BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
Applicant
Biofire Defense, LLC
Product Code
PMN · Microbiology
Decision Date
Jul 17, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3920
Device Class
Class 2
Indications for Use
The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit contains Positive and Negative 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 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) when using the BIOFIRE FILMARRAY Tropical Fever Panel on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems. The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit is designed for and intended to be used solely with the BIOFIRE FILMARRAY Tropical Fever Panel. This product does not replace manufacturer internal controls provided as part of the BIOFIRE FILMARRAY Tropical Fever Panel. Both the Positive and Negative External Controls are provided in a Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic nucleic acid segments in buffer and stabilizer to assess for the presence of each individual assay on the BIOFIRE FILMARRAY Tropical Fever Panel. The Negative Control Injection Vial is non-reactive with the BIOFIRE FILMARRAY Tropical Fever Panel. For In Vitro Diagnostic Use.
Device Story
External quality control kit for BIOFIRE FILMARRAY Tropical Fever (TF) Panel; consists of single-use Control Injection Vials containing dried synthetic RNA segments (positive) or no template (negative). Used in clinical laboratory settings by technicians to monitor assay performance; replaces clinical specimen with molecular grade water. Positive controls assess reverse transcription, amplification, detection, and identification of target pathogens; negative controls confirm lack of cross-reactivity. Instrument software automatically reports results as 'Detected' or 'Not Detected'. Successful runs confirm system integrity; failure indicates potential assay or instrument issues, prompting troubleshooting before clinical testing.
Clinical Evidence
Bench testing only. Multi-site reproducibility study conducted across three sites using three control lots, two operators per site, over five days. Total of 270 replicates for positive and negative controls tested on nine BIOFIRE FILMARRAY 2.0 and ten BIOFIRE FILMARRAY TORCH systems. Positive control agreement: 268/270 (99.3%); Negative control agreement: 269/270 (99.6%). Melt temperature (Tm) analysis demonstrated consistent performance across sites.
Technological Characteristics
Assayed external quality control; Positive control: dried synthetic RNA segments in buffer/stabilizer; Negative control: no template. Form factor: single-use Control Injection Vial. Compatible with BIOFIRE FILMARRAY 2.0 and TORCH systems. Monitors reverse transcription, amplification, detection, and identification.
Indications for Use
Indicated for use as assayed quality controls to monitor performance of in vitro diagnostic nucleic acid testing for chikungunya virus, dengue virus (serotypes 1-4), Leptospira spp., and Plasmodium spp. (including P. falciparum and P. vivax/ovale) using the BIOFIRE FILMARRAY Tropical Fever Panel on BIOFIRE FILMARRAY 2.0 and TORCH systems. Prescription use only.
Regulatory Classification
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
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (K220870)
Submission Summary (Full Text)
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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**
K261475
# **B Applicant**
Biofire Defense, LLC
# **C Proprietary and Established Names**
BIOFIRE FILMARRAY Tropical Fever Panel Control Kit
# **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 BIOFIRE FILMARRAY Tropical Fever Panel Control Kit.
# **B Measurand:**
Multi-analyte external quality control materials for microbiology NAAT assays
# **C Type of Test:**
The BIOFIRE FILMARRAY Tropical Fever (BIOFIRE TF) Panel Control Kit consists of Positive External Controls and Negative External Controls provided in a Control Injection Vial format for direct use with the BIOFIRE TF Panel. The Positive External Controls contain non-infectious RNA segments in buffer and stabilizer embedded on the filter of a Control Injection Vial. The RNA segments are designed to be detected by each of the assays on the BIOFIRE TF
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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Panel. The Negative External Controls are provided as a Control Injection Vial with no template and are non-reactive with the BIOFIRE TF Panel. Each Control Injection Vial is individually packaged and intended for a single use. Vials of Surrogate Sample (molecular grade water) are also provided with the BIOFIRE TF Panel Control Kit which are used in place of a clinical specimen when running the controls.
### III Intended Use/Indications for Use:
#### A Intended Use(s):
See Indications for Use below.
#### B Indication(s) for Use:
The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit contains Positive and Negative 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 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*) when using the BIOFIRE FILMARRAY Tropical Fever Panel on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems. The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit is designed for and intended to be used solely with the BIOFIRE FILMARRAY Tropical Fever Panel. This product does not replace manufacturer internal controls provided as part of the BIOFIRE FILMARRAY Tropical Fever Panel.
