(42 days)
Not Found
No
The description focuses on isothermal nucleic acid amplification technology and instrument-based detection of fluorescent signals. There is no mention of AI or ML being used for data analysis, interpretation, or result reporting. The instrument provides heating, mixing, and detection, and automatically reports results based on the presence or absence of amplified targets.
No.
The device is an in vitro diagnostic test used to detect and differentiate influenza A and B viral RNA; it aids in diagnosis but does not provide therapy or treatment.
Yes
The intended use explicitly states, "It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections," and the device description details a test for "qualitative detection and differentiation of influenza A and influenza B." This matches the definition of a diagnostic device.
No
The device description clearly outlines multiple hardware components including the ID NOW Instrument (repeat use reader), Sample Receiver, Test Base, and Transfer Cartridge, in addition to the software that runs on the instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "rapid molecular in vitro diagnostic test."
- Purpose: The test is designed for the "qualitative detection and discrimination of influenza A and B viral RNA" in patient samples (nasal/nasopharyngeal swabs). This is a diagnostic purpose performed outside of the living body (in vitro).
- Sample Type: It uses biological samples (swabs) collected from patients.
- Aid in Diagnosis: The intended use also states it is "intended for use as an aid in the differential diagnosis of influenza A and B viral infections."
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OZE, OCC, OOI
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 or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.
The ID NOW Influenza A & B 2 system utilizes isothermal nucleic acid amplification technology and is 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 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.
ID NOW Influenza A & B 2 is 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 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 Alere™ Universal Printer can be attached via USB to the ID NOW Instrument to print test results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal or nasopharyngeal swabs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use, in a medical laboratory or point of care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
March 18, 2019
Alere Scarborough, Inc. Angela Drysdale VP, Regulatory Affairs - Infectious Disease 10 Southgate Road Scarborough, Maine 04074
Re: K190204
Trade/Device Name: ID NOW 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, OCC, OOI Dated: March 4, 2019 Received: March 6, 2019
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. 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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Steven R. Gitterman -S for
Uwe Scherf, 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
510(k) Number (if known) K190204
Device Name ID NOW Influenza A & B 2
Indications for Use (Describe)
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 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.
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) | |
|---|---|---|
| ☑ | ☐ |
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3
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: K190204
SUBMITTER
Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Establishment Registration Number: 1221359
CONTACT PERSON
Angela Drysdale (207) 415 - 1393 (Mobile) (207) 730 - 5737 (Office) Angela.drysdale@alere.com (email)
DATE PREPARED
1/31/2019
TRADE NAME ID NOW Influenza A & B 2 Alere™ i Influenza A & B 2
COMMON NAME
ID NOW Flu 2, Alere™ i Flu 2, Alere™ Influenza A & B 2
CLASSIFICATION NAME
Respiratory Viral Panel Multiplex Nucleic Acid System (per 21 CFR 866.3980) Instrumentation for Clinical Multiplex Test Systems (per 21 CFR 862.2570)
CLASSIFICATION Class II
PRODUCT CODE OCC, OZE, OOI
PANEL Microbiology (83)
PREDICATE DEVICE Alere™ i Influenza A & B 2, K173932
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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 or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.
The ID NOW Influenza A & B 2 system utilizes isothermal nucleic acid amplification technology and is 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 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.
ID NOW Influenza A & B 2 is 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 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 Alere™ Universal Printer can be attached via USB to the ID NOW Instrument to print test results.
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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.
COMPARISON TO THE PREDICATE
The purpose of this Special 510k submission is to request a modification of the ID NOW Influenza A & B 2 Product Insert to expand the Specimen Transport and Storage section to include instructions for freezing transport media specimens if they cannot be tested within 72 hours. 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
ID NOW Influenza A & B 2 incorporating the labeling modification was compared to the legally marketed predicate device, the 510(k) cleared ID NOW Influenza A & B 2 test (K173932).
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| 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 |
| 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 |