ALERE BINAXNOW INFLUENZA A & B CARD

K133411 · Alere Scarborough, Inc D/B/A Binax, Inc. · GNX · Dec 5, 2013 · Microbiology

Device Facts

• Record ID: K133411
• Device Name: ALERE BINAXNOW INFLUENZA A & B CARD
• Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.
• Product Code: GNX · Microbiology
• Decision Date: Dec 5, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3330
• Device Class: Class 1

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.

Device Story

The Alere BinaxNOW® Influenza A & B Card is a lateral flow immunochromatographic assay used for rapid differential diagnosis of influenza A and B. Input consists of respiratory specimens (NP swab, nasal swab, or nasal wash/aspirate). The device utilizes monoclonal antibodies immobilized on a membrane support to capture viral nucleoprotein antigens. The test strip is housed in a hinged cardboard card. After sample application, results are visually interpreted at 15 minutes by the presence of colored lines. A blue control line indicates a valid assay. The device is intended for use in clinical settings by healthcare professionals. Results are qualitative and presumptive; negative results require confirmation by cell culture or molecular assays. The device aids clinical decision-making but should not be the sole basis for patient management.

Clinical Evidence

Clinical performance established via prospective and retrospective studies. Prospective study (n=846) compared device to cell culture/DFA; overall sensitivity for Flu A was 81% (95% CI: 74-86%) and specificity 97% (95% CI: 96-98%). Flu B sensitivity was 65% (95% CI: 39-85%) and specificity 100% (95% CI: 99-100%). Retrospective study (n=293) showed Flu A sensitivity 83% (95% CI: 73-90%) and specificity 93% (95% CI: 88-96%). Analytical sensitivity (LOD) and specificity (cross-reactivity with 36 microorganisms) were also evaluated.

Technological Characteristics

Lateral flow immunochromatographic membrane assay. Employs monoclonal antibodies immobilized on a membrane support. Form factor is a hinged, book-shaped cardboard test card. No external energy source required. Standalone manual test. No software or electronic components.

Indications for Use

Indicated for qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal swabs, nasal swabs, and nasal wash/aspirate specimens from patients presenting with influenza-like symptoms. No age or gender restrictions.

Regulatory Classification

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.

Predicate Devices

• Alere BinaxNOW® Influenza A & B Card (K092223)

Submission Summary (Full Text)

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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 K133411

## SUBMITTER

Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Establishment Registration Number: 1221359

## CONTACT PERSON

Angela Drysdale [phone] (Office) [phone] (FAX) [e-mail] (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

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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.

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#### 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% |

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| 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% |

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| 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 |

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| 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<br>(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 | | |

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| 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).

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Angela Drysdale .

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VP Regulatory and Clinical Affairs - Infectious Disease Alere Scarborough, Inc.

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# 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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)