SECQUIRE CELL SEPARATOR

K024080 · Perfusion Partners & Assoc., Inc. · JQC · Jul 2, 2003 · Clinical Chemistry

Device Facts

• Record ID: K024080
• Device Name: SECQUIRE CELL SEPARATOR
• Applicant: Perfusion Partners & Assoc., Inc.
• Product Code: JQC · Clinical Chemistry
• Decision Date: Jul 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2050
• Device Class: Class 1

Intended Use

The SECQUIRE cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care.

Device Story

The SECQUIRE Cell Separator is a laboratory device used at the point of care to process blood samples. It functions to separate blood components to produce low-volume platelet-rich plasma (PRP) and platelet-poor plasma (PPP). The device is intended for use by healthcare professionals in clinical settings. It aids in the preparation of plasma products for subsequent clinical use. The device is subject to a mandatory labeling warning stating that safety and effectiveness for in vivo indications have not been established.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

General purpose laboratory equipment for cell separation. Class I device (Product Code JQC).

Indications for Use

Indicated for the preparation of low volume platelet rich plasma and platelet poor plasma at the point of care.

Regulatory Classification

Identification

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration PPAI Medical 2098 Gaither Road c/o E.J. Smith, Smith Associates Rockville MD 20850 2 2003 JUL PO Box 4341 Crofton, Maryland 21114 Re: k024080 Trade/Device Name: SECQUIRE Cell Separator Regulation Number: CFR 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for specific medical use

Regulatory Class: Class I Product Code: JQC Dated: December 3, 2002 Received: December 10, 2002

Dear Mr. Smith:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings and Precautions section of the device's labeling:

The safety and effectiveness of this device for in vivo indications for use has not been established.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as

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described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, 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).

If you desire specific information about the application of other 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

A. Autman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): K024080

Device Name: SECQUIRE Cell Separator

FDA's Statement of the Indications For Use for device: The SECQUIRE cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care.

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510(k) Number: K024080

Device Name: SECQUIRE Cell Separator

Classification Panel:

## Indications for Use:

The SECQUIRE cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________

ﺎ ﺋ

Suphine Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K024080