(263 days)
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No
The document describes a quality control material for a nucleic acid test and does not mention any AI or ML components in its description, intended use, or performance evaluation.
No.
This device is an external quality control for in vitro laboratory nucleic acid testing, not a therapeutic device. It is used to monitor the performance of an assay, not to treat or diagnose patients directly.
No
Explanation: This device is explicitly described as a "quality control" for in vitro diagnostic tests, not a diagnostic device itself. Its purpose is to monitor the performance of other laboratory nucleic acid testing procedures, not to provide a diagnosis to a patient.
No
The device is described as a "quality control material" comprising "cultured and inactivated viruses" on "swabs" packaged in "foil pouches". This clearly indicates a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring 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 derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. While this specific device is a control, it's used in conjunction with an IVD assay (the Cepheid Xpert® Xpress Flu/RSV assay) to ensure the reliability of the results obtained from patient samples.
- Device Description: The description details the composition of the controls (cultured and inactivated viruses) and how they are used to "monitor RNA extraction, amplification" of the assay. This further reinforces its role in the in vitro diagnostic process.
- Performance Studies: The inclusion of performance studies evaluating the agreement of the positive and negative controls demonstrates that this device is subject to the same kind of performance evaluation as other IVD components.
- Predicate Device: The mention of a predicate device (K182472; Cepheid Xpert® GBS LB Control Panel) which is also a control panel, indicates that this type of device is classified and regulated as an IVD.
In summary, while the Cepheid Xpert® Respiratory Control Panel is not the primary diagnostic assay itself, it is a crucial component used in vitro within a laboratory setting to ensure the accuracy and reliability of an IVD assay. Therefore, it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cepheid Xpert®Respiratory 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 Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A performed with the Cepheid Xpert® Xpress Flu/RSV assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A as the positive control and Coxsackie virus B1 as the negative control.
The Cepheid Xpert®Respiratory 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® Respiratory Control Panel is used to monitor RNA extraction, amplification of the Cepheid Xpert® Xpress Flu/RSV assay. The Cepheid Xpert® Respiratory Control Panel contains cultured viruses inactivated by chemical or radiological treatments. Each Cepheid Xpert® Respiratory Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory syncytial virus A. Each negative control swab contains Coxsackie B1 virus. 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
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Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Cepheid Xpert® Respiratory Control Panel was evaluated in a study that was performed using three different production lots, three sites, using three different GeneXpert® Instrument Systems and six different users.
Positive Analyte Agreement (%):
Influenza A (H1N1): Site 1 (30/30, 100%), Site 2 (30/30, 100%), Site 3 (30/30, 100%), Overall (90/90, 100%)
Influenza A (H3N2): Site 1 (30/30, 100%), Site 2 (30/30, 100%), Site 3 (30/30, 100%), Overall (90/90, 100%)
Influenza B: Site 1 (30/30, 100%), Site 2 (30/30, 100%), Site 3 (30/30, 100%), Overall (90/90, 100%)
Respiratory Syncytial Virus A: Site 1 (30/30, 100%), Site 2 (30/30, 100%), Site 3 (30/30, 100%), Overall (90/90, 100%)
One NO RESULT response was observed; a new control was retested and the expected results were obtained.
Negative Analyte Agreement (%):
Coxsackievirus B1: Site 1 (30/30, 100%), Site 2 (30/30, 100%), Site 3 (31/31, 100%), Overall (91/91, 100%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement: All positive and negative analytes showed 100% agreement across all test 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.
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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.”
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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, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
October, 7 2019
Microbiologics, Inc. Director of Corporate Quality 200 Cooper Avenue North St. Cloud, Minnesota 56303
Re: K190086
Trade/Device Name: Cepheid Xpert Respiratory 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 12, 2019 Received: September 13, 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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 mediation-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,
Tamara Feldblyum, M.S., Ph.D. Chief. Viral Respiratory and STI Branch 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 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 tagline "A safer, healthier world." in a smaller font.
