SOFIA (R) STREP A+ FIA

K141775 · Quidel Corporation · GTY · Dec 16, 2014 · Microbiology

Device Facts

• Record ID: K141775
• Device Name: SOFIA (R) STREP A+ FIA
• Applicant: Quidel Corporation
• Product Code: GTY · Microbiology
• Decision Date: Dec 16, 2014
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Intended Use

The Sofia® Strep A+ FIA detects Group A Streptococcal antigens from throat swabs from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.

Device Story

Sofia® Strep A+ FIA is an immunofluorescence-based lateral flow assay for qualitative detection of Group A Streptococcus (GAS) antigens. Input: throat swab specimen applied to a 2-D barcoded cassette. Operation: specimen is chemically lysed and wicked through a nitrocellulose strip containing europium chelate-impregnated microparticles coated with anti-GAS antibodies; GAS antigens bind to these particles and are captured by secondary antibodies on the strip. The Sofia® analyzer scans the strip using a 365 nm LED and filtered photodiode to detect fluorescent signals (Stokes shift 365 to 618 nm). Output: analyzer processes signals via an assay-specific algorithm to provide a positive, negative, or invalid result on the screen. Used in professional/laboratory settings by healthcare personnel. The device provides objective, automated interpretation of results, aiding in clinical diagnosis of GAS infection. Benefits include rapid, objective detection of GAS antigens, reducing reliance on subjective visual interpretation of lateral flow tests.

Clinical Evidence

Prospective clinical study (n=851) across 7 U.S. sites compared Sofia® Strep A+ FIA results to bacterial culture. Sensitivity was 93.7% (95% CI: 89.1%-96.5%) and specificity was 94.4% (95% CI: 92.4%-95.9%). Discordant analysis performed using an FDA-cleared molecular device. Analytical studies included precision, reproducibility, inclusivity (21 strains), and cross-reactivity/interference (88 organisms). Bench testing confirmed performance stability across temperatures and inter-analyzer consistency.

Technological Characteristics

Lateral-flow immunofluorescence assay. Uses polyclonal rabbit antibodies and Europium chelate-dyed polystyrene microparticles. Reagent solution contains sodium nitrite and hydrochloric acid. Analyzed by Sofia instrument using method-specific algorithms. Qualitative output. Room temperature storage. Built-in procedural control zone and automated cartridge expiration/insertion checks.

Indications for Use

Indicated for symptomatic patients (e.g., sore throat) suspected of having pharyngitis to detect Group A Streptococcal antigens in throat swab specimens.

Regulatory Classification

Identification

Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Predicate Devices

• Sofia® Strep A+ FIA with Sofia® (k123793)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

QUIDEL CORPORATION December 16, 2014 JOHN TAMERIUS SENIOR VICE PRESIDENT, CLINICAL AND REGULATORY 12544 HIGH BLUFF (ADMINISTRATIVE OFFICE LOCATION) SAN DIEGO CA 92130

Re: K141775

Trade/Device Name: Sofia® Strep A+ FIA Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. serological reagents Regulatory Class: I Product Code: GTY Dated: June 30, 2014 Received: July 1, 2014

Dear Dr. Tamerius:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) k141775

Device Name Sofia® Strep A+FIA Assay

#### Indications for Use (Describe)

The Sofia® Strep A+ FIA detects Group A Streptococcal antigens from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) SUMMARY

