(91 days)
Not Found
No
The device is a quality control panel for a nucleic acid test, not the test itself. The description focuses on the composition and performance of the control material, with no mention of AI or ML being used in its function or analysis.
No.
This device is a quality control panel used to monitor the performance of in vitro diagnostic tests, not to treat a disease or condition in a patient.
No
This device is described as an "external positive and negative assayed quality control" intended to "monitor the performance of in vitro laboratory nucleic acid testing procedures." It is not directly used to diagnose a patient.
No
The device is a quality control panel consisting of physical materials (synthetic DNA in buffers, stabilizers, and preservatives) intended for use with a laboratory testing system. It is 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 "monitoring the performance of in vitro laboratory nucleic acid testing procedures". This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, prevention, or treatment of disease.
- Device Description: The device is a "quality control panel" used with an in vitro diagnostic assay (BioFire® Blood Culture Identification 2 (BCID2) Panel). Quality controls are essential components of IVD testing to ensure the accuracy and reliability of the results.
- Care Setting: The intended user is an "in vitro laboratory / clinical laboratories", which are the typical settings where IVD testing is performed.
- Performance Studies: The document describes performance studies (reproducibility testing) conducted in clinical laboratories, which are standard for evaluating the performance of IVD-related products.
- Predicate Device: A predicate device (K190222; FilmArray Pneumonia/Pneumoniaplus Control) is listed, which is also a quality control for an IVD assay. This further supports the classification of this device as an IVD.
While this specific device is a quality control for an IVD, it is considered an IVD itself because it is intended to be used in vitro to assess the performance of another IVD device, thereby contributing to the overall diagnostic process.
N/A
Intended Use / Indications for Use
FilmArray BCID2 Control Panel M416 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 antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faccalis, Enterococcus faccium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire® Blood Culture Identification 2 (BCID2) Panel on the FilmArray® systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device.
Product codes
PMN
Device Description
FilmArray BCID2 Control Panel M416, P/N M416, is a quality control panel consisting of 2 controls, FilmArray BCID2 Positive Control, P/N M41718, and FilmArray BCID2 Negative Control. P/N M41818. The Positive 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® Blood Culture Identification 2 (BCID2) Panel assay (see Table 1. below) on the FilmArray systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray BCID2 Control Panel M416 is processed separately according to BioFire BCID2 Panel assay manufacturer's Instructions for Use for patient samples (positive blood cultures) obtained from individuals suspected of sepsis. Each tube 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: Reproducibility Testing Summary of Internal and External sites
Sample size: 307 tests performed (20 samples for each of 3 lots at MMQCI, 10 samples for each of 3 lots at 3 clinical laboratories; totals include retests)
Key results: Of the total 307 tests performed for the Reproducibility study, there were 300 correct results, positive and negative as listed in Table 2. There were 2 Invalid results and 5 incorrect Positive control results. The samples that gave Invalid results were re-tested according to BioFire instructions and were not included in the Percent Correct analysis in the table below. The incorrect Positive controls were all correct upon retesting. The predetermined acceptance criteria for the FilmArray BCID2 Control Panel M416 Reproducibility study, internal and external, were met for an overall correct result rate of 98.4%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Correct Result Rate: 98.4%
Percent Correct Positive Control: 96.8%
Percent Correct Negative Control: 100.0%
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 acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, while the Department of Health & Human Services logo is in black.
April 2, 2020
Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, Maine 04072
Re: K200010
Trade/Device Name: FilmArray BCID2 Control Panel M416 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 30, 2019 Received: January 2, 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. Branch Chief Bacterial Multiplex and Medical Counter Measures 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) K200010
Device Name
FilmArray BCID2 Control Panel M416
Indications for Use (Describe)
FilmArray BCID2 Control Panel M416 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 antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faccalis, Enterococcus faccium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire® Blood Culture Identification 2 (BCID2) Panel on the FilmArray® systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 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 for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of maroon and yellow colors. The word "MAINE MOLECULAR QUALITY CONTROLS, INC." is written in smaller font below the letters. A yellow abstract design is placed to the left of the letters.
23 Mill Brook Road Saco, Maine 04072 www.mmaci.com hone: 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: December 30, 2019
Device
| Device Trade Name: | FilmArray BCID2 Control Panel M416, P/N M416 |
|---|---|
| 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
K190222; FilmArray Pneumonia/Pneumoniaplus Control, Maine Molecular Quality Controls, Inc.
