(63 days)
The BD MAX™ CT/GC/TV 20-Day QC Panel is intended for use as an external assayed positive quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis with the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The controls comprise cultured and inactivated C. trachomatis, N. qonorrhoeae and T. vaqinalis.
The BD MAX CT/GC/TV™ 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.
The BD MAX™ CT/GC/TV 20-Day QC Panel is used to monitor the extraction, amplification and detection of the BD MAX™ CT/GC/TV Assay. The BD MAX™ CT/GC/TV 20-Day QC Panel contains authentic pathogens inactivated by radiological and temperature treatments. Each BD MAX™ CT/GC/TV 20-Day QC Panel consists of 20 individually packaged positive control pellets in a heat-sealed foil pouch. Each individually packaged pellet consists of inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis pathogens as well as preservatives and stabilized pellet containing inactivated organism(s) is packaged in a 2.0ml labeled micro-centrifuge tube with a red screw cap.
The document describes the BD MAX CT/GC/TV 20-Day QC Panel, an assayed quality control material for clinical microbiology assays. The provided information focuses on the device's performance in a precision and reproducibility study, which serves to demonstrate its functionality and reliability.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly demonstrated by the reported agreement percentages. While explicit "acceptance criteria" values (e.g., "must achieve >95% agreement") are not stated as such, the results show near-perfect agreement, suggesting these values implicitly meet the necessary performance for clearance.
| Analyte | Acceptance Criteria (Implicit) | Reported Device Performance (Agreement %) |
|---|---|---|
| C. trachomatis | (High agreement expected) | 100% |
| N. gonorrhoeae | (High agreement expected) | 99% |
| T. vaginalis | (High agreement expected) | 100% |
Study Proving Device Meets Acceptance Criteria:
A "precision and reproducibility study" was conducted to demonstrate device performance.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For each analyte (C. trachomatis, N. gonorrhoeae, T. vaginalis), a total of 90 tests were performed (30 tests at each of 3 sites).
- This is calculated as: 3 sites * 2 operators/site * 3 lots tested/operator * 5 days/operator = 90 tests per analyte.
- Data Provenance: The study was conducted across three different testing locations. The exact countries are not specified, but the submission is to the U.S. FDA, implying the study was likely conducted in the US or in a manner compliant with US regulatory requirements. The study was prospective as it involved a planned experimental setup to test the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (quality control material for molecular assays) does not typically involve human expert interpretation of results to establish "ground truth" in the way an imaging AI algorithm would. For this device, the "ground truth" is the expected positive result based on the biological composition of the quality control material. The "experts" in this context would be the microbiologists and laboratory personnel who handle the molecular assays and interpret the objective quantitative or qualitative output from the BD MAX™ System. Their qualifications are inherent in their roles as laboratory operators capable of running and interpreting the BD MAX™ CT/GC/TV Assay.
4. Adjudication Method for the Test Set
Not applicable in the traditional sense for this device. The results are objective outputs from the BD MAX™ System (positive or negative detection). The document notes: "Three Unresolved results were obtained; in all cases a new control was retested and the expected results were obtained." This indicates a re-testing protocol for ambiguous results, but not an "adjudication" between conflicting human interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers are interpreting images or data. This device is a quality control material that produces objective results via a molecular diagnostic system. The study focused on the reproducibility of the device itself across different operators, sites, and lots.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence, the performance study is a "standalone" evaluation of the quality control device's ability to consistently produce expected results when processed by the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The performance measured is the agreement of the QC panel with its known positive state when run on the automated system. Human operators initiate the test and record results, but their primary role is execution, not interpretation of a complex output requiring subjective judgment.
7. The Type of Ground Truth Used
The ground truth is based on the known composition of the quality control material. The BD MAX™ CT/GC/TV 20-Day QC Panel contains inactivated C. trachomatis, N. gonorrhoeae, and T. vaginalis pathogens. Therefore, the expected (ground truth) result for each test of the QC panel is "positive" for these analytes. The study explicitly states it "does not include a negative control," further confirming its intended use as a positive control.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a training set. Its "performance" is its ability to consistently yield a positive result when run on a specific molecular diagnostic system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 866.3920 Assayed quality control material for clinical microbiology assays.
(a)
Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”