The ID NOW™ Influenza A & B 2 assay performed on the ID NOW™ Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2016-2017 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Description

ID NOW Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

All ID NOW™ assays utilize isothermal nucleic acid amplification technology and are 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, and
ID NOW™ Instrument repeat use reader .

The reaction tubes in the ID NOW Influenza A & B 2 Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. ID NOW Influenza A & B 2 utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

ID NOW Influenza A & B 2 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 reduces 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 and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellets contained within the Test Base 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. and the date/time the test was performed. 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 a 510(k) submission for the ID NOW™ Influenza A & B 2 assay, specifically focusing on a software modification to mitigate potential false positive Influenza B test results during sequential workflow testing. The submission is a "Special 510(k)," indicating that the changes are minor and do not significantly alter the device's fundamental technology or safety/effectiveness.

The document emphasizes the equivalence to a legally marketed predicate device (ID NOW Influenza A & B 2, K220801). Therefore, the study presented here is primarily a comparative study to demonstrate that the modified device performs equivalently to the predicate, rather than establishing de novo performance characteristics against a clinical ground truth for a novel device.

Here's an analysis of the provided information, framed by your request for acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this Special 510(k) are implicitly tied to demonstrating non-inferiority or equivalence of the modified device's performance to the predicate device, particularly concerning the reduction of false positives for Influenza B. The document states:

"A modification of the ID NOW Influenza A & B 2 algorithm was made, as a preventive measure, to mitigate the potential occurrence of false positive Influenza B test results during sequential workflow testing."
"ID NOW Influenza A & B 2 incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared ID NOW Influenza A & B 2."

While the document states the purpose and the comparison, it does not explicitly list quantitative acceptance criteria (e.g., a specific percentage reduction in false positives, or a non-inferiority margin for sensitivity/specificity) or the reported device performance in a table format as you requested. The provided text is a summary letter and general description, not a detailed study report. For a device like this, the performance data (sensitivity, specificity, positive predictive value, negative predictive value) for both the modified and predicate devices would typically be presented in the detailed 510(k) submission, but this information is not included in the provided excerpt.

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

The provided text does not explicitly state the sample size used for the test set. It mentions the study compares the modified device to the predicate, implying a test set was used for this comparison.

Regarding data provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. These details would be crucial for a full understanding of the study's design.

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

For a molecular diagnostic test like ID NOW Influenza A & B 2, the "ground truth" is typically established by a highly sensitive and specific reference method, such as RT-PCR (Reverse Transcription Polymerase Chain Reaction), which is considered the gold standard for viral detection. The document does not mention the use of human experts (e.g., radiologists) to establish ground truth because this is a laboratory diagnostic assay, not an imaging device. Therefore, no information is provided on expert qualifications or the number of experts.

4. Adjudication Method for the Test Set

Since the ground truth for molecular diagnostics is typically established by a reference laboratory method (e.g., RT-PCR), an "adjudication method" involving human readers (like 2+1 or 3+1 for imaging studies) is not applicable in this context and is therefore not mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable and therefore not done. MRMC studies are typically used for evaluating diagnostic imaging systems where human interpretation plays a critical role, and the impact of AI assistance on human reader performance is being assessed. The ID NOW Influenza A & B 2 is an automated molecular diagnostic test; human "readers" do not interpret results in the same way as in imaging.

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

Yes, the very nature of this device (an automated molecular diagnostic test) means that the performance is standalone (algorithm only without human-in-the-loop performance). The ID NOW Instrument performs the test, processes the sample, and reports results automatically. The software modification described directly impacts this automated process. The comparison to the predicate device would inherently evaluate the standalone performance of the modified algorithm against the predicate algorithm.

7. The Type of Ground Truth Used

As mentioned in point 3, the ground truth for molecular diagnostic tests like this is almost universally established by a highly sensitive and specific reference laboratory method, typically RT-PCR. While the document does not explicitly state "RT-PCR was used as ground truth," this is the industry standard for validating such devices. "Expert consensus," "pathology," or "outcomes data" are generally not the primary ground truth methods for direct viral detection assays.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is a software modification to an existing, cleared device, implying the original device would have undergone substantial training and validation. For a Special 510(k) focusing on a specific bug fix (false positives in sequential workflow), the emphasis is on a targeted verification and validation of the change, rather than retraining a comprehensive model. If a machine learning model were involved, reporting training set size would be crucial, but the description here suggests a more rule-based or algorithmic adjustment.

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

Since no information on a specific "training set" for the software modification is provided, there is also no information on how the ground truth for such a training set (if it existed) was established.

Summary

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October 10, 2023

Abbott Diagnostics Scarborough, Inc. Jessica Stahle Senior Manager Regulatory Affairs 10 Southgate Road Scarborough, Maine 04074

Re: K232775

Trade/Device Name: ID NOW Influenza A & B 2 Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OCC, OZE, OOI Dated: September 8, 2023 Received: September 11, 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 (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).

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Joseph Briggs -S

Joseph Briggs, Ph.D. Deputy Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K232775

Device Name

ID NOW™ Influenza A & B 2

Indications for Use (Describe)

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized, rounded, sans-serif letter 'A' in a light blue color. Below the symbol is the word "Abbott" in a bold, black, sans-serif font.

