoV-2 infection andshould not be used as the sole basis fordiagnosis, treatment, or other patientmanagement decisions. This test isintended for prescription use only andcan be used in Point-of-Care settings.	Negative results do not preclude SARS-CoV-2 infections and should not be used asthe sole basis for treatment or other patientmanagement decisions.Positive results do not rule out co-infectionwith other respiratory pathogens.Performance characteristics for SARS-CoV-2 were established during the 2021-2022SARS-CoV-2 pandemic when SARS-CoV-2Omicron 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 useonly and can be used in Point-of-Caresettings.
Intended Environment forUse	Professional use, in a medical laboratoryor 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 reportgeneration
Assay Information
Sample Type	Direct anterior nasal or nasopharyngealswabs	Direct anterior nasal swabs
SARS-CoV-2 Target	RdRp gene	Nucleocapsid Protein Antigen
Technology	Isothermal nucleic acid amplificationfor detecting the presence/absence ofviral RNA in clinical specimens	lateral flow immunofluorescent sandwichassay for detecting the presence/absence ofthe nucleocapsid protein antigen in clinicalspecimens
Internal Control	Yes	Same
Result Interpretation	Automated	Same
Assay Result	Qualitative	Same
Time to Result	< 10 minutes	About 15 minutes

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PERFORMANCE SUMMARY

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 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

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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.

ID NOW COVID-19 2.0 performance, including 95% confidence intervals (Wilson score), against the composite comparator is provided below.

ID NOW COVID-19 2.0 Performance against Composite Comparator (Nasal and Nasopharyngeal
Swabs Combined)

ID NOW COVID-19 2.0	Composite Comparator Result
	Positive	Negative	Total
Positive	254	10	264
Negative	23	627	650
Total	277	637	914
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)

ID NOW COVID-19 2.0 limit of detection (LoD) in natural nasal swab matrix was determined by evaluating different concentrations of inactivated SARS-CoV-2 virus (USA-WA1/2020).

Presumed negative natural nasal swab specimens were eluted in Universal Transport Media. Swab eluates were combined and mixed thoroughly to create a clinical matrix pool to be used as the diluent. SARS-CoV-2 virus was diluted in this natural nasal matrix pool to generate virus dilutions for testing.

A point estimate was determined using Probit analysis and the LoD was confirmed as the lowest concentration that was detected ≥95% of the time.

The confirmed LoD in natural nasal swab matrix is presented in the table below. Equivalent performance was also verified in natural nasopharyngeal swab matrix.

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Limit of Detection (LoD) Study Results

Virus	Swab Matrix	Claimed LoD
		copies/swab	copies/reaction
SARS-CoV-2 RNA	Nasal Swab	500	20
	Nasopharyngeal Swab	500	20

Analytical Reactivity (Inclusivity)

Wet Testing

An Analytical Reactivity (inclusivity) study was performed to determine whether ID NOW COVID-19 2.0 is able to detect a variety of SARS-CoV-2 strains.

Vendor provided stocks of SARS-CoV-2 strains were diluted in natural nasal swab matrix to approximately 1 – 3 times the limit of detection. Contrived swab samples were prepared by coating 50 microliters of virus dilution onto each swab.

A concentration level was considered "reactive/positive" in this study if all five replicates generated a positive result. If 5/5 COVID-19 positive results were not obtained across all three device lots at the concentration tested, the isolate was tested at increasing concentrations until 5/5 positive results were obtained.

ID NOW COVID-19 2.0 detected all strains tested at the concentrations indicated in the table below:

Analytical Reactivity Study Results

SARS-CoV-2 Strain	DetectedConcentration(copies/reaction)	DetectedConcentration(copies/swab)
Hong Kong/VM200001061/2020	60	1,500
Italy-INMI1	60	1,500
SARS-CoV-2-USA- WA1/2020	58.3	1,457.5
P.2 (Zeta)	26	650
P.1 (Gamma)	61.1	1,527.5
B.1.1.7 (Alpha)	45.9	1,147.5
B.1.429 (Epsilon)	18.7	467.5
B.1.1.318	28.8	720
Wa1-wt	41	1,025
B.1.351 (Beta)	23	575
B.1.1.7 (Alpha)	100.2	2,505
B.1.617.1 (Kappa)	19	475
B.1.617.1 (Kappa)	40.5	1,012.5
B.1.617.2 (Delta)	22.4	560
B.1.617.2 (Delta)	20.7	517.5
B.1.1.529 (Omicron)	60	1,500
BA.2.12.1 (Omicron)	60	1,500
BA.4.6 (Omicron)	60	1,500
BA.5.1 (Omicron)	60	1,500

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BA.5.2 (Omicron)	80	2,000
BE.1 (Omicron)	60	1,500
BF.5 (Omicron)	100	2,500
BF.7 (Omicron)	80	2,000
BA.4.1 (Omicron)	60	1,500
BQ.1 (Omicron)	60	1,500
BQ.1.1 (Omicron)	60	1,500
XBB.1 (Omicron)	80	2,000
XBB.6 (Omicron)	60	1,500

In-Silico Analysis

An alignment was performed with the oligonucleotide primer and probe sequences of the ID NOW COVID-19 2.0 with all publicly available SARS-COV-2 genomic sequences submitted to NCBI Genbank and GISAD databases between December 1, 2019 and December 3-4, 2021. A total of 431,147 high quality SARS-CoV-2 sequences (<1% Ns, unknown or unidentified nucleotides) plus a reference genome were available from NCBI GenBank, and 4,252,920 from GISAID databases. Both datasets contained sequences obtained from human hosts only. 217,267 sequences were present in both databases. To avoid redundancy only the GISAID copies of the duplicated sequences were retained for analysis bringing the total number of high quality human SARS-CoV-2 sequences available from both databases to 4,466,800. Of the total number of sequences analyzed, 3,274 sequences contained at least 1 ambiguous or unidentified nucleotide within the target region, bringing the total number of isolates suitable for inclusivity analysis down to 4,463,526. From this analysis 99,58% of the sequences provided 100% homology to the ID NOW COVID-19 2.0 primer and probe sequences.

An additional alignment was performed with the oligonucleotide primer and probe sequences of the ID NOW COVID-19 2.0 with all publicly available SARS-CoV-2 genomic sequences collected within the United States and submitted to the GISAID database between October 17, 2022 and April 17, 2023. The dataset contained sequences obtained from human hosts only and totaled 382,309 sequences. ID NOW COVID-19 2.0 provided 100% sequence homology across 99.51% of the sequences.

Analytical Specificity (Cross Reactivity)

To determine the analytical specificity of ID NOW COVID-19 2.0, 38 commensal and pathogenic microorganisms (24 viruses, 12 bacteria, and 2 veasts) that may be present in the nasal cavity or nasopharvux were tested. All of the following microorganisms were negative when tested at concentrations ranging from 106 to 107 cells/mL, IFU/mL, or CFU/mL (bacteria), 105 to 108 TCID30/mL, GE/mL or IU/mL (viruses), and 106 to 107 cells/mL or CFU/mL (yeast).

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

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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(HighNegative)	Percent Agreement	87.8%	90.9%	90.0%	89.6%	85.3%, 92.7%
	Count	79/90	80/882	81/90	(240/268)

Virus FreeNegative1	Percent Agreement	100.0%	100.0%	98.9%	99.6%	97.9%, 99.9%
	Count	90/90	89/892	88/892	(267/268)
PositiveControl	Percent Agreement	100%	100%	100%	100%	97.3% - 100%
	Count	45/45	46/46	46/46	(137/137)
NegativeControl	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.

Regulation Number and Section

N/A