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

Intended 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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May 30, 2024

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Rd Saco, Maine 04072

Re: K241289

Trade/Device Name: SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed Quality Control Material For Clinical Microbiology Assays Regulatory Class: Class II Product Code: PMN Dated: May 6, 2024 Received: May 7, 2024

Dear Joan Gordon:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Joseph Briggs -S

Joseph Briggs, Ph.D. Deputy Branch Chief Viral Respiratory and HPV Branch Division of Microbiology Devices

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OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K241289

#### Device Name SPOTFIRE® RSP Pos & Neg Controls SPOTFIRE® RSP Negative Control

#### Indications for Use (Describe)

The SPOTFIRE® RSP Pos & Neg Controls kit is intended for use (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 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 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 Mimi, BIOFIRE SPOTFIRE R/ST Panel, and BIOFIRE SPOTFIRE R/ST Panel Mini assays. The SPOTFIRE RSP Positive Control contains synthetic RNA 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.

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, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini on the BIOFIRE System. SPOTFIRE RSP Negative Control 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. SPOTFIRE RSP Negative Control is comprised of a solution of buffer and preservatives that does not contain target analytes. 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/5/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in large, bold, serif font, with "MM" in a darker color than "QCI". Below the acronym, in a smaller font, is the full name of the company, "Maine Molecular Quality Controls, Inc.". A stylized, abstract graphic in yellow is positioned to the left of the text, resembling a ribbon or a strand of DNA.

# SECTION 4: Special 510(k) Summary

#### 510(k) Number:

Purpose for submission: Changes to existing device (reference K233611) are the addition of BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini to the intended use of SPOTFIRE RSP Pos & Neg Controls, and the packaging of 6 SPOTFIRE® RSP Positive Controls and 6 SPOTFIRE® RSP Negative Controls together in a single kit box. No other changes have been made to device K233611, SPOTFIRE RSP Pos & Neg Controls.

#### Applicant Information:

| Applicant: | Maine Molecular Quality Controls, Inc. | |
|-----------------|-----------------------------------------|--|
| Address: | 23 Mill Brook Road<br>Saco, Maine 04072 | |
| Contact Person: | Joan Gordon, President MMQCI | |
| Phone: | 207-885-1072 extension 201 | |
| Fax: | 207-885-1079 | |
| Email Address: | [e-mail] | |

Preparation Date: April 28, 2024

## Device

| Device Trade Name: | SPOTFIRE® RSP Pos & Neg Controls<br>SPOTFIRE® RSP Negative Control |
|--------------------|--------------------------------------------------------------------|
| Device Type: | Assayed quality control material for clinical microbiology assays |
| Class: | Class II (Special controls) |
| Product code: | PMN |

## Predicate Device

K233611: SPOTFIRE® RSP Pos & Neg Controls SPOTFIRE® RSP Positive Control SPOTFIRE® RSP Negative Control

#### Proposed Change:

Purpose for submission: Changes to existing device (reference K233611) are the addition of the BIOFIRE® SPOTFIRE® R/ST Panel Mini to the intended use of SPOTFIRE RSP Pos & Neg Controls, and the packaging of 6 SPOTFIRE® RSP Positive Controls and 6 SPOTFIRE® RSP Negative Controls together in a single kit box, with subsequent updates of the Indications of Use (FDA Form 3881), and Package Inserts for SPOTFIRE RSP Pos & Neg Controls and SPOTFIRE RSP Negative Control. SPOTFIRE RSP Negative Control (6) will continue to be packaged in a single kit, as for K233611. No other changes have been made to device K233611, SPOTFIRE RSP Pos & Neg Controls.

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Image /page/6/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of brown and yellow colors. To the left of the letters, there is a stylized graphic that resembles a ribbon or a strand, also in yellow. Below the main letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.," is written in a smaller, sans-serif font.

