510(k) · Cleared
ClearedFirst Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.H.P.M., Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Jun 29, 2015 as substantially equivalent to K052115 (First Check Diagnostics, LLC, 2005) after a 31-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Jun 29, 2015
- Review
- 31 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050186 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK050186 Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 2005 · Recalled
- 1 generation backK052115 First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc)…First Check Diagnostics, LLC · 2005 · Recalled
- This deviceK151441 First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup…W.H.P.M., Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050186 | Ameditech Immutest Multi-Drug Screen Panel Iii | Ameditech, Inc. | 2005 | 3 |
| −1 | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine… | First Check Diagnostics, LLC | 2005 | 86 |
| 0 (this device) | K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | 2015 | — |
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 DJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp)…Summary page 4…ncyclidine Toxicology DJG Class II 21 CFR, 862.3650 Opiate Test System Toxicology 5. Predicate Devices: K052115 First Check Multi Drug Cup 12 6. Intended Use First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qua… | 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 10 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 12 other devices also cite its predicate K052115.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, 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 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format. The tests may yield preliminary positive results even when prescription drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to…
Read the full statement (163 words)
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.
The tests may yield preliminary positive results even when prescription drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.
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/K151441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151441: First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151441
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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