SPOTFIRE® RSP Positive Control is intended for use as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel performed on the BIOFIRE® SPOTFIRE® System. SPOTFIRE RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel. This product is not intended to replace manufacturer internal controls provided with the device.

SPOTFIRE® RSP Negative Control is intended for use as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel performed on the BIOFIRE® SPOTFIRE® System. SPOTFIRE RSP Negative Control is comprised of a solution that does not contain target analytes and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel. This product is not intended to replace manufacturer internal controls provided with the device.

Device Description

SPOTFIRE® RSP Pos & Neg Controls, P/N M425, is a quality control panel consisting of 2 separate kits of ready-to-use, liquid controls, SPOTFIRE® RSP Positive Control (Positive Control), P/N M42638 and SPOTFIRE® RSP Negative Control (Negative Control), P/N M42738. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in buffer, stabilizers and preservatives. The RNA in the Positive Control carries RNA segments of all the respiratory pathogens detected by the BIOFIRE® SPOTFIRE® Respiratory (R) Panel on the BIOFIRE® SPOTFIRE® System (see Table 1 below) and is specifically designed for and intended to be used solely with the SPOTFIRE R Panel assay on the SPOTFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE® RSP Pos & Neg Controls, P/N M425, is processed separately according to the SPOTFIRE R Panel assay manufacturer's Instructions for Use for Quality Control testing.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device (SPOTFIRE® RSP Pos & Neg Controls) meets those criteria. The device being reviewed is a quality control material for clinical microbiology assays, not an AI/ML-enabled diagnostic device. Therefore, many of the requested categories pertaining to AI/ML device studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect size of human reader improvement with AI, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the performance study for this quality control material.

Here's the information based on the provided text, focusing on what is applicable to the described device and study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "sensitivity must be > 90%"). Instead, the document refers to "predetermined criteria" for reproducibility that were met. The reported performance is an "overall correct result rate."

Acceptance Criteria (Implied)	Reported Device Performance
Reproducibility of SPOTFIRE RSP Positive and RSP Negative Control is acceptable.	Overall correct result rate of 99.7%.
(External Sites) Predetermined acceptance criteria for reproducibility met.	Overall success rate of 99.6%.
(Internal Sites) Predetermined acceptance criteria for reproducibility met.	Overall correct result rate of 100%.

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

Total Test Results: 361 initially, leading to 351 valid test results after repeating invalid ones.
External Performance Study (Test Set): 232 initially, leading to 225 valid controls after repeating invalid ones.
- Data Provenance: Prospective, collected from 5 near-patient clinical sites across the US (presumably, given the context of FDA submission, though not explicitly stated but implied by "near-patient clinical sites" in the context of an FDA filing for a US company).
Internal Study (Test Set): 129 initially, leading to 126 valid results after repeating invalid ones.
- Data Provenance: Prospective, conducted at MMQCI facility in Saco, Maine, USA.

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

Not Applicable. This is a quality control material where the "ground truth" is inherent to the control material itself (i.e., whether it should be positive for specific analytes or negative for all analytes). The "correctness" of the result is determined by its agreement with the expected outcome for that control. The study evaluates the reproducibility and performance of the control and the assay system, not a diagnostic decision requiring expert consensus.

4. Adjudication Method for the Test Set

Not Applicable. As this is a quality control material, the "ground truth" for each control (whether it should yield a positive or negative result) is predefined by its composition. There is no human adjudication process for categorizing results as "correct" or "incorrect" beyond comparing them to the expected outcome based on the control's design. Invalid results were repeated as per BioFire instructions.

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

Not Applicable. This is not an AI/ML-enabled diagnostic device. No human readers, AI assistance, or comparative effectiveness studies of this nature were performed.

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

Not Applicable. This is a physical quality control material used with an in-vitro diagnostic system (BIOFIRE® SPOTFIRE® System). Its performance is evaluated within that system, not as a standalone algorithm.

7. The Type of Ground Truth Used

Defined Composition: The ground truth for the SPOTFIRE® RSP Positive Control is the presence of synthetic RNA transcripts corresponding to specific respiratory pathogens, manufactured to be detected by the BIOFIRE® SPOTFIRE® Respiratory (R) Panel.
Defined Absence: The ground truth for the SPOTFIRE® RSP Negative Control is the absence of target analytes, designed to yield a negative result.
The "correct" result for each control is based on its predetermined design and expected performance with the intended assay.

