(15 days)
No
The document describes quality control materials for a nucleic acid testing system. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the composition and intended use of the control materials themselves.
No
This device is described as a quality control material intended to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to treat or diagnose patients directly.
No
This device is a quality control material used to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to directly detect diseases in patients. It helps ensure the assays (which are diagnostic) are working correctly.
No
The device description explicitly states that the controls are comprised of "in vitro RNA transcripts and stabilizing solution" and "a solution that does not contain target analytes," which are physical components, not software.
Yes, this 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 "to monitor performance of in vitro laboratory nucleic acid testing procedures". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The "Device Description" further clarifies that the controls are used with the BIOFIRE® SPOTFIRE® Respiratory (R) Panel and BIOFIRE® Respiratory (R) Panel Mini assays, which are themselves IVD tests used to detect pathogens in patient samples. The controls are designed to assess the performance of these diagnostic tests.
- Quality Control: The primary function of these controls is quality control for diagnostic testing. Quality control materials used in laboratory testing to ensure the accuracy and reliability of results are considered IVDs.
- Regulatory Context: The mention of "local, state, federal regulations, and accreditation requirements" for the use of quality control materials also points to their classification as IVDs, as these regulations govern the use of diagnostic devices.
- Predicate Device: The predicate device listed (K221253) is also described as "SPOTFIRE® RSP Pos & Neg Controls," indicating that the previous version of this product was also classified as an IVD.
Therefore, based on the provided information, the SPOTFIRE® RSP Positive Control and SPOTFIRE® RSP Negative Control are clearly intended for use in an in vitro diagnostic setting to monitor the performance of other IVD assays.
N/A
Intended Use / Indications for Use
SPOTFIRE® RSP Positive Control is intended for use (as applicable) as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Adenovirus, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the SPOTFIRE R Panel and the SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
SPOTFIRE® RSP Negative Control is intended for use (as applicable) as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Adenovirus, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Negative Control is comprised of a solution that does not contain target analytes and is designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Product codes
PMN
Device Description
SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 separate kits of ready-to-use, liquid controls, SPOTFIRE RSP Positive Control (Positive Control), P/N M42638 and SPOTFIRE RSP Negative Control (Negative Control), P/N M42738. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA in the Positive Control carries RNA segments of all the respiratory pathogens detected by the SPOTFIRE R Panel (Table 1) and SPOTFIRE R Panel Mini (Table 2) on the SPOTFIRE System and is specifically designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays on the SPOTFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE RSP Pos & Neg Controls, P/N M425, is processed separately according to the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assay manufacturer's Instructions for Use for Quality Control testing.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data presented in the 510(k) submission (K221253) has all required data to support the change to existing the device to include the SPOTFIRE R Panel Mini in the intended use for SPOTFIRE RSP Pos & Neg Controls. No additional performance data are required as the SPOTFIRE RSP Pos & Neg Controls have not been changed, the assay consumables are identical for the SPOTFIRE R Panel used to collect original performance data and the SPOTFIRE R Panel Mini added to the intended use of the device. In addition, the targets reported in the SPOTFIRE R Panel Mini are a subset of the SPOTFIRE R Panel.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 13, 2023
Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, Maine 04072
Re: K230868
Trade/Device Name: SPOTFIRE RSP Pos & Neg Controls, SPOTFIRE RSP Positive Control, 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: March 28, 2023 Received: March 29, 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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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
Enclosure
2
Indications for Use
510(k) Number (if known) K230868
Device Name
SPOTFIRE® RSP Pos & Nez Controls, SPOTFIRE® RSP Positive Control, and SPOTFIRE® RSP Negative Control
Indications for Use (Describe)
SPOTFIRE® RSP Positive Control is intended for use (as applicable) as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Adenovirus, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the SPOTFIRE R Panel and the SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
SPOTFIRE® RSP Negative Control is intended for use (as applicable) as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Adenovirus, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Negative Control is comprised of a solution that does not contain target analytes and is designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
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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Image /page/4/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MMQCI" in a bold, serif font, with the "MM" in a darker color than the "QCI". A stylized golden ribbon-like graphic is draped over the letters. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller, sans-serif font.
Section 5: Special 510 (k) Summary
510(k) Number:
Purpose for submission: Change to existing device (reference K221253) to include the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE R Panel Mini) 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 28, 2023
Device
| Device Trade Name: | SPOTFIRE® RSP Pos & Neg Controls |
|---|---|
| SPOTFIRE® RSP Positive Control | |
| SPOTFIRE® RSP Negative Control | |
| Device Type: | Assayed quality control material for clinical microbiology assays |
| Class: | Class II (Special controls) |
| Product code: | PMN |
Predicate Device
K221253: 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 Panel Mini in the intended use for SPOTFIRE RSP Pos & Neg Controls, with subsequent updates of the Indications of Use (FDA Form 3881), and Package Inserts for SPOTFIRE RSP Positive Control and SPOTFIRE RSP Negative Control. No other changes have been made to the original device referenced in K221253.
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Image /page/5/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MMQCI" in a bold, sans-serif font, with the "MM" in a darker shade and the "QCI" in a lighter shade. To the left of the letters is a stylized graphic that resembles a strand of DNA or a ribbon, colored in a golden hue. Below the letters, in a smaller font, is the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC."
