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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cepheid Xpert GBS LB Control Panel, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document describes a precision and reproducibility study to demonstrate device performance. The acceptance criteria are implicitly 100% agreement for both analytes (S. agalactiae and L. acidophilus) across different sites, operators, and lots.

Analyte	Acceptance Criteria (Agreement %)	Reported Device Performance (Agreement %)
S. agalactiae	100%	100% (90/90)
L. acidophilus	100%	100% (90/90)

Note: The reported device performance for both analytes shows 100% agreement, meeting the implicit acceptance criteria. One ERROR result was obtained for S. agalactiae at Site 1 but was retested with expected results, suggesting the device itself performed correctly once the test was properly executed.

2. Sample Size and Data Provenance

Test Set Sample Size: The study involved a total of 90 tests for each analyte.
- 3 testing locations
- 6 operators (2 per facility)
- 3 different lots of the control panel
- Each operator performed 3 tests (1 per lot) on 5 different days.
- Calculation: 3 (lots) * 5 (days) * 2 (operators/site) * 3 (sites) for each analyte = 90 tests per analyte.
Data Provenance: The document does not explicitly state the country of origin. This was a prospective study conducted for the purpose of demonstrating performance for this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable as this is a quality control material where the expected outcome (positive or negative for specific bacteria) is predetermined by the composition of the control. The "ground truth" is inherent to the control material itself (i.e., S. agalactiae is present in the positive control, L. acidophilus in the negative control).

4. Adjudication Method for the Test Set

Not applicable. The study measures agreement with the expected result of known positive and negative controls, not subjective interpretation requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a study of a quality control material, not a diagnostic device that requires human interpretation. Therefore, there's no "human readers" to compare performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The study evaluated the performance of the Cepheid Xpert GBS LB Control Panel when used with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The results (100% agreement) demonstrate the device's ability to consistently produce the expected outcome.

7. Type of Ground Truth Used

The ground truth used is the known composition of the quality control materials. The positive control contains Streptococcus agalactiae (known to be detected by the assay as GBS positive), and the negative control contains Lactobacillus acidophilus (known not to be detected by the assay as GBS positive).

8. 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 evaluated based on its consistency and accuracy in producing predetermined results when tested.

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

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

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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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510(k) Summary

510(k) Number: K182472

Date: October 18, 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 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:

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 –Bio-Rad Amplichek II (DEN 150058)
Intended Use	The Cepheid Xpert® GBS LB Control Panel isintended for use as external assayed positiveand negative quality control materials tomonitor the performance of in vitro laboratory	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 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 thequalitative detection of Group B Streptococcus(GBS) performed with the Cepheid Xpert® GBSLB Assay on the GeneXpert® InstrumentSystem. The controls comprise cultured andinactivated Streptococcus agalactiae as thepositive control and Lactobacillus acidophilusas the negative control.The Cepheid Xpert® GBS LB Control Panel isnot intended to replace manufacturer controlsprovided with the device.	of Methicillin Resistant Staphylococcus aureus,Methicillin Sensitive Staphylococcus aureus,Clostridium difficile and Vancomycin-resistantEnterococci performed on Cepheid GeneXpertSystems. This product is not intended toreplace manufacturer controls provided with thedevice.This product is only for use with assays andinstruments listed in the Representative ResultsChart in this labeling.
Physical Format	Lyophilized swab	Ready-to-use liquid
Composition	Inactivated microorganisms	Inactivated microorganisms
Analytes	Streptococcus agalactiaeLactobacillus acidophilus	Methicillin Resistant Staphylococcus aureusMethicillin Sensitive Staphylococcus aureusClostridium difficileVancomycin-resistant Enterococci
Test System	Cepheid GeneXpert® 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. 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.

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.”