(28 days)
Not Found
No
The device is a manual immunochromatographic assay with visual interpretation of results, and there is no mention of AI or ML in the description or performance studies.
No
The device is an in vitro diagnostic assay used for the qualitative detection of influenza A and B nucleoprotein antigens, intended to aid in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to aid in the rapid differential diagnosis of influenza A and B viral infections." This confirms its role in disease diagnosis.
No
The device description clearly states it is an "immunochromatographic membrane assay" and describes physical components like a "membrane support," "test strip," and "cardboard, book-shaped hinged test card." This indicates it is a physical in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay. This directly identifies it as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. 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.
Caution: Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples.
Product codes (comma separated list FDA assigned to the subject device)
GNX
Device Description
The Alere BinaxNOW® Influenza A & B Card is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, book-shaped hinged test card.
Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution, saline or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens.
Indicated Patient Age Range
Not Found
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
The clinical performance of the Alere BinaxNOW® Influenza A & B Card was established in multi-center, prospective, clinical studies conducted at a central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season. Additional performance testing was conducted on retrospective frozen clinical samples collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern regions of the United States and from one hospital in Sweden.
A total of 846 prospective specimens collected from children (less than 18 years of age) and adults (18 years or older) were evaluated in the Alere BinaxNOW® Influenza A & B Card and compared to culture/DFA. Evaluated specimens include nasopharyngeal and nasal swabs collected from patients presenting with influenza-like symptoms.
A total of 293 retrospective frozen clinical samples were evaluated in the BinaxNOW® Influenza A & B Test and compared to culture/DFA. All clinical samples were collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern and Midwestern regions of the United States and from one hospital in Sweden.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Studies:
Alere BinaxNOW® Influenza A & B Card Performance vs. Cell Culture / DFA - Prospective Study
- Sample Size: A total of 846 prospective specimens.
- Key Results (Influenza A):
- NP Swab: Sensitivity 77% (95% CI: 65-86%), Specificity 99% (95% CI: 97-100%).
- Nasal Swab: Sensitivity 83% (95% CI: 74-90%), Specificity 96% (95% CI: 93-96%).
- Overall: Sensitivity 81% (95% CI: 74-86%), Specificity 97% (95% CI: 96-98%).
- Key Results (Influenza B):
- NP Swab: Sensitivity 50% (95% CI: 9-91%), Specificity 100% (95% CI: 99-100%).
- Nasal Swab: Sensitivity 69% (95% CI: 39-90%), Specificity 100% (95% CI: 98-100%).
- Overall: Sensitivity 65% (95% CI: 39-85%), Specificity 100% (95% CI: 99-100%).
Alere BinaxNOW® Influenza A & B Card Performance vs. Cell Culture / DFA - Retrospective Study
- Sample Size: A total of 293 retrospective frozen clinical samples.
- Key Results (Influenza A):
- NP Swab: Sensitivity 70% (95% CI: 50-86%), Specificity 90% (95% CI: 81-95%).
- Wash/Aspirate: Sensitivity 89% (95% CI: 78-96%), Specificity 95% (95% CI: 89-98%).
- Overall: Sensitivity 83% (95% CI: 73-90%), Specificity 93% (95% CI: 88-96%).
- Key Results (Influenza B):
- NP Swab: Sensitivity N/A, Specificity 98% (95% CI: 93-100%).
- Wash/Aspirate: Sensitivity 53% (95% CI: 27-78%), Specificity 94% (95% CI: 89-97%).
- Overall: Sensitivity 53% (95% CI: 27-78%), Specificity 92-98%.
Analytical Sensitivity:
- LOD for Flu A/Beijing: 1.03 x 10^2 ng/ml (96% detected, 23/24).
- LOD for Flu B/Harbin: 6.05 x 10^1 ng/ml (96% detected, 23/24).
Reproducibility Study:
- Study Type: Blind study conducted at 3 separate sites using panels of blind coded specimens.
