(90 days)
No
The device is a reagent for flow cytometry and the summary describes its performance characteristics in detecting and quantifying specific cell types, without mentioning any computational analysis or algorithms beyond basic correlation and linearity calculations.
No
This device is for In Vitro Diagnostic Use to analyze T-cells in peripheral blood, not for treating any condition.
Yes
This device is for "In Vitro Diagnostic Use" and is used to detect and quantify T-cells in order to diagnose "immunodeficiency disorders."
No
The device description clearly states it is a purified mouse anti-human antibody conjugated with fluorochromes, which is a biological reagent, 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 CD3+ and CD8+ T-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 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 blood samples.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Mouse Anti-Human T-cell, CD8/RPE, DK25 (DAKO Anti-CD3/FITC and Anti-CD8/RPE) has been developed for use in flow cytometry for the analysis of CD3+ and CD8+ T-cells. This reagent allows simultaneous detection and quantification of CD3+CD8+ cells (CD8 positive T-lymphocytes) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combination for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.
Product codes
GKZ
Device Description
Purified mouse anti-human CD3, Clone UCHT1, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD8, Clone DK25, 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
Performance characteristics have been established by clinical evaluation of compared to the individual single reagent predicate devices that quantitatively measure CD3+ and CD8+ T-cells that have been previously cleared by FDA (DAKO CD3/FITC, Code No. F0818 and DAKO CD8/RPE, Code No. R0806). When flow cytometric tests of peripheral blood samples obtained from apparently healthy adults were completed, correlation of Anti-CD3, UCHT1 with DAKO Anti-CD3/FITC and Anti-CD8/RPE approached a direct 1 : 1 comparison for measurement of CD3+ cells. Correlation of Anti-CD8, DK25 with DAKO Anti-CD3/FITC and Anti-CD8/RPE approached a direct 1 : 1 comparison for measurement of CD8 + cells. Data for the measurement of CD3 + T-cells by DAKO Anti-CD3/FITC and Anti-CD8/RPE reagent compared to DAKO CD3/FITC gave a correlation greater than 0.99 using the whole blood method for flow cytometry. Data for the measurement of CD8+ T-cells by DAKO Anti-CD3/FITC and Anti-CD8/RPE reagent compared to DAKO CD8/RPE gave a correlation greater than 0.98 usinq the whole blood method for flow cytometry.
The CD3 antibody clone. UCHT1, was clustered at the First Leukocyte Typing Workshop. Paris, France, 1982. The CD8 antibody clone, DK25, was clustered at the Third Leukocyte Typing Workshop, Oxford, England, 1986, under another clone designation.
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 CD8/RPE using JM cells gave the following linear equation:
y = 0.06 + 1.01x; 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, plus Anti-CD8/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 Third Leukocyte Typing Workshops indicate that the DAKO Anti-CD3/FITC plus Anti-CD8/RPE reagent performs as well as DAKO CD3/FITC in the detection and enumeration of CD3* lymphocytes while the DAKO Anti-CD3/FITC plus Anti-CD8/RPE reagent performs as well as DAKO CD8/RPE in the detection and enumeration of CD8 ' lymphocytes using flow cytometry. Safety of the DAKO Anti-CD3/FITC plus Anti-CD8/RPE reagent and its individual predicate devices is high as all reagents are used for in vitro testing.
Key Metrics
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Predicate Device(s)
DAKO Monoclonal Mouse Anti-Human T-cell, CD3/FITC, UCHT1 (DAKO Code Number F0818, FDA K942797), DAKO Monoclonal Mouse Anti-Human suppressor/cytotoxic T-cell, CD8/RPE, Clone DK25 (DAKO Code Number R0806, FDA K944253)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 28 8 1996
| 510(k )Summary K955909 | |
|---|---|
| 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: | November 27, 1995 |
| Device Name: | Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + |
| Mouse Anti-Human T-cell, CD8/RPE, DK25 | |
| 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, CD3/FITC, UCHT1 (DAKO Code |
| Number F0818, FDA K942797) and | |
| DAKO Monoclonal Mouse Anti-Human suppressor/cytotoxic T-cell, CD8/RPE, | |
| Clone DK25 (DAKO Code Number R0806, FDA K944253) | |
| Device Description: | Purified mouse anti-human CD3, Clone UCHT1, conjugated with fluorescein |
| isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD8, Clone DK25, | |
| 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 T-cell, | |
| CD8/RPE, DK25 (DAKO Anti-CD3/FITC and Anti-CD8/RPE) has been developed | |
| for use in flow cytometry for the analysis of CD3+ and CD8+ T-cells. | |
| This | |
| reagent allows simultaneous detection and quantification of CD3+CD8+ cells | |
| (CD8 positive T-lymphocytes) in normal and pathological conditions such as | |
| immunodeficiency disorders. It is one component of the suggested monoclonal | |
| antibody (MAb) combination 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+ and CD8+ T-cells that have been previously cleared by FDA | |
| (DAKO CD3/FITC, Code No. F0818 and DAKO CD8/RPE, Code No. R0806). | |
| When flow cytometric tests of peripheral blood samples obtained from | |
| apparently healthy adults were completed, correlation of Anti-CD3, UCHT1 with |
Nov. 27, 1995
1
DAKO Anti-CD3/FITC and Anti-CD8/RPE approached a direct 1 : 1 comparison for measurement of CD3+ cells. Correlation of Anti-CD8, DK25 with DAKO Anti-CD3/FITC and Anti-CD8/RPE approached a direct 1 : 1 comparison for measurement of CD8 + cells. Data for the measurement of CD3 + T-cells by DAKO Anti-CD3/FITC and Anti-CD8/RPE reagent compared to DAKO CD3/FITC gave a correlation greater than 0.99 using the whole blood method for flow Data for the measurement of CD8+ T-cells by DAKO Anticytometry. CD3/FITC and Anti-CD8/RPE reagent compared to DAKO CD8/RPE gave a correlation greater than 0.98 usinq the whole blood method for flow cytometry.
The CD3 antibody clone. UCHT1, was clustered at the First Leukocyte Typing Workshop. Paris, France, 1982. The CD8 antibody clone, DK25, was clustered at the Third Leukocyte Typing Workshop, Oxford, England, 1986, under another clone designation.
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 CD8/RPE using JM cells gave the following linear equation:
y = 0.06 + 1.01x; 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, plus Anti-CD8/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 Third Leukocyte Typing Workshops indicate that the DAKO Anti-CD3/FITC plus Anti-CD8/RPE reagent performs as well as DAKO CD3/FITC in the detection and enumeration of CD3* lymphocytes while the DAKO Anti-CD3/FITC plus Anti-CD8/RPE reagent performs as well as DAKO CD8/RPE in the detection and enumeration of CD8 ' lymphocytes using flow cytometry. Safety of the DAKO Anti-CD3/FITC plus Anti-CD8/RPE reagent and its individual predicate devices is high as all reagents are used for in vitro testing.
Conclusions: