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.

AI/ML Overview

The document describes the modified software for the ID Now Instrument, encompassing ID NOW Influenza A & B 2 and ID NOW Strep A 2 assays. The modification specifically addresses false invalid results caused by baseline values being lower than allowed by the original algorithm, leading to incorrect identification as "Empty Tube Values." This is an algorithm update only, with no changes made to the chemistry of the assays.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified software address the reduction of false invalid results. The document implies that the "performance" here relates to the analytical performance characteristics of the assays (e.g., sensitivity, specificity) remaining equivalent to the predicate devices despite the software change. While explicit numerical acceptance criteria for reduction in false invalid rate are not provided in this excerpt, the study aims to demonstrate that the new algorithm resolves the "false invalid" issue without compromising the core analytical performance.

For ID NOW™ Influenza A & B 2 (with software modification):

Parameter	Acceptance Criteria (Implied: Equivalent to Predicate)	Reported Device Performance (with software modification)
FDA Product Code	OCC, OZE, OOI	OCC, OZE, OOI
Assay Target	Influenza A, Influenza B	Influenza A, Influenza B
Intended Use	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, as an aid in differential diagnosis. Not for Influenza C. Negative results do not preclude infection. Performance characteristics for influenza A established during 2016-2017 influenza season (A/H3 and A/H1N1). Precautions for novel influenza A viruses.	Same as predicate
Intended Environment for Use	Professional use, in a medical laboratory or point of care	Professional use, in a medical laboratory or point of care
Instrumentation	ID NOW™ Instrument	ID NOW™ Instrument
Sample Type	Nasopharyngeal Swab, Nasal Swab and Nasal or Nasopharyngeal Swabs Eluted in Viral Transport Media	Nasopharyngeal Swab, Nasal Swab and Nasal or Nasopharyngeal Swabs Eluted in Viral Transport Media
Influenza A Viral Target	PB2 segment	PB2 segment
Influenza B Viral Target	PA segment	PA segment
Technology	Isothermal nucleic acid amplification	Isothermal nucleic acid amplification
Internal Control	Yes	Yes
Result Interpretation	Automated	Automated
Assay Result	Qualitative	Qualitative
Time to Result	< 15 minutes	< 15 minutes
False Invalid Rate	Reduction of false invalid results associated with low baseline values.	The study (though details not fully in this excerpt) would have demonstrated that the software modification successfully mitigates the false invalid issue without negatively affecting the accuracy or other performance characteristics of the assay.

For ID NOW™ Strep A 2 (with software modification):

Parameter	Acceptance Criteria (Implied: Equivalent to Predicate)	Reported Device Performance (with software modification)
FDA Product Code	PGX, OOI	PGX, OOI
Assay Target	Streptococcus pyogenes	Streptococcus pyogenes
Intended Use	Rapid, instrument-based, molecular in vitro diagnostic test for qualitative detection of Streptococcus pyogenes, Group A Streptococcus bacterial nucleic acid in throat swab specimens from patients with signs and symptoms of pharyngitis, to aid in rapid diagnosis.	Same as predicate
Intended Environment for Use	Professional use, in a medical laboratory or point of care	Professional use, in a medical laboratory or point of care
Instrumentation	ID NOW™ Instrument	ID NOW™ Instrument
Sample Type	Throat Swab	Throat Swab
Target Analyte	Group A Streptococcus (Streptococcus pyogenes)	Group A Streptococcus (Streptococcus pyogenes)
Technology	Isothermal nucleic acid amplification	Isothermal nucleic acid amplification
Internal Control	Yes	Yes
Result Interpretation	Automated	Automated
Assay Result	Qualitative	Qualitative
Time to Result	< 8 minutes	< 8 minutes
False Invalid Rate	Reduction of false invalid results associated with low baseline values.	The study would have demonstrated that the software modification successfully mitigates the false invalid issue without negatively affecting the accuracy or other performance characteristics of the assay.

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

This document describes a Special 510(k) submission which is typically used for well-defined modifications to a legally marketed device where the modification does not affect the fundamental scientific technology of the device or its intended use. In such cases, extensive new clinical studies with large, prospectively collected sample sets might not be required if analytical performance remains equivalent and the specific issue (false invalids) is addressed.

