(41 days)
Not Found
No
The device description and performance studies indicate a traditional immunochromatographic assay with visual interpretation of results, with no mention of AI or ML.
No.
This device is an in vitro diagnostic test designed for the qualitative detection of influenza A and B antigens to aid in diagnosis, not to provide therapy or treatment.
Yes
The device is described as an "in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens" and is "intended to aid in the rapid differential diagnosis of influenza A and B viral infections." This indicates its purpose is to diagnose specific medical conditions.
No
The device description clearly outlines a physical immunochromatographic assay with a test strip, reaction tube, and reagents, indicating it is a hardware-based in vitro diagnostic device, not software-only.
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™ Influenza A & B Test is an "in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body.
- Device Description: The description details how the test works by analyzing a biological sample (nasal swab specimens) using reagents and a test strip to detect specific antigens. This is characteristic of an in vitro diagnostic test.
- Anatomical Site: The test uses samples from the "Nasal cavity or nasopharynx," which are biological specimens.
- Performance Studies: The document describes clinical and analytical studies performed on biological samples to evaluate the device's performance in detecting influenza antigens.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Alere™ Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.
Product codes
GNX
Device Description
The Alere™ Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in nasal swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip.
Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. An Alere™ Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence of pink-to-purple colored Sample Lines. The yellow Control Line turns blue in a valid test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal swab specimens
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
Not Found
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 470 prospective nasal swab specimens, collected from patients of all ages presenting with influenzalike symptoms, were evaluated in the Alere™ Influenza A & B Test and compared to viral culture.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL STUDY
Alere™ Influenza A & B Test Performance vs. Viral Culture – Prospective Study
The clinical performance of the Alere™ Influenza A & B Test was established in a multi-center, prospective, clinical study conducted at seven U.S. trial sites during the 2008-2009 respiratory season.
A total of 470 prospective nasal swab specimens, collected from patients of all ages presenting with influenzalike symptoms, were evaluated in the Alere™ Influenza A & B Test and compared to viral culture. Forty-four percent (44%) of the population tested was 18 years. A/H3 and A/H1 were the predominant influenza A subtypes observed during the times the specimens were collected.
Alere™ Influenza A & B Test Performance vs. Culture
- Influenza Type A:
- Sensitivity: 93.8% (45/48) (95% CI: 83.2, 97.9%)
- Specificity: 95.8% (412/430) (95% CI: 93.5, 97.3%)
- Influenza Type B:
- Sensitivity: 77% (65/84) (95% CI: 67.4, 85.0%)
- Specificity: 98.0% (386/394) (95% CI: 96.1, 99.0%)
The nineteen samples that tested positive on culture for influenza B, but were negative on the Alere™ Influenza A & B Test, were also tested on an investigational RT-PCR assay. Ten (10) of these samples were negative for influenza B by PCR.
The rate of invalid results was 1.9% (9/487) with 95% Cl: 1.0%, 3.5%.
ANALYTICAL STUDIES
ANALYTICAL SENSITIVITY
The Alere™ Influenza A & B Test limit of detection (LOD or C35), defined as the concentration of influenza virus that produces positive Alere™ Influenza A & B Test results approximately 95% of the time, was identified by evaluating different concentrations of 2 subtypes of live influenza A and 2 strains of live influenza B in the Alere™ Influenza A & B Test: Multiple operators tested each concentration of the four influenza strains multiple times.
ANALYTICAL REACTIVITY
The influenza A and B strains listed tested positive in the Alere™ Influenza A & B Test at the concentrations specified. Performance characteristics of the Alere™ Influenza A & B Test for detecting influenza A virus from human specimens were established when H1 and H3 subtypes were prevalent.
The Alere™ Influenza A & B Test was used to test 55 archived respiratory patient specimens, confirmed to be positive for the 2009 H1N1 influenza virus by an FDA cleared RT-PCR assay. Overall, the Alere™ Influenza A & B Test detected 45% (25/55) of the RT-PCR assay positive specimens. The detection rate was 94% (16/17) with the higher titer specimens and 24% (9/38) with the lower titer specimens.
ANALYTICAL SPECIFICITY (CROSS-REACTIVITY)
To determine the analytical specificity of the Alere™ Influenza A & B Test, 54 commensal and pathogenic microorganisms (38 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 108 to 1010 cells/ml, CFU/ml (bacteria), 105 to 108 TCIDso/ml or CEIDso/ml (viruses), and 10° cells/ml (veast).
INTERFERING SUBSTANCES
The following substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated in the Alere™ Influenza A & B Test at the concentrations listed below and were found not to affect test performance. Whole blood (1%) did not interfere with the interpretation of negative Alere™ Influenza A & B Test results, but did interfere with the interpretation of influenza A LOD (or C53) positive samples. Therefore, visibly bloody samples may not be appropriate for use in this test.
