(4 days)
Not Found
No
The summary describes a rapid molecular diagnostic test using isothermal nucleic acid amplification and fluorescence detection. There is no mention of AI, ML, or any algorithms beyond basic signal processing for fluorescence detection and result reporting. The performance metrics are standard for diagnostic assays and do not suggest the use of AI/ML for interpretation or analysis.
No
This device is an in vitro diagnostic test for detecting influenza, not a device used to treat a disease or condition.
Yes
The "Intended Use" section explicitly states that the device is "a rapid molecular in vitro diagnostic test" for the "qualitative detection and discrimination of influenza A and B viral RNA" and is "intended for use as an aid in the differential diagnosis of influenza A and B viral infections."
No
The device description clearly outlines hardware components including a Sample Receiver, Test Base, Transfer Cartridge, and the Alere™ i Instrument (a repeat use reader). The software is part of a larger system that includes physical components for sample processing and detection.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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 from patients with signs and symptoms of respiratory infection."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / 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 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.
Performance characteristics for influenza A were established during the 2012-2013 influenza A/H3 and A/H/N/ 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.
Product codes
OCC, OZE, OOI
Device Description
Alere™ i Influenza A & B is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab specimens collected from patients presenting with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B 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 Influenza A & B 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. Alere™ i Influenza A & B 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 carryover 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 the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellet 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 Alere™ i Instrument separately for influenza A and influenza B. Results 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal swab specimens, nasal cavity or nasopharynx
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
A total of 612 nasal swab specimens were enrolled in this study. Of those, 27 nasal swab specimens did not meet eligibility criteria. A total of 585 direct nasal swab specimens were considered evaluable. Direct nasal swab specimens with flu-like symptoms were collected and tested using the Alere™ i Influenza A & B at the eight study sites. Viral culture performed according to standard virology culture procedures, was utilized as the reference method for this study. Two nasal swabs were collected from one nostril from each subject using standard collection methods. At all sites, one nasal swab was tested directly on Alere™ i Influenza A & B, according to product instructions. The other nasal swab was eluted in 3-mLof viral transport media (VTM). Six of the eight sites (Site 1, Site 4, Site 8, Site 10, Site 11, and Site 12) shipped nasal swab samples in VTM to a central testing laboratory for viral culture testing. This central testing laboratory was located at Site 1, which also participated as a sample collection and Alere™ i Influenza A & B testing site. The nasal swab samples in VTM from Site 2 and Site 9 were cultured on site by a local laboratory. All specimens generating discrepant Alere™ i Influenza A & B and viral culture results were investigated by testing using an FDA-cleared Influenza RT-PCR assay at a central testing laboratory located at Site 1.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL STUDY
Clinical performance characteristics of Alere™ i Influenza A & B were evaluated in a multi-site prospective study during the 2012-2013 flu season in the U.S. A total of eight investigational sites throughout the U.S. participated in the study. To be enrolled in the study, patients had to be presenting at the participating study centers with flu-like symptoms. A total of 585 direct nasal swab specimens were considered evaluable. External control testing, using Alere™ i Influenza A & B Positive and Negative Controls, was performed prior to sample testing each day and on each Alere™ i instrument the testing was performed, at all study sites.
Alere™ i Influenza A & B Influenza A Direct Nasal Swab Performance against Viral Culture:
- Positive: 92 (True Positive), 66* (False Positive)
- Negative: 2b (False Negative), 411 (True Negative)
- Total: 94 (Culture Positive), 477 (Culture Negative)
- Sensitivity: 92/94 = 97.9% (95%CI: 92.6%-99.4%)
