The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica.

The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day OC Panel are not intended to replace manufacturer controls provided with the device.

Device Description

The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are used to monitor the extraction, amplification of the BD MAX™ Enteric Parasite Panel. Both panels contain individually packaged pellets consisting of inactivated, Cryptosporidium parvum, Giardia lamblia, and a recombinant Escherichia coli. The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel differ only by packaged quantity. Each BD MAX™ Enteric Parasite Control Panel consists of 6 individually packaged positive control pellets. Each BD MAX™ Enteric Parasite 20-Day QC Panel consists of 20 individually packaged positive control pellet is individually wrapped with a desiccant in a heat-sealed foil pouch. The organisms are prepared in a buffered solution with materials of animal origin, preservatives and stabilizers. The solution is lyophilized into a ready-to-use pellet containing inactivated orqanism(s) is packaged in a 2.0-ml labeled micro-centrifuge tube with a red screw cap.

The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel do not contain negative controls.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day QC Panel, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" through numerical thresholds for precision and reproducibility in a tabular format. However, the study focuses on agreement for detecting the target analytes. Based on the results, the implied acceptance criterion is 100% agreement for the detection of each analyte.

Analyte	Acceptance Criteria (Implied)	Reported Device Performance (Overall Agreement)
G. lamblia	100% agreement	100% (90/90)
E. histolytica	100% agreement	100% (90/90)
C. parvum	100% agreement	100% (90/90)

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

Sample Size for Test Set:
- For each analyte (G. lamblia, E. histolytica, C. parvum): 90 tests total (30 tests per site x 3 sites).
- The study involved testing 3 different lots of controls, by 6 different operators (2 per facility), over 5 days. Each operator performed 3 tests per day (1 per lot).
- Calculations: 3 Lots x 6 Operators x 5 Days = 90 tests.
Data Provenance: The document does not explicitly state the country of origin. It indicates "three different testing locations" were used, implying it was a multi-site study. It's a prospective study looking at the performance of the control panels.

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

This information is not provided in the document. For a quality control material, the "ground truth" is typically established by the known composition of the control material (i.e., it contains the specified inactivated organisms/recombinant E. coli). The study is evaluating if the device (BD MAX™ Enteric Parasite Panel on the BD MAX™ System) correctly detects these known components when the control is run.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a quality control study for a qualitative detection assay, an "adjudication method" in the typical sense (e.g., for disagreements among human readers) is less applicable. The "results" are the output of the BD MAX™ System (detection or non-detection of the target analytes). The document notes retesting occurred for "Incomplete Run errors" and "Unresolved result," which serves as an internal resolution mechanism rather than an adjudication among independent interpreters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically compares human reader performance (with and without AI assistance) on diagnostic images or complex cases. This document describes a performance study for a diagnostic quality control material, which does not involve human readers interpreting results in the same way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation of the control panel with the BD MAX™ Enteric Parasite Panel and System was conducted. The study assesses the ability of the automated system to detect the known components within the control panel. While human operators initiate the tests, the performance reported (detection of G. lamblia, E. histolytica, C. parvum) is the output of the automated BD MAX™ system, without human interpretation influencing the final "positive" or "negative" call for the presence of the analytes.

7. The Type of Ground Truth Used

The ground truth used is the known composition of the control material. The control panels are manufactured to contain specific inactivated organisms (Cryptosporidium parvum, Giardia lamblia) and recombinant Escherichia coli (as a surrogate for E. histolytica). The "ground truth" is that these analytes are present in the control panels. The study verifies if the BD MAX™ System correctly identifies their presence.

8. The Sample Size for the Training Set

This information is not applicable/not provided for this specific document. This document describes the performance of a quality control material for a previously cleared diagnostic system (BD MAX™ Enteric Parasite Panel on the BD MAX™ System). Quality control materials themselves are not typically "trained" like AI algorithms. The underlying BD MAX™ system and its assays would have had their own development and validation, which might involve training data, but that is not the subject of this 510(k) for the control panels.

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

This information is not applicable/not provided (see point 8).

Summary

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August 15, 2018

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

Re: K181711

Trade/Device Name: BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Dav 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 27, 2018 Received: June 28, 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/cdrl/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

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801 and Part 809); medical device reporting (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.html; 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,

Ribhi Shawar -S For

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

Enclosure

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Indications for Use

510(k) Number (if known) K181711

Device Name BD MAX™ Enteric Parasite Control Panel BD MAXTM Enteric Parasite 20-Day QC Panel

Indications for Use (Describe)

The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day OC Panel are not intended to replace manufacturer controls provided with the device.

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)

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Image /page/3/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 tagline "A safer, healthier world." in a smaller font.

510(k) Summary

510(k) Number: K181711

Date: August 6, 2018

Applicant Information:

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

Device:

Device Trade Names:	BD MAX™ Enteric Parasite Control PanelBD MAX™ Enteric Parasite 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:

The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel do not contain negative controls.

Device Intended Use:

The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day QC Panel are not intended to replace manufacturer controls provided with the device.

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Image /page/4/Picture/0 description: The image shows the Microbiologics logo. The logo features a blue and red circular design on the left, followed by the word "Microbiologics" in blue, with a registered trademark symbol. Below the word, there is a tagline that reads "A safer, healthier world."

Substantial Equivalence:

Characteristic	BD MAX™ Enteric Parasite Control Panel,BD MAX™ Enteric Parasite 20-Day QC Panel	Predicate Device –Bio-Rad Amplichek II (DEN 150058)
Intended Use	The BD MAX™ Enteric Parasite Control Paneland the BD MAX™ Enteric Parasite 20-Day QCPanel are intended for use as external assayedpositive quality control materials to monitor theperformance of in vitro laboratory nucleic acidtesting procedures for the qualitative detectionof Cryptosporidium parvum , Giardia lamblia ,and Entamoeba histolytica performed with theBD MAX™ Enteric Parasite Panel on the BDMAX™ System. The controls comprise culturedand inactivated C. parvum , G. lamblia andrecombinant Escherichia coli . The E. colicarries a plasmid which is a surrogate controlmaterial for detection of E. histolytica .The BD MAX™ Enteric Parasite Control Paneland BD MAX™ Enteric Parasite 20-Day QCPanel are not intended to replace manufacturercontrols provided with the device.	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 Staphylococcusaureus , Methicillin Sensitive Staphylococcusaureus , Clostridium difficile and Vancomycin -resistant Enterococci performed on CepheidGeneXpert Systems. This product is notintended to replace manufacturer controlsprovided with the device.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	Cryptosporidium parvumGiardia lambliaEntamoeba histolytica	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

Summary of Performance Data:

A precision and reproducibility study was conducted to determine device performance. Three different testing locations were used. 6 different operators (2 at each facility) and 3 different lots of the BD MAX™ Enteric Parasite controls 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™ Enteric Parasite Panel.

Analyte	Agreement (%) by Test Site/BD MAX System
	Site 1 1	Site 2 2	Site 3	Overall
G. lamblia	30/30(100)	30/30(100)	30/30(100)	90/90(100)
E. histolytica	30/30(100)	30/30(100)	30/30(100)	90/90(100)
C. parvum	30/30(100)	30/30(100)	30/30(100)	90/90(100)

1 Two Incomplete Run errors occurred; in both cases a new control was retested results were obtained 2 An Unresolved result was obtained with one control was retested and the expected results were obtained

Conclusion

The submitted information in this premarket notification is complets a substantial equivalence decision.

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.”