← Product Code [PMN](/productcode/PMN) · K260577

# FilmArray TF Control Panel M527 (K260577)

_Maine Molecular Quality Controls, Inc. · PMN · May 19, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260577

## Device Facts

- **Applicant:** Maine Molecular Quality Controls, Inc.
- **Product Code:** [PMN](/productcode/PMN.md)
- **Decision Date:** May 19, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3920
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The FilmArray TF Control Panel M527 is intended for use as an external positive and negative assayed quality control to monitor the performance of the BIOFIRE FILMARRAY Tropical Fever (TF) Panel assay on the BIOFIRE FILMARRAY Systems. The BIOFIRE FILMARRAY TF Panel assay qualitatively detects the following target pathogens: chikungunya virus, dengue virus (serotypes 1, 2, 3, and 4), Leptospira spp., and Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale). The FilmArray TF Positive control is composed of synthetic DNA and RNA in stabilizing solutions, buffers, and preservatives. The FilmArray TF Negative control contains buffers and preservatives. The FilmArray TF Control Panel M527 is designed for and intended to be used solely with the BIOFIRE FILMARRAY TF Panel. This product is not intended to replace manufacturer internal controls provided with this device.

## Device Story

Quality control panel consisting of two ready-to-use liquid controls (Positive and Negative); Positive control contains synthetic DNA/RNA corresponding to genome segments of pathogens detected by BIOFIRE FILMARRAY TF Panel (chikungunya, dengue, Leptospira, Plasmodium spp.); Negative control contains buffer/preservatives. Used in clinical laboratory settings to monitor assay performance; processed identically to patient samples on BIOFIRE FILMARRAY 2.0 and TORCH systems. Instrument software automatically reports results as 'Detected', 'Not Detected', or 'Invalid'. Provides external verification of assay integrity; does not replace manufacturer-provided internal controls. Benefits include ensuring reliable detection of tropical fever pathogens by validating the entire analytical process (reverse transcription, amplification, detection, identification).

## Clinical Evidence

Bench testing only. Reproducibility study conducted across 3 sites using 3 lots of positive and negative controls. Total of 255 samples tested (128 positive, 127 negative) using BIOFIRE FILMARRAY 2.0 and Torch systems. Results showed 252 valid tests with 100% correct result rate (100% sensitivity and specificity for control detection).

## Technological Characteristics

Ready-to-use liquid controls; synthetic DNA/RNA in stabilizing buffers/preservatives. Analyte detection via BIOFIRE FILMARRAY 2.0 and TORCH systems (nucleic acid amplification/detection). Shelf-life 12 months at 2-8°C. No specific material standards cited.

## Regulatory 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.

## Special Controls

An assayed quality control material for clinical microbiology assays must comply with the following special controls: (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; Expected values: (ii) Analyte source: (iii) (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., realtime 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 in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(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; (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 21 CFR 809.10(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."

*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.”

## Predicate Devices

- FilmArray GI Control Panel M238 ([K251526](/device/K251526.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K260577

B Applicant

Maine Molecular Quality Controls, Inc.

C Proprietary and Established Names

FilmArray TF Control Panel M527

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  PMN | Class II | 866.3920 | MI  |

## II Submission/Device Overview:

A Purpose for Submission:

To obtain a substantial equivalence determination for the FilmArray TF Control Panel M527.

B Measurand:

Multi-analyte external quality control materials for microbiology NAAT assays

C Type of Test:

The FilmArray TF Control Panel M527, is a quality control panel consisting of two single-use, ready-to-use, liquid controls, FilmArray TF Positive and FilmArray TF Negative. Each kit of FilmArray TF Control Panel M527 is comprised of six tubes of FilmArray TF Positive and six tubes of FilmArray TF Negative. FilmArray TF Positive contains synthetic DNA and RNA corresponding to genome segments of all the pathogens detected by the BIOFIRE FILMARRAY

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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Tropical Fever (TF) Panel suspended in a non-infectious solution of buffers, preservatives and stabilizers. FilmArray TF Negative contains buffer and preservatives with no nucleic acids.

## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for Use:
The FilmArray TF Control Panel M527 is intended for use as an external positive and negative assayed quality control to monitor the performance of the BIOFIRE FILMARRAY Tropical Fever (TF) Panel assay on the BIOFIRE FILMARRAY Systems. The BIOFIRE FILMARRAY TF Panel assay qualitatively detects the following target pathogens: chikungunya virus, dengue virus (serotypes 1, 2, 3, and 4), *Leptospira* spp., and *Plasmodium* spp. (including species differentiation of *Plasmodium falciparum* and *Plasmodium vivax*/ovale). The FilmArray TF Positive control is composed of synthetic DNA and RNA in stabilizing solutions, buffers, and preservatives. The FilmArray TF Negative control contains buffers and preservatives. The FilmArray TF Control Panel M527 is designed for and intended to be used solely with the BIOFIRE FILMARRAY TF Panel. This product is not intended to replace manufacturer internal controls provided with this device.

### C Special Conditions for Use Statement(s):
Rx – For Prescription Use Only

### D Special Instrument Requirements:
BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH systems

## IV Device/System Characteristics:

### A Device Description:
The FilmArray TF Control Panel M527 is a quality control panel consisting of two single-use, ready-to-use, liquid controls: FilmArray TF Positive and FilmArray TF Negative. The FilmArray TF Control Panel M527 is intended for use as external positive and negative quality controls to monitor the detection and identification of all the pathogens detected by BIOFIRE FILMARRAY Tropical Fever (TF) Panel (Table 1). Each kit of FilmArray TF Control Panel M527 is comprised of six tubes of FilmArray TF Positive and six tubes of FilmArray TF Negative. FilmArray TF Positive controls contain synthetic DNA and RNA corresponding to genome segments of all the pathogens detected by the BIOFIRE FILMARRAY TF Panel, suspended in a non-infectious solution of buffers, preservatives and stabilizers. The synthetic DNA and RNA contained in FilmArray TF Positive is specifically designed for and intended to be used solely with the BIOFIRE FILMARRAY TF Panel on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH systems. FilmArray TF Positive contains DNA and RNA corresponding to two viral targets, one parasite, and one bacterial target detected by the BIOFIRE FILMARRAY TF Panel listed in Table 1 below. FilmArray TF Negative serves as a

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true negative control containing buffer and preservatives with no DNA and RNA and listed in Table 1 below.

Table 1. Analytes Detected by the BIOFIRE FILMARRAY TF Panel

|  Viruses  |
| --- |
|  Chikungunya Virus  |
|  Dengue Virus  |
|  Parasites  |
|  Plasmodium spp.  |
|  Plasmodium falciparum  |
|  Plasmodium vivax/ovale  |
|  Bacteria  |
|  Leptospira spp.  |

Assay results for the external controls are reported as “Detected,” “Not Detected,” or “Invalid.”

## B Principle of Operation:

Each liquid control of FilmArray TF Control Panel M527 is processed separately according to the assay manufacturer’s Instructions for Use and monitors the detection and identification of the organisms detected by the BIOFIRE FILMARRAY TF Panel. Results are reported automatically by instrument software as either “Detected”, “Not Detected”, or “Invalid.”

## V Substantial Equivalence Information:

### A Predicate Device Name(s):

FilmArray GI Control Panel M238

### B Predicate 510(k) Number(s):

K251526

### C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K260577 | K251526  |
| --- | --- | --- |
|  Device Trade Name | FilmArray TF Control Panel M527 | FilmArray GI Control Panel M238  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | The FilmArray TF Control Panel M527 is intended for use as an external positive and negative assayed quality control to monitor the | FilmArray GI Control Panel M238 is intended for use as an external positive and negative assayed quality control to monitor the performance of in  |

