(15 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, Adenovirus, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, 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 (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® 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 SPOTFIRE R Panel and the SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.
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, Adenovirus, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, 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 (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Negative Control is comprised of a solution that does not contain target analytes and is designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 separate kits of ready-to-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 pathogens detected by the SPOTFIRE R Panel (Table 1) and SPOTFIRE R Panel Mini (Table 2) on the SPOTFIRE System and is specifically designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays on the SPOTFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE RSP Pos & Neg Controls, P/N M425, is processed separately according to the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assay manufacturer's Instructions for Use for Quality Control testing.
This document describes a 510(k) premarket notification for a change to an existing device, the SPOTFIRE® RSP Pos & Neg Controls. The change specifically involves including the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE R Panel Mini) in the device's intended use. As such, the presented information focuses on demonstrating substantial equivalence rather than a detailed de novo device performance study.
Based on the provided text, the device in question is an "Assayed Quality Control Material For Clinical Microbiology Assays". The performance data presented in the 510(k) submission (K221253) for the original device is deemed sufficient to support the change, meaning no new performance data specific to this submission (K230868) was generated.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states: "No additional performance data are required as the SPOTFIRE RSP Pos & Neg Controls have not been changed, the assay consumables are identical for the SPOTFIRE R Panel used to collect original performance data and the SPOTFIRE R Panel Mini added to the intended use of the device. In addition, the targets reported in the SPOTFIRE R Panel Mini are a subset of the SPOTFIRE R Panel."
This indicates that the performance of the control material (SPOTFIRE® RSP Pos & Neg Controls) with the SPOTFIRE R Panel Mini is expected to be consistent with its performance on the broader SPOTFIRE R Panel, for which performance data was previously submitted and accepted under K221253.
Therefore, the table of acceptance criteria and reported device performance from the original K221253 submission would be relevant, but those details are not provided in this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No new test set was used for this specific 510(k) submission (K230868). The submission relies on performance data from the previous submission (K221253). The document does not provide details of the sample size or data provenance from K221253.
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. As this submission is for a quality control material and not an AI/ML diagnostic algorithm relying on expert interpretation of images, the concept of "experts establishing ground truth" in the same manner as for image-based diagnostics is not directly applicable. For a quality control material, the ground truth is typically established by the known composition of the control material itself (e.g., presence or absence of specific RNA transcripts).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no new test set requiring adjudication of interpretations was presented in this submission.
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, not an AI/ML diagnostic tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device operates as a control for an in vitro diagnostic test, not as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a quality control material like the SPOTFIRE® RSP Pos & Neg Controls, the ground truth is the defined composition of the control material itself.
- Positive Control: Contains "in vitro RNA transcripts" of the target pathogens. So, the ground truth for the positive control is the presence of these specific RNA transcripts.
- Negative Control: Comprised of a "solution that does not contain target analytes." So, the ground truth for the negative control is the absence of the target analytes.
8. The sample size for the training set:
Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
Summary of Device Acceptance & Study Information (Based on the Provided Text):
The acceptance of K230868 is based on demonstrating substantial equivalence to the previously cleared predicate device (K221253). The core argument for acceptance is that:
- The SPOTFIRE® RSP Pos & Neg Controls have not been physically changed.
- The assay consumables for the original SPOTFIRE R Panel and the newly included SPOTFIRE R Panel Mini are identical.
- The targets detected by the SPOTFIRE R Panel Mini are a subset of those included in the SPOTFIRE R Panel, which was already covered by the previous clearance.
Therefore, the performance data previously submitted for K221253 is considered sufficient and no new performance studies specific to the addition of the SPOTFIRE R Panel Mini were required for this submission. The "study that proves the device meets the acceptance criteria" refers to the previously conducted and accepted studies for K221253, the details of which are not included in this document.
§ 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.”