- Key Results: 97% (242/250) agreement with expected test results, with no significant differences within run, between run, between sites, or between operators.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Study - Influenza A:
- NP Swab: Sensitivity 77%, Specificity 99%
- Nasal Swab: Sensitivity 83%, Specificity 96%
- Overall: Sensitivity 81%, Specificity 97%
Prospective Study - Influenza B:
- NP Swab: Sensitivity 50%, Specificity 100%
- Nasal Swab: Sensitivity 69%, Specificity 100%
- Overall: Sensitivity 65%, Specificity 100%
Retrospective Study - Influenza A:
- NP Swab: Sensitivity 70%, Specificity 90%
- Wash/Aspirate: Sensitivity 89%, Specificity 95%
- Overall: Sensitivity 83%, Specificity 93%
Retrospective Study - Influenza B:
- NP Swab: Specificity 98%
- Wash/Aspirate: Sensitivity 53%, Specificity 94%
- Overall: Sensitivity 53%, Specificity 92-98%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
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 K133411
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 BinaxNOW® Influenza A & B Card
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 BinaxNOW® Influenza A & B Card, K092223
DEVICE DESCRIPTION
The Alere BinaxNOW® Influenza A & B Card is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, book-shaped hinged test card.
Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution, saline or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to
DEC 0 5 2013
1
the top of the test strip and the test card is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.
Carlos College of
·
:
:
:
.
:
.
. .
.
2
INTENDED USE
The Alere BinaxNOW® Influenza A & B Card is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. 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.
Caution: Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples.
COMPARISON TO THE PREDICATE
The Alere BinaxNOW® Influenza A & B Card, under consideration in this special 510(k) filing is exactly the same test as the currently 510(k) cleared Alere BinaxNOW® Influenza A & B Card, there have been no modifications to the test; the fundamental scientific technology of the test has not been altered. Both 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
The clinical performance of the Alere BinaxNOW® Influenza A & B Card was established in multi-center, prospective, clinical studies conducted at a central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season. Additional performance testing was conducted on retrospective frozen clinical samples collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern regions of the United States and from one hospital in Sweden.
Clinical Studies:
Alere BinaxNOW® Influenza A & B Card Performance vs. Cell Culture / DFA - Prospective Study
A total of 846 prospective specimens collected from children (less than 18 years of age) and adults (18 years or older) were evaluated in the Alere BinaxNOW® Influenza A & B Card and compared to culture/DFA. Evaluated specimens include nasopharyngeal and nasal swabs collected from patients presenting with influenza-like symptoms. Forty-four percent (44%) of the population tested was male, 56% female, 54% pediatric ( 18 years). No differences in test performance were observed based on patient age or gender. A/H3 and A/H1 were the predominant influenza subtypes observed during this time.
Alere BinaxNOW® Influenza A & B Card performance by sample type versus cell culture / DFA, including 95% confidence intervals, is listed below.
| Alere BinaxNOW® Influenza A & B Card Performance vs. Cell Culture/DFA for Detection of Flu A | |||
|---|---|---|---|
| ---------------------------------------------------------------------------------------------- | -- | -- | -- |
| Test Sensitivity | Test Specificity | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample | +/+ | -/+ | % Sens | 95% CI | Sample | -/- | +/- | % Spec | 95% CI |
| NP Swab | 53 | 16 | 77% | 65-86% | NP Swab | 278 | 3 | 99% | 97-100% |
| Nasal Swab | 85 | 17 | 83% | 74-90% | Nasal Swab | 378 | 16 | 96% | 93-96% |
| Overall | 138 | 33 | 81% | 74-86% | Overall | 656 | 19 | 97% | 96-98% |
3
| Test Sensitivity | ||||
|---|---|---|---|---|
| Sample | +/+ | -/+ | % Sens | 95% CI |
| NP Swab | 2 | 2 | 50% | 9-91% |
| Nasal Swab | 9 | 4 | 69% | 39-90% |
| Overall | 11 | 6 | 65% | 39-85% |
Alere BinaxNOW® Influenza A & B Card Performance vs. Cell Culture/DFA for Detection of Flu B
| Test Specificity | ||||
|---|---|---|---|---|
| Sample | -/- | +/- | % Spec | 95% CI |
| NP Swab | 346 | 0 | 100% | 99-100% |
| Nasal Swab | 481 | 2 | 100% | 98-100% |
| Overall | 827 | 2 | 100% | 99-100% |
Alere BinaxNOW® Influenza A & B Card Performance vs. Cell Culture / DFA - Retrospective Study
A total of 293 retrospective frozen clinical samples were evaluated in the BinaxNOW® Influenza A & B Test and compared to culture/DFA. All clinical samples were collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern and Midwestern regions of the United States and from one hospital in Sweden. Fifty-three percent (53%) of the population tested was male, 47% female, 62% pediatric (