(582 days)
Not Found
No
The device is a quality control panel containing synthetic DNA for monitoring the performance of a separate nucleic acid testing system. There is no mention of AI or ML in the description of the control panel itself or its intended use.
No.
This device is a quality control panel intended to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to treat or diagnose patients.
No
This device is described as an "external positive assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures." It is used to check the accuracy of other diagnostic devices, not to diagnose a patient's condition itself.
No
The device description clearly states that the device is a "quality control panel consisting of 2 controls" which are liquid solutions containing synthetic DNA. This is a physical product, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use as an external positive assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures". The phrase "in vitro laboratory nucleic acid testing procedures" is a key indicator of an IVD.
- Device Description: The description details the composition of the control panel, which contains synthetic DNA designed to be used with the BioFire JI Panel assay. This assay is used for the qualitative detection of pathogens and antimicrobial resistance genes, which are diagnostic purposes.
- Intended User / Care Setting: The intended user is an "in vitro laboratory", further reinforcing its use in a laboratory setting for diagnostic testing.
- Performance Studies: The document describes performance studies conducted to evaluate the reproducibility and external performance of the control panel in a clinical laboratory setting. This is typical for IVD devices.
- Predicate Device: A predicate device (K200010: FilmArray BCID2 Control Panel M416) is listed, which is also a control panel for an IVD assay. This suggests the current device is also intended for a similar IVD purpose.
The device is a quality control for an IVD assay, and quality controls used in conjunction with IVD assays are themselves considered IVDs.
N/A
Intended Use / Indications for Use
BioFire JI Control Panel M420 is intended for use as an external positive assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finezoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire II Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire II Panel assay. This product is not intended to replace manufacturer controls provided with the device.
Product codes
PMN
Device Description
BioFire JI Control Panel M420, P/N M420, is a quality control panel consisting of 2 controls, BioFire JI Positive Control, P/N M42118, and JI Negative Control, P/N M42218. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire® Joint Infection (JI) Panel assay (see Table 1. below) on the BioFire® systems. The Negative Control contains buffers, stabilizers and preservatives. Each liquid control of BioFire JI Control Panel M420 is processed separately according to the BioFire JI Panel assay manufacturer's Instructions for Use for patient samples (synovial fluid) obtained from individuals suspected of infection. Each tube of control contains sufficient liquid for a single use.
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
Three lots of BioFire JI Control M420, consisting of BioFire JI Positive Control and BioFire JI Negative Control, were manufactured by MMQCI. The lots were manufactured and tested such that routine variables including multiple lots of key manufacturing components, different operators, pouch lots, instruments, test sites, and testing over time were incorporated to challenge performance. External and internal studies were performed by testing the 3 lots with the BioFire® JI Panel assay on BioFire FilmArray Systems. The external performance study was performed by testing 10 samples of each of the 3 lots of BioFire JI Control Panel M420 on different days at 3 CLIA-certified clinical sites using 3 FilmArray pouch lots, incorporating multiple operators for a total of 181 tests (1 Invalid result was repeated). The internal reproducibility study was performed by testing 20 samples of each of the 3 lots at MMQCI (Saco, Maine) on different days with 3 pouch lots by 3 operators for a total of 120 tests.
Results and Conclusions: Of the total 301 tests performed for the Reproducibility study, there were 300 correct results, positive and negative as listed in Table 2, and 1 Invalid result. The sample that gave an Invalid result was re-tested according to BioFire instructions and was not included in the Percent Correct analysis in the table below. Reproducibility of BioFire JI Control Panel M420 at 4 sites, across 3 pouch lots, 3 control lots, on multiple instruments by multiple operators is acceptable according to predetermined criteria with an overall correct result rate of 100%. Test results demonstrate robust performance across 4 testing sites.
External Site Testing Details: Of the total 301 reproducibility tests, 181 BioFire JI Control Panel M420 samples were tested at 3 clinical sites. Three lots of BioFire JI Positive Control (D19DEC19A, D23DEC19A, E27DEC19A) and 3 lots of BioFire JI Negative Control (C28NOV18F, A14JUN19G, F29OCT19D) were tested on 3 BioFire JI Panel pouch lots across the 3 sites, incorporating multiple operators and instruments. The laboratories were instructed to run 3 Positive and 3 Negative controls, for each lot, per day on 10 different days. Valid results were obtained for 180 controls. Of the 181 controls tested, 1 gave an Invalid result and was retested according to BioFire Instructions for Use. Correct results were obtained for the retest. The Invalid result was not included in the Percent Correct analysis in the table below.
