(108 days)
The BinaxNOW® Influenza A & B Test 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 results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.
The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & 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 device. 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 device 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 study details for the BinaxNOW® Influenza A & B Test, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for sensitivity and specificity are not explicitly stated as pre-defined targets within the provided text. Instead, the document presents the observed performance of the device against the reference method (cell culture/DFA) in various clinical studies. The substantial equivalence is established by comparing this observed performance to the predicate device, the BD Directigen™ Flu A+B Test (though detailed performance for the predicate is not provided in this summary).
For the purpose of this analysis, we will present the reported device performance from the prospective and retrospective clinical studies.
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA (Prospective Study)
| Target | Sample Type | Reported Sensitivity (%) (95% CI) | Reported Specificity (%) (95% CI) |
|---|---|---|---|
| Influenza A | NP Swab | 77% (65-86%) | 99% (97-100%) |
| Nasal Swab | 83% (74-90%) | 96% (93-98%) | |
| Overall | 81% (74-86%) | 97% (96-98%) | |
| Influenza B | NP Swab | 50% (9-91%) | 100% (99-100%) |
| Nasal Swab | 69% (39-90%) | 100% (98-100%) | |
| Overall | 65% (39-85%) | 100% (99-100%) |
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA (Retrospective Study)
| Target | Sample Type | Reported Sensitivity (%) (95% CI) | Reported Specificity (%) (95% CI) |
|---|---|---|---|
| Influenza A | NP Swab | 70% (50-86%) | 90% (81-95%) |
| Wash/Aspirate | 89% (78-96%) | 95% (89-98%) | |
| Overall | 83% (73-90%) | 93% (88-96%) | |
| Influenza B | NP Swab | N/A (0/0 positive) | 98% (93-100%) |
| Wash/Aspirate | 53% (27-78%) | 94% (89-97%) | |
| Overall | 53% (27-78%) | 96% (92-98%) |
Analytical Sensitivity (Limit of Detection - LOD)
| Influenza Strain | Concentration (ng/ml) | # Detected | % Detected |
|---|---|---|---|
| Flu A/Beijing (LOD) | 1.03 x 10^2 | 23/24 | 96% |
| Flu B/Harbin (LOD) | 6.05 x 10^1 | 23/24 | 96% |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Prospective Study Test Set:
- Total Specimens: 846
- Provenance: Multi-center, "central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season." Data is prospective.
- Patient demographics: 44% male, 54% female, 54% pediatric (<18 years), 46% adult (≥18 years).
- Sample types: Nasopharyngeal (NP) swabs, nasal swabs.
-
Retrospective Study Test Set:
- Total Specimens: 293
- Provenance: Collected from symptomatic patients at multiple physician offices, clinics, and hospitals in the Southern, Northeastern, and Midwestern regions of the United States, and from one hospital in Sweden. Data is retrospective (frozen clinical samples).
- Patient demographics: 53% male, 47% female, 62% pediatric (<18 years), 38% adult (≥18 years).
- Sample types: Nasal wash/aspirate (61%), NP swabs (39%).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It refers to "Cell Culture / DFA" as the reference method. In a typical clinical setting, cell culture and Direct Fluorescent Antibody (DFA) testing would be performed and interpreted by trained laboratory professionals, such as medical technologists or microbiologists. Specific expert qualifications (e.g., years of experience, board certification) are not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for disagreements or indeterminate results between different readers or between the device and the ground truth. The "ground truth" (Cell Culture/DFA) is treated as the definitive reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study is mentioned, as this device is a rapid diagnostic test (immunochromatographic assay) and not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The closest mention of human involvement in interpretation is in the analytical sensitivity study, where "Twelve (12) different operators each interpreted 2 devices run at each concentration," which is an operator variability assessment, not an MRMC study for diagnostic improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an in vitro diagnostic test, meaning its performance is inherently standalone in the sense that the test itself (reagents, membrane, etc.) produces the result. Human interpretation is required to read the pink-to-purple colored Sample Lines and the blue Control Line. However, there is no "algorithm" in the modern AI sense described. The "standalone" performance here refers to the device's ability to detect antigens in specimens without comparison to human interpretation of the same device output; rather, its output is compared to a gold standard (cell culture). The clinical study data presented (sensitivity and specificity) can be considered the standalone performance of the device as interpreted by an operator.
