(28 days)
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.
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.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Device: Alere BinaxNOW® Influenza A & B Card
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a structured table format with specific thresholds. However, the performance summary provides quantitative results against a reference standard (Cell Culture/DFA), which implicitly serve as the criteria the device aims to meet. The implicit acceptance criteria would be for the sensitivity and specificity values to be within acceptable ranges for a rapid diagnostic test, generally aiming for high specificity to minimize false positives and reasonable sensitivity. The study results demonstrate these performance characteristics for the device.
Here's a table summarizing the reported device performance for the clinical studies, which can be interpreted as demonstrating the device meets implicit acceptance criteria for sensitivity and specificity:
Implicit Acceptance Criteria (Demonstrated Performance)
| Performance Metric | Influenza A (Prospective Study) | Influenza B (Prospective Study) | Influenza A (Retrospective Study) | Influenza B (Retrospective Study) |
|---|---|---|---|---|
| Overall Sensitivity | 81% (95% CI: 74-86%) | 65% (95% CI: 39-85%) | 83% (95% CI: 73-90%) | 53% (95% CI: 27-78%) |
| Overall Specificity | 97% (95% CI: 96-98%) | 100% (95% CI: 99-100%) | 93% (95% CI: 88-96%) | 92-98% (CI not fully legible for B) |
2. Sample Sizes Used for the Test Set and Data Provenance
Prospective Study:
- Sample Size: 846 specimens (nasopharyngeal and nasal swabs).
- Data Provenance: Multi-center 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.
Retrospective Study:
- Sample Size: 293 frozen clinical samples.
- Data Provenance: Clinical samples 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.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document refers to "Cell Culture / DFA" (Direct Fluorescent Antibody) as the comparative method for establishing ground truth. This indicates that the ground truth was established by laboratory testing using established and validated methods, rather than clinical expert consensus. Therefore, the concept of "number of experts" or their "qualifications" in the traditional sense of clinical adjudication by physicians is not directly applicable here. The experts would be the laboratory personnel performing and interpreting the cell culture and DFA, who are presumed to be qualified in these laboratory techniques.
4. Adjudication Method (for the test set)
The adjudication method used for the comparison was against Cell Culture / DFA. This means that discrepancies between the device's results and the Cell Culture / DFA results would be evaluated against the "gold standard" of Cell Culture / DFA without a specified clinical adjudication process detailed in the submission. The text does not mention a 2+1, 3+1, or similar expert adjudication process for discordant results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the provided document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. The study focuses on the standalone performance of the Alere BinaxNOW® Influenza A & B Card compared to laboratory reference methods.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance studies of the Alere BinaxNOW® Influenza A & B Card. The results show the performance of the device itself (immunochromatographic assay) in detecting influenza antigens, without human interpretation being the primary variable of interest. While human operators interpret the results (presence/absence of pink-to-purple lines), the study assesses the diagnostic accuracy of the test product against the reference standard. The "Reproducibility Study" involved multiple operators interpreting cards, indicating that human interpretation is part of the device's use, but the primary clinical performance studies (sensitivity/specificity vs. Cell Culture/DFA) evaluate the device's diagnostic capability. The "Analytical Sensitivity" section involved 12 different operators interpreting cards, further indicating that the interpretation by human users is part of the device's intended use and evaluation.
7. The type of Ground Truth Used
The primary ground truth used for both prospective and retrospective clinical studies was Cell Culture / DFA (Direct Fluorescent Antibody). This is a widely accepted and established laboratory method for influenza virus detection.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. This is common for rapid diagnostic devices like the Alere BinaxNOW® Influenza A & B Card, which are developed based on established immunological principles and optimized through R&D, rather than being "trained" in the machine learning sense on a distinct dataset. The clinical studies described are validation studies for the finalized device.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no explicit "training set" mentioned in the context of machine learning. Therefore, the establishment of ground truth for a training set is not applicable here. The device's performance was evaluated against the gold standard of Cell Culture/DFA in clinical validation studies.
{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), and 46% adult (> 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 (<18 years) and 38% adult (≥_18 years). Nasal wash/aspirate specimens comprised approximately 61% of the samples tested, while NP swabs represented 39%. No differences in test performance were observed based on patient age and gender or based on sample type tested.
Alere BinaxNOW® Influenza A & B Card performance by sample type versus cell culture / DFA, including 95% confidence intervals, is listed below.
| Test Sensitivity | ||||
|---|---|---|---|---|
| Sample | +/+ | -/+ | % Sens | 95% CI |
| NP Swab | 19 | 8 | 70% | 50-86% |
| Wash/Aspirate | 51 | 6 | 89% | 78-96% |
| Overall | 70 | 14 | 83% | 73-90% |
| Test Specificity | ||||
| Sample | -/- | +/- | % Spec | 95% CI |
| NP Swab | 77 | 9 | 90% | 81-95% |
| Wash/Aspirate | 117 | 6 | 95% | 89-98% |
| Overall | 194 | 15 | 93% | 88-96% |
Alere BinaxNOW® Influenza A & B Card Performance vs. Cell Culture/DFA for Detection of Flu A
Alere BinaxNOW® Influenza A & B Card Performance vs. Cell Culture/DFA for Detection of Flu B
| Test Sensitivity | ||||
|---|---|---|---|---|
| Sample | +/+ | -/+ | % Sens | 95% CI |
| NP Swab | 0 | 0 | N/A | N/A |
| Wash/Aspirate | 8 | 7 | 53% | 27-78% |
| Overall | 8 | 7 | 53% | 27-78% |
.