- Specificity: 411/477 = 86.2% (95%CI: 82.8%-89.0%)
- Flu A nucleic acid was detected in 58/66 False Positive specimens using an FDA-cleared molecular test
b Flu A nucleic acid was not detected in 1/2 False Negative specimens using an FDA-cleared molecular test
Alere™ i Influenza A & B Influenza B Direct Nasal Swab Performance against Viral Culture:
- Positive: 74 (True Positive), 17 (False Positive)
- Negative: 6 (False Negative), 472 (True Negative)
- Total: 80 (Culture Positive), 489 (Culture Negative)
- Sensitivity: 74/80 = 92.5% (95%CI: 84.6%-96.5%)
- Specificity: 472/489 = 96.5% (95%CI: 94.5%-97.8%)
- Flu B nucleic acid was detected in 15/17 False Positive specimens using an FDA-cleared molecular test
b Flu B nucleic acid was not detected in 4/6 False Negative specimens using an FDA-cleared molecular test
Nasal Swab Performance Obtained for Influenza A and Influenza B with the Alere™ i Influenza A & B in Comparison to Viral Culture - Stratified by Patient Age:
- Influenza A:
- ≤ 5 Years of Age (n = 332): Sensitivity: 98.3% (58/59) (91.0% - 99.7%), Specificity: 89.0% (243/273) (84.7% - 92.2%)
- 6 - ≤ 21 Years of Age (n = 162): Sensitivity: 100% (31/31) (89.0% - 100%), Specificity: 85.5% (112/131) (78.5% - 90.5%)
- ≥ 22 Years of Age (n = 77): Sensitivity: 75.0% (3/4) (30.1% - 95.4%), Specificity: 76.7% (56/73) (65.8% - 84.9%)
- Influenza B:
- ≤ 5 Years of Age (n = 332): Sensitivity: 88.9% (32/36) (74.7% - 95.6%), Specificity: 98.0% (288/294) (95.6% - 99.1%)
- 6 - ≤ 21 Years of Age (n = 162): Sensitivity: 94.4% (34/36) (81.9% - 98.5%), Specificity: 96.8% (122/126) (92.1% - 98.8%)
- ≥ 22 Years of Age (n = 77): Sensitivity: 100% (8/8) (67.6% - 100%), Specificity: 89.9% (62/69) (80.5% - 95.0%)
Invalid Rate (before repeat testing):
- Flu A: 5.8% (34/585) (95% CI: 4.2% to 8.0%)
- Flu B: 3.6% (21/585) (95% CI: 2.4% to 5.4%)
Invalid Rate (after repeat testing):
- Flu A: 2.4% (14/585) (95% CI: 1.4%, 4.0%)
- Flu B: 2.7% (16/585) (95% CI: 1.7%, 4.4%)
ANALYTICAL SENSITIVITY
Limit of detection (LoD) in natural nasal swab matrix by evaluating different concentrations of 3 strains of influenza A and 2 strains of influenza B virus.
- Influenza A strains LoD (TCID50/mL, TCID50/Swab, Genome Equivalents/mL, Genome Equivalents/Swab):**
- A/Puerto Rico/8/34 (A/H1N1): 1.88 x 10^5, 1.88 x 10^3, 4.22 x 10^6, 4.22 x 10^4
- A/Perth/16/2009 (A/H3N2): 8.60 x 10^2, 8.60 x 10^0, 7.91 x 10^4, 7.91 x 10^2
- A/California/7/2009 (A/2009 H1N1 pdm): 1.25 x 10^4, 1.25 x 10^2, 5.20 x 10^6, 5.20 x 10^4
- Influenza B strains LoD (TCID50/mL, TCID50/Swab, Genome Equivalents/mL, Genome Equivalents/Swab):**
- B/Malaysia/2506/2004 (B Victoria lineage): 1.90 x 10^3, 1.90 x 10^1, 7.24 x 10^4, 7.24 x 10^2
- B/Bangladesh/3333/2007 (B Yamagata lineage): 5.55 x 10^2, 5.55 x 10^0, 7.36 x 10^4, 7.36 x 10^2
REPRODUCIBILITY
A reproducibility study was conducted by operators from three sites using panels of blind coded specimens containing negative (below the limit of detection), low positive (at the limit of detection), and moderate positive (above the limit of detection) influenza A and B viral samples. Participants tested each sample multiple times on five different days. All of the true negative samples (90) generated negative test results. There were no significant differences observed within run (replicates tested by one operator), between run (five different days), between sites (three sites), or between operators (six operators).
Reproducibility Study Site-To-Site Qualitative Results (Agreement with expected results):
- HN1 Influenza A:
- Site 1: 66.7% (20/30)
- Site 2: 80.0% (24/30)
- Site 3: 63.3% (19/30)
- Overall: 70.0% (63/90) (59.9%, 78.5%)
- LP Influenza A:
- Site 1: 100% (30/30)
- Site 2: 100% (30/30)
- Site 3: 100% (30/30)
- Overall: 100% (90/90) (95.9%, 100%)
- MP Influenza A:
- Site 1: 100% (30/30)
- Site 2: 100% (30/30)
- Site 3: 100% (30/30)
- Overall: 100% (90/90) (95.9%, 100%)
- HN1 Influenza B:
- Site 1: 86.7% (26/30)
- Site 2: 100% (30/30)
- Site 3: 83.3% (25/30)
- Overall: 90.0% (81/90) (82.1%, 94.6%)
- LP Influenza B:
- Site 1: 93.3% (28/30)
- Site 2: 86.7% (26/30)
- Site 3: 96.7% (29/30)
- Overall: 92.2% (83/90) (84.8%, 96.2%)
- MP Influenza B:
- Site 1: 100% (30/30)
- Site 2: 100% (30/30)
- Site 3: 100% (30/30)
- Overall: 100% (90/90) (95.9%, 100.0%)
- TN:
- Site 1: 100% (30/30)
- Site 2: 100% (30/30)
- Site 3: 100% (30/30)
- Overall: 100% (90/90) (95.9%, 100%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Alere™ i Influenza A & B Influenza A Direct Nasal Swab Performance against Viral Culture:
- Sensitivity: 97.9% (95%CI: 92.6%-99.4%)
- Specificity: 86.2% (95%CI: 82.8%-89.0%)
Alere™ i Influenza A & B Influenza B Direct Nasal Swab Performance against Viral Culture:
- Sensitivity: 92.5% (95%CI: 84.6%-96.5%)
- Specificity: 96.5% (95%CI: 94.5%-97.8%)
Predicate Device(s)
IQuum Liat™ Influenza A/B Assay, K111387
