(63 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 that would involve AI/ML.
No
This device is a blood collection tube used for evaluating blood-sedimentation-rates, which is a diagnostic purpose, not a therapeutic one. Therapeutic devices are used for treating or alleviating a disease or condition.
No
The device is a blood collection tube used to evaluate blood sedimentation rates, which is a measurement rather than a diagnostic interpretation itself.
No
The device description explicitly states it is a "blood collection device," which is a physical hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To evaluate blood-sedimentation-rates". This is a diagnostic test performed on a biological sample (blood) outside of the body (in vitro).
- Device Description: The device is a "blood collection tube with citrate solution" used for "evaluations of blood sedimentation rate". This confirms it's a tool used to collect and prepare a sample for an in vitro diagnostic test.
The core function of the device is to facilitate a diagnostic test performed on a sample taken from the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate.
Indication for Use: To evaluate blood-sedimentation-rates.
Product codes
JKA, GIM, GHC
Device Description
The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate. Both blood collection tubes have the same intended use and contain the same stopper material and additive. The tube material for both the Greiner product and for the Becton Dickinson product is glass.
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
The equivalency of assay results of the two tubes was evaluated by testing paired samples collected in Greiner Vacuette® tubes and Becton Dickinson Vacutainer® tubes.
Summary of Performance Studies
Test results from paired samples for eurythrocyte sedimentation rate were evaluated and good correlation was observed.
Key Metrics
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Predicate Device(s)
Becton Dickinson's Vacutainer® brand citrate ESR tube
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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I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Greiner America, Inc. ("Greiner") is submitting a 510(k) premarket notification for its Greiner Vacuette® eurythrocyte sedimentation rate ("ESR") blood collection tube with citrate solution. The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate.
Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® brand citrate ESR tube. Both blood collection tubes have the same intended use and contain the same stopper material and additive. The tube material for both the Greiner product and for the Becton Dickinson product is glass. The equivalency of assay results of the two tubes was evaluated by testing paired samples collected in Greiner Vacuette® tubes and Becton Dickinson Vacutainer® tubes. Test results from paired samples for eurythrocyte sedimentation rate were evaluated and good correlation was observed.
Greiner's 510(k) has been submitted on April 1, 1997, by Ed Maier, Managing Director, Greiner America, Inc., P.O. Box 953279, Lake Mary, Florida 32795-3279 (407/333-2800).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or bird-like figure with stylized wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 4 1997
Ed Maier · Managinq Director Greiner America, Inc ...... P.O. Box 953279 Lake Mary, Florida 32795-3279
Re : K971220 Greiner Vacuette Blood Collection Tube Requlatory Class: I & II Product Code: JKA, GIM, GHC Dated: May 16, 1997 Received: May 20, 1997
Dear Mr. Maier:
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, Druq, 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 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. ਸੈਂ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: -General (GMP) requlation (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 requlation may result in requlatory 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 regulations.
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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 ene office or compitied, "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 Sitman
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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STATEMENT OF INDICATIONS FOR USE
Device Name:
નયુ
ﺍﻟﺘﻨﺘﻴﻨﺔ
ﺮ
Vacuette® ESR blood collection tube with citrate solution
Indication for Use: - -------
To evaluate blood-sedimentation-rates-----------------------------------------------------------------------------------------------------------------------------------------
(Divis
Division of ory devices
510(k: 497 1220
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
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