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

K210327 · W.H.P.M., Inc. · QBF · Aug 12, 2021 · Clinical Toxicology

Device Facts

• Record ID: K210327
• Device Name: 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
• Applicant: W.H.P.M., Inc.
• Product Code: QBF · Clinical Toxicology
• Decision Date: Aug 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3700
• Device Class: Class 2

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: [Table of cut-offs]. 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-diphenvlpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of cut-offs]. 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.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine; competitive binding principle. Input: human urine sample. Operation: urine migrates via capillary action; target drugs compete with drug-conjugate for binding sites on monoclonal mouse antibody-coated particles. Output: visual colored lines in test region (negative) or absence of line (positive); control line confirms proper function. Used in home or clinical settings; operated by lay users or healthcare professionals. Results are preliminary; require confirmation via GC/MS or LC/MS. Benefits: rapid, simultaneous screening for multiple substances to aid clinical decision-making.

Clinical Evidence

Bench testing only. Precision/reproducibility studies performed over 25 days using three lots. Analytical specificity/interference testing confirmed no interference from common physiological/pathological substances. Cross-reactivity evaluated for propoxyphene metabolites. Method comparison study tested 80 clinical samples (40 negative, 40 positive) against LC/MS. Lay user study conducted with 280 participants across three sites using spiked urine samples at various concentrations relative to cutoffs, demonstrating high accuracy.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding. Single-use device. Components: Dip Card or Cup, package insert, urine collection cup. Sealed in aluminum pouch with desiccant. Qualitative detection based on antigen-antibody immunochemistry.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana) in human urine. Intended for prescription and OTC use. Not intended to distinguish between prescription use and abuse.

Regulatory Classification

Identification

A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Wondfo T-Cup® Multi-Drug Urine Test Cup (K182701)

Submission Summary (Full Text)

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K210327 - Page 1 of 17

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K210327

B Applicant

W.H.P.M., Inc.

C Proprietary and Established Names

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

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QBF | Class II | 21 CFR 862.3700 - Propoxyphene Test System | TX - Clinical Toxicology |
| NGG | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| NFY | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| NFT | Class II | 21 CFR 862.3100 - Amphetamine test system | TX - Clinical Toxicology |
| NFW | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| NFV | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
| NGL | Class II | 21 CFR 862.3650 - Opiate test system | TX - Clinical Toxicology |
| PTG | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |
| LCM | Unclassified | | |

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| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PTH | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| QAW | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |

## II Submission/Device Overview:

### A Purpose for Submission:

Modification of previously cleared devices (k142353, k150162, k151441, k152551, k160793, and k171695) to add propoxyphene device (300 ng/mL cutoff)

### B Measurand:

Propoxyphene

### C Type of Test:

Qualitative lateral flow immunoassay

## III Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) 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 |

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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

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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,

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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.

## C Special Conditions for Use Statement(s):

Rx and OTC

## D Special Instrument Requirements:

None.

## IV Device/System Characteristics:

### A Device Description:

The 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 are immunochromatograph assays for the qualitative design of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine,

K210327 - Page 5 of 17

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Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine,
Propoxyphene, Nortriptyline and Marijuana in human urine. Each assay uses a monoclonal antibodydey conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

## B Principle of Operation:

The First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, and First Sign Multi-Drug Screen Test Cup are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Butalbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

## V Substantial Equivalence Information:

### A Predicate Device Name(s):

Wondfo T-Cup Multi-Drug Urine Test Cup

### B Predicate 510(k) Number(s):

k182701

### C Comparison with Predicate(s):

| Device & Predicate Device(s): | K210327 | K182701 |
| --- | --- | --- |
| Device Trade Name | 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 | Wondfo T-Cup Multi-Drug Urine Test Cup |
| General Device Characteristic Similarities | | |
| Indications For Use | For the qualitative detection of drugs of abuse in urine | Same |
| Assay Principle | Competitive binding, lateral flow | Same |

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| Device & Predicate Device(s): | K210327 | K182701 |
| --- | --- | --- |
| | immunochromatographic assay | |
| Matrix | Urine | Same |
| Test drug cutoffs (ng/mL) | Amphetamine (AMP): 1000 or 500
Oxazepam (BZO): 300
Cocaine (COC): 300 or 150
11-Nor-△9-Tetrahydrocannabinol-9-COOH (THC): 50
Methamphetamine (MET): 1000 or 500
Morphine (OPI 2000/MOP 300): 2000 or 300
Oxycodone (OXY): 100
Butalbital (BAR): 300
Methadone (MTD): 300
Buprenorphine (BUP): 10
D,L-Methylenedioxymethamphetamine (MDMA): 500
Phencyclidine (PCP): 25
Nortriptyline (TCA): 1000
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300
Propoxyphene (PPX): 300 | Same |
| General Device Characteristic Differences | | |
| Intended Use | Prescription and over-the-counter | Over-the-counter |

