(194 days)
Becton Dickinson Simultest LeucoGATE
Not Found
No
The device is a reagent used in flow cytometry for immunophenotyping. While the description mentions "software algorithms" for optimizing gating, there is no indication that these algorithms utilize AI or ML. The focus is on the chemical reagents and their performance characteristics.
No
The device is described as a flow cytometry reagent used for identifying and counting specific cell populations (immunophenotyping) in peripheral blood, not for treating any medical condition.
No
This device is a reagent used in flow cytometry to optimize the gating of lymphocytes, a quality control function for the instrument itself. It helps define cell populations for analysis but does not directly diagnose a condition or disease.
No
The device description clearly states it is a purified mouse anti-human antibody conjugated with fluorochromes, which is a biological reagent, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagents are "for use in flow cytometry" to "optimize the gating of lymphocytes when analyzing peripheral whole blood or peripheral blood mononuclear cell preparations." This involves analyzing biological samples (blood) outside of the body to obtain information about the patient's health status (specifically, the composition of their blood cells).
- Device Description: The device is a reagent (purified antibodies conjugated with fluorochromes) designed to stain specific cell populations in blood samples for analysis.
- Performance Studies: The document describes performance studies including reproducibility, specificity, and correlation with a predicate device. These are typical studies conducted for IVD devices to demonstrate their analytical performance.
- Clinical Laboratory Setting: The intended user is a "Clinical Laboratory," which is where IVD testing is performed.
- Predicate Device: A predicate device (Becton Dickinson Simultest LeucoGATE) is mentioned, which is a common practice for demonstrating substantial equivalence for IVD devices seeking regulatory clearance.
All these factors strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
Monoclonal Mouse Anti-Human Leukocyte Common Antigen, CD45, FITC-Conjugated, Clone T29/33 Monocrollar Wouse First House Anti-Human Mouse Anti-Human Monocyte. CD14, RPE-Conjugated, Clone TUK4 (Anti-CD) 1/RPE, TÜK4) have been developed for use in flow cytometry. This reagent may be used to optimize the gating of lymphocytes when analyzing peripheral whole blood or peripheral blood mononuclear cell preparations. This reagent is one component of the suggested monoclonal antibody (MAb) combination for routine immunophenoryping of lymphocytes in peripheral blood.
Lymphocyte gating is assigned by selection of the upper and lower channel numbers to define the Ivmphocye population and is a quality control function for flow cytometry. Gating verification is lymplocere population and 16 9911% of the cells as CD45 meth CD14 as 2% or less of the cell population.
Note that this definition of "lymphocyte" does not give complete and unambiguous resolution from all other cell types. When optimizing light scatter gates for lymphocytes, operator and/or software algorithms are minimizing the number of lymphocytes excluded while still maintaining acceptable levels of contaminating cell types. Lymphocyte gate purity may be calculated by determining the percentage of non-lymphocyte events within the gate. Most non-lymphocytes are CD14 positive. Because each flow cytometer has different operating characteristics, each laboratory must determine its optimal operating procedure.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
Purified mouse anti-human CD45, Clone T29/33, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD14, Clone TUK4, 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral blood
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)
Binding linearity was determined over serial dilutions of a cell line known to express the antigen diluted with a cell line that has no antigenic sites for each antibody. For Anti-CD45/FITC, the cell line with known antigenic reactivity is Raji cells, while the cell line without antigenic sites is U937 cells. For Anti-CD14/RPE, no cell line could be reliably grown for linearity testing. Linearity results are not available for this antibody. For Anti-CD45/FITC, five dilutions were rested, with linear equations calculated from the results. The equation for Anti-CD45/FITC, T29/33 was y = 0.11% + 0.997x. r = 0.999.
Reproducibility:
Ten replicates from peripheral blood of one donor were run on two flow cytometers from different manufacturers.
Anti-CD45/FITC:
FACScan: Mean % CD45+ 99.8 ± 0.1 SD, %CV 0.1, n=10; Mean % CD45+ 99.7 ± 0.84 SD, %CV 0.85, n=10; Mean % CD45+ 100 ± 0.04 SD, %CV 0.04, n=10.
