← Product Code [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN) · K203680

# BioFire JI Control Panel M420 (K203680)

_Maine Molecular Quality Controls, Inc. · PMN · Jul 22, 2022 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K203680

## Device Facts

- **Applicant:** Maine Molecular Quality Controls, Inc.
- **Product Code:** [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN.md)
- **Decision Date:** Jul 22, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3920
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

BioFire JI Control Panel M420 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finegoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp. and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida and Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire JI Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire JI Panel assay. This product is not intended to replace manufacturer controls provided with the device.

## Device Story

BioFire JI Control Panel M420 provides external positive and negative quality control material for the BioFire Joint Infection (JI) Panel assay. The positive control consists of non-infectious synthetic DNA in a buffer solution, representing the genome segments of pathogens and resistance genes detected by the JI Panel; the negative control consists of buffers, stabilizers, and preservatives. The device is used in clinical laboratories to monitor the performance of the BioFire system's amplification, detection, and identification processes. Operators process the liquid controls similarly to patient synovial fluid samples. The output is a qualitative 'Detected' or 'Not Detected' result for the panel's targets. By verifying the assay's performance, the control helps ensure the accuracy of clinical diagnostic testing for joint infections, supporting reliable clinical decision-making.

## Clinical Evidence

Bench testing only. Reproducibility study conducted across 4 sites (1 internal, 3 clinical) using 3 control lots and 3 pouch lots, totaling 301 tests. Results showed 100% correct result rate (300/301, excluding 1 invalid result). Matrix effect study compared synthetic matrix to human synovial fluid, confirming no interference with assay performance (mean Cp values were comparable).

## Technological Characteristics

Ready-to-use liquid control. Positive control: synthetic DNA in buffers, stabilizers, and preservatives. Negative control: buffers, stabilizers, and preservatives. Monitors amplification, detection, and identification. Compatible with FilmArray 2.0 and FilmArray Torch systems. Single-use packaging. Storage at 2-8°C.

## 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 BCID2 Control Panel M416 ([K200010](/device/K200010.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

K203680

B Applicant

Maine Molecular Quality Controls, Inc.

C Proprietary and Established Names

BioFire JI Control Panel M420

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  PMN | Class II | 21 CFR 866.3920 - Assayed Quality Control Material For Clinical Microbiology Assays | MI - Microbiology  |

## II Submission/Device Overview:

A Purpose for Submission:

To obtain a substantial equivalence determination for the BioFire JI Control Panel M420

B Measurand:

Multi-analyte quality control materials

C Type of Test:

BioFire JI Control Panel M420 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Gram positive and Gram negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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faecalis, Enterococcus faecium, Finegoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., and Serratia marcescens, as well as antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida and Candida albicans on the BioFire JI Panel assay on the BioFire systems.

## Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) for Use:

BioFire JI Control Panel M420 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finegoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp. and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida and Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire JI Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire JI Panel assay. This product is not intended to replace manufacturer controls provided with the device.

### C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

### D Special Instrument Requirements:

The Biofire JI Control Panel was evaluated on the FilmArray 2.0 and FilmArray Torch instruments.

## IV Device/System Characteristics:

### A Device Description:

BioFire JI Control Panel M420, PIN M420, is a quality control panel consisting of two controls: BioFire JI Positive Control, PIN M42118, and JI Negative Control, PIN M42218. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in

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buffers, stabilizers and preservatives. The DNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire JI Panel assay (see Table 1 below) on the BioFire systems. The Negative Control contains only buffers, stabilizers and preservatives.