Reference Device(s)
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
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: K141520
SUBMITTER
Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Establishment Registration Number: 1221359
CONTACT PERSON
Angela Drysdale (207) 730-5737 (Office) (207) 730-5767 (FAX) Angela.drysdale@alere.com (email)
DATE PREPARED
6/10/2014
TRADE NAME Alere™ i Influenza A & B
COMMON NAME Alere™ i flu, Alere™ i, Alere™ Influenza A & B
CLASSIFICATION NAME
Respiratory Viral Panel Multiplex Nucleic Acid Assay (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
IQuum Liat™ Influenza A/B Assay, K111387
1
DEVICE DESCRIPTION
Alere™ i Influenza A & B is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab specimens collected from patients presenting with signs and symptoms of respiratory infection. The Alere™ i Influenza A & B 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 Influenza A & B 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. Alere™ i Influenza A & B 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 carryover 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 the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the lyophilized pellet 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 Alere™ i Instrument separately for influenza A and influenza B. Results 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 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 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 influenza season 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
2
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.
TECHNOLOGICAL CHARACTERISTICS
Alere™ i Influenza A & B and the predicate device, IQuum Liat™ Influenza A/B Assay, have the same intended use, indications for use, and utilize similar basic principles of operation. They are both molecular tests for the qualitative detection of influenza A and B viral nucleic acid.
DEVICE COMPARISON
Alere™ i Influenza A & B was compared to the legally marketed predicate device, the IQuum Liat ™ Influenza A/B Assay.
| Parameter | Alere™ i Influenza A & B | IQuum Liat ™ Influenza A/B Assay (K111387) |
|---|---|---|
| FDA Product Code | OCC, OZE, OO1 | OCC, OOI |
| Assay Target | Influenza A, Influenza B | Same |
| Intended Use | Alere™ i Influenza A & B is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of influenza A and B viral nucleic acid in nasal swab specimens. It is intended to aid in the rapid 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 influenza season 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 | The IQuum Liat™ Influenza A/B Assay performed on the Liat™ Analyzer is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of influenza A virus and influenza B virus RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the differential diagnosis of influenza A and influenza B in humans and is not intended to detect influenza C.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for 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. |
| Parameter | Alere™ i Influenza A & B | IQuum Liat ™ Influenza A/B Assay (K111387) |
| | 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. | |
| Intended Environment for
Use | Professional use, in a medical
laboratory or point-of-care | Professional use, in a medical laboratory |
| Instrumentation | Alere™ i Instrument | Liat ™ Analyzer |
| Self-Contained System | Integrated PC, Software, and Touch
Screen Display | Same |
| Automated Assay | Yes. Sample preparation,
amplification, detection, and result
interpretation. | Same |
| Assay Information | | |
| Sample Type | Nasal Swab | Nasopharyngeal Swab |
| Influenza A Viral Target | PB2 segment | Matrix Gene |
| Influenza B Viral Target | PA segment | Non-Structural Protein (NSP) Gene |
| Technology | Isothermal nucleic acid
amplification for detecting the
presence/absence of viral RNA in
clinical specimens | RT-PCR for detecting the presence/absence of
viral RNA in clinical specimens |
| Detection Method | Assay uses different reporter dyes
for each target | Multiplex assay using different reporter dyes for
each target |
| Internal Control | Yes | Yes |
| Result Interpretation | Automated | Same |
| Assay Result | Qualitative | Same |
| Time to Result | 21 to 60 years | 51 | 20 |
| >60 years | 5 | पे |
| Total | 310 | 275 |
Age and Gender Distribution - Direct Nasal Swab Study
Of the evaluable 585 specimens, Alere™ i Influenza A & B generated influenza A invalid results for 14 specimens and influenza B invalid results for 16 specimens, resulting in a total of 571 specimens for influenza A performance analysis and 569 specimens for influenza B performance analysis.
Compared to the viral culture reference method, the performance of Alere™ i Influenza A and influenza B are presented in the two tables below.