8. The Sample Size for the Training Set

Not Applicable. As this is a quality control material and not an AI/ML model, there is no "training set." The study described evaluates the performance and reproducibility of the manufactured control materials within their intended use.

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

Not Applicable. See point 8.

Summary

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February 03, 2023

Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, Maine 04072

Re: K221253

Trade/Device Name: SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed Quality Control Material For Clinical Microbiology Assays Regulatory Class: Class II Product Code: PMN Dated: April 29, 2022 Received: May 2, 2022

Dear Joan Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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,

Joseph Briggs -S Digitally signed by Joseph Briggs -S Date: 2023.02.03 14:24:15 -05'00'

Joseph Briggs Deputy Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MM" in a dark serif font, with the "QCI" in a lighter, sans-serif font to the right. A stylized, golden swoosh design is placed to the left of the letters, adding a visual element to the logo.

Section 5: 510 (k) Summary

510(k) Number: K221253

Purpose for submission: New product

Applicant Information:

Applicant:	Maine Molecular Quality Controls, Inc.
Address:	23 Mill Brook Road
	Saco, Maine 04072

	Contact Person: Joan Gordon, President MMQCI
Phone:	207-885-1072 extension 201
Fax:	207-885-1079
	Email Address: jgordon@mmqci.com

Preparation Date: April 25, 2022; updated January 20, 2023

Device

Device Trade Name:	SPOTFIRE® RSP Pos & Neg Controls, comprised ofSPOTFIRE® RSP Positive Control and SPOTFIRE® RSPNegative Control
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

A. K202196; BioFire RP2.1/RP2.1plus Control Panel M441

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MMQCI" in a combination of maroon and yellow colors. The "MM" is in maroon, while the "QCI" is in yellow. A stylized yellow graphic element is placed to the left of the letters, adding a visual flair to the logo.

RNA segments of all the respiratory pathogens detected by the BIOFIRE® SPOTFIRE® Respiratory (R) Panel on the BIOFIRE® SPOTFIRE® System (see Table 1 below) and is specifically designed for and intended to be used solely with the SPOTFIRE R Panel assay on the SPOTFIRE System. The Negative Control contains buffer and preservatives with no RNA. Each liquid control of SPOTFIRE® RSP Pos & Neg Controls, P/N M425, is processed separately according to the SPOTFIRE R Panel assay manufacturer's Instructions for Use for Quality Control testing.

Table 1. Respiratory pathogens detected by the SPOTFIRE R Panel
Viruses	Bacteria
Adenovirus	Bordetella parapertussis
Coronavirus 229E, HKU1, OC43, NL631	Bordetella pertussis
Coronavirus SARS-CoV-2	Chlamydia pneumoniae
Human Metapneumovirus	Mycoplasma pneumoniae
Human Rhinovirus/ Enterovirus
Influenza A Virus, subtypes H1-2009, H3
Influenza B Virus
Parainfluenza Virus serotypes 1-42
Respiratory Syncytial Virus

Reported as seasonal Coronavirus (undifferentiated).
Reported as Parainfluenza Virus (undifferentiated).

Device Intended Use of SPOTFIRE® RSP Pos & Neg Controls

SPOTFIRE® RSP Positive Control

Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

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Image /page/5/Picture/0 description: The image contains the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in a serif font, with "MM" in a larger, bold font and "QCI" in a smaller, regular font. Below the acronym, in a smaller font, is the text "MAINE MOLECULAR QUALITY CONTROLS, INC." A stylized, abstract graphic in shades of yellow and gold is positioned to the left of the text, adding a visual element to the logo.

SPOTFIRE® RSP Negative Control

Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

Substantial Equivalence

Maine Molecular Quality Controls, Inc. (MMQCI) proposes that SPOTFIRE RSP Pos & Neg Controls are substantially equivalent to MMQCI's product, BioFire RP2.1/RP2.1plus Control Panel M441 (K202196). The manufacturing processes and components used to manufacture SPOTFIRE RSP Pos & Neg Controls are similar to those of the predicate device. SPOTFIRE RSP Pos & Neg Controls are used as quality controls for assays on the BIOFIRE SPOTFIRE System, while the predicate device is used for assays on the BioFire FilmArray System. However, the 2 systems encompass similar technology; on board extraction and nested multiplexed PCR with assessment of endpoint melting curve data. The rationale for equivalence is listed in Table 3 below.

