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. CBC-4K™ is available in three levels of measured constituents and is run in the same manner as patient specimens.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CBC-4K™ Hematology Control:

The provided document describes a hematology control device, not an AI or imaging device, which means many of the requested criteria for AI/imaging studies (like experts, adjudication, MRMC studies, effect size, standalone performance, training sets, etc.) are not applicable in this context. The acceptance criteria here pertain to the stability and performance of a laboratory reagent for quality control.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability tested by recovery of values	Met acceptance criteria for stability
Values within the Expected Range	Recovery of values was within the Expected Range
Shelf life	Established as 80 days from shipment
Open-vial stability	Established as 12 days, provided proper handling according to instructions

Study Details (as inferable from the text)

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "studies" and "performance data" without specifying the number of samples or runs.
- Data Provenance: Not specified, but given it's a laboratory control, it would have been generated in a controlled laboratory setting (likely R&D Systems' own lab). It is implicitly prospective in nature, as new batches of the control would be tested for stability over time.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. For a hematology control, "ground truth" is established by the well-defined properties of the control material (e.g., target values for cell counts, hemoglobin, etc.) measured against a reference method or validated instrument. It does not involve human expert interpretation in the same way an imaging study would.
Adjudication Method for the Test Set:
- Not Applicable. Adjudication is not relevant for the performance assessment of a laboratory control. The performance is measured objectively against predefined analytical targets and stability parameters.
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is for evaluating human performance, often with and without AI assistance, and is not relevant for a laboratory control.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is a physical reagent, not an algorithm. Its "standalone" performance refers to its intrinsic chemical and biological stability, which was indeed evaluated.
The Type of Ground Truth Used:
- The "ground truth" here is the expected values and stability characteristics of the hematology control, which are determined through rigorous internal testing against established laboratory standards and reference methods. The performance is measured against these predetermined target ranges and the expected duration of stability.
The Sample Size for the Training Set:
- Not Applicable. This device is a control reagent, not an AI model requiring a training set.
How the Ground Truth for the Training Set Was Established:
- Not Applicable.

Summary Specific to K970331:

The document focuses on demonstrating that the CBC-4K™ Hematology Control is substantially equivalent to a predicate device (CBC-3K™) and that its stability performance meets the required criteria for its intended use as a quality control reagent for Cell-Dyn® hematology instruments. The key performance evaluation here is stability, ensuring that the control material maintains its specified characteristics over its shelf life and open-vial period. The assessment is purely analytical and objective, comparing measured values to established target ranges and timeframes.

Summary

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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.

K970331

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

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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.

38 -

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

Regulation Number and Section

§ 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.