Alere™ i Influenza A & B Influenza A Direct Nasal Swab Performance against Viral Culture
| AlereTM Influenza A & B - Flu A | Positive | Negative | Total |
|---|---|---|---|
| Positive | 92 | 66* | 158 |
| Negative | 2b | 411 | 413 |
| Total | 94 | 477 | 571 |
| Sensitivity: 92/94 | 97.9% | (95%CI: 92.6%-99.4%) | |
| Specificity: 411/477 | 86.2% | (95%CI: 82.8%-89.0%) |
ª Flu A nucleic acid was detected in 58/66 False Positive specimens using an FDA-cleared molecular test
b Flu A nucleic acid was not detected in 1/2 False Negative specimens using an FDA-cleared molecular test
Alere™ i Influenza A & B Influenza B Direct Nasal Swab Performance against Viral Culture
| Alere™ i
'Influenza A &
| B - Flu B | Positive | Negative | Total |
|---|---|---|---|
| Positive | 74 | 17 | 91 |
| Negative | 6 | 472 | 478 |
| Total | 80 | 489 | 569 |
| Sensitivity: 74/80 | 92.5% | (95%CI: 84.6%-96.5%) | |
| Specificity: 472//489 | 96.5% (95%CI: 94.5%-97.8%) |
5
ª Flu B nucleic acid was detected in 15/17 False Positive specimens using an FDA-cleared molecular test
6 Flu B nucleic acid was not detected in 4/6 False Negative specimens using an FDA-cleared molecular test
Performance of Alere™ i Influenza A & B for the detection of influenza B versus culture is presented in the table below stratified by patient age.
Nasal Swab Performance Obtained for Influenza A and Influenza B with the Alere™ i Influenza A & B in Comparison to Viral Culture - Stratified by Patient Age
| Influenza
Type | ≤ 5 Years of Age
(n = 332) | | 6 - ≤ 21 Years of Age
(n = 162) | | ≥ 22 Years of Age
(n = 77) | |
|-------------------|-----------------------------------|-------------------------------------|------------------------------------|-------------------------------------|---------------------------------|-----------------------------------|
| | Sensitivity
95% CI | Specificity
95% CI | Sensitivity
95% CI | Specificity
95% CI | Sensitivity
95% CI | Specificity
95% CI |
| Flu A | 98.3%
(58/59)
91.0% - 99.7% | 89.0%
(243/273)
84.7% - 92.2% | 100%
(31/31)
89.0% - 100% | 85.5%
(112/131)
78.5% - 90.5% | 75.0%
(3/4)
30.1% - 95.4% | 76.7%
(56/73)
65.8% - 84.9% |
| Flu B | 88.9%
(32/36)
74.7% - 95.6% | 98.0%
(288/294)
95.6% - 99.1% | 94.4%
(34/36)
81.9% - 98.5% | 96.8%
(122/126)
92.1% - 98.8% | 100%
(8/8)
67.6% - 100% | 89.9%
(62/69)
80.5% - 95.0% |
Alere™ i Influenza A & B detected one mixed influenza A and B infection in the prospective clinical ' evaluation. This sample tested positive for influenza B only by viral culture, but tested positive for influenza A only by an FDA cleared Influenza RT-PCR assay.
During the prospective clinical study, the initial invalid rate {before repeat testing per the product instructions) was 5.8% (34/585) (95% Cl: 4.2% to 8.0%) for Flu A, and 3.6% (21/585) (95% Cl: 2.4% to 5.4%) for Flu B. After repeat testing per the product instructions, the invalid rate was 2.4% (14/585) (95% CI: 1.4%, 4.0%) for Flu A, and 2.7% (16/585) (95% CI: 1.7%, 4.4%) for Flu B.
ANALYTICAL STUDIES
ANALYTICAL SENSITIVITY
Alere™ i Influenza A & B limit of detection (LoD) in natural nasal swab matrix was determined by evaluating different concentrations of 3 strains of influenza A and 2 strains of influenza B virus in Alere™ i Influenza A & B. Three strains of influenza A virus representing each of the three common currently or recently circulating influenza A subtypes (i.e., A/H1N1, A/H3N2 seasonal, and A/H1N1 pandemic (pdm)) and two strains of influenza B virus representing each of the two influenza B genetic lineages (i.e., Victoria and Yamagata) were included in this study.
Presumed negative natural nasal swab specimens were eluted in UTM. Swab elutes were combined and mixed thoroughly to create a clinical matrix pool to be used as the diluent. Each influenza virus strain was diluted in this natural nasal swab matrix pool to generate virus dilutions for testing. The vender provided virus strains were re-titered and the concentrations (in TCIDso/mL) were determined by standard virologic method. The concentration for each dilution (in genome equivalents/mL) was also assessed using laboratory developed and validated influenza A and influenza B quantitative real-time PCR assays.
Contrived nasal swab specimens were prepared by coating 10 microliters of each virus dilution onto the swab. The contrived swab samples were tested according to product instructions.