Both the Positive and Negative External Controls are provided in a Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic nucleic acid segments in buffer and stabilizer to assess for the presence of each individual assay on the BIOFIRE FILMARRAY Tropical Fever Panel. The Negative Control Injection Vial is non-reactive with the BIOFIRE FILMARRAY Tropical Fever Panel.
For In Vitro Diagnostic Use.
#### 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 BIOFIRE TF Panel Control Kit is an assayed external quality control consisting of six Positive Controls and six Negative Controls for monitoring the performance of in vitro laboratory nucleic acid procedures when using the BIOFIRE TF Panel. The controls may be used for monitoring the BIOFIRE TF Panel performance when used with BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems.
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The BIOFIRE TF Panel Control Kit consists of Positive External Controls and Negative External Controls provided in a Control Injection Vial format for direct use with the BIOFIRE TF Panel. The Positive External Controls contain non-infectious RNA segments in buffer and stabilizer embedded on the filter of a Control Injection Vial (Figure 1). The RNA segments are designed to be detected by each of the assays on the BIOFIRE TF Panel. The Negative External Controls are provided as a Control Injection Vial with no template and are non-reactive with the BIOFIRE TF Panel. Each Control Injection Vial is individually packaged and intended for a single use. Vials of Surrogate Sample (molecular grade water) are also provided with the BIOFIRE TF Panel Control Kit which are used in place of a clinical specimen when running the controls.
The BIOFIRE TF Panel Control Kit monitors detection and identification of all pathogens included in by the BIOFIRE TF Panel. A successful Positive External Control run is indicated by all BIOFIRE TF Panel assays reported as “Detected.” A successful Negative External Control run will report all results for the BIOFIRE TF Panel assays as “Not Detected” as shown in Table 1 below.
**Table 1: BIOFIRE TF Panel Control Kit Targets**
| Targets | Expected Result | |
| --- | --- | --- |
| | Positive Control | Negative Control |
| **Viruses** | | |
| Chikungunya virus | Detected | Not Detected |
| Dengue virus | Detected | Not Detected |
| **Parasites** | | |
| *Plasmodium* spp. | Detected | Not Detected |
| *Plasmodium falciparum* | Detected | Not Detected |
| *Plasmodium vivax/ovale* | Detected | Not Detected |
| **Bacteria** | | |
| *Leptospira* spp. | Detected | Not Detected |
## **B Principle of Operation:**
Each positive or negative control included in the BIOFIRE TF Panel Control Kit 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 TF Panel. Results are reported automatically by instrument software as either “Detected” or “Not Detected.”
## **V Substantial Equivalence Information:**
### **A Predicate Device Name(s):**
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
### **B Predicate 510(k) Number(s):**
K220870
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# **C Comparison with Predicate(s):**
| Device & Predicate Device(s): | K261475 | K220870 |
| --- | --- | --- |
| Device Trade Name | BIOFIRE FILMARRAY Tropical Fever Panel Control Kit | BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel |
| **General Device Characteristic Similarities** | | |
| Intended Use/Indications For Use | The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit contains Positive and Negative 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 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*) when using the BIOFIRE FILMARRAY Tropical Fever Panel on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY TORCH Systems. The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit is designed for and | The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel contains Positive and Negative 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 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*) when using the BioFire Global Fever Panel on BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems. The BIOFIRE SHIELD Control Kit |
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| | intended to be used solely with the BIOFIRE FILMARRAY Tropical Fever Panel. This product does not replace manufacturer internal controls provided as part of the BIOFIRE FILMARRAY Tropical Fever Panel. Both the Positive and Negative External Controls are provided in a Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic nucleic acid segments in buffer and stabilizer to assess for the presence of each individual assay on the BIOFIRE FILMARRAY Tropical Fever Panel. The Negative Control Injection Vial is non-reactive with the BIOFIRE FILMARRAY Tropical Fever Panel. | for the BioFire Global Fever Panel is designed for and intended to be used solely with the BioFire Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the BioFire Global Fever Panel device. 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 BioFire Global Fever Panel. The Negative Control Injection Vial contains no DNA and is non-reactive with the BioFire Global Fever Panel assays. |
| --- | --- | --- |
| Physical format | Same | Control Injection Vial |
| Test System | Same | BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY TORCH Systems |
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| Targets | Same | 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). |
| --- | --- | --- |
| General Device Characteristic Differences | | |
| Assay steps monitored | Reverse transcription, Amplification, detection, identification. | Amplification, detection, identification. |
| Composition | Synthetic RNA templates (positive control only) in buffer and stabilizer. | Synthetic DNA segments (positive control only) in buffer and stabilizer. |
## VI Standards/Guidance Documents Referenced:
None
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
#### 1. Precision/Reproducibility:
A multi-site reproducibility study was conducted by testing 270 replicates of BIOFIRE TF Positive control and 270 replicates of BIOFIRE TF Negative control using three lots of each material. Testing with the BIOFIRE TF Panel was conducted across three sites with two operators at each site over five consecutive days and incorporating nine BIOFIRE FILMARRAY 2.0 and ten BIOFIRE FILMARRAY TORCH systems. The agreement between the observed and expected test results for the Positive and Negative Controls across sites is summarized in Table 2.
