K202196 · Maine Molecular Quality Controls, Inc. · PMN · Jun 24, 2021 · Microbiology
Device Facts
Record ID
K202196
Device Name
BioFire RP2.1/RP2.1plus Control Panel M441
Applicant
Maine Molecular Quality Controls, Inc.
Product Code
PMN · Microbiology
Decision Date
Jun 24, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3920
Device Class
Class 2
Indications for Use
BioFire RP2.1/RP2.1plus Control Panel M441 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 Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1 plus) and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays performed on BioFire FilmArray® systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1, BioFire RP2.1plus and BioFire RP2.1-EZ assays. This product is not intended to replace manufacturer controls provided with the device.
Device Story
BioFire RP2.1/RP2.1plus Control Panel M441 consists of two ready-to-use liquid controls: a positive control containing synthetic RNA transcripts of respiratory pathogens and a negative control containing buffer/preservatives. Used in clinical laboratories to monitor the qualitative amplification, detection, and identification steps of BioFire Respiratory Panel 2.1, 2.1plus, and 2.1-EZ assays on BioFire FilmArray systems. The control is processed identically to patient nasopharyngeal swab samples in Viral Transport Media. Healthcare providers use the control results to verify the performance of the nucleic acid testing procedure. Successful detection of the control targets confirms the assay is functioning correctly, ensuring reliable patient test results.
Clinical Evidence
No clinical data. Bench testing only. External and internal precision studies were conducted using three lots of control material and three lots of assay pouches on FilmArray 2.0 and Torch systems. Results showed 100% agreement with expected results for both positive and negative controls. Crossing point (Cp) values demonstrated acceptable reproducibility across operators, days, and lots. Stability studies confirmed 24-month shelf life at -20°C and stability after shipping delays.
Technological Characteristics
Ready-to-use liquid control. Positive control: synthetic RNA transcripts in buffer, stabilizers, and preservatives. Negative control: buffer and preservatives. Monitors reverse transcription, amplification, detection, and identification steps of BioFire FilmArray assays. No electronic components or software algorithms; functions as a biological/chemical reference material.
Indications for Use
Indicated for use as external positive and negative assayed quality control for in vitro nucleic acid testing of respiratory pathogens (viruses and bacteria) on BioFire FilmArray systems. Intended for use by clinical laboratories; prescription use only.
Regulatory Classification
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.
Special Controls
An assayed quality control material for clinical microbiology assays must comply with the following special controls: (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; Expected values: (ii) Analyte source: (iii) (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., realtime 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 in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(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; (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 21 CFR 809.10(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."
*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.”