| Submitted By: | Quidel Corporation<br>12544 High Bluff Drive, Suite 200<br>(Administrative Offices)<br>San Diego, California 92130<br>Telephone: [phone]<br>Fax: [phone] |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | John D. Tamerius, Ph.D. |
| Date Prepared: | June 30, 2014 |
| Device Trade Name: | Sofia® Strep A+ FIA and Sofia |
| Common Name: | Strep A immunological test system and Fluorometer |
| Predicate Devices: | Sofia Strep A FIA for use with Sofia, K123793 |
| Device Classification/Name: | 21 CFR 866.3740 / Streptococcus Group A<br>serological reagents |
| Intended Use: | The Sofia Strep A+ FIA detects Group A<br>Streptococcal antigens from throat swabs from<br>patients with signs and symptoms of pharyngitis, such<br>as sore throat. All negative test results should be<br>confirmed by bacterial culture because negative<br>results do not preclude Group A Strep infection and<br>should not be used as the sole basis for treatment.<br>The test is intended for professional and laboratory<br>use as an aid in the diagnosis of Group A<br>Streptococcal infection. |
| Physiologic Basis of the<br>Test: | Group A Streptococcus is one of the most common<br>causes of acute upper respiratory tract infection. Early<br>diagnosis and treatment of Group A Streptococcal<br>pharyngitis has been shown to reduce the severity of<br>symptoms and serious complications such as<br>rheumatic fever and glomerulonephritis.<br>Conventional procedures for identification of Group A<br>Streptococcus from throat swabs involve the culture,<br>isolation, and subsequent identification of viable<br>pathogen at 24 to 48 hours or longer for results. |

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Device Description: The Sofia Strep A FIA employs immunofluorescence technology that is used with the Sofia analyzer (Sofia) to detect Group A Streptococcal antigen.

> The Sofia Strep A FIA involves the extraction of the antigenic components of the Group A Streptococcus (GAS) bacteria. The patient's swab sample is placed in the Reagent Tube containing the Reagent Solution, during which time the bacterial antigens are extracted, making them more accessible to the specific antibodies. An aliquot of the extracted sample is dispensed into the Cassette sample well. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If Group A Streptococcal antigens are present, they will be bound by antibodies coupled to fluorescent microparticles that migrate through the test strip. The fluorescent microparticles containing bound antigen will be captured by antibodies at a defined location on the test strip where they are detected by Sofia. If antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia.

> Note: The Cassette, now containing the sample, is placed directly inside Sofia for automatically timed development (WALK AWAY Mode).

Sofia scans, measures, and interprets the immunofluorescent signal using method-specific algorithms. Sofia will display the test results (Positive, Negative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected, or transmitted via an LIS connection.

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# Device Comparison:

Note: The shaded cells in Table 1 below identify where there are differences between the proposed and predicate devices.

