(59 days)
DEN 150058
Not Found
No
The device is a quality control panel for a nucleic acid test, consisting of inactivated bacteria on swabs. There is no mention of any computational analysis or algorithms, let alone AI/ML.
No.
The device is described as external quality control material for nucleic acid testing procedures, intended to monitor the performance of an in vitro diagnostic assay, not to directly treat or diagnose a patient.
No
Explanation: The device is described as an "external assayed positive and negative quality control material" used to "monitor the performance of in vitro laboratory nucleic acid testing procedures." It is not intended to diagnose diseases but rather to ensure the accuracy and reliability of diagnostic tests.
No
The device description clearly states it consists of physical swabs containing inactivated pathogens and preservatives, which are hardware components.
Based on the provided text, the 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 external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures". The term "in vitro" directly indicates that the testing is performed outside of a living organism, which is a defining characteristic of IVDs.
- Device Description: The description mentions that the device is used to monitor the "extraction, amplification and detection" of a specific assay (Cepheid Xpert® GBS LB Assay). These are all steps involved in laboratory diagnostic testing.
- Intended User / Care Setting: The intended user is listed as "in vitro laboratory", further reinforcing its use in a laboratory setting for diagnostic purposes.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (DEN 150058) and name (Bio-Rad Amplichek II) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared IVD device.
Therefore, the Cepheid Xpert® GBS LB Control Panel is clearly intended for use in a laboratory setting to control and monitor the performance of an in vitro diagnostic assay, making it an IVD itself.
N/A
Intended Use / Indications for Use
The Cepheid Xpert® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B 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.
Product codes (comma separated list FDA assigned to the subject device)
PMN
Device Description
The Cepheid Xpert® GBS LB Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® GBS LB Assay. The Cepheid Xpert® GBS LB Control Panel contains authentic pathogens inactivated by temperature treatments. Each Cepheid Xpert® GBS LB Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Streptococcus agalactiae (Lancefield's Group B) as well as preservatives and stabilizers. Each negative control swab contains Lactobacillus as well as preservatives and stabilizers. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A precision and reproducibility study was conducted to determine device performance. Three different testing locations were used. Six different operators (2 at each facility) and 3 different lots of the Cepheid Xpert® GBS LB Control Panel were tested over five days. Each operator performed 3 tests (1 per lot) on 5 different days. All testing was performed on a GeneXpert® Instrument System using the Cepheid Xpert® GBS LB Assay.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision and reproducibility study.
Sample size: Not explicitly stated, but 6 operators x 3 tests/operator/day x 5 days = 90 tests per analyte (S. agalactiae and L. acidophilus) across 3 sites.
Key results: 100% agreement for both S. agalactiae and L. acidophilus across all three sites. One ERROR result was obtained, retested, and expected results were obtained.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement (100%)
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.
Bio-Rad Amplichek II (DEN 150058)
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).
Not Found
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2018
Microbiologics, Inc. Tina Sobania Director of Corporate Quality 200 Cooper Avenue North St. Cloud. Minnesota 56303
Re: K182472
Trade/Device Name: Cepheid Xpert GBS LB Control Panel Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: September 5, 2018 Received: September 10, 2018
Dear Tina Sobania:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Steven R. Gitterman -S for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182472
Device Name Cepheid Xpert® GBS LB Control Panel
Indications for Use (Describe)
The Cepheid Xpert® GBS LB Control Panel is 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is the logo for "Microbiologics". 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." in a smaller font.
510(k) Summary
510(k) Number: K182472
Date: October 18, 2018
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® GBS LB Control Panel |
|---|---|
| Common Name: | Assayed quality control material for clinical microbiology assays |
| Classification: | Class II |
| Regulation: | 21 CFR 866.3920 |
| Panel: | 83-Microbiology |
| Product Code: | PMN |
Predicate Device:
Bio-Rad Amplichek II (DEN 150058)
Device Description:
The Cepheid Xpert® GBS LB Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® GBS LB Assay. The Cepheid Xpert® GBS LB Control Panel contains authentic pathogens inactivated by temperature treatments. Each Cepheid Xpert® GBS LB Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Streptococcus agalactiae (Lancefield's Group B) as well as preservatives and stabilizers. Each negative control swab contains Lactobacillus as well as preservatives and stabilizers. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.
Device Intended Use:
The Cepheid Xpert® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococus (GBS) performed with the Cepheid Xpert® GBS LB Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control.
The Cepheid Xpert® GBS LB Control Panel is not intended to replace manufacturer controls provided with the device.
Substantial Equivalence:
| Characteristic | Cepheid Xpert® GBS LB Control Panel | Predicate Device –
Bio-Rad Amplichek II (DEN 150058) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Cepheid Xpert® GBS LB Control Panel is
intended for use as external assayed positive
and negative quality control materials to
monitor the performance of in vitro laboratory | Amplichek II is intended for use as an external
assayed quality control material to monitor the
performance of in vitro laboratory nucleic acid
testing procedures for the qualitative detection |
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Image /page/4/Picture/1 description: The image shows the Microbiologics logo. The logo features a stylized symbol resembling a crescent shape, with one side in blue and the other in red. To the right of the symbol is the word "Microbiologics" in a bold, blue font, with a registered trademark symbol next to it. Below the word is the tagline "A safer, healthier world." in a smaller font.
| | nucleic acid testing procedures for 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. | of Methicillin Resistant Staphylococcus aureus,
Methicillin Sensitive Staphylococcus aureus,
Clostridium difficile and Vancomycin-resistant
Enterococci performed on Cepheid GeneXpert
Systems. This product is not intended to
replace manufacturer controls provided with the
device.
This product is only for use with assays and
instruments listed in the Representative Results
Chart in this labeling. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Format | Lyophilized swab | Ready-to-use liquid |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Analytes | Streptococcus agalactiae
Lactobacillus acidophilus | Methicillin Resistant Staphylococcus aureus
Methicillin Sensitive Staphylococcus aureus
Clostridium difficile
Vancomycin-resistant Enterococci |
| 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:
A precision and reproducibility study was conducted to determine device performance. Three different testing locations were used. Six different operators (2 at each facility) and 3 different lots of the Cepheid Xpert® GBS LB Control Panel were tested over five days. Each operator performed 3 tests (1 per lot) on 5 different days. All testing was performed on a GeneXpert® Instrument System using the Cepheid Xpert® GBS LB Assay.
| Analyte | Agreement (%) by Test Site/ GeneXpert® Instrument System | |||
|---|---|---|---|---|
| Site 1 1 | Site 2 | Site 3 | Overall | |
| S. agalactiae | 30/30 | 30/30 | 30/30 | 90/90 |
| (100) | (100) | (100) | (100) | |
| L. acidophilus | 30/30 | 30/30 | 30/30 | 90/90 |
| (100) | (100) | (100) | (100) |
1One ERROR result was obtained; a new control was retested and the expected results were obtained
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.