ID NOW Influenza A & B 2

K190204 · Alere Scarborough, Inc. · OZE · Mar 18, 2019 · Microbiology

Device Facts

• Record ID: K190204
• Device Name: ID NOW Influenza A & B 2
• Applicant: Alere Scarborough, Inc.
• Product Code: OZE · Microbiology
• Decision Date: Mar 18, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

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. 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

ID NOW Influenza A & B 2 is a rapid, instrument-based molecular diagnostic system for detecting influenza A and B. Input: nasal or nasopharyngeal swabs (direct or in transport media). Operation: system uses isothermal nucleic acid amplification technology within a disposable Test Base containing lyophilized reagents. The ID NOW Instrument provides automated heating, mixing, and fluorescence-based detection of amplified RNA targets using molecular beacons. Output: qualitative results displayed on the instrument, stored in an on-board archive, and optionally printed via USB. Used in professional medical laboratories or point-of-care settings by healthcare providers. The device aids in differential diagnosis by providing rapid results to inform clinical decision-making and patient management. The system design, with testing confined to the disposable Test Base, minimizes instrument contamination and carry-over risk.

Clinical Evidence

Bench testing only. The submission is a labeling modification to expand specimen storage instructions; no new clinical performance data was required to support this change.

Technological Characteristics

Isothermal nucleic acid amplification technology; targets PB2 segment (Flu A) and PA segment (Flu B). Instrumentation: ID NOW Instrument. Sample types: nasal/nasopharyngeal swabs (direct or in VTM). Automated result interpretation. Qualitative output. Time to result: ≤13 minutes.

Indications for Use

Indicated for qualitative detection and discrimination of influenza A and B viral RNA in patients with signs and symptoms of respiratory infection. Specimens include direct nasal or nasopharyngeal swabs and swabs eluted in viral transport media. Not intended for influenza C detection.

Regulatory Classification

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 2 (K173932)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Summary

510(k) Number: K190204

This 510(k) submission contains information/data on modifications made to the applicant’s own Class II 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:

Alere i Influenza A & B 2

510(k) number: K173932

2. Submitter’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):

The results interpretation in the Package Insert and QRI for dual positive influenza A and B results has been changed to simplify the follow up steps. This is a labeling update only, there have been no changes to the Intended Use or fundamental scientific technology of the ID NOW Influenza A & B 2 assay.

The ID NOW Influenza A & B 2 Product Insert has been changed to expand the Specimen Transport and Storage section to include instructions to allow freezing transport media specimens at -80°C directly after collection.

To confirm assay performance will not be negatively impacted by storing VTM (viral transport media) specimens at -80°C a Sample Freeze/Thaw study was performed. For this study negative nasal swabs were eluted in 3mL of VTM and pooled to generate a pooled negative clinical matrix. Positive samples were generated by spiking virus into the pooled negative clinical matrix, at LoD, 2x LoD and 10x LoD. The samples were tested before freezing and after each freeze/thaw cycle, with a total of 3 freeze/thaw cycles. All test results were expected (except one sample, which was correct upon re-testing). This data supports allowing specimen storage at -80°C immediately after collection.

| Freeze/Thaw | Sample Type | Replicates | Flu A Result | Flu B Result |
| --- | --- | --- | --- | --- |
| Reference Kit | Clinical Matrix | 10 | - | - |
| | Flu ALOD | 6 | + | - |
| | Flu B LOD | 6 | - | + |
| | Flu A 2X LOD | 18 | + | - |
| | Flu B 2X LOD | 18 | - | + |
| | Flu A 10X LOD | 6 | + | - |
| | Flu B 10X LOD | 6 | - | + |

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| 1 Freeze/Thaw | Clinical Matrix | 10 | - | -(9/10)+(1/10)¹ |
| --- | --- | --- | --- | --- |
| | Flu A LOD | 6 | + | - |
| | Flu B LOD | 6 | - | + |
| | Flu A 2X LOD | 18 | + | - |
| | Flu B 2X LOD | 18 | - | + |
| | Flu A 10X LOD | 6 | + | - |
| | Flu B 10X LOD | 6 | - | + |
| 2 Freeze/Thaw | Clinical Matrix | 10 | - | - |
| | Flu A LOD | 6 | + | - |
| | Flu B LOD | 6 | - | + |
| | Flu A 2X LOD | 6² | + | - |
| | Flu B 2X LOD | 18 | - | + |
| | Flu A 10X LOD | 6 | + | - |
| | Flu B 10X LOD | 6 | - | + |
| 3 Freeze/Thaw | Clinical Matrix | 10 | - | - |
| | Flu A LOD | 6 | + | - |
| | Flu B LOD | 6 | - | + |
| | Flu A 2X LOD | 18 | + | - |
| | Flu B 2X LOD | 18 | - | + |
| | Flu A 10X LOD | 6 | + | - |
| | Flu B 10X LOD | 6 | - | + |

Note: Each result in the table above represents 100% agreement of all replicates tested unless otherwise noted.
¹ Retest from the same Sample Receiver generated expected results.
² 6 replicates were inadvertently tested instead of 18 replicates

## 4. Comparison Information

A. Similarities

| Parameter | ID NOW Influenza A & B 2
(with labeling modification) | ID NOW Influenza A
& B 2 (K173932) |
| --- | --- | --- |
| FDA Product Code | OCC, OZE, OOI | Same |
| Assay Target | Influenza A, Influenza B | Same |

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| 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.

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 | ID NOW Instrument | Same |
| **Assay Information** | | |
| Sample Type | Nasal or Nasopharyngeal 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 | 13 minutes or less | Same |

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## B. Differences

The QRI and Package Insert have minor additions to expand specimen storage to allow for freezing specimens at -80°C and to simplify the follow-up directions for influenza A and B dual positive results.

The following text was added to the Specimen Transport and Storage section of the Package Insert: “Alternatively, the sample may be frozen at -80°C or colder immediately after collection.”

The results interpretation for Flu A Viral RNA Detected; Flu B Viral RNA Detected was modified to read: “Dual infections of Flu A and Flu B are rare. Repeat testing with a new specimen. If the result is still dual positive, repeat testing with another method before reporting results.”

Section 7 in the QRI was modified to address dual positive infections, it now reads: “Refer to Product Insert instructions for retest procedure in the case of a Dual Flu A and Flu B Positive or Invalid test result.”

## 5. Design Control Activities Summary:

A review of the Failure Mode and Effects Analysis (FMEA) was conducted and documented per Alere Scarborough, Inc. Quality System requirements. The modification made to the Product Insert does not affect the assay procedure and this change was not expected to impact the performance of the test or its safety and effectiveness. However, to confirm assay performance was not negatively impacted a Sample Freeze/Thaw study was performed and is described in section 3 above.

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 modifications and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter 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 device.