(615 days)
NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol CandidaTV Positive Control is a qualitative control containing intact and inactivated Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
NATtrol™ BD MAX Vaginal Panel External Controls are formulated with purified, intact microorganisms that have been chemically modified to render them non-infectious and refrigerator stable. The controls are formulated in a proprietary matrix that contains Fetal Bovine Serum, Human Serum Albumin, and sodium azide.
NATtrol™ BV Positive Control contains intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence.
NATtrol™ Candida/TV Positive Control contains intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis.
NATtrol™ BV Negative Control contains intact and inactivated Lactobacillus crispatus.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NATtrol™ BD MAX Vaginal Panel External Controls.
Disclaimer: The provided text is a 510(k) Summary for a medical device (Assayed Quality Control Material). This type of device does not involve "AI" or "human readers" in the context of diagnostic interpretation. Therefore, sections related to AI/human reader performance, multi-reader multi-case studies, and specific expert qualifications/adjudication methods are not applicable to this type of product and will be marked as such. The "ground truth" here refers to the expected qualitative result for the control material based on its composition.
1. Table of Acceptance Criteria and Reported Device Performance
| Control Type | Target | Acceptance Criteria (Expected Result) | Reported Device Performance (BD MAX Result - Observed/Total) | % Agreement with Expected Results (95% CI) |
|---|---|---|---|---|
| BV Positive Control | BV | Positive | Positive (84/86) | 97.7% (91.9%-99.4%) |
| C group | Negative | Negative (86/86) | 100% (95.7%-100%) | |
| C. krusei | Negative | Negative (86/86) | 100% (95.7%-100%) | |
| C. glabrata | Negative | Negative (86/86) | 100% (95.7%-100%) | |
| TV | Negative | Negative (86/86) | 100% (95.7%-100%) | |
| Candida/TV Positive Control | BV | Negative | Negative (102/104) | 98.1% (93.3%-99.5%) |
| C group | Positive | Positive (103/104) | 99.0% (94.8%-99.8%) | |
| C. krusei | Positive | Positive (103/104) | 99.0% (94.8%-99.8%) | |
| C. glabrata | Positive | Positive (103/104) | 99.0% (94.8%-99.8%) | |
| TV | Positive | Positive (103/104) | 99.0% (94.8%-99.8%) | |
| BV Negative Control | BV | Negative | Negative (191/191) | 100% (98.0%-100%) |
| C group | Negative | Negative (189/191) | 99.0% (96.3%-99.7%) | |
| C. krusei | Negative | Negative (191/191) | 100% (98.0%-100%) | |
| C. glabrata | Negative | Negative (191/191) | 100% (98.0%-100%) | |
| TV | Negative | Negative (191/191) | 100% (98.0%-100%) |
Study Details:
2. Sample size used for the test set and the data provenance
- BV Positive Control: 86 tests (total observations for each target).
- Candida/TV Positive Control: 104 tests (total observations for each target).
- BV Negative Control: 191 tests (total observations for each target).
- Data Provenance: Single site performance study, retrospective (data collected during multiple studies). The country of origin is not explicitly stated, but the sponsor address is Buffalo, NY, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of quality control material, the "ground truth" is based on the known composition of the control and the expected qualitative result (positive/negative) for each target when tested on the BD MAX System. It does not involve expert interpretation or consensus on clinical samples.
4. Adjudication method for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a quality control material for an in vitro diagnostic (nucleic acid testing) system, not an AI software or a device interpreted by human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is framed for AI/algorithm performance. In the context of this device, the "standalone" performance is essentially what is reported: the control material's behavior when run on the BD MAX System as intended. The BD MAX System itself is an automated diagnostic platform, so the control material is tested by the algorithm/system without human interpretative input beyond setting up the test correctly. Therefore, the reported performance is the standalone performance of the control material with the BD MAX system.
7. The type of ground truth used
- Known Composition / Expected Qualitative Result: The positive and negative ground truths for each target for each control were established by the known composition of the control material (e.g., BV Positive Control contains Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and BVAB2 sequence, so it's expected to be positive for BV and negative for the other targets).
8. The sample size for the training set
- Not applicable. This device itself is a quality control material; it is not an algorithm that requires a training set in the conventional machine learning sense. The manufacturer would have developed and optimized the control formulation, but there isn't a "training set" like for a diagnostic algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.”