R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.

Device Description

This control is an assayed whole blood control designed to monitor values on multi-parameter hematology cell counters.

AI/ML Overview

Here's an analysis of the provided text regarding the R&D CBC-4K Plus Retics Hematology Control, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Remaining within the assay range over the life of the product	Passed: The device "passed the acceptance criteria of remaining within the assay range over the life of the product."
Demonstrated precision	Demonstrated (small standard deviation and % CVs): "R&D CBC-4K Plus Retics Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing."
Expiration dating established	Established (75 days closed vial, 8 days open vial): "Expiration dating has been established at 75 days (closed vial) and 8 days (open vial) when stored at 2 - 8° C and handled according to instructions for use."
Substantial equivalence in performance, precision, and stability to predicate device	Substantially Equivalent: "Laboratory testing of 3 validation lots has shown R&D CBC-4K Plus Retics Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device."

Note: The document describes the "life of the product" as 75 days (closed vial) and 8 days (open vial) when stored at 2-8°C.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: "3 validation lots" were used for laboratory testing. The exact number of individual samples within these lots is not specified.
- Data Provenance: The data appears to be prospective as it's generated from "laboratory testing" and validation of new lots of the control product. The country of origin is implicitly the United States, as R&D Systems, Inc. is based in Minneapolis, MN, and the submission is to the FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" for a hematology control would typically be its manufacturing-assigned values and expected stability based on formulation and empirical testing. It's not a diagnostic device that requires expert interpretation of results for ground truth.
Adjudication method for the test set:
- This is not applicable as the device is a quality control material, not a diagnostic device requiring human interpretation and multi-reader adjudication. The performance is assessed against predefined assay ranges and statistical metrics (standard deviation, %CV).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant to diagnostic interpretation by human readers, often with AI assistance, which is not the purpose of a hematology control material.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The concept of "standalone performance" for this device is not applicable in the typical sense of an AI algorithm. The device is the control material itself, and its performance is evaluated instrumentally (on CELL-DYN® hematology instruments) against established criteria and compared to a predicate device. The "algorithm" here is the underlying chemical and biological formulation of the control and its interaction with the specified instruments. The testing described is its standalone performance without human interpretation of its results, though human users would use the results to monitor instruments.
The type of ground truth used:
- The "ground truth" for a quality control material is typically its manufacturing-assigned target values and expected range, along with its stability profile over time under specified storage conditions. The study confirms that the material remains within these predefined assay ranges and demonstrates consistent precision.
The sample size for the training set:
- This information is not provided. For a physical control material like this, there isn't a "training set" in the machine learning sense. The formulation and initial performance characteristics would be established through a developmental phase, which is not detailed here. The "laboratory testing" described seems to be the validation of the final product.
How the ground truth for the training set was established:
- As noted above, the concept of a "training set ground truth" isn't directly applicable. The "ground truth" for the control material itself would be established during its development and manufacturing process, likely through:
  - Formulation science: Developing the chemical and biological composition to achieve desired cell counts and parameters.
  - Reference methods: Assaying the control lots using highly accurate and precise reference methods or instruments to assign initial target values.
  - Stability studies: Conducting real-time and accelerated stability studies to determine expiration dates and storage conditions.
  - Predicate device comparison: Using the performance of the predicate device as a benchmark.

Summary

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JUL 1 2 2005

510(k) Special Summary R&D Systems, Inc. CBC-4K Plus Retics Hematology Control

Date of Summary:	June 29, 2005
Company Name:	R&D Systems, Inc.614 McKinley Place N.E.Minneapolis, MN 55413
Contact name:	Ralph E. Hogancamp612-656-4413, FAX 612-379-6580
Classification name:	Hematology Quality Control Mixture
Product name:	R&D CBC-4K Plus Retics HematologControl
CFR section:	864.8625 Hematology quality controlmixture.

Predicate Device: R&D Systems CBC-4K Hematology Control, K970331 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413

Description: This control is an assayed whole blood control designed to monitor values on multi-parameter hematology cell counters.

Intended use: R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.

Comparison: Both products are used to monitor CELL-DYN® hematology instruments. The R&D CBC-4K Plus Retics added new parameters.

Discussion: Laboratory testing of 3 validation lots has shown R&D CBC-4K Plus Retics Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-4K Plus Retics Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product, R&D CBC-4K Plus Retics Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing. Expiriation dating has been established at 75 days (closed vial) and 8 days (open vial) when stored at 2 - 8° C and handled according to instructons for use.

Conclusion: R&D CBC-4K Plus Retics Hematology Control is a safe and effective control for the above intended use when used as instructed in the package insert.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

JUL 1 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ralph E. Hogancamp Regulatory Affairs Specialist R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413

Re: K051339

Trade/Device Name: R&D CBC-4K Plus Retics Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: June 29, 2005 Received: June30, 2005

Dear Mr. Hogancamp:

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, 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 (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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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobetz Beckerh

Robert L. Becker, Jr., MD, PH. 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): K051339

Device Name: R&D CBC-4K Plus Retics Hematology Control

Indications for Use:

Prescription Use X________AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO USE ANOTHER PAGE IF NEEDED)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K05133 510(k)________________________________________________________________________________________________________________________________________________________________________

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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.