The Cepheid Xpert® SA Nasal Complete Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicilin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) performed with the Cepheid Xpert® SA Nasal Complete Assay on the GeneXpert® Dx System. The controls comprise cultured and inactivated Methicillin-Resistant Staphylococcus aureus as the positive control 1: Staphylococcus aureus as the positive control 2; Staphylococcus epidermidis as the negative control.

The Cepheid Xpert® SA Nasal Complete Control Panel is not intended to replace manufacturer controls provided with the Cepheid Xpert® SA Nasal Complete Assay.

Device Description

The Cepheid Xpert® SA Nasal Complete Control Panel is used to monitor the DNA extraction, amplification and detection processes of the Cepheid Xpert® SA Nasal Complete Assay. The Cepheid Xpert® SA Nasal Complete Control Panel contains cultured microorqanisms inactivated by heat treatments. Each Cepheid Xpert® SA Nasal Complete Control Panel consists of 6 individually packaged Methicillin-Resistant Staphylococcus aureus (MRSA) positive control swabs (positive control 1): 6 individually wrapped Staphylococcus aureus (MSSA) positive controls swabs (positive control 2); and 6 individually wrapped negative control swabs. Each positive control 1 swab contains MRSA at a target level that is designed to provide reproducible performance above the limit of detection for each of the genes targeted by the Cepheid Xpert® SA Nasal Complete Assay: Staphylococcal protein A gene spa (SPA), methicillin resistance gene mecA (mec), and the Staphylococcal cassette chromosome (SCC). Each positive control 2 swab contains MSSA at a target level designed to provide reproducible performance above the limit of detection of the spa gene target of the Cepheid Xpert® SA Nasal Complete Assay. Each negative control swab contains Staphylococcus epidermidis (MSSE) which is methicillin susceptible and not detected by the Cepheid Xpert® SA Nasal Complete Assay. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Cepheid Xpert SA Nasal Complete Control Panel." This device is an assayed quality control material for clinical microbiology assays. It is not an AI/ML-driven device, diagnostic algorithm, or imaging device, but rather a quality control panel used in laboratory testing.

Therefore, many of the typical acceptance criteria and study aspects you've listed, which are relevant to AI/ML or imaging diagnostics (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth sources like pathology, training set size, etc.), do not apply to this type of medical device.

This document describes a performance study to demonstrate the precision and reproducibility of the quality control panel itself. The acceptance criteria relate to the ability of the control panel to consistently produce the expected results when tested with the target assay.

Here's an attempt to extract and reframe the information based on the document, while acknowledging that many of your requested points are not applicable:

Device: Cepheid Xpert® SA Nasal Complete Control Panel
Device Type: Assayed Quality Control Material for Clinical Microbiology Assays

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds for a given metric. However, the study aims to demonstrate 100% agreement with expected results for positive and negative controls. The presented performance data shows this agreement was achieved.

Here's the performance data that implicitly represents the desired outcome (100% correct results):

Analyte Type/Location	Target Mechanism Monitored	Reported Device Performance (Agreement %)	Notes
Positive Control 1 (Methicillin-Resistant Staphylococcus aureus - MRSA)	spa, mec, SCC genes	100% (90/90 successful tests)	3 "NO RESULT" responses were observed initially but were retested with new controls, yielding expected results. This suggests that the failures were likely procedural or related to the specific control unit, rather than a fundamental flaw in the control panel's ability to produce the correct result when working as intended.
Positive Control 2 (Staphylococcus aureus - MSSA)	spa gene	100% (90/90 successful tests)	2 "NO RESULT" responses were observed initially but were retested with new controls, yielding expected results.
Negative Control (Staphylococcus epidermidis)	Not detected	100% (90/90 successful tests)	Multiple "INVALID" and "ERROR" responses were observed across different sites (e.g., 8 INVALID from single user, 1 ERROR, 1 NO RESULT). These were retested with new controls, yielding expected results. This again points to issues with individual control units or testing procedure rather than the overall control type.

