ID NOW Influenza A & B 2

K191534 · Abbott Diagnostics Scarborough, Inc. · OCC · Jul 11, 2019 · Microbiology

Device Facts

• Record ID: K191534
• Device Name: ID NOW Influenza A & B 2
• Applicant: Abbott Diagnostics Scarborough, Inc.
• Product Code: OCC · Microbiology
• Decision Date: Jul 11, 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, automated, in vitro diagnostic test for the qualitative detection and differentiation of influenza A and influenza B viral nucleic acids in direct nasal, nasopharyngeal, and throat swabs from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the diagnosis of influenza A and B viral infections in healthcare settings.

Device Story

ID NOW Influenza A & B 2 is a rapid, instrument-based isothermal nucleic acid amplification test. Input: nasal or nasopharyngeal swabs (direct or eluted in viral transport media). Process: instrument heats elution buffer, transfers sample to Test Base containing lyophilized reagents, performs isothermal amplification, and detects targets via fluorescent molecular beacons. Output: qualitative detection/differentiation of influenza A and B viral RNA, displayed on instrument and stored in on-board archive. Used in professional settings (medical labs, point-of-care) by healthcare providers. Software modification optimizes recognition of partial/non-dispense events (high baseline) and prevents false invalids from system noise in the Normalization Window. Results aid clinical decision-making alongside epidemiological risk factors.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted to assess the impact of software algorithm modifications. Testing confirmed that the updated parameters (NormAveMax lowered to 450 mV; NormMinGrad changed to -2.0 mV/s) successfully optimize sample dispense recognition and prevent false invalid results due to system noise without affecting the fundamental scientific technology or intended use.

Technological Characteristics

Isothermal nucleic acid amplification system. Components: Sample Receiver (elution buffer), Test Base (lyophilized reagents, reaction tubes), Transfer Cartridge, and ID NOW Instrument (reader). Detection: fluorescent molecular beacon. Connectivity: USB port for external printer. Software: algorithm-based result interpretation.

Indications for Use

Indicated for qualitative detection and differentiation of influenza A and B viral nucleic acids in direct nasal, nasopharyngeal, and throat swabs from patients with signs and symptoms of respiratory infection. Intended for use in healthcare settings.

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

• ID NOW Influenza A & B 2 (K190204)

Submission Summary (Full Text)

{0}

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number
K191534

B Applicant
Abbott Diagnostics Scarborough, Inc.

C Proprietary and Established Names
ID NOW Influenza A & B 2

D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| OCC | Class II | 21 CFR 866.3980 - Respiratory Viral Panel Multiplex Nucleic Acid Assay | MI - Microbiology |
| OZE | Class II | 21 CFR 866.3980 - Respiratory viral panel multiplex nucleic acid assay | MI - Microbiology |
| OOI | Class II | 21 CFR 862.2570 - Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

K191534 - Page 1 of 2

{1}

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.

2. Submitter's statement that the INDICATIONS FOR USE/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. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for a modification of the ID NOW Influenza A & B 2 software algorithm to optimize recognition of partial/non-dispense of sample into the Test Base that result in a high baseline and to prevent false invalid results due to system noise in the Normalization Window. To optimize recognition of partial/non-dispense of sample into the Test Base, the NormAveMax in the Tube 2 ROX (internal control) channel was lowered from 900 mV to 450 mV. To prevent false invalid results due to system noise, for all channels the NormMinGrad was changed from -1.0 mV/s to -2.0 mV/s.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

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 submitter'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 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.

K191534 - Page 2 of 2