(297 days)
Not Found
No
The description focuses on traditional flow cytometry methods, antibody binding, and manual gating/analysis of fluorescence data. There is no mention of automated feature extraction, pattern recognition, or learning algorithms typically associated with AI/ML in this context.
No
This device is an in vitro diagnostic (IVD) tool used for identifying and enumerating specific lymphocyte populations in blood, which aids in characterizing and monitoring certain diseases. It is not used for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." The device functions to identify and enumerate specific cell types in blood to characterize and monitor diseases, which is a diagnostic purpose.
No
The device description clearly outlines hardware components (reagent, tubes, flow cytometer) and a physical process involving blood samples, staining, and flow cytometry. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Device Description: The device is a reagent used to identify and enumerate cell populations in blood samples, which is a common in vitro diagnostic procedure.
- Performance Studies: The performance studies described (accuracy, reproducibility, linearity, cross-platform reproducibility) are typical evaluations for an IVD device.
- Predicate Devices: The mention of predicate devices (K913192 and K933486) further indicates that this device is being compared to existing IVD products.
- Anatomical Site: The device is used with blood, which is a biological sample analyzed in vitro.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD8+ lymphocytes in blood.
Indications for Use
- For use with any flow cytometer equipped with a 488 mm laser and capable of decection . in the ranges: 515-545 nm, 562-607 nm, and > 650 nm
- . For use with erythrocyte lysed whole blood
- For use with or without an isotype control .
- To characterize and monitor forms of autoimmune diseases, such as lupus
- . To characterize and monitor congenital or acquired immunodeficiencies, such as SCID or AIDS
Product codes
GKZ
Device Description
The BDIS Trilles T CD3 flucescein isothiocyanate (FITC)/CD8 phycocrythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunoflucescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Tsuppressor/cytotoxic (CD3+CD8+) cells in eythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/JL. The Becon Dickinson Trill BT/TRUCOUNT system for immunophenoryping consists of a flow cycometer (either from BDIS or from another manufacture), conjugated monoclonal reagent (TriTEST CD3 FITC/CD8 PE/CD45 PerCP) and TRICOUNT Absolute Count Tubes,
The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow crometric acquisition and analysis of list mode data. Analysis involves computing the ratio of reagent-positive events to the CD45 positive events, and expressing the ratio as a percentage.
To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, 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).
When monoclonal antibody reagents are added to human whole blood, the flucrochrome-labeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluctochrome-labeled antibodies and the crythrocytes 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 excired by a laser beam.
The three-color reagent permits identification of lymphocyte subsers using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45-positive population using a combination of fluorescence and side scatter parameters. By gaing on the CD45-positive population, a maximum number of lymphocyces may be caprured in the gate and non-lymphocyte contamination may be minimized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Flow cytometry
Anatomical Site
Not Found
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 of the product was established by resting as Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina, and at Becton Dickinson Immunocytomerry Systems laboratories in San Jose, California.
Several studies were performed:
- Accuracy was determined by comparison to both IMK-Lymphocyte Tube E and the FACSCount . system. Accuracy data demonstrated the TriTEST and TriTEST/TRCOUNT product's equivalence to IMK-Lymphocyte Tube E and FACSCount, respectively.
- Use of isony control was studied. Data were analyzed for percent CD3+ and pecent . CD3+CD8+ first using a control to set gates and markers and then using only the stained sample to set gates and quadrant markers. Data indicated that the reagent may be used with or without an isotype control.
- . Reference range studies were performed. Many variables, such as sex, age and geographical location may influence the reference range. Each site must determine its own reference range.
- A stability study was conducted to assess the time effect relating to age of blood (time-from-daw) . and the time effect relating to the age of the stain (time-from-sample preparation), as well :s the combined effect of both. Stability was determined for both percentages and absolute counts. Stability was determined for whole blood samples at 6, 24, 48 and 72 hours post draw. Additionally, stability was measured for stained samples at 6 and 24 hours from time of staining. A combination of the two, time from draw plus time from sample preparation, was studied. Results indicated that either 1) staining the samples within 24 hours of craw and analyzing samples within 24 hours of staining or altenatively, 2) staining the samples with 48 hours of draw and analyzing them within 6 hours is recommended.