Results and Conclusion: Out of 180 tests with valid pouch controls, the correct analytes were detected (for positive controls) or not detected (for negative controls) in all 180 tests, for an overall success rate of 100% (Table 3). Predetermined acceptance criteria for reproducibility were met. BioFire JI Control Panel M420 performed robustly at the 3 external test sites across 3 pouch lots on 19 BioFire FilmArray 2.0 and Torch instruments/ modules, incorporating multiple operators.
Internal Site Testing Details: Run-to-run Precision Testing at MMOCI: Of the total 301 reproducibility tests, 120 BioFire II Control Panel M420 samples were tested over February and March of 2020 at MMQCI's facility. Each control was tested 20 times on 20 different days. Three lots of Positive Control (D19DEC19A, D23DEC19A, E27DEC19A) and 3 lots of Negative Control (C28NOV18F, A14JUN19G, F29OCT19D) were tested on 3 BioFire JI pouch lots, incorporating 3 operators and 2 FilmArray 2.0 instruments (Table 4).
Results and conclusions: All Controls gave correct results for an overall correct result rate of 100%. Predetermined acceptance criteria for reproducibility were met. BioFire JI Control Panel M420 performed robustly on 20 different days at MMQCI across 3 pouch lots on 2 BioFire FilmArray 2.0 instruments, incorporating 3 operators.
Matrix Effects: Human Synovial fluid (Innovative Research) was used. The matrix of the BioFire JI Control Panel M420 is synthetic. A test was performed to investigate the effect of the matrix on the assay. Equal volumes of the same concentration of gDNA Streptococcus pneumoniae, strain TCH8431 (BEI Resources, P/N HM-145D) were spiked into 270uL of BioFire JI Control Panel M420 matrix and 270uL of contrived patient matrix (Human Synovial Fluid; Innovative Research), then tested on the BioFire JI Panel assay in triplicate. Criteria to be met are correct calls for the spiked simulated clinical sample and spiked matrix.
Results and Conclusions: The same expected calls were obtained for the spiked human synovial fluid (simulated clinical sample) and spiked JI matrix (Detected for Streptococcus spp. and S. pneumoniae, Not Detected for all other assays). As indicated in the summary data table below (Table 11), the BioFire JI Control Panel M420 matrix has no effect on the assay.
Key Metrics
Overall correct result rate of 100% for reproducibility studies.
Overall success rate of 100% for external site testing.
All Controls gave correct results for an overall correct result rate of 100% for internal site testing.
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 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 in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, Maine 04072
July 22, 2022
Re: K203680
Trade/Device Name: BioFire JI Control Panel M420 Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed Quality Control Material For Clinical Microbiology Assays Regulatory Class: Class II Product Code: PMN Dated: December 15, 2020 Received: June 14, 2022
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
1
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 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,
Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch 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) K203680
Device Name BioFire JI Control Panel M420
Indications for Use (Describe)
BioFire JI Control Panel M420 is intended for use as an external positive assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finezoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire II Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire II Panel 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 and contact information for Maine Molecular Quality Controls, Inc. The logo consists of the letters "MMQCI" in a stylized font, with the words "MAINE MOLECULAR QUALITY CONTROLS, INC." written below. The contact information includes the address "23 Mill Brook Road, Saco, Maine 04072", the website "www.mmqci.com", the phone number "207-885-1072", and the fax number "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: | December 15, 2020 |
Device
| Device Trade Name: | BioFire JI Control Panel M420, P/N M420 |
|---|---|
| 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
K200010: FilmArray BCID2 Control Panel M416. P/N M416. Maine Molecular Quality Controls, Inc.
Device Description
BioFire JI Control Panel M420, P/N M420, is a quality control panel consisting of 2 controls, BioFire JI Positive Control, P/N M42118, and JI Negative Control, P/N M42218. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire® Joint Infection (JI) Panel assay (see Table 1. below) on the BioFire® systems. The Negative Control contains buffers, stabilizers and preservatives. Each liquid control of BioFire JI Control Panel M420 is processed separately according to the BioFire JI Panel assay manufacturer's Instructions for Use for patient samples (synovial fluid) obtained from individuals suspected of infection. Each tube of control contains sufficient liquid for a single use.