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K260577 - Page 4 of 12
|   | performance of the BIOFIRE FILMARRAY Tropical Fever (TF) Panel assay on the BIOFIRE FILMARRAY Systems.
The BIOFIRE FILMARRAY TF Panel assay qualitatively detects the following target pathogens: chikungunya virus, dengue virus (serotypes 1, 2, 3, and 4), *Leptospira* spp., and *Plasmodium* spp. (including species differentiation of *Plasmodium falciparum* and *Plasmodium vivax/ovale*). The FilmArray TF Positive control is composed of synthetic DNA and RNA in stabilizing solutions, buffers, and preservatives. The FilmArray TF Negative control contains buffers and preservatives. The FilmArray TF Control Panel M527 is designed for and intended to be used solely with the BIOFIRE FILMARRAY TF Panel. This product is not intended to replace manufacturer internal controls provided with this device. | vitro laboratory nucleic acid testing procedures for the qualitative detection of *Campylobacter* (C. jejuni/C. coli/C. upsaliensis), *Clostridium difficile* (toxin A/B), *Plesiomonas shigelloides*, *Salmonella*, *Vibrio* (V. parahaemolyticus/ V. vulnificus/ V. cholerae), (including *Vibrio cholerae*), *Yersinia enterocolitica*, Enteroaggregative *E. coli* (EAEC), Enteropathogenic *E. coli* (EPEC), Enterotoxigenic *E. coli* (ETEC) lt/st, Shiga-like toxin-producing *E. coli* (STEC) stx1/stx2 (*E. coli* O157), Shigella/ Enteroinvasive *E. coli* (EIEC), *Cryptosporidium*, *Cyclospora cayetanensis*, *Entamoeba histolytica*, *Giardia lamblia*, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A and Sapovirus (Genogroups I, II, IV, and V) using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays on BIOFIRE FILMARRAY systems.
The FilmArray GI Control Panel M238 is designed for and intended to be used solely with the BIOFIRE GI Panel and the BIOFIRE GI Panel Mid assays.
The FilmArray GI Control M239, and FilmArray GI Control M240 contains synthetic RNA transcripts in stabilizing solution, buffers, and preservatives. This product is not intended to replace manufacturer internal  |
| --- | --- | --- |

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|   |  | controls provided with these devices.  |
| --- | --- | --- |
|  Physical format | Same | Ready-to-Use Liquid  |
|  Test System | Same | BIOFIRE FILMARRAY 2.0
BIOFIRE FILMARRAY TORCH systems  |
|  Assay steps monitored | Same | Reverse transcription, amplification, detection, identification  |
|  General Device Characteristic Differences |  |   |
|  Targets | Chikungunya virus, Dengue virus (serotypes 1, 2, 3, and 4)
Leptospira spp.
Plasmodium spp.
Plasmodium falciparum
Plasmodium vivax/ovale). | Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium difficile (toxin A/B), Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), (including Vibrio cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2 (E. coli O157), Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A and Sapovirus (Genogroups I, II, IV, and V)  |
|  Composition | Synthetic DNA and RNA transcripts suspended in a non-infectious solution of buffers, preservatives and stabilizers. | Synthetic RNA transcripts suspended in a non-infectious solution of buffers, preservatives and stabilizers.  |
|  Number of assay’s reported targets | 4 | 22  |

VI Standards/Guidance Documents Referenced:

Not applicable

VII Performance Characteristics (if/when applicable):

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# A Analytical Performance:

# 1. Precision:

Within-run precision on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY Torch systems was determined by testing two lots of FilmArray TF Positive, and FilmArray TF Negative controls six times using one pouch lot of the BIOFIRE FILMARRAY TF Panel, at one site, by the same operator and on the same day (Table 2).

Precision study crossing point (Cp) data for FilmArray TF Control Panel M527 were further analyzed to calculate the mean Cp, SD and  $\% \mathrm{CV}$  for each analyte detected by the BIOFIRE FILMARRAY TF Panel for each lot used. Analyses of the Cp data are shown in Table 3 below.

Table 2. Within-run Precision for the FilmArray TF Control Panel M527

|  Control | Control Lot # | Tests | Invalid Results | Pouch Lot # | Correct Results  |
| --- | --- | --- | --- | --- | --- |
|  FilmArray TF Positive | A19SEP24A | 6 | 0 | 309624D | 6/6  |
|  FilmArray TF Positive | F24SEP24A | 6 | 0 | 321324D | 6/6  |
|  FilmArray TF Negative | F15FEB24T | 6 | 0 | 321324D | 6/6  |
|  FilmArray TF Negative | T04JUN24G | 6 | 0 | 309624D | 6/6  |

