(87 days)
Not Found
No
The device is a quality control material for a nucleic acid test, not a diagnostic device that processes data or images. The description focuses on the composition and performance of the control material itself, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an external quality control material used to monitor the performance of in vitro diagnostic tests, not to treat or cure a disease.
No
This device is a quality control material intended to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a quality control panel composed of synthetic DNA and RNA in buffers, stabilizers, and preservatives. This is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring 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 derived from the human body to provide information for diagnostic purposes.
- Device Description: The device is a "quality control panel" used with the FilmArray Pneumonia Panel or Pneumonia Panel plus assays, which are themselves IVDs. Quality controls are essential components of in vitro diagnostic testing to ensure the accuracy and reliability of the results.
- Care Setting: The intended user is an "in vitro laboratory / CLIA-certified clinical sites," which are settings where in vitro diagnostic testing is performed.
- Performance Studies: The performance studies describe testing conducted in "CLIA-certified clinical sites," further indicating its use in a clinical laboratory setting for diagnostic purposes.
- Predicate Device: The predicate device listed (FilmArray RP EZ Control Panel M265) is also a quality control panel for an IVD, reinforcing the classification of this device as an IVD.
While this specific device is a quality control and not the primary diagnostic test itself, it is an integral part of the in vitro diagnostic process and is therefore classified as an IVD.
N/A
Intended Use / Indications for Use
FilmArray Pneumonia/Pneumoniaplus Control is intended for use as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus agalactiae, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumonila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray Pneumonia/ Pneumoniaplus Control is composed of synthetic DNA and RNA designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer internal controls provided with the test system.
Product codes
PMN
Device Description
FilmArray Pneumonia/Pneumoniaplus Control, P/N M340, is a quality control panel consisting of 2 controls, FilmArray Pneumoniaplus Positive (Positive Control), P/N M34235, and FilmArray Pneumonia/Pneumoniaplus Negative Control), P/N M34135. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA and RNA in buffers, stabilizers and preservatives. The DNA and RNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the respiratory pathogens and antimicrobial resistance genes detected and identified by the FilmArray® Pneumonia Panel and Pneumonia Panel plus assays (see Table 1. below) on the FilmArray® systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray Pneumonia/Pneumoniaplus Control is processed separately according to FilmArray® Pneumonia Panel or Pneumonia Panel plus assays manufacturer's Instructions for Use for patient samples (Sputum) obtained from individuals suspected of lower respiratory tract 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
in vitro laboratory nucleic acid testing procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Three lots of FilmArray Pneumonia/Pneumoniaplus Control were manufactured. Internal studies were performed by testing the 3 lots with the FilmArray Pneumonia Panel plus assay on the FilmArray 2.0 or FilmArray Torch systems. This internal study was performed at MMQCI (Saco, Maine) over 60 days with 3 pouch lots by 3 operators.
An external study was performed to assess performance of the FilmArray Pneumonia/Pneumoniaplus Control in a clinical setting at 3 CLIA-certified clinical sites over a period of 10 days using 3 FilmArray pouch lots, incorporating multiple operators and instruments. Two of the external pouch lots were different from MMQCI lots.
For the external site testing, 185 FilmArray Pneumoniaplus Control samples were tested between July 2018 and September 2018 at 3 clinical sites. Three lots of Positive Control (D04MAY18A, H29MAY18A, C12JUN18A) and three lots of Negative Control (E30APR18A, C18MAY18A, D30MAY18A) were tested on 3 Pneumoniaplus pouch lots across the 3 sites, incorporating multiple operators. Three Positive Controls and 3 Negative Controls were run per day/per site over a period of 10 days. Not all testing days were consecutive.
For the internal site testing, 123 FilmArray Pneumonia/Pneumoniaplus Control samples were tested between July 2018 and September 2018 at MMQCI's facility. Three lots of Positive Control (D04MAY18A, H29MAY18A, C12JUN18A) and 3 lots of Negative Control (E30APR18A, C18MAY18A, D30MAY18A) were tested over 60 days on 3 Pneumonia/Pneumoniaplus pouch lots, incorporating 3 operators and 2 FilmArray 2.0 instruments.
For repeatability, 7 samples of FilmArray Pneumonia/Pneumoniaplus Control were tested. Within-run precision was demonstrated by 1 operator testing 1 lot each of FilmArray Positive and FilmArray Pneumonia/Pneumoniaplus Negative, with 1 lot of FilmArray Pneumonia/Pneumoniaplus Panel pouches on one FilmArray 2.0, all within one day at MMQCI.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Total tests: 308. Of 308 tests of FilmArray Pneumoniaplus Control, correct results were reported in 300 tests on the first attempt. There were 2 Negative Controls with false positive results and 6 Positive Controls with false negative results. All produced the correct results upon a single retest for an overall correct result rate of 97.4%.
