(244 days)
Not Found
No
The description details a standard flow cytometry process using reagents and tubes to count cell populations based on fluorescent markers. There is no mention of algorithms, learning, or automated interpretation beyond basic counting and ratio calculations.
No.
The device is for in vitro diagnostic use to identify and enumerate absolute counts of specific T lymphocyte subsets, which is a diagnostic purpose, not a therapeutic one.
Yes
The intended use explicitly states "For in vitro diagnostic use to identify and enumerate absolute counts of T lymphocyte (CD3+), helper/inducer T lymphocyte (CD3+CD4+) and suppressor/cytotoxic T lymphocyte (CD3+CD8+) subsets in blood" and also mentions its use "To characterize and monitor some forms of immunodeficiency, such as in HIV infected individuals" and "To characterize and monitor some forms of autoimmune diseases," which are all diagnostic applications.
No
The device description clearly outlines a system that includes physical components: a reagent (BDIS TriTEST CD4 FITC/CD8 PE/CD3 PerCP), TRUCOUNT Absolute Count Tubes, and a flow cytometer. The process involves physical steps like adding blood to tubes, staining, lysis, and flow cytometric acquisition. While software is likely involved in the analysis of the flow cytometry data, the device as described is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Purpose: The device is intended to identify and enumerate specific cell populations (T lymphocyte subsets) in a biological sample (blood) to aid in the diagnosis and monitoring of certain medical conditions (immunodeficiency, autoimmune diseases). This is a core function of an IVD.
- Sample Type: It uses a biological sample (blood) that is taken from the human body.
- Testing Location: The testing is performed "in vitro" (outside the body) using laboratory equipment (flow cytometer).
N/A
Intended Use / Indications for Use
For in vitro diagnostic use to identify and enumerate absolute counts of T lymphocyte (CD3+), helper/inducer T lymphocyte (CD3+CD4+) and suppressor/cytotoxic T lymphocyte (CD3+CD8+) subsets in blood.
- For use with any flow cytometer equipped with a 488 nm last and capable of detection in . the ranges: 515-545 nm, 562-607 nm, and >650 nm
- For use with erythrocyte lysed whole blood .
- For in vitro diagnostic use .
- To identify and enumerate absolute counts of CD3+ and CD3+CD4+ and CD3+CD8+ . lymphocytes
- To characterize and monitor some forms of immunodeficiency, such as in HIV infected . individuals
- To characterize and monitor some forms of autoimmune diseases .
Product codes
GKZ, 81
Device Description
The BDIS TriTEST CD4 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD3 peridinin chlorophyll protein (PerCP) reagent is a three-color, direct immunofluorescence reagent. When used with TRUCOUNT Absolute Count Tubes it is used for identifying and enumerating absolute counts of I lymphocytes (CD3+), helper/inducer T lymphocytes (CD3+CD4+) and suppressor/cytotoxic I lymphocytes (CD3+CD8+) in erythrocyte-lysed whole blood (LWB). The Becton Dickinson TnTEST / TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacturer), conjugated monoclonal reagent (Tril EST CD4 FITC/CD8 PE/CD3 PeCP) and TRUCOUNT Absolute Count Tubes.
The process to obtain T lymphocyte subset absolute counts includes: 1) obtaining a whole blood sample, 2) adding a precise volume of whole blood directly to the Absolute Count Tube, 3) cell-surface antigen staining with three-color monoclonal antibody reagents, 4) erythrocyte lysis, and 5) flow cytometric acquisition and analysis of list mode data. Analysis for absolute counts requires that the bead region be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is I x (beads/pellet)/(volume of blood sample).
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
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of the product was established by testing at Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina Hospital, and at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California.
Several studies were performed:
- Accuracy data demonstrated the TriTEST/TRUCOUNT product's equivalence to FACSCount.
