# 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

- Pathway: 510(k) (Traditional)
- Applicant: W.H.P.M., Inc.
- Decided: Aug 12, 2021 after 189 days
- Product code: QBF (Test, Propoxyphene, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945610 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup, Guangzhou Wondfo Biotech Co., Ltd. (2018) Summary page 8.

## Indications for use
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.

Source page: https://510kreport.com/device/K210327
Methodology: https://510kreport.com/methodology