The provided excerpt does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). For a software modification intended to fix a specific issue like "false invalid results due to baseline values," the testing typically involves:

Retrospective analysis of stored clinical samples that previously yielded false invalid results.
Prospective testing of both contrived and potentially clinical samples designed to challenge the new algorithm's ability to correctly classify results, especially those with low baseline values.
Analytical studies (e.g., limit of detection, inclusivity/exclusivity) to confirm that the change did not negatively impact the assay's performance characteristics.

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

Given this is a molecular diagnostic test for direct pathogen detection, the ground truth for such devices is typically established through definitive laboratory methods (e.g., highly sensitive PCR, culture, sequencing) rather than expert human interpretation of images or other subjective data. Therefore, the concept of "experts" in the sense of radiologists providing ground truth is not applicable here.

4. Adjudication Method for the Test Set

Not applicable in the context of a molecular diagnostic assay where ground truth is established by objective laboratory methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a molecular diagnostic assay, not an AI-assisted diagnostic imaging device that involves human reader interpretation.

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

Yes, in principle, the "performance" of the algorithm is assessed in a standalone manner. The device outputs a qualitative result ("Positive", "Negative", or "Invalid"). The study demonstrating the effectiveness of the software modification would specifically evaluate the algorithm's ability to correctly interpret the reaction (i.e., generate "Positive" or "Negative" results) and to correctly resolve cases that were previously generating "false invalid" results. There is no human-in-the-loop during the interpretation phase of these tests.

7. The Type of Ground Truth Used

The ground truth for molecular diagnostic tests like ID NOW Influenza A & B 2 and ID NOW Strep A 2 is generally established using reference laboratory methods that reliably detect the target nucleic acid or pathogen. This could include:

Culture: For bacterial targets like Streptococcus pyogenes.
PCR (Polymerase Chain Reaction) or RT-PCR: Highly sensitive and specific molecular methods, often considered the gold standard for detecting viral or bacterial nucleic acids.
Sequencing: To confirm the presence and identity of specific pathogen strains.

The purpose of the software modification was to improve the algorithm's interpretation of internal controls and baseline signals to prevent erroneous invalid results, while ensuring the accuracy (sensitivity and specificity) of positive/negative calls remained consistent with the gold standard.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. For a software modification to an existing algorithm like this, the "training" (or development and refinement) might involve:

Analyzing a dataset of historical internal control and baseline signal data, especially from cases that yielded false invalid results.
Developing and testing new thresholds or algorithms on this historical data.

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

For the purpose of training an algorithm to address "false invalid" results, the "ground truth" would be established by:

Investigating the source of the invalid signal: This might involve re-running the samples on a reference method to determine the true positive/negative status and then analyzing the raw signal data from the initial ID NOW test to understand why the invalid result occurred.
Characterizing "Empty Tube Values": Understanding the expected signal profiles when no reaction occurs or when the internal controls fail, versus when the assay is truly inhibited, or the baseline is genuinely low but still allows for a valid result. The ground truth for these investigations would be meticulously verified analytical data and, if applicable, the true clinical status (positive/negative by a gold standard method).

Summary

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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

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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,

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

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Indications for Use

510(k) Number (if known) K220801

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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Indications for Use

510(k) Number (if known) K220801

Device Name ID NOW Strep A 2

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)

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.

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."

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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: 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™ 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 ●

INTENDED USE

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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

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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	< 15 minutes	Same

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

Parameter	ID NOWTM Strep A 2(with software modification)	ID NOWTM Strep A 2(K173653)
FDA Product Code	PGX, OOI	Same
Assay Target	Streptococcus pyogenes	Same
Intended Use	ID NOWTM Strep A 2 is a rapid, instrument-based, molecular in vitro diagnostic test utilizingisothermal nucleic acid amplification technologyfor the qualitative detection of Streptococcuspyogenes , Group A Streptococcus bacterialnucleic acid in throat swab specimens obtainedfrom patients with signs and symptoms ofpharyngitis. It is intended to aid in the rapiddiagnosis of Group A Streptococcus bacterialinfections.	Same
Intended Environmentfor Use	Professional use, in a medical laboratory orpoint of care	Same
Instrumentation	ID NOWTM Instrument	Same
Assay Information
Sample Type	Throat Swab	Same
Target Analyte	Group A Streptococcus ( Streptococcuspyogenes )	Same

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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	< 8 minutes	Same

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.