Table 2. Multi-site Reproducibility Study Results
| Control Type | Observed/Expected (Percent Agreement) [95% CI] | | | |
| --- | --- | --- | --- | --- |
| | Site 1 | Site 2 | Site 3 | All Sites |
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| Positive | 90/90 (100%) [95.9 – 100.0] | 89/90 (98.9%) [94.0 – 99.8] | 89/90 (98.9%) [94.0 – 99.8] | 268/270 (99.3%) [97.3 – 99.8] |
| --- | --- | --- | --- | --- |
| Negative | 90/90 (100%) [95.9 – 100.0] | 89/90 (98.9%) [94.0 – 99.8] | 90/90 (100%) [95.9 – 100.0] | 269/270 (99.6%) [97.9 – 99.9] |
Additionally, to further evaluate the reproducibility of the Positive Control measurements, the standard deviation of the melt temperatures for each analyte included in the Positive Control material was determined, as shown in Table 3 below.
Table 3. Summary of Tm (°C) Analyses for BIOFIRE FILMARRAY Tropical Fever Panel Positive Controls
| Panel Target | Panel Assay | Observed Tm (°C) (Mean ± StDev) | | | |
| --- | --- | --- | --- | --- | --- |
| | | Site 1 | Site 2 | Site 3 | All Sites (N=268) |
| Chikungunya virus | CHIKV 1 | 85.2 ± 0.2 | 85.1 ± 0.2 | 85.0 ± 0.3 | 85.1 ± 0.3 |
| | CHIKV 2 | 85.1 ± 0.2 | 84.9 ± 0.3 | 84.9 ± 0.3 | 85.0 ± 0.3 |
| Dengue virus | DENV 1 | 83.3 ± 0.2 | 83.2 ± 0.2 | 83.2 ± 0.3 | 83.2 ± 0.3 |
| | DENV 2_1 | 80.5 ± 0.2 | 80.4 ± 0.3 | 80.3 ± 0.3 | 80.4 ± 0.3 |
| | DENV 2_2 | 81.3 ± 0.3 | 81.2 ± 0.2 | 81.1 ± 0.3 | 81.2 ± 0.3 |
| | DENV 3 | 84.6 ±0.2 | 84.5 ±0.3 | 84.5 ±0.3 | 84.5 ±0.3 |
| | DENV 4 | 83.4 ±0.2 | 83.3 ±0.2 | 83.2 ±0.3 | 83.3 ±0.3 |
| *Leptospira* spp. | Leptospira 1 | 81.9 ± 0.2 | 81.8 ± 0.2 | 81.8 ± 0.3 | 81.8 ± 0.3 |
| *Plasmodium* spp. | *Plasmodium* spp. | 80.4 ± 0.2 | 80.3 ± 0.3 | 80.1 ± 0.3 | 80.3 ± 0.3 |
| | *P. falciparum* | 74.8 ± 0.2 | 74.7 ± 0.3 | 74.6 ± 0.3 | 74.7 ± 0.3 |
| | *P. vivax/ovale* | 74.2 ± 0.2 | 74.1 ± 0.2 | 74.0 ± 0.3 | 74.1 ± 0.3 |
The results support the reproducibility of the BIOFIRE TF Panel Control Kit across three separately manufactured control lots, sites, and operators.
# 2. Linearity:
Not applicable
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# 3. Analytical Specificity/Interference:
Not applicable
# 4. Detection Limit and Assay Reportable Range:
Not applicable
# 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Not applicable
# 6. Assay Cut-Off:
Not applicable
# **B Comparison Studies:**
# 1. Method Comparison with Predicate Device:
Not applicable
# 2. Matrix Comparison:
Not applicable
# **C Clinical Studies:**
# 1. Clinical Sensitivity:
Not applicable
# 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:**
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The BIOFIRE TF Panel Control Kit is a qualitative control and the expected results for BIOFIRE TF Panel are listed in Tables 4 and 5 below.
**Table 4. BIOFIRE TF Panel 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 5. BIOFIRE TF Panel 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.
### IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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