Table 3. Precision Data Analysis for the FilmArray TF Control Panel M527

|  Analytes | Lot 1 |   |   | Lot 2 |   |   | Between Lots  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV  |
|  CHIKV 1 | 20 | 0.9 | 4.5% | 16.9 | 0.4 | 2.4% | 18.5 | 1.8 | 9.50%  |
|  CHIKV 2 | 16.7 | 0.1 | 0.6% | 14.2 | 0.6 | 4.2% | 15.4 | 1.3 | 8.50%  |
|  DENV 1 | 18 | 0.1 | 0.6% | 15.6 | 0.5 | 3.2% | 16.8 | 1.3 | 7.80%  |
|  DENV 2_1 | 20.3 | 0.4 | 2.0% | 17.7 | 0.3 | 1.7% | 19 | 1.4 | 7.40%  |
|  DENV 2_2 | 17.8 | 0.2 | 1.1% | 15.6 | 0.6 | 3.8% | 16.7 | 1.2 | 7.50%  |
|  DENV 3 | 20.2 | 0.4 | 2.0% | 17.4 | 0.4 | 2.3% | 18.8 | 1.5 | 8%  |
|  DENV 4 | 17.1 | 0.3 | 1.8% | 15 | 0.6 | 4.0% | 16 | 1.2 | 7.30%  |
|  Plasmodium spp. | 15.5 | 0.4 | 2.6% | 15 | 0.6 | 4.0% | 15.3 | 0.6 | 3.70%  |
|  P. falciparum | 16.5 | 0.3 | 1.8% | 15.9 | 0.6 | 3.8% | 16.2 | 0.5 | 3.40%  |
|  P. vivax/ovale | 17.1 | 1.4 | 8.2% | 16.6 | 0.6 | 3.6% | 16.8 | 1.1 | 6.40%  |
|  Leptospira 1 | 15.7 | 0.3 | 1.9% | 15.1 | 0.8 | 5.3% | 15.4 | 0.6 | 4.20%  |

All results from the precision study for the FilmArray TF Control Panel M527 were valid and with correct calls. These results support the repeatability of the FilmArray TF Control Panel M527 across two separately manufactured control lots.

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# 2. Reproducibility:

A multi-site reproducibility study was conducted by testing one hundred twenty-eight samples of FilmArray TF Positive and one hundred twenty-seven samples of FilmArray TF Negative using three lots of each control. Testing was conducted across three sites with the BIOFIRE FILMARRAY TF Panel using the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY Torch systems. The study included nine unique BioFire Global Fever (GF) Panel pouch lots, 13 operators and multiple instruments, for a total of 255 reproducibility replicates. The BioFire GF Panel pouches are identical to the BioFire FilmArray TF Panel pouches.

Of the 255 samples tested, all the analytes in the positive control were detected, and not detected in the negative control for a  $100\%$  agreement for both controls. Furthermore, three results were invalid and the remaining 252 results were valid and correct calls, as shown in Table 4 below.

Table 4. Summary of Reproducibility Study Results

|  Site | Total Tests | Invalid* | Correct Positive Control Results | Incorrect Positive Control Results | PPA | Correct Negative Control Results | Incorrect Negative Control Results | NPA  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  1 | 120 | 0 | 60 | 0 | 100% | 60 | 0 | 100%  |
|  2 | 73 | 1 | 36 | 0 | 100% | 36 | 0 | 100%  |
|  3 | 62 | 2 | 30 | 0 | 100% | 30 | 0 | 100%  |
|  Total | 255 | 3 | 126 | 0 | 100% | 126 | 0 | 100%  |

*Invalid results are not included in performance calculations

Acceptance criteria for the FilmArray TF Control Panel M527 reproducibility study were established as  $> / = 95\%$  agreement with the expected results e.g., correct calls and  $\mathrm{CV} < 20\%$  for all analytes.

Reproducibility and between-lot crossing point (Cp) data for the FilmArray TF Control Panel M527 at the three sites were further analyzed to calculate the for mean Cp, SD and  $\% \mathrm{CV}$  for each analyte detected by the BIOFIRE FILMARRAY TF Panel. Analyses of the Cp data are shown in Tables 5 and 6 below.

Table 5. FilmArray TF Positive - Reproducibility Data Analysis by Analyte

|  Analytes | Site 1 |   |   | Site 2 |   |   | Site 3 |   |   | Between sites  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV  |
|  CHIKV 1 | 18.47 | 1.21 | 6.6% | 19.49 | 2.03 | 10.4% | 19.61 | 1.92 | 9.8% | 19.19 | 0.63 | 3.3%  |
|  CHIKV 2 | 15.87 | 0.78 | 4.9% | 16.15 | 1.34 | 8.3% | 15.78 | 1.02 | 6.4% | 15.93 | 0.19 | 1.2%  |
|  DENV 1 | 17.32 | 0.76 | 4.4% | 17.55 | 1.48 | 8.5% | 17.23 | 0.92 | 5.4% | 17.37 | 0.17 | 1.0%  |
|  DENV 2_1 | 19.47 | 0.81 | 4.1% | 19.59 | 1.33 | 6.8% | 19.37 | 1.39 | 7.2% | 19.48 | 0.11 | 0.6%  |
|  DENV 2_2 | 17.12 | 0.77 | 4.5% | 17.49 | 1.58 | 9.1% | 17.08 | 1.04 | 6.1% | 17.23 | 0.23 | 1.3%  |

