CBC-5D™ is an in vitro diagnostic reagent composed of human erythrocytes, simulated 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 Coulter® Hematology Systems. CBC-5D™ 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-5D™ Hematology Control:

The provided document describes the 510(k) submission for the CBC-5D™ Hematology Control. It focuses on demonstrating substantial equivalence to a predicate device (CBC-STK™) primarily through performance data related to stability.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Stability (Shelf Life): Recovery of values within the Expected Range through the life of the product.	Shelf life established as 52 days from shipment.
Stability (Open-vial): Recovery of values within the Expected Range, with proper handling.	Open-vial stability established as 12 days, provided product is properly handled.

Note: The document doesn't explicitly state numerical "Expected Ranges" or specific recovery percentages that defined the acceptance. It only states that the results "met acceptance criteria for stability tested by recovery of values within the Expected Range."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the test set used to determine the stability.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). It can be inferred that the studies were likely conducted internally by R&D Systems, Inc. given the context of a 510(k) submission and the company's role.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. For a hematology control, "ground truth" typically refers to the expected target values or ranges derived from well-controlled analytical methods or established reference materials, rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided for this type of device (a hematology control). Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of diagnostic images or clinical data where consensus among experts is needed. For a control material, performance is measured against established analytical targets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers’ performance (e.g., accuracy, efficiency) with and without AI assistance is compared. The CBC-5D™ is a quality control material, not a diagnostic tool requiring human interpretation or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:

No, a standalone algorithm-only performance study was not done. This device is a biochemical control material, not a software algorithm. Its performance is evaluated by its stability and ability to yield consistent results when run on hematology instruments, not by an algorithm's output.

7. The Type of Ground Truth Used:

The ground truth for this device's performance evaluation (stability) would be based on established reference ranges or expected values for the measured hematology parameters (e.g., red blood cell count, white blood cell count, platelet count). These expected ranges would be determined through rigorous analytical testing using reference methods and/or comparison to established control materials. The document states "recovery of values within the Expected Range," implying such a ground truth.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. This device is a quality control material and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable and therefore not provided, as there is no "training set" for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the letters R and D in a bold, stylized font, stacked on top of each other. An ampersand symbol is placed between the two letters. Above the letters, there is a handwritten date that appears to be 2/17/99. The letters and ampersand are black, while the background is white.

K983032

510(k) SUMMARY CBC-5D™ HEMATOLOGY CONTROL

Date of Summary:	August 27, 1998
Company/Institution name:	R&D Systems, Inc.614 McKinley Place NEMinneapolis, MN 55413-2647
Contact Person:	Sue Gallo Phone: (612) 379-2956Fax: (612) 379-6580
Trade name:	CBC-5D™ Hematology Control
Classification/Common Name:	Hematology Quality Control Mixture(per 21 CFR 864.8625)
Classification Code/Device Class:	81JPK Hematology Control Mixturesfor Quality Control/Class II

Substantial equivalence:

CBC-5D™ Hematology Control is substantially equivalent to CBC-STK™, a hematology control previously cleared for in vitro diagnostic use. CBC-STK™ is a trademark of R&D Systems, Inc., 614 McKinley Place NE, Minneapolis, MN 55413. The FDA document number for the predicate device, CBC-STK™, is K934497.

Device description:

CBC-5D™ is an in vitro diagnostic reagent composed of human erythrocytes, simulated 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 Coulter® Hematology Systems. Coulter ® is a trademark of Coulter Electronics. Hialeah, FL. CBC-5D™ is available in three levels of measured constituents and is run in the same manner as patient specimens.

Intended use:

CBC-5D™ is a tri-level hematology control designed to document and monitor values obtained from Coulter® hematology instruments.

Comparison of CBC-4K™ to the predicate device:

CBC-5D™ has the same intended use as the predicate device. The composition of CBC-5D™ is the same as the predicate device except an avian red blood cell surrogate has been added.

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 52 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-5D™ is intended for use as a control to monitor the stability of values obtained from the Coulter® Hematology Systems. The stability data demonstrate that CBC-5D™ is a stable material suitable to use as a control. CBC-5D™ is substantially equivalent to CBC-STK™ previously cleared for in vitro diagnostic use.

Submitted by:
Sue Sallo

Sue Gallo, B.S., M.T. (ASCP) Quality Assurance Coordinator

28 -

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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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

FEB 1 7 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sue Gallo Quality Assurance Coordinator R & D Systems, Inc. 614 McKinley Place, N.E. Minneapolis, Minnesota 55413

Re: K983032

Trade Name: CBC-5D™ Hematology Control/Multiple Regulatory Class: II Product Code: JPK Dated: December 3, 1998 Received: December 4, 1998

Dear Ms. Gallo:

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 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). 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Toaime

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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Date: August 27, 1998

510(k) Number (if known):

CBC-5D™ Device Name:

Page 1 of 1

Submitted by: R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413

Indications for Use:

It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. CBC-5D™ is a tri-level hematology control designed to document and monitor values obtained from Coulter® hematology instruments.

Peter E. Mayhew

(Division Sign-Off) Division of Clinical Laboratory Devices J.G.K. 3032 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.