| Item | Proposed Device | Predicate Device |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Sofia Strep A+ FIA with Sofia | Sofia Strep A FIA with Sofia |
| Intended Use | The Sofia® Strep A+ FIA detects<br>Group A Streptococcal antigens<br>from throat swabs from patients<br>with signs and symptoms of<br>pharyngitis, such as sore throat.<br>All negative test results should be<br>confirmed by bacterial culture<br>because negative results do not<br>preclude Group A Strep infection<br>and should not be used as the<br>sole basis for treatment. The test<br>is intended for professional and<br>laboratory use as an aid in the<br>diagnosis of Group A<br>Streptococcal infection. | The Sofia Strep A FIA employs<br>immunofluorescence technology to<br>detect Group A Streptococcal<br>antigens from throat swabs of<br>symptomatic patients. All negative<br>test results should be confirmed by<br>bacterial culture because negative<br>results do not preclude Group A<br>Strep infection and should not be<br>used as the sole basis for<br>treatment. The test is intended for<br>professional and laboratory use as<br>an aid in the diagnosis of Group A<br>Streptococcal infection. |
| FDA File<br>Number | k141775 | K123793 |
| Manufacturer | Quidel Corporation and LRE | Quidel Corporation and LRE |
| Regulation<br>Number | 21 CFR 866.3740 and<br>21 CFR 866.2560 | 21 CFR 866.3740 and<br>21 CFR 866.2560 |
| Classification<br>Product Code | GTY and KHO | GTY and KHO |
| Instrument | Sofia | Sofia |
| Analyte | Group A Streptococcus | Group A Streptococcus |
| Automated<br>Analysis | Yes | Yes |
| Mode(s) | Walk-Away only | Read-Now and Walk-Away |
| Read Results | Read results on instrument screen<br>or print with optional printer | Read results on instrument screen<br>or print with optional printer |
| Calibrator | Yes - Calibration Cassette and<br>QC Card provided | Yes - Calibration Cassette and<br>QC Card provided |
| Read Result<br>Time | 5 Minutes | 5 Minutes |
| Specimen<br>Types | Throat swab | Throat swab |
| Qualitative | Yes | Yes |
| Test Principle | Immunofluorescence Device | Immunofluorescence Device |
| Item | Proposed Device | Predicate Device |
| Features | Sofia Strep A+ FIA with Sofia | Sofia Strep A FIA with Sofia |
| Format | Lateral-flow Test Cassette | Lateral-flow Test Cassette |
| Antibodies<br>Used | Polyclonal rabbit antibodies that<br>are specific to Group A<br>Streptococcus | Polyclonal rabbit antibodies that<br>are specific to Group A<br>Streptococcus |
| Detection<br>Particle | Polystyrene microparticles dyed<br>with Europium chelate | Polystyrene microparticles dyed<br>with Europium chelate |
| Storage | Room Temperature | Room Temperature |
| Reagent<br>Solution | One reagent bottle containing<br>sodium nitrite and hydrochloric<br>acid in glass ampoule | One reagent bottle containing<br>sodium nitrite and acetic acid in<br>glass ampoule |
| Transfer<br>Device | Fixed volume pipette used to<br>transfer patient sample mixed with<br>reagent into Test Cassette | Fixed volume pipette used to<br>transfer patient sample mixed with<br>reagent into Test Cassette |
| External<br>Controls | Test kit contains Positive and<br>Negative Control Swabs | Test kit contains Positive and<br>Negative Control Swabs |
| Quality Control<br>Features | Built-in features include:<br>• Built-in procedural control<br>zone scanned by the<br>analyzer to determine<br>whether adequate flow<br>occurred<br>• Analyzer prevents used or<br>expired cartridge from being<br>read by the reader<br>• Cassette properly inserted | Built-in features include:<br>• Built-in procedural control<br>zone scanned by the<br>analyzer to determine<br>whether adequate flow<br>occurred<br>• Analyzer prevents used or<br>expired cartridge from being<br>read by the reader<br>• Cassette properly inserted |

# Table 1

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# Summary of Performance Data:

### Sofia Strep A+ FIA Performance vs. Cell Culture and vs. Cell Culture Resolved by PCR

The performance of the Sofia Strep A+ FIA was compared to standard bacterial culture and identification and an FDA-cleared Group A Streptococcus RT-PCR assay in a multi-center clinical field study. This study was conducted by untrained health care personnel during 2014 at 7 distinct CLIA-waived sites in various geographical regions within the United States. In this multicenter, point-of-care (POC) field trial, two (2) throat swabs were collected from eight hundred fiftyone (851) patients with symptoms suggestive of bacterial pharyngitis.

One throat swab was tested fresh at the CLIA-waived site in the Sofia Strep A+ FIA. A second swab was placed into transport medium and transported on cold ice packs to a central Reference Laboratory. The swab was streaked on a sheep blood agar plate (SBA) and cultured for up to 48 hours. A portion of the transport medium was subsequently tested in the PCR assay. The performance of the Sofia Strep A+ FIA was determined by comparison of the rapid FIA test result to the corresponding culture result (Table 2).

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### Table 2 Sofia Strep A+ FIA Performance Compared to Culture

| | Culture | | |
|-----------|---------|-----|-----------------------------------------|
| | Pos | Neg | Sensitivity |
| Sofia Pos | 164 | 38* | 93.7% (164/175)<br>(95%CI=89.1%-96.5%) |
| Sofia Neg | 11** | 638 | Specificity |
| | | | 94.4% (638/676)<br>(95% CI=92.4%-95.9%) |
| Total: | 175 | 676 | PPV |
| | | | 81.2% (164/202) |
| | | | NPV |
| | | | 98.3% (638/649) |

*Of the 38 discordant specimens, 24 of these specimens were positive for GAS when tested with an FDA-cleared molecular device, 14 were negative.

