(323 days)
Not Found
No
The device is a quality control panel for a nucleic acid testing system and does not perform analysis or interpretation using AI/ML.
No.
This device is a quality control panel used to monitor the performance of in vitro diagnostic tests, not to treat any medical condition or patient.
No
This device is a quality control panel used to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to directly diagnose patients. It is used with diagnostic devices (like the BioFire Respiratory Panel 2.1 assay).
No
The device description clearly states that the device is a "quality control panel consisting of 2 ready-to-use, liquid controls". This indicates a physical product containing biological or chemical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "in vitro laboratory nucleic acid testing procedures".
- Device Description: The description details a "quality control panel" used to "monitor the performance of in vitro laboratory nucleic acid testing procedures".
- Regulatory Context: The document includes sections like "Intended Use / Indications for Use", "Device Description", "Summary of Performance Studies", "Key Metrics", and "Predicate Device(s)", which are standard components of regulatory submissions for IVD devices. The mention of a "Predicate Device(s)" with a K number (K173171) further confirms its classification as a medical device, specifically an IVD, as K numbers are associated with FDA clearances for medical devices.
- Function: The device is a control panel used to assess the performance of other IVD assays (BioFire Respiratory Panel 2.1, 2.1 plus, and 2.1-EZ) which are themselves used for diagnosing respiratory infections. Quality controls for diagnostic tests are considered IVDs.
N/A
Intended Use / Indications for Use
BioFire RP2.1/RP2.1plus Control Panel M441 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire Respiratory Panel 2.1 (RP2.1), BioFire Respiratory Panel 2.1 plus) and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) assay performed on the BioFire FilmArray systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1phus and BioFire RP2.1-EZ assay. This product is not intended to replace manufacturer controls provided with the device.
Product codes
PMN
Device Description
BioFire RP2.1/RP2.1plus Control Panel M441, P/N M441, is a quality control panel consisting of 2 ready-to-use, liquid controls, BioFire RP2.1/RP2.1plus Positive (Positive Control) and BioFire RP2.1/RP2.1plus Negative Control). The Positive Control contains noninfectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus), and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays (Table 1. below) on the BioFire® FilmArray systems, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). BioFire RP2.1/RP2.1plus Negative contains buffer and preservatives with no RNA. Each liquid control of BioFire RP2.1/RP2.1plus Control Panel M441 is processed separately according to BioFire RP2.1, RP2.1plus, and RP2.1-EZ assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM).
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
Not Found
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)
Internal studies were performed by testing 3 lots of the Biofire RP2.1/RP2.1plus Control Panel M441 with the BioFire® RP2.1/RP2.1plus assay on BioFire FilmArray Systems. The internal study was performed by testing the 3 lots at MMQCI (Saco, Maine) over 2.5 weeks with 3 pouch lots by 3 operators.
An external study was performed at an independent U.S. facility to assess performance of the BioFire RP2.1/RP2.1plus Control Panel M441 by independent operators on a large number of BioFire FilmArray instruments. The external performance study tested the 3 lots of BioFire RP2.1/RP2.1plus Control Panel M441 over a period of 8 days using 3 BioFire FilmArray pouch lots, incorporating multiple operators and instruments. Two of the BioFire pouch lots used at MMQCI were also used for testing at the external site, for a total of 4 pouch lots used across the 2 sites.
Results and Conclusion: All BioFire RP2.1/RP2.1plus Control Panel M441 controls were correctly detected in the internal and external studies. There was one Invalid result.
A total of 52 BioFire RP2.1/RP2.1plus Control Panel M441 samples were tested between April 29, 2020 and May 8, 2020 at an external test site, independent of MMQCI. Three lots of Positive Control (D24APR20, F28APR20 C29APR20) and three lots of Negative Control (D11MAR20, F09JUL19, L22JUL19) were tested on three BioFire pouch lots, incorporating multiple operators and BioFire FilmArray instruments. All 52 controls tested were successful on the first attempt except for 1 Invalid pouch.
