STATUSFLOW

K982231 · R&D Systems, Inc. · GKZ · Jul 20, 1998 · Hematology

Device Facts

• Record ID: K982231
• Device Name: STATUSFLOW
• Applicant: R&D Systems, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Jul 20, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

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 Story

StatusFlow™ is an assay control mixture consisting of human leukocytes and erythrocytes in a stabilizing medium. It serves as a process control for flow cytometric immunophenotyping. The device is used in clinical laboratory settings by laboratory personnel to verify instrument performance, antibody staining, RBC lysis, and data analysis. It provides a stable reference sample to ensure the accuracy and precision of flow cytometry workflows. The device is stored at 2-8°C and has an established shelf life of 30 days (closed) or 9 days/9 thermal cycles (open).

Clinical Evidence

Bench testing only. Performance attributes of stability and precision were evaluated. The device met acceptance criteria for remaining within the assay range over the product life. Precision was demonstrated via small standard deviations and low %CVs. Expiration dating was established at 30 days closed vial and 9 days (or 9 thermal cycles) open vial when stored at 2-8°C.

Technological Characteristics

Assay control mixture composed of human leukocytes and erythrocytes in a stabilizing medium. Designed for flow cytometry applications. Stability established at 2-8°C. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a process control for immunophenotyping by flow cytometry, including antibody staining, RBC lysis, instrument set-up, instrument performance, and data analysis. Patient population not specified; intended for laboratory use.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• StatusFlow (K961610)

Submission Summary (Full Text)

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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 [phone] 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

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.

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: [phone] FAX: [phone]

WATS: [phone] WATS: [phone]

Customer Service Technical Service & QC Program

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Public Health Service

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# 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 [phone].

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 [phone]. Additionally, for questions on the promotion and " advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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:

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.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| | <img alt="Signature" src="signature.png"/> |
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| 510(k) Number | K982231 |
| Prescription Use | OR Over-The-CounterUse |

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