REPRODUCIBILITY
A reproducibility study of the Alere™ Influenza A & B Test was conducted by operators from 3 sites using panels of blind coded randomized 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 5 different days. The detection rates for the influenza A moderate positive, low positive, and high negative samples were 99.2% (119/120), 94.2% (113/120) and 9.2% (11/120), respectfully. The detection rates for the influenza B moderate positive, low positive, and high negative samples were 99.2% (119/120), 96.7%(116/120) and 7.5% (9/120), respectfully. All of the negative samples (118) generated negative test results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Influenza Type A
- Sensitivity: 93.8% (45/48) (95% CI: 83.2, 97.9%)
- Specificity: 95.8% (412/430) (95% CI: 93.5, 97.3%)
Influenza Type B
- Sensitivity: 77% (65/84) (95% CI: 67.4, 85.0%)
- Specificity: 98.0% (386/394) (95% CI: 96.1, 99.0%)
Invalid rate: 1.9% (9/487) with 95% Cl: 1.0%, 3.5%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3328 Influenza virus antigen detection test system.
(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
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: K133637
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
TRADE NAME Alere™ Influenza A & B Test
COMMON NAME Not Applicable
CLASSIFICATION NAME
Influenza virus serological reagents (per 21 CFR 866.3330)
CLASSIFICATION Class I
PRODUCT CODE GNX
PANEL Microbiology
PREDICATE DEVICE Alere™ Influenza A & B Test, K103610
1
DEVICE DESCRIPTION
The Alere™ Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in nasal swab specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a Test Strip.
Nasal swab samples are added to a Coated Reaction Tube to which an extraction reagent has been added. An Alere™ Influenza A & B Test Strip is then placed in the Coated Reaction Tube holding the extracted liquid sample. Test results are interpreted at 10 minutes based on the presence of pink-to-purple colored Sample Lines. The yellow Control Line turns blue in a valid test.
INTENDED USE
The Alere™ Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.
COMPARISON TO THE PREDICATE
The Alere™ Influenza A & B Test under consideration in this special 510(k) submission is exactly the same as the currently 510(k) cleared Alere™ Influenza A & B Test in all aspects except for the addition of Influenza A H7N9 to the analytical reactivity table. There have been no other modifications to the test, the fundamental scientific technology of the test has not been altered. Both tests use lateral flow immunochromatographic technology. Both tests are rapid immunoassays that employ specific antibodies immobilized onto solid phases to capture and visualize influenza nucleoprotein antigens.
PERFORMANCE SUMMARY
CLINICAL STUDY
Alere™ Influenza A & B Test Performance vs. Viral Culture – Prospective Study
The clinical performance of the Alere™ Influenza A & B Test was established in a multi-center, prospective, clinical study conducted at seven U.S. trial sites during the 2008-2009 respiratory season.
A total of 470 prospective nasal swab specimens, collected from patients of all ages presenting with influenzalike symptoms, were evaluated in the Alere™ Influenza A & B Test and compared to viral culture. Forty-four percent (44%) of the population tested was 18 years. A/H3 and A/H1 were the predominant influenza A subtypes observed during the times the specimens were collected.
Alere™ Influenza A & B Test performance versus viral culture, including 95% confidence intervals, is detailed below.
2
Alere™ Influenza A & B Test Performance vs. Culture
Influenza Type A
| Culture + | Culture - | ||
|---|---|---|---|
| Alere + | 45 | 18 | 63 |
| Alere - | 3 | 412 | 415 |
| 48 | 430 | 478 | |
| Culture + | Culture - | ||
| Alere + | 65 | 8 | 73 |
| Alere - | 19* | 386 | 405 |
| 84 | 394 | 478 |
Sensitivity: 93.8% (45/48) (95% CI: 83.2, 97.9%) Specificity: 95.8% (412/430) (95% CI: 93.5, 97.3%)
Influenza Type B
Sensitivity: 77% (65/84) (95% CI: 67.4, 85.0%) Specificity: 98.0% (386/394) (95% CI: 96.1, 99.0%)
- The nineteen samples that tested positive on culture for influenza B, but were negative on the Alere™ Influenza A & B Test, were also tested on an investigational RT-PCR assay. Ten (10) of these samples were negative for influenza B by PCR.
The rate of invalid results was 1.9% (9/487) with 95% Cl: 1.0%, 3.5%.