Description of Modified Device (inclusion of SPOTFIRE R Panel Mini):
SPOTFIRE RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 separate kits of ready-to-use, liquid controls, SPOTFIRE RSP Positive Control (Positive Control), P/N M42638 and SPOTFIRE RSP Negative Control (Negative Control), P/N M42738. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA in the Positive Control carries RNA segments of all the respiratory pathogens detected by the SPOTFIRE R Panel (Table 1) and SPOTFIRE R Panel Mini (Table 2) on the SPOTFIRE System and is specifically designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays on the SPOTFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE RSP Pos & Neg Controls, P/N M425, is processed separately according to the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assay manufacturer's Instructions for Use for Quality Control testing.
| Viruses | Bacteria |
|---|---|
| Adenovirus | Bordetella parapertussis |
| Coronavirus 229E, HKU1, OC43, | |
| NL631 | Bordetella pertussis |
| Coronavirus SARS-CoV-2 | Chlamydia pneumoniae |
| Human Metapneumovirus | Mycoplasma pneumoniae |
| Human Rhinovirus/ Enterovirus | |
| Influenza A Virus, subtypes H1-2009, | |
| H3 | |
| Influenza B Virus | |
| Parainfluenza Virus serotypes 1-42 | |
| Respiratory Syncytial Virus |
Table 1. Respiratory pathogens detected by the SPOTFIRF R Panel
-
Reported as seasonal Coronavirus (undifferentiated).
-
Reported as Parainfluenza Virus (undifferentiated).
Table 2. Respiratory viruses detected by the SPOTFIRE R Panel Mini
| Coronavirus SARS-CoV-2 |
|---|
| Human Rhinovirus |
| Influenza A Virus |
| Influenza B Virus |
| Respiratory Syncytial Virus |
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Image /page/6/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-brown color and "QCI" in yellow. Below the acronym, in smaller font, is the full name of the company, "Maine Molecular Quality Controls, Inc." To the left of the text is a stylized, abstract graphic in yellow, resembling a ribbon or a strand of DNA.
Modified Device Intended Use of SPOTFIRE RSP Pos & Neg Controls to include the addition SPOTFIRE Respiratory R Panel Mini
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, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, 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 (SPOTFIRE® R Panel) and BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the SPOTFIRE R Panel and the SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
SPOTFIRE® RSP Negative Control:
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, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, 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 (SPOTFIRE® R Panel) and BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® System. SPOTFIRE® RSP Negative Control is comprised of a solution that does not contain target analytes and is designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Note: Product insert includes the Rx symbol.
Substantial Equivalence
Maine Molecular Quality Controls, Inc. (MMQCI) proposes that changes made to the labeling for SPOTFIRE RSP Pos & Neg Controls do not impact substantial equivalence to the predicate device (K221253), SPOTFIRE® RSP Pos & Neg Controls. The manufacturing processes and
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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, stylized letters. A golden ribbon-like design wraps around the letters, adding a touch of elegance. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in smaller font.
components used to manufacture SPOTFIRE RSP Pos & Neg Controls are the same as those of the predicate device. In addition, the targets detected by the SPOTFIRE R Panel Mini are included in the SPOTFIRE R Panel.
| Characteristic | Modified Device:
SPOTFIRE RSP Pos &
Neg Controls | Predicate Device:
K221253
SPOTFIRE RSP
Pos & Neg
Controls |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | External assayed quality
control to monitor in vitro
lab nucleic acid test using
the SPOTFIRE R Panel and
SPOTFIRE R Panel Mini,
performed on the
SPOTFIRE System. | Original 510(k) did
not include the
SPOTFIRE R Panel
Mini |
| Labeling | SPOTFIRE (R) Panel Mini
included in the Product
Insert only, no changes to kit
or tube labels | SPOTFIRE (R)
Panel Mini not
included in the
Product 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) did
not include the
SPOTFIRE R Panel
Mini. This panel
contains 5 viral
targets that are
included in the
SPOTFIRE R Panel |
| Pathogens contained
in the control panel | Respiratory | Same |
| User | Non-lab (CLIA Waived) and
lab professionals (CLIA
certified) | Same |
Table 3. Substantial Equivalence of Predicate Device
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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 bold, capitalized letters. A stylized, golden ribbon-like design wraps around the letters, adding a dynamic and artistic element to the logo. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in smaller font.
Performance Data:
Performance data presented in the 510(k) submission (K221253) has all required data to support the change to existing the device to include the SPOTFIRE R Panel Mini in the intended use for SPOTFIRE RSP Pos & Neg Controls. No additional performance data are required as the SPOTFIRE RSP Pos & Neg Controls have not been changed, the assay consumables are identical for the SPOTFIRE R Panel used to collect original performance data and the SPOTFIRE R Panel Mini added to the intended use of the device. In addition, the targets reported in the SPOTFIRE R Panel Mini are a subset of the SPOTFIRE R Panel.
Results and Conclusion:
Based upon the substantial equivalence characteristics listed in Table 3 and the original performance data (K221253), MMQCI has determined that the proposed change to the intended use (the addition of the SPOTFIRE R Panel Mini assay), supports substantial equivalence to the predicate device K221253, SPOTFIRE RSP Pos & Neg Controls.