(159 days)
The CARDS Q.S. Strep A/Concise Performance Plus Strep A is a sensitive immunoassay for the qualitative detection of group A streptococcal antigen from throat swab specimens. This test is to be used to aid in the diagnosis of diseases caused by group A Streptococcus. The test is for use by health care professionals.
The device, CARDS Q.S. Strep A (also sold under the brand name Concise Performance Plus Strep A), is similar to other FDA-cleared devices used for the qualitative detection of group A streptococcal antigen from throat swab specimens, thereby aiding in the diagnosis of diseases caused by group A Streptococcus. To perform the test, a throat swab specimen is collected. Antigen is extracted from the swab specimen with Reagents A and B. The extracted sample is added to the Reaction Unit. If the sample contains strep A antigen, a pink vertical line forms in the Read Result Window. This pink vertical line, together with the pre-printed blue horizontal line, form a plus sign (+) to indicate a positive result. If strep A antigen is not present in the sample, the Read Result Window shows only the pre-printed blue horizontal line, forming a minus sign (-) to indicate a negative result. As the sample continues to move through the test, the procedural Control Window containing strep A antigen becomes pink. Pink color in the Control Window confirms that the test is functionally active and has been performed correctly. The appearance of blue color in the Test Complete Window indicates the completion of the test. This occurs within approximately 5 minutes of adding the extracted sample to the Reaction Unit.
{
"acceptance_criteria_and_performance": {
"table": [
{
"criterion": "Clinical performance relative to standard culture techniques",
"device_performance": "Not explicitly stated with numerical values for sensitivity, specificity, etc. The document generally states 'excellent intra- and inter-assay precision' and 'reproducibly manufacturable', and concludes 'substantial equivalence' to existing products. Further detail is needed for a comprehensive table."
},
{
"criterion": "Accuracy and reproducibility by office personnel with diverse educational backgrounds",
"device_performance": "Office personnel could perform the test accurately and reproducibly."
},
{
"criterion": "Non-interference by common bacterial microorganisms and potentially interfering substances",
"device_performance": "Common bacterial microorganisms and potentially interfering substances were shown not to interfere with the test's performance."
}
],
"study_details": {
"sample_size_test_set": "Not specified for the multi-center evaluation. 'Numerous studies' were undertaken.",
"data_provenance": "Multi-center evaluation: Not explicitly stated, but physicians' office studies were performed at three geographically distinct sites in the United States, implying US data. Retrospective or prospective not specified.",
"number_of_experts_ground_truth_test_set": "Not specified. Ground truth for the multi-center evaluation was 'standard culture techniques', not expert consensus.",
"qualifications_experts_ground_truth_test_set": "Not applicable as ground truth was culture-based.",
"adjudication_method_test_set": "Not applicable.",
"mrmc_comparative_effectiveness_study": "No, this is a diagnostic immunoassay, not an AI-assisted interpretation device for human readers.",
"standalone_performance_done": "Yes, 'A multi-center evaluation of the CARDS Q.S. Strep A/Concise Performance Plus Strep A test was conducted to determine the clinical performance of the test relative to standard culture techniques'. This describes standalone performance.",
"type_of_ground_truth": "Standard culture techniques were used for ground truth in the multi-center clinical evaluation.",
"sample_size_training_set": "Not applicable. This is not an AI/ML device that requires a training set in the conventional sense.",
"ground_truth_establishment_training_set": "Not applicable."
}
}
}
§ 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.