(60 days)
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No
The device description and performance studies focus on antibody reagents and flow cytometry analysis, with no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is for "In Vitro Diagnostic Use" to analyze cells for diagnostic purposes, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use" and describes its purpose for analysis of T- and B-cells in normal and pathological conditions such as immunodeficiency disorders, which points to a diagnostic function.
No
The device description clearly states it is a reagent (purified mouse anti-human CD2 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 CD2+ T-cells and CD19+ B-cells in peripheral blood using flow cytometry. This analysis is performed on biological samples (blood) outside of the body, which is the definition of an in vitro diagnostic.
- Clinical Application: The intended use mentions analysis in "normal and pathological conditions such as immunodeficiency disorders," indicating a clinical diagnostic purpose.
- Device Description: The description details a reagent (antibodies conjugated with fluorochromes) used to stain cells in a biological sample for analysis. This is typical of IVD reagents.
- Performance Studies: The document describes performance studies comparing the device to predicate devices that are also IVDs (as indicated by their K numbers and names). These studies evaluate the device's ability to accurately measure specific cell populations in clinical samples.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
Mouse Anti-Human T-cell, CD2/FITC, MT910 + Mouse Anti-Human B-cell, CD19/RPE, HD37 (DAKO Anti-CD2/FITC and Anti-CD19/RPE) has been developed for use in flow cytometry for the analysis of CD2+ T-cells and CD19+ B-cells. This reagent allows simultaneous detection and quantification of T- and B-cells in 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 CD2, Clone MT910, 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 CD2+ T-cells and CD19+ B-cells that have been previously cleared by FDA (DAKO CD2/FITC, Code No. F0767 and DAKO CD19/RPE, Code No. R0808). When flow cytometric tests of peripheral blood samples obtained from apparently healthy adults were completed, correlation of Anti-CD2, MT910 with DAKO Anti-CD2/FITC and Anti-CD19/RPE approached a direct 1 : 1 comparison for measurement of CD2+ cells. Correlation of Anti-CD19, HD37 with DAKO Anti-CD2/FITC and Anti-CD19/RPE approached a direct 1 : 1 comparison for measurement of CD19+ cells. Data for the measurement of CD2+ T-cells by DAKO Anti-CD2/FITC and Anti-CD19/RPE reagent compared to DAKO CD2/FITC gave a correlation greater than 0.99 using the whole blood method for flow cytometry on peripheral blood samples from normal and ill patients. Data for the measurement of CD19 + T-cells by DAKO Anti-CD2/FITC and Anti-CD19/RPE reagent compared to DAKO CD19/RPE gave a correlation greater than 0.99 using the whole blood method for flow cytometry on peripheral blood samples from normal and ill patients.
The CD2 antibody clone, MT910, was clustered at the Second Leukocyte Typing Workshop, Boston, 1984. The CD19 antibody clone, HD37, was clustered at the Second Leukocyte Typing Workshop, Boston, 1984.
Linearity testing of DAKO CD2/FITC using JM cells gave the following linear equation: v =- 0.02 + 0.997x; r = 0.9965
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-CD2/FITC, plus 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 Second Leukocyte Typing Workshop indicate that the DAKO Anti-CD2/FITC plus Anti-CD19/RPE reagent performs as well as DAKO CD2/FITC in the detection and enumeration of CD2 Tymphocytes while the DAKO Anti-CD2/FITC plus Anti-CD19/RPE reagent performs as well as DAKO CD19/RPE in the detection and enumeration of CD19* lymphocytes using flow cytometry. Safety of the DAKO Anti-CD2/FITC plus Anti-CD19/RPE reagent and its individual predicate devices is high as all reagents are used for in vitro testing.
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.
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
K961435 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 27, 1995 |
| Device Name: | Mouse Anti-Human T-cell, CD2/FITC, MT910 + |
| 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): | DAKO Monoclonal Mouse Anti-Human T-cell, CD2/FITC, MT910 (DAKO Code |
| Number F0767, FDA K945692) and | |
| DAKO Monoclonal Mouse Anti-Human B-cell, CD19/RPE, | |
| Clone HD37 (DAKO Code Number R0808, FDA K943284) | |
| Device Description: | Purified mouse anti-human CD2, Clone MT910, 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, CD2/FITC, MT910 + Mouse Anti-Human B-cell, | |
| CD19/RPE, HD37 (DAKO Anti-CD2/FITC and Anti-CD19/RPE) has been | |
| developed for use in flow cytometry for the analysis of CD2+ T-cells | |
| and | |
| CD19+ B-cells. This reagent allows simultaneous detection and quantification of | |
| T- and B-cells in 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 CD2+ T-cells and CD19+ B-cells that have been previously cleared by | |
| FDA (DAKO CD2/FITC, Code No. F0767 and DAKO CD19/RPE, Code No. | |
| R0808). When flow cytometric tests of peripheral blood samples obtained from | |
| apparently healthy adults were completed, correlation of Anti-CD2, MT910 with |
1
.
1
DAKO Anti-CD2/FITC and Anti-CD19/RPE approached a direct 1 : 1 comparison for measurement of CD2+ cells. Correlation of Anti-CD19, HD37 with DAKO Anti-CD2/FITC and Anti-CD19/RPE approached a direct 1 : 1 comparison for measurement of CD19+ cells. Data for the measurement of CD2+ T-cells by DAKO Anti-CD2/FITC and Anti-CD19/RPE reagent compared to DAKO CD2/FITC gave a correlation greater than 0.99 using the whole blood method for flow cytometry on peripheral blood samples from normal and ill patients. Data for the measurement of CD19 + T-cells by DAKO Anti-CD2/FITC and Anti-CD19/RPE reagent compared to DAKO CD19/RPE gave a correlation greater than 0.99 using the whole blood method for flow cytometry on peripheral blood samples from normal and ill patients.
The CD2 antibody clone, MT910, was clustered at the Second Leukocyte Typing Workshop, Boston, 1984. The CD19 antibody clone, HD37, was clustered at the Second Leukocyte Typing Workshop, Boston, 1984.
Linearity testing of DAKO CD2/FITC using JM cells gave the following linear equation:
v =- 0.02 + 0.997x; r = 0.9965
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-CD2/FITC, plus 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 Second Leukocyte Typing Workshop indicate that the DAKO Anti-CD2/FITC plus Anti-CD19/RPE reagent performs as well as DAKO CD2/FITC in the detection and enumeration of CD2 Tymphocytes while the DAKO Anti-CD2/FITC plus Anti-CD19/RPE reagent performs as well as DAKO CD19/RPE in the detection and enumeration of CD19* lymphocytes using flow cytometry. Safety of the DAKO Anti-CD2/FITC plus Anti-CD19/RPE reagent and its individual predicate devices is high as all reagents are used for in vitro testing.