(92 days)
No
The description focuses on isothermal nucleic acid amplification technology and fluorescence detection, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic test for the qualitative detection of RSV viral RNA, intended as an aid in diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a rapid molecular in vitro diagnostic test" and that it is "intended for use as an aid in the diagnosis of RSV."
No
The device description clearly outlines multiple hardware components including a Sample Receiver, Test Base, Transfer Cartridge, and the Alere™ i Instrument repeat use reader, which are integral to the device's function.
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 Alere™ i RSV assay is a "rapid molecular in vitro diagnostic test".
- Function: The device is designed to detect the presence of RSV viral RNA in patient samples (nasopharyngeal swabs) to aid in the diagnosis of RSV infection. This is a classic function of an in vitro diagnostic device, which analyzes samples taken from the human body to provide information about a person's health.
- Device Description: The description details the components and process of analyzing the sample outside of the body using chemical and molecular reactions (nucleic acid amplification, fluorescent detection).
Therefore, based on the provided information, the Alere™ i RSV assay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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) 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
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2016
Alere Scarborough, Inc. Angela Drysdale Vice President Regulatory Affairs 10 Southgate Road Scarborough, ME 04074
Re: K161375 Trade/Device Name: Alere i RSV Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid System Regulatory Class: II Product Code: OCC. OOI Dated: May 19, 2016 Received: May 20, 2016
Dear Ms. 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 Parts 801 and 809); medical device reporting (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 Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tamara V. Feldblyum -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
510(k) Number (if known) K161375
Device Name Alere™ i RSV
Indications for Use (Describe)
| 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) 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 ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: K161375
SUBMITTER
Alere Scarborough, Inc. 10 Southgate Road Scarborough, Maine 04074 Establishment Registration Number: 1221359
PRIMARY CONTACT PERSON
Angela Drysdale (207) 730-5737 (office) (207) 730-5767 (FAX) angela.drysdale@alere.com (email)
DATE PREPARED
August 15, 2016
TRADE NAME Alere™ i RSV
COMMON NAME Alere™ i RSV, Alere™ i
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, OOI
PANEL Microbiology (83)
PREDICATE DEVICE
Quidel Molecular RSV + hMPV Assay (Lyra) K131813
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DEVICE DESCRIPTION
The Alere™ i RSV is a rapid, instrument-based 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. The Alere™ i RSV 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
- Alere™ i 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. Alere™ i RSV utilizes a pair of templates (similar to primers) for the specific amplification of RNA from RSV A and B, which occur in two separate reaction tubes. Each reaction tube contains a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets. Alere™ i RSV is 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 minimizes 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, re-suspending the lyophilized pellets contained within the Test Base and initiating target amplification. Heating, mixing and detection by fluorescence are 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.
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 acid 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 in vitro diagnostic test
utilizing an isothermal nucleic acid
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
in
vitro diagnostic test is intended to aid in
the differential diagnosis of RSV and hMPV
infection in humans in conjunction with
clinical and epidemiological risk factors.
This test is not intended to differentiate
the two subtypes of RSV or the four genetic
sub-lineages of hMPV.
Negative results do not preclude RSV
infection and/or hMPV infection and
should not be used as the sole basis for
diagnosis, treatment or other patient
management decisions.
Conversely, positive results do not rule-out
bacterial infection or co-infection with
other viruses. The agent detected may not
be the definite cause of disease. The use of
additional laboratory testing and clinical
presentation must be considered in order
to obtain the final diagnosis of respiratory
viral infection.