External Site Testing: Of 185 tests, correct results were obtained on the first test of 175 controls. Two Negative Controls gave initial false positive results and 3 Positive controls gave initial false negative results. All produced the correct results upon a single retest for an overall correct result rate of 97.3%.
Internal Site Testing: Of 123 tests, all Positive Controls gave correct results except for 3 which gave false negative results. Repeat tests gave correct results on the first retest. All Negative Controls gave correct results. The overall correct result rate at MMQCI was 97.6%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall correct result rate: 97.4%.
External Sites: Correct Positive Control rate 96.8%; Correct Negative Control rate 97.8%; Total Correct 97.3%.
MMQCI Internal Sites: Correct Negative Controls 100%; Correct Positive Controls 95.2%; Total Correct 97.6%.
Repeatability Study: All results were correct (6/6 for Positive Control, 6/6 for Negative Control).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3920 Assayed quality control material for clinical microbiology assays.
(a)
Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below that.
May 3, 2019
Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, Maine 04072
Re: K190222
Trade/Device Name: FilmArray Pneumonia/Pneumoniaplus Control Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: January 15, 2019 Received: February 5, 2019
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190222
Device Name
FilmArray Pneumonia/Pneumoniaplus Control
Indications for Use (Describe)
FilmArray PneumonialPneumoniaplus Control is intended for use as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus agalactiae, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumonila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray Pneumonia/ Pneumoniaplus Control is composed of synthetic DNA and RNA designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer internal controls provided with the test system.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the contact information for MMQCI, or Maine Molecular Quality Controls, Inc. The address is 23 Mill Brook Road, Mill Brook Business Park, Saco, Maine 04072. The website is www.mmqci.com, the phone number is 207-885-1072, and the fax number is 207-885-1079. The logo for MMQCI is also shown.
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: January 14, 2019
Device
| Device Trade Name: | FilmArray Pneumonia/Pneumoniaplus Control, P/N M340 |
|---|---|
| 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
K161573; FilmArray RP EZ Control Panel M265, Maine Molecular Quality Controls, Inc.
Device Description
FilmArray Pneumonia/Pneumoniaplus Control, P/N M340, is a quality control panel consisting of 2 controls, FilmArray Pneumoniaplus Positive (Positive Control), P/N M34235, and FilmArray Pneumonia/Pneumoniaplus Negative Control), P/N M34135. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA and RNA in buffers, stabilizers and preservatives. The DNA and RNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the respiratory pathogens and antimicrobial resistance genes detected and identified by the FilmArray® Pneumonia Panel and Pneumonia Panel plus assays (see Table 1. below) on the FilmArray® systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray Pneumonia/Pneumoniaplus
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for Maine Molecular Quality Controls, Inc. The address is 23 Mill Brook Road, Mill Brook Business Park, Saco, Maine 04072. The website is www.mmqci.com, and the phone and fax numbers are 207-885-1072 and 207-885-1079, respectively.
Control is processed separately according to FilmArray® Pneumonia Panel or Pneumonia Panel plus assays manufacturer's Instructions for Use for patient samples (Sputum) obtained from individuals suspected of lower respiratory tract infection. Each tube of control contains sufficient liquid for a single use.
| Bacteria | |
|---|---|
| Acinetobacter calcoaceticus-baumannii complex | Pseudomonas aeruginosa |
| Enterobacter cloacae complex | Serratia marcescens |
| Escherichia coli | Staphylococcus aureus |
| Haemophilus influenzae | Streptococcus agalactiae |
| Klebsiella aerogenes | Streptococcus pneumoniae |
| Klebsiella oxytoca | Streptococcus pyogenes |
| Klebsiella pneumoniae group | Chlamydia pneumoniae |
| Moraxella catarrhalis | Legionella pneumophila |
| Proteus spp. | Mycoplasma pneumoniae |
| Antimicrobial Resistance Genes | |
| CTX-M | NDM |
| IMP | OXA-48 like |
| KPC | VIM |
| mecA/C and MREJ | |
| Viruses | |
| Adenovirus | Influenza B |
| Coronavirus | Middle East Respiratory Syndrome |
| Coronavirus* | |
| Human Metapneumovirus | Parainfluenza Virus |
| Human Rhinovirus/Enterovirus | Respiratory Syncytial Virus |
| Influenza A |
Table 1. Respiratory pathogens and antimicrobial resistance genes detected by FilmArray®Pneumonia Panel & Pneumonia Panel plus assays.
