(91 days)
FilmArray BCID2 Control Panel M416 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 antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faccalis, Enterococcus faccium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire® Blood Culture Identification 2 (BCID2) Panel on the FilmArray® systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device.
FilmArray BCID2 Control Panel M416, P/N M416, is a quality control panel consisting of 2 controls, FilmArray BCID2 Positive Control, P/N M41718, and FilmArray BCID2 Negative Control. P/N M41818. The Positive Contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire® Blood Culture Identification 2 (BCID2) Panel assay (see Table 1. below) on the FilmArray systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray BCID2 Control Panel M416 is processed separately according to BioFire BCID2 Panel assay manufacturer's Instructions for Use for patient samples (positive blood cultures) obtained from individuals suspected of sepsis. Each tube of contains sufficient liquid for a single use.
This document describes the FilmArray BCID2 Control Panel M416, an assayed quality control device. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall correct result rate of 98.4% for Reproducibility study | Overall Correct Result Rate: 98.4% (300 correct results out of 305 valid tests) Details from Table 2:- Correct Positive Control Result: 150 - Incorrect Positive Control Result: 5 (96.8% correct for positive controls)- Correct Negative Control Result: 150- Incorrect Negative Control Result: 0 (100.0% correct for negative controls)- Invalid Results: 2 (excluded from percentage calculation, re-tested per BioFire instructions) Total Tests: 307 |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 307 total tests were performed for the reproducibility study. After excluding 2 invalid results, 305 valid tests were used for the percentage calculation.
- Internal Testing (MMQCI): 122 tests (20 samples * 3 lots, with 2 repeats)
- External Testing (3 Clinical Laboratories): 186 tests (10 samples * 3 lots * 3 sites, with 6 repeats)
- Data Provenance: The study involved both internal testing at MMQCI (Saco, Maine, USA) and external testing at 3 CLIA-certified clinical laboratories. The study was prospective in nature, as new lots of the control panel were manufactured and then tested according to a predefined protocol.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The device is a quality control material for nucleic acid testing, which typically has an objective ground truth based on the known composition of the synthetic DNA targets. The performance is assessed against the expected positive or negative result for each control.
4. Adjudication method for the test set
This information is not explicitly provided. Given the nature of a quality control material, the results are expected to be either positive or negative for predefined analytes. "Incorrect" results (positive controls) were retested, and those retested correctly are not included in the main performance summary (e.g., "The incorrect Positive controls were all correct upon retesting."). This suggests a form of retesting for discrepant results, rather than an expert adjudication panel.
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 document describes a quality control material for in vitro diagnostic assays, not an AI-powered diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This device is a quality control material, not an algorithm. Its performance is evaluated by its ability to elicit the correct positive or negative response from the BioFire BCID2 Panel assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this quality control material is known composition.
- Positive Control: Contains synthetic DNA corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected by the BioFire BCID2 Panel assay. Therefore, the expected ground truth for the positive control is the detection of all these targets.
- Negative Control: Contains only buffers, stabilizers, and preservatives. The expected ground truth for the negative control is the absence of any detected targets.
8. The sample size for the training set
Not Applicable. This device is a quality control material, not a machine learning algorithm that requires a training set. Its manufacturing and testing involve standard analytical performance studies.
9. How the ground truth for the training set was established
Not Applicable. As explained above, there is no training set for this type of 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.”