510(k) · Cleared
ClearedInstant-View Methamphetamine Urine Cassette Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Scientific Designs, Inc. · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Aug 4, 2000 as substantially equivalent to K970395 (Drial Consultants, Inc., 1997) after a 220-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Aug 4, 2000
- Review
- 220 days
- Class
- Class II
- Product code
- DJC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970395 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970395 Quikstrip One Step MethamphetamineDrial Consultants, Inc. · 1997
- This deviceK994400 Instant-View Methamphetamine Urine Cassette TestAlfa Scientific Designs, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970395 | Quikstrip One Step Methamphetamine | Drial Consultants, Inc. | 1997 | — |
| 0 (this device) | K994400 | Instant-View Methamphetamine Urine Cassette 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 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 |
|---|---|---|---|
| * | K970395 | Quikstrip One Step MethamphetamineSummary page 1…s for the similar intended use. The device used for comparison study is QuikStrip One Step Methamphetamine Test, manufactured by Syntron Bioresearch, Inc. with 510(K) #: K970395, Date of Approval: 06/26/97. Predicate Device This test is a one-step lateral flow chromatographic Device Description immunoas… | 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 K970395.
How does its category compare?
All DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Instant-View Methamphetamine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect methamphetamine in human urine at a cutoff level of 500 ng/ml. It is intended for health care professional use only. The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Methamphetamine to be at a concentration of 1000 ng/ml. This test…
Read the full statement (123 words)
Instant-View Methamphetamine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect methamphetamine in human urine at a cutoff level of 500 ng/ml. It is intended for health care professional use only.
The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Methamphetamine to be at a concentration of 1000 ng/ml.
This 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 test result, particularly when preliminary 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/K994400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994400: Instant-View Methamphetamine Urine Cassette Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994400
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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