Profile II: Mean % CD45+ 88.58 ± 1.16 SD, %CV 1.31, n=10; Mean % CD45+ 95.61 ± 1.18 SD, %CV 1.24, n=10; Mean % CD45+ 94.65 ± 1.47 SD, %CV 1.55, n=10.
Anti-CD14/RPE:
FACScan: Mean % CD14+ 2.30 ± 0.50 SD, %CV 21.92, n=10; Mean % CD14+ 2.63 ± 0.41 SD, %CV 15.46, n=10; Mean % CD14+ 1.57 ± 0.29 SD, %CV 18.63, n=10.
Profile II: Mean % CD14+ 3.02 ± 0.26 SD, %CV 8.66, n=10; Mean % CD14+ 3.67 ± 0.57 SD, %CV 15.58, n=10; Mean % CD14+ 6.41 ± 0.42 SD, %CV 6.60, n=10.
Specificity:
Specificity of Anti-CD45/FITC, T29/33 in combination with Anti-CD14/RPE, TÜK4 has been verified by tests performed on five apparently healthy adult donors of various races at DAKO Corporation (3 Caucasians, 1 Asian, 1 Hispanic). Cell populations tested were RBC's, granulocytes, monocytes, lymphocytes and platelets.
The results indicate antibody binding of Anti-CD45 T29/33 is specific for WBC's, not RBC's or platelets. Anti-CD14/RPE, TÜK4 is specific for monocytes, with some binding noted for granulocytes.
Correlation study:
Correlation of the dual antibody reagent, Anti-CD45/FITC, T29/33, and Anti-CD14/RPE, TUK4 to a predicate dual antibody reagent, Becton Dickinson Simultest LeucoGATE, was determined by testing duplicate samples with each reagent across 150 normal, apparently healthy individuals at three geographically separate laboratories and 27 samples obtained from ill patients.
The regression analysis indicated that there was a 1:1 linear comparison of the DAKO CD45/CD14 to the LeucoGATE CD45/CD14 CD45/FITC.
The linear equations that were generated are:
VIDAKO CO45/CD16 CO45 F callaj = 18.68 + 0.81 X(LoudaGATE CD45 + MIN). r2 = 0.8847
(DAKO CD45/CD14 CD14 .; colla) = 0.44 + 0.91X(1,BUcaGATE CD14 .; calle) . r2 = 0.6187
These equations indicate that the Anti-CD45/FITC, T29/33, and Anti-CD14/RPE, TUK4 reagent and the Becton Dickinson Simultest LeucoGATE reagent are comparable on a 1:1 basis.
Conclusions:
Results of the above testing as well as the information provided by the Third, Fourth and Fifth Leukocyte Typing Workshops indicate that the DAKO Anti-CD45/FITC plus Anti-CD14/RPE reagent performs as well as Becton Dickinson's Simultest LeucoGATE in the detection and enumeration of CD45 ' lymphocytes and the labeling of CD14 positive cells for the exclusion of these cells using flow cytometry for the detection and enumeration of lymphocytes. Safety of the DAKO Anti-CD45/FITC plus Anti-CD14/RPE reagent and its predicate device is high as all reagents are used for in vitro testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 LeucoGATE
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.
Not Found
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).