- Within-soecimen reproducibility was performed at BDIS and at three clinical sites for both . percentage enumeration and absolute counts Results demonstrated acceptable within-sample reproducibility.
- Linearity was determined using blood samples from three normal donors diluted to five t concentrations, ranging from 16,700 to 200 lymphocytes/JLL and from 31,000 to 2,500 WBC/UL. Results indicate the product gives linear results over this range.
- Cross reactivity of these clones is reported in the literature. Conjugation and product famulation . have not changed their specificity.
- Results from a cross platform reproducibility study indicated 1) for absolute count results there . was 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
4.005
Attachment B
Summary of Safery and Effectiveness
NOV 21 1997
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: November 19, 1997
Name of Device and Classification (21 CFR 807.92(a)(2))
Becton Dickinson TriTESTM reagent CD3 FITC/CD8 PE/CD45 PerCl'; Name: TRUCOUNTIM Absolute Count Tubes
Class II Classification:
Predicate Device (21 CFR 807.92(2)(3))
The BDIS TrillEST™ CD3 FITC/CD8 PE/CD45 PerCPreagent, when used to enumerate percentages of lymphootes is substantially equivalent to IMK-Lymphocyte Tube E that was cleared to market under 510(k) K913192. When the TriTEST reagent is used with TRUCOUNT Absolute Count Tubes, it is substantially equivalent to the BDIS FACSCount system cleared under 510(k) K933486.
Description of the Device (21 CFR 807.92(2)(4))
The BDIS Trilles T CD3 flucescein isothiocyanate (FITC)/CD8 phycocrythrin (PE)/CD45 peridinin chlorophyll protein (PeCP) reagent is a three-color, direct immunoflucescence reagent for identifying and enumerating percentages of T lymphocytes (CD3+) and Tsuppressor/cytotoxic (CD3+CD8+) cells in eythrocyte-lysed whole blood (LWB). When used with TRUCOUNT Absolute Count Tubes, the product will yield absolute counts in cells/JL. The Becon Dickinson Trill BT/TRUCOUNT system for immunophenoryping consists of a flow cycometer (either from BDIS or from another manufacture), conjugated monoclonal reagent (TriTEST CD3 FITC/CD8 PE/CD45 PerCP) and TRICOUNT Absolute Count Tubes,
The process to obtain lymphocyte subset percentages includes: 1) obtaining a whole blood sample, 2) cell-surface antigen staining with three-color monoclonal antibody reagents, 3) erythrocyte lysis, and 4) flow crometric acquisition and analysis of list mode data. Analysis involves computing the
CD3/CD8/CD45 510(k) Notification Attachment B: Summary of Safety and Effectiveness
1
Summary of Safety and Effectiveness
ratio of reagent-positive events to the CD45 positive events, and expressing the ratio as a percentage.
To obtain absolute counts, the TriTEST reagent and whole blood are added directly to an Absolute Count Tube prior to lysis. The remaining process, until analysis, is identical to that for percentages. Analysis for absolute counts requires that an additional region, 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).
When monoclonal antibody reagents are added to human whole blood, the flucrochrome-labeled antibodies bind specifically to antigens on the surface of leukocytes, thus identifying lymphocyte populations. The patient blood sample is added to the counting bead pellet and is treated with fluctochrome-labeled antibodies and the crythrocytes 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 excired by a laser beam.
The three-color reagent permits identification of lymphocyte subsers using fluorescence gating instead of forward scatter gating. This three-color reagent allows direct gating on the CD45positive population using a combination of fluorescence and side scatter parameters. By gaing on the CD45-positive population, a maximum number of lymphocyces may be caprured in the gate and non-lymphocyte contamination may be minimized.
