4C®EX 300 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 instrument specific instructions 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.

Device Description

4C -EX 300 Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic medium. 4C®-EX 300 Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. By design, 4C®-EX 300 Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing and hemoglobin determination.

AI/ML Overview

This document describes the COULTER® 4C®-EX 300 Cell Control, a hematology quality control material.
The stated intended use is to "monitor the performance of COULTER® hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., maximum allowable deviation, coefficient of variation). Instead, the performance studies assess the stability and the process for establishing expected values.

Study	Acceptance Criteria (Implicit from Study Design)	Reported Device Performance
Open and Closed Vial Stability	Maintain stable performance over the product's shelf life on specified instruments (DxH 300 and DxH 300C).	Demonstrated acceptable results.
Value Assignment Process	Establish a robust and validated process for determining assigned values for each lot.	Established process for generating assigned value for 4C®-EX 300 Cell Control.
Range Determination Process	Establish a statistically sound method to calculate RDW-SD expected ranges based on existing parameters and their mathematical relationship.	Established RDW-SD expected ranges for each level of 4C®-EX 300 Cell Control.

2. Sample Size and Data Provenance

Test Set Sample Size: The document specifies "3 lots" for the open and closed vial stability study. It does not provide specific sample sizes (e.g., number of vials, number of runs) beyond this. The "Value Assignment Process" and "Range Determination Process" studies describe methodology rather than specific sample sizes of actual test runs.
Data Provenance: The data is generated by Beckman Coulter, Inc. as part of their 510(k) submission for regulatory approval. The studies were conducted internally. There is no information regarding country of origin for the data or if it was retrospective or prospective, though internal studies for regulatory submission are typically prospective for the specific purpose of the submission.

3. Number of Experts to Establish Ground Truth and Qualifications

Number of Experts: The document mentions "multiple analysis of the control product" for value assignment and a "bio-statistician" for range determination. It does not specify the exact number of experts (e.g., laboratory technicians, statisticians) or their specific qualifications (e.g., years of experience, certifications) beyond those functional roles.
Qualifications of Experts:
- For Value Assignment: Implied to be individuals trained and qualified to perform analysis on validated hematology systems using specific Beckman Coulter reagents.
- For Range Determination: A "bio-statistician" is explicitly mentioned, implying expertise in statistical analysis relevant to biological measurements.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The studies focus on internal validation of the control material's stability, value assignment, and range determination. There is no mention of external reviewers or a process for resolving discrepancies in results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC comparative effectiveness) is typically associated with diagnostic algorithms or imaging devices where human readers interpret results with and without AI assistance to assess changes in diagnostic accuracy or efficiency. The COULTER® 4C®-EX 300 Cell Control is a quality control material, not a diagnostic algorithm, and therefore such a study is not applicable to its evaluation.

6. Standalone Performance Study

Yes, in a sense relevant to a quality control material. The "Open and Closed Vial Stability" study, "Value Assignment Process," and "Range Determination Process" evaluate the performance of the control material itself (standalone) in its intended function. These studies assess the inherent characteristics and consistency of the control without direct human interpretation being the primary variable.

7. Type of Ground Truth Used

The ground truth for this quality control material is established through:

Reference Method / Assigned Values: For the "Value Assignment Process," the document states, "Value assignments for each lot of 4C®-EX 300 Cell Control are determined on validated systems using specific Beckman Coulter reagents." This implies that the 'ground truth' for the assigned values is derived from precise measurements on highly controlled and validated reference instruments and methods.
Statistical Derivation: For the "Range Determination Process," the ground truth for the RDW-SD ranges is established by a "bio-statistician" based on the "assigned values and expected ranges of MCV and RDW parameters and the mathematical relationship between these parameters."

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of an algorithm or AI. This product is a control material, not a machine learning model. The studies described are for validation of the control material's performance and the processes used to establish its characteristics, not for training an AI system.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model. For the control material itself, the "ground truth" for its assigned values and ranges are established through the processes described in section 7 (e.g., validated instrument measurements, statistical derivation).

Summary

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510(k) Summary COULTER® 4C®- EX 300 Cell Control

100007

1. Submitted By:

Lourdes Coba Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4079 FAX: (305) 380-4344

NOV 1882010

2. Date Submitted :

March 2, 2010

3. Device Name(s):

3.1 Proprietary Names

COULTER® 4C®-EX 300 Cell Control

3.2 Classification Name

Hematology quality control mixture (21 CFR § 864.8625)

4. Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
COULTER® 4C®-EX 300Cell Control(with additional parameter,RDW-SD)	COULTER® 4C®-ESCell Control	Beckman Coulter,Inc.	K010064

5. Description:

Traditional 510(k) Submission 4C-EX 300 Cell Control Beckman Coulter, Inc.

Page 1 of 3

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ଚ. Intended Use:

4C -EX 300 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 instrument specific instructions 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.

7. Comparison to Predicate(s):

COULTER® 4C®-EX 300 Cell Control with the additional parameter (RDW-SD) is identical to the current COULTER 4C®-ES Cell Control. RDW-SD is a derived parameter from the RBC histogram which is obtained on a new COULTER® hematology analyzer. The control product formulation and manufacturing processes were not modified to obtain the additional parameter.

8. Summary of Performance Data:

Study	Study Design	Study Results
Open andClosed VialStability	Evaluated open and closed vial stabilityof 3 lots of 4C®-EX 300 Cell Control overthe shelf life of the product on a DxH 300and DxH 300C.	4C®-EX 300 CellControl demonstratedacceptable results.
ValueAssignmentProcess	Value assignments for each lot of 4C®-EX 300 Cell Control are determined onvalidated systems using specificBeckman Coulter reagents. AssignedValues are confirmed by multipleanalysis of the control product.	Established process forgenerating assignedvalue for 4C®-EX 300Cell Control.
RangeDeterminationProcess	The expected ranges for RDW-SD werecalculated by a bio-statistician basedupon the assigned values and expectedranges of MCV and RDW parametersand the mathematical relationshipbetween these parameters for each levelof 4C®-EX 300 Cell Control.	Established RDW-SDexpected ranges foreach level of 4C®-EX300 Cell Control.

Traditional 510(k) Submission 4C-EX 300 Cell Control Beckman Coulter, Inc.

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The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.

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

Traditional 510(k) Submission 4C-EX 300 Cell Control Beckman Coulter, Inc.

Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Beckman Coulter, Inc. c/o Ms. Lourdes Coba Staff Regulatory Affairs Specialist 11800 SW 147 Avenue MS 31 B06 Miami, FL 33196

NOV 1 8 2010

Re: K100607

Trade/Device Name: COULTER 4C-EX 300 Cell Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: October 27, 2010 Received: October 28, 2010

Dear Ms. Coba:

.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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 -- Ms. Lourdes Coba

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ia mchan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

NOV 1 8 2010

510(k) Number (if known): K100607

Device Name: COULTER® 4C®-EX 300 Cell Control

Indication 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.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature: Sender R. S. Li

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ki00607

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.