ACON STREP A TWIST TEST DEVICE

K023766 · Acon Laboratories Co. · GTY · Feb 10, 2003 · Microbiology

Device Facts

• Record ID: K023766
• Device Name: ACON STREP A TWIST TEST DEVICE
• Applicant: Acon Laboratories Co.
• Product Code: GTY · Microbiology
• Decision Date: Feb 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

The ACON® Strep A Twist Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

Device Story

The ACON Strep A Twist Rapid Test Device is a lateral flow immunochromatographic assay for qualitative detection of Group A Streptococcal antigen from throat swabs. The device uses a sandwich immunoassay principle with polyclonal antibodies to detect Strep A antigen. When antigen is present at concentrations of approximately 2.5 x 10^2 organisms per swab or greater, a visually discernible colored line appears in the test region. The test is performed at the point-of-care or in professional clinical settings by healthcare providers. The provider extracts the specimen using provided reagents, applies it to the test device, and visually interprets the colored line output after 5 minutes. The result serves as an aid in the diagnosis of Group A Streptococcal infection, allowing for rapid clinical decision-making regarding patient treatment.

Clinical Evidence

Multi-center clinical evaluation of 758 patients with pharyngitis symptoms. Compared ACON device and predicate to confirmed culture. Sensitivity was 90% (95% CI: 86-94%) and specificity was 94% (95% CI: 92-96%) against culture. Overall agreement with culture was 93% (95% CI: 91-95%). Comparison to predicate showed 94% positive agreement, 100% negative agreement, and 98% overall agreement. Cross-reactivity testing with 28 common bacterial/fungal strains showed no interference. Interfering substance testing with common throat products (cough drops, mouthwash, blood) showed no interference.

Technological Characteristics

Lateral flow immunochromatographic membrane particle assay. Uses polyclonal antibodies for sandwich immunoassay. Form factor is a rapid test device/cassette. Requires manual extraction of throat swab using provided reagents. Visual readout of colored lines. No electronic components or software. Sterilization method not specified.

Indications for Use

Indicated for professional and point-of-care use to qualitatively detect Group A Streptococcal antigen in throat swab specimens from patients presenting with signs/symptoms of pharyngitis to aid in diagnosis of Group A Strep infection.

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

• Quidel QuickVue In-Line One-Step Strep A (K954257)

Submission Summary (Full Text)

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# FEB 1 0 2003

#### Summary of Safety and Effectiveness 7.

# 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 ________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Submitter: ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121 Phone: [phone] Fax: [phone]

Date: October 31, 2002

Contact Person: Edward Tung, Ph.D.

Product Name: ACON® Strep A Twist Rapid Test Device

#### Common Name:

Immunochromatographic test for the qualitative detection of Group A Streptococcal antigen from a throat swab specimen.

### Device Classification:

The ACON Strep A Twist Rapid Test Device is similar to other FDA-cleared devices for the qualitative detection of Group A Streptococcus Antigen from throat swab specimens. These tests are used to aid in the diagnosis of Group A Streptococcus infection. (21 CFR 866.3740). Serological test systems for the detection of Group A Streptococcus antigen have been classified as Class I devices.

### Classification Name:

Streptococcus spp. Serological reagents

#### Intended Use:

The ACON Strep A Twist Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

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# Description:

The ACON® Strep A Twist Rapid Test Device is a qualitative, lateral flow immunochromatographic assay for the detection of Strep A antigen from a throat swab. The test is a heterogeneous, sandwich immunoassay, based on the principle of antigen-antibody immunochemistry, which uses a mixture of polyclonal antibodies to reliably produce a visually discernible colored line in the test region if Strep A antigen is present at a concentration of roughly 2.5 x 102 organisms per swab or greater.

# Predicate Device:

Quidel QuickVue In-Line One-Step Strep A

510(k) Number K954257

Quidel Corp. 10165 McKellar Court San Diego, California 92121

# Comparison to a Predicate Device:

A summary comparison of the features of the ACON Strep A Twist Rapid Test Device and the Quidel QuickVue In-Line One-Step Strep A is shown below.

| Feature | ACON® Strep A Twist Rapid Test Device | QuickVue In-Line One-Step Strep A |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A rapid chromatographic immunoassay for the<br>qualitative detection of Strep antigens from<br>throat swab specimens to aid in the diagnosis<br>of Group A Streptococcal infection. | The QuickVue In-Line One-Step Strep A<br>allows for the rapid detection of group A<br>streptococcal antigen directly from patient<br>throat swabs. The test is intended to use as an<br>aid in the diagnosis of group A streptococcal<br>infection. |
| Indications for Use | Professional & point of care use. | Professional & point of care use. |
| Intended Specimen | Throat Swab | Throat Swab |
| Endpoint | Colored Lines | Colored Lines |
| Materials Provided | Test Devices<br>Sterile Swabs<br>Extraction Reagents A & B<br>Positive Control (Non-viable Strep A)<br>Negative Control (Non-viable Strep C)<br>Package Insert<br>Procedure Card | Test Cassettes<br>Sterile Swabs<br>Extraction Solution bottle<br>Positive Control (Heat-inactivated Strep A)<br>Negative Control (Heat-inactivated Strep C)<br>Package Insert<br>Procedure Card<br>Extraction kit for use with Proficiency Testing<br>samples only |
| Methodology | Membrane Particle Assay | Membrane Particle Assay |
| Extraction Reagent<br>Color Reaction | Reagent A - Red Color<br>Reagent B - Clear Color<br>Combined Reagents - Yellow color | Reagent inside bottle - Clear Color<br>Reagent inside ampoule - Clear Color<br>Combined Reagents - Green color |
| Extraction Time | 1 minute | up to 1 minute |
| Test Time | 5 minutes | 5 minutes |
| Format | Immunochemical, Strep A antigen /antibody,<br>immunoassay principle | Immunochemical, Strep A antigen/antibody,<br>immunoassay principle |
| Organism detection | Strep A specific | Strep A specific |

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#### Safety and Effectiveness Data:

#### Accuracy

A multi-center clinical evaluation was conducted with specimens from 758 patients presenting with signs and symptoms of pharyngitis. This evaluation compared the result of the ACON® Strep A Twist Rapid Test Device and another commercially available Strep A test device, the QuickVue In-Line One-Step Strep A test to the customary Strep A confirmed culture technique.

