(134 days)
SPOTFIRE® RSP Positive Control is intended for use (as applicable) as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mimi, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel on the BIOFIRE SPOTFIRE System. SPOTFIRE RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, and BIOFIRE SPOTFIRE R/ST Panel assays. This product is not intended to replace manufacturer internal controls provided with these devices.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
SPOTFIRE® RSP Negative Control is intended for use (as applicable) as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel on the BIOFIRE System. SPOTFIRE RSP Negative Control is comprised of a solution that does not contain target and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, and BIOFIRE SPOTFIRE R/ST Panel assays. This product is not intended to replace manufacturer internal controls provided with these devices.
SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 readyto-use, liquid controls, SPOTFIRE RSP Positive Control (Positive Control), P/N M42638 and SPOTFIRE RSP Negative Control (Negative Control), P/N M42738. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA in the Positive Control carries RNA segments of all the respiratory and sore throat pathogens detected by the BIOFIRE SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel assays, performed on the BIOFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE RSP Pos & Neg Controls is processed separately according to the SPOTFIRE Panel assay manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs or throat swabs placed in transport media) obtained from individuals with signs and symptoms of respiratory tract infection or pharyngitis.
The provided text is a 510(k) Summary for a medical device called "SPOTFIRE RSP Pos & Neg Controls," which are quality control materials for molecular diagnostic assays. The submission is a change to an existing device (K230868) to include compatibility with a new panel, the "BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel."
The document details the device's intended use, its description, and a summary of performance data collected to demonstrate that the modified device remains substantially equivalent to its predicate.
Here's the breakdown of the acceptance criteria and study information, as requested:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Overall Correct Result Rate for the Controls | Overall Correct Result Rate: 99.7% (351 out of 351 valid results were correct). This includes both positive and negative controls across all sites (internal and external). |
| Reproducibility for Positive Control (Percent Correct) | Positive Control: 99.3% correct. (171 out of 172 valid positive control results were correct. One positive control failed due to false negative results for 4 analytes.) |
| Reproducibility for Negative Control (Percent Correct) | Negative Control: 100% correct. (179 out of 179 valid negative control results were correct.) |
| Performance at External Sites (Overall Correct Result Rate) | External Sites Overall: 99.6% correct. (224 out of 225 valid external site results were correct.) |
| Performance at Internal Site (Overall Correct Result Rate) | Internal Site Overall: 100% correct. (126 out of 126 valid internal site results were correct.) |
| Robustness across various conditions (pouch lots, operators, instruments, sites) | The study incorporated: |
- 3 control lots
- 27 pouch lots (across all sites, including one shared between internal and external)
- Multiple operators (specified as "multiple" for external sites, 4 for internal)
- Multiple instruments (specified as "multiple" for external sites, 1 for internal)
- 6 testing sites (5 external clinical sites + 1 internal MMQCI site)
- Testing over time (21 different days for internal testing) |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Total Test Results: 361 initially, with 10 invalid results that were repeated, leading to 351 valid test results used for performance analysis.
- Data Provenance:
- External Study: 232 test results collected from 5 near-patient clinical sites. The document does not specify the country of origin of these sites, but given the FDA submission, it's presumed to be in the USA. This was a prospective study as the sites were asked to follow specific protocols for testing controls during normal operations (e.g., training new operators, new kit shipments, new/repaired instruments).
- Internal Study: 129 test results collected from MMQCI's facility in Saco, Maine (USA). This was also a prospective study.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This study evaluates the performance of quality control materials for in vitro laboratory nucleic acid testing. The "ground truth" here is objective: either the control produced the expected positive result (detecting the specified analytes) or the expected negative result (no target analytes detected).
- Therefore, no human experts (like radiologists) were establishing a subjective "ground truth" diagnosis. The performance is based on whether the automated instrument correctly identifies the presence or absence of the target analytes in the control material as designed.
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Adjudication Method for the Test Set:
- Not applicable in the conventional sense of human expert discrepancies. The performance is measured against the pre-defined composition of the positive and negative control materials.
- Invalid results (instrument errors, failed internal pouch controls) were re-tested according to BioFire instructions and excluded from the "Percent Correct" analysis. This acts as a form of "adjudication" for technical failures rather than diagnostic disagreement.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This study is not evaluating a diagnostic AI algorithm that assists human readers. It's evaluating the performance of quality control materials for a molecular diagnostic assay. The "users" are laboratory professionals (or non-lab professionals in CLIA waived settings) operating the BIOFIRE SPOTFIRE System. The study assessed the reproducibility of the control materials, not the improvement of human readers with AI assistance.
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If a Standalone (algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that the control materials are processed by the BIOFIRE SPOTFIRE System, and the system's output (positive or negative detection of specific analytes) is compared against the known composition of the control. The "human-in-the-loop" would be the technician performing the test, but their role is to follow instructions, not to interpret complex images or data subjectively.
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The Type of Ground Truth Used:
- The ground truth is the known, manufactured composition of the control materials.
- Positive Control: Contains synthetic RNA transcripts for all target respiratory and sore throat pathogens. The ground truth is that these specific targets should be detected by the assay.
- Negative Control: Contains buffer and preservatives with no RNA targets. The ground truth is that no target analytes should be detected.
- The ground truth is the known, manufactured composition of the control materials.
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The Sample Size for the Training Set:
- Not applicable. This device is a quality control material, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development. The control materials are manufactured to a specific design.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for an AI/ML model. The ground truth for the control materials is inherent in their design and manufacturing process.
§ 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.”