Description of Modified Device (inclusion of SPOTFIRE R/ST Panel Mini and packaging change):

SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 12 readyto-use, liquid controls, 6 of SPOTFIRE RSP Positive Control (Positive Control), P/N M42638, and 6 of SPOTFIRE RSP Negative Control (Negative Control), P/N M42738, in a single kit box, and a separate kit of 6 additional SPOTFIRE RSP Negative Controls (Negative Control), P/N M42738. The separate kit of SPOTFIRE RSP Negative Control allows and encourages the end user to check for environmental contamination by testing additional negative controls. 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, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini assays. performed on the BIOFIRE System. (see Tables 1-4 below) SPOTFIRE RSP Pos & Neg Controls are specifically 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 on the BIOFIRE SPOTFIRE 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. Engineering drawings, schematics, etc. are not applicable to the device (device is a reagent).

| Table 1. Respiratory pathogens detected by BIOFIRE SPOTFIRE R Panel | |
|---------------------------------------------------------------------|--------------------------|
| Viruses | Bacteria |
| Adenovirus | Chlamydia pneumoniae |
| Coronavirus SARS-CoV-2 | Mycoplasma pneumoniae |
| Coronavirus (seasonal) | Bordetella parapertussis |
| Human Metapneumovirus | Bordetella pertussis |
| Human Rhinovirus/Enterovirus | |
| Influenza A Virus | |
| Influenza A virus A/H1-2009 | |
| Influenza A virus A/H3 | |
| Influenza B Virus | |
| Parainfluenza | |
| Respiratory Syncytial Virus | |

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Image /page/7/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a stylized font, with the "MM" in a darker color and the "QCI" in a lighter color. The full name of the company is written in smaller letters below the main logo. There is also a graphic of a strand of DNA to the left of the letters.

Table 2. Respiratory viruses detected by the BIOFIRE SPOTFIRE R Panel Mini Coronavirus SARS-CoV-2 Human Rhinovirus Influenza A Virus Influenza B Virus Respiratory Syncytial Virus

| Table 3. Respiratory and sore throat pathogens detected by BIOFIRE SPOTFIRE R/ST Panel | |
|----------------------------------------------------------------------------------------|----------------------------------------------|
| Viruses (Respiratory and Sore Throat) | Bacteria (Respiratory and Sore Throat) |
| Adenovirus | Chlamydia pneumoniae |
| Coronavirus SARS-CoV-2 | Mycoplasma pneumoniae |
| Coronavirus (seasonal) | |
| Human Metapneumovirus | |
| Human Rhinovirus/Enterovirus | |
| Influenza A Virus | |
| Influenza A virus A/H1-2009 | |
| Influenza A virus A/H3 | |
| Influenza B Virus | |
| Parainfluenza | |
| Respiratory Syncytial Virus | |
| | Bacteria (Respiratory Only) |
| | Bordetella parapertussis |
| | Bordetella pertussis |
| | Bacteria (Sore Throat Only) |
| | Streptococcus dysgalactiae (group C/G Strep) |
| | Streptococcus pyogenes (group A Strep) |

| Table 4. Respiratory and sore throat pathogens |
|------------------------------------------------|
| detected by the BIOFIRE SPOTFIRE R/ST |
| Panel Mini. |
| Streptococcus pyogenes (group A Strep) |
| Coronavirus SARS-CoV-2 |
| Human Rhinovirus |
| Influenza A Virus |
| Influenza B Virus |
| Respiratory Syncytial Virus |

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Image /page/8/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a bold, stylized font, with the "M" and "Q" being slightly larger than the other letters. A golden, abstract design element is placed to the left of the letters, resembling a ribbon or a strand of DNA. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller, less prominent font.

Modified Device Intended Use of SPOTFIRE RSP Pos & Neg Controls to include the addition SPOTFIRE Respiratory R/ST Panel Mini

SPOTFIRE RSP Pos & Neg Controls:

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.

SPOTFIRE RSP Negative Control:

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, 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 Negative Control 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. SPOTFIRE RSP Negative Control is comprised of a solution of buffer and preservatives that does not contain target analytes. 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.

