(134 days)
Not Found
No
The document describes a quality control material for a nucleic acid testing system. There is no mention of AI or ML being used in the control material itself or in its intended use for monitoring the performance of the testing system.
No
Explanation: This device is described as a quality control panel used to monitor the performance of in vitro laboratory nucleic acid testing procedures. It is not intended for the direct diagnosis, treatment, or prevention of disease in a patient.
No
This device is described as a quality control material used to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to diagnose a condition in a patient.
No
The device is a quality control panel comprised of liquid controls containing synthetic RNA transcripts and buffer, which are physical components, not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the controls are "intended for use (as applicable) as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures". This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The "Device Description" further clarifies that the controls are used with the BIOFIRE SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel assays, which are themselves IVD assays. The controls are processed "according to the SPOTFIRE Panel assay manufacturer's Instructions for Use for patient samples".
- Regulatory Context: The mention of using quality control materials "in accordance with local, state, federal regulations, and accreditation requirements" also points to the device being subject to regulations governing IVDs.
- Predicate Device: The listing of a predicate device with a K number (K230868) indicates that this device has gone through a regulatory submission process, which is typical for IVDs.
Therefore, the SPOTFIRE® RSP Positive Control and SPOTFIRE® RSP Negative Control are components of an IVD system and are themselves considered IVD devices used for quality control purposes within that system.
N/A
Intended Use / Indications for Use
SPOTFIRE RSP Positive Control:
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:
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.
Product codes (comma separated list FDA assigned to the subject device)
PMN
Device Description
SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 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 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. (see Tables 1-3 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, and BIOFIRE SPOTFIRE R/ST Panel 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Non-lab (CLIA Waived) and lab professionals (CLIA certified)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Three lots of SPOTFIRE RSP Pos & Neg Controls were manufactured by MMQCI at MMQCI's facility in Saco, Maine. The lots were manufactured and tested such that routine variables, including lots of key manufacturing components, different operators, pouch lots, instruments, test sites, and testing over time were incorporated to challenge manufacture processes and product performance. External and internal studies were performed by testing the 3 lots with the SPOTFIRE R/ST Panel assay on the SPOTFIRE System (BioFire Diagnostics) to generate a total of 361 test results.
For the external performance study, 5 near-patient clinical sites tested samples of each of the 3 lots of SPOTFIRE RSP Positive Controls and SPOTFIRE RSP Negative Controls as they would test controls during normal operations, using 25 SPOTFIRE R/ST Panel pouch lots, incorporating multiple operators and instruments for a total of 232 tests, including 7 Invalid results which were repeated. The internal study was performed by testing samples of each of the 3 SPOTFIRE RSP Pos & Neg Controls lots at MMQCI (Saco, Maine) on different days with 3 pouch lots by 3 operators for a total of 129 tests (3 Invalid results were repeated). One of the pouch lots used at the MMOCI site was also used at a clinical site.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Reproducibility study (External and Internal sites)
Sample Size: 361 total tests (232 external, 129 internal)
Key Results:
Of the total 361 tests performed, there were 10 Invalid results which repeated for 351 valid test results. The Invalid results included instrument errors (3) and failed internal pouch controls (7). The Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis. Of the 351 valid results were correct. One SPOTFIRE RSP Positive Control failed due to false negative results for 4 analytes.
Reproducibility of SPOTFIRE RSP Pos & Neg Controls at 6 sites, across 27 pouch lots, 3 control lots, on multiple instruments by multiple operators is acceptable according to predetermined criteria with an overall correct result rate of 99.7%. Test results demonstrate robust performance across 6 testing sites.
External Site Testing Details:
232 samples tested at 5 near-patient clinical sites. 7 Invalid results (4 failed internal pouch controls, 3 instrument errors) were repeated, leading to 225 valid results.
Results: Out of 225 tests with valid results, the correct analytes were detected (for positive controls) or not detected (for negative controls) in 224 tests, for an overall success rate of 99.6%. One SPOTFIRE RSP Positive Control failed due to false negative results for 4 analytes. The predetermined acceptance criteria for reproducibility were met.
