(582 days)
BioFire JI Control Panel M420 is intended for use as an external positive assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finezoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire II Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire II Panel assay. This product is not intended to replace manufacturer controls provided with the device.
BioFire JI Control Panel M420, P/N M420, is a quality control panel consisting of 2 controls, BioFire JI Positive Control, P/N M42118, and JI Negative Control, P/N M42218. The Positive Control 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® Joint Infection (JI) Panel assay (see Table 1. below) on the BioFire® systems. The Negative Control contains buffers, stabilizers and preservatives. Each liquid control of BioFire JI Control Panel M420 is processed separately according to the BioFire JI Panel assay manufacturer's Instructions for Use for patient samples (synovial fluid) obtained from individuals suspected of infection. Each tube of control contains sufficient liquid for a single use.
The provided text describes a 510(k) premarket notification for the BioFire JI Control Panel M420, a quality control material. The study demonstrates the reproducibility of this control panel.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Correct Result Rate | 100% |
| Correct Positive Control Result Rate | 100% |
| Correct Negative Control Result Rate | 100% |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Combined Reproducibility Study: 301 tests (1 Invalid result was repeated and not included in correct analysis, leading to 300 correct results analyzed).
- External Site Testing: 181 tests (1 Invalid result was not included in percent correct analysis, leading to 180 valid results analyzed).
- Internal Site Testing (MMQCI): 120 tests.
- Data Provenance: The study involved both internal (MMQCI, Saco, Maine, USA) and external sites (3 CLIA-certified clinical sites, likely within the US given the FDA submission context). The data is prospective, generated specifically for this performance evaluation.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a ground truth for the test set. Instead, the performance of the control panel is evaluated against its expected positive or negative detection for each target, as designed by the manufacturer (Maine Molecular Quality Controls, Inc.). The BioFire JI Control Panel M420 itself is intended to be an external control for an in vitro laboratory nucleic acid testing procedure (BioFire JI Panel assay).
4. Adjudication Method for the Test Set
No adjudication method is described for the test set. The results are straightforward positive or negative detections as determined by the BioFire JI Panel assay. "Correct" results are based on whether the assay detected what was designed to be in the positive control or did not detect anything in the negative control.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with or without AI assistance. This study focuses on the performance of a quality control material and not on human interpretation or AI assistance.
6. Standalone (Algorithm Only) Performance
This study is inherently a standalone performance evaluation of the BioFire JI Control Panel M420 in combination with the BioFire JI Panel assay. The control panel itself is a diagnostic device (quality control material), not an algorithm. The performance described is the control material's ability to consistently elicit the expected results from the BioFire JI Panel assay.
7. Type of Ground Truth Used
The ground truth used is the expected composition of the BioFire JI Control Panel M420. The Positive Control is "composed of synthetic DNA specifically designed for" and contains "nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire® Joint Infection (JI) Panel assay." The Negative Control is designed to contain "buffers, stabilizers and preservatives" but no target nucleic acid. The "correct" result for each test is predefined based on this engineered composition.
8. Sample Size for the Training Set
This document describes the performance evaluation of a quality control material and does not mention a "training set" in the context of an algorithm or machine learning model.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in this context. The control panel is a manufactured product with a defined composition that serves as its inherent ground truth for validation.
§ 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.”