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Image /page/4/Picture/0 description: The image shows the contact information for MMQCI, or Maine Molecular Quality Controls, Inc. The address is 23 Mill Brook Road, Saco, Maine 04072. The website is www.mmqci.com, the phone number is 207-885-1072, and the fax number is 207-885-1079.
Table 1. Pathogens and antimicrobial resistance genes found in BioFire JI Control Panel M420, detected by BioFire JI Panel assay.
| Positive Control | Negative Control | |
|---|---|---|
| Gram Positive Bacteria | ||
| Anaerococcus prevotii/vaginalis | Detected | Not Detected |
| Clostridium perfringens | Detected | Not Detected |
| Cutibacterium avidum/granulosum | Detected | Not Detected |
| Enterococcus faecalis | Detected | Not Detected |
| Enterococcus faecium | Detected | Not Detected |
| Finegoldia magna | Detected | Not Detected |
| Parvimonas micra | Detected | Not Detected |
| Peptoniphilus | Detected | Not Detected |
| Peptostreptococcus anaerobius | Detected | Not Detected |
| Staphylococcus aureus | Detected | Not Detected |
| Staphylococcus lugdunensis | Detected | Not Detected |
| Streptococcus spp. | Detected | Not Detected |
| Streptococcus agalactiae | Detected | Not Detected |
| Streptococcus pneumoniae | Detected | Not Detected |
| Streptococcus pyogenes | Detected | Not Detected |
| Gram Negative Bacteria | ||
| Bacteroides fragilis | Detected | Not Detected |
| Citrobacter | Detected | Not Detected |
| Enterobacter cloacae complex | Detected | Not Detected |
| Escherichia coli | Detected | Not Detected |
| Haemophilus influenzae | Detected | Not Detected |
| Kingella kingae | Detected | Not Detected |
| Klebsiella aerogenes | Detected | Not Detected |
| Klebsiella pneumoniae group | Detected | Not Detected |
| Morganella morganii | Detected | Not Detected |
| Neisseria gonorrhoeae | Detected | Not Detected |
| Proteus spp. | Detected | Not Detected |
| Pseudomonas aeruginosa | Detected | Not Detected |
| Salmonella spp. | Detected | Not Detected |
| Serratia marcescens | Detected | Not Detected |
| Antimicrobial resistance genes | ||
| CTX-M | Detected | N/A |
| IMP | Detected | N/A |
| KPC | Detected | N/A |
| mecA/C and MREJ (MRSA) | Detected | N/A |
| NDM | Detected | N/A |
| OXA-48-like | Detected | N/A |
| vanA/B | Detected | N/A |
| VIM | Detected | N/A |
| Yeast | ||
| Candida | Detected | Not Detected |
| Candida albicans | Detected | Not Detected |
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Image /page/5/Picture/0 description: The image shows the logo and contact information for Maine Molecular Quality Controls, Inc. The address is 23 Mill Brook Road, Saco, Maine 04072. The website is www.mmqci.com, the phone number is 207-885-1072, and the fax number is 207-885-1079.
Device Intended Use
BioFire JI Control Panel M420 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 Gram positive and Gram negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finegoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida and Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire II Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire JI Panel assay. This product is not intended to replace manufacturer controls provided with the device.
Substantial Equivalence
Maine Molecular Quality Controls, Inc. (MMQCI) proposes that BioFire JI Control Panel M420 is substantially equivalent to currently marketed medical device FilmArray BCID2 Control Panel M416 (K200010). BioFire JI Control Panel M420 is manufactured using the same processes and formulation as for MMQCI's quality control, FilmArray BCID2 Control Panel M416.
| Characteristic | Candidate Device: BioFire
JI Control Panel M420 | Predicate Device:
FilmArray BCID2 Control
Panel M416 (K200010) |
|---------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 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
(Pipette from synovial fluid) | Process like patient sample
(Pipette from blood culture) |
| Composition | Synthetic DNA | Same |
| Assay Steps Monitored | Amplification, detection,
identification | Same |
| Number of targets
monitored in one assay | Multiple, >30 targets | Same, >30 targets |
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Image /page/6/Picture/0 description: This image contains the contact information for Maine Molecular Quality Controls, Inc. The address is listed as 23 Mill Brook Road, Saco, Maine 04072. The phone number is 207-885-1072, and the fax number is 207-885-1079. The website is www.mmqci.com.
