(128 days)
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No
The summary describes a flow cytometry reagent for identifying T-cells and B-cells based on antibody binding and fluorescence, with performance evaluated by correlation and linearity studies. There is no mention of AI or ML algorithms for data analysis or interpretation.
No.
Explanation: The device is described as "For In Vitro Diagnostic Use" and is used for "analysis of T-cells and B-cells" in peripheral blood, which indicates it is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use". Additionally, the device is used for "simultaneous detection and quantification of total T-cells and B-cells in peripheral blood of normal and pathological conditions such as immunodeficiency disorders," which are diagnostic purposes.
No
The device description clearly states it is a reagent (purified mouse anti-human CD3 and CD19 conjugated with fluorochromes) used in flow cytometry, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use".
- Purpose: The device is intended for the analysis of T-cells and B-cells in peripheral blood using flow cytometry. This analysis is performed in vitro (outside the body) on a biological sample (blood).
- Clinical Relevance: The intended use mentions analysis in "normal and pathological conditions such as immunodeficiency disorders," indicating its use in diagnosing or monitoring health conditions.
- Device Description: The description details a reagent (antibodies conjugated with fluorochromes) used to stain cells in a blood sample for analysis. This is a typical component of an IVD test.
- Performance Studies: The document describes performance studies comparing the device to a predicate device for measuring CD3+ T-cells and CD19+ B-cells in peripheral blood samples, further supporting its use as a diagnostic tool.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Mouse Anti-Human B-cell, CD19/RPE, HD37 (DAKO Anti-CD3/FITC and Anti-CD19/RPE) has been developed for use in flow cytometry for the analysis of T-cells and B-cells. This reagent allows simultaneous detection and quantification of total T-cells and B-cells in peripheral blood of normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
Purified mouse anti-human CD3, Clone UCHT1, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD19, Clone HD37, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15 mM NaN3, 0.1M NaCl, stabilized with 1% carrier protein
Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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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 characteristics have been established by clinical evaluation of compared to the individual single reagent predicate devices that quantitatively measure CD3+ T-cells and CD19+ B-cells that have been previously cleared by FDA (Becton Dickinson's Simultest CD3/CD19). When flow cytometric tests of peripheral blood samples obtained from apparently healthy adults were completed, correlation of Simultest CD3/CD19 with DAKO Anti-CD3/FITC and Anti-CD19/RPE approached a direct 1 : 1 comparison for measurement of CD3+ cells. Correlation of Simultest CD3/CD19 with DAKO Anti-CD3/FITC and Anti-CD19/RPE approached a direct 1 : 1 comparison for measurement of CD19+ cells. Data for the measurement of CD3+ T-cells by DAKO Anti-CD3/FITC and Anti-CD19/RPE reagent compared to Simultest CD3/CD19 on peripheral blood samples obtained from apparently healthy adults as well as ill patients gave a correlation greater than 0.98 using the whole blood method for flow cytometry. Data for the measurement of CD19+ T-cells by DAKO Anti-CD3/FITC and Anti-CD19/RPE reagent compared to Simultest CD3/CD19 gave a correlation greater than 0.99 using the whole blood method for flow cytometry.
The CD3 antibody clone, UCHT1, was clustered at the First Leukocyte Typing Workshop, Paris, France, 1982. The CD19 antibody clone, HD37, was clustered at the Second Leukocyte Typing Workshop, Boston, 1984.
Linearity testing of DAKO CD3/FITC using JM cells gave the following linear equation: y = 0.02 + 0.98x; r = 0.999. Linearity testing of DAKO CD19/RPE using Raji cells gave the following linear equation: y = - 0.49% + 0.99x; r = 0.999.
In addition, reproducibility of DAKO reagents using replicates (from peripheral blood) run on two different flow cytometers was measured at three concentrations of each antigen. Cross-reactivity of Anti-CD3/FITC and Anti-CD19/RPE with peripheral blood cells (red blood cells, monocytes, granulocytes, lymphocytes, and platelets) was measured.
Results of the above testing as well as the information provided by the First and Second Leukocyte Typing Workshops indicate that the DAKO Anti-CD3/FITC and Anti-CD19/RPE reagent performs as well as Simultest CD3/CD19 in the detection and enumeration of CD3 * lymphocytes and the DAKO Anti-CD3/FITC and Anti-CD19/RPE reagent performs as well as Simultest CD3/CD19 in the detection and enumeration of CD19 lymphocytes using flow cytometry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Becton Dickinson Simultest CD3/CD19
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.
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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).