The LoD for each influenza strain tested was determined as the lowest virus concentration that was detected ≥ 95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive).
6
The confirmed LoDs in natural nasal swab matrix for each influenza strain tested are presented in the table below:
| Influenza Strain | Influenza A Subtype or Influenza B Genetic Lineage | LoD (TCID50/mL) | LoD (TCID50/Swab)* | LoD (Genome Equivalents/mL) | LoD (Genome Equivalents/Swab)* |
|---|---|---|---|---|---|
| A/Puerto Rico/8/34 | A/H1N1 | $1.88 x 10^5$ | $1.88 x 10^3$ | $4.22 x 10^6$ | ( $4.22 x 10^4$ |
| A/Perth/16/2009 | A/H3N2 | $8.60 x 10^2$ | $8.60 x 10^0$ | $7.91 x 10^4$ | $7.91 x 10^2$ |
| A/California/7/2009 | A/2009 | ||||
| H1N1 pdm | $1.25 x 10^4$ | $1.25 x 10^2$ | $5.20 x 10^6$ | $5.20 x 10^4$ | |
| B/Malaysia/2506/2004 | B Victoria | ||||
| lineage | $1.90 x 10^3$ | $1.90 x 10^1$ | $7.24 x 10^4$ | $7.24 x 10^2$ | |
| B/Bangladesh/3333/2007 | B Yamagata | ||||
| lineage | $5.55 x 10^2$ | $5.55 x 10^0$ | $7.36 x 10^4$ | $7.36 x 10^2$ |
Limit of Detection (LoD) Study Results - Natural Nasal Swab Matrix
*Note: 10 ul of each virus dilution was coated onto a swab
REACTIVITY TESTING
An analytical reactivity (inclusivity) study was performed to determine whether the Alere™ i Influenza A & B assay is able to detect a variety of influenza A and B strains that represent temporal and geographic diversity.
Vender provided stocks of influenza A and B strains were diluted in UTM to generate virus dilutions for testing. The concentration (in TCIDs0/mL, or EID50/mL) for each strain was determined by standard virologic method. The concentration for each dilution (in genome equivalents/ml.) was also assessed using laboratory developed and validated influenza B quantitative real-time PCR assays.
Contrived swab specimens were prepared by coating 10 microliters of virus dilution onto each swab. The contrived swab samples were tested according to product instructions.
The starting dilution concentration selected for testing in this study was higher than the established LoDs in the Limit of Detection study. Each starting dilution per virus strain was tested in triplicates initially. If the initial testing concentration tested positive for all three replicates, the strain was further diluted 10-fold and tested in triplicates until at least one out three replicates generated a negative result. When a negative result was obtained, additional 2-fold dilutions were tested, starting from the highest dilution that produced 100% (3/3) positive results. A concentration level was considered "reactive/positive" in this study for all but one strain tested (i.e., B/Texas/06/2011 – see footnote "c" under the table below) if all three replicates generated a positive result for the expected influenza virus.
The Alere™ i Influenza A & B assay detected all strains tested at the concentrations indicated in the table below:
| Influenza Strain | Influenza A
Subtype or
Influenza B
Genetic
Lineage | Test Concentration (in TCID50 or Genome Equivalents,
unless indicated otherwise) | | | | Flu A
Result
(n=3,
unless
indicated
otherwise
) | Flu B
Result
(n=3,
unless
indicated
otherwise
) |
|--------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------|------------------------------|-----------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| | | TCID50/mL | TCID50/Swab* | Genome
Equivalents/
mL | Genome
Equivalents/Swab* | | |
| A/New Caledonia/20/1999* | A/H1N1 | $9.19 x 10^5$ | $9.19 x 10^3$ | $4.09 x 10^6$ | $4.09 x 10^4$ | + | - |
| A/New Jersey/8/76* | A/H1N1 | $3.41 x 10^1$ | $3.41 x 10^{-1}$ | $1.52 x 10^5$ | $1.52 x 10^3$ | + | - |
Analytical Reactivity Study Results
7