510(k) Summary
510(k) Number: K190086
Date: September 19, 2019
Applicant Information:
Email:
| Applicant: | Microbiologics, Inc. |
|---|---|
| Address: | 200 Cooper Avenue North |
| St. Cloud, MN 56303 | |
| Primary Contact: | Tina Sobania, Director of Corporate Quality |
| Phone: | 320-229-7050 |
Device:
| Device Trade Name: | Cepheid Xpert® Respiratory 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® Respiratory Control Panel is used to monitor RNA extraction, amplification of the Cepheid Xpert® Xpress Flu/RSV assay. The Cepheid Xpert® Respiratory Control Panel contains cultured viruses inactivated by chemical or radiological treatments. Each Cepheid Xpert® Respiratory Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory syncytial virus A. Each negative control swab contains Coxsackie B1 virus. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.
Device Intended Use:
The Cepheid Xpert®Respiratory 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 Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A performed with the Cepheid Xpert® Xpress Flu/RSV assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A as the positive control and Coxsackie virus B1 as the negative control.
The Cepheid Xpert®Respiratory Control Panel is not intended to replace manufacturer controls provided with the device.
Substantial Equivalence:
| Characteristic | Cepheid Xpert® Respiratory Control
Panel | Predicate Device
Cepheid Xpert® GBS LB Control
Panel (K182472) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Cepheid Xpert® Respiratory
Control Panel is intended for us as an
external assayed positive and negative
quality control to monitor the | The Cepheid Xpert® GBS LB Control
Panel is intended for use as external
assayed positive and negative quality
control materials to monitor the |
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Image /page/3/Picture/0 description: The image shows the logo for "Microbiologics". The logo consists of a blue and red circular graphic on the left, followed by the word "Microbiologics" in blue, with a registered trademark symbol. Underneath the word "Microbiologics" is the text "A safer, healthier world".
| | performance of in vitro laboratory
nucleic acid testing procedures for the
qualitative detection of Influenza A
(H1N1) virus, Influenza A (H3N2) virus,
Influenza B virus and Respiratory
Syncytial Virus A performed with the
Cepheid Xpert® Xpress Flu/RSV assay
on the GeneXpert® Instrument System.
The controls comprise cultured and
inactivated Influenza A (H1N1) virus,
Influenza A (H3N2) virus, Influenza B
virus and Respiratory Syncytial Virus A
as the positive control and Coxsackie
virus B1 as the negative control.
The Cepheid Xpert® Respiratory
Control Panel is not intended to
replace manufacturer controls provided
with the device. | 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 | Influenza A (H1N1) virus
Influenza A (H3N2) virus
Influenza B virus
Respiratory Syncytial Virus A
Coxsackie virus B1 | Streptococcus agalactiae
Lactobacillus acidophilus |
| Test System | Cepheid GeneXpert® System | Cepheid GeneXpert® 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:
The performance of the Cepheid Xpert® Respiratory Control Panel was evaluated in a study that was performed using three different production lots, three sites, using three different GeneXpert® Instrument Systems and six different users. The results of the study are summarized below.
| Positive
| Analyte | Agreement (%) by Test Site/GeneXpert® System | |||
|---|---|---|---|---|
| Site 1 | Site 2 | Site 31 | Overall | |
| Influenza A (H1N1) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) | ||||
| Influenza A (H3N2) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) | ||||
| Influenza B | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) | ||||
| Respiratory Syncytial Virus A | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) |
1 One NO RESULT response was observed; a new control was retested and the expected results were obtained.
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Image /page/4/Picture/0 description: The image shows the logo for "Microbiologics". The logo consists of a stylized symbol resembling a partially closed circle with red and blue sections, followed by the word "Microbiologics" in a bold, blue font. Below the word, there is a tagline that reads "A safer, healthier world."
| Negative
| Analyte | Site 1 | Site 2 | Site 3 | Overall |
|---|---|---|---|---|
| Coxsackievirus B1 | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 31/31 | |||
| (100) | 91/91 | |||
| (100) |
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.