(203 days)
CD3/T4
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No
The summary describes a fluorescent reagent used in flow cytometry to identify and enumerate specific cell populations based on antibody binding and fluorescence. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making. The analysis is based on standard flow cytometry gating and enumeration techniques.
No
The device is described as a diagnostic reagent used for the identification and enumeration of lymphocyte subsets in whole blood, which is a diagnostic rather than a therapeutic function.
Yes
The device is described as a "three-color fluorescent reagent" that allows "simultaneous identification and enumeration of total CD3+, total CD4+ and dual-stained CD3+/CD4+ lymphocytes in whole blood by flow cytometry." This type of identification and enumeration of specific cell populations in a biological sample like whole blood is a diagnostic function, as it provides information used to assess a patient's health status or to diagnose a condition (e.g., in the context of HIV, organ transplant monitoring, or autoimmune diseases as mentioned in the test set description).
No
The device is a reagent comprised of antibodies, which are physical substances, not software. The description focuses on the chemical composition and function of the reagent in flow cytometry.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the reagent is used to "identify and enumerate of total CD3+, total CD4+ and dual-stained CD3+/CD4+ lymphocytes in whole blood by flow cytometry." This is a diagnostic purpose, providing information about a patient's immune status.
- Sample Type: The device is used with "whole blood," which is a biological specimen taken from the human body.
- Method: The method used is "flow cytometry," which is a common technique for analyzing cells in biological samples.
- Performance Studies: The document describes performance studies (Accuracy, Linearity, Precision) conducted on human blood specimens to demonstrate the device's ability to accurately measure the targeted lymphocytes.
- Predicate Device: The mention of a predicate device (K922745; CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T4-RD1 Monoclonal Antibody Reagent) further indicates that this device is intended for a diagnostic use, as predicate devices are used for comparison in regulatory submissions for IVDs.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
CYTO-STAT® triCHROME™ CD45-FITC/CD4-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies.
Each antibody is labeled with a different color fluorochrome. The reagent identifies a lymphocyte gate based on CD45 staining (vs. side scatter) and allows simultaneous identification and enumeration of total CD3+, total CD4+ and dual-stained CD3+/CD4+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5, is used to monitor non-specific binding.
Product codes
GKZ
Device Description
CYTO-STAT® triCHROME™ CD45-FITC/CD4-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 to 85 years
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
Normal and abnormal (e.g., Human Immunodeficiency Virus, organ transplant, autoimmune disesease, low white blood cell count) whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 18 to 85 years. Specimens were divided, processed as lysed preparations and assayed in parallel with CD45/CD4/CD3 and CD3/T4.
Summary of Performance Studies
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Accuracy: Studies involved normal and abnormal whole blood specimens from diverse populations. Specimens were divided, processed as lysed preparations, and assayed in parallel with CD45/CD4/CD3 and the predicate device, CD3/T4. CD3+, CD4+, and CD3+/CD4+ percentages (total lymphocyte count) and absolute counts were determined using COULTER® EPICS® XL/XL-MCL flow cytometers gated on lymphocytes. White blood cell counts and 3-part differentials were also obtained. Results from minimums, maximums, means +/- 1 SD, regression and correlation analyses, and analyses of variance demonstrated that the subject device and predicate identify and enumerate essentially identical numbers of targeted lymphocytes.
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Linearity: Three replicate measurements were performed on a concentrated normal whole blood specimen serially diluted to achieve a range of CD3+ and CD4+ (CD3+/CD4+) lymphocyte concentrations. Samples were assayed with CD45/CD4/CD3 and analyzed on a COULTER EPICS XL/XL-MCL flow cytometer gated on lymphocytes. Values were expressed as absolute counts. Regression and correlation analyses of recovered versus expected absolute counts demonstrated linearity of the assay.
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Precision (Within Day/Intralaboratory): Ten replicate measurements were made for each of three levels of CD3+ and CD4+ (CD3+/CD4+) lymphocyte concentrations on the same day using a COULTER EPICS XL/XL-MCL flow cytometer gated on lymphocytes. Levels were obtained by selective depletions of a normal whole blood specimen and assayed with CD45/CD4/CD3. Values were expressed as % of the total lymphocyte count. Results analyzed in terms of mean +/- 1 SD and CV demonstrated within day/intralaboratory precision.
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Precision (Interlaboratory): Ten replicate measurements were made on the same day using different laboratories and COULTER EPICS XL/XL-MCL flow cytometers. All measurements were made on a single normal whole blood specimen divided and assayed with CD45/CD4/CD3. Values were expressed as % of the total lymphocyte count. Results analyzed in terms of mean +/- 1 SD and CV demonstrated interlaboratory precision.
