SPOTFIRE® RSP Positive Control is intended for use (as applicable) 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, Adenovirus, 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 (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® 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 SPOTFIRE R Panel and the SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.

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

SPOTFIRE® RSP Negative Control is intended for use (as applicable) 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, Adenovirus, 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 (SPOTFIRE® R Panel) and BIOFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® 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 SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.

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

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 SPOTFIRE R Panel (Table 1) and SPOTFIRE R Panel Mini (Table 2) on the SPOTFIRE System and is specifically designed for and intended to be used solely with the SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays 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 and SPOTFIRE R Panel Mini assay manufacturer's Instructions for Use for Quality Control testing.

AI/ML Overview

This document describes a 510(k) premarket notification for a change to an existing device, the SPOTFIRE® RSP Pos & Neg Controls. The change specifically involves including the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE R Panel Mini) in the device's intended use. As such, the presented information focuses on demonstrating substantial equivalence rather than a detailed de novo device performance study.

Based on the provided text, the device in question is an "Assayed Quality Control Material For Clinical Microbiology Assays". The performance data presented in the 510(k) submission (K221253) for the original device is deemed sufficient to support the change, meaning no new performance data specific to this submission (K230868) was generated.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document explicitly states: "No additional performance data are required as the SPOTFIRE RSP Pos & Neg Controls have not been changed, the assay consumables are identical for the SPOTFIRE R Panel used to collect original performance data and the SPOTFIRE R Panel Mini added to the intended use of the device. In addition, the targets reported in the SPOTFIRE R Panel Mini are a subset of the SPOTFIRE R Panel."

This indicates that the performance of the control material (SPOTFIRE® RSP Pos & Neg Controls) with the SPOTFIRE R Panel Mini is expected to be consistent with its performance on the broader SPOTFIRE R Panel, for which performance data was previously submitted and accepted under K221253.

Therefore, the table of acceptance criteria and reported device performance from the original K221253 submission would be relevant, but those details are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

No new test set was used for this specific 510(k) submission (K230868). The submission relies on performance data from the previous submission (K221253). The document does not provide details of the sample size or data provenance from K221253.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. As this submission is for a quality control material and not an AI/ML diagnostic algorithm relying on expert interpretation of images, the concept of "experts establishing ground truth" in the same manner as for image-based diagnostics is not directly applicable. For a quality control material, the ground truth is typically established by the known composition of the control material itself (e.g., presence or absence of specific RNA transcripts).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no new test set requiring adjudication of interpretations was presented in this submission.

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 device is a quality control material, not an AI/ML diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable. This device operates as a control for an in vitro diagnostic test, not as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For a quality control material like the SPOTFIRE® RSP Pos & Neg Controls, the ground truth is the defined composition of the control material itself.

Positive Control: Contains "in vitro RNA transcripts" of the target pathogens. So, the ground truth for the positive control is the presence of these specific RNA transcripts.
Negative Control: Comprised of a "solution that does not contain target analytes." So, the ground truth for the negative control is the absence of the target analytes.

8. The sample size for the training set:

Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary of Device Acceptance & Study Information (Based on the Provided Text):

The acceptance of K230868 is based on demonstrating substantial equivalence to the previously cleared predicate device (K221253). The core argument for acceptance is that:

The SPOTFIRE® RSP Pos & Neg Controls have not been physically changed.
The assay consumables for the original SPOTFIRE R Panel and the newly included SPOTFIRE R Panel Mini are identical.
The targets detected by the SPOTFIRE R Panel Mini are a subset of those included in the SPOTFIRE R Panel, which was already covered by the previous clearance.

Therefore, the performance data previously submitted for K221253 is considered sufficient and no new performance studies specific to the addition of the SPOTFIRE R Panel Mini were required for this submission. The "study that proves the device meets the acceptance criteria" refers to the previously conducted and accepted studies for K221253, the details of which are not included in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 13, 2023

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

Re: K230868

Trade/Device Name: SPOTFIRE RSP Pos & Neg Controls, 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: March 28, 2023 Received: March 29, 2023

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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

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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Indications for Use

510(k) Number (if known) K230868

Device Name

SPOTFIRE® RSP Pos & Nez Controls, SPOTFIRE® RSP Positive Control, and SPOTFIRE® RSP Negative Control

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 bold, serif font, with the "MM" in a darker color than the "QCI". A stylized golden ribbon-like graphic is draped over the letters. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller, sans-serif font.

Section 5: Special 510 (k) Summary

510(k) Number:

Purpose for submission: Change to existing device (reference K221253) to include the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE R Panel Mini) in the intended use for SPOTFIRE® RSP Pos & Neg Controls.

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: March 28, 2023

Device

Device Trade Name:	SPOTFIRE® RSP Pos & Neg Controls
	SPOTFIRE® RSP Positive Control
	SPOTFIRE® RSP Negative Control
Device Type:	Assayed quality control material for clinical microbiology assays
Class:	Class II (Special controls)
Product code:	PMN

Predicate Device

K221253: SPOTFIRE® RSP Pos & Neg Controls SPOTFIRE® RSP Positive Control SPOTFIRE® RSP Negative Control

Proposed Change:

The specific change to the existing device is the inclusion of the SPOTFIRE R Panel Mini in the intended use for SPOTFIRE RSP Pos & Neg Controls, with subsequent updates of the Indications of Use (FDA Form 3881), and Package Inserts for SPOTFIRE RSP Positive Control and SPOTFIRE RSP Negative Control. No other changes have been made to the original device referenced in K221253.

