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This page describes products and general use; it is not medical advice.
A sputum cup is a lidded specimen container used to collect and send a sputum sample to a laboratory. It is a regulated medical device in the United States, and the laboratory that will test the sample decides which container it wants. This page covers what the term means, the container types two public laboratory sources specify, the regulatory classification, and labeling and handling. It is written for clinic staff, buyers and students who need to know what a lab expects before a container is chosen.
What a sputum cup is
Sputum is the material brought up from the lower airways by coughing. A sputum cup is the container that holds that specimen between collection and the laboratory. Who uses it: clinic and ward staff who send respiratory samples, public health and hospital microbiology laboratories that receive them, and patients who are given a container to bring back.
A sputum cup is one kind of specimen container. Sputum is a biospecimen, so the general rules for leakproof, labeled and closed containers also apply.
How it is built: what the laboratory sources specify
Laboratory guidance describes the container by its properties rather than by a product name. The Texas Department of State Health Services (DSHS) specifies a sterile, leak-proof, disposable, graduated, screw-top conical tube for mycobacterial testing. NHS Greater Glasgow and Clyde specifies a white-topped sterile container, preferably wide-necked for sputum. The common points are sterility, a closure that does not leak, and a mouth wide enough to receive the specimen.
Types and variants
| Container | Typical use (as stated by the source) | Key difference | Source |
|---|---|---|---|
| Sterile 50 ml leak-proof, disposable, graduated screw-top conical tube | Recommended container for sputum and other specimens sent for mycobacterial (TB) testing | Graduated conical tube; the volume can be read on the container | Texas DSHS |
| White-topped sterile container, preferably wide neck for sputum | Sputum, and also bronchial washings, BAL, CSF and tracheal aspirates in this service’s list | Colour-coded closure; the wide neck is preferred for sputum | NHS Greater Glasgow and Clyde |
These two sources are local laboratory policies, not a universal standard. The receiving laboratory’s own container and instructions govern.
Regulatory status
In the United States a sputum cup falls under the FDA product code LIO, device name “Device, Specimen Collection”, a Class 1 device with regulation number 21 CFR 866.2900 in the Microbiology specialty (openFDA, last updated 2026-10-19, checked 2026-10-31). Under that regulation a microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage after collection and during transport to the laboratory. The regulation says the device may be labeled as sterile; it does not make sterility part of the definition. Class I devices are subject to general controls.
How to choose
Criteria stated by the laboratory sources: use the container the receiving laboratory specifies; a sterile container (both sources); a leak-proof screw closure (DSHS); for sputum, a wide neck is preferred (NHS Greater Glasgow and Clyde); containers sent out for collection should be sterile with caps tightened (DSHS).
Safe use and handling basics
- Label the container clearly. DSHS lists the patient’s name, date of birth, case number, site of the specimen and date of collection.
- DSHS says specimens are refrigerated between collection and processing.
- Transport follows the general rules in specimen bags and biohazard transport.
These points come from one state laboratory’s guidance for TB testing and are not a rule for every test; the receiving laboratory’s instructions govern. Sputum smears for TB are often examined with fluorochrome stains; see auramine-rhodamine staining for that method.
Common mistakes
- Sending a 24-hour pooled sputum. DSHS lists it as unacceptable or limited because a large share is saliva with fewer viable tubercle bacilli.
- Putting the specimen in formalin. DSHS lists it as unacceptable for mycobacterial testing.
- Sending an unlabeled container or one with a loosely fitted cap (DSHS labeling and tightened-cap guidance).
FAQ
Does a sputum cup need to be sterile?
Both laboratory sources specify a sterile container. The FDA regulation allows a specimen collection device to be labeled sterile but does not require it as part of the definition, so follow the receiving laboratory.
Is a sputum cup an FDA-regulated device?
Yes. Under product code LIO it is a Class 1 specimen collection device under 21 CFR 866.2900.
What container does a laboratory specify?
Texas DSHS specifies a sterile 50 ml leak-proof, disposable, graduated screw-top conical tube for mycobacterial testing, and NHS Greater Glasgow and Clyde specifies a white-topped sterile container, preferably wide-necked for sputum. Always use the one the receiving laboratory names.
Sources
- openFDA device classification, product code LIO, https://api.fda.gov/device/classification.json?search=product_code:LIO (checked 2026-10-31).
- 21 CFR 866.2900, Microbiological specimen collection and transport device, https://www.law.cornell.edu/cfr/text/21/866.2900 (checked 2026-10-31).
- Texas DSHS, Collection of Clinical Specimens for Mycobacterial Testing, https://www.dshs.texas.gov/sites/default/files/lab/STL/COLLECTION%20OF%20CLINICAL%20SPECIMENS%20FOR%20MYCOBACTERIAL%20TESTING.pdf (checked 2026-10-31).
- NHS Greater Glasgow and Clyde, Microbiology specimen containers, https://rightdecisions.scot.nhs.uk/ggc-microbiology/sampling/specimen-containers (checked 2026-10-31).