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
JUN 24 1991
સ્વર્જ્યનયત્વે
| 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: | June 19, 1997 | | |
| Device Name: | Mouse Anti-Human CD45/FITC, T29/33 +
Mouse Anti-Human CD14/RPE, TUK4 | | |
| 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 LeucoGATE | | |
| Device Description: | Purified mouse anti-human CD45, Clone T29/33, conjugated with fluorescein
isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD14, Clone
TUK4, 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 CD45/FITC, T29/33 + Mouse Anti-Human CD14/RPE,
TUK4 (DAKO Anti-CD45/FITC and Anti-CD14/RPE) has been developed for use
in flow cytometry to optimize the gating of lymphocytes when analyzing
peripheral whole blood (erythrocyte lysed peripheral blood samples) or
peripheral blood mononuclear cell preparations. 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 | Anti-CD45/FITC, T29/33, and Anti-CD14/RPE, TUK4 is a dual antibody reagent
in which each antibody has a related fluorescent conjugate. This reagent is
used for detection and enumeration in peripheral blood. Clone T29/33 was
clustered at the Third and Fourth International Leukocyte Workshops (In:
McMichael, AJ, et al (Ed's). Leukocyte Typing III, Oxford, New York, Tokyo:
Oxford University Press, 1987). Clone TUK4 was clustered at the Fourth
International Leukocyte Workshop (Knapp, W, et al (eds). Leukocyte Typing
IV, Oxford, New York, Tokyo: Oxford University Press, 1989.) | | |
| | Binding linearity was determined over serial dilutions of a cell line known to | | |
1
express the antigen diluted with a cell line that has no antigenic sites for each antibody. For Anti-CD45/FITC, the cell line with known antigenic reactivity is Raji cells, while the cell line without antigenic sites is U937 cells. For Anti-CD14/RPE, no cell line could be reliably grown for linearity testing. Linearity results are not available for this antibody. For Anti-CD45/FITC, five dilutions were rested, with linear equations calculated from the results. The equation for Anti-CD45/FITC, T29/33 was y = 0.11% + 0.997x. r = 0.999.
Reproducibility of ten replicates from peripheral blood of one donor were run on two flow cytometers from different manufacturers. Different concentrations of antigen from whole blood was not possible to obtain.
| Anti-CD45/FITC | Mean % CD45+ | ± 1 SD | %CV | n |
|---|---|---|---|---|
| FACScan | 99.8 | 0.1 | 0.1 | 10 |
| 99.7 | 0.84 | 0.85 | 10 | |
| 100 | 0.04 | 0.04 | 10 | |
| Profile II | 88.58 | 1.16 | 1.31 | 10 |
| 95.61 | 1.18 | 1.24 | 10 | |
| 94.65 | 1.47 | 1.55 | 10 | |
| Anti-CD14/RPE | Mean % CD14+ | ± 1 SD | %CV | n |
| FACScan | 2.30 | 0.50 | 21.92 | 10 |
| 2.63 | 0.41 | 15.46 | 10 | |
| 1.57 | 0.29 | 18.63 | 10 | |
| Profile II | 3.02 | 0.26 | 8.66 | 10 |
| 3.67 | 0.57 | 15.58 | 10 | |
| 6.41 | 0.42 | 6.60 | 10 |
Specificity of Anti-CD45/FITC, T29/33 in combination with Anti-CD14/RPE, TÜK4 has been verified by tests performed on five apparently healthy adult donors of various races at DAKO Corporation (3 Caucasians, 1 Asian, 1 Hisbanic). Cell populations tested were RBC's, granulocytes, monocytes, lymphocytes and platelets. The results indicate antibody binding of Anti-CD45 T29/33 is specific for WBC's, not RBC's or platelets. Anti-CD14/RPE, TÜK4 is specific for monocytes, with some binding noted for granulocytes.
| | Averages
(n = 5) | % Positive
Red Blood
Cells | % Positive
Granulocyt
es | % Positive
Monocytes | % Positive
Lymphocyt
es | %
Positive
Platelets |
|--|---------------------------|----------------------------------|--------------------------------|--------------------------|-------------------------------|----------------------------|
| | CD45+CD14-
Blood Cells | 0.1
(0.0-0.2) | 13.4
(1.9-35.4) | 96.6
(93.7-
98.8) | 0.2
(0.0-0.3) | 0.1
(0.0-0.2) |
| | CD45+CD14:
Blood Cells | 0.4
(0.1-1.1) | 99.5
(98.0-
100.0) | 99.3
(97.1-
100.0) | 99.0
(96.9-99.9) | 2.0
(0.4-4.5) |
| | CD45-CD14+
Blood Cells | 0.2
(0.0-0.5) | 13.5
(1.9-35.4) | 96.6
(93.7-
98.8) | 0.3
(0.0-0.5) | 0.7
(0.4-1.2) |
Anti-CD45/FITC with Anti-CD14/RPE Specificity
2
Correlation of the dual antibody reagent, Anti-CD45/FITC, T29/33, and Anti-CD14/RPE, TUK4 to a predicate dual antibody reagent, Becton Dickinson Simultest LeucoGATE, was determined by testing duplicate samples with each reagent across 150 normal, apparently healthy individuals at three geographically separate laboratories and 27 samples obtained from ill patients. The regression analysis indicated that there was a 1:1 linear comparison of the DAKO CD45/CD14 to the LeucoGATE CD45/CD14 CD45/FITC. The linear equations that were generated are:
VIDAKO CO45/CD16 CO45 F callaj = 18.68 + 0.81 X(LoudaGATE CD45 + MIN). r2 = 0.8847
(DAKO CD45/CD14 CD14 .; colla) = 0.44 + 0.91X(1,BUcaGATE CD14 .; calle) . r2 = 0.6187
These equations indicate that the Anti-CD45/FITC, T29/33, and Anti-CD14/RPE, TUK4 reagent and the Becton Dickinson Simultest LeucoGATE reagent are comparable on a 1:1 basis.
