Blood Specimen Collection Device

A Blood Specimen Collection Device is a tool used to draw blood for clinical testing. It can be a needle, syringe, or a vacuum-sealed tube.

Intended Use of Blood Specimen Collection Device 

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 of device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Intended Use:

Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing.

Device Description:

Blood Collection Tubes and Blood Collection Tubes are for collecting, transporting and centrifuging blood in a closed tube. The blood collection tube consists of closure assembly, a plastic or glass tube and EDTA additive. The standard closure assembly is a basic rubber stopper. The tube is also available with the Closure Assembly which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are either pink or lavender to indicate the presence of the EDTA additive.

Tubes, Vials, Systems, Serum Separators, Blood Collection

Intended Use:

Blood Collection Set is intended to be used for insertion into a patient’s vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

Device Description:

Components of the device include: (1) Needle cap, (2) Butterfly wings, (3) Safety shield, (4) Needle, (5) Flexible tube, (6) Female luer (adapter), (7) Male luer hub, (8) Puncture needle, (9) Rubber sleeve, (10) Puncture needle protect cover, (11) Holder, (12) Protective cap. The device is available various needle size and flexible tube length.

Oral Fluid Drugs of Abuse and Alcohol Test Specimen Collection Device

Intended Use:

Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for drugs of abuse testing. This device is for prescription use only.

Device Description:

An oral fluid specimen is collected using a split collector with two cellulose pads on a polypropylene stem, placed under the individual’s tongue until the pads are saturated, indicated by a blue color. The collector is then split into two parts (Collector 1 and Collector 2) and placed into separate polypropylene tubes labeled A and B, each containing 3 mL of preservative buffer. The tubes are sealed for storage and transport. The device captures 1 mL of oral fluid, diluted with 3 mL of buffer, resulting in a 1:4 dilution.

Blood/Plasma Collection Device for DNA Testing

Intended Use:

Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.

Device Description:

The Blood DNA Tube is a sterile, single-use plastic tube designed for blood collection. It is made of polyethylene terephthalate (PET) plastic and has a closure assembly that maintains vacuum, ensuring accurate and consistent blood draw. The tube is sealed with a rubber stopper and shield and is intended to be placed inside a tube holder or adaptor with a needle for blood flow. Once the vein is penetrated, the tube is pushed into the holder, and blood enters the tube. After drawing the appropriate amount of blood, the tube is disengaged and inverted 8-10 times to mix the additive with the blood.

Capillary Blood Collection Device for Alternative Site Collection

Intended Use:

Blood Collection Device is a lithium heparin coated single use device intended to be used to collect capillary blood from the upper arm of adults (21 years of age or older) by a healthcare worker. The collected sample is then transported for analysis in a clinical laboratory for the determination of Haemoglobin A1c (HbA1c) using tests intended for monitoring glycemic control.

Device Description:

Blood Collection Device is a single-use, sterilized whole blood specimen collection and transportation device that uses a combination of two mechanisms, capillary action and vacuum extraction, to Obtain A Capillary Blood Sample from the Upper Arm. The Device Contains Lithium Heparin as An Anticoagulant.           

• Analyte Stability Study
• Usability Study
• Precision/Reproducibility
• Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
• Linearity/assay reportable range
• Traceability (controls, calibrators, or method)
• Analytical specificity
• Analytical Sensitivity
• Interfering Substances

Biocompatibility Testing:

• Cytotoxicity Assays
• Sensitization Assays
• Irritation Tests
• Acute and Sub chronic Toxicity Tests
• Genotoxicity Tests

Clinical Testing:

Recommended for the FDA 510K of Tubes, Vacuum Sample, with Anticoagulant