(61 days)
K/DEN number: K990172
No
The summary describes a flow cytometry reagent and its use for cell enumeration based on antibody binding and sequential gating, which are standard flow cytometry techniques and do not inherently involve AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is for "In Vitro Diagnostic Use" for the enumeration of CD4 cells, which provides diagnostic information rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended 'For In Vitro Diagnostic Use' for the enumeration of CD4 absolute cell count and CD4 lymphocyte percentage..."
No
The device is a reagent kit containing fluorescent-labeled monoclonal antibodies, which are physical components used in a laboratory setting with a flow cytometer. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended 'For In Vitro Diagnostic Use'".
- Nature of the Device: The device is a reagent kit containing fluorescent-labeled monoclonal antibodies used to analyze biological samples (blood) outside of the body (in vitro) to provide information about a patient's health status (enumeration of CD4 cells). This is the core definition of an in vitro diagnostic device.
- Use with Diagnostic Instruments: It is intended for use on flow cytometers and in combination with hematology instruments, which are diagnostic devices.
- Clinical Purpose: The enumeration of CD4 cells is a crucial diagnostic and monitoring tool, particularly in the context of immune system health and conditions like HIV.
N/A
Intended Use / Indications for Use
The FlowCARE PLG CD4 Reagent is for use on the COULTER® EPICS® XL™/XL-MCL™ or equivalent flow cytometer. The reagent kit combines two fluorescent-labeled monoclonal antibodies in a sincle reacent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD4 absolute cell count and CD4 lymphocyte percentage in combination with a White Blood Cell (WBC) Count from a hematology instrument as a dual platform measurement, or independently when used in combination with Flow-Count™ Fluorospheres as a single platform measurement.
Product codes
GKZ
Device Description
The FlowCARE PLG CD4 Reagent consists of a two-color antibody reagent composed of CD45-FITC and CD4-PE. The assay is performed on the EPICS XL, Cytomics FC 500, or equivalent Flow Cytometer using appropriate quality control reagents in combination with an optional absolute count reagent, Flow-Count™ Fluorospheres for determination CD4 absolute counts as a single platform measurement, or in combination with a White Blood Cell Count from a hematology analyzer as a dual platform measurement.
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)
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 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
Section 1 D: 510(k) Summary of Safety and Effectiveness for FlowCARE PLG CD4 Reagent
1.0 General Information
| Applicant Name and Address: | Beckman Coulter, Inc.
Cellular Analysis Division
11800 SW 147 Avenue
Miami, FL 33196-2500 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Stan Sugrue, Ph.D.
Senior Regulatory Affairs Specialist
Telephone: (305) 380-4552
FAX: (305) 380-3618
E-mail: stan.sugrue@coulter.com |
| Date: | November 18, 2004 |
| Device Trade Name(s): | FlowCARE™ PLG CD4 Reagent |
| Device Generic Name(s): | Lymphocyte Immunophenotyping monoclonal antibody
reagents |
| Device Classification: | The FlowCARE PLG CD4 Reagent is a Class II medical
device ((81 GKZ). |
2.0 Predicate Device
The FlowCARE PLG CD4 reagent claims substantial equivalence to the tetraONE SYSTEM for EPICS XL Flow Cytometry SYSTEM with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent for the enumeration of CD4 T-Lymphocytes,
FDA 510(k) Number(s): K990172
3.0 Device Description
The FlowCARE PLG CD4 Reagent consists of a two-color antibody reagent composed of CD45-FITC and CD4-PE. The assay is performed on the EPICS XL, Cytomics FC 500, or equivalent Flow Cytometer using appropriate quality control reagents in combination with an optional absolute count reagent, Flow-Count™ Fluorospheres for determination CD4 absolute counts as a single platform measurement, or in combination with a White Blood Cell Count from a hematology analyzer as a dual platform measurement.
4.0 Principle of Method:
The test depends on the ability of a monoclonal antibody to bind to the surface of cells expressing discrete antigenic determinants. Specific cell staining is accomplished by incubating whole blood with the monoclonal antibody reagent. The FlowCARE PLG CD4 Monoclonal Antibody Reagent is a combination of two murine monoclonal antibodies, each conjugated to a specific fluorochrome and specific for different cell surface antigens.
Red blood cells are lysed with the COULTER IMMUNOPREP™ Reagent System and COULTER TQ-PREP™ Workstation or equivalent. The remaining white blood cells are analyzed by flow cytometry using a sequential gating strategy. The total WBC gate is defined in the first histogram (log SS vs CD45-FITC) by the inclusion of all CD45+ events with low, medium and high Side Scatter. A second histogram (log SS vs CD4-PE), gated on the total WBC defined by the first gate, identifies CD4+ lymphocytes by setting a region to include CD40ish'' events with low SS. The CD4% of WBC obtained from this economis used to calculate the CD4 absolute count by multiplication with the WBC count from the hematology analyzer. CD4% of lymphocytes is obtained by defining a lymphocyte in the first histogram identified as the cluster of events exhibiting bright CD45+ fluoresence
Beckman Coulter, Inc. FlowCARE PLG CD4 Reagent
1
and low SS. The percentage is obtained by calculation of the CD4+ gated events divided by the CD45+ lymphocyte events.
