510(k) · Cleared
ClearedInstant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of Abuse Urine Test (Panel, Cup)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jul 6, 2010 as substantially equivalent to K063545 (Alfa Scientific Designs, Inc., 2007) and 1 other predicate after a 179-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Jul 6, 2010
- Review
- 179 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001178 (2000). 15 ancestors in all, the oldest K971218 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 4 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 3 generations backK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- 2 generations backK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
- 1 generation backK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
- This deviceK100051 Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup)…Alfa Scientific Designs, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −4 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −3 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| −2 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | — |
| −1 | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test… | Alfa Scientific Designs, Inc. | 2007 | — |
| 0 (this device) | K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict… | Alfa Scientific Designs, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Summary page 1…paration INSTANT- VIE VI Multi-Drugs Urine Test (510(k) Number: KO063545) Predicate INsTAN- Vic&o Oxycodone Urine Test (510(k) Number: K063545) Devices INSTANT- VIEW® Morphine (300) Urine Test (510(k) Number: K060527) Made by Alfa Scienti… | 2007 |
| * | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…Summary page 1…KO063545) Predicate INsTAN- Vic&o Oxycodone Urine Test (510(k) Number: K063545) Devices INSTANT- VIEW® Morphine (300) Urine Test (510(k) Number: K060527) Made by Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test 5 10(k) Submission… | 2006 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 15 ancestors has a recall.
- 2 other devices also cite its predicate K063545.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use. Abbreviation Test Calibrator Cutoff MORIOP1300 Morphine/Opiates Morphine 309 ng/mL OXY100 Oxycodone Oxycodone 100 ng/inL OXY300 Oxycodone Oxycodone 300 ng/mL This assay provides only* preliminary results. A more…
Read the full statement (117 words)
The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use.
Abbreviation Test Calibrator Cutoff
MORIOP1300 Morphine/Opiates Morphine 309 ng/mL
OXY100 Oxycodone Oxycodone 100 ng/inL
OXY300 Oxycodone Oxycodone 300 ng/mL
This assay provides only* preliminary results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/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/K100051 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100051: Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of Abuse Urine Test (Panel, Cup).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100051
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