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Table 6. FilmArray TF Positive – Lot- to Lot Variability Data Analysis by Analyte

|  Analytes | Lot 1 |   |   | Lot 2 |   |   | Lot 3 |   |   | Total lots  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV | Mean | SD | %CV  |
|  CHIKV 1 | 20.1 | 1.3 | 6.5% | 17.7 | 0.9 | 5.1% | 20.5 | 1.1 | 5.4% | 19.4 | 1.7 | 8.6%  |
|  CHIKV 2 | 16.6 | 0.8 | 4.8% | 15.1 | 0.7 | 4.6% | 16.8 | 0.8 | 4.8% | 16.2 | 1.1 | 6.6%  |
|  DENV 1 | 18 | 1 | 5.6% | 16.6 | 0.7 | 4.2% | 18.2 | 0.8 | 4.4% | 17.6 | 1.1 | 6.2%  |
|  DENV 2_1 | 20 | 0.7 | 3.5% | 18.7 | 0.9 | 4.8% | 20.5 | 1.1 | 5.4% | 19.7 | 1.2 | 5.9%  |
|  DENV 2_2 | 17.8 | 1 | 5.6% | 16.5 | 0.8 | 4.8% | 18 | 0.9 | 5.0% | 17.4 | 1.1 | 6.5%  |
|  DENV 3 | 20.1 | 1.2 | 6.0% | 18.8 | 1.5 | 8.0% | 20.2 | 1.3 | 6.4% | 19.7 | 1.5 | 7.5%  |
|  DENV 4 | 17 | 1 | 5.9% | 15.6 | 0.9 | 5.8% | 17.3 | 0.9 | 5.2% | 16.6 | 1.2 | 7.2%  |
|  Plasmodium spp. | 15.7 | 0.6 | 3.8% | 15.7 | 0.6 | 3.8% | 15.9 | 0.6 | 3.8% | 15.8 | 0.6 | 4%  |
|  P. falciparum | 16.7 | 0.6 | 3.6% | 16.6 | 0.6 | 3.6% | 16.9 | 0.7 | 4.1% | 16.7 | 0.7 | 3.9%  |
|  P. vivax/ovale | 17 | 0.7 | 4.1% | 16.9 | 0.9 | 5.3% | 17.4 | 1 | 5.7% | 17.1 | 0.9 | 5.1%  |
|  Lepto 1 | 15.8 | 0.6 | 3.8% | 15.8 | 0.6 | 3.8% | 16 | 0.6 | 3.8% | 15.8 | 0.6 | 3.9%  |

The results support the reproducibility of the FilmArray TF Control Panel M527 across three separately manufactured control lots, sites, days, and operators.

2. Linearity:

Not applicable

3. Analytical Specificity/Interference:

Not applicable

4. Detection Limit and Assay Reportable Range:

Not applicable

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

a. Closed Vial Real-time Stability

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The FilmArray TF Control Panel M527 closed vial real-time stability study tested three lots of each FilmArray TF Positive and FilmArray TF Negative controls when stored at refrigeration temperature (2° - 8°C) for up to 12 months. Testing was performed with the BIOFIRE FILMARRAY TF Panel on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY Torch systems. The real-time stability study for the FilmArray TF Control Panel M527 supports a shelf-life of 12 months, when stored under refrigerated conditions (2° - 8°C).

## b. Shipping Stability

The FilmArray TF Control Panel M527 shipping study evaluated the control kit performance after shipping in dry-ice and in cold gel packs. Two lots of each FilmArray TF Positive, and FilmArray TF Negative, were used in the study, and all samples were tested with the BIOFIRE FILMARRAY TF Panel on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY Torch systems. Simulated shipping studies for the FilmArray TF Control Panel M527 support stability of the control kit after shipping overnight in dry ice or in cold gel pack.