*Detected by FilmArray Pneumonia Panel plus assay only.
5
Image /page/5/Picture/0 description: The image shows the contact information for a business located at 23 Mill Brook Road, Mill Brook Business Park, Saco, Maine 04072. The website is www.mmqci.com. The phone number is 207-885-1072, and the fax number is 207-885-1079.
Image /page/5/Picture/1 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 a yellow color. To the left of the letters is a yellow swirl design. Below the letters is the full name of the company in a smaller font.
Device Intended Use
FilmArray Pneumonia/Pneumoniaplus Control is intended for use as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray® Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray® systems. FilmArray Pneumonia/Pneumoniaplus Control is composed of synthetic DNA and RNA specifically designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer controls provided with the device.
| Characteristic | Candidate Device:
FilmArray
Pneumonia/Pneumoniaplus
Control | Predicate Device:
FilmArray RP EZ
Control Panel M265
(K161573) |
|---------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| 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
(swab placed in sputum) | Same (pipette as for
VTM) |
| Composition | Synthetic RNA & DNA | Synthetic RNA transcripts |
| Assay Steps Monitored | Reverse transcription
Amplification, detection,
identification | Same |
| Number of targets
monitored in one assay | Multiple | Same |
Substantial Equivalence
6
Image /page/6/Picture/0 description: The image shows the contact information for a business. The address is 23 Mill Brook Road, Mill Brook Business Park, Saco, Maine 04072. The website is www.mmqci.com, the phone number is 207-885-1072, and the fax number is 207-885-1079.
Summary Performance Data
All Test Results
Three lots of FilmArray Pneumonia/Pneumoniaplus Control, FilmArray Pneumonia/Pneumoniaplus Positive (Positive Control), P/N M34235, and FilmArray Pneumonia/Pneumoniaplus Negative Control), P/N M34135, were manufactured by Maine Molecular Quality Controls, Inc. (MMQCI). Internal studies were performed by testing the 3 lots with the FilmArray Pneumonia Panel plus assay on the FilmArray 2.0 or FilmArray Torch systems.
The internal study was performed by testing the 3 lots at MMQCI (Saco, Maine) over 60 days with 3 pouch lots by 3 operators. An external study was performed to assess performance of the FilmArray Pneumonia/Pneumoniaplus Control in a clinical setting. The external performance study tested the 3 lots of FilmArray Pneumonia/Pneumoniaplus Control at 3 CLIA-certified clinical sites over a period of 10 days using 3 FilmArray pouch lots, incorporating multiple operators and instruments. Two of the external pouch lots were different from MMQCI lots.
Of 308 tests of FilmArray Pneumoniaplus Control, correct results were reported in 300 tests on the first attempt. There were 2 Negative Controls with false positive results and 6 Positive Controls with false negative results. All produced the correct results upon a single retest for an overall correct result rate of 97.4%.
| 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 |
|-------|----------------|---------|------------------------------------------|--------------------------------------------|-------------------------------------------|------------------------------------------|--------------------------------------------|-------------------------------------------|-----------------------------|
| 4 | 308 | 0 | 150 | 6 | 96.2% | 150 | 2 | 98.7% | 97.4% |
External Site Testing
Of the total 308 tests. 185 FilmArray Pneumoniaplus Control samples were tested between July 2018 and September 2018 at 3 clinical sites. Three lots of Positive Control (D04MAY18A, H29MAY18A, C12JUN18A) and three lots of Negative Control (E30APR18A, C18MAY18A, D30MAY18A) were tested on 3 Pneumoniaplus pouch lots across the 3 sites, incorporating multiple operators. Three Positive Controls and 3 Negative Controls were run per day/per site over a period of 10 days. Not all testing days were consecutive. Correct results were obtained on the first test of 175 controls. Two Negative Controls gave initial false positive
7
Image /page/7/Picture/0 description: The image shows the address and contact information for MMQCI, or Maine Molecular Quality Controls, Inc. The address is 23 Mill Brook Road, Mill Brook Business Park, 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 3 Positive controls gave initial false negative results. All produced the correct results upon a single retest for an overall correct result rate of 97.3%.