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§ 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
JUN 14 1996
510(k )Summary
| Submitter: | DAKO Corporation
6392 Via Real
Carpinteria, CA 93013
(805)566-6655 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Gretchen M. Murray, Ph.D., Regulatory Affairs Asst. Manager |
| Date Summary
Prepared: | December 8, 1995 |
| Device Name: | Mouse Anti-Human T-cell, CD3/FITC, UCHT1 +
Mouse Anti-Human B-cell, CD19/RPE, HD37 |
| Device
Classification: | Class II according to 21 CFR 864.5220, on the basis that monoclonal antibodies
are accessories for automated differential cell counters. |
| Panel: | This device classification is under the Hematology and Pathology devices panel,
Division of Clinical Laboratory Devices. |
| Product Code: | GKZ |
| Predicate Device(s): | Becton Dickinson Simultest CD3/CD19 |
| Device Description: | Purified mouse anti-human CD3, Clone UCHT1, conjugated with fluorescein
isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD19, Clone
HD37, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH
7.2, 15 mM NaN3, 0.1M NaCl, stabilized with 1% carrier protein
Subpopulations of lymphocytes may be stained with fluorochrome-conjugated
antibody and evaluated in peripheral blood specimens when contaminating red
blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation
of WBC's are selected for assessment based upon cell morphology. |
| Intended Use: | For In Vitro Diagnostic Use
Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Mouse Anti-Human B-cell,
CD19/RPE, HD37 (DAKO Anti-CD3/FITC and Anti-CD19/RPE) has been
developed for use in flow cytometry for the analysis of T-cells and B-cells. This
reagent allows simultaneous detection and quantification of total T-cells and B-
cells in peripheral blood of normal and pathological conditions such as
immunodeficiency disorders. It is one component of the suggested monoclonal
antibody (MAb) combinations for routine immunophenotyping of lymphocytes in
peripheral blood using flow cytometry. |
| Comparison of
Technological
Characteristics | Performance characteristics have been established by clinical evaluation of
compared to the individual single reagent predicate devices that quantitatively
measure CD3+ T-cells and CD19+ B-cells that have been previously cleared by
FDA (Becton Dickinson's Simultest CD3/CD19). When flow cytometric tests of
peripheral blood samples obtained from apparently healthy adults were
completed, correlation of Simultest CD3/CD19 with DAKO Anti-CD3/FITC and
Anti-CD19/RPE approached a direct 1 : 1 comparison for measurement of CD3+
cells. Correlation of Simultest CD3/CD19 with DAKO Anti-CD3/FITC and Anti-
CD19/RPE approached a direct 1 : 1 comparison for measurement of CD19+ |
1
,
. .
1
cells. Data for the measurement of CD3+ T-cells by DAKO Anti-CD3/FITC and Anti-CD19/RPE reagent compared to Simultest CD3/CD19 on peripheral blood samples obtained from apparently healthy adults as well as ill patients gave a correlation greater than 0.98 using the whole blood method for flow cytometry. Data for the measurement of CD19+ T-cells by DAKO Anti-CD3/FITC and Anti-CD19/RPE reagent compared to Simultest CD3/CD19 gave a correlation greater than 0.99 using the whole blood method for flow cytometry.
The CD3 antibody clone, UCHT1, was clustered at the First Leukocyte Typing Workshop, Paris, France, 1982. The CD19 antibody clone, HD37, was clustered at the Second Leukocyte Typing Workshop, Boston, 1984.
Linearity testing of DAKO CD3/FITC using JM cells gave the following linear equation:
y = 0.02 + 0.98x; r = 0.999
Linearity testing of DAKO CD19/RPE using Raji cells gave the following linear equation:
y = - 0.49% + 0.99x; r = 0.999
In addition, reproducibility of DAKO reagents using replicates (from peripheral blood) run on two different flow cytometers was measured at three concentrations of each antigen. Cross-reactivity of Anti-CD3/FITC and Anti-CD19/RPE with peripheral blood cells (red blood cells, monocytes, granulocytes, lymphocytes, and platelets) was measured.
Conclusions:
Results of the above testing as well as the information provided by the First and Second Leukocyte Typing Workshops indicate that the DAKO Anti-CD3/FITC and Anti-CD19/RPE reagent performs as well as Simultest CD3/CD19 in the detection and enumeration of CD3 * lymphocytes and the DAKO Anti-CD3/FITC and Anti-CD19/RPE reagent performs as well as Simultest CD3/CD19 in the detection and enumeration of CD19 lymphocytes using flow cytometry. Safety of the DAKO Anti-CD3/FITC olus Anti-CD19/RPE reagent and its predicate device is high as are all reagents used for in vitro testing.