Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)

K143187 · Healgen Scientific,, LLC · DJG · Jan 27, 2015 · Clinical Toxicology

Device Facts

• Record ID: K143187
• Device Name: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
• Applicant: Healgen Scientific,, LLC
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jan 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. 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 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. It is intended for over-the-counter and for prescription use. Healgen Oxycodone Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. 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 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. It is intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assay; detects Amphetamine or Oxycodone in human urine; competitive binding principle using monoclonal mouse antibodies. Urine sample migrates via capillary action; target drug competes with drug-conjugate for antibody binding sites. Presence of drug above cutoff saturates binding sites, preventing colored line formation at test region; absence of drug allows binding, resulting in visible colored line. Control line confirms proper test performance. Available in strip, cassette, dip card, and cup formats. Used in point-of-care or home settings by lay users or clinicians. Provides preliminary qualitative results; requires GC/MS confirmation. Aids in identifying potential drug use; clinical judgment required for interpretation.

Clinical Evidence

No clinical studies performed. Bench testing included precision (n=50 per lot/format), analytical specificity/cross-reactivity, interference testing, and method comparison against GC/MS. Lay-user study (n=1120) across three sites confirmed ease of use and performance accuracy across various concentrations relative to cutoff. All results demonstrated substantial equivalence to predicate.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: strip, cassette, dip card, cup. Analyte-specific monoclonal mouse antibodies. Qualitative visual readout. Stable at 4-30°C for 24 months. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Amphetamine (1000 ng/mL cutoff) or Oxycodone (100 ng/mL cutoff) in human urine. Intended for OTC and prescription use in adults and adolescents. Not intended to distinguish between prescription use and abuse for Oxycodone.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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

• First Check Multi Drug Cup 12 (k052115)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k143187

B. Purpose for Submission:
New device

C. Measurand:
Amphetamine and oxycodone

D. Type of Test:
Qualitative immunochromatographic assay

E. Applicant:
Healgen Scientific, LLC.

F. Proprietary and Established Names:
Healgen Amphetamine Test
Healgen Oxycodone Test

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 21 CFR 862.3100, Amphetamine test system | Toxicology (91) |
| DJG | Class II | 21 CFR 862.3650, Opiate test system | Toxicology (91) |

H. Intended Use:
1. Intended use(s):
Refer to Indications for Use below.

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2. Indication(s) for use:

**Healgen Amphetamine Test**

Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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 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. It is intended for over-the-counter and for prescription use.

**Healgen Oxycodone Test**

Healgen Oxycodone Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. 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 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. It is intended for over-the-counter and for prescription use.

3. Special conditions for use statement(s):

For over the counter (OTC) and prescription use

4. Special instrument requirements:

Not applicable. The devices are visually read single-use devices.

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I. Device Description:

The Healgen Amphetamine Test and Healgen Oxycodone Test come in four formats: Strip, Cassette, Cup, and Dip Card. The Healgen tests use a lateral flow system for the qualitative detection of Amphetamine and Oxycodone in human urine. The tests are intended for use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. Information regarding confirmatory testing – the second step in the process is provided in the instructions for use.

J. Substantial Equivalence Information:

1. Predicate device name(s):

First Check Multi Drug Cup 12

2. Predicate 510(k) number(s):

k052115

3. Comparison with predicate:

| Similarities and Differences | | | |
| --- | --- | --- | --- |
| Item | Healgen Amphetamine Test (Candidate Device) | Healgen Oxycodone Test (Candidate Device) | k052115 |
| Indications for Use | For the qualitative determination of amphetamine | For the qualitative determination of oxycodone | For the qualitative determination of 12 drugs including amphetamine and oxycodone |
| Principle | Same | Same | Immunochromatographic lateral flow assay |
| Cutoff Concentration | Same | Same | AMP: 1000 ng/mL
OXY: 100 ng/mL |
| Intended Use Population | For over-the-counter and prescription use | For over-the-counter and prescription use | For over-the-counter use |
| Configuration | Strip, Cassette, Dip Card, Cup | Strip, Cassette, Dip Card, Cup | Cup |
| Type of Test | Same | Same | Qualitative |
| Specimen Type | Same | Same | Urine |

K. Standard/Guidance Document Referenced (if applicable):

None referenced.

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L. Test Principle:

The Healgen Amphetamine and Oxycodone Urine Tests use a lateral flow system for the qualitative detection of Amphetamine and Oxycodone in human urine. Each assay uses a monoclonal anti-mouse antibody-dye conjugate against the drugs containing gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in the test membranes.