FilmArray Pneumonia/Pneumoniaplus Control performed reproducibly across 3 clinical sites using multiple pouch lots and incorporating multiple operators.
| Table 3. Summary of External Results for 3 Control Lots | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | 0 | 30 | 0 | 100% | 30 | 1 | 96.8% | 60 |
| 2 | 63 | 0 | 30 | 2 | 93.8% | 30 | 1 | 96.8% | 60 |
| 3 | 61 | 0 | 30 | 1 | 96.8% | 30 | 0 | 100% | 60 |
| All | |||||||||
| Sites | 185 | 0 | 90 | 3 | 96.8% | 90 | 2 | 97.8% | 97.3% |
8
Image /page/8/Picture/0 description: The image shows the contact information for Maine Molecular Quality Controls, Inc. The address is 23 Mill Brook Road, Mill Brook Business Park, Saco, Maine 04072. The website is www.mmqci.com, the phone number is 207-885-1072, and the fax number is 207-885-1079.
Internal Site Testing
Of the total 308 tests, 123 FilmArray Pneumonia/Pneumoniaplus Control samples were tested between July 2018 and September 2018 at MMQCI's facility. Three lots of Positive Control (D04MAY18A, H29MAY18A, C12JUN18A) and 3 lots of Negative Control (E30APR18A, C18MAY18A, D30MAY18A) were tested over 60 days on 3 Pneumonia/Pneumoniaplus pouch lots, incorporating 3 operators and 2 FilmArray 2.0 instruments. All Positive Controls gave correct results except for 3 which gave false negative results. Repeat tests gave correct results on the first retest. All Negative Controls gave correct results. The overall correct result rate at MMQCI was 97.6%.
| Table 4. Summary of Run-to-run Precision Testing for 3 Control Lots at MMQCI | ||||||||
|---|---|---|---|---|---|---|---|---|
| Control | Control Lot # | No. of | ||||||
| Tests | Invalid | Correct | ||||||
| Results | Incorrect | |||||||
| Results | Percent | |||||||
| Correct | ||||||||
| FilmArray Pneumonia/Pneumoniaplus | ||||||||
| Negative | E30APR18A | 20 | 0 | 20 | 0 | 100% | ||
| FilmArray Pneumonia/Pneumoniaplus | ||||||||
| Negative | C18MAY18A | 20 | 0 | 20 | 0 | 100% | ||
| FilmArray Pneumonia/Pneumoniaplus | ||||||||
| Negative | D30MAY18A | 20 | 0 | 20 | 0 | 100% | ||
| FilmArray Pneumonia/Pneumoniaplus | ||||||||
| Positive | D04MAY18A | 21 | 0 | 20 | 1 | 95.2% | ||
| FilmArray Pneumonia/Pneumoniaplus | ||||||||
| Positive | A29MAY18A | 21 | 0 | 20 | 1 | 95.2% | ||
| FilmArray Pneumonia/Pneumoniaplus | ||||||||
| Positive | C12JUN18A | 21 | 0 | 20 | 1 | 95.2% | ||
| TOTAL | 123 | 0 | 120 | 3 | 97.6% |
9
Image /page/9/Picture/0 description: The image shows the contact information for MMQCI, or Maine Molecular Quality Controls, Inc. The address is 23 Mill Brook Road, Mill Brook Business Park, Saco, Maine 04072. The website is www.mmqci.com, the phone number is 207-885-1072, and the fax number is 207-885-1079.
Internal Site Testing: Repeatability
In addition to the 123 control samples listed in Table 4 above, 7 samples of FilmArray Pneumonia/Pneumoniaplus Control were tested to demonstrate repeatability.
Within-run Testing: Within-run precision (repeatability) was demonstrated by 1 operator testing Pneumonia/Pneumoniaplus 1 lot each FilmArray Positive and FilmArray Pneumonia/Pneumoniaplus Negative, with 1 lot of FilmArray PneumoniaPheumoniaplus Panel pouches on one FilmArray 2.0, all within one day at MMQCI.
Conclusion: All results were correct.
| Table 5. Summary of Within-run Precision at MMQCI | |||||
|---|---|---|---|---|---|
| Control | Control Lot # | Number | |||
| of Tests | Date of | ||||
| Testing | Pouch | ||||
| Lot | Correct | ||||
| Results | |||||
| FilmArray Pneumonia / | |||||
| Pneumoniaplus Positive Control | D04MAY18A | 6 | 8/21/2018 | 697017 | 6/6 |
| FilmArray Pneumonia / | |||||
| Pneumoniaplus Negative Control | E30APR18A | 6 | 8/21/2018 | 697017 | 6/6 |