All BioFire RP2.1/RP2.1plus Positive controls and all BioFire RP2.1/RP2.1plus Negative controls gave correct results, with 1 Invalid pouch. BioFire RP2.1/RP2.1plus Control Panel M441 performed robustly when tested at the external site across 3 pouch lots, on multiple BioFire FilmArray 2.0 and Torch instruments/ modules, incorporating multiple operators.
Precision Testing: Precision was demonstrated by testing 3 lots of BioFire RP2.1/RP2.1plus Positive control and 3 lots of BioFire RP2.1/RP2.1plus Negative control at MMQCI's facility in Saco, Maine over 20 days with 3 pouch lots by 3 operators using two FilmArray® 2.0 instruments. All BioFire RP2.1/RP2.1plus Control Panel M441 controls were correctly detected. No Invalid results were seen.
Conclusion: BioFire RP2.1/RP2.1plus Control Panel M441 is a robust and reproducible control panel across multiple control and reagent lots.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Summary of All Test Results: Internal and External Sites:
Total Tests: 172
Invalid: 1*
Correct Positive Control Result: 86
Incorrect Positive Control Result: 0
Percent Correct Positive Control: 100%
Correct Negative Control Result: 85
Incorrect Negative Control Result: 0
Percent Correct Negative Control: 100%
Summary of External Results for 3 Control Lots:
Total Tests: 52
Invalid: 1*
Correct Positive Control Result: 26
Incorrect Positive Control Result: 0
Percent Correct Positive Control: 100%
Correct Negative Control Result: 25
Incorrect Negative Control Result: 0
Percent Correct Negative Control: 100%
Summary of Precision Testing for 3 Control Lots at MMQCI:
FilmArray RP2.1/RP2.1plus Positive (Control Lot #D24APR20, F28APR20, C29APR20):
No. of Tests: 20 for each lot (total 60)
Invalid: 0 for each lot (total 0)
Correct Results: 20 for each lot (total 60)
Incorrect Results: 0 for each lot (total 0)
Percent Correct: 100% for each lot (total 100%)
FilmArray RP2.1/RP2.1plus Negative (Control Lot #D11MAR20, F09JUL19, L22JUL19):
No. of Tests: 20 for each lot (total 60)
Invalid: 0 for each lot (total 0)
Correct Results: 20 for each lot (total 60)
Incorrect Results: 0 for each lot (total 0)
Percent Correct: 100% for each lot (total 100%)
Overall Precision Testing:
TOTAL Tests: 120
Invalid: 0
Correct Results: 120
Incorrect Results: 0
Percent Correct: 100%
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.”
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, Maine 04072
June 24, 2021
Re: K202196
Trade/Device Name: BioFire RP2.1/RP2.1plus Control Panel M441 Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: July 30, 2020 Received: August 5, 2020
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 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
1
- 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 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.
Kristian Roth, Ph.D. Deputy Director (Acting) Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202196
Device Name BioFire RP2.1/RP2.1plus Control Panel M441
Indications for Use (Describe)
BioFire RP2.1/RP2.1plus Control Panel M441 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire Respiratory Panel 2.1 (RP2.1), BioFire Respiratory Panel 2.1 plus) and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) assay performed on the BioFire FilmArray systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1phus and BioFire RP2.1-EZ assay. This product is not intended to replace manufacturer controls provided with the device.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in a stylized font, with "MM" in dark red and "QCI" in yellow. A yellow abstract design is to the left of the acronym. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller, sans-serif font.
