(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."
}
}
}
{0}------------------------------------------------
XI. SUMMARY OF SAFETY AND EFFECTIVENESS
APR 1 5 1996
Product:
CARDS® Q.S.® Strep A; or Concise® Performance Plus™ Strep A
Distributor:
Pacific Biotech, Incorporated a subsidiary of QUIDEL Corporation 10165 McKellar Court San Diego, CA 92121
Device Classification:
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. The FDA has proposed that serological tests systems for the identification of group A Streptococcus from clinical specimens be classified as Class I.
Intended Use:
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.
Physiologic Basis for the Test:
Group A Streptococci are organisms that typically cause illness such as tonsillitis, pharyngitis and scarlet fever. If untreated, these infections can lead to complications such as rheumatic fever and glomerulonephritis.
Principle of the Test:
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.
{1}------------------------------------------------
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.
Safety and Effectiveness:
Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to other commercially available products for qualitative detection of group A streptococcal antigen. These studies included the following:
-
- The test was shown to be similar to other commercially distributed tests in terms of features and intended use.
-
- The test was shown to have excellent intra- and inter-assay precision.
-
- Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable.
-
- Common bacterial microorganisms and potentially interferring substances were shown not to interfere with the test's performance.
-
- 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 to establish substantial equivalence.
{2}------------------------------------------------
-
- Physicians' Office studies were conducted to show that office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. These studies were performed at three geographically distinct sites in the United States.
-
- Stability studies are underway to establish the shelf-life of the product as well as its optimal storage and shipping conditions.
Conclusion:
These studies demonstrated the substantial equivalence of the CARDS Q.S. Strep A/Concise Performance Plus Strep A to existing products already marketed. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
§ 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.