The Alere™ i Influenza A & B assay performed on the Alere™ i 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 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 conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Negative results do not preciude 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 2012-2013 and the 2014-2015 influenza seasons when influenza 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.

Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus progeness, 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.

All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.

The Alere™ i RSV assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection of respiratory syncytial virus (RSV) virus (RSV) virus (RSV) virus (RSV) virus (RSV) viral RNA in direct nasopharyngeal swabs and nasopharyngeal swabs cluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the diagnosis of RSV in children < 18 years and adults ≥60 years in conjunction with clinical and epidemiological risk factors.

The Alere i Influenza A & B 2 assay performed on the Alere i 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 cases unless a BSL 3+ facility is available to receive and culture specimens.

Device Description

Alere™ i Influenza A & B is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal or nasopharyngeal swab specimens eluted in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.

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

Alere™ i RSV is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of respiratory syncytial virus (RSV) viral RNA from direct nasopharyngeal swab (NPS) and NPS eluted in viral transport media from patients with signs and symptoms of respiratory infection.

Alere™ i 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 Alere™ i 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 sinqle use, disposable for transfer of the eluted sample to the Test Base, and ●
Alere™ i Instrument repeat use reader .

The reaction tubes in the Alere™ i Influenza A & B and Alere™ i Influenza A & B 2 Test Base contain the reaqents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B 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 Alere™ i Strep A 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. Alere™ i Strep A 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.

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

All Alere™ i assays are performed within the confinement of the Test Base, and no other part of the Alere™ i 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 Alere™ i 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 Iyophilized pellets contained within the Test Base and initiating bacterial lysis (for Alere™ i Strep A) and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.

Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i 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 Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.

AI/ML Overview

This document describes a Special 510(k) submission for the Alere™ i Instrument and its associated assays (Influenza A & B, Strep A, RSV, and Influenza A & B 2). The purpose of this submission is to address a software modification to the Alere™ i Instrument's algorithm to mitigate issues with false invalid results due to baseline values being lower than allowed, which were incorrectly identified as "Empty Tube Values." The submission states that there have been no changes made to the chemistry of the assays.

The document highlights the substantial equivalence of the modified devices to their legally marketed predicate devices. However, it does not contain specific acceptance criteria or detailed study data to prove the device meets these criteria. Instead, it focuses on comparing the modified devices with their predicates, stating that all parameters (FDA Product Code, Assay Target, Intended Use, Intended Environment for Use, Instrumentation, Sample Type, Viral/Bacterial Target, Technology, Internal Control, Result Interpretation, Assay Result, and Time to Result) are "Same" as the predicate devices.

Given the information provided, it is not possible to complete a table of acceptance criteria and reported device performance, nor can we detail the study that proves the device meets the acceptance criteria, as this specific information is not present in the provided text. The document asserts "substantial equivalence" based on the described software modification and the consistency of other parameters with the predicate devices.

Therefore, the following information can be extracted or derived based on the provided text, with many fields remaining unascertainable:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that the modified devices are "substantially equivalent" to their predicate devices and lists various parameters which are "Same" as the predicates. No specific numerical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are detailed for the modified device or its predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The submission focuses on the software modification and states that no changes were made to the assay chemistry. It does not describe any new clinical studies or test sets with sample sizes for the modified device to demonstrate its performance against new acceptance criteria. It refers to historical performance characteristics for influenza A established during certain influenza seasons for the Alere™ i Influenza A & B and Alere™ i Influenza A & B 2 assays.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. As there is no description of a new clinical study with a test set and ground truth establishment, these details are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an in vitro diagnostic test for detecting viral/bacterial RNA/DNA, not an AI-assisted diagnostic imaging device that involves human readers.

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

The device is described as an "instrument-based, molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology" with "automated" result interpretation. This implies a standalone (algorithm only) performance, i.e., without human-in-the-loop performance influencing the assay result. However, specific standalone performance study details are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the original performance characteristics mentioned for the influenza assays, it can be inferred that the ground truth would have been established by a reference method for detecting viral RNA, likely PCR or viral culture, rather than expert consensus or pathology in the context of an IVD. However, the document does not explicitly state the ground truth used for performance characteristics, nor does it detail ground truth for any new studies related to the software modification.