Internal Site Testing Details:
129 samples tested at MMQCI facility in Saco, Maine over 21 different days. 3 Invalid results were repeated, leading to 126 valid results.
Results: All 126 valid results were correct for an overall correct result rate of 100%. Predetermined acceptance criteria for reproducibility were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Correct Result Rate: 99.7%
External Site Correct Result Rate: 99.6%
Internal Site Correct Result Rate: 100%
Correct Positive Control Result: 99.3% (overall), 99.1% (external)
Correct Negative Control Result: 100% (overall), 100% (external and internal)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
March 26, 2024
Image /page/0/Picture/1 description: The image contains the logos of the 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 eagle and text encircling it. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Rd Saco, Maine 04072
Re: K233611
Trade/Device Name: SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed Quality Control Material For Clinical Microbiology Assays Regulatory Class: Class II Product Code: PMN Dated: November 3, 2023 Received: November 13, 2023
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.
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"
1
(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 OS 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Joseph Briggs -S
Joseph Briggs Deputy Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233611
Device Name SPOTFIRE RSP Pos & Neg Controls (M425); SPOTFIRE RSP Positive Control (M42638); SPOTFIRE RSP Negative Control (M42738)
Indications for Use (Describe) SPOTFIRE RSP Positive Control:
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:
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.
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.
3
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4
Image /page/4/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 maroon and yellow colors. The "MM" is in maroon, while the "QCI" is in yellow. The full company name is written in smaller font below the letters. A yellow swoosh design is behind the letters.
Section 5: 510 (k) Summary
510(k) Number:
Purpose for submission: Change to existing device (reference K230868) to include the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel (SPOTFIRE R/ST Panel) in the intended use for SPOTFIRE RSP Pos & Neg Controls.
Applicant Information:
Applicant: | Maine Molecular Quality Controls, Inc |
---|---|
Address: | 23 Mill Brook Road |
Saco, Maine 04072 | |
Contact Person: | Joan Gordon, President MMQCI |
Phone: | 207-885-1072 extension 201 |
Fax: | 207-885-1079 |
Email Address: | jgordon@mmqci.com |
Preparation Date: March 19, 2024
Device
| Device Trade Name: | SPOTFIRE RSP Pos & Neg Controls, model M425
SPOTFIRE RSP Positive Control, model M42638
SPOTFIRE RSP Negative Control, model M42738 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Quality Control Material for Microbiology Assays |
| Device Type: | Assayed quality control material for clinical microbiology
assays |
| Class: | Class II (Special controls) |
| Regulation: | 21 CFR 866.3920 |
| Panel: | Microbiology - 83 |
| Product code: | PMN |
Predicate Device
K230868 SPOTFIRE RSP Pos & Neg Controls SPOTFIRE RSP Positive Control SPOTFIRE RSP Negative Control
Proposed Change:
The specific change to the existing device is the inclusion of the SPOTFIRE R/ST Panel in the intended use for SPOTFIRE RSP Pos & Neg Controls, with subsequent updates of the Indications of Use (FDA Form 3881), Package Inserts for SPOTFIRE RSP Positive Control and
5
Image /page/5/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of maroon and yellow. The "MM" is in maroon, while the "QCI" is in yellow. The text "MAINE MOLECULAR QUALITY CONTROLS, INC." is written in a smaller font below the letters. There is also a yellow swirl design on the left side of the logo.
SPOTFIRE RSP Negative Control, and the addition of data for SPOTFIRE R/ST Panel analytes Streptococcus dysgalactiae (Group C/G Strep) and Streptococcus pyogenes (Group A Strep) to this submission. No other changes have been made to the original device referenced in K230868.
Description of Modified Device (inclusion of use with SPOTFIRE R/ST Panel)
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. (see Tables 1-3 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, and BIOFIRE SPOTFIRE R/ST Panel 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.