{4}------------------------------------------------
| Test Specificity | ||||
|---|---|---|---|---|
| Sample | % Spec | 95% CI | ||
| NP Swab | 111 | J | 98% | 93-100% |
| Wash / Aspirate | 155 | 10 | 94% | 89-97% |
| Overall | 266 | 12 | તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત | 92-98% |
Analytical Sensitivity:
The Alere BinaxNOW® Influenza A & B Card limit of detection (LOD), defined as the concentration of influenza virus that produces positive Alere BinaxNOW® Influenza A & B Card results approximately 95% of the time, was identified by evaluating different concentrations of inactivated Flu A/Beijing and inactivated Flu B/Harbin in the Alere BinaxNOW® Influenza A & B Card.
Twelve different operators each interpreted two cards run at each concentration for a total of 24 determinations per level. The following results identify a concentration of 1.03 x 10º ng/ml as the LOD for Flu A/Beijing and 6.05 x 101 ng/ml for Flu B/Harbin.
| Flu A/Beijing | ||
|---|---|---|
| Concentration (ng/ml) | # Detected | % Detected |
| 1.03 x 102 (LOD) | 23/24 | 96 |
| 5.60 x 101 (Cutoff) | * | 50 |
| 3.27 x 101 (High Neg) | 4/24 | 17 |
| True Negative | 0/24 | 0 |
| Flu B/Harbin | ||
|---|---|---|
| Concentration (ng/ml) | # Detected | % Detected |
| 6.05 x 101 (LOD) | 23/24 | 96 |
| 2.42 x 101 (Cutoff) | 11/24 | 46 |
| 1.51 x 101 (High Neg) | 6/24 | 25 |
| True Negative | 0/24 | 0 |
*Linear regression was used to calculate a line equation, which was then used to project the cutoff concentration of Flu A/Beijing.
Analytical Reactivity:
The influenza A and B strains listed tested positive in the Alere BinaxNOW® Influenza A & B Card at concentrations specified. Although the specific influenza strains causing infection in humans can vary from vear to year, all contain the conserved nucleoproteins targeted by the Alere BinaxNOW® Influenza A & B Card ? Performance characteristics of the Alere BinaxNOW® Influenza A & B Card for detecting influenza A virus from human specimens was 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 | ATCC # | Concentration |
|---|---|---|
| Flu A/WS/33 (H1N1) | VR-825 | 102-106 CEID50/ml |
| Flu A/NWS/33 (H1N1) | VR-219 | 102-106 CEID50/ml |
| Flu A/Hong Kong/8/68 (H3N2) | VR-544 | 102-106 CEID50/ml |
| Flu A/Aichi/2/68 (H3N2) | VR-547 | 102-106 CEID50/ml |
| Flu A/New Jersey /8/76 (Hsw1N1) | VR-897 | 102-106 CEID50/ml |
| Flu A/Mal/302/54 (H1N1) | VR-98 | 102-106 CEID50/ml |
| Flu A/Port Chalmers/1/73 (H3N2) | VR-810 | 102-106 CEID50/ml |
{5}------------------------------------------------
| Flu A/Hong Kong/156/97 (H5N1) | - | $1.3 x 10^2$ TCID50/ml |
|---|---|---|
| Flu A/Vietnam/1194/04 (H5N1) | - | $1.0 x 10^4$ TCID50/ml |
| Flu A/California/04/2009 (H1N1) swl(swine lineage) | - | $5.63 x 10^4$ TCID50/ml |
| Flu A/Auckland/1/2009 A(H1N1) swl | - | $1.0 x 10^5$ TCID50/ml |
| Flu A/Auckland/3/2009 A(H1N1) swl | - | $1.0 x 10^5$ TCID50/ml |
| Flu A/Chicken/NY/117228-7/01 (H5N2) | - | $1.0 x 10^4$ EID50/ml |
| Flu A/Turkey/VA/SEP-66/02 (H7N2) | - | $1.0 x 10^5$ EID50/ml |
| Flu A/A/ANHUI/1/2013 (H7N9) | - | $1.94 x 10^6$ EID50/ml |
| Flu B/Lee/40 | VR-101 | $10^2$ - $10^6$ CEID50/ml |
| Flu B/Brigit | VR-786 | $10^2$ - $10^6$ CEID50/ml |
| Flu B/Russia/69 | VR-790 | $10^2$ - $10^6$ CEID50/ml |
| Flu B/Hong Kong/5/72 | VR-791 | $10^2$ - $10^6$ CEID50/ml |
| Flu B/R75 | VR-789 | $10^2$ - $10^6$ CEID50/ml |
Although this test has been shown to detect the Flu A/California/04/2009 (H1N1) and Flu A/Anhui/1/2013 (H7N9) viruses cultured from positive human specimens, the performance characteristics of this card with human specimens infected with these two influenza viruses have not been established. The Alere BinaxNOW® Influenza A & B Card 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 H 1N 1 or H7N9 influenza virus in clinical specimens is unknown.
