The BD MAX™ CT/GC/TV 20-Day QC Panel is intended for use as an external assayed positive quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis with the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The controls comprise cultured and inactivated C. trachomatis, N. qonorrhoeae and T. vaqinalis.

The BD MAX CT/GC/TV™ 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.

Device Description

The BD MAX™ CT/GC/TV 20-Day QC Panel is used to monitor the extraction, amplification and detection of the BD MAX™ CT/GC/TV Assay. The BD MAX™ CT/GC/TV 20-Day QC Panel contains authentic pathogens inactivated by radiological and temperature treatments. Each BD MAX™ CT/GC/TV 20-Day QC Panel consists of 20 individually packaged positive control pellets in a heat-sealed foil pouch. Each individually packaged pellet consists of inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis pathogens as well as preservatives and stabilized pellet containing inactivated organism(s) is packaged in a 2.0ml labeled micro-centrifuge tube with a red screw cap.

AI/ML Overview

The document describes the BD MAX CT/GC/TV 20-Day QC Panel, an assayed quality control material for clinical microbiology assays. The provided information focuses on the device's performance in a precision and reproducibility study, which serves to demonstrate its functionality and reliability.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated by the reported agreement percentages. While explicit "acceptance criteria" values (e.g., "must achieve >95% agreement") are not stated as such, the results show near-perfect agreement, suggesting these values implicitly meet the necessary performance for clearance.

Analyte	Acceptance Criteria (Implicit)	Reported Device Performance (Agreement %)
C. trachomatis	(High agreement expected)	100%
N. gonorrhoeae	(High agreement expected)	99%
T. vaginalis	(High agreement expected)	100%

Study Proving Device Meets Acceptance Criteria:

A "precision and reproducibility study" was conducted to demonstrate device performance.

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

Test Set Sample Size: For each analyte (C. trachomatis, N. gonorrhoeae, T. vaginalis), a total of 90 tests were performed (30 tests at each of 3 sites).
- This is calculated as: 3 sites * 2 operators/site * 3 lots tested/operator * 5 days/operator = 90 tests per analyte.
Data Provenance: The study was conducted across three different testing locations. The exact countries are not specified, but the submission is to the U.S. FDA, implying the study was likely conducted in the US or in a manner compliant with US regulatory requirements. The study was prospective as it involved a planned experimental setup to test the device's performance.

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

This type of device (quality control material for molecular assays) does not typically involve human expert interpretation of results to establish "ground truth" in the way an imaging AI algorithm would. For this device, the "ground truth" is the expected positive result based on the biological composition of the quality control material. The "experts" in this context would be the microbiologists and laboratory personnel who handle the molecular assays and interpret the objective quantitative or qualitative output from the BD MAX™ System. Their qualifications are inherent in their roles as laboratory operators capable of running and interpreting the BD MAX™ CT/GC/TV Assay.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for this device. The results are objective outputs from the BD MAX™ System (positive or negative detection). The document notes: "Three Unresolved results were obtained; in all cases a new control was retested and the expected results were obtained." This indicates a re-testing protocol for ambiguous results, but not an "adjudication" between conflicting human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers are interpreting images or data. This device is a quality control material that produces objective results via a molecular diagnostic system. The study focused on the reproducibility of the device itself across different operators, sites, and lots.

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

Yes, in essence, the performance study is a "standalone" evaluation of the quality control device's ability to consistently produce expected results when processed by the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The performance measured is the agreement of the QC panel with its known positive state when run on the automated system. Human operators initiate the test and record results, but their primary role is execution, not interpretation of a complex output requiring subjective judgment.

7. The Type of Ground Truth Used

The ground truth is based on the known composition of the quality control material. The BD MAX™ CT/GC/TV 20-Day QC Panel contains inactivated C. trachomatis, N. gonorrhoeae, and T. vaginalis pathogens. Therefore, the expected (ground truth) result for each test of the QC panel is "positive" for these analytes. The study explicitly states it "does not include a negative control," further confirming its intended use as a positive control.

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. Its "performance" is its ability to consistently yield a positive result when run on a specific molecular diagnostic system.