Table 1. Respiratory pathogens detected by BIOFIRE SPOTFIRE R Panel | |
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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/6/Picture/1 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in a stylized font, with the "MM" in a dark red color and the "QCI" in yellow. A golden, abstract design element curves around the letters, adding a visual flair to the logo. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.," is written in a smaller, dark font.
| 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) | Bacteria (Respiratory Only) |
Human Metapneumovirus | Bordetella parapertussis |
Human Rhinovirus/ Enterovirus | Bordetella pertussis |
Influenza A Virus | Bacteria (Sore Throat Only) |
Influenza A virus A/H1-2009 | Streptococcus dysgalactiae (group C/G Strep) |
Influenza A virus A/H3 | Streptococcus pyogenes (group A Strep) |
Influenza B Virus | |
Parainfluenza | |
Respiratory Syncytial Virus |
Intended Use of SPOTFIRE RSP Pos & Neg Controls modified to include the addition SPOTFIRE R/ST Panel
SPOTFIRE RSP Positive Control:
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, 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)
7
Image /page/7/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in bold, with "MM" in a dark red color and "QCI" in a yellow color. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.," is written in a smaller, dark red font. A stylized, curved yellow shape is on the left side of the logo.
Panel Mini, 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:
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, 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, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel on the BIOFIRE SPOTFIRE 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 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.
Substantial Equivalence
Maine Molecular Quality Controls, Inc. (MMQCI) proposes that the changes made to the labeling of SPOTFIRE RSP Pos & Neg Controls to include the additional intended use of SPOTFIRE R/ST Panel do not impact substantial equivalence to SPOTFIRE RSP Pos & Neg Controls (K230868). There have been no changes to the predicate device, other than labeling. The rationale for equivalence is listed in Table 4 below.
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Image /page/8/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in a combination of maroon and yellow colors. The full name of the company, "Maine Molecular Quality Controls, Inc.," is written in a smaller font size below the acronym. A stylized yellow graphic element is placed to the left of the text, adding a visual accent to the logo.
Table 4. Substantial Equivalence of Predicate Devices
| Characteristic | Candidate Device:
SPOTFIRE RSP Pos &
Neg Controls | Predicate Device: SPOTFIRE
RSP Pos & Neg Controls
(K230868) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended Use | External assayed quality
control to monitor in vitro
lab nucleic acid test using
the SPOTFIRE R Panel,
SPOTFIRE R Panel Mini,
and SPOTFIRE R/ST Panel
performed on the
SPOTFIRE System. | Original 510(k) IFU did
not include the
SPOTFIRE R/ST Panel |
| Labeling | SPOTFIRE R/ST Panel
added to the Package Insert,
no changes to Kit or Tube
labels. | SPOTFIRE R/ST Panel not
included in Package Insert |
| Physical format | Ready-to-Use Liquid | Same |
| Directions for Use | Process like patient sample | Same |
| Composition | Synthetic RNA transcripts | Same |
| Assay steps
monitored | Reverse transcription,
amplification, detection,
identification | Same |
| Test System | SPOTFIRE | Same |
| Number of targets
monitored in one
assay | Multiple | Original 510(k) data did not
include the sore throat targets
detected by SPOTFIRE R/ST
Panel |
| Pathogens
contained in the
control panel | Respiratory and Sore Throat | Respiratory |
| User | Non-lab (CLIA Waived)
and lab professionals (CLIA
certified) | Same |
Summary of Performance Data
Three lots of SPOTFIRE RSP Pos & Neg Controls were manufactured by MMQCI at MMQCI's facility in Saco, Maine. The lots were manufactured and tested such that routine variables,
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Image /page/9/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MMQCI" in a combination of maroon and yellow colors. The word "MAINE MOLECULAR QUALITY CONTROLS, INC." is written in a smaller font below the letters. A yellow, abstract design element is placed to the left of the text.
including lots of key manufacturing components, different operators, pouch lots, instruments, test sites, and testing over time were incorporated to challenge manufacture processes and product performance. External and internal studies were performed by testing the 3 lots with the SPOTFIRE R/ST Panel assay on the SPOTFIRE System (BioFire Diagnostics) to generate a total of 361 test results.
