(203 days)
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No
The summary describes a fluorescent reagent and its use in flow cytometry for identifying and enumerating lymphocyte populations based on antibody binding. There is no mention of algorithms, machine learning, or AI being used for data analysis or interpretation. The performance studies focus on traditional statistical methods like regression, correlation, and analysis of variance.
No.
This device is an in-vitro diagnostic reagent used for identifying and enumerating specific lymphocyte populations in whole blood, which is a diagnostic function, not a therapeutic one.
Yes
The device is identified in the 'Intended Use/Indications for Use' section as a reagent for the "identification and enumeration of total CD3+, total CD8+ and dual-stained CD3+/CD8+ lymphocytes in whole blood by flow cytometry." This process is used to diagnose and monitor various conditions.
No
The device is a reagent, which is a chemical substance used in a laboratory test. It is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "identify and enumerate of total CD3+, total CD8+ and dual-stained CD3+/CD8+ lymphocytes in whole blood by flow cytometry." This is a diagnostic purpose, providing information about a patient's immune status.
- Anatomical Site: The device is used on "Whole blood," which is a biological specimen taken from the human body.
- Device Description: The device is a "three-color fluorescent reagent comprised of three murine monoclonal antibodies," which are used to label specific cells in the blood for analysis.
- Performance Studies: The document describes performance studies (Accuracy, Linearity, Precision) conducted on human blood specimens (normal and abnormal) to demonstrate the device's ability to accurately measure the targeted lymphocytes.
- Predicate Device: The mention of a predicate device (K922744; CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T8-RD1 Monoclonal Antibody Reagent) which is also a flow cytometry reagent for analyzing lymphocytes, further supports its classification as an IVD.
The device is designed to be used in vitro (outside the body) to examine a biological specimen (whole blood) for diagnostic purposes (identifying and enumerating specific lymphocyte populations). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CYTO-STAT® triCHROME™ CD45-FITC/CD8-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 CD8+ and dual-stained CD3+/CD8+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PCS, is used to monitor non-specific binding.
Product codes
GKZ
Device Description
CYTO-STAT® triCHROME™ CD45-FITC/CD8-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. CD45/CD8/CD3 contains CD45 to identify a lymphocyte gate for making CD3, CD8 and CD3/CD8 measurements.
Mab Conjugation: CD45: FITC (Fluorescein Isothiocyanate). CD8: RD1 (Phycoerythrin). CD3: PC5 (Phycoerythrin-Cy5).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Normal and absormal (e.g., Human Immodeficiency Virus, organ transplant, autoimmume discesses, low white blood cell count) whole blood upscimens were collected from goographically diverse populations of males and females unselected as to race and ranging in are from 18 to 85 years.
Intended User / Care Setting
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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 absormal (e.g., Human Immodeficiency Virus, organ transplant, autoimmume discesses, low white blood cell count) whole blood upscimens were collected from goographically diverse populations of males and females unselected as to race and ranging in are from 18 to 85 years. Specimens were divided, processed as lysed properations and asseryed in parallel with CD45/CD8/CD3 and CD3/T8. CD3+, CD8+ and CD3+/CD8+ percentages expressed in terms of the total fymsbocyte count and absolute counts (cells/ul.) were detecrained with COULTER® EPICS® XL/XL-MCL. flow cytometers gated on lymphocytes. White blood cell counts and 3-part differentials were obtained for all specimens.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Product testing to assess the performance of CD45/CD3. Studies were designed in line with instructions for use provided in the Product Package Insect and performance specifications. Specimens were assayed with CD3/78 for comparison purposes. The results of product testing demonstrated that CD45/CD8/CD3 met all performance specifications and provided mature T (CD3+) and suppressoricytotoxic T (CD8+) lymphocyte values comparable to those of CD3/T8.