An additional table for quantitative performance (Mean Ct and %CV) is provided for the positive controls and sample processing control, demonstrating reproducibility of the cycle threshold values across sites:

Analyte/Target Gene	Site 1 Mean Ct (%CV)	Site 2 Mean Ct (%CV)	Site 3 Mean Ct (%CV)	All Sites Mean Ct (%CV)
MRSA (SPA)	27.0 (2.7)	28.1 (2.3)	27.8 (2.2)	27.6 (3.0)
MRSA (mec)	27.3 (2.6)	28.4 (2.0)	28.1 (2.1)	27.9 (2.8)
MRSA (SCC)	28.5 (2.3)	29.6 (1.9)	29.3 (2.1)	29.1 (2.7)
MSSA (SPA)	26.8 (2.7)	27.8 (2.5)	27.4 (2.8)	27.3 (3.0)
SPC (Negative Ctrl)	32.0 (4.2)	31.8 (3.5)	32.1 (4.4)	32.0 (4.0)

2. Sample size used for the test set and the data provenance

Test Sample Size:
- For each of the three types of controls (MRSA positive, MSSA positive, negative), there were 90 tests performed in total.
- This was derived from: 3 testing locations x 2 operators/location x 3 lots x (minimum of) 3 tests/lot/operator/day over 5 days (totaling 30 tests per control type per site before accounting for specific retests). The summary table shows 30 tests per site, so 3 sites * 30 tests/site = 90 tests.
Data Provenance: The document implies the data was collected prospectively as part of a performance study to support the 510(k) submission. Geographic origin is not specified but would typically be within the country of the applicant (USA, based on the address).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: For a quality control material, the "ground truth" is inherent to the known composition of the control and the expected output of the assay it monitors (e.g., a positive control should be positive for specific targets). There is no "expert adjudication" or "radiologist experience" involved in establishing this kind of ground truth. The expected results are defined by the analytical properties of the material.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: As there's no subjective interpretation, no adjudication method is needed. The results are quantitative (Ct values) or qualitative (Positive/Negative) based on the instrument's reporting. The document mentions retesting "NO RESULT," "INVALID," or "ERROR" samples, which is a standard laboratory practice for troubleshooting, not an adjudication process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This is a quality control material, not an AI/ML diagnostic system. No human readers or AI assistance are involved in interpreting its direct output.

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

Not Applicable: This is not an algorithm. The "standalone" performance demonstrated is the ability of the control panel itself to reliably elicit the expected response from the GeneXpert Dx System.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Analytical Ground Truth: The ground truth is the known composition of the control panel (e.g., contains inactivated MRSA, contains inactivated MSSA, contains inactivated S. epidermidis) and the expected analytical response of the target assay (Cepheid Xpert SA Nasal Complete Assay). For instance, an MRSA positive control should result in detection of SPA, mec, and SCC genes.

8. The sample size for the training set

Not Applicable: This device is a quality control material, not an algorithm that requires a training set.

9. How the ground truth for the training set was established

Not Applicable: As above, there is no training set for this type of device. The characteristics of the control panel (contents, concentration) are established during its manufacturing and characterization process, not through a "ground truth establishment" phase for machine learning.

Summary

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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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

June 25, 2019

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

Re: K191168

Trade/Device Name: Cepheid Xpert SA Nasal Complete 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: April 30, 2019 Received: May 1, 2019

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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. M.Sc., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the Microbiologics logo. The logo features a stylized symbol resembling a crescent moon or a partial circle in blue and red. To the right of the symbol, the word "Microbiologics" is written in a bold, blue sans-serif font. Below the word, there is a thin red line, and beneath that, the tagline "A safer, healthier world." is written in a smaller, lighter blue font.

510(k) Summary

510(k) Number: K191168

Date: June 10, 2019

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® SA Nasal Complete 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:

Cepheid Xpert® GBS LB Control Panel

Device Description:

Device Intended Use:

The Cepheid Xpert® SA Nasal Complete Control Panel is not intended to replace manufacturer controls provided with the Cepheid Xpert® SA Nasal Complete Assay.

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Image /page/3/Picture/0 description: The image shows the Microbiologics logo. The logo features a stylized symbol in red and blue, 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.