7. The Type of Ground Truth Used
The type of ground truth used is Cell Culture / DFA (Direct Fluorescent Antibody testing). This is a common and accepted laboratory reference method for influenza virus detection.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development or algorithm training. Since this is an immunochromatographic assay and not an AI/ML-based device, there isn't a traditional "training set" as understood in machine learning. The clinical and analytical studies serve to validate the device's performance against established methods.
9. How the Ground Truth for the Training Set Was Established
As there is no traditional "training set" for an AI/ML algorithm, this question is not directly applicable. The "ground truth" for the performance evaluation (test sets) was established using Cell Culture/DFA, which are established laboratory techniques performed by trained personnel.
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K062109
The purpose of this 510(k) submission is to expand the Indications for Use claim to add nasal swab specimens, modify the caution statement related to the determination of sensitivity by testing of archived specimens, expand the Analytical Reactivity claim to include two additional influenza A strains, provide data supporting the use of additional transport media, and to update the labeling in compliance with FDA Guidance: In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Requlatory Path, as well as minor modifications consistent with competitor claims of the currently 510(k) cleared BinaxNOW® Influenza A & B Test (510(k) #K053126, originally cleared as 510(k) #K041049).
To establish substantial equivalence to the predicate, the BinaxNOW® Influenza A & B Test was compared to the BD Directigen™ Flu A+B Test (510(k) # K001364),
SUBMITTER
Binax, Inc., d/b/a Inverness Medical Professional Diagnostics 10 Southgate Road Scarborough, Maine 04074 (207) 730-5739 (Office) (207) 730-5710 (FAX) Establishment Registration Number: 1221359
CONTACT PERSON
Angela Drvsdale angela.drysdale@binax.com (email)
ALTERNATE CONTACT PERSON
Pamela Angell pam.angell@binax.com (email)
DATE PREPARED July 17, 2006
TRADE NAME BinaxNOW® Influenza A & B Test
COMMON NAME
NOW® Flu A/B Test, NOW® Influenza A/B, NOW® Influenza A & B, Binax NOW® Influenza A & B, Binax NOW® Influenza A/B
CLASSIFICATION NAME
Antigen, CF (including CF Controls), Influenza Virus A, B, C (per 21 CFR 866.3330)
PREDICATE DEVICE
BD Directigen™ Flu A+B Test: K001364
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DEVICE DESCRIPTION
The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & 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 device,
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 device 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.
INTENDED USE
The BinaxNOW® Influenza A & B Test 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 results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.
TECHNOLOGICAL CHARACTERISTICS
The BinaxNOW® Influenza A & B Test uses lateral flow immunochromatographic technology while the BD Directigen™ Flu A+B test is an enzyme immunoassay (EIA) membrane test. Both tests are rapid immunoassays that employ specific antibodies immobilized onto a solid phase to capture and visualize influenza nucleoprotein antigens.
PERFORMANCE SUMMARY
CLINICAL STUDIES
The clinical performance of the BinaxNOW® Influenza A & B Test 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 and Midwestern regions of the United States and from one hospital in Sweden.
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA - Prospective Study
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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 BinaxNOW® Influenza A & B Test and compared to culture/DFA. Evaluated specimens include nasopharyngeal swabs and nasal swabs collected from patients presenting with influenza-like symptoms. Fortyfour percent (44%) of the population tested was male, 54% 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.
