(126 days)
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No
The device description and performance studies indicate a traditional immunoassay, with no mention of AI/ML or related concepts.
No
This device is an in vitro diagnostic test kit used for qualitative detection of strep antigen; it does not provide therapy.
Yes
The device is described as an "immunoassay in vitro diagnostic test kit" and performs "qualitative detection of group A strep antigen from throat swabs," which is a diagnostic function.
No
The device description explicitly states it is a "solid phase migratory chromatography immunoassay in vitro diagnostic test kit," which is a hardware-based test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: It explicitly states "qualitative detection of group A strep antigen from throat swabs". This describes a test performed on a biological sample (throat swab) outside of the body to diagnose a condition (presence of group A strep antigen).
- Device Description: It is described as a "solid phase migratory chromatography immunoassay in vitro diagnostic test kit". The term "in vitro diagnostic test kit" directly identifies it as an IVD.
These two points are sufficient to confirm that the device is an IVD.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
Excel OneStep Group A Strep Antigen Module Test is Excel Scientific, Inc.'s name for the professional use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of group A strep antigen from throat swabs. During correlation studies, prior to using the Excel OneStep Group A Strep Antigen assay, each throat swab was used to incculate a sheep blood (trypticase) soy agar plate for culture. Group A Streptococci were confirmed by a latex agglutination assay (a commercially available strep grouping kit from Diagnostic Product Corporation, Los Angeles, CA). The exact difference between the two methodologies are as follows:
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- The Excel OneStep Group A Strep Antigen Module Test utilizes the chemical extraction of a carbohydrate antigen from group A streptococcus from the throat swabs followed by the utilization of migratory color immunoassay technology for the qualitative detection of group A streptococcus. The test module has two polyclonal antibodies , one immobilized on the porous membrane, while the other antibody on an absorbent near the sample application is conjugated with colloidal gold particles as signaling molecules. A swab specimen taken from a patient's throat is treated with a fresh mixture of Reagent A and Reagent B to extract out the group A streptococcus antigen. The extract is then transferred to the reaction module with the aid of a transfer pipette and allowed to migrate throughout the absorbent and porous membrane in the reaction module by capillary action until it reaches the opposite end of the read window (in approximately 6~7 minutes). The antibody-antibody/colloidal gold double antibody sandwich assay is formed if strep A antigen is present in the throat swab. If two colored lines develop in the read zone, one in the test zone and the other in the control zone, the presence of strep A antigen is indicative. The absence of this antigen will result in only a single color line located in the control zone in the read window. The appearance of a single colored line for negative specimens also gives an added measure of quality control by demonstrating antibody recognition, assuring that the procedure was performed correctly and that the reagents are chemically active. A drying agent is enclosed with the reaction module in a sealed foil pouch to ensure the stability of the reactive reagents.
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- In the culturing procedure, isolation of streptococcal group A organisms includes the use of culture plates followed by a confirmation assay (such as DPC's latex agglutination strep grouping kit) for strep A. A sheep blood (trypticase) soy agar plate (containing 5% or 10% sheep blood) is used for the cultivation and isolation of microorganisms from the throat swabs and for visualizing hemolytic reactions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
throat swabs
Indicated Patient Age Range
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Intended User / Care Setting
professional use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
Image /page/0/Picture/0 description: The image shows the word "EXCEL" in bold, white letters against a black, rounded rectangle. Below the rectangle, there is a phrase that begins with "Commitment to Excellence". The text is smaller than the word "EXCEL" and appears to be a tagline or motto associated with the brand or concept represented by the word "EXCEL".
OCT - 7 1996
Summary of Safety and Effectiveness
Excel OneStep Group A Strep Antigen Module Test
Excel OneStep Group A Strep Antigen Module Test is Excel Scientific, Inc.'s name for the professional use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of group A strep antigen from throat swabs. During correlation studies, prior to using the Excel OneStep Group A Strep Antigen assay, each throat swab was used to incculate a sheep blood (trypticase) soy agar plate for culture. Group A Streptococci were confirmed by a latex agglutination assay (a commercially available strep grouping kit from Diagnostic Product Corporation, Los Angeles, CA). The exact difference between the two methodologies are as follows:
-
- The Excel OneStep Group A Strep Antigen Module Test utilizes the chemical extraction of a carbohydrate antigen from group A streptococcus from the throat swabs followed by the utilization of migratory color immunoassay technology for the qualitative detection of group A streptococcus. The test module has two polyclonal antibodies , one immobilized on the porous membrane, while the other antibody on an absorbent near the sample application is conjugated with colloidal gold particles as signaling molecules. A swab specimen taken from a patient's throat is treated with a fresh mixture of Reagent A and Reagent B to extract out the group A streptococcus antigen. The extract is then transferred to the reaction module with the aid of a transfer pipette and allowed to migrate throughout the absorbent and porous membrane in the reaction module by capillary action until it reaches the opposite end of the read window (in approximately 6~7 minutes). The antibody-antibody/colloidal gold double antibody sandwich assay is formed if strep A antigen is present in the throat swab. If two colored lines develop in the read window, one in the test zone and the other in the control zone, the presence of strep A antigen is indicative. The absence of this antigen will result in only a single color line located in the control zone in the read window. The appearance of a single colored line for negative specimens also gives an added measure of quality control by demonstrating antibody recognition, assuring that the procedure was performed correctly and that the reagents are chemically active. A drying agent is enclosed with the reaction module in a sealed foil pouch to ensure the stability of the reactive reagents.
-
- In the culturing procedure, isolation of streptococcal group A organisms includes the use of culture plates followed by a confirmation assay (such as DPC's latex agglutination strep grouping kit) for strep A. A sheep blood (trypticase) soy agar plate (containing 5% or 10% sheep blood) is used for the cultivation and isolation of microorganisms from the throat swabs and for visualizing hemolytic reactions.