510(k) · Cleared
ClearedFirst Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.H.P.M., Inc. · QBF Test, Propoxyphene, Over The Counter
Cleared on Aug 12, 2021 as substantially equivalent to K182701 (Guangzhou Wondfo Biotech Co., Ltd., 2018) after a 189-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Aug 12, 2021
- Review
- 189 days
- Class
- Class II
- Product code
- QBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945610 (1995). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 6 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 5 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 4 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 3 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 2 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 1 generation backK182701 Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · Recalled
- This deviceK210327 First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup…W.H.P.M., Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −6 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −5 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −4 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −3 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −2 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −1 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | 1 |
| 0 (this device) | K210327 | First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First… | W.H.P.M., Inc. | 2021 | — |
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 QBF? 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 |
|---|---|---|---|
| * | K182701 | Wondfo T-Cup Multi-Drug Urine Test CupSummary page 8…II 862.3870, Cannabinoids Test Toxicology Cannabinoids System 5. Predicate Devices: K182701 Wondfo T-Cup® Multi-Drug Urine Test Cup 6. Intended Use First Sign Multi-Drug Test Dip Card is competitive binding, latera… | 2018 |
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 26 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 28 ancestors have a recall of any class.
- 6 other devices also cite its predicate K182701.
How does its category compare?
All QBF devicesQBF Test, Propoxyphene, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QBF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QBF
Too few QBF 510(k)s in any year since 2007 to give a median.
Recalls per year · QBF
No recall names QBF since 2007.
Adverse event reports per year · QBF
No MAUDE report names QBF 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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Drug(Identifier)…
Read the full statement (1,018 words)
First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Drug(Identifier) — Cut-off level
Amphetamine (AMP) — 1000ng/mL or 500 ng/mL
Buprenorphine (BUP) — 10 ng/mL
Butalbital (BAR) — 300 ng/mL
Oxazepam (BZO) — 300 ng/mL
Cocaine (COC) — 300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) — 300 ng/mL
Methamphetamine (MET) — 1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA) — 500 ng/mL
Morphine (MOP 300/OPI 2000) — 2000ng/mL or 300 ng/mL
Methadone (MDT) — 300 ng/mL
Oxycodone (OXY) — 100 ng/mL
Phencyclidine (PCP) — 25 ng/mL
Propoxyphene (PPX) — 300 ng/mL
Nortriptyline (TCA) — 1000 ng/mL
Marijuana (THC) — 50 ng/mL
Configuration of the First Sign Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
First Sign Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Drug(Identifier) — Cut-off level
Amphetamine (AMP) — 1000ng/mL or 500 ng/mL
Buprenorphine (BUP) — 10 ng/mL
Butalbital (BAR) — 300 ng/mL
Oxazepam (BZO) — 300 ng/mL
Cocaine (COC) — 300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) — 300 ng/mL
Methamphetamine (MET) — 1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA) — 500 ng/mL
Morphine (MOP 300/OPI 2000) — 2000ng/mL or 300 ng/mL
Methadone (MDT) — 300 ng/mL
Oxycodone (OXY) — 100 ng/mL
Phencyclidine (PCP) — 25 ng/mL
Propoxyphene (PPX) — 300 ng/mL
Nortriptyline (TCA) — 1000 ng/mL
Marijuana (THC) — 50 ng/mL
Configuration of the First Sign Multi-Drug Test Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
First Sign Multi-Drug Screen Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Drug(Identifier) — Cut-off level
Amphetamine (AMP) — 1000ng/mL or 500 ng/mL
Buprenorphine (BUP) — 10 ng/mL
Butalbital (BAR) — 300 ng/mL
Oxazepam (BZO) — 300 ng/mL
Cocaine (COC) — 300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) — 300 ng/mL
Methamphetamine (MET) — 1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA) — 500 ng/mL
Morphine (MOP 300/OPI 2000) — 2000ng/mL or 300 ng/mL
Methadone (MDT) — 300 ng/mL
Oxycodone (OXY) — 100 ng/mL
Phencyclidine (PCP) — 25 ng/mL
Propoxyphene (PPX) — 300 ng/mL
Nortriptyline (TCA) — 1000 ng/mL
Marijuana (THC) — 50 ng/mL
Configuration of the First Sign Multi-Drug Screen Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only. It is for prescription use.
First Sign Multi-Drug Screen Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Drug(Identifier) — Cut-off level
Amphetamine (AMP) — 1000ng/mL or 500 ng/mL
Buprenorphine (BUP) — 10 ng/mL
Butalbital (BAR) — 300 ng/mL
Oxazepam (BZO) — 300 ng/mL
Cocaine (COC) — 300ng/mL or 150 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDT) — 300 ng/mL
Methamphetamine (MET) — 1000ng/mL or 500 ng/mL
Methylenedioxy-methamphetamine (MDMA) — 500 ng/mL
Morphine (MOP 300/OPI 2000) — 2000ng/mL or 300 ng/mL
Methadone (MDT) — 300 ng/mL
Oxycodone (OXY) — 100 ng/mL
Phencyclidine (PCP) — 25 ng/mL
Propoxyphene (PPX) — 300 ng/mL
Nortriptyline (TCA) — 1000 ng/mL
Marijuana (THC) — 50 ng/mL
Configuration of the First Sign Multi-Drug Screen Test Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only. It is for prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210327: First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210327
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