- A stability study was conducted to assess the time effect relating to age of blood (time-from-draw) and the time effect relating to the age of the stain (time-from-sample preparation), as well as the combined effect of both. Results indicate that for the calculation of absolute counts, blood specimen should be stained within 24 hours of draw, and analysis of the stained samples should occur within 24 hours or alternatively, the blood specimen can be stained within 48 hours of draw and analyzed within 6 hours.
- Within-specimen reproducibility was performed at BDIS; 10 replicates from 1 high, 1 medium, and 1 low were assessed. Within-specimen reproducibility was also performed at 3 clinical sites; 3 aliquots from each donor were assessed. Results demonstrated acceptable within-sample reproducibility.
- Linearity was determined using blood samples from 3 normal donors diluted to 5 concentrations, ranging from 16,700 to 200 lymphocytes/uL and from 31,000 to 2,500 WBC/uL. Results indicate a linear response over this range.
- Cross reactivity of these clones is reported in the literature. Conjugation and product formulation have not changed their specificity.
- Results from a cross platform reproducibility study for determining absolute counts using TriTEST CD4 FITC/CD8 PE/CD3 PerCP reagent with TRUCOUNT Absolute Count Tubes indicated a small (
§ 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
Attachment F
Summary of Safety and Effectiveness
DEC - I
Submitter Information (21 CFR 807.92(a)(1))
Becton Dickinson Immunocytometry Systems Submitter: 2350 Qume Drive San Jose, CA 95131-1807
Anna Longwell, Esq. Contact: Director, Regulatory Affairs - Corporate (408) 954-2254
Summary date: March 31, 1997
Name of Device and Classification (21 CFR 807.92(a)(2))
- Becton Dickinson Tril EST TM reagent CD4 FITC/CD8 PE/CD3 PecP; Name: TRUCOUNTIM Absolute Count Tubes
Classification: Class II
Predicate Device (21 CFR 807.92(a)(3))
The BDIS TriTEST™ CD4 FITC/CD8 PE/CD3 PerCP reagent with TRUCOUNT Absolute Count Tubes is substantially equivalent to FACSCount (cleared to market under K933486).
Description of the Device (21 CFR 807.92(2)(4))
The BDIS TriTEST CD4 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD3 peridinin chlorophyll protein (PerCP) reagent is a three-color, direct immunofluorescence reagent. When used with TRUCOUNT Absolute Count Tubes it is used for identifying and enumerating absolute counts of I lymphocytes (CD3+), helper/inducer T lymphocytes (CD3+CD4+) and suppressor/cytotoxic I lymphocytes (CD3+CD8+) in erythrocyte-lysed whole blood (LWB). The Becton Dickinson TnTEST / TRUCOUNT system for immunophenotyping consists of a flow cytometer (either from BDIS or from another manufacturer), conjugated monoclonal reagent (Tril EST CD4 FITC/CD8 PE/CD3 PeCP) and TRUCOUNT Absolute Count Tubes.
The process to obtain T lymphocyte subset absolute counts includes: 1) obtaining a whole blood sample, 2) adding a precise volume of whole blood directly to the Absolute Count Tube, 3) cell-surface antigen staining with three-color monoclonal antibody reagents, 4) erythrocyte lysis, and 5) flow cytometric acquisition and analysis of list mode data. Analysis for absolute counts requires that the bead region be identified and the events in this region counted. The proportion of reagent positive events to bead events (P) is computed. The absolute count is I x (beads/pellet)/(volume of blood sample).
1
Summary of Safety and Effectiveness
When monoclonal antibody reagents are added to human whole blood, the fluorochrome-In held antibodies bind specifically to antigens on the surface of leucocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead peller and is treated with fluorochrome-labeled antibodies and the erythrocytes are lysed with FACS® Lysing Solution. The flow cytometer is set up so that cell populations for most samples occupy approximately the same region of fluorescence space. The sample is then introduced into the flow cytometer and the stained cells and beads fluoresce when excited by a laser beam.
The three-color reagent permits identification of T lymphocyte subsets using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD3+ population using a combination of fluorescence and side scatter parameters. By gating on the CD3+ population, a maximum number of T lymphocytes may be captured in the gate.
