(107 days)
No
The summary describes a standard flow cytometer and does not mention any AI or ML components or capabilities.
No.
The device is described as an "In Vitro Diagnostic Use in clinical laboratories" for "qualitative and quantitative measurement of biological and physical properties of cells and other particles," indicating it is for diagnostic purposes, not therapeutic intervention.
Yes
Explanation: The "Device Description" section states that the device is "designed for In Vitro Diagnostic Use in clinical laboratories."
No
The device description explicitly states it is a "bench top laboratory instrument" and describes hardware components like laser beams and detectors, indicating it is a physical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "qualitative and quantitative measurement of biological and physical properties of cells and other particles." This type of measurement on biological samples is a core function of IVDs.
- Device Description: The description clearly states the device is "designed for In Vitro Diagnostic Use in clinical laboratories." This is a direct declaration of its intended use as an IVD.
- Intended User/Care Setting: The intended user is "Clinical laboratories," which is a typical setting for IVD use.
The information provided strongly indicates that the Cytomics FC 500 MPL is intended for use in a clinical laboratory setting to perform diagnostic measurements on biological samples, which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cytomics FC 500 MPL is a system for the qualitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
Product codes
GKZ
Device Description
The Cytomics FC 500 MPL Flow Cytometer (FC 500 MPL) is a bench top laboratory instrument designed for In Vitro Diagnostic Use in clinical laboratories.
The FC 500 MPL provides qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single file.
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
In Vitro Diagnostic Use in clinical laboratories.
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
KO71681
2007
Summary of Safety and Effectiveness for Cytomics FC 500 MPL Flow Cytometer
1.0 General Information
| Device Generic Name(s): | Automated differential cell counter |
|---|---|
| Device Trade Name(s): | Cytomics FC 500 MPL Flow Cytometer |
| Device Classification: | Class II medical device. |
| Applicant Name and Address: | Beckman Coulter, Inc. |
| Cellular Analysis Division | |
| 11800 SW 147 Avenue | |
| Miami, FL 33196-2500 |
Date:
June 18, 2007
2.0 Legally Marketed Device(s)
The FC 500 MPL Flow Cytometer claims substantial equivalence to the previously cleared FC 500 Flow Cytometer.
FDA 510(k) Number(s): K030828
3.0 Device Description
The Cytomics FC 500 MPL Flow Cytometer (FC 500 MPL) is a bench top laboratory instrument designed for In Vitro Diagnostic Use in clinical laboratories.
The FC 500 MPL provides qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single file.
4.0 Principle of Method:
The FC 500 MPL uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single file. The instrument can simultaneously measure forward scatter, side scatter, and five fluorescent dyes using one or two lasers at 488 nm and either 635 nm (solid-state laser) or 633 nm (HeNe laser). Therefore, the instrument can perform correlated multiparameter analyses of individual cells.
To ensure that the cells move through the laser beam one at a time, the instrument uses hydrodynamic focusing in the flow cell. As the stream of sheath fluid is flowing through the flow cell, a stream of sample is injected into the middle of the sheath stream. The sheath stream surrounds, but does not mix with the sample stream, and its pressure focuses the sample stream so that the cells flow through the laser beam single file.
Before the laser beam reaches the sample stream, cross-cylindrical lenses focus the beam keeping it perpendicular to the sample stream flow while making the beam small enough to illuminate only one cell at a time.
1
As the cells in the sample stream go through the sensing area of the flow cell, the laser beam illuminates them. The cells scatter the laser light and emit lluorescent light from fluorescent dyes attached to them. The scattered laser light and fluorescent light are collected, separated and measured.
The cytometer has seven sensors, each generating a voltage pulse signal as each cell passes through the laser beam. The voltage pulse signal is proportional to the intensity of the light the sensor received. The cytometer electronics amplify, condition, integrate and analyze these pulses.
The results of sample analysis appear on the workstation screen as graphs in which the user defines the parameters on the plot axes. To analyze the data, regions and gates are defined by the user to select the cells of interest, and then statistics are generated.
5.0 Indications for Use:
The FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
6.0 Description of the modification:
The FC 500 MPL design is based upon the FC 500 flow cytometer. Hardware, software and labeling changes were made to support sample presentation / introduction from multi-well plates. Additional software and labeling modifications were made to support a 21 CFR Part 11 compliance option.
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 features a stylized eagle with its wings spread, symbolizing protection and care. 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
Beckman Coulter, Inc. C/O Lourdes Coba 11800 SW 147th Avenue Miami, Florida 33196-2500
Re: K071681
Trade/Device Name: FC 500 MPL Flow Cytometer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: June 18, 2007 Received: June 19, 2007
OCT 4 2007
Dear Ms. Coba:
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. Iisting 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 - Lourdes Coba
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,
Jauphine Bautista
Robert L. Becker, Jr., M.D., Ph.D.
Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: FC 500 MPL Flow Cytometer
Indications for Use:
The Cytomics FC 500 MPL is a system for the qualitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
Prescription Use (per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auschine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K07168
(k)
Cytomics FC 500 MPL Flow Cytometer - Special 510(k) Notification Beckman Coulter, Inc.
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