Analytical Specificity (Cross-Reactivity):
To determine the analytical specificity of the Alere BinaxNOW® Influenza A & B Card, 36 commensal and pathogenic microorganisms (27 bacteria, 8 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 104 to 10º TCIDso/ml (viruses), 107 to 10º organisms/ml (bacteria) and 10º organisms/ml (yeast).
| Bacteria | Viruses | Yeast |
|---|---|---|
| Acinetobacter | Adenovirus | Candida albicans |
| Bordetella pertussis | Coronavirus | |
| Enterococcus faecalis | Coxsackie B4 | |
| Escherichia coli | Cytomegalovirus (CMV) | |
| Gardnerella vaginalis | Parainfluenza 1 | |
| Haemophilus influenzae | Parainfluenza 2 | |
| Klebsiella pneumoniae | Parainfluenza 3 | |
| Lactobacillus casei | Respiratory Syncytial Virus (RSV) | |
| Legionella pneumophila | ||
| Listeria monocytogenes | ||
| Moraxella catarrhalis | ||
| 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 |
{6}------------------------------------------------
| Bacteria | Viruses | Yeast |
|---|---|---|
| Streptococcus, Group A | ||
| Streptococcus, Group B | ||
| Streptococcus, Group C | ||
| Streptococcus, Group F | ||
| Streptococcus mutans | ||
| Streptococcus pneumoniae |
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 BinaxNOW® Influenza A & B Card at the concentrations listed and were found not to affect test performance. Whole blood (1%) did not interfere with the interpretation of negative Alere BinaxNOW® Influenza A & B Card results, but did interfere with the interpretation of Flu A LOD positive samples. Therefore, visibly bloody samples may not be appropriate for use in this test.
| Substance | Concentration |
|---|---|
| 1 OTC mouthwash | 20% |
| 3 OTC nasal sprays | 15% |
| 3 OTC throat drops | 15% |
| 2 OTC throat sprays | 20% |
| 4-acetamidophenol | 10 mg/ml |
| Acetylsalicylic acid | 15 mg/ml |
| Albuterol | 20 mg/ml |
| Chlorpheniramine | 5 mg/ml |
| Dextromethorphan | 10 mg/ml |
| Diphenhydramine | 5 mg/ml |
| Guaiacol glycerol ether | 20 mg/ml |
| Oxymetazoline | 0.05% |
| Phenylephrine | 50 mg/ml |
| Phenylpropanolamine | 20 mg/ml |
| Rebetol® | 500 ng/ml |
| Relenza® | 20 mg/ml |
| Rimantadine | 500 ng/ml |
| Synagis® | 0.1 mg/ml |
| Tamiflu® | 50 mg/ml |
Reproducibility Study:
A blind study of the Alcre BinaxNOW® Influenza A & B Card was conducted at 3 separate sites using panels of blind coded specimens containing negative, low positive, and moderate positive samples. Participants tested each sample multiple times on 3 different days. There was 97% (242/250) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (3 different days), between sites (3 sites), or between operators (6 operators).
Signed _
Date __
Angela Drysdale .
{7}------------------------------------------------
VP Regulatory and Clinical Affairs - Infectious Disease Alere Scarborough, Inc.
.
:
and the state of the state of the states of the states
. .
.
. . . . . .
and the comments of the comments of the comments of the comments of the comments of
: : .
:
. 11 - 11 - 11
. . . .
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The text appears to be in a circular arrangement, but the resolution makes it difficult to read. The graphic in the center features three curved lines that resemble a bird in flight or a stylized representation of movement. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Ding Administration 10903 New Hampshire Avenue Document Control Center - WO66-(ibb) Silver Spring, MI) 20993-0002
ALERE SCARBOROUGH INC. ANGELA DRYSDALE VP OF REGULATORY AND CLINICAL AFFAIRS - INFECTIOUS DISEASE 10 SOUTHGATE ROAD SCARBOROUGH ME 04074 December 5, 2013
Re: K133411
Trade/Device Name: Alere BinaxNOW" Influenza A & B Card Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza virus scrological reagents Regulatory Class: 1 Product Code: GNX Dated: November 5, 2013 Received: November 7, 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 cither 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.
{9}------------------------------------------------
Page 2—Ms. Drysdale
If you desire specific advice for your device on our labeling regulations (2) 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/Safetw/ReportaProblem/default.htm for the CDRFF's Office of Surveillance and Biometries/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/Resources/orYou/Industrv/default.htm.
Sincerely vours.
Uwe Scherf -S ior
Sally Hoivat. M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Indications For Use
510(k) Number (if known): K133411
Device Name: Alere BinaxNOW® Influenza A & B Card
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
§ 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.