| A/Brisbane/59/2007 * | A/H1N1 | $2.11 \times 10^4$ | $2.11 \times 10^2$ | $3.39 \times 10^5$ | $3.39 \times 10^3$ | + | - |
|---|---|---|---|---|---|---|---|
| A/WSN/33 * | A/H1N1 | $2.11 \times 10^2$ | $2.11 \times 10^0$ | $2.43 \times 10^5$ | $2.43 \times 10^3$ | + | - |
| A/Port Chalmers/1/73 | A/H3N2 | $4.22 \times 10^4$ | $4.22 \times 10^2$ | $1.31 \times 10^6$ | $1.31 \times 10^4$ | + | - |
| A/Hong Kong/8/68 | A/H3N2 | $7.03 \times 10^0$ | $7.03 \times 10^{-2}$ | $2.70 \times 10^5$ | $2.70 \times 10^3$ | + | - |
| A/Aichi/2/68 | A/H3N2 | $2.08 \times 10^5$ | $2.08 \times 10^3$ | $7.47 \times 10^6$ | $7.47 \times 10^4$ | + | - |
| A/Victoria/3/75 | A/H3N2 | $3.68 \times 10^5$ | $3.68 \times 10^3$ | $3.39 \times 10^6$ | $3.39 \times 10^4$ | + | - |
| A/Wisconsin/67/2005 | A/H3N2 | $6.81 \times 10^4$ | $6.81 \times 10^2$ | $2.57 \times 10^6$ | $2.57 \times 10^4$ | + | - |
| A/Brisbane/10/2007 | A/H3N2 | $3.16 \times 10^2$ | $3.16 \times 10^0$ | $3.37 \times 10^5$ | $3.37 \times 10^3$ | + | - |
| A/Texas/50/2012 | A/H3N2 | $2.50 \times 10^0$ | $2.50 \times 10^{-2}$ | $6.35 \times 10^3$ | $6.35 \times 10^1$ | + | - |
| A/Victoria/361/2011 | A/H3N2 | $1.56 \times 10^1$ | $1.56 \times 10^{-1}$ | $3.53 \times 10^5$ | $3.53 \times 10^3$ | + | - |
| A/California/4/2009 | A/H1N1 (pdm) | $1.47 \times 10^4$ | $1.47 \times 10^2$ | $1.07 \times 10^6$ | $1.07 \times 10^4$ | + | - |
| A/Maryland/04/2011 | A/H1N1 (pdm) | $7.88 \times 10^4$ | $7.88 \times 10^2$ | $3.81 \times 10^6$ | $3.81 \times 10^4$ | + | - |
| A/New York/18/2009 | A/H1N1 (pdm) | $1.25 \times 10^2$ | $1.25 \times 10^0$ | $9.16 \times 10^5$ | $9.16 \times 10^3$ | + | - |
| A/Anhui/1/2013 | |||||||
| (Inactivated)* | A/H7N9 | ||||||
| (Detected in | |||||||
| China in 2013) | $4.00 \times 10^6$ | ||||||
| EID50/mL | $4.00 \times 10^4$ | ||||||
| EID50/Swab | $1.72 \times 10^6$ | $1.72 \times 10^4$ | + | - | |||
| A/Indiana/10/2011* | A/H3N2v | $2.00 \times 10^8$ | |||||
| EID50/mL | $2.00 \times 10^6$ | ||||||
| EID50/Swab | $2.00 \times 10^6$ | $2.00 \times 10^4$ | + | - | |||
| B/Lee/40 | Victoria Lineage | $5.00 \times 10^1$ | |||||
| CEID50/mL | $5.00 \times 10^{-1}$ | ||||||
| CEID50/Swab | $5.40 \times 10^4$ | $5.40 \times 10^2$ | - | + | |||
| B/Victoria/504/2000 | Victoria Lineage | $1.19 \times 10^3$ | $1.19 \times 10^1$ | $8.29 \times 10^4$ | $8.29 \times 10^2$ | - | + |
| B/Nevada/03/2011 | Victoria Lineage | $1.75 \times 10^3$ | $1.75 \times 10^1$ | $1.13 \times 10^5$ | $1.13 \times 10^3$ | - | + |
| B/Montana/05/2012 | Victoria Lineage | $9.00 \times 10^1$ | $9.00 \times 10^{-1}$ | $2.55 \times 10^4$ | $2.55 \times 10^2$ | - | + |
| B/Maryland/1/59 | Yamagata | ||||||
| Lineage | $8.51 \times 10^2$ | $8.51 \times 10^0$ | $1.13 \times 10^5$ | $1.13 \times 10^3$ | - | + | |
| B/Russia/69b | Yamagata | ||||||
| Lineage | $4.44 \times 10^1$ | $4.44 \times 10^{-1}$ | $2.96 \times 10^6$ | $2.96 \times 10^4$ | - | + | |
| B/Wisconsin/01/2010c | Yamagata | ||||||
| Lineage | $3.68 \times 10^4$ | $3.68 \times 10^2$ | $1.16 \times 10^6$ | $1.16 \times 10^4$ | - | + | |
| B/Massachusetts/2/2012 | Yamagata | ||||||
| Lineage | $6.25 \times 10^1$ | $6.25 \times 10^{-1}$ | $2.28 \times 10^5$ | $2.28 \times 10^3$ | - | + | |
| B/Texas/06/2011c | Yamagata | $2.89 \times 10^5$ | $6.25 \times 10^3$ | $2.00 \times 10^6$ | $2.00 \times 10^4$ | - | + |
- Note: 10 ul of each virus dilution was coated onto a swab
" Although this test has been shown to detect A/H/N9 (detected in China in 2013) and A/H3N2v viruses cultured from positive human respiratory specimens tharacterstics of this device with clinical specimens that are positive for the A/H1N1 (pre-2009 pandemic), A/H7N9 (detected in China in 2013) and A/H3N2v viruses have not been established.