23 Mill Brook Road Mill Brook Business Park Saco, Maine 04072 www.mmaci.com Phone: 207-885-1072 Fax: 207-885-1079
Section 5: 510 (k) Summary
510(k) Number:
Purpose for submission: New product
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: July 30, 2020
Device
| Device Trade Name: | BioFire RP2.1/RP2.1plus Control Panel M441 |
|---|---|
| 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
K173171; FilmArray RP2/RP2plus Control Panel, P/N 315
Device Description
BioFire RP2.1/RP2.1plus Control Panel M441, P/N M441, is a quality control panel consisting of 2 ready-to-use, liquid controls, BioFire RP2.1/RP2.1plus Positive (Positive Control) and BioFire RP2.1/RP2.1plus Negative Control). The Positive Control contains noninfectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus), and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays (Table 1. below) on the BioFire® FilmArray systems, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). BioFire RP2.1/RP2.1plus Negative contains buffer and preservatives with no RNA. Each liquid control of BioFire RP2.1/RP2.1plus
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 "MM" in a dark red color, with the letters "QCI" in yellow. A yellow swirl design is to the left of the letters. The full name of the company is written in smaller font below the letters.
Control Panel M441 is processed separately according to BioFire RP2.1, RP2.1plus, and RP2.1-EZ assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).
| Table 1. Respiratory pathogens detected by BioFire RP2.1, RP2.1plus, and RP2.1-EZ
| assays. | |
|---|---|
| Respiratory Pathogens | |
| Adenovirus | Influenza B |
| Coronavirus 229E | Parainfluenza Virus 1 |
| Coronavirus HKU1 | Parainfluenza Virus 2 |
| Coronavirus NL63 | Parainfluenza Virus 3 |
| Coronavirus OC43 | Parainfluenza Virus 4 |
| Middle East Respiratory Syndrome Coronavirus* | Respiratory Syncytial Virus |
| Severe Acute Respiratory Syndrome Coronavirus 2 | Bordetella parapertussis (IS001) |
| Human Metapneumovirus | Bordetella pertussis (ptxP) |
| Human Rhinovirus/ Enterovirus | Chlamydia pneumoniae |
| Influenza A, subtypes H1, H1-2009, H3 | Mycoplasma pneumoniae |
*Detected by BioFire RP2.1plus assay only.
Device Intended Use
BioFire RP2.1/RP2.1plus Control Panel M441 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1 plus) and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays performed on BioFire FilmArray® systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1, BioFire RP2.1plus and BioFire RP2.1-EZ assays. This product is not intended to replace manufacturer controls provided with the device.
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Image /page/5/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. The words "MAINE MOLECULAR QUALITY CONTROLS, INC." are written in a smaller font below the letters. A yellow graphic is on the left side of the logo.
Substantial Equivalence
BioFire RP2.1/RP2.1plus Control Panel M441 is manufactured using processes and a formula identical to those for MMQCI's quality control FilmArray RP2/RP2plus Control Panel (K173171), except for the addition of SARS-CoV-2 synthetic RNA. The Intended Use of the 2 control panels is the same.
| Characteristic | Candidate Device: BioFire
RP2.1/RP2.1plus Control Panel
M441 | Predicate Device:
FilmArray
RP2/RP2plus Control
Panel (K173171) |
|---------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use | External assayed quality control to
monitor in vitro lab nucleic acid test | Same |
| 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 |
| Number of targets
monitored in one assay | Multiple | Same |
| Pathogens contained in
the control panel | Respiratory, including SARS-CoV-2 | Same, not SARS-CoV-2 |
Summary Performance Data
Three lots of BioFire RP2.1/RP2.1plus Control Panel M441. BioFire RP2.1/RP2.1plus Positive (Positive Control), P/N M44321, and BioFire RP2.1/RP2.1plus Negative Control), P/N M44221, were manufactured by MMQCI. Internal studies were performed by testing the 3 lots with the BioFire® RP2.1/RP2.1plus assay on BioFire FilmArray Systems.
The internal study was performed by testing the 3 lots at MMQCI (Saco, Maine) over 2.5 weeks with 3 pouch lots by 3 operators. An external study was performed at an independent U.S. facility to assess performance of the BioFire RP2.1/RP2.1plus Control Panel M441 by independent operators on a large number of BioFire FilmArray instruments. The external performance study tested the 3 lots of BioFire RP2.1/RP2.1plus Control Panel M441 over a period of 8 days using 3 BioFire FilmArray pouch lots, incorporating multiple operators and instruments. Two of the BioFire pouch lots used at MMQCI were also used for testing at the external site, for a total of 4 pouch lots used across the 2 sites.
