(219 days)
The Trinity Biotech Uni-Gold™ Strep A Test Kit is a rapid immunoassay for the qualitative detection of Streptococcal A antigen from throat swabs, or the confirmation of beta-hemolytic colonies obtained from blood agar plates.
The Trinity Biotech Uni-Gold™ Strep A Test Kit is intended for use in hospital laboratories and physicians' offices as an aid in the diagnosis of Group A Streptococcal pharyngitis.
Immunoassay: Strep A antigen, when present, binds to the anti-Strep A antibody conjugated to a gold dye. As this complex travels along the membrane, it becomes immobilized at the test region, resulting in the formation of a red line. Excess antibodygold conjugate further migrates along the membrane and binds to the control region, forming another red line. In the absence of Strep A antigen, a red line will only be formed at the control region.
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Acceptance Criteria and Device Performance Study for Uni-Gold™ Strep A Test Kit
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or percentage format. Instead, it describes analytical performance parameters that the device demonstrated. The primary "acceptance" for this 510(k) submission is substantial equivalence to the predicate device, which implies comparable performance in key areas.
| Parameter | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Uni-Gold™ Strep A Test Kit) |
|---|---|---|
| Analytical Sensitivity | Comparable to predicate device's sensitivity | 1.0 x 10^5 cells/swab |
| Analytical Specificity | No cross-reactivity with common interfering organisms | No false positives with tested organisms at 1 x 10^6 concentration (Staphylococcus aureus at 1 x 10^6 organisms) |
2. Sample Size Used for the Test Set and Data Provenance
The document focuses on analytical studies rather than clinical studies with patient samples for the test set.
- Analytical Sensitivity Test Set: Serial dilutions of S. pyogenes cultures. The exact number of dilutions or individual tests performed is not specified, only that testing continued until interpretations became "negative."
- Analytical Specificity Test Set: The sample size for the analytical specificity (cross-reactivity) test set includes 19 different organisms. For each organism, testing was performed at a concentration of approximately 1 x 10^6 (or 1 x 10^6 for Staphylococcus aureus).
- Data Provenance: The studies are described as "Laboratory studies" and did not involve human subjects. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical clinical sense. These are in-house, non-clinical evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. The studies described are analytical (laboratory-based) and do not involve human interpretation of results for establishing ground truth. The "ground truth" for analytical sensitivity was known concentrations of S. pyogenes, and for analytical specificity, the known identity and concentration of non-Strep A organisms.
4. Adjudication Method for the Test Set
This section is not applicable as the studies are analytical and do not involve human adjudication of results in the way clinical studies often do. The results (positive/negative) would be determined by the visual presence or absence of a red line.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory analytical performance, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are standalone in the sense that they evaluate the performance of the device itself (the immunoassay) without human-in-the-loop performance being a variable. The test results (red line present/absent) are interpreted directly from the device's output.
7. Type of Ground Truth Used
- Analytical Sensitivity: Known concentrations of Streptococcus pyogenes (Strep A) cultures.
- Analytical Specificity: Known identities and concentrations of various non-Strep A organisms.
8. Sample Size for the Training Set
This information is not applicable. The Uni-Gold™ Strep A Test Kit is an immunoassay (a rapid diagnostic test), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of AI development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI algorithm.
§ 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.