510(k) · Cleared
ClearedFirst Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.H.P.M., Inc. · NFT Test, Amphetamine, Over The Counter
Cleared on Feb 5, 2018 as substantially equivalent to K122809 (Advin Biotech, 2013) after a 243-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Feb 5, 2018
- Review
- 243 days
- Class
- Class II
- Product code
- NFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945610 (1995). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 5 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 4 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 3 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 2 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 1 generation backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- This deviceK171695 First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test…W.H.P.M., Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −5 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −4 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −3 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −2 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −1 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| 0 (this device) | K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First… | W.H.P.M., Inc. | 2018 | — |
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 |
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 NFT? 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 NFT device
- #1 K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest…score 20.3 · 9 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 |
|---|---|---|---|
| * | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and CupSummary page 5…862.3610, Toxicology Methamphetamine Methamphetamine Test System (91) 5. Predicate Devices: K122809, Advin Multi-Drug Screen Test 6. Intended Use First Sign® Multi-Drug Cup Test is a qualitative lateral flow immunoassay i… | 2013 |
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 23 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 27 ancestors have a recall of any class.
- 11 other devices also cite its predicate K122809.
How does its category compare?
All NFT devicesNFT Test, Amphetamine, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NFT
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFT
37in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFT
No recall names NFT since 2007.
Adverse event reports per year · NFT
No MAUDE report names NFT since 2007.
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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 6 | 56 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 63 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 4 | 31 | 0 | 0 |
| 2025 | 8 | 37 | 0 | 0 |
| 2026 | 5 | 35 | 0 | — |
What is it indicated for?
First Sign® Drug of Abuse Cup Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used…
Read the full statement (410 words)
First Sign® Drug of Abuse Cup Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of
Marijuana in human urine at cut-off concentration of 20 ng/mL.
The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed
analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration
and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when
the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for prescription use.
First Sign® Drug of Abuse Dip Card Test Marijuana is a qualitative lateral flow immunoassay intended for the detection
of Marijuana in human urine at cut-off concentration of 20 ng/mL.
The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed
analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration
and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when
the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for prescription use.
First Sign® Multi-Drug Cup Test is a qualitative lateral flow immunoassay intended for the detection of
Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, 150 ng/mL, and
500 ng/mL, respectively.
The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed
analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration
and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when
the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter use.
First Sign® Multi-Drug Dip Card Test is a qualitative lateral flow immunoassay intended for the detection of
Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, 150 ng/mL, and
500 ng/mL, respectively.
The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed
analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration
and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when
the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171695: First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171695
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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