(63 days)
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.
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.
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. The device's performance was evaluated by comparing it to a legally marketed predicate device, Becton Dickinson's Vacutainer® brand citrate ESR tube.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalency of assay results for erythrocyte sedimentation rate (ESR) between the Greiner Vacuette® tube and the predicate device (Becton Dickinson Vacutainer® tube). | "Test results from paired samples for erythrocyte sedimentation rate were evaluated and good correlation was observed." (K971220, Section I) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. The text only mentions "paired samples."
- Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. The study focuses on comparing the assay results between two collection tubes, rather than subjective interpretation of results requiring expert consensus for ground truth.
4. Adjudication method for the test set:
- This information is not applicable and therefore not provided. The study compares quantitative assay results, not subjective interpretations that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable and therefore not provided. This is a study for a blood collection tube, not an AI-assisted diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable and therefore not provided. This is a study for a blood collection tube, not an algorithm or AI.
7. The type of ground truth used:
- The ground truth used was the ESR measurement obtained using the legally marketed predicate device (Becton Dickinson Vacutainer® brand citrate ESR tube). The study's objective was to demonstrate equivalence to this established method.
8. The sample size for the training set:
- This information is not applicable and therefore not provided. This study is not for an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- This information is not applicable and therefore not provided, as there is no training set for this type of device.
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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).
WA01A/ 81264 . 1
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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 _________________________________________________________________________________________________________________________________________________________
WA0 LA/ 81264 . 1
§ 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.