(43 days)
None
No
The summary describes a flow cytometry reagent and associated software for cell enumeration, with no mention of AI or ML capabilities. The analysis software mentioned (MultiSET™, CELLQuest™, CELLQuest Pro™, LYSYS™ II) are standard flow cytometry analysis tools, not explicitly AI/ML driven.
No
The device is a diagnostic reagent used for identifying and enumerating specific cell types in blood for diagnostic purposes, not for treating or curing a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "To characterize and monitor some forms of autoimmune disease" and "To characterize and monitor some forms of immunodeficiency disease, such as in HIV- infected individuals," which are diagnostic purposes.
No
The device is a reagent and counting beads, which are physical components used in flow cytometry. While it mentions software for analysis, the core device is not software-only.
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 reagent is for "identifying and enumerating percentages of T lymphocytes (CD3+) and T helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood." It also mentions its use "To characterize and monitor some forms of autoimmune disease" and "To characterize and monitor some forms of immunodeficiency disease, such as in HIV- infected individuals." These are all diagnostic purposes performed on biological samples (blood) outside of the body.
- Device Description: The description confirms it's a "three-color, direct immunofluorescence reagent" used with flow cytometry to analyze blood cells. This is a typical setup for in vitro diagnostic testing.
- Anatomical Site: The analysis is performed on "Erythrocyte-lysed whole peripheral blood," which is a biological sample.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Intended Use / Indications for Use
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/uL.
Indications For Use:
- For use with any flow cytometer equipped with a 488 nm laser and capable of . detection in the ranges: 510-545 nm, 562-607 nm, and >650 nm
- For use in erythrocyte-lysed whole peripheral blood .
- For use with or without isotype control .
- To characterize and monitor some forms of autoimmune disease .
- To characterize and monitor some forms of immunodeficiency disease, such as in . HIV- infected individuals
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/μL. If used with Becton Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™, CELLQuest Pro™ or LYSYS™ II software.
The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes vields 50 tests.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
erythrocyte-lysed whole blood (LWB)
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 data from validation testing supports equivalency.
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.”
0
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1.0 Submitted By
BD Biosciences 2350 Qume Drive San Jose, CA 95131-1807
JUN - 6 2007
Contact:
Nobuko Nakajima Senior Regulatory Affairs Specialist Phone (408) 954-4109 Fax (408) 954-2495 Nobuko Nakajima@bd.com
Submission date
April 20, 2007
2.0 Device Name and Classification
a) BD™Tritest CD3/CD4/CD45 with Trucount Absolute count Tubes
b) 864.5220 Automated differential cell counter, GKZ class II
3.0 Intended Use
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/uL.
4.0 Basic description of the device ·
The BD TriTEST™ CD3FITC/CD4PE/CD45 PerCP reagent is a threecolor, direct immunofluorescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Thelper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB). When used with TRUCOUNT™ Absolute Count Tubes, the product produces absolute counts in cells/μL. If used with Becton BD Biosciences Special 510(k): Device Modification Notification Tritest CD3/CD4/CD45 with Trucount Absolute Count tubes 04/20/2007
1
Dickinson flow cytometers, the product can be used with MultiSET™ software for analysis as an accessory, or customers may perform analysis using CELLQuest™, CELLQuest Pro™ or LYSYS™ II software.
The reagent vials and counting bead vials are packaged separately. Each vial of this reagent yields 50 tests. Each package of counting bead tubes vields 50 tests.
5.0 Predicate Device
The BD™Tritest CD3/CD4/CD45 with Trucount Absolute Count Tubes currently in distribution was originally cleared by CDRH in 1997 under the 510(k) number of K965053.
6.0 Comparison to the Predicate(s)
The modifications to the legally marketed device (BD™Tritest CD3/CD4/CD45 with Trucount Absolute Count Tubes) intends to extend the sample stability claim for EDTA from 48 to 72 hours
The Intended use and the indications of the modified device, as described in its labeling are the same as the intended use and indications for the original predicate device.
7.0 Summary of Performance Data
Performance data from validation testing supports equivalency.
This Summary of safety and effectiveness is being submitted in accordance with the requirements of compliance with SMDA 1990 and 21 CFR 807.92.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN -6 2007
Nobuko Nakajima BD Biosciences 2350 Oume Drive San Jose, California 95131-1807
Re: K071141
Trade/Device Name: BD Tritest CD3/CD4/CD5 with BD Trucount Absolute Count tubes Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: April 20, 2007 Received: April 24, 2007
Dear Mr. Nakajima:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
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Page 2 – Nobuko Nakajima
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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) 276-0450. 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert Becker
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K071141
Device Name: BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count tubes
Indications For Use:
- For use with any flow cytometer equipped with a 488 nm laser and capable of . detection in the ranges: 510-545 nm, 562-607 nm, and >650 nm
- For use in erythrocyte-lysed whole peripheral blood .
- For use with or without isotype control .
- To characterize and monitor some forms of autoimmune disease .
- To characterize and monitor some forms of immunodeficiency disease, such as in . HIV- infected individuals
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Josephine Baututa
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071141