Characteristic	Candidate Device:SPOTFIRE RSP Pos &Neg Controls	PredicateDevice:BioFireRP2.1/RP2.1plusControl PanelM441 (K202196)
Intended Use	External assayed qualitycontrol to monitor in vitrolab nucleic acid test	Same
Physical format	Ready-to-Use Liquid	Same
Directions for Use	Process like patient sample	Same
Composition	Synthetic RNA transcripts	Same

Table 3. Substantial Equivalence of Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MMQCI" in a stylized font, with the "MM" in a dark red color and the "QCI" in black. Below the letters, there is the full name of the company, "Maine Molecular Quality Controls, Inc.", in a smaller font. A yellow graphic element is placed to the left of the letters, adding a visual accent to the logo.

Assay stepsmonitored	Reverse transcription,amplification, detection,identification	Same
Test System	SPOTFIRE	FilmArray 2.0 orFilmArray Torch
Number of targetsmonitored in oneassay	Multiple	Same
Pathogenscontained in thecontrol panel	Respiratory	Respiratory
User	Non-lab (CLIA Waived)and lab professionals (CLIAcertified)	Lab professionals(CLIA certified)

Summary of Performance Data

Three (3) lots of SPOTFIRE RSP Positive Control and 3 of SPOTFIRE RSP Negative Control, were manufactured by MMQCI's facility in Saco, Maine. The lots were manufactured and tested such that routine variables, including lots of key manufacturing components, different operators, pouch lots, instruments, test sites, and testing over time were incorporated to challenge manufacture processes and product performance. External and internal studies were performed by testing the 3 lots with the SPOTFIRE R Panel assay on the SPOTFIRE System (BioFire Diagnostics) to generate a total of 361 test results.

For the external performance study, 5 near-patient clinical sites (the SPOTFIRE R Panel intended use environment) tested samples of each of the 3 lots of SPOTFIRE RSP Positive Controls and SPOTFIRE RSP Negative Controls as they would test controls during normal operations, using 25 SPOTFIRE R Panel pouch lots, incorporating multiple operators and instruments for a total of 232 tests, including 7 with Invalid results which were repeated. The internal study was performed by testing samples of each of the 3 lots at MMQCI (Saco, Maine) on different days with 3 pouch lots by 3 operators for a total of 129 tests (3 controls with Invalid results were repeated). One of the pouch lots used at the MMQCI site was also used at a clinical site.

Results and Conclusions:

Of the total 361 tests performed, there were 10 Invalid results which were repeated for 351 valid test results. The Invalid results instrument errors (3) and failed internal pouch controls (7). The Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis in Table 2 below. Of the 351 valid results, 350 results were correct. One SPOTFIRE RSP Positive Control failed due to false negative results for 3 analytes.

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Image /page/7/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a bold, serif font. The "MM" is in a dark red color, while the "QCI" is in a slightly lighter shade of red. To the left of the letters, there is a stylized, abstract design in a golden yellow color, resembling a brushstroke or a ribbon. The words "MAINE MOLECULAR QUALITY CONTROLS, INC." are written in a smaller font size below the letters "MMQCI".

Reproducibility of SPOTFIRE RSP Positive and RSP Negative Control at 6 sites, across 27 unque pouch lots, 3 control lots, on multiple instruments by multiple operators is acceptable according to predetermined criteria with an overall correct result rate of 99.7%. Test results demonstrate robust performance across 6 testing sites.

Summary of Reproducibility Test Results: External and Internal Sites
TotalTests	Invalid*	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrectPositiveControl	CorrectNegativeControlResult	IncorrectNegativeControlResult	PercentCorrectNegativeControl	TotalPercentCorrect
361	10	171	1	99.3%	179	0	100%	99.7%

Table 2. SPOTFIRE RSP Positive and Negative Controls, all sites.

*The Invalid samples were not included in the Percent Correct analysis.

External Site Testing Details

A total of 232 samples of SPOTFIRE RSP Positive and RSP Negative Control were tested at 5 near-patient clinical sites, the BIOFIRE SPOTFIRE R Panel intended use environment. The sites were asked to follow the SPOTFIRE R Panel IUO Quick Guide to run the controls as they would during normal operations, e.g. training a new operator, receiving new shipments of R Panel test kits, receiving new or repaired instrumentation, and whenever the test kits have been stored at an incorrect temperature. It was recommended a negative quality control sample be run at least monthly to monitor for environmental contamination. The amount of QC a site performed was based on the number of operators they had and the amount of SPOTFIRE R Panel testing their site performed.

