K Number
K220801
Device Name
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Date Cleared
2022-06-24

(98 days)

Product Code
Regulation Number
866.3980
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 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. ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.
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. ID NOW™ Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens. 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. The reaction tubes in the ID NOW™ Strep A 2 Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. ID NOW™ Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target. All ID NOW™ assays are 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 initiating bacterial lysis (for ID NOW™ Strep A 2) 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.
More Information

Not Found

No
The description focuses on isothermal nucleic acid amplification technology and fluorescence detection, with no mention of AI or ML in the device's operation or result interpretation.

No
The device is an in vitro diagnostic test used to detect and discriminate influenza A and B viral RNA or Streptococcus pyogenes bacterial nucleic acid to aid in diagnosis, not to treat a condition.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "a rapid molecular in vitro diagnostic test" for detecting and discriminating influenza A and B viral RNA and later mentions it's "intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections."

No

The device description explicitly details multiple hardware components including the ID NOW™ Instrument (repeat use reader), Sample Receiver, Test Base, and Transfer Cartridge, which are essential for the device's function.

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

Here's why:

  • Explicitly stated in the Intended Use/Indications for Use: The document clearly states: "The ID NOW™ Influenza A & B 2 assay performed on the ID NOW™ Instrument is a rapid molecular in vitro diagnostic test..." and "ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test...".
  • Performs testing on biological specimens: The device analyzes nasal, nasopharyngeal, and throat swab specimens.
  • Provides information for diagnosis: The intended use states it is "intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans" and "It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections."
  • Utilizes laboratory techniques: The device uses isothermal nucleic acid amplification technology, which is a laboratory-based technique.

All of these points align with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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 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.

ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

Product codes (comma separated list FDA assigned to the subject device)

OCC, OZE, OOI, PGX

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.

ID NOW™ Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens.

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.

The reaction tubes in the ID NOW™ Strep A 2 Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. ID NOW™ Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target.

All ID NOW™ assays are 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 initiating bacterial lysis (for ID NOW™ Strep A 2) 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasal or nasopharyngeal swabs, throat swab specimens

Indicated Patient Age Range

patients with signs and symptoms of respiratory infection, patients with signs and symptoms of pharyngitis

Intended User / Care Setting

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 and ID NOW™ Strep A 2 algorithm was made to mitigate issues with false invalid results due to baseline values that are lower than allowed by the algorithm and incorrectly identified as Empty Tube Values. This is an algorithm update only, there have been no changes made to the chemistry of the assays.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K171792, K173653

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

§ 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.

0

Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Date: June 24, 2022

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

Re: K220801

Trade/Device Name: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 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, PGX Dated: March 16, 2022 Received: March 18, 2022

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,

Himani Bisht, Ph.D. Assistant Director Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K220801

Device Name ID NOW Influenza A & B 2

Indications for Use (Describe)

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 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.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Indications for Use

510(k) Number (if known) K220801

Device Name ID NOW Strep A 2

Indications for Use (Describe)

ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

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: K220801

SUBMITTER

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

PRIMARY CONTACT PERSON

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

SECONDARY CONTACT PERSON

Angela Drysdale (207) 415 - 1393 (Mobile) (207) 730 - 5737 (Office) angela.drysdale@abbott.com (email)

DATE PREPARED

3/16/2022

TRADE NAME ID NOW™ Influenza A & B 2 ID NOW™ Strep A 2

COMMON NAME

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

CLASSIFICATION NAME

Respiratory Viral Panel Multiplex Nucleic Acid System (per 21 CFR 866.3980) Streptococcus spp Nucleic Acid-Based Assay (per 21 CFR 866.2680) Instrumentation for Clinical Multiplex Test Systems (per 21 CFR 862.2570)

CLASSIFICATION

Class II

PRODUCT CODE

OCC, OZE, OOI PGX, OOI

PANEL Microbiology (83)

PREDICATE DEVICE ID NOW™ Influenza A & B 2, K171792 ID NOW™ Strep A 2, K173653

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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.

ID NOW™ Strep A 2 is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens.

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.

The reaction tubes in the ID NOW™ Strep A 2 Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. ID NOW™ Strep A 2 utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target.

All ID NOW™ assays are 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 initiating bacterial lysis (for ID NOW™ Strep A 2) 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.

INTENDED USE

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.

6

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 evidemiological 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.

ID NOW™ Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus pyogenes. Group A Streptococus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

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 and ID NOW™ Strep A 2 algorithm was made to mitigate issues with false invalid results due to baseline values that are lower than allowed by the algorithm and incorrectly identified as Empty Tube Values. This is an algorithm update only, there have been no changes made to the chemistry of the assays.

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.

| | ID NOW TM Influenza A & B 2
(with software modification) | ID NOW TM Influenza A
& B 2 (K171792) |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Parameter | | |
| FDA Product Code | OCC,OZE, OOI | Same |
| Assay Target | Influenza A, Influenza B | Same |
| Intended Use | The ID NOWTM Influenza A & B 2 assay performed on the ID NOWTM 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 | Same |

7

| Parameter | ID NOW™ Influenza A & B 2
(with software modification) | ID NOW™ Influenza A
& B 2 (K171792) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| | 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. | |
| Intended Environment for Use | Professional use, in a medical laboratory or point of care | Same |
| Instrumentation | ID NOW™ Instrument | Same |
| Assay Information | | |
| Sample Type | Nasopharyngeal Swab, Nasal Swab and Nasal or Nasopharyngeal Swabs Eluted in Viral Transport Media | 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 | Streptococcus pyogenes | Same |
| Intended Use | ID NOWTM Strep A 2 is a rapid, instrument-
based, molecular in vitro diagnostic test utilizing
isothermal nucleic acid amplification technology
for the qualitative detection of Streptococcus
pyogenes , Group A Streptococcus bacterial
nucleic acid in throat swab specimens obtained
from patients with signs and symptoms of
pharyngitis. It is intended to aid in the rapid
diagnosis of Group A Streptococcus bacterial
infections. | Same |
| Intended Environment
for Use | Professional use, in a medical laboratory or
point of care | Same |
| Instrumentation | ID NOWTM Instrument | Same |
| Assay Information | | |
| Sample Type | Throat Swab | Same |
| Target Analyte | Group A Streptococcus ( Streptococcus
pyogenes ) | Same |

8

510(K) SUMMARY

| Parameter | ID NOW™ Strep A 2
(with software modification) | ID NOW™ Strep A 2
(K173653) |
|-----------------------|---------------------------------------------------|--------------------------------|
| Technology | Isothermal nucleic acid amplification | Same |
| Internal Control | Yes | Same |
| Result Interpretation | Automated | Same |
| Assay Result | Qualitative | Same |
| Time to Result |