(55 days)
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No
The document describes a quality control panel for a nucleic acid test, focusing on the biological components and their intended use for monitoring assay performance. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is a quality control panel for an in vitro diagnostic test, not a device used for therapy or treatment.
No
Explanation: The device is described as a quality control panel intended to monitor the performance of nucleic acid testing procedures, not to diagnose a condition in a patient. It is used to ensure the accuracy of other diagnostic tests.
No
The device description clearly states it contains cultured microorganisms and swabs, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device 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". This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details that the device is used to monitor the "DNA extraction, amplification and detection processes" of an in vitro assay. This further confirms its role in the in vitro diagnostic workflow.
- Care Setting: The intended user is an "in vitro laboratory", which is where in vitro diagnostic testing is performed.
The device is a quality control for an IVD assay, and quality controls for IVD assays are themselves considered IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PMN
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Nasal
Indicated Patient Age Range
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Intended User / Care Setting
in vitro laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key results:
Positive Analytes:
Methicillin-Resistant Staphylococcus aureus (SPA, mec, SCC): Overall Correct Result 90/90 (100%)
Staphylococcus aureus (SPA): Overall Correct Result 90/90 (100%)
Negative Analyte:
Staphylococcus epidermidis: Overall Correct Result 90/90 (100%)
%CV for SPA, mec, SCC for Methicillin-Resistant Staphylococcus aureus ranged from 1.9 to 3.0.
%CV for SPA for Staphylococcus aureus was 3.0.
%CV for SPC for Staphylococcus epidermidis was 4.0.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement (%) by Test Site/GeneXpert® System:
Methicillin-Resistant Staphylococcus aureus (SPA, mec, SCC):
Site 1 Correct Result: 30/30 (100)
Site 2 Correct Result: 30/30 (100)
Site 3 Correct Result: 30/30 (100)
Site 3 NO RESULT: 1
Overall Correct Result: 90/90 (100)
Staphylococcus aureus (SPA):
Site 1 Correct Result: 30/30 (100)
Site 2 Correct Result: 30/30 (100)
Site 3 Correct Result: 30/30 (100)
Site 3 NO RESULT: 2
Overall Correct Result: 90/90 (100)
Negative Analyte: Staphylococcus epidermidis:
Site 1 Correct Result: 30/30 (100)
Site 2 INVALID: 84
Site 2 Correct Result: 30/30 (100)
Site 3 INVALID: 2
Site 3 ERROR: 1
Site 3 Correct Result: 30/30 (100)
Site 3 INVALID: 4
Site 3 NO RESULT: 1
Overall Correct Result: 90/90 (100)
Mean Ct (%CV) for positive analytes.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.”
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 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
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/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 North |
| St. 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:
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.
Device Intended Use:
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.
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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 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 | ||
| Methicillin-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. | 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. | ||
| Physical Format | Lyophilized swab | Lyophilized swab |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Analytes | Methicillin-Resistant Staphylococcus aureus | |
| Staphylococcus aureus | ||
| Staphylococcus epidermidis | Streptococcus agalactiae | |
| Lactobacillus acidophilus | ||
| Test System | Cepheid GeneXpert® Dx System | Cepheid GeneXpert® Instrument |
| System | ||
| Directions for Use | Process like patient sample | Process like patient sample |
| Assay Steps | ||
| 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® 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.
| Positive
Analyte
| Location | Agreement (%) by Test Site/GeneXpert® System | ||||
|---|---|---|---|---|---|
| Assay Response | Site 1 | ||||
| Correct | |||||
| Result | Site 2 | ||||
| Correct | |||||
| Result | Site 31 | ||||
| Correct | |||||
| Result | Site 31 | ||||
| NO | |||||
| RESULT | Overall | ||||
| Correct | |||||
| Result | |||||
| Methicillin-Resistant | |||||
| Staphylococcus 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.
| Negative
| Analyte | Agreement (%) by Test Site/GeneXpert® System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Location | Site 11 | Site 21,3 | Site 31,2 | Overall | |||||
| Assay | |||||||||
| Response | Correct | ||||||||
| Result | INVALID | Correct | |||||||
| Result | INVALID | ERROR | Correct | ||||||
| Result | INVALID | NO | |||||||
| RESULT | Correct | ||||||||
| Result | |||||||||
| Staphylococcus | |||||||||
| epidermidis | 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.