(89 days)
FilmArray Warrior Control Panel M290 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bacillus anthracis (Chromosomal element, pXO1, Coxiella burnetii, Francisella tularensis, Yersinia pestis, Ebola virus and Marburg virus on the FilmArray NGDS Warrior Panel performed on FilmArray 2.0 systems. FilmArray Warrior Control Panel M290 is composed of synthetic DNA specifically designed for and intended to be used solely with the FilmArray NGDS Warrior Panel assay. This product is not intended to replace manufacturer internal FilmArray NGDS Warrior Panel controls provided with the device.
FilmArray Warrior Control Panel M290, P/N M290, is a quality control panel consisting of 2 controls, FilmArray Warrior Positive Control, P/N M291 and FilmArray Warrior Negative Control, P/N M292. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA carries segments of all biothreat agents detected by the FilmArray NGDS Warrior Panel assay (Table 1. below) on FilmArray 2.0 systems. The Negative Control is comprised of non-specific DNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray Warrior Control Panel M290 is processed separately according to FilmArray NGDS Warrior Panel assay manufacturer's Instructions for Use for Blood Samples.
The document describes the performance study for the FilmArray Warrior Control Panel M290, an assayed quality control material for clinical microbiology assays.
Here's the breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document implies an acceptance criterion for "Percent Correct" results of 95% or greater for the external clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance (Table 2: All Sites) |
|---|---|
| External Site Performance: | 99.4% Total Correct Results |
| Percent Correct Positive Control ≥ 95% | 98.8% |
| Percent Correct Negative Control ≥ 95% | 100% |
2. Sample Size and Data Provenance
Test Set (External Study):
- Total Tests: 310 (163 positive controls, 147 negative controls)
- Data Provenance: Retrospective and prospective. The study was conducted over 6 months at 5 clinical laboratory sites, incorporating 12 unique pouch lots and multiple operators. The document does not specify countries of origin, but "clinical laboratory sites" typically refers to facilities within the country of the product's intended market (USA, based on FDA review).
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a quality control material, not an AI or diagnostic device that requires expert interpretation for establishing ground truth. The "ground truth" for the controls is their known composition (positive for specific pathogens, negative for all pathogens).
4. Adjudication Method
Not applicable, as this is a quality control material with known positive and negative components, not a diagnostic device requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This study focuses on the performance of a quality control material in monitoring the FilmArray NGDS Warrior Panel assay, not on the effectiveness of human readers, with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire study describes the performance of the FilmArray Warrior Control Panel M290 itself, demonstrating its ability to produce expected positive and negative results when run on the FilmArray NGDS Warrior Panel.
7. Type of Ground Truth Used
Known Composition: The ground truth is the known synthetic DNA composition of the positive and negative control panels.
- Positive Control: Contains synthetic DNA segments for all biothreat agents detected by the FilmArray NGDS Warrior Panel assay (Bacillus anthracis: Chromosomal element, pXO1, pXO2, Coxiella burnetii, Francisella tularensis, Yersinia pestis, Ebola virus and Marburg virus).
- Negative Control: Comprised of non-specific DNA.
8. Sample Size for the Training Set
Not applicable. This is a quality control material, not a machine learning model, so there is no "training set" in the traditional sense. The controls are designed with known compositions to test the performance of a diagnostic assay.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set. The ground truth for the control material itself is based on its manufactured composition.
§ 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.”