BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381

K041071 · Becton, Dickinson & CO · JKA · May 14, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041071
• Device Name: BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
• Applicant: Becton, Dickinson & CO
• Product Code: JKA · Clinical Chemistry
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

The BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube are plastic evacuated blood collection tubes that provide a means of collecting, transporting, and processing blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Plus Tube and the BD Vacutainer® Trace Element K2EDTA Plus Tube is used for trace element testing (e.g., Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc).

Device Story

Plastic evacuated blood collection tubes (13x100, 6ml) with Royal blue Hemogard™ closures; contain silica clot activator or K2EDTA additive. Used for collection, transport, and processing of blood samples in a closed system. Facilitates trace element testing (e.g., Arsenic, Lead, Mercury). Used in clinical settings by healthcare professionals. Provides a stable environment for blood samples prior to laboratory analysis; ensures sample integrity for trace element quantification.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance criteria met following material and additive modifications.

Technological Characteristics

Plastic evacuated blood collection tubes (13x100, 6ml); Royal blue Hemogard™ closure; Additives: Silica clot activator or K2EDTA. Closed system design.

Indications for Use

Indicated for use in patients requiring blood collection for trace element testing, including Arsenic, Cadmium, Calcium, Chromium, Copper, Iron, Lead, Magnesium, Manganese, Mercury, Selenium, and Zinc.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K041071

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.)

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 FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for: the tube material is changed form glass to plastic; the additive is changed from none to silica clot activator for the serum tube and from Na₂EDTA to K₂EDTA for the EDTA tube; the draw volume is changed from 7 ml to 6 ml for both tubes.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, physical characteristics, operating principle, sterilization method.

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

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.