StatusFlow" is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, RBC lysis, instrument set-up, instrument performance and data analysis.

Device Description

The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. StatusFlow "" is composed of human leukocytes and erythrocytes in a stabilizing medium.

AI/ML Overview

The provided document is a 510(k) summary for the StatusFlow CD4 Low Whole Blood Process Control for Flow Cytometry, a device manufactured by R&D Systems, Inc. It describes the device, its intended use, and substantial equivalence to a predicate device. It also briefly mentions nonclinical testing performed. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria values, a detailed study description, sample sizes for test and training sets, or expert qualifications and adjudication methods as would be found in a comprehensive study report.

Based on the available information, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (as reported)	Reported Device Performance (as reported)
Stability	Remaining within the assay range over the life of the product.	StatusFlow 40 passed this criterion. Expiration dating established at 30 days closed vial and 9 days (or 9 thermal cycles) open vial when stored at 2-8°C and handled according to instructions.
Precision	Not explicitly stated as a numerical criterion, but implied to be "small standard deviations and low %CVs."	Demonstrated by small standard deviations and low %CVs obtained during testing.

Study Details

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified in the provided document.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is described as "Nonclinical testing," which typically means laboratory-based testing rather than clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable or not specified. This device is a process control for immunophenotyping, not a diagnostic device that requires expert interpretation of results to establish ground truth for testing. The "ground truth" for a control would be its known component concentrations or characteristics, established through manufacturing and established analytical methods.
Qualifications of Experts: Not applicable or not specified.

4. Adjudication method for the test set:

Adjudication Method: Not applicable or not specified. Since it's a process control, the "ground truth" (or target values) would be determined by the manufacturing process and quality control, not by expert adjudication of observational data.

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:

MRMC Study: No. This device is a process control for flow cytometry, not an AI-assisted diagnostic tool. An MRMC study is therefore not relevant.
Effect Size of Human Readers with/without AI: Not applicable.

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

Standalone Performance: Not applicable. This is a laboratory reagent/control, not an algorithm or AI system.

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

Type of Ground Truth: The ground truth for a process control like StatusFlow would be analytical reference values established during its manufacturing and characterization (e.g., known concentrations/percentages of leukocyte subsets). These values would be determined through validated laboratory methods, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Sample Size (Training Set): Not applicable or not specified. As a process control, the development likely involves extensive R&D and optimization, but the concept of a "training set" in the context of machine learning or AI does not apply here. The document details "nonclinical testing" related to stability and precision, implying laboratory studies to characterize the product's performance.

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

How Ground Truth Established (Training Set): Not applicable. The "ground truth" for the development and testing of such a control would be the controlled manufacturing process and validated analytical methods used to characterize the product's components and expected performance.

Summary

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Special 510(k) Summary StatusFlowLo™

Date of Summary: June 25, 1998 Company Name: R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact name: Kenneth T. Edds. Ph.D. 612-379-2956, FAX 612-379-6580 automated differential cell counter Classification name: Product name:

CFR section: Device Class: StatusFlow CD4 Low Whole Blood Process Control for Flow Cytometry 864.5220 Class II

Device to which substantial equivalence is claimed: StatusFlow, manufactured by R&D Systems, Inc. 510(k) number: K961610

Intended use: StatusFlow '10 is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, RBC lysis, instrument set-up, intrument performance and data analysis.

StatusFlow 40 has an intended use that is similar to the predicate device and includes a reduced level of CD3+/CD4+ cells. The technologies of the two devices are similar.

Nonclinical testing centered on the performance attributes of stability and precision. StatusFlow 40 passed the acceptance criteria of remaining within the assay range over the life of the product. StatusFlow - also demonstrated precision as indicated by the small standard deviations and low %CVs obtained during testing. Expiration dating has been established at 30 days closed vial and 9 days (or 9 thermal cycles) open vial when stored at 2-8°C and handled according to instructions for use.

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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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human figures, one behind the other, with their arms raised.

JUL 2 0 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth T. Edds, Ph.D. Requlatory Affairs Manager R&D Systems, Inc. 614 McKinley Place, N.E. Minneapolis, MN 55413 1

Re : K982231 StatusFloworm Trade Name: Requlatory Class: II Product Code: GKZ Dated: June 25, 1998 Received: June 25, 1998

Dear Dr. Edds:

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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 at (301) 443-6597 or at its

internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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长982231 510(k) Number:

Device Name:StatusFlow™

Indications for Use:

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

510(k) Number	K982231
Prescription Use	OR Over-The-CounterUse

(Optional Format 1-2-96)

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”