When the absorbent end of the tests are immersed into the urine specimen, the urine is absorbed into the devices by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane. When sample drug levels are zero or below the target Cut-Off, antibody-dye conjugate binds to the drug-protein conjugate immobilized in the Test Region (T) of the devices. This produces a colored Test line that, regardless of its intensity, indicates a negative result.

When sample drug levels are at or above the target Cut-Off, the free drug in the sample binds to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the devices. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C), if the tests have been performed properly because of the antibody-dye conjugate binding to anti-mouse IgG immobilized in the Control Region(C) of the devices.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The precision performance of the Healgen Amphetamine and Oxycodone tests was evaluated using 3 lots for each format (Strip, Cassette, Cup, Dip Card) of the device. Each lot was evaluated by a different operator. The testing consisted of analyzing samples in 2 runs per day for 25 days (n = 50 per lot) and by spiking drug free urine samples to achieve 100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off drug concentrations. Each drug concentration was confirmed by GC/MS. Results are summarized below for each lot and device.

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Strip Format

| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Amphetamine | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 18/32 | 18/32 | 18/32 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
| Oxycodone | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 20/30 | 20/30 | 20/30 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |

Cassette Format

| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Amphetamine | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 20/30 | 20/30 | 20/30 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
| Oxycodone | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 20/30 | 20/30 | 20/30 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |

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DipCard Format

| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Amphetamine | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 20/30 | 20/30 | 20/30 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
| Oxycodone | Negative | 50 | 50/0 | 50/0 | 50/0 |
| --- | --- | --- | --- | --- | --- |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 24/26 | 24/26 | 24/26 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |

Cup Format

| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Amphetamine | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 18/32 | 18/32 | 18/32 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
| Oxycodone | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 16/34 | 16/34 | 16/34 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |

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b. Linearity/assay reportable range:

Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

External control materials are not supplied with the devices; however, the package inserts provides information on how to obtain control materials.

Stability protocols and acceptance criteria of all test formats were reviewed and deemed acceptable. The stability information supports the claimed shelf life of 24 months at 4 to 30 °C. The information also supports that the devices are stable for 35 days when exposed to extreme transport temperatures of -20 °C to 40 °C.

d. Detection limit:

Not applicable. The assays are intended for qualitative use.

e. Analytical specificity:

Cross-reactivity was evaluated by spiking various concentrations of similarly structured drug compounds into drug-free urine using three lots of each device for all formats. Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. The percent cross-reactivity of those compounds is listed below:

Amphetamine

| Compound | Concentration Equivalent to the Cutoff | Cross-Reactivity |
| --- | --- | --- |
| D-Amphetamine | 1000 ng/mL | 100% |
| Amphetamine Sulfate | 1000 ng/mL | 100% |
| Phentermine | 1250 ng/mL | 80% |
| (+/-)-4-Hydroxyamphetamine HCL | 600 ng/mL | 167% |
| L-Amphetamine | 20,000 ng/mL | 5% |

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| (+/-)-Methylene dioxyamphetamine (MDA) | 1500 ng/mL | 67% |
| --- | --- | --- |
| D,L-Amphetamine (Amphetamine Sulfate) | 1000 ng/mL | 100% |
| d-Methamphetamine | > 100,000 ng/mL | < 1% |
| 1-Methamphetamine | > 100,000 ng/mL | < 1% |
| ephedrine | > 100,000 ng/mL | < 1% |
| 3,4-Methylenedioxy ethylamphetamine (MDEA) | > 100,000 ng/mL | < 1% |
| 3,4-methylenedioxy-methamphetamine (MDMA) | > 100,000 ng/mL | < 1% |

Oxycodone

| Compound | Concentration Equivalent to the Cutoff | Cross-Reactivity |
| --- | --- | --- |
| Oxycodone | 100 ng/mL | 100% |
| Oxymorphone | 750 ng/mL | 13% |
| Dihydrocodeine | 12,500 ng/mL | 0.8% |
| Codeine | 50,000 ng/mL | 0.2% |
| Thebaine | 50,000 ng/mL | 0.2% |
| Ethyl Morphine | 75,000 ng/mL | 0.1% |
| Morphine | >100,000 ng/mL | < 0.1% |
| Acetylmorphine | >100,000 ng/mL | < 0.1% |
| Buprenorphine | >100,000 ng/mL | < 0.1% |
| Ethylmorphine | >100,000 ng/mL | < 0.1% |
| Hydromorphone | >100,000 ng/mL | < 0.1% |
| Hydrocodone | >100,000 ng/mL | < 0.1% |

Interference studies were performed using 100 µg/mL of commonly administered or OTC compounds (endogenous compounds, drugs, drug metabolites) that are

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commonly found in urine. These compounds were tested in urine containing $\pm 25\%$ cutoff concentration for each analyte using three lots of each device for all formats. The following compounds were found not to interfere when tested at $100~\mu \mathrm{g / mL}$ concentration.

Amphetamine

| Acetophenetidin |
| --- |
| N-Acetylprocainamide |
| Acetylsalicylic Acid (Aspirin) |
| Aminopyrine |
| Amitriptyline |
| Amoxicillin |
| Amobarbital |
| Ampicillin |
| Apomorphine |
| L-Ascorbic Acid |
| Aspartame |
| Atropine |
| Benzilic acid |
| Benzphetamine |
| Bezoic Acid |
| Bilirubin |
| Caffeine |
| Chloramphenicol |
| Chlordiazepoxide HCL |
| Chloroquine |
| Chlorothiazide |
| Chlorpheniramine |
| Chlorpromazine |
| Cholesterol |
| Clomipramine |
| Clonidine hydrochloride |
| Codeine |
| Cortisone |
| Cotinine(-) |
| Creatinine |
| Deoxyepinephrine |
| Dextromethorphan |
| Diazepam |
| --- |
| Diflunisal |
| Digoxin |
| Doxylamine |
| Ecgonine methylester |
| R(-)-Epinephrine |
| Erythromycin |
| Estrone-3-sulfate |
| Ethyl-p-aminobenzoate |
| Fenoprofen |
| Furosemide |
| Gentisic acid |
| Hemoglobin |
| Hydralazine |
| Hydrochlorothiazide |
| Hydrocodone |
| Hydrocortisone |
| a-Hydroxyhippuric acid |
| p-Hydroxymethamphetamine |
| Ibuprofen |
| Imipramine |
| Isoxsuprine |
| Isoproterenol-(+/-) |
| Ketamine |
| Labetalol |
| Levorphanol |
| Loperamide |
| Maprotiline |
| Meprobamate |
| Methadone |
| Methoxyphenamine |
| Methylphenidate |
| Nalbuphine |
| --- |
| Nalidixic acid |
| Naloxone hydrochloride |
| Naltrexone hydrochloride |
| Naproxen |
| Niacinamide |
| Nifedipine |
| Norethindrone |
| Norpropoxyphene |
| Noscapine |
| Oxazepam |
| Oxycodone |
| Oxymetazoline |
| Papaverine |
| Penicillin |
| Pentobarbital |
| Perphenazine |
| Phencyclidine |
| Phenelzine |
| Phenobarbital |
| Phenylephrine-L |
| Phenylethylamine |
| Phenylpropanolamine |
| Prednisolone Acetate |
| Prednisone |
| Procaine (Novocaine) |
| Promazine |
| Promethazine |
| Propoxyphene,d- |
| Propranolol |
| Pseudoephedrine HCL |
| Quinidine |
| Quinine |

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| Ranitidine(Zantac) |
| --- |
| Salicylic Acid |
| Secobarbital |
| Serotonin |
| Sulfamethazine |
| Sulindac |
| Temazepam |
| 11-Nor-Δ9-Tetrahydrocannabinol |
| Tetracycline |
| Tetrahydrozoline |
| --- |
| Thebaine |
| Thiamine |
| L-Thyroxine |
| Thioridazine Hydrochloride |
| Triamterene |
| Triflupromazine Hydrochloride |
| Trimethoprim |
| Trimipramine |
| --- |
| Tryptamine |
| DL-Tryptophan |
| Tyramine |
| D/L-Tyrosine |
| Uric Acid |
| Verapamil |
| Zomepirac |

