The FilmArray® Global Fever Panel External Control Kit contains Positive External Controls intended for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of FilmArray® Global Fever Panel targets on FilmArray® 2.0 systems. The Global Fever Panel External Control Kit is designed for and intended to be used solely with the FilmArray Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the Global Fever Panel device.

Device Description

The FilmArray Global Fever Panel External Control Kit contains Positive and Negative External Controls. The Positive External Control has been optimized to be detected by all pathogen assays contained in the Global Fever Panel (Table 1). The Negative External Control contains no nucleic acid and a successful run will be negative for all assays on the panel. These controls are not intended to replace the internal FilmArray Global Fever Panel pouch controls (RNA process control and second stage PCR array control). The Global Fever Panel External Control Kit contains no biological hazards and is 100% non-infectious.

The External Controls are referenced in the Ouick Guide and product literature as Control Injection Vials. The use of room-temperature stable External Controls contained within an injection vial simplifies the workflow and allows for use of the External Controls in settings where access to refrigeration may be limited. Each individually packaged, ready-to-use FilmArray Global Fever External Control is processed separately according to the Instructions for Use, and follows the procedure as outlined in the Quick Guide for the FilmArray Global Fever External Control Kit. Each External Control Injection Vial is intended for a single use.

The Global Fever Panel External Control Kit is designed to mitigate the risk of control contamination and misuse when evaluating clinical samples on the FilmArray 2.0 System.

Negative External Controls are tested using the Negative External Control protocol, which monitors for contamination from both external control material and target pathogens; it will fail if either is detected.
The Positive External Contains DNA sequences that produce signature amplicon melting temperature (Tm) values distinct from the amplicon Tm values produced by each of the pathogens detected by the Global Fever Panel. By design, the Positive ECM will not be detected when using the Global Fever Panel Whole Blood Protocol, and reciprocally, amplified pathogen-specific nucleic acid will not be detected when using the Positive External Control Protocol. Through modification of the sequence between the inner primers for each ECM target, the Tm value of the amplicon is shifted to higher or lower Tm values relative to the expected Global Fever Panel target amplicon while running the same Global Fever Panel pouches with the same physical pouch manipulation in the FilmArray 2.0 Instrument. Positive External Control-specific pouch module software detects the expected shifted Tm values as being from ECM amplicon, thereby evaluating the performance of the FilmArray 2.0 System. Also, the modification of the ECM sequence mitigates possible contamination events and does not cause false positives in clinical samples. In the unlikely event that Positive ECM or ECM amplicon is introduced into a patient sample, the resulting amplification Tm value(s) is not detected within the pathogen(s) Tm window in the Global Fever Panel Whole Blood Protocol. where different Tm windows are used to detect amplified pathogen sequence.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the FilmArray Global Fever Panel External Control Kit:

Note: This document describes an external control kit for an in vitro diagnostic device, not a diagnostic device itself. As such, some of the typical criteria for diagnostic devices (like sensitivity, specificity for patient outcomes, or MRMC studies) are not directly applicable or reported in the same way. The focus here is on the performance of the control kit in monitoring the primary diagnostic device.

Acceptance Criteria and Device Performance for FilmArray Global Fever Panel External Control Kit

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance (FilmArray Global Fever Panel External Control Kit)
Clinical Performance (Field Use)
Positive External Control "Passed" Rate ≥ 95% (based on expected results)	99.4% (159/160 completed with expected result, one user error suspected for the failed case)
Negative External Control "Passed" Rate ≥ 95% (based on expected results)	98.7% (155/157 completed with expected result, two failed; one identified pathogen contamination, one user error suspected).
Overall External Control "Passed" Rate ≥ 95% (based on expected results)	99.1% (314/317) - Calculated from the percentages for positive and negative controls provided. The document also states 98.7% separately for the sum, likely indicating the sum of successful passes (313) from total (317).
Repeatability (Within-Lab Consistency)
Positive External Control "Passed" Rate = 100%	100% (45/45)
Negative External Control "Passed" Rate = 100%	100% (45/45)
Positive External Control Tm Standard Deviation (implicitly low)	0.1-0.2°C (for all target assays)
Positive External Control Coefficient of Variation (CV) (implicitly low)	0.1-0.3% (for all target assays)
Multi-Site Reproducibility (Between-Lab Consistency)
Positive External Control "Passed" Rate ≥ 95% for each site and overall	Site 1: 93.3% (42/45 - one site below 95%)Site 2: 100% (45/45)Site 3: 100% (45/45)All Sites Overall: 97.8% (132/135 - meets ≥95% requirement)
Negative External Control "Passed" Rate ≥ 95% for each site and overall	Site 1: 100% (45/45)Site 2: 97.8% (44/45)Site 3: 97.8% (44/45)All Sites Overall: 98.5% (133/135 - meets ≥95% requirement)
Overall Agreement with Expected Result for both Positive and Negative Controls Across all sites	98.1% (265/270), 95% CI [95.7-99.2%]
Negative External Control detecting contamination (implicitly, ability to detect contamination)	Identified one instance of pathogen contamination out of 157 tests in clinical testing. In reproducibility, two failures due to pathogen detection (not ECM contamination), suspected laboratory contamination. (Demonstrates ability to detect contamination as intended.)
Positive External Control not causing false positives in clinical samples (implicitly, design efficacy)	The modification of the ECM sequence mitigates possible contamination events and does not cause false positives in clinical samples. In the unlikely event of ECM introduction into a patient sample, resulting amplification Tm values are not detected within pathogen Tm windows. (Design feature to prevent false positives in clinical samples due to the control material itself.)