Three lots of SPOTFIRE RSP Positive Control (A02NOV20, B06NOV20, C10NOV20) and 4 lots of SPOTFIRE RSP Negative Control (F09JUL19, D11MAR20, H05MAY20, C13MAY20) were tested on 25 SPOTFIRE R Panel pouch lots across the 5 sites, incorporating multiple operators and instruments. Of the 232 controls tested, there were 7 with Invalid results which were repeated for a total of 225 controls with valid results. Of the 7 Invalid results, 4 were due to failed internal pouch controls and 3 were due to instrument errors.

Results and Conclusion:

Out of 225 tests with valid results, the correct analytes were detected (for positive controls) or not detected (for negative controls) in 224 tests, for an overall success rate of 99.6% (Table 4). One SPOTFIRE RSP Positive Control failed due to false negative results for 3 analytes. The predetermined acceptance criteria for reproducibility were met. SPOTFIRE RSP Positive Control and RSP Negative Control performed robustly at the 5 external test sites across 25 pouch lots on the SPOTFIRE System, incorporating multiple operators.

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Image /page/8/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in a stylized font, with the "MM" and "CI" in a dark serif font and the "Q" in a bright yellow sans-serif font. A golden, curved graphic element is placed to the left of the acronym, adding a visual flair to the design. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller, sans-serif font.

Table 4. Summary of External Reproducibility Results for 3 Control Lots at 5 Clinical Sites

Site	TotalTests	Invalid	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrectPositiveControl	CorrectNegativeControlResult	IncorrectNegativeControlResult	PercentCorrectNegativeControl	TotalPercentCorrect
1	26	0	13	0	100%	13	0	100%	100%
2	33	1	13	0	100%	19	0	100%	100%
3	120	4	53	1	98.1%	62	0	100%	99.1%
4	44	1	21	0	100%	22	0	100%	100%
5	9	1	8	0	100%	NA	NA	NA	100%
AllSites	232	7*	108	1	99.1%	116	0	100%	99.6%

*Invalid results were not included in percent correct.

Internal Site Testing Details

Run-to-run Precision Testing at MMQCI: Of the total 361 reproducibility tests, 129 SPOTFIRE RSP Positive Control and SPOTFIRE RSP Negative Control samples were tested on 21 different days at MMQCI's facility in Saco, Maine. Three lots of Positive Control (A02NOV20, B06NOV20, C10NOV20) and 3 lots of Negative Control (F09JUL19, D11MAR20, H05MAY20) were tested on 3 SPOTFIRE R pouch lots, incorporating 4 operators and 1 SPOTFIRE instrument (Table 5). One of the pouch lots was also used for the external site testing.

Results and conclusions:

Of the 129 results, 3 were Invalid which were repeated for a total of 126 valid results. All 126 of the valid results were correct for an overall correct result rate of 100%. Predetermined acceptance criteria for reproducibility were met. SPOTFIRE RSP Positive Control and SPOTFIRE RSP Negative Control performed robustly on 21 different days at MMQCI across 3 pouch lots on 1 SPOTFIRE instrument, incorporating 4 operators.

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Image /page/9/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of colors. The "MM" is in a dark red color, while the "QCI" is in a bright yellow color. A stylized yellow graphic element is placed to the left of the letters, adding a visual flair to the logo.

Table 5. SPOTFIRE RSP Positive Control and SPOTFIRE RSP Negative Control: Reproducibility results at MMQCI.

Control	ControlLot#	No. ofTests	Invalid*	CorrectResults	PercentCorrect
SPOTFIRE RSP Positive Control	A02NOV20	23	2	21	100%
SPOTFIRE RSP Positive Control	B06NOV20	21	0	21	100%
SPOTFIRE RSP Positive Control	C10NOV20	22	1	21	100%
SPOTFIRE RSP Negative Control	F09JUL19	21	0	21	100%
SPOTFIRE RSP Negative Control	D11MAR20	21	0	21	100%
SPOTFIRE RSP Negative Control	H05MAY20	21	0	21	100%
*Invalid results were not included in percentcorrect.	TOTAL	129	3	126	100%

The above information supports the substantial equivalence of the SPOTFIRE RSP Positive and Negative Controls to the predicate device.

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.”