**Of the 11 discordant specimens, 3 were negative when tested with an FDA-cleared molecular device, 8 were positive.

## Reproducibility Studies

The reproducibility of the Sofia Strep A+ FIA was evaluated at 3 different laboratories. Two different operators at each site tested a series of coded, contrived samples, prepared in negative clinical matrix, ranging from negative (no bacteria) to moderate positive (3 x LoD) Group A Streptococcus. The inter-laboratory agreement (Table 3) for negative samples was 90-100% and 87-100% for positive samples. The intra-laboratory agreement (Table 4) for all samples ranged from 93-95%.

| Site | Negative*<br>(C₀) | High Negative*<br>(C₅) | Low Positive**<br>(C₉₅) | Mod Positive**<br>(C₁₀₀) |
|------------------------------------|-----------------------|------------------------|-------------------------|--------------------------|
| 1 | 30/30 | 27/30 | 27/30 | 30/30 |
| 2 | 30/30 | 29/30 | 23/30 | 30/30 |
| 3 | 30/30 | 25/30 | 28/30 | 30/30 |
| Total | 90/90 | 81/90 | 78/90 | 90/90 |
| % Overall<br>Agreement<br>(95% CI) | 100%<br>(95.9-100.0%) | 90%<br>(82.1-94.7%) | 87%<br>(78.1-92.2%) | 100%<br>(95.9-100.0%) |

Table 3 Sofia Strep A+ FIA Reproducibility Study Inter-laboratory Agreement

*Bacteria not detected/total

**Bacteria detected/total

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Table 4 Sofia Strep A+ FIA Reproducibility Study Intra-laboratory Agreement

| Site | Negative*<br>(Co) | High Negative*<br>(Cis) | Low Positive**<br>(C95) | Mod. Positive**<br>(C100) | % Overall<br>Agreement<br>(95% CI) |
|------|-------------------|-------------------------|-------------------------|---------------------------|------------------------------------|
| 1 | 30/30 | 27/30 | 27/30 | 30/30 | 95% (114/120)<br>(89.5-97.7%) |
| 2 | 30/30 | 29/30 | 23/30 | 30/30 | 93% (112/120)<br>(87.4-96.6%) |
| 3 | 30/30 | 25/30 | 28/30 | 30/30 | 94% (113/120)<br>(88.5-97.2%) |

*Bacteria not detected/total

**Bacteria detected/total

# Limit of Detection

The limit of detection (LoD) for the Sofia Strep A+ FIA was determined using 3 strains of Group A Streptococcus pyogenes. The LoD ranged from 2.76E+03 to 8.13E+03 colony forming units (cfu)/test (Table 5).

Table 5 Sofia Strep A+ FIA Limits of Detection

| Strain | Minimum Detectable Level* |
|--------------------|---------------------------|
| Bruno [CIP 104226] | 4.00E+03 cfu/test |
| CDC-SS-1402 | 8.13E+03 cfu/test |
| CDC-SS-1460 | 2.76E+03 cfu/test |

cfu/test = colony forming units/test

*The levels of bacteria were determined by limiting dilution, bacterial culture, and colony counting to give cfu/test.

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### Analytical Reactivity

Analytical reactivity for the Sofia Strep A+ FIA was demonstrated using 21 strains of Group A Streptococcus pyogenes tested at 1.74E+04 colony forming units (cfu)/test (Table 6).

