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

Indications for 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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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k103041

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k960857(Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

A. To change the labeled centrifugation speed from 2200g to 1800-2200g.

B. To change the labeled centrifugation time from 15 min. to 10-15 min.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and centrifugation time and speed. Studies include method comparison.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. FMEA

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.