Substantial Equivalence:

Characteristic	Cepheid Xpert® SA Nasal Complete	Cepheid Xpert® GBS LB Control
	Control Panel	Panel (K182472)
Intended Use	The Cepheid Xpert® SA Nasal CompleteControl Panel is intended for use as anexternal assayed positive and negativequality control to monitor the performance ofin vitro laboratory nucleic acid testingprocedures for the qualitative detection ofMethicillin-Resistant Staphylococcus aureus(MRSA) and Staphylococcus aureus (SA)performed with the Cepheid Xpert® SANasal Complete Assay on the GeneXpert®Dx System. The controls comprise culturedand inactivated Methicillin-ResistantStaphylococcus aureus as the positivecontrol 1; Staphylococcus aureus as thepositive control 2; Staphylococcusepidermidis as the negative control.The Cepheid Xpert® SA Nasal CompleteControl Panel is not intended to replacemanufacturer controls provided with theCepheid Xpert® SA Nasal Complete Assay.	The Cepheid Xpert® GBS LB ControlPanel is intended for use as externalassayed positive and negative qualitycontrol materials to monitor theperformance of in vitro laboratorynucleic acid testing procedures for thequalitative detection of Group BStreptococcus (GBS) performed withthe Cepheid Xpert® GBS LB Assay onthe GeneXpert® Instrument System.The controls comprise cultured andinactivated Streptococcus agalactiaeas the positive control andLactobacillus acidophilus as thenegative control.The Cepheid Xpert® GBS LB ControlPanel is not intended to replacemanufacturer controls provided withthe device.
Physical Format	Lyophilized swab	Lyophilized swab
Composition	Inactivated microorganisms	Inactivated microorganisms
Analytes	Methicillin-Resistant Staphylococcus aureusStaphylococcus aureusStaphylococcus epidermidis	Streptococcus agalactiaeLactobacillus acidophilus
Test System	Cepheid GeneXpert® Dx System	Cepheid GeneXpert® InstrumentSystem
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® SA Nasal Complete Control Panel were tested over five days. Each operator performed a minimum of 3 tests (1 per lot) on 5 different days. All testing was performed on a GeneXpert® Dx System using the Cepheid Xpert® SA Nasal Complete Assay.

PositiveAnalyteLocation	Agreement (%) by Test Site/GeneXpert® System
Assay Response	Site 1CorrectResult	Site 2CorrectResult	Site 31CorrectResult	Site 31NORESULT	OverallCorrectResult
Methicillin-ResistantStaphylococcus aureus(SPA, mec, SCC)	30/30(100)	30/30(100)	30/30(100)	1	90/90(100)
Staphylococcus aureus(SPA)	30/30(100)	30/30(100)	30/30(100)	2	90/90(100)

1 Three NO RESULT responses were observed; new controls were retested and the expected results were obtained.

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Image /page/4/Picture/0 description: The image shows the Microbiologics logo. The logo consists of a stylized symbol to the left, resembling a blue and red crescent shape. To the right of the symbol is the word "Microbiologics" in a bold, dark blue font, with a registered trademark symbol. Below the word is the tagline "A safer, healthier world." in a smaller, lighter font.

NegativeAnalyte	Agreement (%) by Test Site/GeneXpert® System
Location	Site 11	Site 21,3			Site 31,2		Overall
AssayResponse	CorrectResult	INVALID	CorrectResult	INVALID	ERROR	CorrectResult	INVALID	NORESULT	CorrectResult
Staphylococcusepidermidis	30/30(100)	84	30/30(100)	2	1	30/30(100)	4	1	90/90(100)

1 Multiple INVALID responses were observed; new controls were retested and the expected results were obtained.

2 One NO RESULT response was observed; a new control was retested and the expected results were obtained. 3 One ERROR response was observed; a new control was retested, and the expected results were obtained.

4 Eight INVALID responses from single user.

Site	6027 Mean Ct (%CV)
	SPA	mec	SCC
1	27.0 (2.7)	27.3 (2.6)	28.5 (2.3)
2	28.1 (2.3)	28.4 (2.0)	29.6 (1.9)
3	27.8 (2.2)	28.1 (2.1)	29.3 (2.1)
All Sites	27.6 (3.0)	27.9 (2.8)	29.1 (2.7)

%CV: Percent Coefficient of Variation

Site	6028 Mean Ct(%CV)SPA
1	26.8 (2.7)
2	27.8 (2.5)
3	27.4 (2.8)
All Sites	27.3 (3.0)

%CV: Percent Coefficient of Variation
---------------------------------------	--

Site	6029 Mean Ct(%CV)
	SPC
1	32.0 (4.2)
2	31.8 (3.5)
3	32.1 (4.4)
All Sites	32.0 (4.0)

%CV: Percent Coefficient of Variation; SPC: Sample Processing Control

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.”