BD MAX CT/GC/TV 20-Day QC Panel

K181683 · Microbiologics, Inc. · PMN · Aug 28, 2018 · Microbiology

Device Facts

• Record ID: K181683
• Device Name: BD MAX CT/GC/TV 20-Day QC Panel
• Applicant: Microbiologics, Inc.
• Product Code: PMN · Microbiology
• Decision Date: Aug 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

Indications for Use

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 Story

The BD MAX™ CT/GC/TV 20-Day QC Panel provides external positive quality control for clinical laboratory nucleic acid testing. The device consists of 20 individually packaged lyophilized pellets containing inactivated Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Laboratory personnel process the control pellet like a patient sample within the BD MAX™ System. The system performs extraction, amplification, and detection of the target pathogens. The output is a qualitative result used by the healthcare provider to verify the performance of the assay and the instrument. This monitoring ensures the reliability of patient test results, helping clinicians accurately diagnose these infections.

Clinical Evidence

Precision and reproducibility study conducted across three testing sites using six operators and three lots over five days. Testing performed on BD MAX™ instruments using the BD MAX™ CT/GC/TV assay. Results showed high agreement: C. trachomatis 100% (90/90), N. gonorrhoeae 99% (89/90), and T. vaginalis 100% (90/90). Three unresolved results were resolved upon retesting.

Technological Characteristics

Lyophilized pellet containing inactivated C. trachomatis, N. gonorrhoeae, and T. vaginalis. Packaged in 2.0ml micro-centrifuge tubes. Designed for use with the BD MAX™ System for nucleic acid extraction, amplification, and detection. No negative control included.

Indications for Use

Indicated 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 using the BD MAX™ CT/GC/TV Assay on the BD MAX™ System.

Regulatory Classification

Identification

An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.

Special Controls

An assayed quality control material for clinical microbiology assays must comply with the following special controls: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; Expected values: (ii) Analyte source: (iii) (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and, (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., realtime stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays: (C) Stating if the material is a surrogate control; (D)The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following statement: "This product is not intended to replace manufacturer controls provided with the device." (iii)A limiting statement that reads "Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements."

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; (ii) Expected values; (iii) Analyte source; (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays; (C) Stating if the material is a surrogate control; and (D) The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.” (iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”

Predicate Devices

• Bio-Rad Amplichek II (DEN 150058)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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 North<br>St. Cloud, MN 56303 |
| Primary Contact: | Tina Sobania, Director of Corporate Qua |
| Primary Contact: | Tina Sobania, Director of Corporate Quality |
| Phone: | 320-229-7050 |
| Email: | [e-mail] |

# 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:

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.

# Device Intended Use:

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.

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

# Substantial Equivalence:

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

| | trachomatis, Neisseria gonorrhoeae and<br>Trichomonas vaginalis with the BD MAX™<br>CT/GC/TV Assay on the BD MAX™<br>System. The controls comprise cultured<br>and inactivated C. trachomatis, N.<br>gonorrhoeae and T. vaginalis. | Clostridium difficile and Vancomycin-resistant<br>Enterococci performed on Cepheid GeneXpert<br>Systems. This product is not intended to<br>replace manufacturer controls provided with<br>the device. |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The BD MAX CT/GC/TV™ 20-Day QC<br>Panel is not intended to replace<br>manufacturer controls provided with the<br>device. | This product is only for use with assays and<br>instruments listed in the Representative<br>Results Chart in this labeling. |
| Physical Format | Lyophilized pellet | Ready-to-use liquid |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Analytes | Chlamydia trachomatis<br>Neisseria gonorrhoeae<br>Trichomonas vaginalis | Methicillin Resistant Staphylococcus aureus<br>Methicillin Sensitive Staphylococcus aureus<br>Clostridium difficile<br>Vancomycin-resistant Enterococci |
| Test System | BD MAX System | Cepheid GeneXpert System |
| Directions for Use | Process like patient sample | Process like patient sample |
| Assay Steps<br>Monitored | Extraction, amplification, and detection | Extraction, amplification, detection |
| Number of Targets<br>monitored in one<br>assay | 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<br>(100) | 30/30<br>(100) | 30/30<br>(100) | 90/90<br>(100) |
| N. gonorrhoeae | 30/30<br>(100) | 30/30<br>(100) | 29/30<br>(97) | 89/90<br>(99) |
| T. vaginalis | 30/30<br>(100) | 30/30<br>(100) | 30/30<br>(100) | 90/90<br>(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 [e-mail]

"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."