| 5.0
Comparison | Characteristic | tetraONE System for EPICS XL Flow
Cytometry System
(Predicate) | FlowCARE PLG CD4 Reagent |
|-------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | T-Lymphocytes
enumeration | Enumerates CD4+
T-Lymphocytes | Enumerates CD4+
T-Lymphocytes |
| | Analytical
instrumentation | Deployed on EPICS® XL-MCL™ flow
cytometer | Can be deployed on EPICS®
XL-MCL™ flow cytometer |
| | Analysis Reagents | Uses CYTO-STAT® tetraCHROME™
CD45-FITC/CD4-RD1/CD8-ECD/CD3-
PC5 | CD45-FITC and CD4-PE (RD1)
monoclonal dye conjugates are
identical to CD45-FITC/CD4-RD1
tetraCHROME™ reagent
components |
| | Analysis Reagents | Uses Flow-Count™ Fluorospheres
absolute count reagent | Can use Flow-Count™
Fluorospheres absolute count
reagent or equivalent |
| | Setup Reagents | Flow-Set™ Fluorospheres
CYTO-COMP™ Cell Kit
CYTO-COMP™ Reagent Kit | Same or equivalent reagents |
| | QC Reagents | IMMUNO-TROL™ Control Cells
IMMUNO-TROL™ Low Control
Cells | Same or equivalent reagents |
| | Differences | Analysis Reagents | Uses 4-color fluorochrome reagent
(CYTO-STAT® tetraCHROME™ CD45-
FITC/CD4-RD1/CD8-ECD/CD3-PC5) |
| Analysis Software | | System II™ Automated analysis using
cellSTAT 3D™ algorithm | Manual analysis using customer
created protocols according to
package insert |
| Flow Cytometer | | EPICS® XL-MCL™ flow cytometry
system only | EPICS XL-MCL, Cytomics
FC500, or any equivalent flow
cytometry system |
| Specimen Age | | ≤ 6 hours (with automated
software) | ≤ 120 hours (5 days)* |
| | | ≤ 72 hours (without automated
software, tetraCHROME CD45-
FITC/CD4-RD1/CD8-ECD/CD3-
PC5) | * The specimen age limit for dual
platform measurement is
dependent upon the claims for
the hematology analyzer but not
to exceed five days. |
| Intended Use | | Enumeration of total T, B, and
NK lymphocytes
Enumeration of three major T-
lymphocyte subset populations | Enumeration of CD4+
T-Lymphocytes only |
Comparison to Predicate 5.0
Indications for Use: (Intended Use Statement from Package insert) 6.0
The FlowCARE PLG CD4 Reagent is for use on the COULTER® EPICS® XL™/XL-MCL™ or equivalent flow cytometer. The reagent kit combines two fluorescent-labeled monoclonal antibodies in a sincle reacent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD4 absolute cell count and CD4 lymphocyte percentage in combination with a White Blood Cell (WBC) Count from a hematology instrument as a dual platform measurement, or independently when used in combination with Flow-Count™ Fluorospheres as a single platform measurement.
7.0 Conclusion:
The FlowCARE™ PLG Reagent is substantially equivalent 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 for the enumeration of the CD4 T-Lymphocyte subpopulation.
Beckman Coulter, Inc. FlowCARE PLG CD4 Reagent
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
JAN 1 9 2005
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 S.W. 147th Avenue P.O. Box 169015 Miami, FL 33116-9015
Re: K043215
Trade/Device Name: FlowCARE™ PLG CD4 Reagent Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: November 22, 2004 Received: November 23, 2004
Dear Dr. Sugrue:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ase stared in the energently 76, 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 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.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Section 1C:
INDICATIONS FOR USE
510(k) Number (if known):
Not assigned K043215
Device:
FlowCARE™ PLG CD4 Reagent
Intended Use
The FlowCARE PLG CD4 Reagent is for use on the Coulter® EPICS® XL ™/XL-MCL™ or equivalent flow cytometer. The reagent kit combines two fluorescent-labeled monoclonal antibodies in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD4 absolute cell count and CD4 lymphocyte percentage in combination with a White Blood Cell (WBC) Count from a hematology instrument as a dual platform measurement, or independently when used in combination with Flow-Count ™ Fluorospheres as a single platform measurement.
The FlowCARE PLG CD4 Reagent provides the ability to measure CD4+ cells by utilizing a panleukocyte gating (PLG) approach where CD4+ T-cell enumeration is based on the use of all leukocytes, instead of on lymphocytes only, as the matching common denominator between the hematology generated WBC and the flow cytometric enumeration. A sequential gating strategy is used to include all CD45+ leukocytes and to measure the CD4+% of total leukocyte values generated from this gate.
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 Use (Per 21 CFR 801.109)
OR
Over-The-Counter
Juxhine Kiu lahte
Division/Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
K043215
510(k)
Beckman Coulter, Inc. FlowCARE PLG CD4 Reagent