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

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

Summary

{0}------------------------------------------------

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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 28, 2018

Microbiologics, Inc. Tina Sobania Director of Corporate Quality 200 Cooper Avenue North St. Cloud, Minnesota 56303

Re: K181683

Trade/Device Name: BD MAX CT/GC/TV 20-Day OC Panel Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: June 20, 2018 Received: June 26, 2018

Dear Tina Sobania:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Uwe Scherf. Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the Microbiologics logo. The logo features a stylized blue and red circle on the left, followed by the word "Microbiologics" in blue, with a registered trademark symbol. Below the word, there is a red line and the text "A safer, healthier world." in a smaller font.

510(k) Summary

510(k) Number: TBD

Date: August 6, 2018

Applicant Information:

Applicant:	Microbiologics, Inc.
Address:	200 Cooper Avenue NorthSt. Cloud, MN 56303
Primary Contact:	Tina Sobania, Director of Corporate Qua
Primary Contact:	Tina Sobania, Director of Corporate Quality
Phone:	320-229-7050
Email:	tsobania@microbiologics.com

Device:

Device Trade Name:	BD MAX™ CT/GC/TV 20-Day QC Panel
Common Name:	Assayed quality control material for clinical microbiology assays
Classification:	Class II
Regulation:	21 CFR 866.3920
Panel:	83-Microbiology
Product Code:	PMN

Predicate Device:

Bio-Rad Amplichek II (DEN 150058)

Device Description:

Device Intended Use:

The BD MAX CT/GC/TV™ 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.

Characteristic	BD MAX™ CT/GC/TV 20-Day QC Panel	Predicate Device –Bio-Rad Amplichek II (DEN 150058)
Intended Use	The BD MAX™ CT/GC/TV 20-Day QC Panel is intended for use as an externalassayed positive quality control material tomonitor the performance of in vitrolaboratory nucleic acid testing proceduresfor the qualitative detection of Chlamydia	Amplichek II is intended for use as an externalassayed quality control material to monitor theperformance of in vitro laboratory nucleic acidtesting procedures for the qualitative detectionof Methicillin Resistant Staphylococcus aureus ,Methicillin Sensitive Staphylococcus aureus ,

Substantial Equivalence:

{3}------------------------------------------------

	trachomatis, Neisseria gonorrhoeae andTrichomonas vaginalis with the BD MAX™CT/GC/TV Assay on the BD MAX™System. The controls comprise culturedand inactivated C. trachomatis, N.gonorrhoeae and T. vaginalis.	Clostridium difficile and Vancomycin-resistantEnterococci performed on Cepheid GeneXpertSystems. This product is not intended toreplace manufacturer controls provided withthe device.
	The BD MAX CT/GC/TV™ 20-Day QCPanel is not intended to replacemanufacturer controls provided with thedevice.	This product is only for use with assays andinstruments listed in the RepresentativeResults Chart in this labeling.
Physical Format	Lyophilized pellet	Ready-to-use liquid
Composition	Inactivated microorganisms	Inactivated microorganisms
Analytes	Chlamydia trachomatisNeisseria gonorrhoeaeTrichomonas vaginalis	Methicillin Resistant Staphylococcus aureusMethicillin Sensitive Staphylococcus aureusClostridium difficileVancomycin-resistant Enterococci
Test System	BD MAX System	Cepheid GeneXpert System
Directions for Use	Process like patient sample	Process like patient sample
Assay StepsMonitored	Extraction, amplification, and detection	Extraction, amplification, detection
Number of Targetsmonitored in oneassay	Multiple	Multiple

Summary of Performance Data:

A precision and reproducibility study was conducted to determine device performance. Three different testing locations were used. Six different operators (2 at each facility) and 3 different lots of the BD MAX™ CT/GC/TV 20-Day QC Panel were tested over five days. Each operator performed 3 tests (1 per lot) on 5 different days. All testing was performed on BD MAX™ instruments using the BD MAX™ CT/GC/TV assay.

Analyte	Agreement (%) by Test Site/BD MAX System
	Site 1 1	Site 2 1	Site 3	Overall
C. trachomatis	30/30(100)	30/30(100)	30/30(100)	90/90(100)
N. gonorrhoeae	30/30(100)	30/30(100)	29/30(97)	89/90(99)
T. vaginalis	30/30(100)	30/30(100)	30/30(100)	90/90(100)

'Three Unresolved results were obtained; in all cases a new control was retested and the expected results were obtained

The BD MAX™ CT/GC/TV 20-Day QC Panel does not include a negative control.

Conclusion

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

	Type of Use (Select one or both, as applicable)
--	-------------------------------------------------	--	--	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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.”