- Influenza B/Russia/69 lowest level in which 3/3 replicates were positive is approximately 40 to 150 x the LoD (as comparing to the Genome Equivalents/Syab values generated in the LoD with simulated clinical matrix study testing B/Malaysia/2008, respectively). A polymorphism within segment PA of the Influenza B genome was identified at a position which is 4 nucleotides from the 3 -nd of template 2. This G to A polynorphism results in a C/C (product/template) match to an A/C (product/template) mismatch is determined to be moderately destabilizing, and coupled to its position only 4 nucleotides from the 3 recognition region, its impact on annealing is potentially great. The frequency of this G to A polymorphism is determined to be very low. In analyzing the strains present in the NCBI Influenza Virus Resource database from 2/2005 to 3/2014 (N=986), no strains contained this polymorphism, suggesting that it has not been circulating for an extended period of time.
^ Influenza B/Wisconsin/01/2010 lowest level in which 3/3 replicates were positive is approximately 15 to 60 x the LoD, and Influenza B/Texas/06/2011 lowest level in which at least 1/3 replicates were positive is approximately 25 to 100 x the LoD (as comparing to the Genome Equivalents/Swab values generated in the LoD with simulated clinical matrix study testing B/Malaysia/2008, respectively). A single G to A polymorphism within segment PA of the Influenza B genome was identified at a position which is 5 nucleotides from the 3'-end of the molecular beacon annealing region. The G to A polymorphism results in a C/G match to a C/A mismatch between the molecular beacon and product 1. The C/A mismatch is detabilizing that can significantly reduce assay sensitivity. An assessment of what impact this polymorphism would have on the melting temperature (Tm) of the molecular beacon (product 1 annealing was performed and the results showed a Tm drop from 62.3℃ to 55.6℃, just below the assay running temperature. This suggests that annealing would occur, but at a greatly reduced level, with a concomitivity. The frequency of this G to A polymorphism is found at a frequency of approximately 5% within the NCBI Influenza Virus Resource database covering the time from 2/2005 through 3/2014.
ANALYTICAL SPECIFICITY (CROSS-REACTIVITY)
To determine the analytical specificity of Alere™ i Influenza A & B, 53 commensal and pathogenic microorganisms (37 bacteria, 15 viruses and 1 yeast) that may be present in the nasal cavity or nasopharynx were tested. All of the following microorganisms were negative when tested at concentrations.ranging from
8
108 to 10ª cells/mL, CFU/mL (bacteria), 104 to 10º TCIDs0/mL or CEID50/mL (viruses), and 10º cells/mL (yeast).
Bacteria
Acinetobacter calcoaceticus Bacteroides fragilis Bordetella pertussis Chlamydia pneumoniae Corynebacterium diphtheriae Enterococcus faecalis Escherichia coli Gardnerella vaginalis Haemophilus influenzae Klebsiella pneumoniae Lactobacillus casei Lactobacillus plantarum Leaionella pneumophila Listeria monocytogenes Moraxella/Branhamella catarrhalis Mycobacterium avium Mycobacterium intracellulare Mycobacterium tuberculosis Mycoplasma pneumoniae Neisseria gonorrhoeae Neisseria meningitidis Neisseria sicca Neisseria subflava Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Staphylococcus epidermidis Streptococcus, Group A Streptococcus, Group B Streptococcus, Group C Streptococcus, Group F Streptococcus, Group G Streptococcus mutans Streptococcus pneumoniae Streptococcus salivarius Streptococcus sanguinis
Viruses
- Adenovirus type 1 · Candida albicans Adenovirus type 7 Human Coronavirus OC43 Human Coronavirus 229E Enterovirus/Coxsackievirus B4 Human Cytomegalovirus (CMV) (Herpes V) Epstein Barr Virus Human metapneumovirus Measles (Edmonston) Mumps (Enders) Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Respiratory Syncytial Virus type B Rhinovirus type 1A
Yeast
INTERFERING SUBSTANCES
The following substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated with Alere™ i Influenza A & B at the concentrations listed below and were found not to affect test performance.