Conclusions:
Results of the above testing as well as the information provided by the Third, Fourth and Fifth Leukocyte Typing Workshops indicate that the DAKO Anti-CD45/FITC plus Anti-CD14/RPE reagent performs as well as Becton Dickinson's Simultest LeucoGATE in the detection and enumeration of CD45 ' lymphocytes and the labeling of CD14 positive cells for the exclusion of these cells using flow cytometry for the detection and enumeration of lymphocytes. Safety of the DAKO Anti-CD45/FITC plus Anti-CD14/RPE reagent and its predicate device is high as all reagents are used for in vitro testing.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of a staff with a serpent entwined around it, and a pair of wings at the top.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 24 1997
Gretchen M. Murray, Ph.D. Regulatory Affairs Asst. Manager DAKO Corporation 6392 Via Real ………… Carpinteria, CA 93013
Re: K964974/S001
Trade Name: Monoclonal Mouse Anti-Human Leukocyte Common Antigen, CD45, FITCconjugated. Clone T29/33 and Monoclonal Mouse Anti-Human Monocyte, CD14, RPE Conjugated, Clone TOK 4 Regulatory Class: II Product Code: GKZ Dated: March 28, 1997 Received: April 04, 1997
Dear Dr. Murray:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
4
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to the market:
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page _ of _
0(k) Number (if known):
evice Name: Monoclonal Mouse Anti-Human Leucocyte Common Antigen, CD45, FITCevice Name: monocronal nouse internant used on t-Human Monocyte, CD14, RPE-Conjugated, Clone TUK4 dications For Use:
Monoclonal Mouse Anti-Human Leukocyte Common Antigen, CD45, FITC-Conjugated, Clone T29/33 Monocrollar Wouse First House Anti-Human Mouse Anti-Human Monocyte. CD14, RPE-Conjugated, Clone TUK4 (Anti-CD) 1/RPE, TÜK4) have been developed for use in flow cytometry. This reagent may be used to optimize the gating of lymphocytes when analyzing peripheral whole blood or peripheral blood mononuclear cell preparations. This reagent is one component of the suggested monoclonal antibody (MAb) combination for routine immunophenoryping of lymphocytes in peripheral blood.
Lymphocyte gating is assigned by selection of the upper and lower channel numbers to define the Ivmphocye population and is a quality control function for flow cytometry. Gating verification is lymplocere population and 16 9911% of the cells as CD45 meth CD14 as 2% or less of the cell population. 19
Note that this definition of "lymphocyte" does not give complete and unambiguous resolution from all other cell types. When optimizing light scatter gates for lymphocytes, operator and/or software algorithms are minimizing the number of lymphocytes excluded while still maintaining acceptable levels of contaminating cell types. Lymphocyte gate purity may be calculated by determining the percentage of non-lymphocyte events within the gate. Most non-lymphocytes are CD14 positive. Because each flow cytometer has different operating characteristics, each laboratory must determine its optimal operating procedure.
(Division Sign-Off)
Division of Clinical Laborator tory Devices
510(k) Number
Citeur Matin
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
escription Use ✓
er 21 CFR 801.109)
D Use
er 21 CFR 801.119)
OR
Over-The-Counter Use
(Optional Format 1-2-96)