BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706

K093972 · Becton, Dickinson & CO · JKA · Jan 21, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093972
• Device Name: BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
• Applicant: Becton, Dickinson & CO
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jan 21, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

The BD Microtainer® K₂EDTA tube with Microgard Closure and Extender is intended for the collection, transport, and processing of capillary blood specimens.

Device Story

BD Microtainer® MAP Microtube is a blood collection device for skin puncture specimens. It features a one-piece plastic reservoir and integrated extender, providing external dimensions of a standard 13x75mm tube for compatibility with high-throughput hematology instrument racks. The interior is spray-coated with K2EDTA. The lavender cap includes a penetrable septum, allowing automated instruments to sample blood directly without removing the cap or transferring the specimen. Used in clinical settings by healthcare professionals; the device streamlines workflow by eliminating manual sample transfer steps. Benefits include reduced risk of sample exposure and improved compatibility with automated laboratory processing.

Clinical Evidence

Mechanical, simulated use, and clinical testing were performed to demonstrate safety and effectiveness. No specific clinical trial metrics (e.g., sensitivity, specificity) were provided in the summary document.

Technological Characteristics

Plastic reservoir with integrated extender (13x75mm dimensions); K2EDTA additive; penetrable septum cap. Compatible with high-throughput hematology instruments. Manual and automated processing modes.

Indications for Use

Indicated for collection, transport, and processing of capillary blood specimens in patients requiring blood analysis.

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

• BD Microtainer® K₂EDTA tube with Microgard Closure and Extender (K940905)

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 K093972

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 BD Microtainer® K₂EDTA tube with Microgard Closure and Extender, K940905, previously cleared device.
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 modification to the BD Microtainer® K₂EDTA tube design.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the tube Cap Closure (a penetrable cap closure) and tube Integrated Extender (a one piece integrated reservoir/extender).
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 (see page 23)
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. (see pages 19-22)
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 (see Attachment 3)
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. (see Attachment 3)
iii) A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

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.