510(k) SUMMARY

This summary of 510(k) substantial equivalence is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K232775

SUBMITTER

Abbott Diagnostics Scarborough , Inc. 10 Southgate Road Scarborough, Maine 04074 Establishment Registration Number: 1221359

PRIMARY CONTACT PERSON

Jessica Stahle Senior Manager Regulatory Affairs Phone: (207) 730-6353 Email: jessica.stahle@abbott.com

SECONDARY CONTACT PERSON

Angela Drysdale (207) 415-1393 (Mobile) angela.drysdale@abbott.com (email)

DATE PREPARED

9/8/2023

TRADE NAME ID NOW™ Influenza A & B 2

COMMON NAME ID NOW™ Flu 2, Alere™ i Flu 2, Alere™ i Influenza A & B 2

CLASSIFICATION NAME

Respiratory Viral Panel Multiplex Nucleic Acid System (per 21 CFR 866.3980) Instrumentation for Clinical Multiplex Test Systems (per 21 CFR 862.2570)

CLASSIFICATION Class II

PRODUCT CODE OCC, OZE, OOI

PANEL Microbiology (83)

PREDICATE DEVICE

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Image /page/4/Picture/1 description: The image shows the Abbott logo. The logo consists of a stylized letter 'A' in blue, positioned above the word "Abbott" in black, bold font. The 'A' is designed with rounded edges and a gap in the middle, giving it a modern and distinctive look.

ID NOW Influenza A & B 2, K220801

DEVICE DESCRIPTION

All ID NOW™ assays utilize isothermal nucleic acid amplification technology and are 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, and
ID NOW™ Instrument repeat use reader .

INTENDED USE

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Image /page/5/Picture/1 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter "a" in blue, positioned above the company name "Abbott" in black, sans-serif font. The "a" is designed with rounded edges and a gap in the upper right corner, giving it a modern and distinctive look. The overall design is clean and professional, reflecting the company's focus on health and innovation.

differential diagnosis of influenza A and B viral infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

COMPARISON TO THE PREDICATE

The purpose of this Special 510(k) submission is to bring to market a modification of the software contained on the ID NOW™ Instrument. A modification of the ID NOW Influenza A & B 2 algorithm was made, as a preventive measure, to mitigate the potential occurrence of false positive Influenza B test results during sequential workflow testing

There have been no changes made to other software components and no changes were made to the chemistry of the assay.

In addition, this Special 510(k) captures labeling updates to ID NOW Influenza A & B 2 to describe use of the optional, sequential workflow which allows a single patient sample to be used to run both ID NOW COVID-19 2.0 and ID NOW Influenza A &B 2 by reusing the ID NOW COVID-19 2.0 Sample Receiver with ID NOW Influenza A & B 2. Introduction of the optional, sequential workflow was first cleared for use in the ID NOW COVID-19 2.0 510(k) K221925, decision dated August 10, 2023

ID NOW Influenza A & B 2 incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared ID NOW Influenza A & B 2.

Parameter	ID NOW™ Influenza A & B 2(with software modification)	ID NOW™ Influenza A& B 2 (K220801)
FDA Product Code	OCC,OZE, OOI	Same
Assay Target	Influenza A, Influenza B	Same
Intended Use	The ID NOW™ Influenza A & B 2 assay performedon the ID NOW™ Instrument is a rapid molecularin vitro diagnostic test utilizing an isothermalnucleic acid amplification technology for thequalitative detection and discrimination ofinfluenza A and B viral RNA in direct nasal ornasopharyngeal swabs and nasal or	Same
Parameter	ID NOWTM Influenza A & B 2(with software modification)	ID NOWTM Influenza A & B 2 (K220801)
	nasopharyngeal swabs eluted in viral transportmedia from patients with signs and symptoms ofrespiratory infection. It is intended for use as anaid in the differential diagnosis of influenza A andB viral infections in humans in conjunction withclinical and epidemiological risk factors. Theassay is not intended to detect the presence ofinfluenza C virus.
	Negative results do not preclude influenza virusinfection and should not be used as the sole basisfor diagnosis, treatment or other patientmanagement decisions.
	Performance characteristics for influenza A wereestablished during the 2012-2013 and the 2014-2015 influenza seasons when influenza A/H3 andA/H1N1 pandemic were the predominantinfluenza A viruses in circulation. When otherinfluenza A viruses are emerging, performancecharacteristics may vary.
	If infection with a novel influenza A virus issuspected based on current clinical andepidemiological screening criteria recommendedby public health authorities, specimens should becollected with appropriate infection controlprecautions for novel virulent Influenza virusesand sent to state or local health department fortesting. Viral culture should not be attempted inthese cases unless a BSL 3+ facility is available toreceive and culture specimens.
Intended Environmentfor Use	Professional use, in a medical laboratory or pointof care	Same
Instrumentation	ID NOWTM Instrument	Same
Assay Information
Sample Type	Nasopharyngeal Swab, Nasal Swab and Nasal orNasopharyngeal Swabs Eluted in Viral TransportMedia	Same
Influenza A Viral Target	PB2 segment	Same
Influenza B Viral Target	PA segment	Same
Technology	Isothermal nucleic acid amplification	Same
Internal Control	Yes	Same
Result Interpretation	Automated	Same
Assay Result	Qualitative	Same
Time to Result	< 15 minutes	Same

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Image /page/6/Picture/1 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter "a" in blue, positioned above the company name "Abbott" in black, bold font. The "a" is designed with rounded edges and a modern, minimalist aesthetic. The overall design is clean and professional, reflecting the company's focus on health and innovation.

Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.