5C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your Product Manuals or On-line Help System.)

The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.

Device Description

5C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic, bacteriostatic medium. 5C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. By design, 5C Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination and White Blood Cell differentiation using VCS technology.

AI/ML Overview

The provided 510(k) summary (K060464) describes the addition of a new parameter (RDW-SD) to an existing device, the COULTER® 5C® Cell Control. It explicitly states that the control product formulation and manufacturing processes were not modified to obtain the additional parameter. Because the device itself (the control material) is not being altered and is simply being used to monitor a new, derived parameter, the submission focuses primarily on stability studies of the control material with the RDW-SD parameter, rather than a comparative effectiveness study of the control material against a separate ground truth for RDW-SD.

Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not directly applicable or are not explicitly detailed in this type of submission. The acceptance criteria generally relate to the stability of the control material, and its ability to provide consistent RDW-SD values over time suitable for monitoring instrument performance.

Here's an attempt to answer based on the provided document, addressing each point as much as possible:

Acceptance Criteria and Reported Device Performance

The document states: "Stability studies of 5C Cell Control with RDW-SD parameter support the Beckman Coulter stability claims of 13 events within 13 days (open vial) and 95 days (closed vial)." This implies that the acceptance criteria for the "device" (the control material with the RDW-SD parameter) are its stability within these timeframes. The reported performance is that it meets these stability claims.

Acceptance Criteria	Reported Device Performance
Stability: 13 events within 13 days (open vial)	Supported (meets claims)
Stability: 95 days (closed vial)	Supported (meets claims)

Note: The specific numerical ranges or statistical measures used to demonstrate "stability" (e.g., coefficient of variation, deviation from target values) are not provided in this summary. These would typically be detailed in the full premarket notification but are summarized here by directly stating support for the claims.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "stability studies" without detailing the number of control vials, lots, or measurements taken.
- Data Provenance: Not explicitly stated. It is implied to be from internal Beckman Coulter studies, likely conducted in their facilities. The country of origin is not specified, but Beckman Coulter is a US-based company, suggesting the studies would be conducted in the US or under US regulatory standards. The studies would be prospective in nature, as they are designed to test the stability of newly manufactured control material over time.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the conventional sense. For a quality control material like 5C Cell Control, "ground truth" for a parameter like RDW-SD is typically established by:
  - Traceability to a reference measurement procedure: The instrument that measures RDW-SD is calibrated against reference methods or materials.
  - Consensus values from multiple instruments: The manufacturer determines expected values and ranges for their control material by running it on multiple, well-calibrated instruments.
- There is no mention of human experts directly establishing a "ground truth" for RDW-SD values on the control material in the context of this 510(k) summary. The ground truth would be the expected or assigned values based on instrument performance and calibration.
Adjudication method for the test set:
- Not applicable. This is not a study requiring human interpretation or adjudication (e.g., image reading). The "test set" would be the measurements of RDW-SD from the control material over time. Data validity would be assessed by statistical methods against predefined acceptance criteria for stability.
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:
- Not applicable. This device is a hematology quality control material, not an AI-assisted diagnostic tool or an imaging device requiring human readers or adjudication.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a control material for an automated hematology analyzer. The "algorithm" here would be the analyzer's software that calculates RDW-SD from the raw RBC histogram data. The stability studies assess the control's ability to consistently challenge this algorithm and the overall instrument performance. The human-in-the-loop is the laboratory technologist monitoring the results against the expected range.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the RDW-SD parameter of the 5C Cell Control is the assigned value and expected range provided by Beckman Coulter. These values are derived from extensive testing on their hematology analyzers (as mentioned, on a new COULTER hematology analyzer that is described as having a "510k submission pending" for its RDW-SD capability). This established value acts as the reference for monitoring instrument accuracy and precision, which is the intended use of the control. It's essentially a manufacturer-established reference value based on instrument performance and calibration.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K 060464

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two white curved lines running through it. To the right of the circle are the words "BECKMAN" on the top line and "COULTER" on the bottom line, both in a bold, sans-serif font.

MAR 2 8 2006

510(k) Summary Parameter Addition (RDW-SD) to COULTER 5C Cell Control

1. Submitted By:

Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4191 FAX: (305) 380-3618

2. Date Submitted:

February 21, 2006

3. Device Name(s):

3.1 Proprietary Names

COULTER® 5C® Cell Control

3.2 Classification Name

Hematology quality control mixture (21 CFR § 864.8625)

4. Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
COULTER® 5C® CellControl	COULTER® 5C® CellControl(Cleared as COULTER® PXCell Control)	Beckman Coulter, Inc.	K912133

5. Description:

Beckman Coulter , Inc. 11800 S.W. 147th Avenue Miami, FL 33196-2500

Mailing Address:

11800 S.W. 147th Avenue P.O. Box 169015 Miami, FL 33116-9015

Customer Service: (800) 526-7694 Product Information: (800) 526-69321 (800) 327-6531 (305) 380-3800 Internet: www.beckmancouiter.com

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accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination and White Blood Cell differentiation using VCS technology.

ి. Intended Use:

The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.

7. Comparison to Predicate(s):

COULTER 5C Cell Control with the additional parameter (RDW-SD) is identical to the current COULTER 5C Cell Control. RDW-SD is a derived parameter from the RBC histogram which is obtained on a new COULTER hematology analyzer (5106 submission pending). The control product formulation and manufacturing processes were not modified to obtain the additional parameter.

8. Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stability studies of 5C Cell Control with RDW-SD parameter support the Beckman Coulter stability claims of 13 events within 13 days (open vial) and 95 days (closed vial).

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

MAR 2 8 2000

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Ms. Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500

K060464 Trade/Device Name: COULTER® 5C® Cell Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: February 21, 2006 Received: February 22, 2006

Dear Ms. Nadler:

Re:

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 (OS) 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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Page 2 -

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,

Robert Beckerh

Robert L. Becker, Jr., MD, PK 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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page 1 of

510(k) Number (if known):

Device Name: COULTER® 5C® Cell Control

Indications for Use:

The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.

(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)
OR
Over-the-Counter Use
Optional Format 1-2-96

Division Sign Off

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K060464

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.