Written and maintained by CASRAI Editorial Board
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General information for laboratory and clinic staff, not medical advice. Anyone collecting a specimen should follow the instructions of the ordering laboratory and clinician.
Short answer
A 24-hour urine collection jug is a large specimen container, described in one hospital laboratory handbook as a clean, wide-mouthed plastic container with a lid that holds about 3 L. In U.S. regulation it falls under specimen transport and storage containers (21 CFR 864.3250), Class I. Which jug, and whether it holds a preservative, is set by the test the laboratory is running.
Definition and scope
The term “jug” is informal. Laboratories and suppliers also say bottle, container, or “24-hour urine collection kit.” This page uses “jug” for the container itself and “kit” for any bundle sold or issued with it. The test being ordered, not the word on the label, decides what is required.
The regulation defines a specimen transport and storage container as a device intended to contain biological specimens, body waste, or body exudate during storage and transport. It may be empty or prefilled, and a prefilled container holds a fixative solution or other general-purpose reagent to preserve the specimen (21 CFR 864.3250, checked 2026-10-31).
How the container is used in practice
The University of Iowa Hospitals and Clinics pathology handbook (checked 2026-10-31) describes the container as a disposable, clean plastic container with a wide mouth and a plastic lid, large enough to hold about 3 L. It notes that amber containers may be needed for light-sensitive tests, and that some urine tests require the collection to be refrigerated while it is being gathered.
The same handbook calls for the appropriate preservative at the correct concentration, and warns to assume that all preservatives are hazardous. It asks for the container and requisition to carry patient identification (name, hospital number), the tests required, the preservative used, and the start and end date and time, because a strictly timed 24-hour specimen is required: many soluble substances vary over the course of the day.
ARUP Laboratories (checked 2026-10-31) states that most 24-hour specimens can be collected in a clean, nonmetal container without preservatives if the specimen is kept refrigerated or on ice. ARUP supplies its own 24-hour collection containers (supply number 16419) with peel-off labels to record times and volume. For labeling practice in general, see specimen labeling error prevention.
Jug, bottle, container or kit: what the terms mean
Plain versus preservative-containing containers
Per 21 CFR 864.3250, a container can be empty or prefilled with a fixative or general-purpose reagent. ARUP says many 24-hour urine specimens need no preservative if kept cold; Iowa says some tests do require a preservative. The ordering laboratory’s test directory settles which applies to a given test.
Kit
No standard “kit” for 24-hour collection is defined by 21 CFR 864.3250, the University of Iowa handbook or ARUP. ARUP’s description is the closest: a collection container with peel-off labels for times and volume. Contents of any commercial kit should be read from that product’s own instructions for use. For the smaller spot-collection products, see the urine collection kit guide, the urine hat guide and the urine tube guide.
Where it matters for labs, clinics and supply decisions
Regulatory status
Under 21 CFR 864.3250 the device is Class I (general controls) and exempt from premarket notification, subject to the limitations in 21 CFR 807 and 864.9. If it is not labeled sterile, it is exempt from the quality system regulation (part 820) except for records (820.35) and complaint files. Containers that are part of an over-the-counter test sample collection system for drugs of abuse testing are excluded from this regulation (checked 2026-10-31). For how classes and pathways relate, see FDA medical device classification, 510(k) and PMA.
Checklist of attributes to confirm with the ordering laboratory
| Attribute | What the source says | Source |
|---|---|---|
| Size and form | Wide-mouthed plastic container with lid, large enough for about 3 L | University of Iowa pathology handbook |
| Light protection | Amber container may be needed for light-sensitive tests | University of Iowa pathology handbook |
| Preservative | Correct preservative at the correct concentration for the test; preservatives treated as hazardous; or none if kept cold | University of Iowa; ARUP |
| Temperature during collection | Some tests require refrigeration; ARUP allows unpreserved collection if refrigerated or on ice | University of Iowa; ARUP |
| Labels | Patient identification, tests, preservative, start and end date and time; ARUP supplies peel-off labels for times and volume | University of Iowa; ARUP |
| Material | Clean, nonmetal container | ARUP |
| One preservative per collection | Urine should not be collected at the same time for two or more tests that need different preservatives (citing Tietz) | ARUP |
Related handling topics on this site include biohazard bag and container requirements.
Common misunderstandings
- “Any large bottle will do.” Iowa and ARUP both describe clean, purpose-chosen containers, and ARUP specifies nonmetal. The test, not size alone, sets the requirement.
- “Every collection needs a preservative.” ARUP states most can be collected without one if kept refrigerated or on ice; some tests do need one.
- “One jug can serve several tests.” ARUP, citing Tietz, advises against collecting at the same time for tests with different preservatives.
- “A kit is a regulated standard bundle.” The regulation covers the container as a specimen transport and storage device; it does not define a kit.
FAQ
What is a 24-hour urine collection kit?
No standard kit is defined by 21 CFR 864.3250, the University of Iowa handbook or ARUP. ARUP’s collection container with peel-off labels for times and volume is one laboratory’s example; contents of any other kit come from its own instructions for use.
Is a 24-hour urine jug a regulated medical device?
Yes, as a specimen transport and storage container under 21 CFR 864.3250: Class I, exempt from 510(k) subject to the stated limitations (checked 2026-10-31).
Does the jug contain a preservative?
It depends on the test. The container may be empty or prefilled under the regulation, and the ordering laboratory specifies which preservative, if any.
Sources
All sources checked 2026-10-31.
- 21 CFR 864.3250, Specimen transport and storage container: https://www.law.cornell.edu/cfr/text/21/864.3250
- University of Iowa Hospitals and Clinics, pathology handbook, 24-hour urine collection: https://www.healthcare.uiowa.edu/path_handbook/Appendix/TechServ/24hr_urine.html
- ARUP Laboratories, urine specimen collection and handling: https://aruplab.com/testing/resources/specimen/urine
