(92 days)
Not Found
No
The device is a quality control panel for a nucleic acid test and does not involve data processing or analysis that would typically utilize AI/ML. The description focuses on the biological components and testing methodology.
No
Explanation: This device is a quality control panel used to monitor the performance of in vitro diagnostic tests, not to treat or diagnose patients directly.
No
This device is a control panel used to monitor the performance of an in vitro diagnostic assay, not a diagnostic device itself. It does not diagnose disease in patients but rather verifies the proper functioning of the diagnostic test.
No
The device is a physical control panel consisting of swabs containing biological material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "in vitro laboratory nucleic acid testing procedures." This is a key characteristic of IVDs, which are used to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The description details the components and how it is used to "monitor the extraction, amplification and detection" of an assay. This monitoring function is performed in vitro (outside the body) on laboratory samples.
- Intended User / Care Setting: It is intended for use in an "in vitro laboratory," further reinforcing its IVD nature.
- Function: The device acts as a quality control for a diagnostic assay (the Cepheid Xpert® CT/NG assay). Quality controls are essential components of IVD testing to ensure the accuracy and reliability of the results.
While it's a control panel and not the primary diagnostic assay itself, it is an integral part of the in vitro diagnostic process for detecting Chlamydia trachomatis and Neisseria gonorrhoeae.
N/A
Intended Use / Indications for Use
The Cepheid Xpert® CT/NG 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 Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert® CT/NG assay on the GeneXpert® Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control.
The Cepheid Xpert® CT/NG Control Panel is not intended to replace manufacturer controls provided with the device.
Product codes (comma separated list FDA assigned to the subject device)
PMN
Device Description
The Cepheid Xpert® CT/NG Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® CT/NG Assay. The Cepheid Xpert® CT/NG Control Panel contains authentic pathogens inactivated by radiological or temperature treatments. Each Cepheid Xpert® CT/NG Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Chlamydia trachomatis and Neisseria gonorrhoeae as well as preservatives and stabilizers. Each negative control swab contains human cells as well as preservatives and stabilizers. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit.
Performance Results for Positive Control:
- Site 1: C. trachomatis 31/31 (100%), N. gonorrhoeae (NG2) 31/31 (100%), N. gonorrhoeae (NG4) 31/31 (100%), SPC 31/31 (100%)
- Site 2: C. trachomatis 31/31 (100%), N. gonorrhoeae (NG2) 31/31 (100%), N. gonorrhoeae (NG4) 31/31 (100%), SPC 31/31 (100%)
- Site 3: C. trachomatis 30/30 (100%), N. gonorrhoeae (NG2) 30/30 (100%), N. gonorrhoeae (NG4) 30/30 (100%), SPC 30/30 (100%)
- Overall: C. trachomatis 92/92 (100%), N. gonorrhoeae (NG2) 92/92 (100%), N. gonorrhoeae (NG4) 92/92 (100%), SPC 92/92 (100%)
Performance Results for Negative Control:
- Site 1: SAC 33/33 (100%), SPC 33/33 (100%)
- Site 2: SAC 34/34 (100%), SPC 34/34 (100%)
- Site 3: SAC 30/30 (100%), SPC 30/30 (100%)
- Overall: SAC 97/97 (100%), SPC 97/97 (100%)
Mean Ct (%CV) for Positive Control:
- Site 1: CT1 31.3 (1.3), NG2 31.2 (1.4), NG4 30.6 (1.5)
- Site 2: CT1 31.2 (2.6), NG2 31.8 (2.1), NG4 31.1 (2.6)
- Site 3: CT1 33.0 (3.9), NG2 33.4 (4.1), NG4 32.5 (4.0)
- All Sites: CT1 31.8 (3.8), NG2 32.1 (4.0), NG4 31.4 (3.9)
Mean Ct (%CV) for Negative Control:
- Site 1: SAC 27.3 (1.8), SPC 31.6 (0.9)
- Site 2: SAC 27.7 (1.8), SPC 31.4 (0.7)
- Site 3: SAC 28.8 (4.1), SPC 31.5 (0.5)
- All Sites: SAC 27.9 (3.5), SPC 31.5 (0.7)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement (%) with Expected Results:
Positive Control: 100% for all targets (C. trachomatis, N. gonorrhoeae (NG2), N. gonorrhoeae (NG4), and SPC) across all sites.
Negative Control: 100% for SAC and SPC across all sites.
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.
Not Found
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.”
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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 USA seal. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 8, 2019
Microbiologics, Inc. Tina Sobania Director of Corporate Quality 200 Cooper Avenue North St. Cloud, Minnesota 56303
Re: K190223
Trade/Device Name: Cepheid Xpert CT/NG 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: February 4, 2019 Received: February 5, 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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Uwe Scherf, 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 blue and red symbol resembling a crescent shape or an incomplete circle on the left. To the right of the symbol is the company name "Microbiologics" in a bold, blue, sans-serif font, with a registered trademark symbol. Below the company name, there is a thin red line, and underneath that, the tagline "A safer, healthier world." is written in a smaller, italicized font.
510(k) Summary
510(k) Number: K190223
Date: May 1, 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® CT/NG 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 (K182472)
Device Description:
The Cepheid Xpert® CT/NG Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® CT/NG Assay. The Cepheid Xpert® CT/NG Control Panel contains authentic pathogens inactivated by radiological or temperature treatments. Each Cepheid Xpert® CT/NG Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Chlamydia trachomatis and Neisseria gonorrhoeae as well as preservatives and stabilizers. Each negative control swab contains human cells 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® CT/NG 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 Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert® CT/NG assay on the GeneXpert® Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control.
