(91 days)
Not Found
BD FACSCalibur flow cytometer,BCI EPICS-XL flow cytometer,BCI FC500 flow cytometer
No
The description focuses on traditional flow cytometry techniques and reagents for identifying and enumerating cell populations, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is used for the identification and enumeration of specific immune cells to assess CMV-specific immune status, which is a diagnostic purpose, not a therapeutic intervention.
Yes
This device is used for the identification and enumeration of CMV-specific CD8+ lymphocytes to assess CMV-specific immune status, which directly aids in diagnosing and monitoring a patient's condition related to CMV infection.
No
The device description clearly outlines physical components such as vials of antibodies, beads, lysing agent, fixative, and tetramers. These are tangible reagents used in a laboratory assay, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "identification and enumeration of cytomegalovirus (CMV) -specific CD8+ lymphocytes in whole blood by flow cytometry, and for the assessment of CMV-specific immune status in immunosuppressed stem cell transplant recipients." This involves testing a biological sample (whole blood) in vitro (outside the body) to provide information about a patient's health status (CMV-specific immune status).
- Device Description: The device is a kit containing reagents (antibodies, tetramers, beads, lysing agent, fixative) designed to be used with a flow cytometer to analyze components of whole blood. This is a typical setup for an in vitro diagnostic assay.
- Anatomical Site: The sample is "Whole blood," which is a biological specimen collected from a patient for analysis.
- Summary of Performance Studies: The studies described (Specificity, Linear Range, Accuracy and Recovery, Analytical Sensitivity, Reproducibility, Expected Reference Range, Clinical Data) are all standard types of performance studies conducted for IVD devices to demonstrate their analytical and clinical validity.
- Key Metrics: The metrics reported (Sensitivity, Specificity, Accuracy, Reproducibility, etc.) are also standard metrics used to evaluate the performance of IVD devices.
The device is designed to be used in vitro to analyze a biological sample and provide information relevant to a patient's health, which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Beckman Coulter's iTAg MHC Tetramer-CMV is for the identification and enumeration of cytomegalovirus (CMV)-specific CD8+ lymphocytes in whole blood by flow cytometry, and for the assessment of CMV-specific immune status in immunosuppressed stem cell transplant patients. The assay is limited to individuals with the following HLA types: A0101, A0201, B0702, B0801,B*3501.
Product codes
GKZ
Device Description
iTAg™ MHC Tetramer CMV is similar to existing CD (cluster differentiation) technology, measuring subsets of an individual's total leukocyte population. The tetramer kits include five tetramers specific for particular CD3+CD8+ cell receptors. While 5 alleles are provided for this assay, an individual's analysis may use up to 4 of these 5 tetramers.
Tetramers enumerate CD3+CD8+ subsets by flow cytometry, similar to antibodies: Same specimen (whole blood), indication (identification and enumeration of lymphocyte populations), platform (flow cytometry), fluorochromes, Flow-Count Fluorospheres, and accessory reagents. The assay components include:
- . Vials of anti-CD8 FITC
- . Vials of anti-CD4 PE
- Vials of anti-CD3 PC5 .
- Vials of Flow-Count Beads ●
- . Vials of lysing agent
- . Vials of fixative
- Up to 5 vials of individual Tetramers labeled with PE .
- . Vials of negative Tetramer labeled with PE
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
flow cytometry
Anatomical Site
whole 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
Specificity: There was no significant interference from common interferents such as Monocytes, graulocytes, platelets and red blood cells. There was no significant interference from similar viral response (EBV). The tetramers were specific for the identified alleles.
Linear Range: The Deming regression analysis showed acceptable correlation between the expected and actual values for absolute counts of CMV tetramer positive cells. The upper limit of the linear range for tetramer-positive cells varied by allele depending on the sample tested, but ranged from 119 to >300 cells per microliter.
Accuracy and Recovery: All of the tetramers tested demonstrated acceptable recovery based on the percent recovery for cells per microliter and % tetramer positive. The overall percent recovery across three tetramers was 96%.
Analytical Sensitivity: Functional assay sensitivity was determined to be 1.0 cell per microliter for absolute counts and 0.2% tetramer positive.
Reproducibility:
- Intra-laboratory (within-lab) assay reproducibility ranged between 1.3% CV . and 16.3% CV.
- Inter-laboratory (between-lab) assay reproducibility ranged from 0.9% CV to . 13.3% CV when performed at Beckman Coulter Inc. facilities, and from 2.6% CV to 29.6% CV when performed at the Beckman Coulter Inc. and two external sites.