For the external performance study, 5 near-patient clinical sites tested samples of each of the 3 lots of SPOTFIRE RSP Positive Controls and SPOTFIRE RSP Negative Controls as they would test controls during normal operations, using 25 SPOTFIRE R/ST Panel pouch lots, incorporating multiple operators and instruments for a total of 232 tests, including 7 Invalid results which were repeated. The internal study was performed by testing samples of each of the 3 SPOTFIRE RSP Pos & Neg Controls lots at MMQCI (Saco, Maine) on different days with 3 pouch lots by 3 operators for a total of 129 tests (3 Invalid results were repeated). One of the pouch lots used at the MMOCI site was also used at a clinical site.
Results and Conclusions:
Of the total 361 tests performed, there were 10 Invalid results which repeated for 351 valid test results. The Invalid results included instrument errors (3) and failed internal pouch controls (7). The Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis in Table 5 below. Of the 351 valid results were correct. One SPOTFIRE RSP Positive Control failed due to false negative results for 4 analytes.
Reproducibility of SPOTFIRE RSP Pos & Neg Controls at 6 sites, across 27 pouch lots, 3 control lots, on multiple instruments by multiple operators is acceptable according to predetermined criteria with an overall correct result rate of 99.7%. Test results demonstrate robust performance across 6 testing sites.
Summary of Reproducibility Test Results: External and Internal Sites | |||||||||
---|---|---|---|---|---|---|---|---|---|
Total | |||||||||
Tests | Invalid* | Correct | |||||||
Positive | |||||||||
Control | |||||||||
Result | Incorrect | ||||||||
Positive | |||||||||
Control | |||||||||
Result | Percent | ||||||||
Correct | |||||||||
Positive | |||||||||
Control | Correct | ||||||||
Negative | |||||||||
Control | |||||||||
Result | Incorrect | ||||||||
Negative | |||||||||
Control | |||||||||
Result | Percent | ||||||||
Correct | |||||||||
Negative | |||||||||
Control | Total | ||||||||
Percent | |||||||||
Correct | |||||||||
361 | 10 | 171 | 1 | 99.3% | 179 | 0 | 100% | 99.7% |
Table 5. SPOTFIRE RSP Pos & Neg Controls: Reproducibility results, all sites.
*The Invalid samples were not included in the Percent Correct analysis.
External Site Testing Details
A total of 232 samples of SPOTFIRE RSP Positive and RSP Negative Controls were tested at 5 near-patient clinical sites. The sites were asked to follow the SPOTFIRE R/ST Panel IUO Quick Guide to run the controls as they would during normal operations, e.g. training a new operator, receiving new shipments of R/ST Panel test kits, receiving new or repaired instrumentation, and
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Image /page/10/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 "MM" in a larger size and a darker red color, and "QCI" in a smaller size and a lighter red color. 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 yellow swirl design is placed to the left of the letters, adding a visual element to the logo.
whenever the test kits have been stored at an incorrect temperature. It was recommended a negative quality control sample be run at least monthly to monitor for environmental contamination. The amount of QC a site performed was based on the number of operators they had and the amount of SPOTFIRE R/ST Panel testing their site performed.
Three lots of SPOTFIRE RSP Positive Control (A02NOV20, B06NOV20, C10NOV20) and 4 lots of SPOTFIRE RSP Negative Control (F09JUL19, D11MAR20, H05MAY20, C13MAY20) were tested on 25 SPOTFIRE R/ST Panel pouch lots across the 5 sites, incorporating multiple operators and instruments. Of the 232 samples tested, there were 7 Invalid results which were repeated for a total of 225 valid results. Of the 7 Invalid results, 4 were failed internal pouch controls and 3 were due to instrument errors.
Results and Conclusion:
Out of 225 tests with valid results, the correct analytes were detected (for positive controls) or not detected (for negative controls) in 224 tests, for an overall success rate of 99.6% (Table 5). One SPOTFIRE RSP Positive Control failed due to false negative results for 4 analytes. The predetermined acceptance criteria for reproducibility were met. SPOTFIRE RSP Positive Control and RSP Negative Control performed robustly at the 5 external test sites across 25 pouch lots on the SPOTFIRE System, incorporating multiple operators.