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Image /page/6/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. To the left of the letters, there is a stylized, abstract design in yellow, resembling a brushstroke or a flowing ribbon. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.," is written in smaller, maroon font.
Results and Conclusion:
All BioFire RP2.1/RP2.1plus Control Panel M441 controls were correctly detected in the internal and external studies. There was one Invalid result.
| Table 2. Summary of All Test Results: Internal and External Sites | ||||||||
|---|---|---|---|---|---|---|---|---|
| Number | ||||||||
| of 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 | ||||||||
| 2 | 172 | 1* | 86 | 0 | 100% | 85 | 0 | 100% |
*The Invalid result was not included in percent correct.
External Site Testing
A total of 52 BioFire RP2.1/RP2.1plus Control Panel M441 samples were tested between April 29, 2020 and May 8, 2020 at an external test site, independent of MMQCI. Three lots of Positive Control (D24APR20, F28APR20 C29APR20) and three lots of Negative Control (D11MAR20, F09JUL19, L22JUL19) were tested on three BioFire pouch lots, incorporating multiple operators and BioFire FilmArray instruments. All 52 controls tested were successful on the first attempt except for 1 Invalid pouch.
Results and Conclusion:
All BioFire RP2.1/RP2.1plus Positive controls and all BioFire RP2.1/RP2.1plus Negative controls gave correct results, with 1 Invalid pouch. BioFire RP2.1/RP2.1plus Control Panel M441 performed robustly when tested at the external site across 3 pouch lots, on multiple BioFire FilmArray 2.0 and Torch instruments/ modules, incorporating multiple operators.
| Table 3. Summary of External Results for 3 Control Lots | |||||||
|---|---|---|---|---|---|---|---|
| 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 | |||||||
| 52 | 1* | 26 | 0 | 100% | 25 | 0 | 100% |
- The Invalid sample was not included in the Percent Correct analysis.
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Image /page/7/Picture/0 description: The image contains the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in a stylized font, with "MM" in a dark red color and "QCI" in yellow. To the left of the acronym is a yellow graphic that resembles a stylized strand of DNA or a brushstroke. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.," is written in a smaller, sans-serif font.
Precision Testing
Precision was demonstrated by testing 3 lots of BioFire RP2.1/RP2.1plus Positive control and 3 lots of BioFire RP2.1/RP2.1plus Negative control at MMQCI's facility in Saco, Maine over 20 days with 3 pouch lots by 3 operators using two FilmArray® 2.0 instruments. All BioFire RP2.1/RP2.1plus Control Panel M441 controls were correctly detected. No Invalid results were seen.
Results and Conclusion:
BioFire RP2.1/RP2.1plus Control Panel M441 is a robust and reproducible control panel across multiple control and reagent lots.
| Table 4. Summary of Precision Testing for 3 Control Lots at MMQCI | ||||||
|---|---|---|---|---|---|---|
| Control | Control Lot # | No. of Tests | Invalid | Correct Results | Incorrect Results | Percent Correct |
| FilmArray RP2.1/RP2.1plus Positive | D24APR20 | 20 | 0 | 20 | 0 | 100% |
| FilmArray RP2.1/RP2.1plus Positive | F28APR20 | 20 | 0 | 20 | 0 | 100% |
| FilmArray RP2.1/RP2.1plus Positive | C29APR20 | 20 | 0 | 20 | 0 | 100% |
| FilmArray RP2.1/RP2.1plus Negative | D11MAR20 | 20 | 0 | 20 | 0 | 100% |
| FilmArray RP2.1/RP2.1plus Negative | F09JUL19 | 20 | 0 | 20 | 0 | 100% |
| FilmArray RP2.1/RP2.1plus Negative | L22JUL19 | 20 | 0 | 20 | 0 | 100% |
| TOTAL | 120 | 0 | 120 | 0 | 100% |