(78 days)
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No
The document describes a hematology control reagent, which is a stable material used to verify the accuracy and precision of hematology instruments. There is no mention of AI or ML in the intended use, device description, or performance studies. The device is a reagent, not a software or hardware system that would typically incorporate AI/ML for analysis or interpretation.
No.
The device is described as an in vitro diagnostic reagent used to verify the accuracy and precision of hematology instruments, not to treat a medical condition.
No
This device is a control material (reagent) used to verify the accuracy and precision of hematology instruments, not a device that directly diagnoses a medical condition or disease in a patient.
No
The device is described as an in vitro diagnostic reagent composed of biological materials (human erythrocytes, mammalian leukocytes, and platelets) suspended in a fluid. This indicates it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is "designed to document and monitor values obtained from Cell-Dyn ® hematology instruments." This indicates it's used to assess the performance of a diagnostic device.
- Device Description: The description clearly states "CBC-4K™ is an in vitro diagnostic reagent". It also describes its composition and purpose in verifying the accuracy and precision of hematology systems, which are diagnostic instruments.
- Composition: It is composed of biological components (human erythrocytes, mammalian leukocytes, and platelets) suspended in a fluid, which is typical for in vitro diagnostic reagents used for blood analysis.
- Function: It is used to "verify accuracy and precision" of a diagnostic instrument (Cell-Dyn® Hematology Systems). This is a key function of a quality control material, which falls under the umbrella of IVDs.
- Usage: It is "run in the same manner as patient specimens," indicating it's used within the diagnostic workflow.
All these points strongly support the classification of CBC-4K™ as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CBC-4K™ is a tri-level hematology control designed to document and monitor values obtained from Cell-Dyn ® hematology instruments.
Product codes
81JPK
Device Description
CBC-4K™ is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes and platelets suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of verifying accuracy and precision of Cell-Dyn® Hematology Systems. Cell-Dyn® is a trademark of Abbott Diagnostics, Abbott Park, Illinois. CBC-4K™ is available in three levels of measured constituents and is run in the same manner as patient specimens.
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
Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 80 days from shipment and the openvial stability is 12 days provided that the product is properly handled according to the package insert instructions.
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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§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Image /page/0/Picture/0 description: The image shows a logo for "R&D SYSTEMS". The logo is in black and white and features the letters "R" and "D" in a stylized font. The word "SYSTEMS" is written in a smaller font below the letters "R" and "D". The logo appears to be for a company or organization that is involved in research and development.
510(k) SUMMARY CBC-4K™ HEMATOLOGY CONTROL
Date of Summary:
Company/Institution name:
Contact Person:
Trade name:
Classification/Common Name:
Classification Code/Device Class:
January 27, 1997
R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413-2647
Phone: (612) 379-2956 Sue Gallo Fax: (612) 379-6580
CBC-4K™ Hematology Control
Hematology Quality Control Mixture (per 21 CFR 864.8625)
Classification Code/Device Class:
81JPK Hematology Control Mixtures for Quality Control/Class II
Substantial equivalence:
CBC-4KT™ Hematology Control is substantially equivalent to CBC-3K™, a hematology control currently being sold for in vitro diagnostic use. CBC-3K™ is a trademark of R&D Systems, Inc., 614 McKinley Place N. E., Minneapolis, MN 55413. The FDA document number for the predicate device, CBC-3K™, is K904464.
Device description:
CBC-4K™ is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes and platelets suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of verifying accuracy and precision of Cell-Dyn® Hematology Systems. Cell-Dyn® is a trademark of Abbott Diagnostics, Abbott Park, Illinois. CBC-4K™ is available in three levels of measured constituents and is run in the same manner as patient specimens.
Intended use:
2000
المتحدة المستقل المستوى المستوى المستوى المستوى المستوى المستقب المستوى المستقب المستقب المستقب المستقب المستقب المستقب المستقب المستقب المستقب المستقب المستقب المستقب المست
CBC-4K™ is a tri-level hematology control designed to document and monitor values obtained from Cell-Dyn ® hematology instruments.
Comparison of CBC-4K™ to the predicate device:
CBC-4K™ has the same intended use as the predicate device. The composition of CBC-4K™ is the same as the predicate device except a nucleated red blood cell surrogate has been added. This parameter is measured by the Cell-Dyn® 4000 but not by other models of Cell-Dyn® hematology analyzers.
Discussion of performance data:
The determination of substantial equivalence is based on an assessment of performance data. Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 80 days from shipment and the openvial stability is 12 days provided that the product is properly handled according to the package insert instructions.
Conclusions:
CBC-4K™ is intended for use as a control to monitor the stability of values obtained from the Abbott Cell-Dyn® Hematology Systems. The stability data demonstrate that CBC-4K™ is a stable material suitable to use as a control. CBC-4K™ is substantially equivalent to CBC-3K™ currently sold for in vitro diagnostic use.
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Submitted by:
Sue Sallo
Sue Gallo, B.S., M.T. (ASCP) Quality Assurance Coordinator
R&D Systems, Inc. 614 McKinlev 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
APR 16 1997