8. The sample size for the training set:

This information is not provided in the document. Since this is a software modification to an existing algorithm for an IVD, it's possible the "training set" concept as used in AI/ML might not directly apply, or details about algorithm development data are not included.

9. How the ground truth for the training set was established:

This information is not provided in the document.

In summary, the provided document is a 510(k) summary for a software modification to existing IVD devices, asserting substantial equivalence to predicates without detailing new clinical studies, acceptance criteria, or performance data for the modified device.

Summary

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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 box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 26, 2017

Alere Scarborough, Inc. Angela Drysdale VP, Regulatory Affairs - Infectious Disease 10 Southgate Road Scarborough, Maine 04074

Re: K173932

Trade/Device Name: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i 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: OZE, OOI, PGX, OCC Dated: December 21, 2017 Received: December 26, 2017

Dear Angela Drysdale:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

{1}------------------------------------------------

Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kristian M. Roth -S

For:

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT – ALERE™ i INFLUENZA A & B

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below

510(k) Number (if known)
K173932
Device Name
Alere™ i Influenza A & B

Indications for Use (Describe)

Negative results do not preciude 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.

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."

FORM FDA 3881 (8/14)

PSC Publishang Services (301) 443-6740

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT – ALERE™ i STREP A

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)	K173932
Device Name	Alere™ i Strep A

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."

FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740 ER

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT – ALERE™ i RSV

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)	K173932
Device Name	Alere™ i RSV

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."

FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740 EF

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT – ALERE™ i INFLUENZA A & B 2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Indications for Use

510(k) Number (if known)	K173932
Device Name	Alere i 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.

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 cases unless a BSL 3+ facility is available to receive and culture specimens.

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

{6}------------------------------------------------

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: _K173932

SUBMITTER

Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Establishment Registration Number: 1221359

PRIMARY CONTACT PERSON

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

DATE PREPARED

12/21/2017

TRADE NAME

Alere™ i Influenza A & B Alere™ i Strep A Alere™ i RSV Alere™ i Influenza A & B 2

COMMON NAME

Alere™ i Flu, Alere™ i, Alere™ Influenza A & B Alere™ i Strep, Alere™ Strep A Alere™ i RSV, Alere™ i Flu 2, Alere™ Influenza A & B 2

CLASSIFICATION NAME

Respiratory Viral Pan 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

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PANEL

Microbiology (83)

PREDICATE DEVICE

Alere™ i Influenza A & B, K163266 Alere™ i Strep A, K151690 Alere™ i RSV, K161375 Alere™ i Influenza A & B 2, K171792

DEVICE DESCRIPTION

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

All Alere™ i 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 sinqle use, disposable for transfer of the eluted sample to the Test Base, and ●
Alere™ i Instrument repeat use reader .

{8}------------------------------------------------

amplification of RNA from RSV A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.

INTENDED USE

The Alere™ i Influenza A & B assay performed on the Alere™ 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 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 conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Neqative 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 2012-2013 and the 2014-2015 influenza seasons 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.

Alere™ i Strep A is a rapid, instrument-based, molecular in viro 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.

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The Alere™ i RSV assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic amplification technology for the qualitative detection of respiratory syncytial virus (RSV) viral RNA in direct nasopharyngeal swabs and 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 diagnosis of RSV in children <18 years and adults >60 years in conjunction with clinical and epidemiological risk factors.

The Alere™ i Influenza A & B 2 assay performed on the Alere™ i 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.

Neqative 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 510k submission is to bring to market a modification of the software contained on the Alere™ i Instrument. A modification of the Alere™ i Influenza A & B, Alere™ i RSV, and Alere™ i Influenza A & B 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.

Alere™ i Influenza A & B incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared Alere™ i Influenza A & B test.

