(27 days)
VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.
VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® tube with sodium heparin may be used to collect a whole blood/plasma sample. The tube is composed of clear plastic. The cap is made of plastic and rubber. The tube size is 13 x 75 mm. The tube is equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Device Performance for Greiner VACUETTE® Evacuated Blood Collection Tubes with Sodium Heparin (K011699)
This 510(k) summary focuses on demonstrating "substantial equivalence" of the new device to a predicate device, rather than explicit, numerical acceptance criteria for various performance metrics. The core acceptance criterion is that the new device (sodium heparin tube) performs equivalently to the predicate device (lithium heparin tube) for commonly tested plasma analytes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Greiner VACUETTE® tube with lithium heparin - K# 960857) | The Greiner VACUETTE® tube with sodium heparin was found to be substantially equivalent to the Greiner VACUETTE® tube with lithium heparin. |
| Same Intended Use as Predicate Device | Both devices have the same intended use: collection, transport, and processing of blood for testing serum, plasma, or whole blood in the clinical laboratory. Specific to these plasma tubes, their intended use is for testing plasma or whole blood. |
| Same Tube Material and Stopper Material as Predicate Device | Both blood collection tubes have the same tube material and stopper material. |
| Equivalent Performance of 27 Analytes Commonly Tested in Plasma Compared to Predicate Device (Lithium Heparin) | A study demonstrated "equivalent performance" of the two anticoagulants (sodium heparin and lithium heparin) for 27 analytes commonly tested in plasma. While specific numerical acceptance thresholds (e.g., within X% difference, correlation coefficient > Y) are not explicitly stated, "equivalent performance" implies that the differences observed were within clinically acceptable limits, justifying substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Blood collected from 40 donors.
- Data Provenance: Not explicitly stated (e.g., country of origin, ethnicity). It is a prospective study, as blood was collected specifically for this comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This study does not involve human readers establishing ground truth for diagnostic accuracy, but rather a direct comparison of analytical equivalence between two medical devices for laboratory assays. The "ground truth" here is the measured analyte concentration/activity, determined by an assay performed in a clinical laboratory setting. The experts involved would be laboratory personnel performing the analyses, but their qualifications and numbers are not detailed as they would be for image interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is an analytical equivalence study, not an diagnostic accuracy study involving multiple readers and adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI algorithms interpreting medical images or other diagnostic data, where human readers interact with the AI. This 510(k) is for a basic blood collection device comparing the performance of different anticoagulant additives.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a blood collection tube, not an AI algorithm. Its performance is intrinsic to the chemical and physical characteristics of the tube and its additives, affecting subsequent laboratory analyses.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measured values of 27 analytes commonly tested in plasma. This is essentially laboratory reference measurements obtained from clinical laboratory assays. The comparison is between the values obtained from blood collected in the sodium heparin tube versus the lithium heparin tube.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this device is not an AI/machine learning algorithm.
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Mav 31, 2001
510(K) SUMMARY
Greiner VACUETTE® Evacuated Blood Collection Tubes with Sodium Heparin
Greiner VACUETTE® North America, Inc. P.O Box 1026 Monroe, NC 28111
For information regarding this 510(k) Summary, please contact Greiner VACUETTE® North America, Douglas L. Harris.
Device Names:
| Proprietary Name: | VACUETTE® Evacuated Blood Collection Tube with Sodium Heparin |
|---|---|
| Common Name: | Blood Collection Tube with Sodium Heparin |
| Classification Name: | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Device Description:
VACUETTE® Tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The VACUETTE® tube with sodium heparin may be used to collect a whole blood/plasma sample. The tube is composed of clear plastic. The cap is made of plastic and rubber. The tube size is 13 x 75 mm. The tube is equipped with a vacuum tube holder to assist in positioning the product when obtaining blood samples. The vacuum tube holder is composed of plastic.
Intended Use:
The Greiner VACUETTE® blood collection tube with sodium heparin additive is an evacuated blood collection device that is used for the collection of venous blood. The VACUETTE® Tube is used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.
Substantial Equivalence:
The Greiner VACUETTE® tube with sodium heparin has been found to be substantially equivalent to the Greiner VACUETTE® tube with lithium heparin (K# 960857). Both blood collection tubes have the same intended use and contain the same tube material and stopper material. The tubes have different additives. The predicate device, Greiner VACUETTE® plasma tube with lithium heparin, contains lithium heparin as the anticoaqulant. The Greiner VACUETTE® plasma tube with sodium heparin contains sodium heparin as the anticoagulant.
A study was conducted on blood collected from 40 donors into each type of tube. Test results of 27 analytes commonly tested in plasma showed equivalent performance of the two anticoagulants.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Greiner Bio-One Vacuette North America c/o Ms. Judith J. Smith Principal Suenna Partners, L.L.C. P.O. Box 103 Baldwin, MD 21013
JUN 2 8 2001
510(k) Number: K011699 Re: STO(K) Name: Vacuette® Blood Collection Tubes with Sodium Heparin Regulation Number: 862.1675 Regulatory Class: II Product Code: JKA Dated: May 31, 2001 Received: June 1, 2001
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becally be o(x) = is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device meetstate conmistoc prov to that have been reclassified in accordance with the provisions of the Alliendiffens, of to devices man have occast . You may, therefore, market the device, subject to Tecteral Food, Drug, and Ocentent Fee et. The general controls provisions of the Act include the general controls provincils of the Fring 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 (Fremarket Approval), it they of backed f Federal Regulations, Title 21, Parts 800 to 895. allecting your device can of rounning assumes compliance with the Good Manufacturing in A Substantally equiralene acterimeral (GMP) regulation (21 CFR Part 820) and that, through Practice for Mearcal bonn the Food and Drug Administration (FDA) will verify such penodic offir inspections, alle i oow alle GMP regulation may result in regulatory action. In assumptions: Transle to configer announcements concerning your device in the Federal addition, PDA may Puonen rainer annovour premarket notification submission does not affect Register. Flease note: this response to your proam proam 542 of the Act for devices under the ally obligation you might in Control provisions, or other Federal laws or regulations.
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Page 2
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 nothication. The FDA inding of successification 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 If you desire specific advice for your do revices), please contact the Office of Compliance at additionally 607.10 for m Prito diagnestions on the promotion and advertising of your device, (301) 594-4388. Additionally, for question of (101) 594-4639. Also, please note the regulation prease conact the Office or Compilance (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small illionnation on your responsionnes are use are momber (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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510(k) Number (if known):
Device Name: VACUETTE® Blood Collection Tubes with sodium heparin
Indications For Use:
VACUETTE® tubes with sodium heparin are used to collect, transport and process blood for testing plasma or whole blood in the clinical laboratory.
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Division of Clinical Laboratory Devices
510(k) Number
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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.