Expected Reference Range: The expected reference range based on apparently healthy CMV sero-negative donors was 0 to 0.8 tetramer cells per microliter. The reference range determined for apparently healthy CMV sero-positive donors was 0 to 46.6 cells per microliter.
Instrument comparison: BD FACSCalibur flow cytometer and the BCI EPICS-XL flow cytometer were tested. The flow cytometers were shown to give comparable results and can be used interchangeably. The Deming regression analysis showed good correlation between the BD FACSCalibur flow cytometer and the BCI EPICS-XL flow cytometer for tetramer absolute counts with an equation of y =0.9697x -0.3255, r = 0.9978, where y is the BD FACSCalibur flow cytometer and x is the BCI EPICS-XL flow cytometer.
The Deming regression analysis also showed good correlation between the flow cytometers for % tetramer positive with an equation of y = 0.9800x -0.0152, r = 0.9982, where y is the BD FACSCalibur flow cytometer and x is the BCI EPICS-XL flow cytometer.
In addition to the above study, BCI FC500 flow cytometer and the BCI EPICS-XL flow cytometers were tested. The flow cytometers were shown to give comparable results and can be used interchangeably. The Deming regression analysis showed acceptable correlation between the BCI FC500 flow cytometer and the BCI EPICS-XL flow cytometer for CMV tetramer+ absolute counts with an equation of y = 0.9812X +0.1527, r = 0.9921, where y is the BCI FC500 flow cytometer and x is the BCI EPICS-XL flow cytometer.
The Deming regression analysis also showed acceptable correlation between the flow cytometers for CMV tetramer+ percent with an equation of y = 1.0426X -0.0448, r = 0.995, where y is the BCI FC500 flow cytometer and x is the BCI EPICS-XL flow cytometer.
The imprecision for CMV tetramer+ absolute counts was comparable between instruments and averaged less than 10% CV for all samples tested.
Clinical Data: The samples were HLA-typed and tested for CMV immune status by immunoassay. The data demonstrate utility for Beckman Coulter's iTAg MHC Tetramer-CMV in monitoring CMV-specific CD8+ T cells to assess immune status and risk of recurrent or persistent CMV infection or CMV disease (CMVD) in immunosuppressed stem cell transplant recipients, allowing clinicians to further refine pre-emptive therapeutic strategies in appropriate high-risk populations.
Key Metrics
Specificity, Linear Range, Accuracy, Recovery, Analytical Sensitivity, Reproducibility, Expected Reference Range, Imprecision
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, and the words "BECKMAN COULTER" in bold black letters to the right of the circle. The word "BECKMAN" is on top of the word "COULTER".
AUG 1 - 2005
510(k) Summarv
General information:
Device Generic Name: Automated Differential Cell Counter
Device Trade Name: iTAg MHC Tetramer-CMV
Device Classification: 21 CFR 864.5220
| Applicant Name and Address | Beckman Coulter, Inc.
7330 Carroll Rd.
San Diego, CA 92121 |
| ---------------------------- | ------------------------------------------------------------------ |
|---|
Device Description:
iTAg™ MHC Tetramer CMV is similar to existing CD (cluster differentiation) technology, measuring subsets of an individual's total leukocyte population. The tetramer kits include five tetramers specific for particular CD3+CD8+ cell receptors. While 5 alleles are provided for this assay, an individual's analysis may use up to 4 of these 5 tetramers.
Tetramers enumerate CD3+CD8+ subsets by flow cytometry, similar to antibodies: Same specimen (whole blood), indication (identification and enumeration of lymphocyte populations), platform (flow cytometry), fluorochromes, Flow-Count Fluorospheres, and accessory reagents. The assay components include:
- . Vials of anti-CD8 FITC
- . Vials of anti-CD4 PE
- Vials of anti-CD3 PC5 .
- Vials of Flow-Count Beads ●
- . Vials of lysing agent
- . Vials of fixative
- Up to 5 vials of individual Tetramers labeled with PE .
- . Vials of negative Tetramer labeled with PE
1
Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside. The company name is written in a bold, sans-serif font, with "BECKMAN" on top and "COULTER" below.
Summary of Studies
Specificity: There was no significant interference from common interferents such as Monocytes, graulocytes, platelets and red blood cells. There was no significant interference from similar viral response (EBV). The tetramers were specific for the identified alleles.