Substance
Mucin Whole Blood Sinus Buster Nasal Spray NeoSynephrine Cold & Sinus Extra Strength Spray
Concentration
20 µg/mL 50 µl/mL 200 µl/mL 200 µl/mL
9
Zicam Extreme Congestion Relief 4-acetamidophenol Acetylsalicylic acid Albuterol Chlopheniramine Dexamethasone Dextromethorphan Diphenhydramine› Doxylamine Succinate Ephedrine Flunisolide Guaiacol glycerol ether Mupirocin Oxymetazoline Phenylephrine Rebetol Relenza Rimatadine Tamiflu Tobryamycin Triamcinolone
200 µl/mL 200 µg/mL 650 ug/mL 400 ng/mL 145 ng/mL 0.80 mg/mL 1 µl/mL 5 µg/mL 236 ng/mL 237 ng/mL 6.8 ng/mL 3.5 ng/mL 12 mg/mL 0.6 mg/mL 12 mg/mL 4.5 µg/mL 282 ng/mL 282 ng/mL 1.1 µg/mL 2.43 mg/mL 40 µg/mL
10
REPRODUCIBILITY
A reproducibility study of Alere™ i Influenza A & B was conducted by operators from three sites using panels of blind coded specimens containing negative (below the limit of detection), low positive (at the limit of detection), and moderate positive (above the limit of detection) influenza A and B viral samples.
Virus dilutions were prepared using one influenza A strain and one influenza B strain in Universal Transport Medium (UTM). The concentrations of the viral stocks (in TCID50/mL) were determined by standard virologic method prior to inactivation by the venders. The concentration for each dilution (in genome equivalents/mL] was also assessed using laboratory developed and validated influenza B quantitative real-time PCR assays.
Contrived nasal swab specimens were prepared by coating 10 microliters of each virus dilution onto the swab. The contrived swab samples were tested according to product instructions.
Participants tested each sample multiple times on five different days. The percent agreement with expected results for the influenza A moderate positive, and high negative samples were 100% (90/90), 100 % (90/90) and 70% (63/90), respectfully. The percent agreement with expected result for the influenza B moderate positive, low positive, and high negative samples were 100% (90/90), 92% (83/90) and 90% (81/90), respectfully. All of the true negative samples (90) generated negative test results. There were no significant differences observed within run (replicates tested by one operator), between run (five different days), between sites (three sites), or between operators (six operators).
The Reproducibility Study site-to-site qualitative results (agreements with expected results) are presented in the table below:
| and and the first to the simple simple simments of the states of the light | The December 2017 - Overall Percent | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample f | Site 1 | * Site 2 | Site 3 Site 3 | ||||||
| Category . | Percent. | ||||||||
| Agreement | Percent | ||||||||
| oreement . | Percent War | ||||||||
| Agreement | Agreement an | 1. 17 19 11. 11. 11. 11.11. | |||||||
| HN1 | |||||||||
| Influenza A | 66.7% | 20/30 | 80.0% | 24/30 | 63.3% | 19/30 | 70.0% | ||
| (63/90) | (59.9%, 78.5%) | ||||||||
| LP | |||||||||
| Influenza A | 100% | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | ||
| (90/90) | (95.9%, 100%) | ||||||||
| MP | |||||||||
| Influenza A | 100% | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | ||
| (90/90) | (95.9%, 100%) | ||||||||
| HNI | |||||||||
| Influenza B | 86.7% | 26/30 | 100% | 30/30 | 83.3% | 25/30 | 90.0% | ||
| (81/90) | (82.1%, 94.6%) | ||||||||
| LP | |||||||||
| Influenza B | 93.3% | 28/30 | 86.7% | 26/30 | 96.7% | 29/30 | 92.2% | ||
| (83/90) | (84.8%, 96.2%) | ||||||||
| MP | |||||||||
| Influenza B | 100% | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | ||
| (90/90) | (95.9%, | ||||||||
| 100.0%) | |||||||||
| TN | 100% | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | ||
| (90/90) | (95.9%, 100%) |
Reproducibility Study Site-To-Site Qualitative Results
1Percent Agreement correlates to the percent of negative results.
Signed _
Date
Angela Drysdale VP. Regulatory & Clinical Affairs – Infectious Disease Alere Scarborough, Inc.
11
Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
June 13, 2014
Alere Scarborough, Inc. Angela Drysdale Vice President, Regulatory and Clinical Affairs - Infectious Disease 10 Southgate Road Scarborough, ME 04074
Re: K141520
Trade/Device Name: Alere™ i Influenza A&B Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: II Product Code: OCC. OZE. OOI Dated: June 06, 2014 Received: June 09, 2014
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
12
Page 2- Angela Drysdale
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.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Uwe Scherf -S for
Sally A. Hojvat, M.Sc., Ph.D. · Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
13
Indications for Use
510(k) Number (if known) K141520
Device Name Alere™ i Influenza A&B
Indications for Use (Describe)
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 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.
Performance characteristics for influenza A were established during the 2012-2013 influenza A/H3 and A/H/N/ 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Tamara V. Feldblyum -S 2014.06.12 09:27:31 -04'00'
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