(25 days)
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No
The summary describes a biological assay control mixture and its performance characteristics, with no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is described as an "assay control mixture" and a "control for antibody staining, RBC lysis, instrument set-up, instrument performance and data analysis" for flow cytometry. It is used to evaluate the performance of an immunophenotyping assay, not to treat a condition in a patient.
No
The device is described as an "assay control mixture" and a "control for antibody staining, RBC lysis, instrument set-up, instrument performance and data analysis." It is used to ensure the reliability of a flow cytometry process, not to provide a diagnosis itself.
No
The device description explicitly states the product is an "assay control mixture" composed of "human leukocytes and erythrocytes in a stabilizing medium," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "complete process control for immunophenotyping by flow cytometry." Immunophenotyping is a laboratory technique used to identify and quantify different cell populations, typically in blood or other body fluids. This is a diagnostic process performed in vitro (outside the body).
- Device Description: The device is described as an "assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples." This further reinforces its use in a laboratory setting for analyzing biological samples.
- Input Imaging Modality: Flow cytometry is a technique used to analyze the physical and chemical characteristics of particles in a fluid as they pass through a laser beam. This is a common method used in in vitro diagnostic testing.
The device is a control used in vitro to ensure the accuracy and reliability of a diagnostic test (immunophenotyping by flow cytometry). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
StatusFlow" is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, RBC lysis, instrument set-up, instrument performance and data analysis.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. StatusFlow "" is composed of human leukocytes and erythrocytes in a stabilizing medium.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing centered on the performance attributes of stability and precision. StatusFlow 40 passed the acceptance criteria of remaining within the assay range over the life of the product. StatusFlow - also demonstrated precision as indicated by the small standard deviations and low %CVs obtained during testing. Expiration dating has been established at 30 days closed vial and 9 days (or 9 thermal cycles) open vial when stored at 2-8°C and handled according to instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.”
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Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 8, 2, 2, 3, and 1. The numbers are written in a cursive style, and the letter 'K' is also handwritten.
Image /page/0/Picture/2 description: The image shows a logo with the letters 'R' and 'D' in a bold, sans-serif font. Between the letters, there is a graphic that appears to be a stylized image of a ship or boat. Below the letters, there is some text that is difficult to read due to the image quality, but it seems to be the name of the company or organization associated with the logo.
Special 510(k) Summary StatusFlowLo™
Date of Summary: June 25, 1998 Company Name: R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact name: Kenneth T. Edds. Ph.D. 612-379-2956, FAX 612-379-6580 automated differential cell counter Classification name: Product name:
CFR section: Device Class: StatusFlow CD4 Low Whole Blood Process Control for Flow Cytometry 864.5220 Class II
Device to which substantial equivalence is claimed: StatusFlow, manufactured by R&D Systems, Inc. 510(k) number: K961610
The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. StatusFlow "" is composed of human leukocytes and erythrocytes in a stabilizing medium.
Intended use: StatusFlow '10 is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, RBC lysis, instrument set-up, intrument performance and data analysis.
StatusFlow 40 has an intended use that is similar to the predicate device and includes a reduced level of CD3+/CD4+ cells. The technologies of the two devices are similar.
Nonclinical testing centered on the performance attributes of stability and precision. StatusFlow 40 passed the acceptance criteria of remaining within the assay range over the life of the product. StatusFlow - also demonstrated precision as indicated by the small standard deviations and low %CVs obtained during testing. Expiration dating has been established at 30 days closed vial and 9 days (or 9 thermal cycles) open vial when stored at 2-8°C and handled according to instructions for use.
R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413
Phone: (612) 379-2956 FAX: (612) 379-6580
WATS: (800) 428-4246 WATS: (800) 523-3395
Customer Service Technical Service & QC Program
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Public Health Service
Image /page/1/Picture/2 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 three human figures, one behind the other, with their arms raised.
JUL 2 0 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds, Ph.D. Requlatory Affairs Manager R&D Systems, Inc. 614 McKinley Place, N.E. Minneapolis, MN 55413 1
Re : K982231 StatusFloworm Trade Name: Requlatory Class: II Product Code: GKZ Dated: June 25, 1998 Received: June 25, 1998
Dear Dr. Edds:
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 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 against 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug 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.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 at (301) 443-6597 or at its
internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
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长982231 510(k) Number:
Device Name:StatusFlow™
Indications for Use:
StatusFlow" is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, RBC lysis, instrument set-up, instrument performance and data analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| 510(k) Number | K982231 |
| Prescription Use | OR Over-The-CounterUse |
(Optional Format 1-2-96)
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