SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

K241289 · Maine Molecular Quality Controls, Inc. · PMN · May 30, 2024 · Microbiology

Device Facts

• Record ID: K241289
• Device Name: SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
• Applicant: Maine Molecular Quality Controls, Inc.
• Product Code: PMN · Microbiology
• Decision Date: May 30, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

Indications for Use

The SPOTFIRE® RSP Pos & Neg Controls kit is intended for use (as applicable) as an external positive and 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, Mycoplasma pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus, Coronavirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus/Enterovirus, 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, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini on the BIOFIRE SPOTFIRE System. SPOTFIRE RSP Pos & Neg Controls is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel, and BIOFIRE SPOTFIRE R/ST Panel Mini assays. The SPOTFIRE RSP Positive Control contains synthetic NA transcripts in stabilizing solution and the SPOTFIRE RSP Negative Control contains buffers and preservatives. 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.

Device Story

Quality control materials; used to monitor performance of in vitro diagnostic assays for respiratory pathogens; provides external verification of test procedure accuracy; used by laboratory professionals in clinical settings; ensures assay reliability; no changes to device format or formulation; modification limited to labeling update for additional assay panel compatibility.

Clinical Evidence

No clinical data. Bench testing only. Performance data from predicate K233611 supports the inclusion of the R/ST Panel Mini, as the assay consumables and target pathogens are identical or subsets of those previously validated.

Technological Characteristics

Ready-to-use liquid control. Positive control: synthetic RNA transcripts in stabilizing solution. Negative control: buffer and preservatives. No target analytes in negative control. Designed for use with BIOFIRE SPOTFIRE System. No mechanical or electronic components; reagent-only device.

Indications for Use

Indicated for use as external quality control materials for monitoring the performance of in vitro diagnostic assays detecting respiratory pathogens in clinical laboratory settings.

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.”

Predicate Devices

• SPOTFIRE® RSP Pos & Neg Controls (K233611)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K241289

B Applicant

Maine Molecular Quality Controls, Inc.

C Proprietary and Established Names

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PMN | Class II | 21 CFR 866.3920 - Assayed Quality Control Material For Clinical Microbiology Assays | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II, device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for a revision to the device labeling to include use of the device with an additional assay panel; there were no changes to the device format or formulation and no new performance data were reviewed.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their pre-amendment) device.

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