Quick facts
- An evacuated blood collection tube is a sealed tube with a pre-set vacuum that draws a fixed volume of blood when the stopper is pierced.
- In the United States a blood specimen collection device is a named Class II entry at 21 CFR 862.1675, and the identification paragraph names "blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes".
- The needle is a separate article; a hypodermic single lumen needle is named at 21 CFR 880.5570.
- In Canada Schedule 1 to the Medical Devices Regulations names no collection tube. The tube is a non-invasive device, and the needle that enters the skin is a surgically invasive device at Class II under Rule 1(1).
- The cap colour is not decoration: it records the additive inside, and the additive decides what the tube can be used for.
- The entries and rule text below were checked against the current eCFR text and the Regulations on 2026-10-07.
An evacuated blood collection tube is the colour-capped tube a phlebotomist pushes onto a holder after the needle is in the vein. The vacuum inside is set at manufacture to pull a fixed volume, which is why the tube fills to a line and stops. The class of the tube and the class of the needle are two different questions in both countries, and a draw that records one class is describing two devices as one.
What is inside an evacuated tube?
The tube is not empty. A plain tube holds only a vacuum; a treated tube holds an additive that either prevents clotting or helps blood clot and separate. The additive is what the cap colour records, and the colour is a quick read for the person drawing. Getting the additive wrong changes the result, which is why the tube is chosen for the test before the draw and not after.
| Cap colour | Additive | What the tube is for |
|---|---|---|
| Light blue | Sodium citrate | Coagulation tests |
| Gold or red-grey | Clot activator and gel | Serum chemistry; serum separated on site |
| Green | Heparin | Some chemistry and blood gas tests |
| Lavender or purple | EDTA | Haematology and blood bank work |
| Grey | Sodium fluoride and oxalate | Glucose testing |
| Red | None; plain | Serum where no additive is wanted |
How do Canada and the United States treat an evacuated tube?
The two countries classify the tube and the needle separately, and reach the same practical place by different routes.
| Item | Canada | United States |
|---|---|---|
| Named entry for the tube | None in Schedule 1 | 21 CFR 862.1675, blood specimen collection device |
| Class of the tube | Non-invasive device under the general rules | Class II |
| Named entry for the needle | None; rule-based | 21 CFR 880.5570 |
| Class of the needle | Rule 1(1), surgically invasive, Class II | Its own entry and class |
| Basis of the class | Intended use recorded for the device | The named entry it is filed under |
| Records expected | Establishment licence and device records where a device | Listing and premarket requirements for a Class II device |
In the United States the entry is broad. Section 862.1675(a) describes a device intended for medical purposes to collect and handle blood specimens and to separate serum from the cellular part before further testing, and the identification paragraph then names the tubes, vials, systems, serum separators, trays and vacuum tubes that fall under it. Section 862.1675(b) places the device in Class II, one class above the general-purpose labware that sits around it on the bench, and the openFDA device classification API lists the entry under product code JKA.
Canada does not name a collection tube. A tube that receives blood does not itself penetrate the body, so it is not a surgically invasive device; it is a non-invasive device reached by the general rules. The needle is the invasive part, and Rule 1(1) of the Medical Devices Regulations places surgically invasive devices in Class II. A serum separator tube, which holds a gel and a clot activator and does something to the specimen rather than only containing it, is the item that most often prompts the question, and in Canada its status follows from the intended use recorded for it.
Why does the tube class differ from the class of general labware?
Because the tube is doing work. A plain container holds a specimen; an evacuated tube draws a set volume, and a serum separator tube also separates the specimen before it is tested. The US entry is written to cover that handling step, which is why it sits at Class II while the racks, trays and general labware around it sit lower. A buyer who treats a tube as a commodity bottle and a rack as a device has the two the wrong way round.
Which standard covers the draw?
The standard that governs the draw is CLSI's, and it is shared by both countries. The Clinical and Laboratory Standards Institute publishes the collection standards a laboratory follows for venous blood, covering the order of draw, the fill volume and the handling of each tube type, and the CLSI standards catalogue lists the current editions. The laboratory competence side sits in ISO 15189:2022, and the pre-analytical rules a receiving laboratory applies are set out in the Public Health Ontario test index and in its specimen acceptance criteria.
| Element | What the standard covers | Why it matters at the draw |
|---|---|---|
| Order of draw | Which tube follows which | A carry-over between additives can change a result |
| Fill volume | How full a tube must be | A short citrate tube skews a coagulation result |
| Mixing | How many inversions per additive | An unmixed EDTA tube can clot |
| Labelling | What goes on the tube and when | A tube labelled away from the patient is a rejected sample |
| Transport | How the sample travels | A delay outside the acceptance window is a rejected sample |
Which consumables does a draw station restock?
