(89 days)
Not Found
No
The device is a quality control panel for a nucleic acid testing system. The description focuses on the composition and performance of the control material, with no mention of AI or ML for data analysis or interpretation.
No.
The device is described as a quality control panel for monitoring the performance of in vitro laboratory nucleic acid testing procedures, not for treating or diagnosing a disease or condition in a patient.
No
This device is a quality control panel intended to monitor the performance of nucleic acid testing procedures, not to diagnose a patient.
No
The device is a quality control panel composed of synthetic DNA in buffers, stabilizers, and preservatives, which are physical components, 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 the performance of in vitro laboratory nucleic acid testing procedures." This directly aligns with the definition of an IVD, which are used to examine specimens taken from the human body to provide information for diagnostic purposes. While this specific device is a control panel and not directly diagnosing a patient, it is essential for ensuring the accuracy and reliability of the diagnostic test (the FilmArray NGDS Warrior Panel assay).
- Device Description: It describes the product as a "quality control panel" used with a specific in vitro diagnostic assay (FilmArray NGDS Warrior Panel).
- Intended User / Care Setting: It specifies "in vitro laboratory / clinical laboratory sites," which are the typical settings where IVDs are used.
- Performance Studies: The document details performance studies conducted in clinical laboratory settings, which is standard practice for evaluating IVDs and their associated controls.
- Predicate Device: It lists a predicate device with a K number (K161573), which is a regulatory identifier for medical devices, including IVDs, cleared by the FDA. The predicate device is also a control panel for an IVD.
While this device is a control for an IVD rather than the primary diagnostic test itself, it falls under the umbrella of IVDs because it is an accessory used to ensure the proper functioning and accuracy of an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
FilmArray Warrior Control Panel M290 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 Bacillus anthracis (Chromosomal element, pXO1, Coxiella burnetii, Francisella tularensis, Yersinia pestis, Ebola virus and Marburg virus on the FilmArray NGDS Warrior Panel performed on FilmArray 2.0 systems. FilmArray Warrior Control Panel M290 is composed of synthetic DNA specifically designed for and intended to be used solely with the FilmArray NGDS Warrior Panel assay. This product is not intended to replace manufacturer internal FilmArray NGDS Warrior Panel controls provided with the device.
Product codes (comma separated list FDA assigned to the subject device)
PMN
Device Description
FilmArray Warrior Control Panel M290, P/N M290, is a quality control panel consisting of 2 controls, FilmArray Warrior Positive Control, P/N M291 and FilmArray Warrior Negative Control, P/N M292. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA carries segments of all biothreat agents detected by the FilmArray NGDS Warrior Panel assay (Table 1. below) on FilmArray 2.0 systems. The Negative Control is comprised of non-specific DNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray Warrior Control Panel M290 is processed separately according to FilmArray NGDS Warrior Panel assay manufacturer's Instructions for Use for Blood Samples.
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
Internal Study:
Sample Size: Not explicitly stated, but 3 lots of controls were tested over 23 days using 4 pouch lots by 3 operators.
Data Source: MMQCI (Saco, Maine)
Annotation Protocol: The controls were tested to confirm performance, and results were evaluated as "Correct Positive Control Result" or "Correct Negative Control Result." Invalid results were noted.
External Study:
Sample Size: 3 lots of FilmArray Warrior Control Panel M290 were tested at 5 clinical laboratory sites. A total of 310 external controls were tested (163 positive and 147 negative).
Data Source: 5 clinical laboratory sites
Annotation Protocol: Performance was assessed over 6 months, incorporating 12 unique pouch lots and multiple operators. Results were evaluated as "Correct Positive Control Result" or "Correct Negative Control Result." Invalid results were noted.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All Test Results (Internal and External Studies Combined)
Study Type: Performance Study
Sample Size: 434 total tests (excluding 4 invalid re-tested samples due to BioFire instructions).
Standalone Performance:
- Correct Positive Control Result: 221
- Incorrect Positive Control Result: 2
- Percent Correct Positive Control: 99.1%
- Correct Negative Control Result: 207
- Incorrect Negative Control Result: 0
- Percent Correct Negative Control: 100%
Key Results: All FilmArray Warrior Positive Controls were correctly detected except for 2 control samples in the external study. One reported "Not Detected" for pXO1, and another for pXO1 and Yersinia pestis. All FilmArray Warrior Negative Controls gave Correct Negative Control Results. 4 Invalid results were caused by internal control pouch failures.
External Site Testing
Study Type: Clinical Performance Study
Sample Size: 310 external controls (163 positive and 147 negative).