VI Standards/Guidance Documents Referenced:

None referenced.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of $\pm 100\%$, $\pm 75\%$, $\pm 50\%$, $\pm 25\%$ from the cutoff and at the $300~\mathrm{ng/mL}$ cutoff for Propoxyphene (PPX). Samples with concentration of $-100\%$ cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS or GC/MS. For each concentration, tests were performed two runs per day for 25

K210327 - Page 7 of 17

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days using three lots of test cups. The results for Propoxyphene are summarized in the following tables. The precision data for AMP1000, COC300 and THC were reported in k142353. Results for BUP, BAR and MOP 300 were reported in k152551. The data for BZO, MET1000 and MOP 2000 were reported in k150162. The data for MTD, PCP and OXY were reported in k151441. The data for EDDP, MDMA and TCA were reported in k160793. The data for AMP 500, COC150 and MET 500 were reported in k171695.

Propoxyphene dip card:

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Propoxyphene cup:

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

2. Linearity:

Not applicable, these devices are intended for qualitative use only.

3. Analytical Specificity/Interference:

Interference Studies:

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above propoxyphene cut-off levels. These urine samples were tested using three lots of each device. Compounds that showed no interference at a concentration of 100 µg/mL are summarized in the following tables. There were no differences observed between the Dip Card and the Cup formats. The interferences data for AMP1000, COC300 and THC were reported in k142353. Results for BUP, BAR and MOP 300 were reported in k152551. The data for BZO, MET1000 and MOP 2000 were reported in k150162. The data for MTD, PCP and OXY were reported in k151441. The data for EDDP, MDMA and TCA were reported in k160793. The data for AMP 500, COC150 and MET 500 were reported in k171695.

The following compounds did not cause any positive or negative interference with the propoxyphene assay.

| Acetaminophen | β-Estradiol | Oxalic acid |
| --- | --- | --- |
| Acetophenetidin | Ethanol | Oxolinic acid |
| N-Acetylprocainamide | Erythromycin | Oxymetazoline |

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K210327 - Page 9 of 17

| Acetylsalicylic acid | Fenoprofen | Papaverine |
| --- | --- | --- |
| Albumin | Furosemide | Penicillin G |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amoxicillin | Hemoglobin | Phenelzine |
| Ampicillin | Hydralazine | Prednisone |
| Apomorphine | Hydrochlorothiazide | (±)-Propranolol |
| Ascorbic acid | Hydrocortisone | Pseudoephedrine |
| Aspartame | O-Hydroxyhippuric acid | Quinine |
| Atropine | 3-Hydroxytyramine | Ranitidine |
| Benzilic acid | Ibuprofen | Salicylic acid |
| Benzoic acid | Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Chloral hydrate | Ketamine | Sulindac |
| Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Loperamide | Tetrahydrozoline |
| Cholesterol | Meperidine | Thiamine |
| Clonidine | Meprobamate | Thioridazine |
| Cortisone | Methoxyphenamine | Triamterene |
| (-)-Cotinine | Nalidixic acid | Trifluoperazine |
| Creatinine | Naloxone | Trimethoprim |
| Deoxycorticosterone | Naltrexone | DL-Tryptophan |
| Dextromethorphan | Naproxen | Tyramine |
| Diclofenac | Niacinamide | DL-Tyrosine |
| Diflunisal | Nifedipine | Uric acid |
| Digoxin | Norethindrone | Verapamil |
| Diphenhydramine | Noscapine | Zomepirac |
| Ecgonine methyl ester | (±)-Octopamine | |

## Cross-Reactivity Studies:

Cross-reactivity studies were performed to determine drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for propoxyphene. The cross-reactivity data for AMP1000, COC300 and THC were reported in k142353. The data for BUP, BAR and MOP 300 were reported in k152551. The data for BZO, MET1000 and MOP 2000 were reported in k150162. The data for MTD, PCP and OXY were reported in k151441. The data for EDDP, MDMA and TCA were reported in k160793. The data for AMP 500, COC150 and MET 500 were reported in k171695.

| Propoxyphene
(Cut off = 300 ng/mL) | Result Positive (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| d-Propoxyphene | 300 | 100% |
| Norpropoxyphene | 1500 | 20% |

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Effect of Urine Specific Gravity and Urine pH:

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above propoxyphene cut-off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% cut-off. There were no differences observed between the First Sign Multi-Drug Test Dip Card and First Sign Multi-Drug Test Cup.