Summary Performance Data
Three lots of BioFire JI Control M420, consisting of BioFire JI Positive Control and BioFire JI Negative Control, were manufactured by MMQCI. The lots were manufactured and tested such that routine variables including multiple lots of key manufacturing components, different operators, pouch lots, instruments, test sites, and testing over time were incorporated to challenge performance. External and internal studies were performed by testing the 3 lots with the BioFire® JI Panel assay on BioFire FilmArray Systems. The external performance study was performed by testing 10 samples of each of the 3 lots of BioFire JI Control Panel M420 on different days at 3 CLIA-certified clinical sites using 3 FilmArray pouch lots, incorporating multiple operators for a total of 181 tests (1 Invalid result was repeated). The internal reproducibility study was performed by testing 20 samples of each of the 3 lots at MMQCI (Saco, Maine) on different days with 3 pouch lots by 3 operators for a total of 120 tests.
Results and Conclusions:
Of the total 301 tests performed for the Reproducibility study, there were 300 correct results, positive and negative as listed in Table 2, and 1 Invalid result. The sample that gave an Invalid result was re-tested according to BioFire instructions and was not included in the Percent Correct analysis in the table below.
Reproducibility of BioFire JI Control Panel M420 at 4 sites, across 3 pouch lots, 3 control lots, on multiple instruments by multiple operators is acceptable according to predetermined criteria with an overall correct result rate of 100%. Test results demonstrate robust performance across 4 testing sites.
| Summary of Reproducibility Test Results: MMQCI and 3 Clinical Laboratory 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 | ||||||||
| 301 | 1 | 150 | 0 | 100% | 150 | 0 | 100% | 100% |
Table 2. BioFire JI Control Panel M420: Reproducibility results, all sites.
*The Invalid sample was re-tested according to BioFire instructions and was not included in the Percent Correct analysis.
External Site Testing Details
Of the total 301 reproducibility tests. 181 BioFire JI Control Panel M420 samples were tested at 3 clinical sites. Three lots of BioFire JI Positive Control (D19DEC19A, D23DEC19A, E27DEC19A) and 3 lots of BioFire JI Negative Control (C28NOV18F, A14JUN19G, F29OCT19D) were tested on 3 BioFire JI Panel pouch lots across the 3 sites, incorporating multiple operators and instruments. The laboratories were instructed to run 3 Positive and 3 Negative controls, for each lot, per day on 10 different days. Valid results were obtained for 180 controls. Of the 181 controls tested, 1 gave an Invalid result and was retested according to BioFire Instructions for Use. Correct results were obtained for the retest. The Invalid result was not included in the Percent Correct analysis in the table below.
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Image /page/7/Picture/0 description: The image shows the contact information for MMQCI, or Maine Molecular Quality Controls, Inc. The address is 23 Mill Brook Road, Saco, Maine 04072. The website is www.mmqci.com, the phone number is 207-885-1072, and the fax number is 207-885-1079.
Results and Conclusion:
Out of 180 tests with valid pouch controls, the correct analytes were detected (for positive controls) or not detected (for negative controls) in all 180 tests, for an overall success rate of 100% (Table 3). Predetermined acceptance criteria for reproducibility were met. BioFire JI Control Panel M420 performed robustly at the 3 external test sites across 3 pouch lots on 19 BioFire FilmArray 2.0 and Torch instruments/ modules, incorporating multiple operators.
Table 3. BioFire JI Control Panel M420: Summary of Reproducibility Results for 3 Control Lots at 3 Clinical Sites
| Summary of External Results for 3 Control Lots of BioFire JI Control Panel M420 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | 61 | 1* | 30 | 0 | 100% | 30 | 0 | 100% | 100% |
| 2 | 60 | 0 | 30 | 0 | 100% | 30 | 0 | 100% | 100% |
| 3 | 60 | 0 | 30 | 0 | 100% | 30 | 0 | 100% | 100% |
| All | |||||||||
| Sites | 181 | 1* | 90 | 0 | 100% | 90 | 0 | 100% | 100% |
*Invalid result was not included in percent correct.