Standalone Performance:
- Overall Percent Total Correct Results: 99.4%
- Correct Positive Control Result: 161
- Incorrect Positive Control Result: 2
- Percent Correct Positive Control: 98.8%
- Correct Negative Control Result: 147
- Incorrect Negative Control Result: 0
- Percent Correct Negative Control: 100%
Key Results: All controls gave correct results except for 2 FilmArray Warrior Positive Controls at 2 different sites. One sample showed "Not Detected" for pXO1 and Yersinia pestis, and another for pXO1. The expected percentage of correct results for the clinical study was 95% or greater. No Invalid results were reported in the external study.
Reproducibility - Within-run Testing
Study Type: Reproducibility Study
Sample Size: 6 tests each for Positive and Negative Controls.
Key Results: All results were correct and reproducible.
Reproducibility - Precision Testing
Study Type: Precision Study
Sample Size: 124 total tests across 6 lots of controls.
Standalone Performance:
- Percent Correct Positive Control: 100%
- Percent Correct Negative Control: 100%
Key Results: All FilmArray Warrior Positive Control biothreat pathogens were correctly detected. 4 tests were excluded due to Invalid results caused by internal pouch control failures. All results were 100% correct after re-testing or exclusion of invalid samples.
Reproducibility - Lot-to-Lot Testing
Study Type: Reproducibility Study
Sample Size: Sub-set of precision testing (7 or 8 tests per control lot).
Key Results: All results were correct and reproducible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Percentage correct results are provided)
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.
K161573; FilmArray RP EZ Control Panel M265
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
March 14, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Maine Molecular Quality Controls, Inc. Joan Gordon 23 Mill Brook Road Saco, ME 04072
Re: K163522
Trade/Device Name: FilmArray Warrior Control Panel M290 Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II (Special Controls) Product Code: PMN Dated: December 13, 2016 Received: December 15, 2016
Dear Ms. 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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
Page 2 - Ms. Gordon
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Steven R. Gitterman -S for
Uwe Scherf, M.Sc., 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) K163522
Device Name FimlArray Warrior Control Panel M290
Indications for Use (Describe)
FilmArray Warrior Control Panel M290 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 Bacillus anthracis (Chromosomal element, pXO1, Coxiella burnetii, Francisella tularensis, Yersinia pestis, Ebola virus and Marburg virus on the FilmArray NGDS Warrior Panel performed on FilmArray 2.0 systems. FilmArray Warrior Control Panel M290 is composed of synthetic DNA specifically designed for and intended to be used solely with the FilmArray NGDS Warrior Panel assay. This product is not intended to replace manufacturer internal FilmArray NGDS Warrior Panel 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 serif font, with the "MM" in a bold, golden color and the "QCI" in a dark brown color. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.," is written in a smaller, sans-serif font. A golden, abstract design resembling a strand of DNA or a stylized wave is positioned to the left of the letters, adding a visual element that suggests the company's focus on molecular quality control.
510 (k) Summary
510(k) Number: K163522
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 12, 2016
Device
| Device Trade Name: | FilmArray Warrior Control Panel M290, model M290 |
|---|---|
| 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 Warrior Control Panel M290, P/N M290, is a quality control panel consisting of 2 controls, FilmArray Warrior Positive Control, P/N M291 and FilmArray Warrior Negative Control, P/N M292. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA carries segments of all biothreat agents detected by the FilmArray NGDS Warrior Panel assay (Table 1. below) on FilmArray 2.0 systems. The Negative Control is comprised of non-specific DNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray Warrior Control Panel M290 is
4
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 stylized font, with the "MM" in a dark red color and the "QCI" in a lighter yellow color. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller font. A yellow, abstract design resembling a brushstroke or a strand of DNA is positioned to the left of the letters, adding a visual element to the logo.
processed separately according to FilmArray NGDS Warrior Panel assay manufacturer's Instructions for Use for Blood Samples.
| Bacillus anthracis: Chromosomal element, pXO1, pXO2 |
|---|
| Coxiella burnetii |
| Francisella tularensis |
| Yersinia pestis |
| Ebola Virus |
| Marburg Virus |
| Table 1. Biothreat pathogens detected by FilmArray NGDS Warrior Panel | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | ----------------------------------------------------------------------- |
Device Intended Use
FilmArray Warrior Control Panel M290 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 Bacillus anthracis (Chromosomal element, pXO1, pXO2), Coxiella burnetii, Francisella tularensis, Yersinia pestis, Ebola virus and Marburg virus on the FilmArray NGDS Warrior Panel performed on FilmArray 2.0 systems. FilmArray Warrior Control Panel M290 is composed of synthetic DNA specifically designed for and intended to be used solely with the FilmArray NGDS Warrior Panel assay. This product is not intended to replace manufacturer internal FilmArray NGDS Warrior Panel controls provided with the device.
