(116 days)
Not Found
No
The description focuses on flow cytometry and antibody binding for cell identification and counting, with analysis performed by standard clinical software. There is no mention of AI or ML techniques for data processing or interpretation.
No.
The device is used for identification and enumeration of cell populations, which is a diagnostic purpose, not a therapeutic one.
Yes
The device identifies and determines the percentages and absolute counts of various T, B, and natural killer (NK) cell populations, which are measurements used in diagnostic procedures to assess a patient's immune system.
No
The device description explicitly states that the device includes a reagent (BD Multitest 6-Color TBNK Reagent) and tubes (BD Trucount tubes), which are physical components, not solely software. It also mentions the use of flow cytometers (BD FACSCanto and BD FACSCanto II) and lysing solution, further indicating hardware and chemical components are integral to the device's function. While software is used for analysis, the device itself is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagent is used to "identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood." This is a diagnostic purpose, providing information about a patient's immune cell populations.
- Device Description: The description details how the reagent interacts with a biological sample (whole blood) in vitro (outside the body) to provide diagnostic information. The process involves staining cells with antibodies and analyzing them using a flow cytometer.
- Anatomical Site: The sample is "peripheral blood," which is a biological specimen taken from the body for analysis.
- Performance Studies: The performance studies describe clinical and non-clinical testing to demonstrate the device's accuracy and reliability in providing diagnostic results (lymphocyte population percentages and counts).
- Predicate Device: The predicate device is also an IVD (indicated by the K number and name, which is a previous version of a similar diagnostic product).
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
BD Multitest™ 6-color TBNK reagent with optional BD Trucount™ tubes is a sixcolor direct immunofluorescence reagent for use with BD FACSCanto™ and BD FACSCanto™ II flow cytometers to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
BD Multitest 6-color TBNK reagent and BD Trucount tubes can be used with the BD FACS™ Loader.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
Human lymphocytes can be divided into three major subset populations based on their biologic function and cell-surface antigen expression: T Ivmphocytes (CD3+), B lymphocytes (CD19+), and Natural Killer (NK) cells (CD16+ and/or CD56+). CD3+ T lymphocytes can be further divided into CD4+ T lymphocytes and CD8+ T lymphocytes.
BD Multitest 6-Color TBNK Reagent is a monoclonal antibody cocktail of CD3-FITC/ CD16-PE + CD56-PE/ CD45-PerCP-Cy5.5/ CD4-PE-Cy7/ CD19-APC/ CD8-APC-Cy7.
When the reagent is used to stain a known volume of whole blood, the fluorochrome-labeled antibodies in the reagent bind specifically to leucocyte surface antigens. The stained samples are treated with BD FACS™ Lysing Solution to lyse erythrocytes prior to acquisition and analysis on the BD FACSCanto or BD FACSCanto II flow cytometer. During acquisition, the cells travel past two spatially separated laser beams. The cells scatter the laser light and the cell-bound fluorochrome-labeled antibodies fluoresce. These scatter and fluorescence signals are detected by the flow cytometer and provide information about the cell's relative size, internal complexity and fluorescence intensity. During analysis by BD FACSCanto clinical software, the lymphocyte population percentages are determined. Lymphocyte population absolute counts may be determined if Ivmphocvte data from another method is manually entered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral blood
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance study data from testing supported the determination of substantial equivalence. Performance testing to support substantial equivalence included clinical and non-clinical studies. Clinical testing was done for precision and method comparison to the predicate. Non-clinical testing was done for method comparison, functionality and file-based equivalency.
Clinical Precision:
Lymphocyte population percentages met the predetermined acceptance criteria: the upper one-sided 95% confidence bound on the standard deviation (SD) for the within-device precision must be ≤2.5 on the investigational system.
Clinical Method Comparison:
Lymphocyte population percentages, in comparison to the predicate, met the predetermined acceptance criteria: the 95% confidence interval (CI) of the mean difference between the investigational and predicate systems must be within an absolute ±3% or a relative ±10% of the predicate mean, whichever is greater.
Non-Clinical Method Comparison:
Lymphocyte population percentages, in comparison to the predicate, met the predetermined acceptance criteria: the 95% Cl of the mean difference between the test and predicate population shall be within +/-3% absolute or +/-10% relative to the predicate mean, whichever is greater.
Non-Clinical Software Functionality:
BD FACSCanto clinical software version 2.4 met the predetermined functional requirements for software development (including functionality such as cytometer setup & optimization, acquisition/analysis worklist, Lab Manager, user preferences, running a QC sample, and user interface).
Non-Clinical File-Based Equivalency for Software:
BD FACSCanto clinical software version 2.4 met the predetermined functional requirements for providing results equivalent to the results from the previously released version of the software, (BD FACSCanto clinical software version 2.2).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
Not Found
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
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510(k) SUMMARY
1. Submitted By:
BD Biosciences 2350 Qume Drive San Jose, CA 95131-1807
'JUL 31 2009
Contact: Katv Campbell Regulatory Affairs Specialist Phone (408) 518-5066 Fax (408) 954-2495 katv campbell@bd.com
Submission date: April 3, 2009
2. Device Name and Classification:
a) BD Multitest™ 6-color TBNK Reagent b) 21 CFR 864.5220, Automated differential cell counter, GKZ, Class II
3. Currently Marketed Predicate Device:
BD Multitest™ 6-Color TBNK with Trucount™ Tubes [510(k) # K060375]
4. Intended Use:
BD Multitest 6-color TBNK reagent with optional BD Trucount™ tubes is a sixcolor direct immunofluorescence reagent for use with BD FACSCanto™ and BD FACSCanto™ II flow cytometers to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
BD Multitest 6-color TBNK reagent and BD Trucount tubes can be used with the BD FACS™ Loader.