Key Results: Product testing demonstrated that CD45/CD4/CD3 met all performance specifications and provided mature T (CD3+) and inducer T (CD4+; CD3+/CD4+) lymphocyte values comparable to those of CD3/T4.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
| COULTER CORPORATION
P.O. Box 169015
Miami, Florida 33116-9015 USA
(305) 380-3800
(800) 327-6531
| Product Information: (800) 526-6932 | |
|---|---|
| Date: | June 14, 1996 |
| Title: | Summary of Safety and Effectiveness Information For 510(k) Premarket Notification |
| Product: | CYTO-STAT® triCHROME™ CD45-FITC/CD4-RD1/CD3-PC5 Monoclonal Antibody Reagent With Isotypic Control |
| Company: | Coulter Corporation |
| 11800 SW 147 Avenue | |
| Miami, FL 33196-2500 | |
| Contact: | Dr. Marion S. Gaide (M/C: 31-B06) |
| Senior Regulatory Affairs Specialist | |
| Corporate Regulatory Affairs | |
| Telephone: | 305-380-2594 |
| Common or Usual or Classification Name: | Lymphocyte Immunophenotyping Monoclonal Antibody Reagents |
| Product Classification: | Product Code: GKZ; C.F.R. Section: 864.5220; Classification Panel: Hematology and Pathology Devices; Device Class: II |
| Intended Use: | CYTO-STAT® triCHROME™ CD45-FITC/CD4-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. |
| Each antibody is labeled with a different color fluorochrome. The reagent identifies a lymphocyte gate based on CD45 staining (vs. side scatter) and allows simultaneous identification and enumeration of total CD3+, total CD4+ and dual-stained CD3+/CD4+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5, is used to monitor non-specific binding. | |
| Substantial Equivalence: | 510(k) Premarket Notification: K922745 |
| CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T4-RD1 Monoclonal Antibody Reagent | |
| Product Differences: | CD45/CD4/CD3 and CD3/T4 are essentially identical with respect to features and principles of operation. Each liquid reagent allows simultaneous identification and enumeration of more than one T lymphocyte population (CD3+; CD4+; CD3+/CD4+) in a single specimen using a single reagent. Each reagent also requires a separate isotypic control to monitor non-specific binding. |
| The one difference between the reagents is that CD45/CD4/CD3 contains CD45 to identify a lymphocyte gate for making CD3, CD4 and CD3+/CD4+ measurements. In contrast, CD3/T4 requires a separate reagent, CYTO-STAT®/COULTER CLONE® Mo2-RD1/KC56 (T-200)-FITC, for this purpose. | |
| Mab Conjugation: CD45: FITC (Fluorescein Isothiocyanate). CD4: RD1 (Phycoerythrin). CD3: PC5 (Phycoerythrin-Cy5). |
l
1
Product testing to assess the performance of CD45/CD4/CD3 is described below. Studies were Product Testing: designed in line with instructions for use in the Product Package Insert and performance specifications. Specimens were assayed with CD3/T4 for comparison purposes. The results of product testing demonstrated that CD45/CD4/CD3 met all performance specifications and provided mature T (CD3+) and inducer T (CD4+; CD3+/CD4+) Jymphocyte values comparable to those of CD3/T4.
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- Accuracy:
Normal and abnormal (e.g., Human Immunodeficiency Virus, organ transplant, autoimmune disesease, low white blood cell count) whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 18 to 85 years. Specimens were divided, processed as lysed preparations and assayed in parallel with CD45/CD4/CD3 and CD3/T4. CD3+, CD4+ and CD3+/CD4+ percentages expressed in terms of the total lymphocyte count and absolute counts (cells/ul.) were determined with COULTER® EPICS® XL/XL-MCL flow cytometers gated on lymphocytes. White blood cell counts and 3-part differentials were obtained for all specimens.
- Accuracy:
Results analyzed in terms of minimums, maximums, means ± 1 SD, regression and correlation analyses, and analyses of variance demonstrated that CD45/CD4/CD3 and CD3/T4 identify and enumerate essentially identical numbers of the targeted lymphocytes in whole blood specimens.
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- Linearity:
Three replicate measurements were made on a concentrated normal whole blood specimen serially diluted to achieve a range of CD3+ and CD4+ (CD3+/CD4+) lymphocyte concentrations. Samples were assayed with CD45/CD4/CD3 and analyzed on a COULTER EPICS XL/XL-MCL flow cytometer gated on lymphocytes. Values were expressed in terms of absolute counts (cells/uL).
- Linearity:
Results analyzed in terms of regression and correlation analyses for recovered versus expected absolute counts demonstrated linearity of the assay.
-
- Precision (Within Day/Intralaboratory):
Ten replicate measurements were made for each of three levels of CD3+ and CD4+ (CD3+/CD4+) lymphocyte concentrations on the same day using a COULTER EPICS XL/XL-MCL flow cytometer gated on lymphocytes. Levels were obtained by selective depletions of a normal whole blood specimen and assayed with CD45/CD4/CD3. Values were expressed in terms of % of the total lymphocyte count.
- Precision (Within Day/Intralaboratory):
Results analyzed in terms of mean ± 1 SD and CV demonstrated within day/intralaboratory precision of the assay.
-
- Precision (Interlaboratory):
Ten replicate measurements on were made on the same day using different laboratories and COULTER EPICS XL/XL-MCL flow cytometers. All measurements were made on a single normal whole blood specimen divided and assayed with CD45/CD4/CD3. Values were expressed in terms of % of the total lymphocyte count.
- Precision (Interlaboratory):
Results analyzed in terms of mean ± 1 SD and CV demonstrated interlaboratory precision of the assay.
Marion S. Gaide, Ph.D.
Marion S. Gaide, Ph.D. Senior Regulatory Affairs Specialist Corporate Regulatory Affairs 4543se
June 14, 1996
Date