Device Description
FilmArray BCID2 Control Panel M416, P/N M416, is a quality control panel consisting of 2 controls, FilmArray BCID2 Positive Control, P/N M41718, and FilmArray BCID2 Negative Control. P/N M41818. The Positive 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® Blood Culture Identification 2 (BCID2) Panel assay (see Table 1. below) on the FilmArray systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray BCID2 Control Panel M416 is processed separately according to BioFire BCID2 Panel assay manufacturer's Instructions for Use for patient samples (positive blood cultures)
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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 combination of maroon and yellow. To the left of the letters is a stylized graphic in yellow, resembling a brush stroke or a flowing ribbon. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.," is written in smaller font.
obtained from individuals suspected of sepsis. Each tube of contains sufficient liquid for a single use.
| Antimicrobial resistance genes | |
|---|---|
| CTX-M | mecA/C and MREJ (MRSA) |
| IMP | NDM |
| KPC | OXA-48-like |
| mcr-1 | vanA/B |
| mecA/C | VIM |
| Gram Positive Bacteria | |
| Enterococcus faecalis | Streptococcus spp. |
| Enterococcus faecium | Streptococcus agalactiae (Group B) |
| Listeria monocytogenes | Streptococcus pneumoniae |
| Staphylococcus spp. | Streptococcus pyogenes (Group A) |
| Staphylococcus aureus | |
| Staphylococcus epidermidis | |
| Staphylococcus lugdunensis | |
| Gram Negative Bacteria | |
| Acinetobacter calcoaceticus-baumannii complex | Enteric bacteria |
| Bacteroides fragilis | Proteus spp. |
| Enteric bacteria | Salmonella spp |
| Enterobacter cloacae complex | Serratia marcescens |
| Escherichia coli | Haemophilus influenzae |
| Klebsiella aerogenes | Neisseria meningitidis |
| Klebsiella oxytoca | Pseudomonas aeruginosa |
| Klebsiella pneumoniae group | Stenotrophomonas maltophilia |
| Yeast | |
| Candida albicans | Candida parapsilosis |
| Candida auris | Candida tropicalis |
| Candida glabrata | Cryptococcus neoformans/gattii |
| Candida krusei |
Table 1. Pathogens and antimicrobial resistance genes found in FilmArray BCID2 Control Panel M416, detected by BioFire BCID2 Panel assay.
Device Intended Use
FilmArray BCID2 Control Panel M416 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 antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptocccus pyogenes (Group A), Acinetobacter calcoaceticusbaumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group,
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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, serif font, with "MM" in a dark red color and "QCI" in a lighter shade of red. Below the letters, there is the text "MAINE MOLECULAR QUALITY CONTROLS, INC." in a smaller, sans-serif font. To the left of the letters, there is an abstract, curved design in a yellow color, which appears to be a stylized representation of a wave or ribbon.
Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida auris, Candida glabrata, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire® Blood Culture Identification 2 (BCID2) Panel assay on FilmArray® systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device.
| Characteristic | Candidate Device:
FilmArray BCID2 Control
Panel M416 | Predicate Device:
FilmArray
Pneumonia/Pneumoniaplus
Control (K190222) |
|---------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 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 blood culture
tube) | Process like patient sample
(Pipette from sputum or BAL
tube) |
| Composition | Synthetic DNA | Synthetic DNA, and RNA
transcripts |
| Assay Steps Monitored | Amplification, detection,
identification | Same plus reverse
transcription |
| Number of targets
monitored in one assay | Multiple, >30 targets | Same, >30 targets |
Substantial Equivalence
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Image /page/6/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a serif font, with "MM" in a dark red color and "QCI" in black. Below the letters, the full name of the company is written in a smaller font. A golden, abstract brushstroke-like design is placed to the left of the letters, adding a decorative element to the logo.
Summary Performance Data
Precision: Reproducibility Testing Summary of Internal and External sites
Three lots of FilmArray BCID2 Control Panel M416 consisting of FilmArray BCID2 Positive Control and FilmArray BCID2 Negative Control were manufactured by MMQCI. Reproducibility studies were performed by testing the 3 control lots with the BioFire BCID2 Panel assay on FilmArray systems at MMQCI and 3 clinical laboratories. 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 in the study.
Internal testing at MMQCI (Saco, Maine) was performed by testing 20 samples of each of the 3 lots on different days over approximately 6 weeks, with 3 pouch lots by 4 operators for a total of 122 (2 repeats) tests.
The external performance study to assess the FilmArray BCID2 Control Panel M416 in a clinical setting was performed by testing 10 samples of each of the 3 lots of BCID2 Control Panel M416 on different days at 3 CLIA-certified clinical sites using 3 FilmArray pouch lots and incorporating multiple operators for a total of 186 (6 repeats) tests.
Summary Results and Conclusions:
Of the total 307 tests performed for the Reproducibility study, there were 300 correct results, positive and negative as listed in Table 2. There were 2 Invalid results and 5 incorrect Positive control results. The samples that gave Invalid results were re-tested according to BioFire instructions and were not included in the Percent Correct analysis in the table below. The incorrect Positive controls were all correct upon retesting. The predetermined acceptance criteria for the FilmArray BCID2 Control Panel M416 Reproducibility study, internal and external, were met for an overall correct result rate of 98.4%.
| 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 |
|----------------------------------------------------------------------------------|----------|------------------------------------------|--------------------------------------------|-------------------------------------------|------------------------------------------|--------------------------------------------|-------------------------------------------|-----------------------------|
| Summary of Reproducibility Test Results at MMQCI and 3 Clinical Laboratory Sites | | | | | | | | |
| 307 | 2 | 150 | 5 | 96.8% | 150 | 0 | 100.0% | 98.4% |
| Table 2. FilmArray BCID2 Control Panel M416: Reproducibility results, all sites. | ||
|---|---|---|
*The 2 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.