510(k) · Cleared
ClearedXenta Drug Screen Cup, Xenta Drug Screen Dipcard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xenta Biomedical Science Co., Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Feb 6, 2023 as substantially equivalent to K153050 (Co-Innovation Biotech Co., Ltd., 2016) after a 132-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Feb 6, 2023
- Review
- 132 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945610 (1995). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 7 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 6 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 5 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 4 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 3 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 2 generations backK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014
- 1 generation backK153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2016
- This deviceK222955 Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −7 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −6 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −5 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −4 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −3 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −2 | K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2014 | — |
| −1 | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2016 | — |
| 0 (this device) | K222955 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardSummary page 4…21 CFR 862.3610 Methamphetamine test system Device class: ClassⅡ Panel: Toxicology Product code: DIO,DJG,LDJ,DJC 4. The Predicate Devices K153050 Rapid Single/Multi-drug Test Cup Rapid Single/Multi-drug Test Dipcard 5. Device Description… | 2016 |
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 28 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 30 ancestors have a recall of any class.
- 4 other devices also cite its predicate K153050.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Test Calibrator Cut-off level Marijuana (THC) Delta-9-THC-COOH 50 ng/mL Cocaine (COC) Benzoylecgonine 300 ng/mL Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine 500 ng/mL Methamphetamine (MET)…
Read the full statement (155 words)
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to
qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
Test Calibrator Cut-off level
Marijuana (THC) Delta-9-THC-COOH 50 ng/mL
Cocaine (COC) Benzoylecgonine 300 ng/mL
Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine 500 ng/mL
Methamphetamine (MET) D-Methamphetamine 1000 ng/mL
Morphine 300 (MOP) Morphine 300 ng/mL
The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or
multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro
diagnostics use. They are intended for prescription use.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the
preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse
test result, particularly when preliminary positive results are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222955: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222955
Report an extraction error
Are you the manufacturer?
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