5. Basic description of the device:
Human lymphocytes can be divided into three major subset populations based on their biologic function and cell-surface antigen expression: T Ivmphocytes (CD3+), B lymphocytes (CD19+), and Natural Killer (NK) cells (CD16+ and/or CD56+). CD3+ T lymphocytes can be further divided into CD4+ T lymphocytes and CD8+ T lymphocytes.
BD Multitest 6-Color TBNK Reagent is a monoclonal antibody cocktail of CD3-FITC/ CD16-PE + CD56-PE/ CD45-PerCP-Cy5.5/ CD4-PE-Cy7/ CD19-APC/ CD8-APC-Cy7.
1
When the reagent is used to stain a known volume of whole blood, the fluorochrome-labeled antibodies in the reagent bind specifically to leucocyte surface antigens. The stained samples are treated with BD FACS™ Lysing Solution to lyse erythrocytes prior to acquisition and analysis on the BD FACSCanto or BD FACSCanto II flow cytometer. During acquisition, the cells travel past two spatially separated laser beams. The cells scatter the laser light and the cell-bound fluorochrome-labeled antibodies fluoresce. These scatter and fluorescence signals are detected by the flow cytometer and provide information about the cell's relative size, internal complexity and fluorescence intensity. During analysis by BD FACSCanto clinical software, the lymphocyte population percentages are determined. Lymphocyte population absolute counts may be determined if Ivmphocvte data from another method is manually entered.
6. Comparison to the Predicate:
The content and intent of the intended use and indications of BD Multitest 6-Color TBNK Reagent, as described in its labeling, are the same as the intended use and indications of the original predicate device. The fundamental scientific technology also remains the same. In addition, BD Multitest 6-Color TBNK Reagent is substantially equivalent to the predicate (K060375) in:
- · Clinical Application
- Monoclonal antibody reagent composition
- · Instrument used
The modification enables the use of BD Trucount tubes to be optional. The use of the reagent without BD Trucount Tubes may be more appropriate for those clinicians who need only fymphocyte population percentages or who prefer to use lymphocyte data from another method to determine lymphocyte population absolute counts.
Performance studies confirm that the devices are substantially equivalent in performance characteristics and the device modification does not raise any unresolved issues of safety or efficacy.
7. Summary of Performance Data:
Performance study data from testing supported the determination of substantial equivalence. Performance testing to support substantial equivalence included clinical and non-clinical studies. Clinical testing was done for precision and method comparison to the predicate. Non-clinical testing was done for method comparison, functionality and file-based equivalency.
Clinical Precision:
Lymphocyte population percentages met the predetermined acceptance criteria: the upper one-sided 95% confidence bound on the standard deviation (SD) for the within-device precision must be ≤2.5 on the investigational system.
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Clinical Method Comparison:
Lymphocyte population percentages, in comparison to the predicate, met the predetermined acceptance criteria: the 95% confidence interval (CI) of the mean difference between the investigational and predicate systems must be within an absolute ±3% or a relative ±10% of the predicate mean, whichever is greater.
Non-Clinical Method Comparison:
Lymphocyte population percentages, in comparison to the predicate, met the predetermined acceptance criteria: the 95% Cl of the mean difference between the test and predicate population shall be within +/-3% absolute or +/-10% relative to the predicate mean, whichever is greater.
Non-Clinical Software Functionality:
BD FACSCanto clinical software version 2.4 met the predetermined functional requirements for software development (including functionality such as cytometer setup & optimization, acquisition/analysis worklist, Lab Manager, user preferences, running a QC sample, and user interface).
Non-Clinical File-Based Equivalency for Software:
BD FACSCanto clinical software version 2.4 met the predetermined functional requirements for providing results equivalent to the results from the previously released version of the software, (BD FACSCanto clinical software version 2.2).
This 510(k) Summary is being submitted in accordance with the requirements of compliance with SMDA 1990 and 21 CFR 807.92.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH" is arranged vertically along the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
BD Biosciences c/o Katy Campbell Regulatory Affairs Specialist 2350 Qume Drive San Jose, California 95131-1807
JUL 81 2009
Re: K090967
Trade Name: BD Multitest™ 6-color TBNK Reagent with Trucount™ Tubes Regulation Number: 21 CFR §864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Codes: GKZ Dated: July 22, 2009 Received: July 23, 2009
Dear Ms. Campbell:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 - Ms. Katy Campbell
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
i m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K090967
Device Name: BD Multitest™ 6-color TBNK Reagent
Indication For Use:
BD Multitest™ 6-color TBNK reagent with optional BD Trucount™ tubes is a sixcolor direct immunofluorescence reagent for use with BD FACSCanto™ and BD FACSCanto™ II flow cytometers to identify and determine the percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
BD Multitest 6-color TBNK reagent and BD Trucount tubes can be used with the BD FACS™ Loader.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Maria M. Chen
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090967
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