← Product Code [OCC](/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC) · K173932 # Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (K173932) _Alere Scarborough, Inc. · OCC · Jan 26, 2018 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC/K173932 ## Device Facts - **Applicant:** Alere Scarborough, Inc. - **Product Code:** [OCC](/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC.md) - **Decision Date:** Jan 26, 2018 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.3980 - **Device Class:** Class 2 - **Review Panel:** Microbiology - **Attributes:** Pediatric ## Indications for Use 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 nasal 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 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. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens ## Device Story Alere i system performs rapid molecular isothermal nucleic acid amplification for respiratory pathogens (Flu A/B, Strep A, RSV). System comprises disposable Sample Receiver, Test Base (with lyophilized reagents), Transfer Cartridge, and reusable Alere i Instrument. Operator inserts components into instrument; instrument automatically heats elution buffer, mixes sample, and performs isothermal amplification. Fluorescence detection identifies target nucleic acids. Results displayed on instrument, stored in on-board archive, and optionally printed via USB. Used in professional medical labs or point-of-care settings. Software update modifies algorithm to mitigate false invalid results caused by low baseline values misidentified as empty tube values. No changes to assay chemistry. ## Clinical Evidence No clinical data presented; submission is a software modification to address technical performance (false invalid results) of the existing, cleared assay platform. ## Technological Characteristics Isothermal nucleic acid amplification; fluorescence-based detection; automated heating and mixing; disposable sample receiver/test base/cartridge; reusable reader instrument; USB connectivity for printing; software-based qualitative result interpretation. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Alere™ i Influenza A & B ([K163266](/device/K163266.md)) - Alere™ i Strep A ([K151690](/device/K151690.md)) - Alere™ i RSV ([K161375](/device/K161375.md)) - Alere™ i Influenza A & B 2 ([K171792](/device/K171792.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY 510(k) Number: K173932 This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable: 1. The name and 510(k) number of the applicant’s previously cleared device. (For a preamendments device, a statement to this effect has been provided.) 2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. Description of the device MODIFICATION(S): This change was for a modification of the Alere i Influenza A & B, Alere i Strep A, Alere i RSV, and Alere i Influenza A & B 2 algorithm was made to mitigate issues with false invalid results due to baselines that are lower than allowed by the algorithm and incorrectly identified as Empty Tube Values. The Norm Window baseline minimum setting was changed from 1.0 mV/s to 0.1 mV/s for each of the assays identified above. This is an algorithm update only, there have been no changes made to the chemistry of the assays. The only impact of this change is related to invalid results, the threshold for positive and negative results has not changed and there is no change to assay performance. There are no changes to the user interface and no changes to product labeling are required. The Intended Use of Alere i Influenza A & B, Alere i Strep A, Alere i RSV, and Alere i Influenza A & B 2 as described in the 510k cleared labeling, has not changed because of this modification. The modification does not alter the fundamental technology of the Alere i Influenza A & B, Alere i Strep A, Alere i RSV, and Alere i Influenza A & B 2 assays or the Alere i Instrument. The unmodified and modified devices are identical in assay formulation and there has been no change in the test procedure. The only changes are to the software as described above. 4. The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. 5. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including labeling, intended use, physical characteristics, and assay information: Similarities {1} | 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 | 2 {2} | Parameter | Alere™ i Influenza A & B (with software modification) | Alere™ i Influenza A & B (K163266) | | --- | --- | --- | | Intended Use | 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 nasal 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 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. 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 | Same | 3 {3} 4 | Parameter | Alere™ i Influenza A & B (with software modification) | Alere™ i Influenza A & B (K163266) | | --- | --- | --- | | Intended Environment for Use | Professional use, in a medical laboratory or point of care | Same | | Instrumentation | Alere™ i Instrument | Same | | Assay Information | | | | Sample Type | 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 | | 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 Environment for Use | Professional use, in a medical laboratory or point of care | Same | | Instrumentation | Alere i Instrument | Same | {4} 5 | 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 | | 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 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. | Same | | 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 | | 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 | {5} | Intended Use | 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 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. 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. | Same | | --- | --- | --- | | Intended Environment for Use | Professional use, in a medical laboratory or point of care | Same | | Instrumentation | Alere™ i Instrument | Same | | **Assay Information** | | | | Sample Type | Nasopharyngeal Swab, Nasal Swab and Nasal or Nasopharyngeal Swabs Eluted in Viral Transport Media | Same | 6 {6} | 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 | ## Differences ### Alere i Influenza A&B The Alere i Influenza A & B package insert will have the following footnote to the table for the original cross-reactivity study to reflect subsequent additional cross-reactivity information— *Some cross-reactivity was observed for Proteus vulgaris at concentrations greater than 7 x10⁸, Moraxella catarrhalis at concentrations greater than 2x10⁹, and Serratia marcescens at concentrations greater than 3 x10⁹. ### Alere i Influenza A&B 2 The Alere i package inserts will be updated to reflect the intended designation for room temperature storage. It will now state 15-30°C for room temperature (previously this was defined as 18-22°C). ## 6. A Design Control Activities Summary: A risk assessment of the modified Alere i Instrument software was conducted and documented according to the firm’s Quality System requirements. This assessment included a standard Failure Mode and Effects Analysis (FMEA). Base on this risk assessment, the modification made to the software embedded on the Alere i Instrument does not affect the assay procedure and the change is not expected to impact the performance of the test or its safety and effectiveness. Certain validation studies were conducted to confirm that the assay performance was not negatively impacted by the software modification. The following aspects of the system were analyzed: - Test workflows were verified to ensure they reflect the proper settings and configuration. - Regression testing was performed to verify that the changes to Baseline values did not impact the core software. - Code review was performed - To ensure that changing the baseline did not affect previously collected data used to support regulatory submissions, and thus product claims, CSV and/or JSON files from verification and validations studies that were used to support product claims for each assay were re-analyzed. Each CSV and/or JSON file was processed by the on-board instrument algorithm via the software unit test framework. As an output of the on-board analysis, a summary of the results was generated. The firm provided a summary of the results from these software validation studies. {7} 7. Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. 8 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC/K173932](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OCC/K173932) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com