(139 days)
Not Found
No
The device is a reagent for flow cytometry and the analysis described is based on standard statistical methods, not AI/ML.
No
This device is a diagnostic reagent designed to identify and enumerate lymphocyte populations for the purpose of aiding in the diagnosis and monitoring of disease states, not for treatment.
Yes
The device is described as aiding in the identification of abnormal levels of CD3+ lymphocytes, which "may aid in the diagnosis and/or prognosis of unidentified disease conditions," and "may aid in the diagnosis and/or prognosis of immunodeficiency disease." This explicitly indicates a diagnostic purpose.
No
The device is a reagent, which is a chemical substance used in a laboratory test, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagent is used for the "simultaneous identification and enumeration of total CD3+CD56+ lymphocytes in whole blood by flow cytometry." It also mentions that the results "may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation," and "may aid in the diagnosis and/or prognosis of unidentified disease conditions" and "immunodeficiency disease such as infection with human immunodeficiency virus (HIV)." These are all diagnostic purposes.
- Sample Type: The device is used with "whole blood," which is a human specimen.
- Method: The analysis is performed "in whole blood by flow cytometry," which is an in vitro technique.
- Predicate Device: The predicate device listed (K982172) is also an IVD, which further supports the classification of this device as an IVD.
The device is designed to be used outside of the body to examine specimens from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-PC5, is used to monitor nonspecific staining.
CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluoresent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5.
CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocvte levels following organ transplantation.
To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or progrosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (induce) and CD8+ (suppressor/cytoxic) T lymphocytes and corresponding T478 ratios, may aid in the diagnois and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations.
NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells.
As part of a Three Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 is a three-color fluorescont reagent. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-. CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-PCS, is used to monitor nonspecific staining. The triCHROME CD45-FITCMsIgGT+RD1/MsgG1-PCS is a three-color reagent with three murine monoclonal antibodies, each labeled with a different fluorochrome. This product is intended for use as a quality control reagent to monitor nonspecific antibody binding in cell surface staining procedures using CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two monoclonal antibodies.
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
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)
- Accuracy: Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 19 to 84 years. Specimens were divided, processed as lysed preparations and assayed in parallel with CD45/CD56/CD3 and CD3/CD56. CD3+ and CD3-/CD56+ percentages expressed in terms of the total lymphocyte count and absolute counts (cells/uL) were determined with COULTER® EPICS® XL-MCL ™ flow cytomerers gated on lymphocytes. White blood cell counts and 5-part differentials were obtained for all specimens. Results analyzed in terms of minimums, maximums, means ± 1 SD, confidence intervals, regression analyses and analyses of variance demonstrated that CD45/CD3 and CD3/CD56 identify and enumerate essentially identical numbers of the targeted lymphocytes in whole blood specimens.
- Linearity: Three replicate measurements were made on a concentrated COULTER™ CYTO-TROL Cclls sample serially diluted to achieve a range of CD3+ and CD3-/CD56+ lymphocyte concentrations, Samples were assayed with CD45/CD56/CD3 and analyzed on a COULTER® EPICS® XL-MCL™ flow cytometer gated on lymphocytes. Values were expressed in terms of absolute count (cclls/uL). Results analyzed in terms of regression and correlation analyses for recovered vs. expected absolute counts demonstrated Linearity of the assay.
- Precision: Within Run (Intralaboratory): Ten replicate measurements were made for each of three levels of CD3+ and CD3-/CD56+ lymphocyte concentrations on the same day using a COULTER® EPICS® XL-MCL™ flow cytometer gated on lymphocytes. Levels were obtained by selective screening of normal whole blood specimens and assayed with CD45/CD56/CD3. Values were expressed in terms of percentage of the total lymphocyte count. Results analyzed in terms of mean ± 1 SD and CV demonstrated Within Day (Intralaboratory) Precision of the assay.
- Precision (Interlaboratory): Ton replicate measurements on were made on the same day using different laboratories and COULTER® EPICS® XL-MCL™ flow cytomcters. All measurements were made on a single normal whole blood specimen divided and assayed with CD45/CD56/CD3, Values were expressed in terms of percentage 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): 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.