Table 1. Pathogens and antimicrobial resistance genes found in BioFire JI Control Panel M420, detected by the BioFire JI Panel Assay.

|  Analyte  |   |   |   |
| --- | --- | --- | --- |
|  Gram Positive Bacteria  |   |   |   |
|  Anaerococcus prevotii/vaginalis | Enterococcus faecalis | Peptoniphilus | Streptococcus mutans  |
|  Clostridium perfringens | Enterococcus faecium | Peptostreptococcus anaerobius | Streptococcus agalactiae  |
|  Cutibacterium avidum | Finegoldia magna | Staphylococcus aureus | Streptococcus pneumoniae  |
|  Cutibacterium granulosum | Parvimonas micra | Staphylococcus lugdunensis | Streptococcus pyogenes  |
|  Gram Negative Bacteria  |   |   |   |
|  Bacteroides fragilis | Haemophilus influenzae | Morganella morganii | Salmonella spp.  |
|  Citrobacter | Kingella kingae | Neisseria gonorrhoeae | Serratia marcescens  |
|  Enterobacter cloacae complex | Klebsiella aerogenes | Proteus spp. |   |
|  Escherichia coli | Klebsiella pneumoniae group | Pseudomonas aeruginosa |   |
|  Yeast  |   |   |   |
|  Candida spp. |   | Candida albicans  |   |
|  Antimicrobial Resistance Genes  |   |   |   |
|  CTX-M | KPC | NDM | vanA/B  |
|  IMP | mecA/C and MREJ (MRSA) | OXA-48-like | VIM  |

B Principle of Operation:

Not applicable.

V Substantial Equivalence Information:

A Predicate Device Name(s):

FilmArray BCID2 Control Panel M416

B Predicate 510(k) Number(s):

K200010

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C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K203680 | K200010  |
| --- | --- | --- |
|  Device Trade Name | BioFire JI Control Panel M420 | FilmArray BCID2 Control Panel M416  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | BioFire JI Control Panel M420 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finegoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp. | FilmArray BCID2 Control Panel M416 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticusbaumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas  |

K203680 - Page 4 of 11

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K203680 - Page 5 of 11
|   | and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida and Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire JI Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire JI Panel assay. This product is not intended to replace manufacturer controls provided with the device. | aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens:Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire Blood Culture Identification 2 (BCID2) Panel assay on FilmArray systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device  |
| --- | --- | --- |
|  Physical Format | Ready-to-use liquid | Same  |
|  Directions for Use | Process like patient sample (pipette from synovial fluid) | Process like patient sample (pipette from blood culture)  |
|  Composition | Synthetic DNA | Same  |
|  Assay Steps Monitored | Amplification, detection, identification | Same  |
|  Number of targets monitored in one assay | Multiple, > 30 targets | Same, >30 targets  |
|  General Device Characteristic Differences |  |   |
|  Targets | CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finegoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus | CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B),  |

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K203680 - Page 6 of 11

|   | aureus. Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., Serratia marcescens, Candida, and Candida albicans | Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus baumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii  |
| --- | --- | --- |

VI Standards/Guidance Documents Referenced:

None referenced.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

A multi-site reproducibility study was performed with the BioFire JI Control Panel on FilmArray 2.0 and FilmArray Torch systems. Testing included evaluation of 10 samples of each of three lots of BioFire JI Control Panel M420 on different days at three CLIA-certified clinical sites using three BioFire JI Panel pouch lots, incorporating multiple operators for a total of 181 tests (one Invalid result was repeated).

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Out of the 90 positive and 90 negative controls tested with valid pouch controls, the correct analytes were detected (for positive controls) or not detected (for negative controls) resulting in a correct call rate of 100% (Table 2).

Table 2. BioFire JI Control Panel M420: Summary of Reproducibility Results

|  Site | Total Tests | Invalid | Correct Positive Control Result | Incorrect Positive Control Result | % Correct Positive Control Result (95% CI) | Correct Negative Control Result | Incorrect Negative Control Result | % Correct Negative Control Result (95% CI)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  1 | 61 | 1* | 30 | 0 | 100 | 30 | 0 | 100  |
|  2 | 60 | 0 | 30 | 0 | 100 | 30 | 0 | 100  |
|  3 | 60 | 0 | 30 | 0 | 100 | 30 | 0 | 100  |
|  All | 181 | 1* | 90 | 0 | 100 (95.9%-100.0%) | 90 | 0 | 100 (95.9%-100.0%)  |

*Invalid result was not included in percent correct

An internal precision study was performed by testing 20 samples of each of three lots of BioFire JI Control Panel M420 on different days with three BioFire JI Panel pouch lots by three operators for a total of 120 tests. The same pouch lots were used for both internal and external testing. All controls gave correct positive or negative results (Table 3).