Parameter	Alere™ i Influenza A & B(with software modification)	Alere™ i Influenza A & B(K163266)
FDA Product Code	OCC,OZE, OOI	Same
Assay Target	Influenza A, Influenza B	Same
Intended Use	The Alere™ i Influenza A & B assay performed onthe Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermalnucleic acid amplification technology for thequalitative detection and discrimination of	Same
Parameter	Alere™ i Influenza A & B(with software modification)	Alere™ i Influenza A & B(K163266)
	influenza A and B viral RNA in nasal swabs andnasal or nasopharyngeal swabs eluted in viraltransport media from patients with signs andsymptoms of respiratory infection. It is intendedfor use as an aid in the differential diagnosis ofinfluenza A and B viral infections in humans inconjunction with clinical and epidemiological riskfactors. The assay is not intended to detect thepresence of influenza C virus.
	Intended Environmentfor Use		Professional use, in a medical laboratory or pointof care	Same
	Instrumentation		Alere™ i Instrument	Same
	Assay Information
Sample Type	Nasal Swab and Nasal or Nasopharyngeal SwabsEluted 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

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{11}------------------------------------------------

Alere™ i Strep A incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared Alere™ i Strep A test.

Parameter	Alere™ i Strep A(with software modification)	Alere™ i Strep A(K151690)
FDA Product Code	PGX, OOI	Same
Assay Target	Streptococcus pyogenes	Same
Intended Use	Alere™ i Strep A 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.All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.	Same
Intended Environmentfor Use	Professional use, in a medical laboratory or point of care	Same
Instrumentation	Alere™ i Instrument	Same
Assay Information
Sample Type	Throat Swab	Same
Target Analyte	Group A Streptococcus ( Streptococcus pyogenes )	Same
Technology	Isothermal nucleic acid amplification	Same
Internal Control	Yes	Same
Result Interpretation	Automated	Same
Assay Result	Qualitative	Same
Time to Result	< 8 minutes	Same

Alere™ i RSV incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared Alere™ i RSV test.

Parameter	Alere™ i RSV(with software modification)	Alere™ i RSV(K161375)
FDA Product Code	OCC, OOI	Same
Assay Target	RSV	Same
Intended Use	The Alere™ i RSV assay performed on theAlere™ i Instrument is a rapid molecular invitro diagnostic test utilizing an isothermalnucleic amplification technology for the	Same

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Parameter	Alere™ i RSV(with software modification)	Alere™ i RSV(K161375)
	qualitative detection of respiratory syncytial virus (RSV) viral RNA in direct nasopharyngeal swabs and 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 diagnosis of RSV in children <18 years and adults ≥60 years in conjunction with clinical and epidemiological risk factors.
Intended Environment for Use	Professional us, in a medical laboratory or point-of-care	Same
Instrumentation	Alere™ i Instrument	Same
Assay Information
Sample Type	Nasopharyngeal Swab, Nasopharyngeal Swab eluted in Viral Transport Media	Same
RSV Target	NS2 gene and nucleopcapsid gene N	Same
Technology	Isothermal nucleic acid amplification	Same
Internal Control	Yes	Same
Result Interpretation	Automated	Same
Assay Result	Qualitative	Same
Time to Result	< 13 minutes	Same

Alere™ i Influenza A & B 2 incorporating the software modification was compared to the legally marketed predicate device, the 510(k) cleared Alere™ i Influenza A & B 2 test.

Parameter	Alere™ i Influenza A & B 2(with software modification)	Alere™ i Influenza A & B 2(K163266)
FDA Product Code	OCC,OZE, OOI	Same
Assay Target	Influenza A, Influenza B	Same
Intended Use	The Alere™ i Influenza A & B 2 assay performedon the Alere™ i Instrument is a rapid molecular invitro 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 ornasopharyngeal 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 Aand B viral infections in humans in conjunctionwith clinical and epidemiological risk factors. Theassay is not intended to detect the presence ofinfluenza C virus.	Same
Parameter	Alere™ i Influenza A & B 2(with software modification)	Alere™ i Influenza A & B 2(K163266)
	Negative results do not preclude influenza virusinfection and should not be used as the solebasis for 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	Alere™ i 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

{13}------------------------------------------------

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.