Internal Site Testing Details
Run-to-run Precision Testing at MMOCI: Of the total 301 reproducibility tests, 120 BioFire II Control Panel M420 samples were tested over February and March of 2020 at MMQCI's facility. Each control was tested 20 times on 20 different days. Three lots of Positive Control (D19DEC19A, D23DEC19A, E27DEC19A) and 3 lots of Negative Control (C28NOV18F, A14JUN19G, F29OCT19D) were tested on 3 BioFire JI pouch lots, incorporating 3 operators and 2 FilmArray 2.0 instruments (Table 4).
Results and conclusions:
All Controls gave correct results for an overall correct result rate of 100%. Predetermined acceptance criteria for reproducibility were met. BioFire JI Control Panel M420 performed robustly on 20 different days at MMQCI across 3 pouch lots on 2 BioFire FilmArray 2.0 instruments, incorporating 3 operators.
| Summary of Precision Testing for 3 JI Control Lots at MMQCI | ||||||
|---|---|---|---|---|---|---|
| Control | Control Lot # | No. of | ||||
| Tests | Invalid | Correct | ||||
| Results | Incorrect | |||||
| Results | Percent | |||||
| Correct | ||||||
| BioFire JI Negative Control | C28NOV18F | 20 | 0 | 20 | 0 | 100% |
| BioFire JI Negative Control | A14JUN19G | 20 | 0 | 20 | 0 | 100% |
| BioFire JI Negative Control | F29OCT19D | 20 | 0 | 20 | 0 | 100% |
| BioFire JI Positive Control | D19DEC19A | 20 | 0 | 20 | 0 | 100% |
| BioFire JI Positive Control | D23DEC19A | 20 | 0 | 20 | 0 | 100% |
| BioFire JI Positive Control | E27DEC19A | 20 | 0 | 20 | 0 | 100% |
| TOTAL | 120 | 0 | 120 | 0 | 100% |
Table 4. FilmArray BCID2 Control Panel M416: Reproducibility results at MMOCI.
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Image /page/8/Picture/0 description: The image shows the contact information for MMQCI (Maine Molecular Quality Controls, Inc.). The address is 23 Mill Brook Road, Saco, Maine 04072. The website is www.mmqci.com, the phone number is 207-885-1072, and the fax number is 207-885-1079.
Matrix Effects
Human Synovial fluid used for the study: Single Donor Human Synovial Fluid, Part Number IRHUSYNS1ML, Company: Innovative Research
The matrix of the BioFire JI Control Panel M420 is synthetic, which allows for reproducible manufacturing and stability, provides a non-infectious material for the laboratory staff and carries the control DNA through the extraction process. Since the matrix is not identical to that of the routine JI assay sample, synovial fluid, a test was performed to investigate the effect of the matrix on the assay. Equal volumes of the same concentration of gDNA Streptococcus pneumoniae, strain TCH8431 (BEI Resources, P/N HM-145D) were spiked into 270uL of BioFire JI Control Panel M420 matrix and 270uL of contrived patient matrix (Human Synovial Fluid; Innovative Research), then tested on the BioFire JI Panel assay in triplicate. Criteria to be met are correct calls for the spiked simulated clinical sample and spiked matrix.
Results and Conclusions:
The same expected calls were obtained for the spiked human synovial fluid (simulated clinical sample) and spiked JI matrix (Detected for Streptococcus spp. and S. pneumoniae, Not Detected for all other assays)
As indicated in the summary data table below (Table 11), the BioFire JI Control Panel M420 matrix has no effect on the assay.
| Pathogen
| Analyte | Spiked BEI S.pneumoniae Crossing Point (Cp) | |||||||
|---|---|---|---|---|---|---|---|---|
| MMQCI JI Matrix | Mean Cp | Human Synovial Fluid (SF) | Mean Cp | |||||
| Streptococcus | 10.8 | 10.4 | 12.7 | 11.3 | 11.4 | 11.8 | 11.7 | 11.6 |
| Spneumoniae | 9.3 | 9.1 | 10.3 | 9.6 | 10.1 | 10.3 | 10.2 | 10.2 |