Cepheid Xpert GBS LB Control Panel

K182472 · Microbiologics, Inc. · PMN · Nov 8, 2018 · Microbiology

Device Facts

• Record ID: K182472
• Device Name: Cepheid Xpert GBS LB Control Panel
• Applicant: Microbiologics, Inc.
• Product Code: PMN · Microbiology
• Decision Date: Nov 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

Intended Use

The Cepheid Xpert® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert® GBS LB Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert® GBS LB Control Panel is not intended to replace manufacturer controls provided with the device.

Device Story

External quality control material; monitors extraction, amplification, and detection steps of Cepheid Xpert GBS LB Assay. Input: lyophilized swabs containing temperature-inactivated Streptococcus agalactiae (positive) or Lactobacillus acidophilus (negative). Used in clinical laboratories; processed like patient samples on GeneXpert Instrument System. Output: qualitative detection results compared against expected values. Assists healthcare providers in verifying assay performance and system integrity; ensures reliable diagnostic results for GBS detection.

Clinical Evidence

No clinical data. Bench testing only. Reproducibility study conducted across 3 sites, 5 days, 2 operators, using 3 lots (90 replicates total). All positive controls (n=90) and negative controls (n=91) produced expected qualitative results (100% correct). One instrument error occurred but was resolved upon retest.

Technological Characteristics

Lyophilized swab format; contains temperature-inactivated microorganisms (S. agalactiae, L. acidophilus) with stabilizers/preservatives. Packaged with desiccant in heat-sealed foil. Designed for use with Cepheid GeneXpert System. No electronic components; non-instrumented control material.

Indications for Use

Indicated for use as external quality control material for laboratory nucleic acid testing of Group B Streptococcus (GBS) using the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument 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 (DEN150058)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 8, 2018

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

Re: K182472

Trade/Device Name: Cepheid Xpert GBS LB Control 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: September 5, 2018 Received: September 10, 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

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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.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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Steven R. Gitterman -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) K182472

Device Name Cepheid Xpert® GBS LB Control Panel

#### Indications for Use (Describe)

The Cepheid Xpert® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert® GBS LB Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control.

The Cepheid Xpert® GBS LB Control Panel is 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 is the logo for "Microbiologics". 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 red line and the text "A safer, healthier world." in a smaller font.

## 510(k) Summary

#### 510(k) Number: K182472

Date: October 18, 2018

## Applicant Information:

| Applicant: | Microbiologics, Inc. |
|------------------|------------------------------------------------|
| Address: | 200 Cooper Avenue North<br>St. Cloud, MN 56303 |
| Primary Contact: | Tina Sobania, Director of Corporate Quality |
| Phone: | 320-229-7050 |
| Email: | [e-mail] |

## Device:

| Device Trade Name: | Cepheid Xpert® GBS LB Control 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 Cepheid Xpert® GBS LB Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® GBS LB Assay. The Cepheid Xpert® GBS LB Control Panel contains authentic pathogens inactivated by temperature treatments. Each Cepheid Xpert® GBS LB Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Streptococcus agalactiae (Lancefield's Group B) as well as preservatives and stabilizers. Each negative control swab contains Lactobacillus as well as preservatives and stabilizers. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

## Device Intended Use:

The Cepheid Xpert® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococus (GBS) performed with the Cepheid Xpert® GBS LB Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control.

The Cepheid Xpert® GBS LB Control Panel is not intended to replace manufacturer controls provided with the device.

## Substantial Equivalence:

| Characteristic | Cepheid Xpert® GBS LB Control Panel | Predicate Device –<br>Bio-Rad Amplichek II (DEN 150058) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Cepheid Xpert® GBS LB Control Panel is<br>intended for use as external assayed positive<br>and negative quality control materials to<br>monitor the performance of <i>in vitro</i> laboratory | 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 |

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Image /page/4/Picture/1 description: The image shows the Microbiologics logo. The logo features a stylized symbol resembling a crescent shape, with one side in blue and the other in red. To the right of the symbol is the word "Microbiologics" in a bold, blue font, with a registered trademark symbol next to it. Below the word is the tagline "A safer, healthier world." in a smaller font.

| | nucleic acid testing procedures for the<br>qualitative detection of Group B Streptococcus<br>(GBS) performed with the Cepheid Xpert® GBS<br>LB Assay on the GeneXpert® Instrument<br>System. The controls comprise cultured and<br>inactivated Streptococcus agalactiae as the<br>positive control and Lactobacillus acidophilus<br>as the negative control.<br><br>The Cepheid Xpert® GBS LB Control Panel is<br>not intended to replace manufacturer controls<br>provided with the device. | of Methicillin Resistant Staphylococcus aureus,<br>Methicillin Sensitive Staphylococcus aureus,<br>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 the<br>device.<br><br>This product is only for use with assays and<br>instruments listed in the Representative Results<br>Chart in this labeling. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Format | Lyophilized swab | Ready-to-use liquid |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Analytes | Streptococcus agalactiae<br>Lactobacillus acidophilus | Methicillin Resistant Staphylococcus aureus<br>Methicillin Sensitive Staphylococcus aureus<br>Clostridium difficile<br>Vancomycin-resistant Enterococci |
| Test System | Cepheid GeneXpert® 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 |

## 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 Cepheid Xpert® GBS LB Control Panel were tested over five days. Each operator performed 3 tests (1 per lot) on 5 different days. All testing was performed on a GeneXpert® Instrument System using the Cepheid Xpert® GBS LB Assay.

| Analyte | Agreement (%) by Test Site/ GeneXpert® Instrument System | | | |
|----------------|----------------------------------------------------------|--------|--------|---------|
| | Site 1 1 | Site 2 | Site 3 | Overall |
| S. agalactiae | 30/30 | 30/30 | 30/30 | 90/90 |
| | (100) | (100) | (100) | (100) |
| L. acidophilus | 30/30 | 30/30 | 30/30 | 90/90 |
| | (100) | (100) | (100) | (100) |

1One ERROR result was obtained; a new control was retested and the expected results were obtained

## Conclusion

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