510(k) · Cleared
ClearedOntrak Testcup-ER
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Nov 18, 1998 as substantially equivalent to K881816 (Roche Diagnostic Systems, Inc., 1988) and 1 other predicate after a 54-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 18, 1998
- Review
- 54 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881816 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK881816 Abuscreen (R) Ontrak (TM) for BarbituratesRoche Diagnostic Systems, Inc. · 1988
- This deviceK983388 Ontrak Testcup-ERRoche Diagnostic Systems, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881816 | Abuscreen (R) Ontrak (TM) for Barbiturates | Roche Diagnostic Systems, Inc. | 1988 | — |
| 0 (this device) | K983388 | Ontrak Testcup-ER | Roche Diagnostic Systems, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K881816 | Abuscreen (R) Ontrak (TM) for BarbituratesSummary page 2…tems, Inc. claims equivalence. Table 2 Product Name Predicate Product Date Predicate Name Predicate 510(k) Cleared Number ONTRAK TESTCUP-er Abuscreen ONTRAK for 7/28/88 K881816 Barbiturates Barbiturates ONTRAK TESTCUP-er Abuscreen ONTRAK for 4/5/91 K910590 Benzodiazepines Benzodiazepines IV. Description… | 1988 |
| * | K910590 | Abuscreen Ontrak for BenzodiazepineSummary page 2…icate Name Predicate 510(k) Cleared Number ONTRAK TESTCUP-er Abuscreen ONTRAK for 7/28/88 K881816 Barbiturates Barbiturates ONTRAK TESTCUP-er Abuscreen ONTRAK for 4/5/91 K910590 Benzodiazepines Benzodiazepines IV. Description of the Device/Statement of Intended Use: The ONTRAK TESTCUP-er is an in vitro… | 1991 |
| † | K944231 | Ontrak Testcup Collection/Urinalysis Panel for Cocaine, Morphine and THC | 1994 |
| † | K962411 | Ontrak Testcup Amphetamines | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K881816.
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 ONTRAK TESTCUP -er is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. ONTRAK TESTCUP-er simultaneously tests for the presence of multiple drugs or drug metabolites. The ONTRAK TESTCUP - er profile consists of amphetamines (1000 ng/mL cutoff), cocaine metabolite (300 ng/mL cutoff), barbiturates (200 ng/mL cutoff), benzodiazepines (200 ng/mL), and morphine (300 ng/mL cutoff).
Measurements obtained by this device are used in the diagnosis and treatment of amphetamine, cocaine, barbiturate, benzodiazepine, and morphine use or overdose.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983388: Ontrak Testcup-ER.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983388
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026