| Streptococcus pyogenes Strain |
|-------------------------------------|
| Strain #1 (ATCC-19615) |
| Strain #2 (ATCC-700942) |
| Strain #3 (ATCC-700952) |
| Strain #4 (Clinical Isolate-52123) |
| Strain #5 (Clinical Isolate-52120) |
| Strain #6 (Clinical Isolate-62055) |
| Strain #7 (Clinical Isolate-52152) |
| Strain #8 (Clinical Isolate-62092) |
| Strain #9 (Clinical Isolate-52151) |
| Strain #10 (ATCC-700482) |
| Strain #11 (ATCC-BAA-1315) |
| Strain #12 (ATCC-700459) |
| Strain #13 (ATCC-12203) |
| Strain #14 (ATCC-700944) |
| Strain #15 (Clinical Isolate-52154) |
| Strain #16 (Clinical Isolate-5036) |
| Strain #17 (Clinical Isolate-5095) |
| Strain #18 (Clinical Isolate-5017) |
| Strain #19 (Clinical Isolate-5060) |
| Strain #20 (Clinical Isolate-5112) |
| Strain #21 (Clinical Isolate-5008) |

Table 6 Analytical Reactivity

# Analytical Specificity

Cross Reactivity

The cross reactivity of the Sofia Strep A+ FIA was evaluated with a total of 61 non-Group A Streptococcus bacterial and fungal microorganisms, and 26 viral isolates. None of the microorganisms or viruses listed below in Table 7 showed any sign of cross reactivity in the assay. The same microorganisms and viruses in Table 7 were pre-mixed with Group A Strep and tested in the Sofia Strep A+ FIA.