BinaxNOW® A & B Test performance by sample type versus cell culture / DFA, including 95% confidence intervals, is listed below.
| Test Sensitivity | Test Specificity | |||||||
|---|---|---|---|---|---|---|---|---|
| Sample | +/+ | -/+ | % Sens | 95% CI | -/- | +/- | % Spec | 95% CI |
| NP Swab | 53 | 16 | 77% | 65-86% | 278 | 3 | 99% | 97-100% |
| Nasal Swab | 85 | 17 | 83% | 74-90% | 378 | 16 | 96% | 93-98% |
| Overall | 138 | 33 | 81% | 74-86% | 656 | 19 | 97% | 96-98% |
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA for Detection of Flu A
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA for Detection of Flu B
| Sample | Test Sensitivity | Test Specificity | ||||||
|---|---|---|---|---|---|---|---|---|
| +/+ | -/+ | % Sens | 95% CI | -/- | +/- | % Spec | 95% CI | |
| NP Swab | 2 | 2 | 50% | 9-91% | 346 | 0 | 100% | 99-100% |
| Nasal Swab | 9 | 4 | 69% | 39-90% | 481 | 2 | 100% | 98-100% |
| Overall | 11 | 6 | 65% | 39-85% | 827 | 2 | 100% | 99-100% |
BinaxNOW® Influenza A & B Test 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.
BinaxNOW® A & B Test performance by sample type versus cell culture / DFA, including 95% confidence intervals, is listed below.
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BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA for Detection of Flu A
| Test Sensitivity | Test Specificity | |||||||
|---|---|---|---|---|---|---|---|---|
| Sample | +/+ | -/+ | % Sens | 95% CI | -/- | +/- | % Spec | 95% CI |
| NP Swab | 19 | 8 | 70% | 50-86% | 77 | 9 | 90% | 81-95% |
| Wash/Aspirate | 51 | 6 | 89% | 78-96% | 117 | 6 | 95% | 89-98% |
| Overall | 70 | 14 | 83% | 73-90% | 194 | 15 | 93% | 88-96% |
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA for Detection of Flu B
| Test Sensitivity | Test Specificity | |||||||
|---|---|---|---|---|---|---|---|---|
| Sample | +/+ | -/+ | %Sens | 95% CI | -/- | +/- | %Spec | 95% CI |
| NP Swab | 0 | 0 | N/A | N/A | 111 | 2 | 98% | 93-100% |
| Wash/Aspirate | 8 | 7 | 53% | 27-78% | 155 | 10 | 94% | 89-97% |
| Overall | 8 | 7 | 53% | 27-78% | 266 | 12 | 96% | 92-98% |
ANALYTICAL STUDIES
ANALYTICAL SENSITIVITY
The BinaxNOW® test limit of detection (LOD), defined as the concentration of influenza virus that produces positive BinaxNOW® test results approximately 95% of the time, was identified by evaluating different concentrations of inactivated Flu A/Beijing and inactivated Flu B/Harbin in the BinaxNOW® test.
Twelve (12) different operators each interpreted 2 devices run at each concentration for a total of 24 determinations per level. The following results identify a concentration of 1.03 x 102 ng/ml as the LOD for Flu A/Beijing and 6.05 x 101 ng/ml for Flu B/Hohnin.
| Influenza 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 |
| Influenza 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.