A blood draw station restocks as a set. The sterile graduated 90 mL specimen cups cover the collection side where a sample is poured off, and the double-tipped cotton swabs are the prep item at the station. Where samples are sent out, a laboratory that also monitors its own steriliser pairs the sterilization monitoring collection with the 24-hour monitoring five-pack trial. Laboratories and multi-site groups ordering at case level use the wholesale ordering page, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
How is the needle handled after the draw?
The needle is the sharp end and is treated as such. The safety device on a modern holder is activated while the needle is still in the patient, the needle is left on the holder, and the whole assembly goes into a sharps container at the point of use. Nothing about the tube's class changes the sharps rule; the tube is what receives the specimen, and the needle is what carries the injury risk. The CCOHS guidance on needlestick injuries sets out the exposure practice, and the WHO manual covers the same ground for laboratories.
Sources
- 21 CFR 862.1675, Blood specimen collection device
- 21 CFR 880.5570, Hypodermic single lumen needle
- 21 CFR 864.4010, General purpose reagent
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- Health Canada, medical devices
- CLSI, clinical and laboratory standards
- CLSI standards and products
- ISO 15189:2022, medical laboratories, requirements for quality and competence
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management of medical devices
- Public Health Ontario, laboratory services test information index
- Public Health Ontario, specimen acceptance criteria
- College of Medical Laboratory Technologists of Ontario
- Institute for Quality Management in Healthcare
- CCOHS, needlestick injuries
- World Health Organization, laboratory biosafety manual
- US FDA, medical devices
Where a draw lot is recorded
A draw that is not logged cannot be traced back to a tube lot if a result is questioned. The printable blood draw and tube lot log is a blank form with columns for the patient, the time, the tube type, the lot and the collector, so a recall or a repeat draw can be tied to the exact tubes used. The draw log generator on the same page sizes the form to the number of draw stations a clinic runs. No account and no sign-up are needed to open either one.
Every draw station and every tube range is different. Ask a compliance specialist and you will get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Serum separator tubes in Canada vs the US: order of draw
- EDTA tubes in Canada vs the US: which order of draw rules
- Blood collection tube systems in Canada vs the US: which order
CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the class of a device and the records kept by a clinic belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
Is an evacuated blood collection tube a Class II device in the United States?
Yes. Section 862.1675 places the blood specimen collection device in Class II, and the identification paragraph states that the type may include blood collection tubes, vials, systems, serum separators, blood collection trays and vacuum sample tubes.
How does Canada classify a collection tube?
Schedule 1 names no collection tube. The tube that receives the specimen is a non-invasive device under the general rules, while the needle that penetrates the skin is a surgically invasive device placed in Class II by Rule 1(1).
What does the cap colour mean?
The cap colour records the additive inside the tube. Light blue is sodium citrate for coagulation, gold or red-grey is a clot activator and gel for serum, green is heparin, lavender is EDTA for haematology, and grey is fluoride and oxalate for glucose.
Why does a serum separator tube sit in Class II in the US?
Because the entry covers handling as well as containing. A serum separator holds a gel and a clot activator and separates the specimen before testing, so the entry is written to cover the separation step and the class sits at Class II.
Is the needle part of the tube device?
No. The needle is a separate article with its own entry, such as 21 CFR 880.5570, and in Canada it is classified by rule as a surgically invasive device. The tube and the needle are two devices for two purposes.
Which standard sets the order of draw?
The CLSI collection standards set the order of draw, the fill volume and the mixing for venous blood, and the laboratory competence requirements sit in ISO 15189:2022.
Does the class change with the additive in the tube?
The class of the tube in the United States follows the named entry, which covers tubes, vials, systems and serum separators. The additive changes what the tube is for, not which country's entry applies to it.
Where should a draw be logged?
The printable blood draw and tube lot log at the compliance log centre has columns for the patient, time, tube type, lot and collector, and the draw log generator on the same page sizes the form to the number of draw stations a clinic runs.
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