510(k) · Cleared
Recalled · Class II · 2020Toxcup Drug Screen Cup Amp/Coc/Met/Opi/PCP/THC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Branan Medical Corp. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Aug 21, 2003 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.
- Decided
- Aug 21, 2003
- Review
- 50 days
- Class
- Class II
- Product code
- DIO
- Recalls
- 2
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2020 | Class II | Z-3045-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Mar 26, 2014 | Class II | Z-1508-2014 | Labeling Change Control | May be labeled with incorrect result interpretation graphics on the ToxCup lid label. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ToxCupTMDrug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations: AMP — d-Amphetamine — 1000 ng/ml COC — Benzoylecgonine — 300 ng/ml MET500 — d-Methamphetamine — 500 ng/ml 0PI2000 — Morphine — 2000 ng/ml OPI300* — Morphine — 300ng/mI * PCP —…
Read the full statement (135 words)
The ToxCupTMDrug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations:
AMP — d-Amphetamine — 1000 ng/ml
COC — Benzoylecgonine — 300 ng/ml
MET500 — d-Methamphetamine — 500 ng/ml
0PI2000 — Morphine — 2000 ng/ml
OPI300* — Morphine — 300ng/mI *
PCP — Phencyclidine — 25 ng/ml
THC — 11-nor-A9-Tetrahydrocannabinol-9-carboxylicacid — 50 ng/ml
*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 n g h . and the optional cut-off concentration indicated.
The ToxCupTMDrug Screen Cup provides visual, qualitative results for multiple drugs-of-abused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032057: Toxcup Drug Screen Cup Amp/Coc/Met/Opi/PCP/THC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032057
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026