The Cepheid Xpert® CT/NG Control Panel is not intended to replace manufacturer controls provided with the device.
Substantial Equivalence:
| Characteristic | Cepheid Xpert® CT/NG Control Panel | Predicate Device -
Cepheid Xpert® GBS LB Control Panel
(K182472) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Cepheid Xpert® CT/NG Control Panel is
intended for use as an external assayed
positive and negative quality control to monitor | The Cepheid Xpert® GBS LB Control Panel is
intended for use as external assayed positive
and negative quality control materials to monitor |
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Image /page/3/Picture/0 description: The image shows the Microbiologics logo. 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."
| | the performance of in vitro laboratory nucleic
acid testing procedures for the qualitative | the performance of in vitro laboratory nucleic
acid testing procedures for the qualitative |
|--------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | detection of Chlamydia trachomatis (CT) and | detection of Group B Streptococcus (GBS) |
| | Neisseria gonorrhoeae (NG) performed with | performed with the Cepheid Xpert® GBS LB |
| | the Cepheid Xpert® CT/NG assay on the
GeneXpert® System. The controls comprise | Assay on the GeneXpert® Instrument System. |
| | cultured and inactivated Chlamydia trachomatis | The controls comprise cultured and inactivated
Streptococcus agalactiae as the positive control |
| | and Neisseria gonorrhoeae as the positive | and Lactobacillus acidophilus as the negative |
| | control and human cells as the negative | control. |
| | control. | |
| | The Cepheid Xpert® CT/NG Control Panel is | The Cepheid Xpert® GBS LB Control Panel is
not intended to replace manufacturer controls |
| | not intended to replace manufacturer controls | provided with the device. |
| | provided with the device. | |
| Physical Format | Lyophilized swab | Lyophilized swab |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Analytes | Chlamydia trachomatis | Streptococcus agalactiae |
| | Neisseria gonorrhoeae | Lactobacillus acidophilus |
| | Human epithelial cells | |
| Test System | Cepheid GeneXpert® System | Cepheid GeneXpert® System |
| Directions for Use | Process like patient sample | Process like patient sample |
| Assay Steps | Extraction, amplification, and detection | Extraction, amplification, detection |
| Monitored | | |
Summary of Performance Data:
The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit.
| Positive
| Target | Agreement (%) with Expected Results, by Test Site | Site 1 1,4 | Site 2 2,4 | Site 3 | Overall |
|---|---|---|---|---|---|
| C. trachomatis | 31/31 | ||||
| (100) | 31/31 | ||||
| (100) | 30/30 | ||||
| (100) | 92/92 | ||||
| (100) | |||||
| N. gonorrhoeae | |||||
| (NG2) | 31/31 | ||||
| (100) | 31/31 | ||||
| (100) | 30/30 | ||||
| (100) | 92/92 | ||||
| (100) | |||||
| N. gonorrhoeae | |||||
| (NG4) | 31/31 | ||||
| (100) | 31/31 | ||||
| (100) | 30/30 | ||||
| (100) | 92/92 | ||||
| (100) | |||||
| SPC3 | 31/31 | ||||
| (100) | 31/31 | ||||
| (100) | 30/30 | ||||
| (100) | 92/92 | ||||
| (100) |
1 Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained.
2 Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 SPC: Sample Processing Control
4 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls.
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Image /page/4/Picture/0 description: The image shows the logo for "Microbiologics". The logo features a stylized symbol resembling a crescent shape in blue and red, followed by the word "Microbiologics" in a bold, dark blue font. Below the word, there is a thin red line and the tagline "A safer, healthier world." in a smaller, lighter font.
| Negative
| Target | Agreement (%) with Expected Results, by Test Site | |||
|---|---|---|---|---|
| Site 11,2,3 | Site 22,3 | Site 3 | Overall | |
| SAC | 33/33 | |||
| (100) | 34/34 | |||
| (100) | 30/30 | |||
| (100) | 97/97 | |||
| (100) | ||||
| SPC | 33/33 | |||
| (100) | 34/34 | |||
| (100) | 30/30 | |||
| (100) | 97/97 | |||
| (100) |
1 Two ERROR results were observed at Site 1; in all cases a new control was retested and the expected results were obtained. 2 One Negative Control at Site 1 and two Negative Controls at Site 2 generated a positive result for NG2 target, however the qualitative results were negative in each case because the Xpert® CT/NG Assays requires both NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested.
3 More than 30 measurements were taken as extra negative controls were ran during re-tests of positive controls.
| Site | Mean Ct (%CV) Positive Control | ||
|---|---|---|---|
| CT1 | NG2 | NG4 | |
| 1 | 31.3 (1.3) | 31.2 (1.4) | 30.6 (1.5) |
| 2 | 31.2 (2.6) | 31.8 (2.1) | 31.1 (2.6) |
| 3 | 33.0 (3.9) | 33.4 (4.1) | 32.5 (4.0) |
| All | |||
| Sites | 31.8 (3.8) | 32.1 (4.0) | 31.4 (3.9) |
%CV: Percent Coefficient of Variation; SPC: Sample Processing Control
| Site | Mean Ct (%CV) Negative
Control | |
|--------------|-----------------------------------|------------|
| | SAC | SPC |
| 1 | 27.3 (1.8) | 31.6 (0.9) |
| 2 | 27.7 (1.8) | 31.4 (0.7) |
| 3 | 28.8 (4.1) | 31.5 (0.5) |
| All
Sites | 27.9 (3.5) | 31.5 (0.7) |
%CV: Percent Coefficient of Variation; SAC: Sample Adequacy Control; SPC: Sample Processing Control
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.