QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM

K972969 · Innovative Medical Technologies, Inc. · GIO · Sep 22, 1997 · Hematology

Device Facts

• Record ID: K972969
• Device Name: QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
• Applicant: Innovative Medical Technologies, Inc.
• Product Code: GIO · Hematology
• Decision Date: Sep 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6150
• Device Class: Class 1

Intended Use

The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.

Device Story

Quick-Draw Capillary Whole Blood Collection System facilitates capillary blood collection; consists of collector, collection tube, and battery-operated vacuum handle. Device placed at puncture site (finger/heel); vacuum aspiration draws blood into collection tube. Used in clinical settings for diagnostic specimen acquisition. Simplifies collection process compared to manual methods; improves specimen retrieval efficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-operated vacuum aspiration system; includes collector, collection tube, and handle. Mechanical suction principle.

Indications for Use

Indicated for the collection of whole blood specimens from capillary puncture sites (finger or heel stick) for in vitro diagnostic use.

Regulatory Classification

Identification

A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

Submission Summary (Full Text)

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

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 an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.

SEP 2 2 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bradley Brown . President Innovative Medical Technologies, Inc. 10661 Rene Lenexa, KS 66215

K972969 Re : Quick-Draw Capillary Whole Blood Collection System Regulatory Class: II Product Code: JKA, GIO Dated: August 6, 1997 Received: Auqust 11, 1997

Dear Mr. Brown:

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.

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

Page 2

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 [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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

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

Attachment 5 Page 1 Innovative Medical Tech. Lenexa, KS.

Page 1 of 1

510(k) Number (if known): not known

Quick-Draw Capillary Whole Blood Collection Device name: System.

Indications for use:

The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)

Carol C. Benson f Alfred Montgomery
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K972969