REACTIVITY TESTING
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The influenza A and B strains listed tested positive in the BinaxNOW® Influenza A & B Test at concentrations specified. Although the specific influenza strains causing infection in humans can vary year to year, all contain the conserved nucleoproteins targeted by the BinaxNOW® test.1 Performance characteristics of the BinaxNOW® Influenza Á & B Test 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 StrainConcentration | ATCC # | |
|---|---|---|
| Flu A/WS/33 (H1N1)CEID50/ml | VR-825 | 102-106 |
| Flu A/NWS/33 (H1N1)CEID50/ml | VR-219 | 102-106 |
| Flu A/Hong Kong/8/68 (H3N2)CEID50/ml | VR-544 | 102-106 |
| Flu A/Aichi/2/68 (H3N2)CEID50/ml | VR-547 | 102-106 |
| Flu A/New Jersey/8/76 (Hsw1N1)CEID50/ml | VR-897 | 102-106 |
| Flu A/Mal/302/54 (H1N1)CEID50/ml | VR-98 | 102-106 |
| Flu A/Port Chalmers/1/73 (H3N2)CEID50/ml | VR-810 | 102-106 |
| Flu A/Hong Kong/156/97 (H5N1)102 TCID50/ml | - | 1.3 × |
| Flu A/Vietnam/1194/04 (H5N1)104 TCID50/ml | - | 1.0 × |
| Flu A/Chicken/NY/117228-7/01 (H5N2)104 EID50/ml | - | 1.0 × |
| Flu A/Turkey/VA/SEP-66/02 (H7N2)105 EID50/ml | - | 1.0 × |
| Flu B/Lee/40CEID50/ml | VR-101 | 102-106 |
| Flu B/BrigitCEID50/ml | VR-786 | 102-106 |
| Flu B/Russia/69CEID50/ml | VR-790 | 102-106 |
| Flu B/Hong Kong/5/72CEID50/ml | VR-791 | 102-106 |
| Flu B/R75CEID50/ml | VR-789 | 102-106 |
ANALYTICAL SPECIFICITY (CROSS-REACTIVITY)
To determine the analytical specificity of the BinaxNOW® Influenza A & B Test, 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 blowing microorganisms were negative when tested at concentrations ranging from 10ª to 10ª TCIDso/ml (viruses), 107 to 10° organisms/ml (bacteria), and 10° organisms/ml (yo st).
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Yeast Candida
| Bacteria | Viruses |
|---|---|
| Acinetobacter | Adenovirus |
| 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 | |
| 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 attificially introduced into the nasal cavity or nasopharynx, were evaluated in the BinaxNOW® Influenza A & B Test at the concentrations listed and were found not to affect test performance. Whole blood (1%) did not interfere with the interpretation of negative BinaxNOW® test results, but did interfere with the interpretation of Flot 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% |
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| 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 |
TRANSPORT MEDIA
The following transport media were tested in the BinaxNOW® Influenza A & B Test as neqative samples (no virus present) and after inoculation with the LOD levels of Influenza A & B. Media did not impact BinaxNOW® test performance, with the media alone testing negative in the NOW® test and media inoculated with LOD Influenza A & B testing positive on the appropriate test line in BinaxNOW® test.
Amies Media Brain Heart Infusion Broth Dulbecco Medium Hank's Balanced Salt Solution M4 Media M4-RT Media M5 Media Phosphate Buffer Solution Saline Stuart's Media Tryptose Phosphate Broth UTM-RT Media Veal Infusion Broth
It has been determined that Sucrose-Phosphate Buffer may not be suitable for use with this test.
REPRODUCIBILITY
A blind study of the BinaxNOW® Influenza A & B Test 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 | |
|---|---|
| Pamela Angell | |
| Director, Worldwide Clinical Affairs, IMPD Scarborough | |
| Binax, Inc., d/b/a Inverness Medical Professional Diagnostics | |
| Date |
- 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
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Image /page/7/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, surrounded by a circular border. The text "U.S. Department of Health & Human Services" is written along the border of the circle. The eagle is drawn with thick, flowing lines, giving it a modern and abstract appearance.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Angela Drysdale Clinical Affairs Specialist Binax, Inc. 10 Southgate Road Scarborough, ME 04074
NOV - 9 2006
Re: K062109 Trade/Device Name: BinaxNOW® Influenza A & B Tcst Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: October 28, 2006 Received: October 30, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, autry
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):
BinaxNOW® Influenza A & B Test Device Name:
Indications For Use:
The BinaxNOW® Influenza A & B Test 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 results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - (CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| [Signature] |
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________
§ 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.