Intended Use (21 CFR 807.92(a)(5))
For in vitro diagnostic use to identify and enumerate absolute counts of T lymphocyte (CD3+), helper/inducer T lymphocyte (CD3+CD4+) and suppressor/cytotoxic T lymphocyte (CD3+CD8+) subsets in blood.
Indications for Use
- For use with any flow cytometer equipped with a 488 nm last and capable of detection in . the ranges: 515-545 nm, 562-607 nm, and >650 nm
- For use with erythrocyte lysed whole blood .
- For in vitro diagnostic use .
- To identify and enumerate absolute counts of CD3+ and CD3+CD4+ and CD3+CD8+ . lymphocytes
- To characterize and monitor some forms of immunodeficiency, such as in HIV infected . individuals
- To characterize and monitor some forms of autoimmune diseases .
Clinical Utility
The determination of T lymphocyte (CD3+), helper/inducer T lymphocyte (CD3+CD4+) and suppressor/cytotoxic T lymphocyte (CD3+CD8+) has been found useful in monitoring some forms of immunodeficiency and autoimmune disease.
Comparison to Predicate Device (21 CFR 807.92(a)(6))
The TriTEST /TRUCOUNT system (for absolute counts) is substantially equivalent to the FACSCount system for CD3+, CD3+CD4+ and for CD3+CD8+, (cleared to market under K933486). Both the TriTEST reagent with TRUCOUNT tubes and the predicate device yield equivalent results for the same analytes, and both are intended for use as an in vitro diagnostic test using a flow cytometer-based instrument and recommended computer hardware and software. Results demonstrate that the products yield essentially equivalent performance characteristics.
CD4/CD8/CD3/T RUCKINT 510(k) Notification Attachment F: Summary of Safety and Effectiveness
2
ﺔ ﺍﻟﻤ
Performance Data (21 CFR 807.92(b)(2))
Performance of the product was established by testing at Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina Hospital, and at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California.
Several studies were performed:
- Accuracy data demonstrated the TriTEST/TRUCOUNT product's equivalence to ● FACSCount.
- A stability study was conducted to assess the time effect relating to age of blood (time-. from-draw) and the time effect relating to the age of the stain (time-from-sample preparation), as well as the combined effect of both. Results indicate that for the calculation of absolute counts, blood specimen should be stained within 24 hours of draw, and analysis of the stained samples should occur within 24 hours or alternatively, the blood specimen can be stained within 48 hours of draw and analyzed within 6 hours.
- Within-specimen reproducibility was performed at BDIS; 10 replicates from 1 high, 1 . medium, and 1 low were assessed. Within-specimen reproducibility was also performed at 3 clinical sites; 3 aliquots from each donor were assessed. Results demonstrated acceptable within-sample reproducibility.
- . Linearity was determined using blood samples from 3 normal donors diluted to 5 concentrations, ranging from 16,700 to 200 lymphocytes/uL and from 31,000 to 2,500 WBC/uL. Results indicate a linear response over this range.
- Cross reactivity of these clones is reported in the literature. Conjugation and product . formulation have not changed their specificity.
- Results from a cross platform reproducibility study for determining absolute counts using . TriTEST CD4 FITC/CD8 PE/CD3 PerCP reagent with TRUCOUNT Absolute Count Tubes indicated a small (650 nm
- � For use with ervthrocyte lysed whole blood
- � For in vitro diagnostic use
- To identify and enumerate absolute counts of CD3+ and CD3+CD4 and � CD3+CD8+ lymphocytes
- � To characterize and monitor some forms of immunodeficiency, such as in HIV infected individuals
- ◆ To characterize and monitor some forms of autoimmune diseases
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maher
Oivision Sign-Off) Division of Clinical Laboratory Devices Laboratory Devices Laboratury Devices Laboratory Devices Laboratory Devices Laboratory Devices Laboratory December 510(k) Number
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)