Explanations of Implicit Criteria:

For a quality control material, the primary acceptance criteria are its ability to consistently produce the expected positive or negative results, and for negative controls, its ability to detect contamination.
The document implies that a "passed" rate of ≥95% is acceptable for field performance and multi-site reproducibility. For repeatability, 100% pass rates are shown, indicating a high standard for within-lab consistency.
Low Tm standard deviation and CV for positive controls are implicit acceptance criteria for consistent amplification and melting characteristics.

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

Clinical Testing (Field Use):
- Sample Size: 317 External Control tests (160 Positive, 157 Negative).
- Data Provenance: Prospective, collected between July 2019 and January 2020, from "six sites" (implied to be clinical laboratories). The country of origin is not explicitly stated but assumed to be the US based on FDA submission.
Repeatability:
- Sample Size: 90 External Control tests (45 Positive, 45 Negative).
- Data Provenance: In-house study, one operator, one kit lot, one instrument, over 14 days. Retrospective based on experimental design.
Multi-Site Reproducibility:
- Sample Size: 270 External Control tests (135 Positive, 135 Negative).
- Data Provenance: Multi-site study involving "three sites," "three External Control kits," "three reagent pouch lots," "two operators and three FilmArray 2.0 instruments at each site." This is a prospective experimental study.

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

This device is an external control kit, not a diagnostic device for patient samples. Therefore, the "ground truth" is based on the expected output of the control material (i.e., Positive Control = "Passed" with expected amplicon melts, Negative Control = "Passed" with no amplicon melts/no pathogen detection).
The "truth" is inherent in the design of the control material (synthetic DNA designed to produce specific signals or no signal) and the proper functioning of the FilmArray 2.0 system. No human experts were used to establish ground truth in the traditional sense of disease diagnosis for these control materials. The system itself determines "passed" or "failed" based on pre-programmed criteria for the control.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense. The device (FilmArray 2.0 System) with its specific "External Control-specific protocols" internally adjudicates whether a run "passed" or "failed" based on expected amplicon melt curves (for positive) or absence of melts and pathogen detection (for negative). The results are "overall passed or failed results."
For the clinical testing study, if a control failed, the site "immediately tested a new External Control and obtained the expected result," suggesting internal site-level re-testing but not a formal expert adjudication of the initial failed result. The cause of failure (e.g., user error, contamination) was noted where apparent.

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

No MRMC study was done. This is an in vitro diagnostic control kit, not an AI-assisted diagnostic imaging or pathology device. The "reader" here is the automated FilmArray 2.0 system. The study focuses on the performance and reliability of the control kit itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance data presented could be considered standalone algorithm performance in the context of the FilmArray 2.0 instrument processing the control material. The instrument's software interprets the results of the control runs and determines if they "passed" or "failed" based on programmed criteria for the specific control and panel. Human intervention is primarily in performing the test, not in interpreting the primary outcome of the control run.

7. The Type of Ground Truth Used

The ground truth used is expert design specification and expected performance for a quality control material.
- Positive Controls: Designed with "dried synthetic DNA segments" to produce expected amplicon melting temperature (Tm) values, specific for the External Control melt range and distinct from pathogen Tm values. Ground truth is that these segments should amplify and produce these specific Tm values.
- Negative Controls: Designed to contain "no DNA" and be non-reactive. Ground truth is that these should not produce any amplification or pathogen detection.
This is not pathology, outcomes data, or expert consensus on clinical findings, but rather a verification that the control material itself performs as designed and intended to monitor the system's performance.

8. The Sample Size for the Training Set

Not applicable / No specific training set mentioned. For an in vitro diagnostic control kit, the "training" typically involves the development and calibration of the control material and the associated instrument software during the design phase. The document describes verification and validation studies (clinical, repeatability, reproducibility), which assess the final product's performance, rather than a separate training set for a machine learning algorithm.