In this study, there were a total of four invalid results, two with the Quidel product and two with the ACON product. These invalid results were excluded from the data analysis. The data from this study vielded the following results:

ACON Strep A Twist Rapid Test Device compared to QuickVue In-Line One-Step Strep A.

| Positive Agreement: 130/138 = 94% (89-97)* |
|----------------------------------------------|
| Negative Agreement: 375/375 = 100% (99-100)* |
| Overall Agreement: 505/513 = 98% (97-99)* |

ACON Strep A Twist Rapid Test Device compared to Strep A confirmed Culture

| Sensitivity: | |
|--------------|--|
| Specificity: | |
| Accuracy: | |

| vice compared to Strep A confirmed C |
|--------------------------------------|
| 240/265 = 90% (86-94)* |
| 464/491 = 94% (92-96)* |
| 704/756 = 93% (91-95)* |

* Denotes 95% confidence intervals

#### Sensitivity

Nine (9) different strains of Strep A were evaluated with the ACON Strep A Twist Rapid Test Device. The minimum detectable level differed slightly depending upon the strain being tested. The detection level of all of the strains was roughly within one magnitude in concentration of each other. Seven (7) strains showed a minimum detectable level at roughly 10° organisms per swab while two (2) strains showed a minimum detectable level at roughly 10 organisms per swab.

In addition, the throat swab specimens from the study that yielded beta-hemolytic colony growth were assigned a semi-quantitative value expressed as rare, 1+, 2+, 3+ or 4+. The ability of the ACON Strep A Twist Rapid Test Device to detect these various concentration levels is shown below.

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| Culture Classification | ACON/Culture | % Correct |
|------------------------------|--------------|-----------|
| Negative (Specificity) | 464/491 | 94% |
| Rare | 4/11 | 36% |
| 1+ | 16/20 | 80% |
| 2+ | 17/23 | 74% |
| 3+ | 26/29 | 90% |
| 4+ | 175/182 | 96% |
| Total Positive (Sensitivity) | 238/265 | 90% |
| Total (Overall Agreement) | 702/756 | 93% |

# Specificity

Specificity studies were conducted by individually spiking the various bacterial strains listed below on swabs at a final concentration of 1.0 x 107 org/swab, then evaluating the swabs in duplicate according to the package insert. None of the organism demonstrated any cross-reactivity in the test. The organisms tested were:

| Bordetella pertussis | Staphylococcus aureus |
|-----------------------------|----------------------------|
| Branhamella catarrhalis | Staphylococcus epidermidis |
| Candida albicans | Strep B |
| Corynebacterium diphtheriae | Strep C |
| Enterococcus durans | Strep F |
| Enterococcus faecalis | Strep G |
| Hemophilus influenzae | Streptococcus mutans |
| Klebsiella pneumoniae | Streptococcus pneumoniae |
| Neisseria gonorrhea | Streptococcus sanguis |
| Neisseria meningitidis | Streptococcus intermedius |
| Neisseria sicca | Streptococcus oralis |
| Neisseria subflava | Streptococcus mitis |
| Pseudomonas aeruginosa | Streptococcus anginosus |
| Serratia marcescens | Escherichia coli |

# Interfering Substances

No interference to an expected negative or positive result was observed in our studies when using specimens containing the following substances at a final concentration of 1% (Mucin at 1 mg/swab):

| Cherry Halls Cough Drops | Vicks Chloraseptic Spray |
|---------------------------|---------------------------|
| Menthol Halls Cough Drops | Cepacol Sore Throat Spray |
| Robitussin Cough Syrup | Listerine Mouthwash |
| Dimetapp Cough Elixir | Scope Mouthwash |
| Whole Blood at 100uL | Mucin (at 1 mg/swab) |

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# Intra and Inter-assay Variability

Studies to evaluate inter- and inter-assay variability demonstrated that the test yielded that expected results >99% of the time

#### Lot-to-Lot Variability

Studies to evaluate the manufacturability and consistency of the product on a lot-to-lot basis have shown this test to be highly reproducible.

#### Conclusion

These studies demonstrate the substantial equivalency of the ACON® Strep A Twist Rapid Test Device to the QuickVue In-Line One-Step Strep A, which is already marketed. They further demonstrate the suitability of this product for professional and point-of-care use, in addition to demonstrating its safety and effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 0 2003

Edward Tung, Ph.D. Director of Regulatory Affairs Acon Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, CA 92121

Re: k023766

Trade/Device Name: Acon® Strep A Twist Rapid Test Device Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus Spp. Serological Reagents Regulatory Class: Class I Product Code: GTY Dated: November 8, 2002 Received: November 12, 2002

Dear Dr. Tung:

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 vour 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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### Page 2 -

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE 9.

510(k) Number:

K023766

Device Name:

The ACON® Strep A Twist Rapid Test Device

Indications For Use:

The ACON® Strep A Twist Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

(Please do not write below this point) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ レ

(Per 21 CFR 801.109)

Or

Over-The-Counter Use

Freddie Jr. Pool.

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number KD23766