(25 days)
Not Found
No
The summary describes monoclonal antibody reagents used in flow cytometry for cell identification and enumeration, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as an "In Vitro Diagnostic" reagent for identifying and enumerating lymphocyte percentages and counts in whole blood flow cytometry, which is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent is intended "For In Vitro Diagnostic Use," allowing for the identification and enumeration of various lymphocyte populations and ratios in whole blood flow cytometry, which are used for diagnostic purposes.
No
The device description explicitly states the products are "combination of four murine monoclonal antibodies, each conjugated to a different fluorochrome," which are physical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states that the reagents are intended "For In Vitro Diagnostic Use".
- Purpose: The intended use describes the identification and enumeration of specific cell populations in whole blood using flow cytometry, which is a diagnostic process performed outside of the body (in vitro).
- Clinical Laboratory Setting: The "Intended User / Care Setting" is listed as "Clinical Laboratory Devices," which is where IVDs are typically used.
N/A
Intended Use / Indications for Use
CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained.
CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can be obtained as well.
Product codes
GKZ
Device Description
The products are:
The CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent. Each is a combination of four murine monoclonal antibodies, each conjugated to a different fluorochrome and specific for a different cell surface antigen. Specifically.
CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 . Monoclonal antibody reagent allows the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained.
CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal antibody reagent . allows the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can be obtained as well.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Flow Cytometry
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)
Not Found
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
KO3O4O8
MAR 0 4 2003
Summary of Safety and Effectiveness for CYTO-STAT® tetraCHROME™ CD45-Section 1 D: FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents
1.0 General Information
| Device Generic Name(s): | Lymphocyte Immunophenotyping monoclonal antibody
reagents |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name(s): | CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-
ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-
FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody
Reagents |
| Device Classification: | CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-
ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-
FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody
Reagents are Class II medical devices. |
| Applicant Name and Address: | Beckman Coulter, Inc.
Cellular Analysis Division
11800 SW 147 Avenue
Miami, FL 33196-2500 |
| Date: | February 6, 2003 |
2.0 Legally Marketed Device(s)
The CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents claims substantial equivalence to the previously cleared tetraONE System for EPICS XL Flow Cytometry System with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and with CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent
FDA 510(k) Number(s): K990172
3.0 Device Description
The products are:
The CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent. Each is a combination of four murine monoclonal antibodies, each conjugated to a different fluorochrome and specific for a different cell surface antigen. Specifically.
CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 . Monoclonal antibody reagent allows the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole
1
blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained.
CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal antibody reagent . allows the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can be obtained as well.
Principle of Method: 4.0
The CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents are combinations of four murine monoclonal antibodies, each conjugated to a different fluorochrome and specific for a different cell surface antigen. The test depends on the ability of a monoclonal antibody to bind to the surface of cells expressing discrete antigenic determinants. Red blood cell are lysed and the remaining white blood cells are analyzed on a flow cytometer (COULTER EPICS XL, FC 500 or equivalent flow cytometer). The analysis may be automated, as with XL with System II software which automates standardization of light scatter, fluorescence intensities and adjustment of color compensation settings and tetraONE SYSTEM software which provides automated analysis of lymphocyte subpopulations. Alternatively, the operator may perform the analysis by adjusting and other operational parameters to optimize results when working with non-routine samples.
5.0 Indications for Use:
CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can be obtained as well.
6.0 Description of the modification:
The currently marketed tetraONE System for EPICS XL Flow Cytometry System with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and with CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent is an automated analysis method for simultaneous identification and enumeration of lymphocvte subpopulations (CD3+, CD4+, CD8+, CD19+and CD56+) combining four-color fluorescent monoclonal antibody reagents, quality control reagents, optional absolute count reagent and software. This premarket notification is for the use of the two monoclonal antibody reagent system components as stand alone reagents on any equivalent flow cytometer system, allowing the operator to manually adjust gating and other operational parameters to optimize results at their discretion.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Premarket Product Regulatory Compliance Beckman Coulter, Inc. 11800 SW 147 Avenue MC 31-B06 Miami, Florida 33196-2500
MAR 0 4 2003
K030408 Re:
Trade/Device Name: CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents Regulation Number: 21 CFR § 864.5220 Regulation Name: Lymphocyte Immunophenotyping monoclonal antibody reagents Regulatory Class: II Product Code: GKZ Dated: February 6, 2003 Received: February 7, 2003
Dear Dr. Sugrue:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE Section 1C:
Not assigned 510(k) Number (if known): CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-Device: ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents
Indications For Use:
CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained.
CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. This reagent can also provide the total lymphocyte percentage.
21 CFR 864.5220
Lymphocyte Immunophenotyping monoclonal antibody reagents
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Churchen Bruton
(Division/Sign/ Division of Clinical Laboratory Devices 510(k) Number 8030408
Beckman Coulter, Inc. Special 510(k): Device Modification TetraCHROME_Rgts_510k.doc
CYTO-STAT® tetraCHROME™ Monoclonal Antibodies