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

Not applicable. As the device is not an AI/ML algorithm that undergoes a training process with a specific ground truth dataset, this question does not directly apply. The "ground truth" for the development of the control kit and its interpretation by the FilmArray system would have been established internally during product development based on molecular biology principles, assay design, synthetic DNA characteristics, and instrument calibration standards.

Summary

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November 20, 2020

BioFire Defense. LLC Cynthia Phillips VP of Regulatory, Quality, and Clinical Affairs 79 West 4500 South, Suite 14 Salt Lake City, Utah 84107

Re: K202382

Trade/Device Name: FilmArray Global Fever Panel External Control Kit Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: August 19, 2020 Received: August 20, 2020

Dear Cynthia Phillips:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Respiratory 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

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Indications for Use

510(k) Number (if known) K202382

Device Name

FilmArray Global Fever Panel External Control Kit

Indications for Use (Describe)

Both the Positive and Negative External Controls are provided in a FilmArray Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic DNA segments in buffer and stabilizer to assess the presence of each individual assay on the FilmArray Global Fever Panel. The Negative Control Injection Vial contains no DNA, and is nonreactive with the Global Fever Panel assays.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) Number:

Purpose for submission: New product Applicant Information:

Applicant:	BioFire Defense, LLC
Address:	79 West 4500 South, Suite 14Salt Lake City, Utah 84107
Contact Person:	Cynthia Phillips, VP of Regulatory, Quality, and Clinical Affairs
Phone:	801-262-3592 extension 1370
Fax:	801-447-6907
Email Address:	cynthia.phillips@biofiredefense.com

Preparation Date: August 19, 2020

De vice

Device Trade Name:	FilmArray® Global Fever Panel External Control Kit
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

FilmArray Warrior Control Panel M290 (K163522)

De vice De scription

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Disease	Pathogen Assay Result	Type
Leptospirosis	Leptospira spp.	Bacterial
Malaria	Plasmodium spp.Plasmodium falciparumPlasmodium vivax/ovale	Protozoan
Chikungunya fever	Chikungunya virus	Viral
Dengue fever	Dengue virus	Viral

Table 1. Pathogens Detected by the FilmArray Global Fever Panel

The Global Fever Panel External Control Kit is designed to mitigate the risk of control contamination and misuse when evaluating clinical samples on the FilmArray 2.0 System.

Negative External Controls are tested using the Negative External Control protocol, ● which monitors for contamination from both external control material and target pathogens; it will fail if either is detected.
The Positive External Contains DNA sequences that produce signature amplicon melting temperature (Tm) values distinct from the amplicon Tm values produced by each of the pathogens detected by the Global Fever Panel. By design, the Positive ECM will not be detected when using the Global Fever Panel Whole Blood Protocol, and reciprocally, amplified pathogen-specific nucleic acid will not be detected when using the Positive External Control Protocol. Through modification of the sequence between the inner primers for each ECM target, the Tm value of the amplicon is shifted to higher or

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lower Tm values relative to the expected Global Fever Panel target amplicon while running the same Global Fever Panel pouches with the same physical pouch manipulation in the FilmArray 2.0 Instrument. Positive External Control-specific pouch module software detects the expected shifted Tm values as being from ECM amplicon, thereby evaluating the performance of the FilmArray 2.0 System. Also, the modification of the ECM sequence mitigates possible contamination events and does not cause false positives in clinical samples. In the unlikely event that Positive ECM or ECM amplicon is introduced into a patient sample, the resulting amplification Tm value(s) is not detected within the pathogen(s) Tm window in the Global Fever Panel Whole Blood Protocol. where different Tm windows are used to detect amplified pathogen sequence.

De vice Intended Use

The FilmArray® Global Fever Panel External Control Kit contains Positive and Negative External Controls intended for use as assaved quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of FilmArray® Global Fever Panel targets on FilmArray® 2.0 systems. The Global Fever Panel External Control Kit is designed for and intended to be used solely with the FilmArray Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the Global Fever Panel device.

Element	New Device:FilmArray Global Fever PanelExternal Control Kit	Predicate:FilmArray Warrior Control PanelM290 (K163522)
Indications for Use	Positive and Negative Externalassayed quality controls to monitormultiple targets in an in vitro labnucleic acid diagnostic test	Same
Technological Principles	Nested multiplex RT-PCR followed bymelting analysis to confirm identity ofamplified product.	Same
Test Interpretation	Automated test interpretation andreport generation. User cannot accessraw data.	Same
Sample Preparation Method	Process like patient sample.	Same
Composition	Tm-shifted Synthetic DNA	Synthetic DNA
Physical format	External Control Material dried onControl Injection Vialfilter	Ready-to-use liquid

Substantial Equivalence

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	New Device:	Predicate:
Element	FilmArray Global Fever PanelExternal Control Kit	FilmArray Warrior Control PanelM290 (K163522)
Reagent Storage	Reagents are stored at roomtemperature (18° to 30°C).	Reagents are stored refrigerated(2°C to 8°C).
Pouch Module Software	External Control-specific protocolsproviding overall passed or failedresults.	Sample specific protocolsproviding pathogen-specificresults.

