510(k) · Cleared
ClearedInstant-View Marijuana (THC) Urine Dip Strip Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Jun 21, 2000 as substantially equivalent to K963654 (Syntron Bioresearch, Inc., 1997) after a 176-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jun 21, 2000
- Review
- 176 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963654 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK963654 Quikstrip Onestep Marijuana (THC) TestSyntron Bioresearch, Inc. · 1997
- This deviceK994410 Instant-View Marijuana (THC) Urine Dip Strip TestAlfa Scientific Designs, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963654 | Quikstrip Onestep Marijuana (THC) Test | Syntron Bioresearch, Inc. | 1997 | — |
| 0 (this device) | K994410 | Instant-View Marijuana (THC) Urine Dip Strip Test | Alfa Scientific Designs, Inc. | 2000 | — |
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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 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 |
|---|---|---|---|
| * | K963654 | Quikstrip Onestep Marijuana (THC) TestSummary page 1…devices for the similar intended use. The device used for comparison study is QuikStrip One Step Marijuana Test, manufactured by Syntron Bioresearch, Inc. with 510(K) #: K963654, Date of Approval: 02/28/97. Device Description This test is a one-step lateral flow chromatographic immunoassay. Intended Use… | 1997 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K963654.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Instant-View Marijuana (THC) Urine Dip StripTest is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9, THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only. The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order…
Read the full statement (106 words)
Instant-View Marijuana (THC) Urine Dip StripTest is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9, THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.
The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminarily positive results are used.
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/K994410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994410: Instant-View Marijuana (THC) Urine Dip Strip Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994410
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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