Linear Range: The Deming regression analysis showed acceptable correlation between the expected and actual values for absolute counts of CMV tetramer positive cells. The upper limit of the linear range for tetramer-positive cells varied by allele depending on the sample tested, but ranged from 119 to >300 cells per microliter.
Accuracy and Recovery: All of the tetramers tested demonstrated acceptable recovery based on the percent recovery for cells per microliter and % tetramer positive. The overall percent recovery across three tetramers was 96%.
Analytical Sensitivity: Functional assay sensitivity was determined to be 1.0 cell per microliter for absolute counts and 0.2% tetramer positive.
Reproducibility:
- Intra-laboratory (within-lab) assay reproducibility ranged between 1.3% CV . and 16.3% CV.
- Inter-laboratory (between-lab) assay reproducibility ranged from 0.9% CV to . 13.3% CV when performed at Beckman Coulter Inc. facilities, and from 2.6% CV to 29.6% CV when performed at the Beckman Coulter Inc. and two external sites.
Expected Reference Range: The expected reference range based on apparently healthy CMV sero-negative donors was 0 to 0.8 tetramer cells per microliter. The reference range determined for apparently healthy CMV sero-positive donors was 0 to 46.6 cells per microliter.
Instrument comparison: BD FACSCalibur flow cytometer and the BCI EPICS-XL flow cytometer were tested. The flow cytometers were shown to give comparable results and can be used interchangeably. The Deming regression analysis showed good correlation between the BD FACSCalibur flow cytometer and the BCI EPICS-XL flow cytometer for tetramer absolute counts with an equation of y =0.9697x -0.3255, r = 0.9978, where y is the BD FACSCalibur flow cytometer and x is the BCI EPICS-XL flow cytometer.
The Deming regression analysis also showed good correlation between the flow cvtometers for % tetramer positive with an equation of y = 0.9800x -0.0152, r = 0.9982, where y is the BD FACSCalibur flow cytometer and x is the BCI EPICS-XL flow cytometer.
In addition to the above study, BCI FC500 flow cytometer and the BCI EPICS-XL flow cytometers were tested. The flow cytometers were shown to give comparable results and can be used interchangeably. The Deming regression analysis showed acceptable correlation between the BCI FC500 flow cytometer and the BCI EPICS-
2
Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside. The text "BECKMAN" is above the text "COULTER".
XL flow cytometer for CMV tetramer+ absolute counts with an equation of y = 0.9812X +0.1527, r = 0.9921, where y is the BCI FC500 flow cytometer and x is the BCI EPICS-XL flow cytometer.
The Deming regression analysis also showed acceptable correlation between the flow cytometers for CMV tetramer+ percent with an equation of y = 1.0426X -0.0448, r = 0.995, where y is the BCI FC500 flow cytometer and x is the BCI EPICS-XL flow cytometer.
The imprecision for CMV tetramer+ absolute counts was comparable between instruments and averaged less than 10% CV for all samples tested.
Clinical Data: The samples were HLA-typed and tested for CMV immune status by immunoassay. The data demonstrate utility for Beckman Coulter's iTAg MHC Tetramer-CMV in monitoring CMV-specific CD8+ T cells to assess immune status and risk of recurrent or persistent CMV infection or CMV disease (CMVD) in immunosuppressed stem cell transplant recipients, allowing clinicians to further refine pre-emptive therapeutic strategies in appropriate high-risk populations.
Conclusion
The data generated demonstrates acceptable non-clinical (laboratory) performance, and good correlation between the iTAg MHC Tetramer-CMV and the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
AUG 1 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Beckman Coulter, Inc. c/o Ms Mara Caler 7330 Carroll Rd. San Diego, CA 92121
Re: K051122
Trade/Device Name: iTAg MHC Tetramer - CMV Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: April 29, 2005 Received: May 2, 2005
Dear Ms Caler:
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, P/ Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use 15/102
510(k) Number (if known):_
Device Name:__ iTAg MHC Tetramer CMV assay
Indications For Use:
Beckman Coulter's iTAg MHC Tetramer-CMV is for the identification and eoumeration of cytomegalovirus (CMV) -specific CD8+ lymphocytes in whole blood by flow cytometry, and for the assessment of CMV-specific immune status Blood by non cylomony in immunosuppressed stem cell transplant and nets. The assay is limited to individuals with the following HLA types: A0101, A0201, B0702, B0801,B*3501.
(a) Classification name: Automated Cell Counter, 21 CFR 864.5220
(b) Classification. Class II
Prescription Use _ V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of of
Maria M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051122
CONFIDENTIAL