4. Assay Reportable Range:

Not applicable.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

A shelf-life stability of 24 months from the date of manufacture is claimed.

6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

See section VII.A.1.

## B Comparison Studies:

1. Method Comparison with Predicate Device:

A method comparison study for the First Sign Multi-Drug Test Dip Card and the First Sign Multi-Drug Test Cup were performed in-house by three laboratory personnel for each candidate device. The operators tested 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The propoxyphene results are presented in the tables below. The accuracy data for AMP1000, COC300 and THC were reported in k142353. The data for BUP, BAR and MOP 300 were reported in k152551. The data for BZO, MET1000 and MOP 2000 were reported in k150162. The data for MTD, PCP and OXY were reported in k151441. The data for EDDP, MDMA and TCA were reported in k160793. The data for AMP 500, COC150 and MET 500 were reported in k171695.

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Propoxyphene Dip Card:

| | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 20 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |

Discordant Results for Propoxyphene Dip Card:

| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 20200406-030 | 268.2 | Positive |
| Viewer B | 20200408-001 | 277.6 | Positive |
| Viewer A | 20200407-003 | 332.0 | Negative |

Propoxyphene Cup:

| | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |

Discordant Results for Propoxyphene Cup:

| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 20200408-032 | 292.8 | Positive |
| Viewer C | 20200408-032 | 292.8 | Positive |
| Viewer A | 20200406-010 | 327.4 | Negative |

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# Lay user study:

A lay user study was conducted at three intended user sites by 280 lay users for each device format. The lay users had diverse educational and professional backgrounds and and ranged in age from 18 to $>50$ years. Urine samples were prepared at the following concentrations; negative, $\pm 75\%$ , $\pm 50\%$ , $\pm 25\%$ of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Typical results are summarized in the below tables.

First Sign Multi-Drug Test Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150):

| Assay | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% Cut off | -75% Cut off | -50% Cut off | -25% Cut off | +25% Cut off | +25% Cut off | +25% Cut off |
| AMP 500 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| BAR 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| BZO 300 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| BUP 10 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| COC 150 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| EDDP 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | | | | | | | |

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K210327 - Page 13 of 17
| Assay | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% Cut off | -75% Cut off | -50% Cut off | -25% Cut off | +25% Cut off | +25% Cut off | +25% Cut off |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MDMA 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MET 500 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| MOP 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MTD 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| OXY 100 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| PCP 25 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| PPX 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |

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| Assay | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% Cut off | -75% Cut off | -50% Cut off | -25% Cut off | +25% Cut off | +25% Cut off | +25% Cut off |
| | % Correct Results | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| TCA 1000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| THC 50 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |

First Sign Multi-Drug Test Configuration 2 (including AMP 1000, MET 1000, MOP 2000 (OPI), COC 300):

| Assay | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% Cut off | -75% Cut off | -50% Cut off | -25% Cut off | +25% Cut off | +25% Cut off | +25% Cut off |
| AMP 500 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| BAR 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| BZO 300 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| BUP 10 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |

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K210327 - Page 15 of 17
| Assay | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% Cut off | -75% Cut off | -50% Cut off | -25% Cut off | +25% Cut off | +25% Cut off | +25% Cut off |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| COC 150 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| EDDP 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MDMA 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MET 500 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MOP 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| MTD 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| OXY 100 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |

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| Assay | Results | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% Cut off | -75% Cut off | -50% Cut off | -25% Cut off | +25% Cut off | +25% Cut off | +25% Cut off |
| | % Correct Results | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| PCP 25 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| PPX 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| TCA 1000 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| THC 50 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | % Correct Results | 100% | 100% | 100% | 95% | 100% | 100% | 100% |

2. Matrix Comparison:

Not applicable. The assays are only intended for use with urine samples.

C Clinical Studies:

Not applicable.

1. Clinical Sensitivity:

Not applicable.

2. Clinical Specificity:

Not applicable.

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3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable.

D Clinical Cut-Off:

Not applicable.

E Expected Values/Reference Range:

Not applicable.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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