Intended Use (21 CFR 807.92(a)(5))
For in vitro diagnostic use to identify and enumerate percentages and absolute counts of CD3+ and CD3+CD8+ lymphocytes in blood.
Indications for Use
- For use with any flow cytometer equipped with a 488 mm laser and capable of decection . in the ranges: 515-545 nm, 562-607 nm, and > 650 nm
- . For use with erythrocyte lysed whole blood
- For use with or without an isotype control .
- To characterize and monitor forms of autoimmune diseases, such as lupus
- . To characterize and monitor congenital or acquired immunodeficiencies, such as SCID or AIDS
CD3/CD8/CD45/TRUCOUNT 510(k) Nasification Assachment B: Summary of Safety and Effectiveness
2
Summary of Safety and Effectiveness
Clinical Utility
The determination of CD3+ and CD3+CD8+ lymphocytes has been found useful in monitoring some forms of immunodeficiency and autoimmune disease.
Comparison to Predicate Device (21 CFR 807.92(a)(6))
The CD3 FITC/CD8 PE/CD45 PerCP TriTEST reagent, when used to enumerate percentages of lymphocytes, is substantially equivalent to the IMK-Lymphocyte Tube E that was cleared to market under 510(k) K913192. When used with TRUCOUNT Absolute Count Tubes to enumerate absolute counts, it is substantially equivalent to the FACSCount System (K933486) for CD3+and CD3+CD8+. Both the TriTEST product and the predicate devices 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. The products differ in the steps used to determine analysis gates to identify the lymphocyte popul:tion.
Performance Data (21 CFR 807.92(b)(2))
Performance of the product was established by resting as Cleveland Clinic, Johns Hopkins Hospital, Institute of Tropical Medicine, University of North Carolina, and at Becton Dickinson Immunocytomerry Systems laboratories in San Jose, California.
Several studies were performed:
- Accuracy was determined by comparison to both IMK-Lymphocyte Tube E and the FACSCount . system. Accuracy data demonstrated the TriTEST and TriTEST/TRCOUNT product's equivalence to IMK-Lymphocyte Tube E and FACSCount, respectively.
- Use of isony control was studied. Data were analyzed for percent CD3+ and pecent . CD3+CD8+ first using a control to set gates and markers and then using only the stained sample to set gates and quadrant markers. Data indicated that the reagent may be used with or without an isotype control.
- . Reference range studies were performed. Many variables, such as sex, age and geographical location may influence the reference range. Each site must determine its own reference range.
- A stability study was conducted to assess the time effect relating to age of blood (time-from-daw) . and the time effect relating to the age of the stain (time-from-sample preparation), as well :s the
3
Summary of Safety and Effectiveness
combined effect of both. Stability was determined for both percentages and absolute counts. Stability was determined for whole blood samples at 6, 24, 48 and 72 hours post draw. Additionally, stability was measured for stained samples at 6 and 24 hours from time of staining. A combination of the two, time from draw plus time from sample preparation, was studied. Results indicated that either 1) staining the samples within 24 hours of craw and analyzing samples within 24 hours of staining or altenatively, 2) staining the samples with 48 hours of draw and analyzing them within 6 hours is recommended.
- Within-soecimen reproducibility was performed at BDIS and at three clinical sites for both . percentage enumeration and absolute counts Results demonstrated acceptable within-sample reproducibility.
- Linearity was determined using blood samples from three normal donors diluted to five t concentrations, ranging from 16,700 to 200 lymphocytes/JLL and from 31,000 to 2,500 WBC/UL. Results indicate the product gives linear results over this range.
- Cross reactivity of these clones is reported in the literature. Conjugation and product famulation . have not changed their specificity.
- Results from a cross platform reproducibility study indicated 1) for absolute count results there . was a small ( 650 nm
- For use with crythrocyte lysed whole blood .
- For use with or without an isotype control .
- To characterize and monitor forms of autoimmune diseases, such as lupus .
- To characterize and monitor congenital or acquired immunodeficiencies, such as SCID or . AIDS
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maher
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)