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
NOV COULTER CORPORATION P.O. BOX 169015 Date: November 4, 1998 Miami Florida 33116-9015 USA Customer Service: (800) 526-769 Summary of Safety and Effectiveness Information For 510(k) Premarket Notification Title: Product Information: (800) 526-6932 (800) 327-6531 (305) 357-653 www.coulicr.com Product: CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RDJ/MsIgG1-PC5 Isotypic Control Coulter Corporation Company; 10.17 11 11 11 11 11 11 11 11 11800 SW 147 Avenue Miami, FL 33196-2500 ... ... . . Contact: Dr. Marion S. Gaide (M/C: 31-B06) Senior Regulatory Affairs Specialist 1. . . . . ( ' ' . . . Sun 10 11 11 Corporate Regulatory Affairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yollars for note to be and 12. I mades! (, addrivers , trans , Telephone: (305) 380-2594 Mary College Comments of : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lymphocyte Immunophenotyping Monoclonal Antibody Reagent with Isotypic Control Kray at to marker Classified on the 2014 Product Classification: Product Code: GKZ; C.F.R. Section: 864.5220; Classification Hematology and Pathology Devices; Device Class: II Panel: いた。 Produkt K
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Come of Moscore Matther CYTO STATE Conceller CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 is a three-color fluorescont reagent · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · time in thorochrome. The reagent allows simultancous identification and enumeration of total CD3+ and CD3-. ... .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No do C V a la triCHROMETM CD45-FITC/MsIgG1-PCS, is used to monitor nonspecific staining. range of the count of the triCHROME CD45-FITCMsIgGT+RD1/MsgG1-PCS is a threesed in filloresear color in we lighted of three inutine monoclonal antibodies. Each antibody is labeled with a different store of the color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of Course In nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® a monoloriCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two monoclonal Colletter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Caracta, Vanchestia Substantial Equivalence: 510(k) Premarket Notification: K982172 CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent with CYTO-STAT®/COULTER CLONE® MsIgG1-RD1/MsIgG1-FITC Isotypic Control Product Comparison: The CD45/CD56/CD3 and CD3/CD56 systems are essentially identical with respect to features and principles of operation. Each liquid reagent allows simultaneous identification and enumeration of more than one lymphocyte population (CD3+ and CD3-/CD56+) in a single specimen using a single reagent. Bach system also requires an isotypic control to monitor nonspecific binding. The difference between the systems is that CD45/CD36/CD3 contains CD45 to identify a lymphocyte gate for making CD3+ and CD3-/CD56+ measurcments. CD3/CD56 rcquires a scparate reagent, CYTO-STAT®/COULTER CLONE® Mo2-RD1/KCS6 (T-200)-FITC, for this purpose. MAb Conjugation: CD45: FITC
(Fluorescein Isothiocyanate). CD56: RD1 (Phycoerythrin). CD3: PCS (Phycoerythrin-Cy5),
1
- Product testing to assess the performance of CDAS/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/CD56 for comparison purposes. The results of product testing demonstrated that CD45/CD56/CD3 meets all performance specifications and provides mature T (CD3+) and NK (CD3-/CD56+) lymphocyte values comparable to those of CD3/CD56.
- l . Accuracy:
Normal and abnormal whole blood specimens were collected from geographically diverse populations of males and females unselected as to race and ranging in age from 19 to 84 years. Specimens were divided, processed as lysed preparations and assayed in parallel with CD45/CD56/CD3 and CD3/CD56. CD3+ and CD3-/CD56+ percentages expressed in terms of the total lymphocyte count and absolute counts (cells/uL) were determined with COULTER® EPICS® XL-MCL ™ flow cytomerers gated on lymphocytes. White blood cell counts and 5-part differentials were obtained for all specimens.
Results analyzed in terms of minimums, maximums, means ± 1 SD, confidence intervals, regression analyses and analyses of variance demonstrated that CD45/CD3 and CD3/CD56 identify and enumerate essentially identical numbers of the targeted lymphocytes in whole blood specimens.
-
- Linearity:
Three replicate measurements were made on a concentrated COULTER™ CYTO-TROL Cclls sample serially diluted to achieve a range of CD3+ and CD3-/CD56+ lymphocyte concentrations, Samples were assayed with CD45/CD56/CD3 and analyzed on a COULTER® EPICS® XL-MCL™ flow cytometer gated on lymphocytes. Values were expressed in terms of absolute count (cclls/uL).
- Linearity:
Results analyzed in terms of regression and correlation analyses for recovered vs. expected absolute counts demonstrated Linearity of the assay.
- Precision: Within Run (Intralaboratory): 3.
Ten replicate measurements were made for each of three levels of CD3+ and CD3-/CD56+ lymphocyte concentrations on the same day using a COULTER® EPICS® XL-MCL™ flow cytometer gated on lymphocytes. Levels were obtained by selective screening of normal whole blood specimens and assayed with CD45/CD56/CD3. Values were expressed in terms of percentage of the total lymphocyte count.
Results analyzed in terms of mean ± 1 SD and CV demonstrated Within Day (Intralaboratory) Precision of the assay.
-
- Precision (Interlaboratory):
Ton replicate measurements on were made on the same day using different laboratories and COULTER® EPICS® XL-MCL™ flow cytomcters. All measurements were made on a single normal whole blood specimen divided and assayed with CD45/CD56/CD3, Values were expressed in terms of percentage 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. Gaido, Ph.D.
Senior Regulatory Affairs Specialist Corporate Regulatory Affairs
November 4, 1998
Date
2
Received: October 1, 1998
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes extending from its back, symbolizing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Marion S. Gaide, Ph.D. Senior Regulatory Affairs Specialist Coulter Corporation P.O. Box 169015 NOV રે 1998 Miami, Florida 33116-9015 Re : к982166/S1 Trade Name: CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with CYTO-STAT® triCHROME™ CD45-FITC/MsIqG1-RD1/MsIgG1-PC5 Isotypic Control Regulatory Class: II Product Code: GKZ Dated: September 29, 1998
Dear Dr. Gaide:
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 legally marketed predicate 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 aqainst 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, throuqh periodic QS inspections, the Food and Druq 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.
3
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 proceed 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
4
Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): Not Yet Assigned
CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent Device Name: with CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5 Isotypic Control
Indications For Use:
CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-PC5, is used to monitor nonspecific staining.
CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluoresent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5.
CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocvte levels following organ transplantation.
To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or progrosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (induce) and CD8+ (suppressor/cytoxic) T lymphocytes and corresponding T478 ratios, may aid in the diagnois and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations.
NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells.
As part of a Three Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)Division Sian-Om Division of Clinical Laboratory Devices 510/k) Nimber
510i4us2