Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System. Refer to the System HELP or Instructions for Use.

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

Device Description

Body Fluid Control is a reference product prepared from treated, stabilized human erythrocytes suspended in an isotonic medium. Body Fluid Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. Body Fluid Control confirms and monitors instrument accuracy and precision performance by providing measurements during counting.

AI/ML Overview

This submission (K082162) is for the COULTER® Body Fluid Control, a hematology quality control material. It is a control product, not a diagnostic device that performs measurements on patient samples with an AI component. Therefore, the typical acceptance criteria and study designs involving AI-driven performance metrics, ground truth establishment, and expert adjudication are not applicable here.

Instead, the "performance" of this device relates to its stability and its ability to consistently monitor the accuracy and precision of instruments like the UniCel® DxH 800 COULTER Cellular Analysis System. The study mentioned focuses on the control material's stability, not its diagnostic accuracy in identifying medical conditions.

Here's an breakdown of the provided information in the context of a quality control device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" in the way a diagnostic device might have performance thresholds (e.g., sensitivity, specificity). For a quality control material, acceptance is based on its stability and its ability to provide consistent "assigned values and expected ranges" for monitoring an instrument's performance.

Acceptance Criteria (Implied for a QC Material)	Reported Device Performance (from text)
Stability (Closed Vial)	120 days
Stability (Open Vial)	16 days (for 18 events)
Ability to monitor instrument accuracy and precision.	"Body Fluid Control confirms and monitors instrument accuracy and precision performance by providing measurements during counting."
Ability to verify measuring range.	"The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range."
Substantial Equivalence to Predicate	Found substantially equivalent to COULTER® 5C® Cell Control (Cleared as COULTER® PX Cell Control) (K912133 & K060464).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Stability studies of Body Fluid Control." It does not specify the sample size used for these studies, nor the country of origin, or if they were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. For a quality control material, the "ground truth" would be established by reference methods or manufacturing specifications to determine the assigned values and expected ranges for the control. The document does not detail this process but implies that "assigned values and expected ranges on the TABLE OF EXPECTED RESULTS" are provided with the product.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is not an AI algorithm requiring adjudication of its output.

5. 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 is not a diagnostic device or an AI assistant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a quality control material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for a quality control material like this would be the reference values and expected ranges established during its manufacturing and characterization process. These values are determined through rigorous testing with calibrated instruments and established methodologies to ensure the control material is stable and provides consistent results within specified analytical ranges. The document states, "The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range."

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary

{0}------------------------------------------------

K082162

FEB - 3 2009

510(k) Summary COULTER® Body Fluid Control

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

2. Date Submitted:

July 30, 2008

3. Device Name(s):

3:1 Proprietary Names

COULTER® Body Fluid Control

3.2 Classification Name

Hematology quality control mixture (21 CFR § 864.8625)

4. Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
COULTER® BodyFluid Control	COULTER® 5C®Cell Control(Cleared asCOULTER® PX CellControl)	Beckman Coulter, Inc.	K912133&K060464

COULTER® Body Fluid Control Traditional 510(k) Notification

Page 16

... . . -----------------

{1}------------------------------------------------

5. Description:

Intended Use: 6.

7. Comparison to Predicate(s):

COULTER Body Fluid Control is similar to the current COULTER 5C Cell Control except for the number of parameters reported and their respective concentrations. The product is used to monitor the RBC and TNC (white blood cells) measurements from the Body Fluid cycle on the UniCel® DxH 800 analyzer (pending 510(k) clearance K081930).

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 Body Fluid Control support the Beckman Coulter stability claims of 18 events within 16 days (open vial) and 120 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.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The central symbol appears to be an abstract representation, possibly of an eagle or other bird-like figure, with three stylized wing or feather shapes.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB -3 2009

Re: K082162

Trade/Device Name: Coulter® Body Fluid Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: January 06, 2009 Received: January 07, 2009

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.

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.

{3}------------------------------------------------

Page 2 - Ms. Lourdes Coba

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria M. Chan

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: COULTER® Body Fluid Control

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of 1.
Office of
Evaluation
K082162

COULTER® Body Fluid Control Traditional 510(k) Notification

Page 14

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.