(53 days)
To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.
The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material.
The provided text describes a 510(k) submission for a labeling change to the Greiner VACUETTE® blood collection tube. The change is to include therapeutic drug monitoring (TDM) as an indicated use. The submission aims to demonstrate substantial equivalence to both Greiner's previously cleared device (K960858) and Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for agreement, bias, or precision). However, the implicit acceptance criterion is "no significant clinical difference" between the modified Greiner VACUETTE® tubes and the predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| No significant clinical difference compared to previously cleared Greiner VACUETTE® tubes (K960858) | "No clinically significant difference was noted in these comparison studies." |
| No significant clinical difference compared to Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes | "No clinically significant difference was noted in these comparison studies." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "clinical tests" and "comparison studies" but does not provide details on the number of samples or subjects involved.
- Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a blood collection tube, and the "ground truth" for its performance comparison would typically involve laboratory measurements and statistical analysis of collected blood samples, not expert interpretation of images or other subjective data.
4. Adjudication Method for the Test Set:
Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable for this type of device. MRMC studies are typically used for evaluating diagnostic imaging or AI devices where human reader performance is a key outcome.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device (blood collection tube), not an algorithm or AI.
7. Type of Ground Truth Used:
The "ground truth" in this context refers to the results obtained from analyses of blood samples collected in the predicate devices. The study compares the performance of the Greiner VACUETTE® tubes (with and without gel separator, and with the proposed TDM indication) against these established methods. The comparison likely involved measuring various analytes relevant to therapeutic drug monitoring and other clinical laboratory tests.
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not a machine learning algorithm that requires a training set. The "studies" mentioned are performance comparison studies, not model training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
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DEC 28 1998
1983952
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Greiner Meditech. Inc. ("Greiner") is submitting a labeling change to its already approved VACUETTE® blood collection tube with clot activator and gel separator (K960858). The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material. The product is intended for use in collecting, transporting, storing and processing blood serum from cellular components of blood. The labeling change is to exclude the existing contraindication on labeling of the VACUETTE® Blood Collection tube with clot activator and gel separator for use of the tube in therapeutic drug monitoring, and to include on the labeling a statement that the tubes are suitable for such use.
Greiner is claiming substantial equivalence to its previously cleared VACUETTE® blood collection tube with clot activator and gel separator (K960858) and to Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes. The modified blood collection tubes still will have the same basic intended use as the cleared VACUETTE® tube, with the additional use for therapeutic drug monitoring. The plastic tube material, clot activator and gel separator material will remain the same as in the cleared VACUETTE® tube (K960858). Clinical tests show that there is no significant clinical difference between Greiner VACUETTE® blood collection tubes with clot activator and gel separator and Becton Dickinson plain glass blood collection tubes. Clinical tests compared Greiner VACUETTE® blood collection tubes with clot activator and no gel separator, and VACUETTE® blood collection tubes with clot activator and gel separator to Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes. No clinically significant difference was noted in these comparison studies.
Greiner's 510(k) has been submitted on November 2, 1998 by Doug Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, MD 21014 (410) 836-8228.
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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three overlapping lines that resemble a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
DEC 28 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Douglas L. Harris Managing Director Greiner Meditech, Inc. P.O. Box 943 Bel Air, MD 21014
Re: K983952 Trade Name: VACUETTE® Blood Collection Tube w/ Clot Activator and Gel Separator Regulatory Class: II Product Code: JKA November 5, 1998 Dated: Received: November 5, 1998
Dear Mr. Harris:
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 legally marketed predicate 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 regulations 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 requlation (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 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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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/dsma/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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P.O. Box 943 Bel Air, Maryland 21014
510(k) Number (if known): K983952
Device Name: VACUETTE® Blood Collection Tube with Clot Activator and Gel Separator
Indications For Use: To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.
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(Division Sign-Off) Division of Clinical Laboratory Devices 1983957 510(k) Number _
Prescription Use X
Over-the-Counter Use _
§ 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.