ANALYTICAL STUDIES
ANALYTICAL SENSITIVITY
The Alere™ Influenza A & B Test limit of detection (LOD or C35), defined as the concentration of influenza virus that produces positive Alere™ Influenza A & B Test results approximately 95% of the time, was identified by evaluating different concentrations of 2 subtypes of live influenza A and 2 strains of live influenza B in the Alere™ Influenza A & B Test: Multiple operators tested each concentration of the four influenza strains multiple times. The concentrations identified as the LOD (or Cos) levels for each strain tested are listed below.
| Influenza Subtype | Concentration
(TCID50/ml) | # Detected per
Total Tests | % Detected |
|--------------------------------|------------------------------|-------------------------------|------------|
| Influenza A/HongKong/8/68 | $2.37 \times 10^4$ | 64/66 | 97% |
| Influenza A/PuertoRico/8/34 | $3.16 \times 10^5$ | 37/42 | 88% |
| Influenza B/Malaysia/2506/2004 | $3.00 \times 10^6$ | 19/20 | 95% |
| Influenza B/Lee/40 | $4.20 \times 10^5$ | 19/20 | 95% |
ANALYTICAL REACTIVITY
The influenza A and B strains listed tested positive in the Alere™ Influenza A & B Test at the concentrations specified. Although the specific influenza strains causing infection in humans can vary year to year, all contain the conserved nucleoproteins targeted by the Alere™ Influenza A & B Test! Performance characteristics of the Alere™ Influenza A & B Test for detecting influenza A virus from human specimens were established when H1 and H3 subtypes were prevalent. Performance characteristics of the test when other influenza A virus subtypes are emerging as human pathogens have not been established.
Influenza Strain
Flu A/Port Chalmers/1/73 (H3N2) Flu A/WS/33 (H1N1) Flu A/Aichi/2/68 (H3N2) Flu A/Malaya/302/54 (H1N1) Flu A/New Jersey/8/76 (H1N1) Flu A/Denver/1/57 (H1N1) Flu A/Victoria/3/75 (H3N2)
Concentration
5.6 x 105 TCID50/ml 5.0 x 104 TCID50/ml 3.0 x 104 TCID50/ml 6.0 x 105 TCID50/ml 2.8 x 105 TCID50/ml 8.9 x 103 TCID50/ml 1.8 x 104 TCID50/ml
3
1.5 x 105 TCID50/ml Flu A/Solomon Islands/3/2006 (H1N1) Flu A/Brisbane/10/07 (H3N2) 2.5 x 106 EIU50/ml Flu A/PuertoRico/8/34 (H1N1) 5.6 x 105 TCID50/ml Flu A/Wisconsin/67/2005 (H3N2) 1.3 x 105 TCID50/ml Flu A/Hong Kong/8/68 (H3N2) 7.9 x 103 TCID50/ml Flu A/California/04/2009 (H1N1) 1.4 x 105 TCID50/ml Flu A/ANHUI/1/2013 (H7N9) 8.7 x 106 EID50/ml Flu B/Florida/02/2006 1.4 x 104 TCID50/ml Flu B/Florida/04/2006 7.1 x 104 TCID50/ml Flu B/Florida/07/04 8.5 x 104 TCID50/ml Flu B/Malaysia/2506/04 1.5 x 106 TCID50/ml Flu B/Panama/45/90 1.7 x 104 TCID50/ml Flu B/R75 5.0 x 105 TCID50/ml Flu B/Russia/69 2.2 x 106 TCID50/ml 1.0 x 105 TCID50/ml Flu B/Taiwan/2/62 Flu B/Mass/3/66 1.5 x 105 TCID50/ml Flu B/Lee/40 1.8 x 105 TCID50/ml
The Alere™ Influenza A & B Test was used to test 55 archived respiratory patient specimens, confirmed to be positive for the 2009 H1N1 influenza virus by an FDA cleared RT-PCR assay. Overall, the Alere™ Influenza A & B Test detected 45% (25/55) of the RT-PCR assay positive specimens. The detection rate was 94% (16/17) with the higher titer specimens and 24% (9/38) with the lower titer specimens.
Although this test has been shown to detect the Flu A/California/04/2009 (H1N1) and A/Anhui/1/2013 (H7N9) viruses cultured from positive human specimens, the performance characteristics of this device with fresh (non-frozen) human specimens infected with these two influenza viruses have not been established. The Alere™ Influenza A & B test can distinguish between influenza A and B viruses, but it does not differentiate seasonal influenza A virus from influenza A 2009 H1N1 or influenza A H7N9. The ability to detect human infection with the 2009 H1N1 or H7N9 influenza virus in clinical specimens is unknown.
