(67 days)
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No
The document describes a biological control material for flow cytometry, not a software or analytical device that would typically incorporate AI/ML. There are no mentions of AI, ML, algorithms, or data processing beyond standard performance metrics.
No
The device is described as a control for immunophenotyping and flow cytometric determinations, not for treating any condition or disease. It is used in diagnostic processes to ensure accuracy of testing.
No
This device is described as a "control" and "assay control mixture" used to evaluate instrument performance and ensure consistency in immunophenotyping, rather than to diagnose a medical condition in a patient.
No
The device description clearly states it is a "stabilized preparation of human peripheral leukocytes and erythrocytes" and an "assay control mixture," indicating it is a physical substance, not software.
Based on the provided information, the R&D Systems' Whole Blood Flow Control (WBFC) is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states it is "to be used as a control in the complete immunophenotyping process which includes: antibody staining, RBC lysis, instrument set-up and instrument performance." This process is performed in vitro (outside the body) on biological samples (whole blood).
- Device Description: The description confirms it's an "assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples." Again, this is an in vitro assay.
- Predicate Device: The mention of a predicate device (CD Chex, manufactured by Streck Laboratories) with a K number (K920997) strongly indicates that this device is being submitted for regulatory clearance as an IVD. Predicate devices are used to demonstrate substantial equivalence for new IVDs.
Therefore, the R&D Systems' Whole Blood Flow Control fits the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
R&D Systems' Whole Blood Flow Control (WBFC) is a stabilized preparation of human peripheral leukocytes and erythrocytes to be used as a control in the complete immunophenotyping process which includes: antibody staining, RBC lysis, instrument set-up and instrument performance.
Product codes
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Device Description
The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. R&D Systems' Whole Blood Flow Control 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
Nonclinical testing centered on the performance attributes of stability and precision. WBFC passed the acceptance criteria of remaining within the assay range over the life of the product. WBFC also demonstrated precision as indicated by the small standard deviations and low CVs obtained during the testing. WBFC was also compared, in terms of precision, to freshly drawn whole blood and found to exhibit similar reproducibility of performance. Expiration dating has been established as 28 days closed vial and 7 days open vial when stored at 2-8°C and handled according to instructions for use.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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/0 description: The image shows the logo for R&D Systems. The logo features a stylized "R&D" in a bold, sans-serif font, with the "&" symbol intertwined between the "R" and "D". Below the letters, the word "SYSTEMS" is written in a distressed, blocky font, giving it a textured appearance.
Product name:
CFR section:
Device Class:
| JUL | - 1 1996 |
|---|---|
| ----- | ---------- |
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510(k) Summary R&D Systems' Whole Blood Flow Control
| Date of Summary: | April 25, 1996 |
|---|---|
| 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 | |
| Classification name: | automated differential cell counter |
R&D Whole Blood Flow Control 864.5220 Class II
Device to which substantial equivalence is claimed: CD Chex, manufactured by Streck Laboratories, 14306 Industrial Rd. Omaha, NE 68144. 510(k) number: K920997
The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. R&D Systems' Whole Blood Flow Control is composed of human leukocytes and erythrocytes in a stabilizing medium.
Intended use: R&D Systems' Whole Blood Flow Control (WBFC) is a stabilized preparation of human peripheral leukocytes and erythrocytes to be used as a control in the complete immunophenotyping process which includes: antibody staining, RBC lysis, instrument set-up and instrument performance.
R&D Systems' Whole Blood Flow Control has an intended use that is similar to the predicate device but, in addition, includes the lysis of red blood cells in the control protocol. The technologies of the two devices are similar.
Nonclinical testing centered on the performance attributes of stability and precision. WBFC passed the acceptance criteria of remaining within the assay range over the life of the product. WBFC also demonstrated precision as indicated by the small standard deviations and low CVs obtained during the testing. WBFC was also compared, in terms of precision, to freshly drawn whole blood and found to exhibit similar reproducibility of performance. Expiration dating has been established as 28 days closed vial and 7 days 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) 343-7475