510(k) · Cleared
ClearedUniscan -Doa System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Unison Biotech, Inc. · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Oct 9, 2008 as substantially equivalent to K043242 (Biosite Incorporated, 2005) after a 244-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Oct 9, 2008
- Review
- 244 days
- Class
- Class II
- Product code
- DJC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012745 (2002). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 DJC? 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 DJC device
- #1 K253705 Healgen® Accurate Oral Fluid Drug Testscore 12.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K043242 | Triage Tox Drug ScreenSummary page 2…heir metabolites by one step, chromatographic, and competitive immunoassay technology. Currently marketed Triage TOX Drug Screen (whose 510(k) number is K043242) is used for substantial equivalence predicate kit. All of these products are based on the same immunochemical principle of… | 2005 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K043242.
How does its category compare?
All DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DJC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJC
258in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJC
No recall names DJC since 2007.
Adverse event reports per year · DJC
2in 2018
MAUDE reports naming product code DJC, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 3 | 258 | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
TUBI's UNISCAN-DoA is a system intended for use in Drugs of Abuse Screening Tests. This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with d-methamphetamine/morphine/ 11 -nor-A 9 -THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of…
Read the full statement (120 words)
TUBI's UNISCAN-DoA is a system intended for use in Drugs of Abuse Screening Tests.
This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with d-methamphetamine/morphine/ 11 -nor-A 9 -THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of 1000/300/50 ng/ml. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any Drug of Abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080347: Uniscan -Doa System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080347
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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