ANALYTICAL SPECIFICITY (CROSS-REACTIVITY)
To determine the analytical specificity of the Alere™ Influenza A & B Test, 54 commensal and pathogenic microorganisms (38 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 108 to 1010 cells/ml, CFU/ml (bacteria), 105 to 108 TCIDso/ml or CEIDso/ml (viruses), and 10° cells/ml (veast).
| Bacteria | Viruses | Yeast |
|---|---|---|
| Acinetobacter calcoaceticus | Adenovirus type 1 | Candida albicans |
| Bacteroides fragilis | Adenovirus type 7 | |
| Bordetella pertussis | Coronavirus OC43 | |
| Chlamydia pneumoniae | Coronavirus 229E | |
| Corynebacterium diphtheria | Coxsackievirus B4 | |
| Enterococcus faecalis | Cytomegalovirus (CMV) (Herpes V) | |
| Escherichia coli | Epstein Barr Virus | |
| Gardnerella vaginalis | Human metapneumovirus | |
| Haemophilus influenzae | Measles (Edmonston) | |
| Klebsiella pneumoniae | Mumps (Enders) | |
| Lactobacillus casei | Parainfluenza 1 |
4
Lactobacillus plantarum Parainfluenza 2 Legionella pneumophila Parainfluenza 3 Respiratory Syncytial Virus type B Listeria monocytogenes Moraxella catarrhalis Rhinovirus type 1A 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 aureus (Cowan protein A producing strain) Staphylococcus epidermidis Streptococcus, Group A Streptococcus, Group B Streptococcus, Group C Streptococcus, Group F Streptococcus, Group G Streptococcus mutans Streptococcus pneumoniae Streptococcus salivaris Streptococcus sanguis
INTERFERING SUBSTANCES
The following substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated in the Alere™ Influenza A & B Test at the concentrations listed below and were found not to affect test performance. Whole blood (1%) did not interfere with the interpretation of negative Alere™ Influenza A & B Test results, but did interfere with the interpretation of influenza A LOD (or C53) positive samples. Therefore, visibly bloody samples may not be appropriate for use in this test.
| Substance | Concentration |
|---|---|
| 3 OTC nasal sprays | 10%. |
| 3 OTC mouthwashes | 10% |
| 3 OTC throat drops | 10% |
| 4-acetamidophenol | 10 mg/ml |
| Acetylsalicylic acid | 20 mg/ml |
| Albuterol | 20 mg/ml |
| Chlorpheniramine | 5 mg/ml |
| Dexamethasone | 5 mg/ml |
| Dextromethorphan | 10 mg/ml |
| Diphenhydramine | 5 mg/ml |
| Doxylamine succinate | 1 mg/ml |
5
| Flunisolide | 3 mg/ml |
|---|---|
| Guaiacol glycerol ether | 20 mg/ml |
| Mucin | 1% |
| Mupirocin | 250 µg/ml |
| Oxymetazoline | 10 mg/ml |
| Phenylephrine | 10 mg/ml |
| Phenylpropanolamine | 20 mg/ml |
| Rebetol® (Ribavirin) | 500 ng/ml |
| Relenza® (Zanamivir) | 20 mg/ml |
| Rimantadine | 500 ng/ml |
| Tamiflu® (Oseltamivir) | 100 mg/ml |
| Tobramycin | 40 mg/ml |
| Triamcinolone | 14 mg/ml |
REPRODUCIBILITY
A reproducibility study of the Alere™ Influenza A & B Test was conducted by operators from 3 sites using panels of blind coded randomized 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 5 different days. The detection rates for the influenza A moderate positive, low positive, and high negative samples were 99.2% (119/120), 94.2% (113/120) and 9.2% (11/120), respectfully. The detection rates for the influenza B moderate positive, low positive, and high negative samples were 99.2% (119/120), 96.7%(116/120) and 7.5% (9/120), respectfully. All of the negative samples (118) generated negative test results.
Signed __
Date _
Angela Drysdale
VP Regulatory and Clinical Affairs – Infectious Disease
Alere Scarborough, Inc.
- Dowdle, W.R. Kendal, A.P., and Noble, G.R. 1980. Influenza Virus, p 836-884. Manual of Clinical Microbiology, 3rd edition, In Lennette, et. Al (ed.). American Society for Microbiology, Washington, D.C
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2013
ALERE SCARBOROUGH, INC. ANGELA DRYSDALE VP OF REGULATORY AND CLINICAL AFFAIRS - INFECTIOUS DISEASE 10 SOUTHGATE ROAD SCARBOROUGH ME 04074
Re: K133637
Trade/Device Name: Alere™ Influenza A & B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus serological reagents Regulatory Class: I Product Code: GNX Dated: November 4, 2013 Received: November 27, 2013
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.
7
Page 2-Ms. Drysdale
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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.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/ReportalProblem/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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sally A
Sally 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
8
Indications For Use
510(k) Number (if known): K133637
Device Name: Alere™ Influenza A & B Test
Intended Use: The Alere™ Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2013.12.16 15:32:37 -05'00'