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Image /page/9/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a bold, serif font, with the "MM" in a darker shade than the "QCI". Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller, sans-serif font. A stylized, golden ribbon-like design curves around the letters, adding a touch of elegance to the logo.

#### Substantial Equivalence

Maine Molecular Quality Controls, Inc. (MMQCI) proposes that changes made to the labeling and packaging for SPOTFIRE RSP Pos & Neg Controls do not impact substantial equivalence to the predicate device (K233611), SPOTFIRE® RSP Pos & Neg Controls. The manufacturing processes and components used to manufacture SPOTFIRE RSP Pos & Neg Controls are the same as those of the predicate device. No changes have been made to the predicate device, other than labeling and kit box. In addition, the targets detected by the SPOTFIRE R/ST Panel Mini are included in the SPOTFIRE R/ST Panel.

| Table 5. Substantial<br>Equivalence of Predicate<br>Device Characteristic | Modified Device: SPOTFIRE RSP<br>Pos & Neg Controls | Predicate Device: K233611<br>SPOTFIRE RSP Pos & Neg<br>Controls |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | External assayed quality control to<br>monitor <i>in vitro</i> lab nucleic acid<br>testing using SPOTFIRE R Panel,<br>SPOTFIRE R Panel Mini,<br>SPOTFIRE R/ST Panel, and<br>SPOTFIRE R/ST Panel Mini<br>performed on SPOTFIRE System. | Same except the Predicate<br>Intended Use did not include<br>the SPOTFIRE R/ST Panel<br>Mini. |
| Labeling | SPOTFIRE R/ST Panel Mini is<br>included in the Product Insert with no<br>changes to kit or tube labels. | SPOTFIRE R/ST Panel Mini is<br>not included in the Product<br>Insert. |
| Physical format | Ready-to-Use Liquid | Same |
| Packaging | 1 kit box for 6 each Positive and<br>Negative Controls, and 1 kit box for<br>6 Negative Controls. | 1 kit box for 6 Positive<br>Controls, and 1 kit box for 6<br>Negative Controls. |
| Directions for Use | Process like patient sample. | Same |
| Composition | Synthetic RNA transcripts | Same |
| Assay steps monitored | Reverse transcription, amplification,<br>detection, identification | Same |
| Test System | SPOTFIRE | same |
| Number of targets<br>monitored in one assay | Multiple | Same targets. Predicate did<br>not include a report for the 5<br>SPOTFIRE R/ST Panel Mini<br>pathogens alone. However,<br>all 5 pathogens are detected<br>using the SPOTFIRE R/ST<br>Panel, K233611. |
| Pathogens contained in the<br>control panel | Respiratory and Sore Throat | same |

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Image /page/10/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a bold, serif font. Below the letters, the words "MAINE MOLECULAR QUALITY CONTROLS, INC." are written in a smaller font. To the left of the text is a stylized graphic of a DNA strand.

Non-lab (CLIA Waived) and lab professionals (CLIA certified)

same

## Performance Data:

Performance data presented in the predicate 510(k) submission (K233611) has all the required data to support the labeling change to the existing device to include the SPOTFIRE R/ST Panel Mini in the intended use for SPOTFIRE RSP Pos & Neg Controls, and the packaging change to combine Positive and Negative controls in a single kit box. 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/ST Panel used to collect original performance data and the SPOTFIRE R Panel Mini. In addition, the targets reported in the SPOTFIRE R/ST Panel Mini are a subset of the SPOTFIRE R/ST Panel.

## Results and Conclusion:

Based upon the substantial equivalence characteristics listed in Table 5 and the original performance data (K233611), MMQCI has determined that the proposed change to the intended use (the addition of the SPOTFIRE R/ST Panel Mini assay), and the packaging to contain Positive and Negative controls in the same kit box, supports substantial equivalence to the predicate device K233611, SPOTFIRE RSP Pos & Neg Controls.