- Accuracy: Results analyzed in terms of minimums, maximums, means ± 1 SD, regreession and correlation analyses, and analyses of variance demonstrated that CD45/CD3 and CD3/78 identify and enumerate essentially identical numbers of the targeted lymphocytes in whole blood specimens
- Linearity: Three replicate measurements were made on a concentrated normal whole blood specimen serially diluted to achieve a runge of ten CD3+ (CD3+/CD3+/CD8+) lymphocyte concentrations. Samples were assayed with CD45/CD3 and analyzed on a COULTER EPICS XLXL-MCL flow cytometer gated on lymphocytes. Values were expressed in terms of absolute count (cells/uL). 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 CD8+ (CD3+/CD8+) 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/CD8/CD3. Values were expressed in terms of % of the total lymphocyte count. Results analyzed in terms of mean ± 1 SD and CV demonstrated within dievintralaboratory 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 apecimen divided and assayed with CD45/CD8/CD3. Values were expressed in terms of % of the total lymphocyte count. Results analyzed in terms of mean ± 1 SD and CV demonstrated interlaboratory precision of the assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 | Date: | June 14, 1996 | Image: Coulter Logo
K962305
JAN. 6, 1997 | | | |
|-------------------------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--|--|--|
| (305) 380-3800
(800) 327-6531
Product Information: (800) 526-8932 | Title: | Summary of Safety and Effectiveness Information For 510(k) Premarket
Notification | | | | |
| | Product: | CYTO-STAT® triCHROME™ CD45-FITC/CD8-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/CD8-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
CD8+ and dual-stained CD3+/CD8+ lymphocytes in whole blood by flow
cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-
FITC/MsIgG1-RD1/MsIgG1-PCS, is used to monitor non-specific binding. | | | | |
| | Substantial Equivalence: | 510(k) Premarket Notification: K922744
CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T8-RD1
Monoclonal Antibody Reagent | | | | |
| | Product Differences: | CD45/CD8/CD3 and CD3/T8 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+; CD8+; CD3+/CD8+) 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/CD8/CD3
contains CD45 to identify a lymphocyte gate for making CD3, CD8
and CD3/CD8 measurements. In contrast, CD3/T8 requires a separate
reagent, CYTO-STAT®/COULTER CLONE® Mo2-RD1/KC56
(T-200)-FITC, for this purpose. | | | | |
| | | Mab Conjugation: CD45: FITC (Fluorescein Isothiocyanate). CD8:
RD1 (Phycoerythrin). CD3: PC5 (Phycoerythrin-Cy5). | | | | |
. . . . . . .
4232216-0 R 12-13
1
Product Testing:
Product tasting to assess the performance of CD45/CD3 is described below. Studies were designed in line with instructions for use provided in the Product Package Insect and performance specifications. Specimens were assayed with CD3/78 for comparison purposes. The results of product testing demonstrated that CD45/CD8/CD3 met all performance specifications and provided mature T (CD3+) and suppressoricytotoxic T (CD8+) lymphocyte values comparable to those of CD3/T8.
-
- Accuracy:
Normal and absormal (e.g., Human Immodeficiency Virus, organ transplant, autoimmume discesses, low white blood cell count) whole blood upscimens were collected from goographically diverse populations of males and females unselected as to race and ranging in are from 18 to 85 years. Specimens were divided, processed as lysed properations and asseryed in parallel with CD45/CD8/CD3 and CD3/T8. CD3+, CD8+ and CD3+/CD8+ percentages expressed in terms of the total fymsbocyte count and absolute counts (cells/ul.) were detecrained 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, regreession and correlation analyses, and analyses of variance demonstrated that CD45/CD3 and CD3/78 identify and enumerate essentially identical numbers of the targeted lymphocytes in whole blood specimens
-
- Linearity:
Three replicate measurements were made on a concentrated normal whole blood specimen serially diluted to achieve a runge of ten CD3+ (CD3+/CD3+/CD8+) lymphocyte concentrations. Samples were assayed with CD45/CD3 and analyzed on a COULTER EPICS XLXL-MCL flow cytometer gated on lymphocytes. Values were expressed in terms of absolute count (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); 3.
Ten replicate measurements were made for each of three levels of CD3+ and CD8+ (CD3+/CD8+) 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/CD8/CD3. Values were expressed in terms of % of the total lymphocyte count.
Results analyzed in terms of mean ± 1 SD and CV demonstrated within dievintralaboratory 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 apecimen divided and assayed with CD45/CD8/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. Guide, Ph.D.
.
Senior Regulatory Affairs Specialist Corporate Regulatory Affairs 45838c
June 14, 1996
Date
24