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.

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.

AI/ML Overview

The document describes the FilmArray Pneumonia/Pneumoniaplus Control, a quality control material intended to monitor the performance of in-vitro laboratory nucleic acid testing procedures conducted with the FilmArray Pneumonia Panel or Pneumonia Panel plus assays.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

While explicit "acceptance criteria" against which individual performance metrics (e.g., minimum percentage correct results) are not provided in the document, the studies demonstrate consistent high performance. The "Total Percent Correct" for both external and internal testing can be considered the device performance. The objective is for the controls to consistently produce the correct positive or negative results.

Metric	Acceptance Criteria (Implied)	Reported Device Performance (External Study)	Reported Device Performance (Internal Study)
Overall Correct Result Rate	High Consistency (e.g., >95%)	97.3%	97.6%
Correct Positive Control Result Rate	High Consistency	96.8%	95.2% (lowest for individual lots)
Correct Negative Control Result Rate	High Consistency	97.8%	100%
Invalid Results	0% (Ideally)	0%	0%
Reproducibility	Consistent across sites	Demonstrated (consistent high percentages)	Demonstrated (consistent high percentages)
Repeatability (within-run)	100%	Not explicitly reported for external study	100% (6/6 for both positive and negative)

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Overall): 308 tests of FilmArray Pneumonia/Pneumoniaplus Control.
- External Study: 185 samples.
- Internal Study: 123 samples.
Data Provenance: The studies were conducted by Maine Molecular Quality Controls, Inc. (MMQCI) for the internal portion, and at 3 CLIA-certified clinical sites for the external portion. This indicates a mix of controlled laboratory (internal) and real-world clinical (external) settings within the United States. The data is prospective, as it explicitly states the studies were performed over defined periods (e.g., 60 days for internal, 10 days for external).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable in this context. The "ground truth" for a quality control material like this is inherent in its design: a positive control should produce a positive result for specific targets, and a negative control should produce a negative result. There are no "experts" involved in determining the ground truth for the control itself, as it is a manufactured reference material with known components.

4. Adjudication Method for the Test Set

The document mentions that for initial false positive or false negative results, a single retest was performed, and all retests produced the correct results. This indicates an informal adjudication through retesting, rather than a formal expert-based adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. The device is a quality control material for in-vitro diagnostic assays, not an AI-powered diagnostic device for human interpretation or a device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a quality control material, not an algorithm or an AI device. Its performance is evaluated by how accurately an assay (FilmArray Pneumonia Panel) detects its known synthetic components.

7. The Type of Ground Truth Used

The ground truth used is the known composition of the control material.

The Positive Control contains synthetic DNA and RNA corresponding to the genome segments of targeted respiratory pathogens and antimicrobial resistance genes. Therefore, the "ground truth" is that these targets should be detected.
The Negative Control contains only buffers, stabilizers, and preservatives, with no target nucleic acids. Therefore, the "ground truth" is that no targets should be detected.

8. The Sample Size for the Training Set

This is not applicable. The FilmArray Pneumonia/Pneumoniaplus Control is a quality control material, not an algorithm developed through machine learning. Therefore, there is no "training set" in the context of AI or algorithm development.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8. The "ground truth" (known composition) for the control material itself is established during its manufacturing and characterization by Maine Molecular Quality Controls, Inc., where the synthetic DNA/RNA components are precisely designed and incorporated into the positive control, and the negative control is formulated to be free of these target analytes.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K190222

Device Name

FilmArray Pneumonia/Pneumoniaplus Control

Indications for Use (Describe)

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 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 microbiologyassays
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

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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 SyndromeCoronavirus*
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.

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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:FilmArrayPneumonia/PneumoniaplusControl	Predicate Device:FilmArray RP EZControl Panel M265(K161573)
Intended Use	External assayed qualitycontrol to monitor in vitrolab 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 forVTM)
Composition	Synthetic RNA & DNA	Synthetic RNA transcripts
Assay Steps Monitored	Reverse transcriptionAmplification, detection,identification	Same
Number of targetsmonitored in one assay	Multiple	Same

Substantial Equivalence

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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	TotalTests	Invalid	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrectPositiveControl	CorrectNegativeControlResult	IncorrectNegativeControlResult	PercentCorrectNegativeControl	TotalPercentCorrect
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

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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	TotalTests	Invalid	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrectPositiveControl	CorrectNegativeControlResult	IncorrectNegativeControlResult	PercentCorrectNegativeControl	TotalPercentCorrect
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
AllSites	185	0	90	3	96.8%	90	2	97.8%	97.3%

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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. ofTests	Invalid	CorrectResults	IncorrectResults	PercentCorrect
FilmArray Pneumonia/PneumoniaplusNegative	E30APR18A	20	0	20	0	100%
FilmArray Pneumonia/PneumoniaplusNegative	C18MAY18A	20	0	20	0	100%
FilmArray Pneumonia/PneumoniaplusNegative	D30MAY18A	20	0	20	0	100%
FilmArray Pneumonia/PneumoniaplusPositive	D04MAY18A	21	0	20	1	95.2%
FilmArray Pneumonia/PneumoniaplusPositive	A29MAY18A	21	0	20	1	95.2%
FilmArray Pneumonia/PneumoniaplusPositive	C12JUN18A	21	0	20	1	95.2%
	TOTAL	123	0	120	3	97.6%

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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 #	Numberof Tests	Date ofTesting	PouchLot	CorrectResults
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

Regulation Number and Section

§ 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.”