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ICA2506-14
BioTeke
14 defined analytes
A fixed 14-analyte configuration with documented cut-off concentrations for professional evaluation and procurement.
Visual result interpretation
Read the control and test lines directly on the cup. A timer is required; the procedure does not require an analyzer.
Documentation for evaluation
Review the instructions for use, study details and 510(k) clearance information before discussing procurement.
Product specifications
| Product name | BioTeke Multi-Drug Urine Test Cup |
| Configuration | Fixed 14-panel urine test cup |
| Specimen | Human urine |
| Method | Competitive lateral flow immunochromatographic assay |
| Result type | Qualitative; preliminary |
| Use | In vitro diagnostic use |
| Kit contents | 1 test cup and user instruction; 1 test/kit |
| Additional equipment | Watch, clock or timer; clean, dry container if required |
| Operating temperature | 59–86°F (15–30°C) |
| Storage temperature | 35.6–86°F (2–30°C), sealed pouch |
| Expiration | See package label |
| After opening | Use within 1 hour; single use only |
Collection and visual reading
This overview does not replace the instructions for use. Perform the test at 59–86°F (15–30°C) and test immediately after urine collection.
01 Prepare
Open the foil pouch and remove the cup. Use within one hour of opening.
02 Collect and close
Add urine above the minimum fill line. Tighten the lid, place the cup on a flat surface, start timing and peel off the result label.
03 Read and interpret
Follow the reading time in the supplied instructions for use. Do not interpret results after 10 minutes.
Collection and visual reading
Negative
Both C and T lines appear. A faint test line is also negative. Drug may still be present below the cut-off.
Preliminary positive
The C line appears and the T line is absent. Use a more specific method to obtain a confirmed result.
Invalid
The C line is absent, whether or not a T line appears. Repeat with a new cup.
Review the evidence behind the panel
The instructions for use report precision and reproducibility testing with three lots over 25 days, with two runs per day at concentrations around each cut-off. They also include clinical specimen comparison results against LC-MS/MS, reported by analyte and operator.
Results vary by analyte and concentration. Review the full study tables, cross-reactivity information and limitations rather than applying a single accuracy percentage to the entire panel.
Product documents for your review
Instructions for Use
Intended use, cut-offs, procedure, result interpretation, performance studies and limitations.
510(k) clearance letter
Device name and clearance reference K261409, dated September 10, 2026.
Which items does this 14-panel cup test?
See the complete panel table for all 14 analytes.
Does a positive result confirm drug use?
No. The test provides a preliminary result. A more specific method is required for confirmation; GC/MS or LC/MS is preferred. A positive result does not establish intoxication or the drug concentration in urine.
Does a faint test line count as negative?
Yes. When the control line is present, any visible pink test line is interpreted as negative. Always follow the supplied instructions for use.
How should unopened cups be stored?
Store sealed pouches at 35.6–86°F (2–30°C), away from direct sunlight, moisture and heat. Check the package label for the expiration date.
Can distributors request samples and pricing?
Yes. Submit a distribution inquiry with your evaluation needs. Sample charges depend on the quantity requested, and BioTeke will discuss pricing and order requirements with you.
