VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR

K103041 · Greiner Bio-One North America, Inc. · JKA · Nov 9, 2010 · Clinical Chemistry

Device Facts

• Record ID: K103041
• Device Name: VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
• Applicant: Greiner Bio-One North America, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Nov 9, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

VACUETTE® Blood Collection Tubes with Lithium Heparin and Gel Separator are used to collect, transport and process blood for testing plasma in the clinical laboratory.

Device Story

VACUETTE® evacuated blood collection tubes consist of plastic tubes with pre-defined vacuum for precise draw volumes and color-coded safety caps. Tubes contain lithium heparin additive and a barrier gel with specific gravity between blood cells and plasma. During centrifugation, gel moves to form a stable barrier separating plasma from cells. Plasma is aspirated directly from the collection tube, eliminating transfer steps. Used in clinical laboratories by laboratory personnel. Modification involves updated centrifugation parameters: 1800-2200 g for 10-15 minutes. Benefits include streamlined processing and reduced sample handling.

Clinical Evidence

Method comparison studies performed to validate performance following changes to centrifugation speed and time parameters. No clinical trial data required; bench testing and design control verification activities confirmed acceptance criteria met.

Technological Characteristics

Plastic evacuated tubes with pre-defined vacuum. Contains lithium heparin additive and barrier gel. Dimensions/form factor standard for venous blood collection. Complies with ISO 6710 and CLSI standards. No software or electronic components.

Indications for Use

Indicated for venous blood collection and serum/plasma separation from cells in patients requiring clinical laboratory testing.

Regulatory Classification

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.

Predicate Devices

• Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel

Submission Summary (Full Text)

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K103041

NOV - 9 2010

November 8, 2010

### 510(k) SUMMARY

#### CONTACT:

47

Manfred Abel Greiner Bio-One North America, Inc. P.O Box 1026 Monroe, NC 28111

#### NAME OF DEVICE:

Trade Name:

Common Names/Descriptions: Classification Name:

Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel Evacuated Blood Collection System Tubes, Vials, Systems, Serum Separators, Blood Collection

PREDICATE DEVICE:

Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel

# DEVICE DESCRIPTION:

#### INTENDED USE:

VACUETTE® Blood Collection Tubes with Lithium Heparin and Gel Separator are used to collect, transport and process blood for testing plasma in the clinical laboratory.

## DESCRIPTION:

VACUETTE® Evacuated Blood Collection Tubes are plastic tubes with a pre-defined vacuum for exact draw volumes. They are fitted with color coded VACUETTE® Safety Caps (green for heparin tubes). The tubes, additive concentrations, volumes of liguid additives, and their permitted tolerances, as well as the blood-to-additive ratio, are in accordance to the requirements and recommendations of the international standards ISO 6710 "Single use containers for venous blood specimen collection" and the Clinical and Laboratory Standards Institute's Approved Standards (CLSI).

VACUETTE® Evacuated Blood Collection Tubes with Lithium Heparin and Gel contain a barrier gel in the tube. The specific gravity of this material lies between the blood cells and plasma. During centrifugation the gel barrier moves upward, where it forms a stable barrier separating the plasma from cells. Plasma may be aspirated directly from the collection tube, which eliminates the need for transfer to another container.

The changes for the VACUETTE® Evacuated Blood Collection Tube with Lithium Heparin and Gel are in the Instructions for Use (IFU):

- Recommended g-force (relative centrifugal force, rcf) change from 2200 g to . a range of 1800 - 2200 g.
- Recommended tube spin time change from 15 minutes to a range of 10 15 . minutes.

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# SUBSTANTIAL EQUIVALENCE:

The Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel described in this submission is substantially equivalent to the predicate device in intended use, design, or composition of the tube. Verification studies were performed to demonstrate that the lower centrifugation speed and time did not affect laboratory results compared to the current centrifugation speed and time. The following table summarizes the validation and verification studies, the acceptance criteria, and the results.

| Parameters | Risks | Tests<br>Performed | Pre-Determined<br>Acceptance<br>Criteria | Test Results |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Modification of<br>the centrifuge g<br>force and time<br>(From 15<br>minutes at 2200<br>g to 10 minutes<br>at 1800 g) | 1. Incomplete<br>gel barrier<br>formation<br>causing<br>incomplete<br>separation of<br>plasma and red<br>blood cells | Method<br>comparison<br>study between<br>the current<br>centrifuge<br>speed and time<br>versus the<br>modified<br>centrifuge<br>speed and time<br>from 40 patients<br>(51 analytes<br>tested) | Visually<br>inspected all of<br>the tubes after<br>centrifugation and<br>before starting<br>analysis: 99% of<br>the time all gel<br>barriers must be<br>properly formed<br>and stable | Passed: All met<br>acceptance<br>criteria<br>(100% of tubes<br>formed stable<br>gel barriers) |
| | 2. Inaccurate<br>results of the<br>analytes tested<br>from the<br>plasma | Method<br>comparison<br>study between<br>the current<br>centrifuge<br>speed and time<br>versus the<br>modified<br>centrifuge<br>speed and time<br>from 40 patients<br>(51 analytes<br>tested) | All test results<br>must yield:<br>1. Deming slope<br>of $1.0 \pm 0.1$<br>2. No statistically<br>significant<br>difference<br>between results:<br>using Deming<br>Method, the 95%<br>confidence<br>intervals include<br>the ideal values<br>(i.e. 0.00 in<br>constant bias or<br>1.00 in<br>proportional bias) | Passed: All met<br>acceptance<br>criteria |

#### rv of the Verification and Validation Activity Q.

The analysis of the data from this study demonstrated that the current modified centrifugation conditions for the VACUETTE® Evacuated Blood Collection System are equivalent and can be used for a broad range of clinical chemistry and immunology tests.

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Food and Drug Administration · 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Greiner Bio-One North America, Inc. c/o Judi Smith, LLC, Principal PO Box 103 Baldwin, MD 21013 USA

Re: k103041

> Trade Name: Greiner VACUETTE® Blood Collection Tube with Lithium Heparin and Gel Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Codes: JKA Dated: October 5, 2010 NOV - 9 2010 Received: October 14, 2010

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

NOV - 9 2010

510(k) Number (if known): k103041

Device Name: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel

Indication For Use:

டு VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator are used to collect, transport and process blood for testing plasma in the clinical laboratory.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K 103041 510(k)