BINAX STREP A TEST

K960712 · Binax, Inc. · GTZ · Mar 22, 1996 · Microbiology

Device Facts

• Record ID: K960712
• Device Name: BINAX STREP A TEST
• Applicant: Binax, Inc.
• Product Code: GTZ · Microbiology
• Decision Date: Mar 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

The Binax Strep A Test is intended for in vitro diagnostic use in clinical and physician office laboratories to qualitatively detect the presence of Streptococcus pyogenes Group A antigen from throat swabs.

Device Story

Immunochromatographic membrane assay for detection of Streptococcus pyogenes Group A antigen from throat swabs. Device consists of cardboard, book-shaped hinged unit containing test strip with gold-conjugated and immobilized anti-Strep A antibodies. Operator inserts throat swab into well, adds extraction reagents, rotates swab, and closes device. Extracted antigen binds to immobilized antibody and gold-conjugate, producing visual result within 6 minutes. Used in clinical and physician office laboratories. Provides rapid qualitative results to assist healthcare providers in diagnosing Group A Streptococcal pharyngitis, facilitating timely clinical decision-making regarding antibiotic therapy.

Clinical Evidence

Clinical evaluation included 81 physician office patient samples compared to culture. Binax sensitivity 80% (vs 90% for predicates); specificity 97% (vs 96% Quidel, 95% Abbott). Analytical studies included cross-reactivity testing with 25 respiratory organisms, reproducibility testing with 6 operators, and control failure validation. Direct sensitivity comparison at 1x10^5 organisms/test showed Binax 84%, Abbott 89%, Quidel 39%.

Technological Characteristics

Immunochromatographic membrane assay. Utilizes gold-conjugated and immobilized anti-Strep A antibodies. Form factor: cardboard, book-shaped hinged device with integrated swab well and test strip. Manual extraction process. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of Streptococcus pyogenes Group A antigen from throat swabs in patients presenting with symptoms of pharyngitis in clinical and physician office laboratory settings.

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 (K934484)
• Abbott TestPack Plus (K901274)
• Abbott TestPack Plus (K922345)

Submission Summary (Full Text)

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MAR 22 1990
K900712

Binax, Inc.
*Binax Strep A Test for Streptococcus pyogenes Group A antigen*
510(k) Notification

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. The submitter of this premarket notification is

Pamela S. Angell
Binax, Inc.
217 Read Street
Portland, Maine 04103

The contact person is Pamela S. Angell.

2. The name of the device is *Binax Strep A Test*, also known as Strep A ICT. The classification name per Section 866.3740 is "Streptococcus Spp. Serological Reagents."

3. The device is substantially equivalent to Quidel QuickVue In-Line One-Step (510(k) no. K934484) and Abbott TestPack Plus (510(k) nos. K901274 & K922345) Strep A Tests.

4. The *Binax Strep A Test* is an immunochromatographic membrane assay to detect *Streptococcus pyogenes Group A antigen* from throat swabs. A test strip, containing gold-conjugated and immobilized anti-Strep A antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A throat swab is inserted into the swab well, extraction reagents are added from dropper bottles, the swab is rotated three times, and following a 1 minute incubation, the test device is closed. Extracted antigen captured by immobilized anti-Strep A antibody reacts to bind the visualizing gold-conjugate. There are no transferring steps, the sample is contained, and results are available within 6 minutes.

5. The *Binax Strep A Test* is intended for *in vitro* diagnostic use in clinical and physician office laboratories to qualitatively detect the presence of *Streptococcus pyogenes Group A antigen* from throat swabs. The indication statements are the same as those made for the predicate devices.

6. The technological characteristics of the *Binax Strep A Test* are the same or similar to those found with the predicate devices. All tests utilize antibodies specific for *Streptococcus pyogenes Group A antigen* for capture and conjugated antibody for detection. Both the *Binax Strep A Test* and the Quidel QuickVue use an on-board or in-the-device extraction of antigen. Abbott TestPack Plus requires a separate extraction step.

7. Test sensitivity and specificity were determined by testing throat swabs collected from 81 physician office patients in both the Binax test and in culture (page 35). To further demonstrate Binax test specificity, 20 culture negative samples collected

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Binax, Inc.
Binax Strep A Test for Streptococcus pyogenes Group A antigen
510(k) Notification

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

from subjects who had just consumed 1 of 2 commercially available sore throat medications (page 59) were tested in the Binax test.

Inter- and intra-site reproducibility of the Binax test was examined when 6 operators of varied educational levels each tested 60 blind coded sample swabs (page 50).

25 organisms found primarily in the throat, oropharynx, mucous membranes or respiratory tract were tested for cross-reactivity in the Binax test at $10^{7}$ organisms per test (page 56). A mucoid Streptococcus A strain was tested at $10^{5}$ organisms per test (page 56).

Finally, the ability of the Binax Strep A Test control to indicate test failure was evaluated when each of 3 operators ran 20 kit controls in a panel of 20 devices, 8 of which had been rendered inoperative. The number of defective devices and the defect itself were not apparent to the operator (page 62).

Preliminary stability studies of positive and negative control swabs and of device and extraction reagents are ongoing at various temperatures (page 67).

8. The Binax Strep A Test is substantially equivalent to both predicates when compared to the "Gold Standard" - culture. Binax, Quidel and Abbott test sensitivities, when calculated against sheep blood agar confirmed positive specimens, are substantially equivalent. Binax test sensitivity is 80%, while Abbott and Quidel are both 90% (page 12).

A direct comparison of Binax and predicate test sensitivities performed at Binax further substantiates equivalence. The Binax, Abbott and Quidel tests detected 3 x $10^{5}$ organisms per test 100%, 96% and 95% of the time, respectively. The Binax test detected 1 x $10^{5}$ organisms per test 84% of the time while the Abbott test detected this concentration of organism 89% and Quidel 39% of the time (page 66).

Binax test specificity is 97% vs. Quidel specificity of 96% and Abbott specificity of 95% (page 12).

Signed Pamela S. Angell Date 2/16/96

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