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Image /page/5/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MMQCI" in a bold, sans-serif font, with the "MM" in a darker shade and the "QCI" in a lighter shade. To the left of the letters is a stylized graphic that resembles a strand of DNA or a ribbon, colored in a golden hue. Below the letters, in a smaller font, is the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC."

Description of Modified Device (inclusion of SPOTFIRE R Panel Mini):

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

Table 1. Respiratory pathogens detected by the SPOTFIRF R Panel

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

Table 2. Respiratory viruses detected by the SPOTFIRE R Panel Mini

Coronavirus SARS-CoV-2
Human Rhinovirus
Influenza A Virus
Influenza B Virus
Respiratory Syncytial Virus

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Image /page/6/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in bold, with "MM" in a dark red-brown color and "QCI" in yellow. Below the acronym, in smaller font, is the full name of the company, "Maine Molecular Quality Controls, Inc." To the left of the text is a stylized, abstract graphic in yellow, resembling a ribbon or a strand of DNA.

Modified Device Intended Use of SPOTFIRE RSP Pos & Neg Controls to include the addition SPOTFIRE Respiratory R Panel Mini

SPOTFIRE® RSP Positive Control:

SPOTFIRE® RSP Positive Control is intended for use (as applicable) 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/Enterovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE® R Panel) and BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® 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 SPOTFIRE R Panel and the SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.

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

SPOTFIRE® RSP Negative Control:

SPOTFIRE® RSP Negative Control is intended for use (as applicable) 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/Enterovirus, Influenza A Subtype H1-2009. Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE® R Panel) and BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE® R Panel Mini) assays performed on the BIOFIRE® 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 SPOTFIRE R Panel and SPOTFIRE R Panel Mini assays. This product is not intended to replace manufacturer internal controls provided with the device.

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

Note: Product insert includes the Rx symbol.

Substantial Equivalence

Maine Molecular Quality Controls, Inc. (MMQCI) proposes that changes made to the labeling for SPOTFIRE RSP Pos & Neg Controls do not impact substantial equivalence to the predicate device (K221253), SPOTFIRE® RSP Pos & Neg Controls. The manufacturing processes and

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Image /page/7/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in bold, stylized letters. A golden ribbon-like design wraps around the letters, adding a touch of elegance. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in smaller font.

components used to manufacture SPOTFIRE RSP Pos & Neg Controls are the same as those of the predicate device. In addition, the targets detected by the SPOTFIRE R Panel Mini are included in the SPOTFIRE R Panel.

Characteristic	Modified Device:SPOTFIRE RSP Pos &Neg Controls	Predicate Device:K221253SPOTFIRE RSPPos & NegControls
Intended Use	External assayed qualitycontrol to monitor in vitrolab nucleic acid test usingthe SPOTFIRE R Panel andSPOTFIRE R Panel Mini,performed on theSPOTFIRE System.	Original 510(k) didnot include theSPOTFIRE R PanelMini
Labeling	SPOTFIRE (R) Panel Miniincluded in the ProductInsert only, no changes to kitor tube labels	SPOTFIRE (R)Panel Mini notincluded in theProduct Insert
Physical format	Ready-to-Use Liquid	Same
Directions for Use	Process like patient sample	Same
Composition	Synthetic RNA transcripts	Same
Assay steps monitored	Reverse transcription,amplification, detection,identification	Same
Test System	SPOTFIRE	Same
Number of targetsmonitored in oneassay	Multiple	Original 510(k) didnot include theSPOTFIRE R PanelMini. This panelcontains 5 viraltargets that areincluded in theSPOTFIRE R Panel
Pathogens containedin the control panel	Respiratory	Same
User	Non-lab (CLIA Waived) andlab professionals (CLIAcertified)	Same

Table 3. Substantial Equivalence of Predicate Device

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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 bold, capitalized letters. A stylized, golden ribbon-like design wraps around the letters, adding a dynamic and artistic element to the logo. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in smaller font.

Performance Data:

Performance data presented in the 510(k) submission (K221253) has all required data to support the change to existing the device to include the SPOTFIRE R Panel Mini in the intended use for SPOTFIRE RSP Pos & Neg Controls. No additional performance data are required as the SPOTFIRE RSP Pos & Neg Controls have not been changed, the assay consumables are identical for the SPOTFIRE R Panel used to collect original performance data and the SPOTFIRE R Panel Mini added to the intended use of the device. In addition, the targets reported in the SPOTFIRE R Panel Mini are a subset of the SPOTFIRE R Panel.

Results and Conclusion:

Based upon the substantial equivalence characteristics listed in Table 3 and the original performance data (K221253), MMQCI has determined that the proposed change to the intended use (the addition of the SPOTFIRE R Panel Mini assay), supports substantial equivalence to the predicate device K221253, SPOTFIRE RSP Pos & Neg Controls.

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.”