(82 days)
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No
The summary describes a blood collection tube, which is a passive device and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The device description indicates it is a blood collection tube, which is used for diagnostic purposes (collecting a specimen for testing), not for treating a disease or condition.
No
The device is described as a "Plasma or whole blood collection device" which implies it is for specimen collection, not for diagnosing a condition.
No
The device description clearly states it is an "Evacuated Blood Collection Tube Gray Stopper," which is a physical hardware component used for collecting blood.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Plasma or whole blood collection device where glycolytic inhibition of the specimen is required." This clearly indicates the device is used to collect biological specimens (plasma or whole blood) for subsequent testing or analysis.
- Device Description: The description "Evacuated Blood Collection Tube Gray Stopper" is consistent with a device used for collecting blood for laboratory testing. The gray stopper typically indicates the presence of an anticoagulant and a glycolytic inhibitor, which are used to preserve the sample for specific types of in vitro tests (like glucose testing).
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Collecting and preserving biological specimens for laboratory analysis falls squarely within the scope of IVD use.
While the document doesn't explicitly state "for in vitro diagnostic use," the intended use and device description strongly imply this purpose. The lack of information about image processing, AI, patient age, etc., further supports that this is a basic specimen collection device used as part of a larger IVD process, rather than a complex diagnostic instrument itself.
N/A
Intended Use / Indications for Use
Plasma or whole blood collection device where glycolytic inhibition of the specimen is reguired.
Product codes
JKA
Device Description
Evacuated Blood Collection Tube, Gray Stopper
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s):
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Reference Device(s):
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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.
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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 (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
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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)
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OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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