Substantial Equivalence
| Characteristic | Candidate Device:
FilmArray Warrior
Control Panel M290 | 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 | Same |
| Composition | Synthetic DNA | Synthetic RNA
transcripts |
| Assay Steps Monitored | Amplification, detection,
identification | Same plus reverse
transcription |
| Number of targets
monitored in one assay | Multiple | Same |
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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 stylized font, with the words "Maine Molecular Quality Controls, Inc." written in a smaller font underneath. A yellow, abstract design element is placed to the left of the text, adding a visual accent to the logo.
Summary Performance Data
All Test Results
Three lots of FilmArray Warrior Control Panel M290, FilmArray Warrior Positive Control and FilmArray Warrior Negative Control, were manufactured by MMQCI and tested using the FilmArray NGDS Warrior Panel on the FilmArray instrument 2.0 system to confirm performance. The lots were manufactured and tested incorporating variables including multiple lots of key manufacturing components, different operators, pouch lots and test sites over six months. Internal and external studies were performed.
The internal study was performed by testing the 3 lots at MMQCI (Saco, Maine) over 23 days with 4 pouch lots by 3 operators. An external study was performed to assess performance of FilmArray Warrior Control Panel M290 in a clinical setting. The external performance study tested the 3 lots of FilmArray Warrior Control Panel M290 at 5 clinical laboratory sites, over 6 months, incorporating 12 unique pouch lots and multiple operators.
All FilmArray Warrior Positive Controls were correctly detected in the internal and external studies (Correct Positive Control Result) except for 2 control samples tested in the external study. One FilmArray Warrior Positive Control test reported Detected for all pathogens except for pXO1 which reported as Not Detected. A second FilmArray Warrior Positive Control test result was Detected for all pathogens except for pXO1 and Yersinia pestis, which reported as Not Detected.
All FilmArray Warrior Negative Controls gave Correct Negative Control Results. There were 4 Invalid results caused by internal control pouch failures; 2 for the FilmArray Warrior Positive Control and 2 for the FilmArray Warrior Negative Control.
| Table 1. Summary of All Test Results | ||||||||
|---|---|---|---|---|---|---|---|---|
| Number | ||||||||
| of sites | Total | |||||||
| Tests | Invalid | Correct | ||||||
| Positive | ||||||||
| Control | ||||||||
| Result | Incorrect | |||||||
| Positive | ||||||||
| Control | ||||||||
| Result | Percent | |||||||
| Correct* | ||||||||
| Positive | ||||||||
| Control | Correct | |||||||
| Negative | ||||||||
| Control | ||||||||
| Result | Incorrect | |||||||
| Negative | ||||||||
| control | ||||||||
| Result | Percent | |||||||
| Correct* | ||||||||
| Negative | ||||||||
| Control | ||||||||
| 6 | 434 | 4 | 221 | 2 | 99.1% | 207 | 0 | 100% |
*The 4 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.
External Site Testing
Three lots of FilmArray Warrior Control Panel M290, FilmArray Warrior Positive Control (Pos) and FilmArray Warrior Negative Control (Neg), were manufactured by MMOCI. They were tested by the FilmArray NGDS Warrior Panel on the FilmArray instrument 2.0 system as follows: Lot 1, Pos C18MAR16/ Neg A02NOV15, was tested at 5 clinical sites over 6 months using 9 pouch lots, incorporating multiple operators. Lots 2 and 3, Pos C01JUL16/ Neg
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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 bold, serif font, with "MM" in a larger size than "QCI". Below the letters, there is the text "MAINE MOLECULAR QUALITY CONTROLS, INC." in a smaller, sans-serif font. A stylized, golden swirl design is placed to the left of the text, adding a decorative element to the logo.
B01JUL16, and Pos B15JUL16/ Neg A15JUL16, were tested at 2 of the 5 clinical sites on 10 different days, using 3 pouch lots, incorporating multiple operators.
A total of 310 external controls were tested (163 positive and 147 negative). There were no Invalid results. All controls gave correct results except for 2 FilmArray Warrior Positive Controls at 2 different sites. One sample of Lot 2 Pos C01JUL16 gave a Not Detected for pXO1 and Yersinia pestis with all other biothreat pathogens detected at Site B, and another sample of Lot 2 Pos C01JUL16 gave a Not Detected for pXO1with all other biothreat pathogens reported as Detected at Site E for the same pouch lot. The expected percentage of correct results for the clinical study was 95% or greater.