## 6. Assay Cut-Off:

Not applicable

## B Comparison Studies:

1. Method Comparison with Predicate Device:

Not applicable

2. Matrix Comparison:

The FilmArray TF Control Panel M527 is formulated as synthetic, non-infectious material. To demonstrate equivalent performance between the synthetic material of the controls and clinical sample matrix on the BIOFIRE FILMARRAY TF panel, a study was conducted where gDNA *Plasmodium falciparum* was spiked into FilmArray TF Positive control matrix and EDTA whole blood in a 1:200 dilution, then tested in duplicate with the BIOFIRE FILMARRAY TF Panel on the BIOFIRE FA 2.0 and BIOFIRE FA Torch systems. The acceptance criterion is 100% agreement between the spiked EDTA whole blood and spiked FilmArray TF Positive control matrix.

After testing, 100% agreement between the spiked simulated clinical sample matrix and spiked FilmArray TF Positive control matrix was observed ("Detected" for *Plasmodium* spp. and *Plasmodium falciparum*; "Not Detected" for all other analytes), as seen in Table 7. The mean Crossing points (Cp) for *Plasmodium* spp. and *Plasmodium falciparum* across both sample types were similar, as seen in Table 8.

Table 7. FilmArray TF Positive Control – Matrix Testing

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|  Analytes | Positive Control | Negative Control |   | P. falciparum spiked into FilmArray TF Positive Control matrix |   | P. falciparum spiked into simulated patient sample matrix (EDTA Whole blood)  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |  FilmArray TF Pos F24SEP24A | Unspiked Whole Blood | Unspiked control Matrix | P. falciparum spiked in Control Matrix |   | P. falciparum spiked in Whole Blood  |   |
|  CHIKV 1 | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |
|  CHIKV 2 | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |
|  DENV 1 | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |
|  DENV 2_1 | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |
|  DENV 2_2 | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |
|  DENV 3 | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |
|  DENV 4 | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |
|  Plasmodium spp. | Detected | Not Detected | Not Detected | Detected | Detected | Detected | Detected  |
|  Plasmodium falciparum | Detected | Not Detected | Not Detected | Detected | Detected | Detected | Detected  |
|  Plasmodium vivax/ovale | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |
|  Leptospira 1 | Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected | Not Detected  |

Table 8. Matrix Testing Data Analysis

|  Pathogen Analyte | Plasmodium falciparum spiked into FilmArray TF Positive Control matrix and patient sample matrix (EDTA Whole Blood)  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  MMQCI Control Matrix |   | Mean | Whole blood |   | Mean Cp  |
|  Plasmodium spp. | 10.3 | 9.8 | 10.1 | 10.7 | 11.5 | 11.1  |
|  Plasmodium falciparum | 16.5 | 15.7 | 16.1 | 17.2 | 17.4 | 17.3  |

The results demonstrate that the FilmArray TF Control Panel M527 matrix has no effect on target detection (no inhibition and/or false negative results) when tested with the BIOFIRE FILMARRAY TF Panel.

## C Clinical Studies:

1. Clinical Sensitivity:

Not applicable

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2. Clinical Specificity:

Not applicable

3. Clinical Cut-Off:

Not applicable

4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable

# D Expected Values/Reference Range:

The BioFire FilmArray TF Control Panel M527 is a qualitative control and the expected results for BIOFIRE FILMARRAY TF Panel are listed in Tables 9 and 10 below.

Table 9. FilmArray TF Positive Control

|  FilmArray TF Positive Control | Expected Result  |
| --- | --- |
|  Viruses  |   |
|  Chikungunya virus | Detected  |
|  Dengue virus | Detected  |
|  Parasites  |   |
|  Plasmodium spp. | Detected  |
|  Plasmodium falciparum | Detected  |
|  Plasmodium vivax/ovale | Detected  |
|  Bacteria  |   |
|  Leptospira spp. | Detected  |

Table 10. FilmArray TF Negative Control

|  FilmArray TF Negative Control | Expected Result  |
| --- | --- |
|  Viruses  |   |
|  Chikungunya virus | Not Detected  |
|  Dengue virus | Not Detected  |
|  Parasites  |   |
|  Plasmodium spp. | Not Detected  |
|  Plasmodium falciparum | Not Detected  |
|  Plasmodium vivax/ovale | Not Detected  |
|  Bacteria  |   |
|  Leptospira spp. | Not Detected  |

# VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

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IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/device/K260577](https://fda.innolitics.com/device/K260577)

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