| Table 7 |
|------------------|
| Cross Reactivity |

| Organism/Virus | Test Concentration** |
|-----------------------------------------------------------------|--------------------------------|
| Arcanobacterium haemolyticum | 3.00E+05 cfu/test |
| Bacteroides fragilis | 3.00E+07 cfu/test |
| Bordetella pertussis | 3.00E+07 cfu/test |
| Candida albicans | 3.00E+04 cfu/test |
| Corynebacterium diphtheriae | 3.00E+05 cfu/test |
| Corynebacterium pseudodiphtheriticum* | 3.00E+06 cfu/test |
| Enterococcus faecalis* | 1.40E+06 cfu/test |
| Organism/Virus | Test Concentration** |
| Enterococcus faecium | 3.00E+06 cfu/test |
| Escherichia coli | 1.50E+07 cfu/test |
| Fusobacterium necrophorum | 3.00E+06 cfu/test |
| Haemophilus influenzae | 3.00E+07 cfu/test |
| Haemophilus parahaemolyticus | 3.00E+06 cfu/test |
| Klebsielle pneumoniae | 3.00E+07 cfu/test |
| Moraxella catarrhalis | 3.00E+06 cfu/test |
| Neisseria gonorrhoeae | 3.00E+06 cfu/test |
| Neisseria lactamica | 3.00E+06 cfu/test |
| Neisseria meningitidis | 3.00E+06 cfu/test |
| Neisseria sicca | 3.00E+07 cfu/test |
| Neisseria subflava | 3.00E+07 cfu/test |
| Proteus vulgaris | 3.00E+07 cfu/test |
| Pseudomonas aeruginosa | 3.00E+06 cfu/test |
| Serratia marcescens | 3.00E+07 cfu/test |
| Staphylococcus aureus* | 3.00E+06 cfu/test |
| Staphylococcus epidermidis | 3.00E+06 cfu/test |
| Staphylococcus haemolyticus | 3.00E+05 cfu/test |
| Staphylococcus intermedius | 3.00E+05 cfu/test |
| Staphylococcus saprophyticus | 3.00E+06 cfu/test |
| Streptococcus anginosus | 3.00E+06 cfu/test |
| Streptococcus gordonii | 3.00E+04 cfu/test |
| Streptococcus mitis | 3.00E+04 cfu/test |
| Streptococcus mutans* | 3.00E+06 cfu/test |
| Streptococcus oralis | 3.00E+06 cfu/test |
| Streptococcus parasanginis* | 3.00E+06 cfu/test |
| Streptococcus pneumoniae | 3.00E+06 cfu/test |
| Streptococcus salivaris | 3.00E+05 cfu/test |
| Streptococcus sanguinis | 3.00E+06 cfu/test |
| Streptococcus Group B Strain #1:<br>Streptococcus agalactiae | 3.00E+06 cfu/test |
| Streptococcus Group B Strain #2 | 3.00E+06 cfu/test |
| Streptococcus Group B Strain #3 | 3.00E+06 cfu/test |
| Streptococcus Group B Strain #4 | 3.00E+06 cfu/test |
| Streptococcus Group B Strain #5 | 3.00E+06 cfu/test |
| Streptococcus Group C Strain #1 | 3.00E+06 cfu/test |
| Streptococcus Group C Strain #2 | 3.00E+06 cfu/test |
| Streptococcus Group C Strain #3 | 3.00E+06 cfu/test |
| Streptococcus Group C Strain #4:<br>Streptococcus dysgalactiae* | 3.00E+06 cfu/test |
| Organism/Virus | Test Concentration** |
| Streptococcus Group C Strain #5 | 3.00E+05 cfu/test |
| Streptococcus Group D Strain #1:<br>Enterococcus casseliflavus | 3.00E+06 cfu/test |
| Streptococcus Group D Strain #2 | 3.00E+06 cfu/test |
| Streptococcus Group D Strain #3* | 3.00E+06 cfu/test |
| Streptococcus Group D strain #4:<br>Enterococcus faecalis | 3.00E+06 cfu/test |
| Streptococcus Group D strain #5:<br>Enterococcus faecalis | 3.00E+06 cfu/test |
| Streptococcus Group F Strain #1 | 1.00E+05 cfu/test |
| Streptococcus Group F Strain #2 | 3.00E+06 cfu/test |
| Streptococcus Group F Strain #3 | 1.00E+06 cfu/test |
| Streptococcus Group F Strain #4* | 3.00E+05 cfu/test |
| Streptococcus Group F Strain #5 | 3.00E+05 cfu/test |
| Streptococcus Group G strain #1:<br>Streptococcus dysgalactiae | 3.00E+07 cfu/test |
| Streptococcus Group G Strain #2 | 3.00E+06 cfu/test |
| Streptococcus Group G Strain #3 | 3.00E+06 cfu/test |
| Streptococcus Group G Strain #4 | 3.00E+06 cfu/test |
| Streptococcus Group G Strain #5 | 3.00E+06 cfu/test |
| Adenovirus Type 1* | 3.00E+11 TCID50/test |
| Adenovirus Type 3* | 3.00E+05 TCID50/test |
| Adenovirus Type 4 | 7.50E+03 TCID50/test |
| Adenovirus Type 5 | 3.00E+05 TCID50/test |
| Adenovirus Type 11 | 3.00E+04 TCID50/test |
| Coronavirus 229E | 3.00E+04 TCID50/test |
| Coronavirus OC43 | 3.00E+04 TCID50/test |
| Coxsackievirus B5 (Faulkner) | 3.00E+06 TCID50/test |
| Cytomegalovirus (Towne) | 3.00E+03 TCID50/test |
| Echovirus Type 3 | 1.50E+04 TCID50/test |
| Epstein Barr Virus (EBV)* | 3.00E+07 genome<br>copies/test |
| Herpes Simplex Virus 1 | 3.00E+04 TCID50/test |
| Herpes Simplex Virus 2 | 3.00E+04 TCID50/test |
| Influenza A/New Jersey/8/76 (H1N1) | 3.00E+04 TCID50/test |
| Influenza A/Victoria/3/75 (H3N2) | 3.00E+04 TCID50/test |
| Influenza B/Hong Kong/5/72 | 3.00E+04 TCID50/test |
| Influenza B/Panama/45/90 | 1.50E+04 TCID50/test |
| Influenza C/Taylor/1233/47 | 1.50E+04 TCID50/test |
| Measles (Edmonston) | 3.00E+04 TCID50/test |
| Mumps (Enders)* | 3.00E+03 TCID50/test |
| Organism/Virus | Test Concentration** |
| Parainfluenza virus 1 | 3.00E+04 TCID50/test |
| Parainfluenza virus 2 | 1.10E+05 TCID50/test |
| Parainfluenza virus 3 | 6.80E+05 TCID50/test |
| Parainfluenza virus 4A | 3.00E+04 TCID50/test |
| Rhinovirus Type 2 | 3.00E+03 TCID50/test |
| Rhinovirus Type 15 | 3.00E+04 TCID50/test |

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

cfu/test = colony forming units/test TCID50/test = 50% tissue culture infectious dose

*This organism/virus may interfere with this assay.