| Table 2. Summary of External Test Results for 3 Control Lots | ||||||||
|---|---|---|---|---|---|---|---|---|
| External | ||||||||
| Site | Total | |||||||
| Tests | Percent | |||||||
| Total | ||||||||
| Correct | ||||||||
| Results | Correct | |||||||
| Positive | ||||||||
| Control | ||||||||
| Result | Incorrect | |||||||
| Positive | ||||||||
| Control | ||||||||
| Result | Percent | |||||||
| Correct | ||||||||
| Positive | ||||||||
| Control | Correct | |||||||
| Negative | ||||||||
| Control | ||||||||
| Result | Incorrect | |||||||
| Negative | ||||||||
| control | ||||||||
| Result | Percent | |||||||
| Correct | ||||||||
| Negative | ||||||||
| Control | ||||||||
| A | 41 | 100% | 20 | 0 | 100% | 21 | 0 | 100% |
| B | 104 | 99.1% | 58 | 1 | 98.3% | 45 | 0 | 100% |
| C | 51 | 100% | 26 | 0 | 100% | 25 | 0 | 100% |
| D | 60 | 100% | 31 | 0 | 100% | 29 | 0 | 100% |
| E | 54 | 98.1% | 26 | 1 | 96.3% | 27 | 0 | 100% |
| All Sites | 310 | 99.4% | 161 | 2 | 98.8% | 147 | 0 | 100% |
Reproducibility
NOTE: The FilmArray 2.0 is a random access instrument. Therefore, 'runs' refer to replicates tested on the same day.
Within-run Testing: Within-run reproducibility was demonstrated by 1 operator testing 1 lot each of FilmArray Warrior Positive Control and FilmArray Warrior Negative Control with 1 lot of NGDS Warrior Panel pouches on the FilmArray 2.0, each within one day at MMQCl. All results were correct and reproducible.
| Table 3. Summary of Within-run Reproducibility Results | |||||
|---|---|---|---|---|---|
| Control | Control | ||||
| Lot# | No. of | ||||
| Tests | Date of | ||||
| Testing | Pouch | ||||
| Lot | Correct | ||||
| Results |
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Image /page/7/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a stylized font, with the "MM" in a larger, darker font and the "QCI" in a smaller, lighter font. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller font. To the left of the letters, there is an abstract design in yellow, resembling a flowing or liquid shape.
| FilmArray Warrior Positive Control | C01JUL16 | 6 | 8-8-16 | 151216 | 6/6 |
|---|---|---|---|---|---|
| FilmArray Warrior Negative Control | B01JUL16 | 6 | 8-19-16 | 151216 | 6/6 |
Precision Testing: Precision was demonstrated by testing 3 lots of FilmArray Warrior Positive Control and 3 lots of FilmArray Warrior Negative Control at MMQCI over multiple days with 4 reagent lots by 3 operators using one FilmArray 2.0 instrument. All FilmArray Warrior Positive Control biothreat pathogens were correctly detected. Four tests were excluded from final data analysis due to Invalid results caused by internal pouch control failures.
| Table 4. Summary of Precision Testing for 3 Control Lots at MMQCI | ||||||
|---|---|---|---|---|---|---|
| Control | Control Lot # | No. of Tests | Invalid | Correct Results | Incorrect Results | Percent Correct* |
| FilmArray Warrior Positive Control | C18MAR16 | 20 | 0 | 21 | 0 | 100% |
| FilmArray Warrior Negative Control | A02NOV15 | 20 | 0 | 20 | 0 | 100% |
| FilmArray Warrior Positive Control | C01JUL16 | 20 | 0 | 20 | 0 | 100% |
| FilmArray Warrior Negative Control | B01JUL16 | 21 | 1 | 20 | 0 | 100% |
| FilmArray Warrior Positive Control | B15JUL16 | 22 | 2 | 20 | 0 | 100% |
| FilmArray Warrior Negative Control | A15JUL16 | 21 | 1 | 20 | 0 | 100% |
| TOTAL | 124 | 4 | 120 | 0 | 100 % |
*The 4 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.
Lot-to-Lot Testing: A subset of the above testing in Table 4 was used to demonstrate Lot-to-lot reproducibility by testing 3 lots of FilmArray Warrior Control Panel M290 using the same pouch lot on the same instrument at MMQCI. All results were correct and reproducible.
| Table 5. Summary of Lot-to-Lot Testing | ||||
|---|---|---|---|---|
| Control Lot # | Number of Tests | Pouch Lot | Correct Results | |
| FilmArray Warrior Positive Control | C18MAR16 | 7 | 160314 | 7/7 |
| FilmArray Warrior Negative Control | A02NOV15 | 7 | 160314 | 7/7 |
| FilmArray Warrior Positive Control | C01JUL16 | 7 | 160314 | 7/7 |
| FilmArray Warrior Negative Control | B01JUL16 | 8 (1 Invalid) | 160314 | 7/7 |
| FilmArray Warrior Positive Control | B15JUL16 | 7 | 160314 | 7/7 |
| FilmArray Warrior Negative Control | A15JUL16 | 7 | 160314 | 7/7 |