Summary Performance Data

Clinical Testing

During the prospective clinical evaluation of the FilmArray Global Fever Panel, six sites were required to perform one valid Global Fever Panel External Control test at the start of each day of specimen testing or contamination monitoring. A valid External Control run was one that exactly matched the expected results for each analyte in the mix (i.e., Positive or Negative). Results are shown in Table 2.

Table 2. FilmArray Global Fever Panel External Control Performance as Compared to the Expected ('Passed') Result

External ControlType	Completed with ExpectedResult	Total Completed	%
Positive	159a	160	99.4%
Negative	155a	157	98.7%
Overall	314	317	99.1%

ª Appeared that user accidentally swapped Positive External Control-loaded pouches on instrument load.

Between July 2019 and January 2020, a total of 317 External Control tests (160 positive and 157 negative) were completed and had internal pouch controls that passed. Two Positive External Controls (2/160; 1.3%) and two Negative External Controls (2/157; 1.3%) had unexpected (Failed) results, for an overall External Control 'Passed' rate of 98.7% (313/317). Negative External Control testing identified one instance of pathogen contamination out of 157 tests, but no instances of External Control amplicon contamination. In all cases of a 'Failed' External Control test, the site immediately tested a new External Control and obtained the expected result.

Repeatability / Multi-Site Reproducibility

Repeatability was evaluated by having one operator testing one kit lot of External Controls using one reagent kit lot on one FilmArray 2.0 Instrument over 14 days. Table 3 shows the results for the Repeatability evaluation.

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Global Fever PanelExternal Control Type	Expected Result	Observed/Expected(Percent Agreement)
Positive	Passed 1	45/45(100%)
Negative	Passed 2	45/45(100%)

Table 3. Summary of Global Fever Panel External Control Repeatability Test Results

1 All Global Fever Panel assays have a positive amplicon melt in the External Control melt range.

2 All Global Fever Panel assays have no melt in both the External Control melt range and in the pathogen melt range.

All 45 Positive and 45 Negative External Controls passed with no failures and therefore no additional testing was performed. For Positive External Controls, all target assays had Tm standard deviations between 0.1-0.2℃, with coefficient of variation (CV) between 0.1-0.3%. Combined with the pass rate, these results demonstrate repeatability for both the Negative and Positive External Controls.

The reproducibility of External Control test results was evaluated in a multi-site study using three External Control kits and three reagent pouch lots. Testing was performed at three sites, with two operators and three FilmArray 2.0 instruments at each site.

The percent agreement between the observed and expected test results for the Positive and Negative External Controls per test site and overall are shown in Table 4.

Table 4. Multi-Site Reproducibility Test Results of the Global Fever Panel Positive and Negative External Controls

Global FeverPanel ExternalControl Type	Expected Result	Observed/Expected(Percent Agreement)[95% Confidence Interval]
		Site 1	Site 2	Site 3	All Sites
Positive	Passed 1	42/45(93.3%)	45/45(100%)	45/45(100%)	132/135(97.8%)[93.7-99.2%]
Negative	Passed 2	45/45(100%)	44/45 3(97.8%)	44/45 4(97.8%)	133/135(98.5%)[94.8-99.6%]
Overall Agreement with ExpectedResult					265/270(98.1%)[95.7-99.2%]

1 All Global Fever Panel assays have a positive amplicon melt in the External Control melt range.

2 All Global Fever Panel assays have no melt in both the External Control melt range and in the pathogen melt range.

3 Unexpected detection of pathogen amplicon for an off-panel assay, suspected laboratory contamination.

4 Unexpected detection of pathogen amplicon for DENV 2 1 assay, suspected laboratory contamination.

The expected 'Passed' results for Positive External Controls were observed in 132 out of 135 (97.8%) tests, meeting the required pass rate of ≥95%. Three Positive External Controls failed; one failed due a single assay being called negative, and the other two showed no amplification of

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External Control Material for any of the Global Fever Panel assays. For Negative External Controls, 133 out of 135 (98.5%) tests passed. The two Negative External Control failures were caused by detection of pathogen and not due to contamination with Positive External Control material.

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.”