(48 days)
DEN 150058
Not Found
No
The document describes quality control materials for a nucleic acid testing system and does not mention any AI or ML components.
No
The device is described as an external assayed positive quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures, not for treating any condition or disease.
No
The device is described as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures, not to provide a diagnosis itself.
No
The device description clearly states the product consists of "individually packaged pellets consisting of inactivated, Cryptosporidium parvum, Giardia lamblia, and a recombinant Escherichia coli," which are physical biological materials, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the panels are "intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures". The phrase "in vitro laboratory nucleic acid testing procedures" is a key indicator of an IVD.
- Device Description: The description details the composition of the controls, which are used to "monitor the extraction, amplification of the BD MAX™ Enteric Parasite Panel." This monitoring is done within a laboratory setting, supporting the IVD classification.
- Intended User / Care Setting: The intended user is an "in vitro laboratory," which is the typical setting for IVD use.
- Performance Studies: The performance studies describe testing conducted in "different testing locations" by "operators" using "BD MAX™ instruments," all consistent with laboratory-based testing using an IVD.
- Predicate Device: The mention of a "Predicate Device" with a K number (DEN 150058 Bio-Rad Amplichek II) is a strong indicator that this device is being compared to another device that has already been classified as an IVD by a regulatory body (likely the FDA in the US).
Based on the provided information, the BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel clearly fit the definition of an In Vitro Diagnostic device. They are used in a laboratory setting to assess the performance of another IVD (the BD MAX™ Enteric Parasite Panel) by testing biological samples (nucleic acids extracted from the control materials).
N/A
Intended Use / Indications for Use
The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica.
The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day OC Panel are 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 BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are used to monitor the extraction, amplification of the BD MAX™ Enteric Parasite Panel. Both panels contain individually packaged pellets consisting of inactivated, Cryptosporidium parvum, Giardia lamblia, and a recombinant Escherichia coli. The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel differ only by packaged quantity. Each BD MAX™ Enteric Parasite Control Panel consists of 6 individually packaged positive control pellets. Each BD MAX™ Enteric Parasite 20-Day QC Panel consists of 20 individually packaged positive control pellet is individually wrapped with a desiccant in a heat-sealed foil pouch. The organisms are prepared in a buffered solution with materials of animal origin, preservatives and stabilizers. The solution is lyophilized into a ready-to-use pellet containing inactivated orqanism(s) is packaged in a 2.0-ml labeled micro-centrifuge tube with a red screw cap.
The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel do not contain negative controls.
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. 6 different operators (2 at each facility) and 3 different lots of the BD MAX™ Enteric Parasite controls 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™ Enteric Parasite Panel.
| Analyte | Agreement (%) by Test Site/BD MAX System |
|---|
| Site 1 1 | Site 2 2 | Site 3 | Overall
G. lamblia | 30/30 (100) | 30/30 (100) | 30/30 (100) | 90/90 (100)
E. histolytica | 30/30 (100) | 30/30 (100) | 30/30 (100) | 90/90 (100)
C. parvum | 30/30 (100) | 30/30 (100) | 30/30 (100) | 90/90 (100)
1 Two Incomplete Run errors occurred; in both cases a new control was retested results were obtained
2 An Unresolved result was obtained with one control was retested and the expected results were obtained
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement percentages are 100% for all analytes (G. lamblia, E. histolytica, C. parvum) across all sites and in overall results.
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.”
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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 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 15, 2018
Microbiologics. Inc. Tina Sobania Director of Corporate Quality 200 Cooper Avenue North St. Cloud. Minnesota 56303
Re: K181711
Trade/Device Name: BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Dav 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 27, 2018 Received: June 28, 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/cdrl/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 (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,
Ribhi Shawar -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) K181711
Device Name BD MAX™ Enteric Parasite Control Panel BD MAXTM Enteric Parasite 20-Day QC Panel
Indications for Use (Describe)
The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica.
The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day OC Panel are 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 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 tagline "A safer, healthier world." in a smaller font.
510(k) Summary
510(k) Number: K181711
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 Quality |
| Phone: | 320-229-7050 |
| Email: | tsobania@microbiologics.com |
Device:
| Device Trade Names: | BD MAX™ Enteric Parasite Control Panel
BD MAX™ Enteric Parasite 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™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are used to monitor the extraction, amplification of the BD MAX™ Enteric Parasite Panel. Both panels contain individually packaged pellets consisting of inactivated, Cryptosporidium parvum, Giardia lamblia, and a recombinant Escherichia coli. The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel differ only by packaged quantity. Each BD MAX™ Enteric Parasite Control Panel consists of 6 individually packaged positive control pellets. Each BD MAX™ Enteric Parasite 20-Day QC Panel consists of 20 individually packaged positive control pellet is individually wrapped with a desiccant in a heat-sealed foil pouch. The organisms are prepared in a buffered solution with materials of animal origin, preservatives and stabilizers. The solution is lyophilized into a ready-to-use pellet containing inactivated orqanism(s) is packaged in a 2.0-ml labeled micro-centrifuge tube with a red screw cap.
The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel do not contain negative controls.
Device Intended Use:
The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica.
The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day QC Panel are not intended to replace manufacturer controls provided with the device.
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Image /page/4/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 tagline that reads "A safer, healthier world."
Substantial Equivalence:
| Characteristic | BD MAX™ Enteric Parasite Control Panel,
BD MAX™ Enteric Parasite 20-Day QC Panel | Predicate Device –
Bio-Rad Amplichek II (DEN 150058) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD MAX™ Enteric Parasite Control Panel
and the BD MAX™ Enteric Parasite 20-Day QC
Panel are intended for use as external assayed
positive quality control materials to monitor the
performance of in vitro laboratory nucleic acid
testing procedures for the qualitative detection
of Cryptosporidium parvum , Giardia lamblia ,
and Entamoeba histolytica performed with the
BD MAX™ Enteric Parasite Panel on the BD
MAX™ System. The controls comprise cultured
and inactivated C. parvum , G. lamblia and
recombinant Escherichia coli . The E. coli
carries a plasmid which is a surrogate control
material for detection of E. histolytica .
The BD MAX™ Enteric Parasite Control Panel
and BD MAX™ Enteric Parasite 20-Day QC
Panel are not intended to replace manufacturer
controls provided with the device. | 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 , 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 pellet | Ready-to-use liquid |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Analytes | Cryptosporidium parvum
Giardia lamblia
Entamoeba histolytica | 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 |
Summary of Performance Data:
A precision and reproducibility study was conducted to determine device performance. Three different testing locations were used. 6 different operators (2 at each facility) and 3 different lots of the BD MAX™ Enteric Parasite controls 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™ Enteric Parasite Panel.
| Analyte | Agreement (%) by Test Site/BD MAX System | |||
|---|---|---|---|---|
| Site 1 1 | Site 2 2 | Site 3 | Overall | |
| G. lamblia | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) | ||||
| E. histolytica | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) | ||||
| C. parvum | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 30/30 | |||
| (100) | 90/90 | |||
| (100) |
1 Two Incomplete Run errors occurred; in both cases a new control was retested results were obtained 2 An Unresolved result was obtained with one control was retested and the expected results were obtained
Conclusion
The submitted information in this premarket notification is complets a substantial equivalence decision.