(30 days)
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No
The device description details a simple immunochromatographic assay with no mention of computational analysis, image processing, or any terms related to AI/ML. The performance studies focus on traditional laboratory testing metrics.
No.
The device is intended for in vitro diagnostic use to detect the presence of Streptococcus pyogenes Group A antigen, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Binax Strep A Test is intended for in vitro diagnostic use."
No
The device description clearly outlines a physical immunochromatographic membrane assay with a test strip, swab well, and extraction reagents, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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 pyoqenes Group A antigen from throat swabs."
This statement directly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / 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 pyoqenes Group A antigen from throat swabs. The indication statements are the same as those made for the predicate devices.
Product codes
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Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
throat swabs
Indicated Patient Age Range
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Intended User / Care Setting
clinical and physician office laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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 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 test (page 56). A mucoid in the Binax test at 107 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).
Summary of Performance Studies
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 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 test (page 56). A mucoid in the Binax test at 107 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).
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 105 organisms per test 100%, 96% and 95% of the time, respectively. The Binax test detected 1 x 105 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).
Key Metrics
Binax test sensitivity is 80%.
Binax test specificity is 97%.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3740
Streptococcus spp. serological reagents.(a)
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 identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
MAR 22 996
Binax, Inc. Binax Strep A Test for Streptococcus pyogenes Group A antigen 510(k) Notification
K96071a
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.
- 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.
-
- 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."
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- 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.
-
- 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 pyoqenes Group A antigen from throat swabs. The indication statements are the same as those made for the predicate devices.
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- 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.
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- 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
1
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 test (page 56). A mucoid
in the Binax test at 107 organisms per test (page 56). A mucoid 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 neqative control swabs and of device and extraction reagents are ongoing at various temperatures (page 67).
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- 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 105 organisms per test 100%, 96% and 95% of the time, respectively. The Binax test detected 1 x 105 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).
- 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).
Binax test specificity is 97% vs. Quidel specificity of 96% and Abbott specificity of 95% (page 12).
| Signed | Pamela S. Angell | Date 21/6/94 |
|---|---|---|
| Pamela S. Angell |