(63 days)
DEN 150058
DEN 150058
No
The device is a quality control material for a nucleic acid testing system and does not involve data processing or algorithmic analysis.
No
The device is a quality control material used to monitor the performance of diagnostic tests, not to treat a condition.
No
This device is a quality control panel used to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to perform a diagnosis on a patient itself. It is explicitly stated: "The BD MAX™ CT/GC/TV 20-Day QC Panel is not intended to replace manufacturer controls provided with the device." and it monitors "in vitro laboratory nucleic acid testing procedures".
No
The device description clearly states it is a physical product consisting of inactivated pathogens in pellets and tubes, intended for use as a quality control material in laboratory testing. It is not software.
Based on the provided information, 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 quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures". The term "in vitro laboratory nucleic acid testing procedures" clearly indicates that the device is used outside of the body to analyze biological samples.
- Device Description: The description details the composition of the control material, which contains inactivated pathogens used in laboratory testing.
- Intended User / Care Setting: The intended user is an "in vitro laboratory", further reinforcing its use in a laboratory setting for diagnostic purposes.
- Performance Studies: The description of performance studies involves testing the device in a laboratory setting using the BD MAX™ CT/GC/TV assay on BD MAX™ instruments, which are also IVD devices.
- Predicate Device: The mention of a predicate device (DEN 150058 Bio-Rad Amplichek II) which is also a quality control material for IVD testing, suggests that this device falls under the same regulatory category.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures. In this case, the device provides information about the performance of an IVD assay used to detect pathogens related to physiological or pathological states.
N/A
Intended Use / Indications for Use
The BD MAX™ CT/GC/TV 20-Day QC Panel is intended for use as an external assayed positive quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis with the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The controls comprise cultured and inactivated C. trachomatis, N. qonorrhoeae and T. vaqinalis.
The BD MAX CT/GC/TV™ 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.
Product codes
PMN
Device Description
The BD MAX™ CT/GC/TV 20-Day QC Panel is used to monitor the extraction, amplification and detection of the BD MAX™ CT/GC/TV Assay. The BD MAX™ CT/GC/TV 20-Day QC Panel contains authentic pathogens inactivated by radiological and temperature treatments. Each BD MAX™ CT/GC/TV 20-Day QC Panel consists of 20 individually packaged positive control pellets in a heat-sealed foil pouch. Each individually packaged pellet consists of inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis pathogens as well as preservatives and stabilized pellet containing inactivated organism(s) is packaged in a 2.0ml labeled micro-centrifuge tube with a red screw cap.
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
in vitro laboratory
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
Not Found
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 BD MAX™ CT/GC/TV 20-Day QC Panel were tested over five days. Each operator performed 3 tests (1 per lot) on 5 different days. All testing was performed on BD MAX™ instruments using the BD MAX™ CT/GC/TV assay.
Key results:
C. trachomatis:
Site 1: 30/30 (100)
Site 2: 30/30 (100)
Site 3: 30/30 (100)
Overall: 90/90 (100)
N. gonorrhoeae:
Site 1: 30/30 (100)
Site 2: 30/30 (100)
Site 3: 29/30 (97)
Overall: 89/90 (99)
T. vaginalis:
Site 1: 30/30 (100)
Site 2: 30/30 (100)
Site 3: 30/30 (100)
Overall: 90/90 (100)
'Three Unresolved results were obtained; in all cases a new control was retested and the expected results were obtained.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement (%) by Test Site/BD MAX System
Predicate Device(s)
Bio-Rad Amplichek II (DEN 150058)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 28, 2018
Microbiologics, Inc. Tina Sobania Director of Corporate Quality 200 Cooper Avenue North St. Cloud, Minnesota 56303
Re: K181683
Trade/Device Name: BD MAX CT/GC/TV 20-Day OC 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: June 20, 2018 Received: June 26, 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.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 Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the Microbiologics logo. The logo features a stylized blue and red circle 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: TBD
Date: August 6, 2018
Applicant Information:
| Applicant: | Microbiologics, Inc. |
|---|---|
| Address: | 200 Cooper Avenue North |
| St. Cloud, MN 56303 | |
| Primary Contact: | Tina Sobania, Director of Corporate Qua |
| Primary Contact: | Tina Sobania, Director of Corporate Quality |
| Phone: | 320-229-7050 |
| Email: | tsobania@microbiologics.com |
Device:
| Device Trade Name: | BD MAX™ CT/GC/TV 20-Day QC 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 BD MAX™ CT/GC/TV 20-Day QC Panel is used to monitor the extraction, amplification and detection of the BD MAX™ CT/GC/TV Assay. The BD MAX™ CT/GC/TV 20-Day QC Panel contains authentic pathogens inactivated by radiological and temperature treatments. Each BD MAX™ CT/GC/TV 20-Day QC Panel consists of 20 individually packaged positive control pellets in a heat-sealed foil pouch. Each individually packaged pellet consists of inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis pathogens as well as preservatives and stabilized pellet containing inactivated organism(s) is packaged in a 2.0ml labeled micro-centrifuge tube with a red screw cap.
Device Intended Use:
The BD MAX™ CT/GC/TV 20-Day QC Panel is intended for use as an external assayed positive quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis with the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The controls comprise cultured and inactivated C. trachomatis, N. qonorrhoeae and T. vaqinalis.
The BD MAX CT/GC/TV™ 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.
| Characteristic | BD MAX™ CT/GC/TV 20-Day QC Panel | Predicate Device –
Bio-Rad Amplichek II (DEN 150058) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD MAX™ CT/GC/TV 20-Day QC Panel is intended for use as an external
assayed positive quality control material to
monitor the performance of in vitro
laboratory nucleic acid testing procedures
for the qualitative detection of Chlamydia | 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
of Methicillin Resistant Staphylococcus aureus ,
Methicillin Sensitive Staphylococcus aureus , |
Substantial Equivalence:
3
| | trachomatis, Neisseria gonorrhoeae and
Trichomonas vaginalis with the BD MAX™
CT/GC/TV Assay on the BD MAX™
System. The controls comprise cultured
and inactivated C. trachomatis, N.
gonorrhoeae and T. vaginalis. | Clostridium difficile and Vancomycin-resistant
Enterococci performed on Cepheid GeneXpert
Systems. This product is not intended to
replace manufacturer controls provided with
the device. |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The BD MAX CT/GC/TV™ 20-Day QC
Panel 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 pellet | Ready-to-use liquid |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Analytes | Chlamydia trachomatis
Neisseria gonorrhoeae
Trichomonas vaginalis | Methicillin Resistant Staphylococcus aureus
Methicillin Sensitive Staphylococcus aureus
Clostridium difficile
Vancomycin-resistant Enterococci |
| Test System | BD MAX 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 |
| Number of Targets
monitored in one
assay | Multiple | Multiple |
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 BD MAX™ CT/GC/TV 20-Day QC Panel were tested over five days. Each operator performed 3 tests (1 per lot) on 5 different days. All testing was performed on BD MAX™ instruments using the BD MAX™ CT/GC/TV assay.
| Analyte | Agreement (%) by Test Site/BD MAX System | |||
|---|---|---|---|---|
| Site 1 1 | Site 2 1 | Site 3 | Overall | |
| C. trachomatis | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) | ||||
| N. gonorrhoeae | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 29/30 | |||
| (97) | 89/90 | |||
| (99) | ||||
| T. vaginalis | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) |
'Three Unresolved results were obtained; in all cases a new control was retested and the expected results were obtained
The BD MAX™ CT/GC/TV 20-Day QC Panel does not include a negative control.
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
4
Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."