TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER by TRI-TECH, INC.

The provided text describes a 510(k) clearance for an Evacuated Blood Collection Tube with a Gray Stopper (K971111). This document states the device is "substantially equivalent" to legally marketed predicate devices, which means it doesn't require a new clinical study to prove safety and effectiveness.

Therefore, the document does not contain any information about:

Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, etc.)
A study proving the device meets acceptance criteria
Sample sizes for test or training sets
Data provenance
Number of experts or their qualifications for ground truth establishment
Adjudication methods
Multi-reader multi-case (MRMC) comparative effectiveness studies
Standalone algorithm performance studies
Type of ground truth used
How ground truth for the training set was established

The document is a regulatory clearance letter, not a clinical study report. It focuses on the legal and regulatory aspects of device marketing, based on the device's equivalence to existing products rather than a new demonstration of performance through a clinical trial.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 16 De.

Bruce Martz FDA Officer Tri-Tech, Inc. 4019 Executive Park Boulevard, SE Southport, North Carolina 28461

Re: K971111 Tri-Tech Inc., Evacuated Blood Collection Tube, Gray Stopper Regulatory Class: II Product Code: JKA Dated: May 21, 1997 Received: May 27, 1997

Dear Mr. Martz:

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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General. (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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.gov/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}------------------------------------------------

Page 2 of 2

610(k) Number (if known):___K9711111

Device Name: Evacuated Blood Collection Tube Gray Stopper

Indications For Use:

体

Plasma or whole blood collection device where glycolytic inhibition of the specimen is reguired.

(Division Sign-Off)

Division of Clinical Vaboratory Devices 510(k) Number _

(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)

់

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.