Summary of External Results for 3 Lots of SPOTFIRE RSP Pos & Neg Controls | |||||||||
---|---|---|---|---|---|---|---|---|---|
Site | Total | ||||||||
Tests | Invalid | Correct | |||||||
Positive | |||||||||
Control | |||||||||
Result | Incorrect | ||||||||
Positive | |||||||||
Control | |||||||||
Result | Percent | ||||||||
Correct | |||||||||
Positive | |||||||||
Control | Correct | ||||||||
Negative | |||||||||
Control | |||||||||
Result | Incorrect | ||||||||
Negative | |||||||||
Control | |||||||||
Result | Percent | ||||||||
Correct | |||||||||
Negative | |||||||||
Control | Total | ||||||||
Percent | |||||||||
Correct | |||||||||
1 | 26 | 0 | 13 | 0 | 100% | 13 | 0 | 100% | 100% |
2 | 33 | 1 | 13 | 0 | 100% | 19 | 0 | 100% | 100% |
3 | 120 | 4 | 53 | 1 | 98.1% | 62 | 0 | 100% | 99.1% |
4 | 44 | 1 | 21 | 0 | 100% | 22 | 0 | 100% | 100% |
5 | 9 | 1 | 8 | 0 | 100% | NA | NA | NA | NA |
All | |||||||||
Sites | 232 | 7* | 108 | 1 | 99.1% | 116 | 0 | 100% | 99.6% |
Table 5. Summary of External Reproducibility Results for 3 Control Lots at 5 Clinical Sites
*Invalid results were not included in percent correct.
Internal Site Testing Details
Run-to-run Precision Testing at MMOCI: Of the total 361 reproducibility tests. 129 SPOTFIRE RSP Positive Control and SPOTFIRE RSP Negative Control samples were tested on 21 different days at MMQCI's facility in Saco, Maine. Three lots of Positive Control (A02NOV20, B06NOV20, C10NOV20) and 3 lots of Negative Control (F09JUL19, D11MAR20, H05MAY20)
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Image /page/11/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 a yellow abstract design to the left of the letters.
were tested on 3 SPOTFIRE R/ST pouch lots, incorporating 4 operators and 1 SPOTFIRE instrument (Table 6). One of the pouch lots was also used for the external site testing.
Results and conclusions:
Of the 129 results, 3 were Invalid which were repeated for a total of 126 valid results. All 126 of the valid results were correct for an overall correct result rate of 100%. Predetermined acceptance criteria for reproducibility were met. SPOTFIRE RSP Positive Control and SPOTFIRE RSP Negative Control performed robustly on 21 different days at MMQCI across 3 pouch lots on 1 SPOTFIRE instrument, incorporating 4 operators.
Control | Control Lot # | No. of Tests | Invalid* | Correct Results | Incorrect Results | Percent Correct |
---|---|---|---|---|---|---|
SPOTFIRE RSP Positive Control | A02NOV20 | 23 | 2 | 21 | 0 | 100% |
SPOTFIRE RSP Positive Control | B06NOV20 | 21 | 0 | 21 | 0 | 100% |
SPOTFIRE RSP Positive Control | C10NOV20 | 22 | 1 | 21 | 0 | 100% |
SPOTFIRE RSP Negative Control | F09JUL19 | 21 | 0 | 21 | 0 | 100% |
SPOTFIRE RSP Negative Control | D11MAR20 | 21 | 0 | 21 | 0 | 100% |
SPOTFIRE RSP Negative Control | H05MAY20 | 21 | 0 | 21 | 0 | 100% |
TOTAL | 129 | 3 | 126 | 0 | 100% |
Table 6. SPOTFIRE RSP Pos & Neg Controls: Reproducibility results at MMQCL
Overall Conclusion
The above information supports the substantial equivalence of the SPOTFIRE RSP Positive and Negative Controls to the predicate device.