(73 days)
Not Found
No
The summary describes a reagent kit for flow cytometry and does not mention any AI or ML components in its description, intended use, or performance studies.
No
This device is an in vitro diagnostic reagent kit used for enumerating specific cell types, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the reagent kit is intended "For In Vitro Diagnostic Use" for enumerating specific cell types in combination with a WBC count from a hematology instrument. This clearly indicates its use in diagnosing or monitoring health conditions.
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).
The "Intended Use / Indications for Use" section explicitly states: "It is intended 'For In Vitro Diagnostic Use'". This is the primary indicator that the device is an IVD.
Furthermore, the description of the device and its intended use (enumerating cell populations in blood samples using flow cytometry) aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The FlowCARE TLG Reagent kit combines four fluorescent labeled monoclonal antibodics in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD3+, CD3+CD4+ and CD3+CD8+ absolute cell count and CD3+, CD3+CD4+ and CD3+CD8+ lymphocyte percentage in combination with a White Blood Ccll (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 TLG Reagent is designed for use on the COULTER® EPICSTM XL™/XL=MCL=M or a suitably equipped flow cytometer with a 488 mm laser capable of detecting light scatter (forward and side) and a minimum of four-color fluorescence emission detectable in the following ranges: 504 - 541 nm, 568 - 590 nm, 610 - 635 nm, and 660 - 680 nm. Users should refer to the manufacturer's instrument manuals for specific instructions for setting PMT voltages and fluorescence compensation prior to analysis.
Product codes
GKZ
Device Description
The FlowCARE™ TLG Reagent consists of a four-color antibody reagent composed of CD45-FITC, CD4-PE, CD8-ECD, and CD3-PC5. The assay is performed on the EPICS XL or suitably equipped flow cytometer using appropriate quality control reagents in combination with an optional absolute count reagent, Flow-Count™ Fluorospheres, for determination of CD3+, CD3+CD4+, and CD3+CD8+ 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
Accuracy, precision, and linearity studies were conducted and demonstrated acceptable performance per the manufacturer specifications. The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.
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
510(k) Summary FlowCARE™ TLG Reagent
AUG 1 4 2008
Submitted By: Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4191 FAX: (305) 380-3618
- 2.0 Date Submitted: May 30, 2008
1.0
3.0 Device Name(s):
- 3.1 Proprietary Names FlowCARE™ TLG Reagent
3.2 Classification Name Automated differential cell counter (21 CFR § 864.5220)
4.0 Predicate Devices:
| Candidate | Predicates | Manufacturer | Docket
Number |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------|
| FlowCARE™ TLG
Reagent | tetraONE™ SYSTEM
for EPICS XL Flow
Cytometry SYSTEM
with CYTO-STAT©
tetraCHROMETM CD45-
FITC/CD4-RD1/CD8-
ECD/CD3-PC5
Monoclonal Antibody
Reagent | Beckman Coulter, Inc. | K990172 |
રે () Description:
The FlowCARE™ TLG Reagent consists of a four-color antibody reagent composed of CD45-FITC, CD4-PE, CD8-ECD, and CD3-PC5. The assay is performed on the EPICS XL or suitably equipped flow cytometer using appropriate quality control reagents in combination with an optional absolute
FlowCARE™ TLG Reagent Abbreviated 510(k) Notification
Page 18 of 59
1
count reagent, Flow-Count™ Fluorospheres, for determination of CD3+, CD3+CD4+, and CD3+CD8+ 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.
6.0 Intended Use:
The FlowCARE TLG Reagent kit combines four fluorescent labeled monoclonal antibodies in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD3+, CD3+CD4+ and CD3+CD8+ absolute cell count and CD3+, CD3+CD4+ and CD3+CD8+ 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 TLG Reagent is designed for use on the COULTER® EPICS™ XLTM/XL-MCL™ or a suitably equipped flow cytometer with a 488 nm laser capable of detecting light scatter (forward and side) and a minimum of four-color fluorescence emission detectable in the following ranges: 504 - 541 nm, 568 -590 nm, 610 - 635 nm, and 660 - 680 nm. Users should refer to the manufacturer's instrument manuals for specific instructions for setting PMT voltages and fluorescence compensation prior to analysis.
| Comparison | Characteristic | tetraONE System for
EPICS XL Flow
Cytometry System
(Predicate) | FlowCARE TLG Reagent |
|--------------|-------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | Intended Use | Enumeration of three
major T-lymphocyte
subset populations
(CD3+, CD3+CD4+,
CD3+CD8+) | Same |
| | Analytical
Instrumentation | Deployed on EPICS®
XL-MCL™ flow
cytometer | Deployed on EPICS® XL-
MCL™ flow cytometer or
suitably equipped flow
cytometer |
| | Analysis
Reagents | Uses CYTO-STAT®
tetraCHROME™ CD45-
FITC/CD4-RD1/CD8-
ECD/CD3-PC5 | CD45-FITC, CD4-PE
(RD1), CD8-ECD, and
CD3-PC5 monoclonal dye
conjugates are identical to
CD45-FITC/CD4-
RD1/CD8-ECD/CD3-PC5
tetraCHROME™ reagent
components |
7.0 Comparison to Predicate(s):
FlowCARE™ TLG Reagent Abbreviated 510(k) Notification
Page 19 of 59
2
| Comparison | Characteristic | tetraONE System for
EPICS XL Flow Cytometry
System (Predicate) | FlowCARE TLG
Reagent |
|-------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Analysis Reagents | Uses Flow-Count™
Fluorospheres absolute count
reagent | Same |
| | 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 Software | System II™ Automated
analysis using cellSTAT
3D™ algorithm | Manual analysis using
customer created
protocols according to
package insert |
| | Specimen Age | • ≤ 6 hours (with
automated software)
• ≤ 72 hours (without
automated software,
tetraCHROME CD45-
FITC/CD4-RD1/CD8-
ECD/CD3-PC5) | ≤ 120 hours (5 days)*
- The specimen age
limit for dual platform
measurement is
dependent upon the
claims for the
hematology analyzer but |
8.0 Summary of Performance Data:
Accuracy, precision, and linearity studies were conducted and demonstrated acceptable performance per the manufacturer specifications. The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with a snake winding around it, topped with a pair of wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 4 2008
Beckman Coulter, Inc. c/o Ms. Nancy Nadler Staff Regulatory Affairs Specialist 11800 SW 147 Ave, M/C: 31-B06 Miami, FL. 33196-2500
Re: K081526
Trade/Device Name: FlowCARE™ TLG Reagent Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: May 30, 2008 Received: June 02, 2008
Dear Ms. Nadler:
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 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.
4
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M Chan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known):
Device Name: FlowCARE™ TLG Reagent
Indication For Use:
The FlowCARE TLG Reagent kit combines four fluorescent labeled monoclonal antibodics in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD3+, CD3+CD4+ and CD3+CD8+ absolute cell count and CD3+, CD3+CD4+ and CD3+CD8+ lymphocyte percentage in combination with a White Blood Ccll (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 TLG Reagent is designed for use on the COULTER® EPICSTM XL™/XL=MCL=M or a suitably equipped flow cytometer with a 488 mm laser capable of detecting light scatter (forward and side) and a minimum of four-color fluorescence emission detectable in the following ranges: 504 - 541 nm, 568 - 590 nm, 610 - 635 nm, and 660 - 680 nm. Users should refer to the manufacturer's instrument manuals for specific instructions for setting PMT voltages and fluorescence compensation prior to analysis.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ _ _ _ _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Mava Inclos
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081526
FlowCARE™ TLG Reagent Abbreviated 510(k) Notification
Page 16 of 59