Table 3. BioFire JI Control Panel M420: Summary of Internal Precision Results

|  Control | Lot # | No. Tests | Invalid | Correct Results | Incorrect Results | Percent Correct [95% CI]  |
| --- | --- | --- | --- | --- | --- | --- |
|  BioFire JI Negative Control | 1 | 20 | 0 | 20 | 0 | 100  |
|   |  2 | 20 | 0 | 20 | 0 | 100  |
|   |  3 | 20 | 0 | 20 | 0 | 100  |
|   |  Total | 60 | 0 | 60 | 0 | 100% [94-100%]  |
|  BioFire JI Positive Control | 1 | 20 | 0 | 20 | 0 | 100  |
|   |  2 | 20 | 0 | 20 | 0 | 100  |
|   |  3 | 20 | 0 | 20 | 0 | 100  |
|   | Total | 60 | 0 | 60 | 0 | 100% [94-100%]  |

A Cp data analysis was also conducted for the precision study results and no significant difference in the mean Cp values was observed based on testing of different Biofire JI Positive control lots on different days by multiple operators at external and internal sites. The reproducibility and precision studies evaluating the BioFire JI Control Panel M420 are acceptable.

2. Linearity:

Not applicable.

3. Analytical Specificity/Interference:

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Not applicable.

4. **Assay Reportable Range:**
Not applicable.

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

**Open Vial Stability**

Not applicable because the BioFire JI Control Panel M420 is packaged for single use.

**Real-Time Stability Program**

Real-time stability studies are ongoing to support product claims and to monitor potential assay modifications for which the BioFire JI Control Panel M420 is indicated for use. Real-time stability study protocols and acceptance criteria were reviewed and found to be acceptable.

**Shipping Stability**

MMQCI ships DNA-based controls, such as BioFire JI Control Panel M420, on frozen gel packs with overnight delivery (U.S.), or 4-7 days (ex-U.S.), ensuring that the control material remains cold upon receipt. The control material is expected to be stored at 2-8°C upon receipt, as indicated in the BioFire JI Control Panel M420 package insert. A shipping study was performed to confirm the shipping process does not negatively impact performance, with and without a shipping delay with consequent arrival of gel packs no longer frozen or cold, and to investigate two extreme temperature excursions: 37°C and -20°C, that might occur during shipping. The study evaluated two lots of the BioFire JI Positive Control that was placed with two frozen gel packs. After two days, some vials were returned to the refrigerator at 2-8°C, and subsequently tested using the BioFire JI Panel assay, thus representing usual customer receipt of product. To simulate a shipping delay, the remaining 'shipped' vials from the two lots of the BioFire JI Positive Control were removed from the shipping box after two days and stored for up to six days at ambient room temperature. The vials were then returned to the refrigerator and subsequently tested using the BioFire JI Panel assay.

The study demonstrated that the BioFire JI Control Panel M420 is stable for two days on frozen gel packs in MMQCI's standard shipping box. BioFire JI Positive Control is stable after six days at ambient temperatures of approximately 19-21°C. The BioFire JI Control Panel M420 should be stored refrigerated (2-8°C) as indicated in the package insert.

To investigate control performance after exposure to extreme temperatures, two tubes each of two lots of BioFire JI Positive Control were warmed to room temperature, placed at -20°C and 37°C and subsequently tested using the BioFire JI Panel assay. The results from this study demonstrate that an overnight exposure to -20°C and 37°C does not impact control performance.

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6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

Not applicable.