**The levels of bacteria were determined by limiting dilution, bacterial culture, and colony counting to give cfu/test. Virus concentrations were determined by standard virology methods, Reed-Muench.

### Interfering Substances

Several over-the-counter (OTC) products, whole blood, mucin and blood agar were evaluated with the Sofia Strep A+ FIA at the levels tested (Table 8).

Table 8 Interference Testing

| Substance | Concentration |
|---------------------------------------------------------------------------------------------------------|---------------|
| Crest Pro-Health Deep Clean Mint Mouth wash (Cetylpyridinium chloride) | 24% v/v |
| Listerine Original Antiseptic Mouth wash (Eucalyptol, Menthol, Methyl salicylate, and Thymol) | 24% v/v |
| Listerine Cool Mint Antiseptic Mouth wash (Eucalyptol, Menthol, Methyl salicylate, and Thymol) | 24% v/v |
| RiteAid Sore throat relief (Benzocaine and Menthol) | 24% v/v |
| Chloraseptic Max Sore Throat (Phenol and Glycerin) | 24% v/v |
| Dimetapp Children's Cold & Cough (Brompheniramine maleate, Dextromethorphan HBr, and Phenylephrine HCI) | 24% v/v |
| RiteAid Children's Cold & Allergy (Brompheniramine maleate and Phenylephrine HCI) | 24% v/v |
| CVS Children's Cold & Cough DM (Brompheniramine maleate, Dextromethorphan HBr, and Phenylephrine HCI) | 24% v/v |
| RiteAid tussin cough&cold mucus relief CF (Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCI) | 24% v/v |
| Robitussin Max Strength Multi-Symptom CF Max (Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCI) | 24% v/v |
| Robitussin Night Time Multi-Symptom Cold CF (Acetaminophen, Diphenhydramine HCl, and Phenylephrine HCI) | 24% v/v |
| Cepacol Sore Throat Cherry (Benzocaine and Menthol) | 24% w/v |
| Halls Triple Soothing Action Cherry (Menthol) | 24% w/v |
| Halls Triple Soothing Action Menthol-lyptus (Menthol) | 24% w/v |
| Ricola Natural Herb Cough Drops (Menthol) | 24% w/v |
| Sucrets Complete Vapor Cherry (Dyclonine Hydrochloride and Menthol) | 24% w/v |
| Chloraseptic Sore Throat Cherry (Phenol and Glycerin) | 24% w/v |
| BreathSavers Spearmint (Cetylpyridinium chloride) | 24% w/v |

{14}------------------------------------------------

| Substance | Concentration |
|-------------------------------------------------------------------------|---------------|
| Tic Tac freshmints (Eucalyptol, Menthol, Methyl salicylate, and Thymol) | 24% w/v |
| Cheetos, Flaming Hot | 12% w/v |
| Doritos, Nacho Flavor | 12% w/v* |
| Fresh Whole Blood | 75 µL/swab** |
| Mucin | 4.3% w/v*** |
| Sheep Blood Agar (5% Sheep Blood) | 24% w/v |
| Horse Blood Agar (5% Horse Blood) | 24% w/v |

*Nacho Flavor Doritos interfered at 25% w/v

** Fresh Whole Blood interfered at 100 µL/swab

14 100n Whole Blood Intonered at 100 perowas
*** Bovine submaxillary mucin interfered at 28.7 mg/mL

# Conclusion:

These studies demonstrated the substantial equivalence of the Sofia Strep A+ FIA with the Sofia to the existing product Sofia Strep A FIA with Sofia (K123793).