(42 days)
Not Found
Not Found
No
The description focuses on a mechanical vacuum device for blood collection and does not mention any AI/ML components or functions.
No
This device is designed for the collection of blood specimens for in vitro diagnostic use, not for treating a disease or condition.
No
The document states the device is "intended for in vitro diagnostic use to facilitate the collection of whole blood specimens". It collects specimens but does not perform diagnostic analysis itself.
No
The device description explicitly states it is composed of hardware components: the Quick-Draw collector, a collection tube, and a battery-operated vacuum device (Quick-Draw Handle).
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use and Device Description: Both sections clearly state that the system is "intended for in vitro diagnostic use".
- Function: The device is designed to collect whole blood specimens, which are then used for in vitro diagnostic testing. The collection of the sample is a crucial step in the overall diagnostic process.
N/A
Intended Use / 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.
Product codes
JKA, GIO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger or heel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.6150 Capillary blood collection tube.
(a)
Identification. A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
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 (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 (301) 443-6597 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