The Quidel Molecular RSV + hMPV Assay
can be performed using the Life
Technologies QuantStudio™ Dx RT-PCR
Instrument, the Applied Biosystems®
7500 Fast Dx RT-PCR Instrument, or the
Cepheid SmartCycler® II System. |
| Parameter | Alere™ i RSV | Quidel Molecular RSV + hMPV Assay
(Lyra) (K122189, K131813) |
| Intended
Environment for Use | Professional use, in a medical
laboratory or point-of-care | Professional use, in a medical laboratory |
| Instrumentation | Alere™ i Instrument | Cepheid SmartCycler® II System, the
Applied Biosystems® 7500 Fast Dx RT-
PCR Instrument, or the Life Technologies
QuantStudio™ Dx RT-PCR Instrument |
| Assay Information | | |
| Sample Type | Nasopharyngeal Swab,
Nasopharyngeal Swab eluted in Viral
Transport Media | Nasopharyngeal swab and nasal swab |
| RSV Target | NS2 gene and nucleocapsid gene N | NS2 genes, L viral polymerase |
| Technology | Isothermal nucleic acid amplification
for detecting the presence/absence of
viral RNA in clinical specimens. | RT-PCR-based system for detecting the
presence or absence of viral RNA in clinical
specimens |
| Internal Control | Yes | Yes |
| Results Interpretation | Automated | Same |
| Assay Result | Qualitative | Same |
| Time to Result | Bacteria | Viruses |
|---------------------------|----------------|
| Bordetella bronchiseptica | Adenovirus 2 |
| Chlamydia pneumonia | Adenovirus 3 |
| Chlamydia trachomatis | Adenovirus 4 |
| Neisseria mucosa | Adenovirus 5 |
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Proteus mirabilis
Adenovirus 11 Adenovirus 14 Adenovirus 31 Coronavirus NL63 Coxsackievirus B35 Echovirus 6 Echovirus 9 Echovirus 11 Enterovirus 71
INTERFERING SUBSTANCES
The following substances, naturally present or artificially introduced into the nasal cavity/nasopharynx were evaluated with Alere™ i RSV at the concentrations listed below and were found not to affect test performance.
| Substance | Concentration |
|---|---|
| Mucin | 0.0625% |
| Whole Blood | 1% |
| NeoSynephrine Cold & Sinus Extra Strength Spray | 20% |
| Afrin Pump Mist Original | 20% |
| Ocean Saline | 20% |
| Chloroseptic Max | 20% |
| Zicam Allergy Relief | 20% |
| Beclomethasone | 0.068 mg/mL |
| Dexamethasone | 0.48 mg/mL |
| Flunisolide | 0.04 mg/mL |
| Triamcinolone | 0.04 mg/mL |
| Budesonide | 0.051 mg/mL |
| Mometasone furoate | 0.04 mg/mL |
| Fluticasone propionate | 0.04 mg/mL |
| Zanamivir (Relenza) | 0.284 mg/mL |
| Mupirocin | 4.3 mg/mL |
| Tobramycin | 1.44 mg/mL |
INHIBITION BY OTHER MICROORGANISMS
Alere™ i RSV test performance in the presence of non-RSV respiratory pathogens was evaluated. Vendor provided stocks of RSV A and B strains were diluted in UTM to approximately 3 times the limit of detection. Contrived RSV A and B positive swab specimens were prepared by coating 10 microliters of virus dilution onto each swab. The following panel of non-RSV viruses was tested at the concentration provided in the table below and was found not to affect test performance.
| Virus Panel | Concentration
(TCID50/ml) |
|--------------------|------------------------------|
| Adenovirus Type 1 | 1.58 x 107 |
| Rhinovirus Type 1A | 1.58 x 107 |
| Influenza A | 5.00 x 107 |
| Influenza B | 1.00 x 108 |
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CARRY-OVER CONTAMINATION
An analytical carry-over study was performed to demonstrate that when recommended laboratory practices are followed, there is little risk of false positive results caused by carryover or crosscontamination in the Alere™ i RSV test. Vendor provided stocks of RSV A and B strains were diluted in UTM to approximately 30 times the limit of detection. Contrived RSV A and B positive swab specimens were prepared by coating 10 microliters of virus dilution onto each swab. Testing of the contrived positive swabs was alternated with testing of a negative swab sample for a total of 15 rounds. In addition, testing of contrived positive VTM samples was alternated with negative VTM samples following the test procedure for Nasopharyngeal Swab Eluted in Viral Transport Media for a total of 15 rounds. No false positive results were observed in this study.
REPRODUCIBILITY
A reproducibility study of Alere™ i RSV was conducted by operators from 3 sites using panels of blind coded specimens containing negative, low positive (at the limit of detection), and moderate positive (above the limit of detection) RSV A and B samples. Participants tested each sample multiple times on 5 different days. The percent agreement with expected results for the RSV A moderate positive and low positive samples were 100% (89/89) and 98.9% (89/90), respectively. The percent agreement with expected results for the RSV B moderate positive and low positive samples were 98.9% (89/90) and 100% (90/90), respectively. All of the negative samples (90) generated negative test results. There were no significant differences within run (replicates tested by one operator), between run (5 different days), between sites (3 sites), or between operators (9 operators).
The results of the analytical and clinical studies performed with Alere™ i RSV support the determination of substantial equivalence in accordance with the stated intended use and device labeling.