## B Comparison Studies:

1. Method Comparison with Predicate Device:

Not applicable.

2. Matrix Effects:

The matrix of the BioFire JI Control Panel M420 is synthetic. To investigate the potential effects of the synthetic matrix on the BioFire JI Panel assay, equal volumes of the same concentration of gDNA *Streptococcus pneumoniae*, strain TCH8431 (BEI Resources, P/N HM-145D) were spiked into 270μL of BioFire JI Control Panel M420 matrix and 270μL of synovial fluid (Human Synovial Fluid; Innovative Research), then tested on the BioFire JI Panel assay in triplicate. The acceptance criteria were correct results for all spiked synovial fluid and spiked synthetic matrix samples.

The expected results were obtained for all spiked human synovial fluid and spiked BioFire JI Control Panel M420 synthetic matrix (Detected for *Streptococcus spp.* and *S. pneumoniae*, Not Detected for all other assays).

The results indicated that the BioFire JI Control Panel M420 matrix has no effect on the assay.

## C Clinical Studies:

1. Clinical Sensitivity:

Not applicable.

2. Clinical Specificity:

Not applicable.

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

Not applicable.

## D Clinical Cut-Off:

Not Applicable

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# E Expected Values/Reference Range:

BioFire JI Control Panel M420 is a qualitative control and the expected results are listed in the table below.

Table 5. BioFire JI Control Panel M420 Positive and Negative Result Summary

|  Analyte | Positive Control | Negative Control  |
| --- | --- | --- |
|  Anaerococcus prevotii/vaginalis | Detected | Not Detected  |
|  Clostridium perfringens | Detected | Not Detected  |
|  Cutibacterium avidum | Detected | Not Detected  |
|  Cutibacterium granulosum | Detected | Not Detected  |
|  Enterococcus faecalis | Detected | Not Detected  |
|  Enterococcus faecium | Detected | Not Detected  |
|  Finegoldia magna | Detected | Not Detected  |
|  Parvimonas micra | Detected | Not Detected  |
|  Peptoniphilus | Detected | Not Detected  |
|  Peptostreptococcus anaerobius | Detected | Not Detected  |
|  Staphylococcus aureus | Detected | Not Detected  |
|  Staphylococcus lugdunensis | Detected | Not Detected  |
|  Streptococcus mutans | Detected | Not Detected  |
|  Streptococcus agalactiae | Detected | Not Detected  |
|  Streptococcus pneumoniae | Detected | Not Detected  |
|  Streptococcus pyogenes | Detected | Not Detected  |
|  Bacteroides fragilis | Detected | Not Detected  |
|  Citrobacter | Detected | Not Detected  |
|  Crobacter cloacae complex | Detected | Not Detected  |
|  Escherichia coli | Detected | Not Detected  |
|  Haemophilus influenzae | Detected | Not Detected  |
|  Kingella kingae | Detected | Not Detected  |
|  Klebsiella aerogenes | Detected | Not Detected  |
|  Klebsiella pneumoniae group | Detected | Not Detected  |
|  Morganella morganii | Detected | Not Detected  |
|  Neisseria gonorrhoeae | Detected | Not Detected  |
|  Proteus spp. | Detected | Not Detected  |
|  Pseudomonas aeruginosa | Detected | Not Detected  |
|  Salmonella spp. | Detected | Not Detected  |
|  Serratia marcescens | Detected | Not Detected  |
|  Candida spp. | Detected | Not Detected  |
|  Candida albicans | Detected | Not Detected  |
|  AMR Genes  |   |   |
|  CTX-M | Detected | N/A  |
|  IMP | Detected | N/A  |
|  KPC | Detected | N/A  |
|  mecA/C and MREJ (MRSA) | Detected | N/A  |
|  NDM | Detected | N/A  |
|  OXA-48-like | Detected | N/A  |
|  vanA/B | Detected | N/A  |
|  VIM | Detected | N/A  |

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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.

K203680 - Page 11 of 11

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K203680](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K203680)

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