# Oxycodone

| Acetophenetidin |
| --- |
| N-Acetylprocainamide |
| Acetylsalicylic Acid (Aspirin) |
| Aminopyrine |
| Amitriptyline |
| Amoxicillin |
| Amobarbital |
| D-Amphetamine |
| L-Amphetamine |
| Amphetamine Sulfate |
| Ampicinine (Ampicillin) |
| Apomorphine |
| L-Ascorbic Acid |
| Aspartame |
| Atropine |
| Benzilic acid |
| Benzphetamine |
| Bezoic Acid |
| Bilirubin |
| Caffeine |
| Chloramphenicol |
| Chlordiazepoxide HCL |
| Chloroquine |
| Chlorothiazide |
| Chlorpheniramine |
| Chlorpromazine |
| --- |
| Cholesterol |
| Clomipramine |
| Clonidine hydrochloride |
| Cortisone |
| Cotinine(-) |
| Creatinine |
| Deoxyepinephrine |
| Dextromethorphan |
| Diazepam |
| Diflunisal |
| Digoxin |
| Doxylamine |
| Ecgonine methylester |
| R(-)-Epinephrine |
| Erythromycin |
| Estrone-3-sulfate |
| Ethyl-p-aminobenzoate |
| Fenoprofen |
| Furosemide |
| Gentisic acid |
| Hemoglobin |
| Hydralazine |
| (+/-)-4-Hydroxyamphetamine HCL |
| Hydrochlorothiazide |
| Hydrocodone |
| --- |
| Hydrocortisone |
| a -Hydroxyhippuric acid |
| p-Hydroxymethamphetamine |
| Ibuprofen |
| Imipramine |
| Isoxsuprine |
| Isoproterenol-(+/-) |
| Ketamine |
| Labetalol |
| Levorphanol |
| Loperamide |
| Maprotiline |
| Meprobamate |
| Methadone |
| Methoxyphenamine |
| (+/-)-Methylenedioxyamphetamine (MDA) |
| Methylphenidate |
| Nalbuphine |
| Nalidixic acid |
| Naloxone hydrochloride |
| Naltrexone hydrochloride |
| Naproxen |
| Niacinamide |

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| Nifedipine |
| --- |
| Norethindrone |
| Norpropoxyphene |
| Noscapine |
| Oxazepam |
| Oxymetazoline |
| Papaverine |
| Penicillin |
| Pentobarbital |
| Perphenazine |
| Phencyclidine |
| Phenelzine |
| Phenobarbital |
| Phentermine |
| Phenylephrine-L |
| Phenylethylamine |
| Phenylpropanolamine |
| Prednisolone Acetate |
| Prednisone |
| --- |
| Procaine(Novocaine) |
| Promazine |
| Promethazine |
| Propoxyphene,d- |
| Propranolol |
| Pseudoephedrine HCL |
| Quinidine |
| Quinine |
| Ranitidine(Zantac) |
| Salicylic Acid |
| Secobarbital |
| Serotonin |
| Sulfamethazine |
| Sulindac |
| Temazepam |
| 11-Nor-Δ9-Tetrahydrocannabinol |
| Tetracycline |
| --- |
| Tetrahydrozoline |
| Thiamine |
| L-Thyroxine |
| Thioridazine Hydrochloride |
| Triamterene |
| Triflupromazine Hydrochloride |
| Trimethoprim |
| Trimipramine |
| Tryptamine |
| DL-Tryptophan |
| Tyramine |
| D/L-Tyrosine |
| Uric Acid |
| Verapamil |
| Zomepirac |

Specific Gravity and pH studies:

Twelve urine samples with specific gravity ranges (1.000-1.035) were collected and spiked with each drug at 25% below and 25% above cutoff levels. Each sample was tested using three lots of each format of the test devices. The results showed that a specific gravity range of 1.000 to 1.035 does not affect the accuracy of the tests.

A negative urine pool was adjusted to a pH range of 4.00 to 9.00 in 1 pH unit increments and was spiked with each drug at 25% below and 25% above cutoff levels. Samples were tested using three lots of each format of the devices, and results showed that urine pH range of 4.00 to 9.00 does not affect the accuracy of the accuracy of the tests.

f. Assay cut-off:

The assay cutoff characterization study was performed using the Healgen Amphetamine Test and the Healgen Oxycodone Test with three lots for each format (Cup, Dip Card, Cassette, and Strip format) by three operators. The study samples were made by spiking drug-free urine samples (confirmed by GC/MS) with known amounts of amphetamine or oxycodone. Results are shown in the tables below:

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Strip Format

| Drug Test | Cut off Level | n | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Amphetamine | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 42/48 | 42/48 | 45/45 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
| Oxycodone | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 48/42 | 42/48 | 42/48 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |

Cassette Format

| Drug Test | Cut off Level | n | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Amphetamine | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 45/45 | 45/45 | 42/48 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
| Oxycodone | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 42/48 | 45/45 | 51/39 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |

Dip Card Format

| Drug Test | Cut off Level | n | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Amphetamine | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 42/48 | 42/48 | 45/45 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
| Oxycodone | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 45/45 | 48/42 | 42/48 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |

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Cup Format

| Drug Test | Cut off Level | n | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Amphetamine | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 42/48 | 42/48 | 42/48 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
| Oxycodone | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 45/45 | 42/48 | 45/45 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |

# 2. Comparison studies:

# a. Method comparison with predicate device:

The method comparison for the Healgen Amphetamine Test and the Healgen Oxycodone Test was performed internally against the reference method, GC/MS. Operators ran 80 unaltered urine samples on each format of the devices, where each device format was tested by an independent set of three operators. The samples were masked and randomized prior to testing and device results were compared to GC/MS. The results are presented in the table below:

Amphetamine Strip Format

| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (>+50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 14 | 23 |
| | Negative | 10 | 16 | 14 | 3 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 14 | 23 |
| | Negative | 10 | 16 | 14 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |

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Discordant Results with Amphetamine Strip

| Operator | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- |
| Operator A | 1006 | Negative |
| Operator A | 1009 | Negative |
| Operator A | 1010 | Negative |
| Operator B | 1011 | Negative |
| Operator B | 1006 | Negative |
| Operator B | 1009 | Negative |
| Operator C | 1011 | Negative |
| Operator C | 1006 | Negative |
| Operator C | 1009 | Negative |
| Operator C | 1010 | Negative |

Amphetamine Cassette Format

| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (>+50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 16 | 14 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 14 | 23 |
| | Negative | 10 | 16 | 14 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 14 | 23 |
| | Negative | 10 | 16 | 14 | 3 | 0 |

Discordant Results with Amphetamine Cassette

| Operator | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- |
| Operator A | 1006 | Negative |
| Operator A | 1009 | Negative |
| Operator B | 1011 | Negative |
| Operator B | 1006 | Negative |
| Operator B | 1009 | Negative |
| Operator C | 1006 | Negative |
| Operator C | 1009 | Negative |
| Operator C | 1010 | Negative |

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15

Amphetamine Cup Format

| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 16 | 14 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 16 | 14 | 2 | 0 |

Discordant Results with Amphetamine Cup

| Operator | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- |
| Operator A | 1006 | Negative |
| Operator A | 1010 | Negative |
| Operator B | 1011 | Negative |
| Operator B | 1006 | Negative |
| Operator B | 1009 | Negative |
| Operator B | 1015 | Negative |
| Operator C | 1006 | Negative |
| Operator C | 1010 | Negative |

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16

Amphetamine Dip Card Format

| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (>+50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 16 | 14 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |

Discordant Results with Amphetamine Dip Card

| Operator | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- |
| Operator A | 1006 | Negative |
| Operator A | 1010 | Negative |
| Operator B | 1011 | Negative |
| Operator B | 1006 | Negative |
| Operator B | 1009 | Negative |
| Operator B | 1015 | Negative |
| Operator C | 1011 | Negative |
| Operator C | 1006 | Negative |
| Operator C | 1009 | Negative |
| Operator C | 1010 | Negative |

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Oxycodone Strip Format

| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

Discordant Results with Oxycodone Strip

| Operator | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- |
| Operator A | 101 | Negative |
| Operator A | 103 | Negative |
| Operator A | 105 | Negative |
| Operator B | 101 | Negative |
| Operator B | 105 | Negative |
| Operator C | 101 | Negative |
| Operator C | 103 | Negative |
| Operator C | 105 | Negative |

Oxycodone Cassette Format

| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

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Discordant Results with Oxycodone Cassette

| Operator | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- |
| Operator A | 101 | Negative |
| Operator A | 103 | Negative |
| Operator A | 105 | Negative |
| Operator B | 101 | Negative |
| Operator B | 103 | Negative |
| Operator B | 105 | Negative |
| Operator C | 101 | Negative |
| Operator C | 103 | Negative |
| Operator C | 105 | Negative |

Oxycodone Dip Card Format

| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (>+50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

Discordant Results with Oxycodone Dip Card

| Operator | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- |
| Operator A | 101 | Negative |
| Operator A | 103 | Negative |
| Operator A | 105 | Negative |
| Operator B | 101 | Negative |
| Operator B | 105 | Negative |
| Operator C | 101 | Negative |
| Operator C | 103 | Negative |
| Operator C | 105 | Negative |

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Oxycodone Cup Format

| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and | Near Cutoff Positive by GC/MS (between cutoff and | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | 15 | 15 | 3 | 0 |

Discordant Results with Oxycodone Cup

| Operator | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- |
| Operator A | 101 | Negative |
| Operator A | 103 | Negative |
| Operator A | 105 | Negative |
| Operator B | 101 | Negative |
| Operator B | 103 | Negative |
| Operator B | 105 | Negative |
| Operator C | 101 | Negative |
| Operator C | 103 | Negative |
| Operator C | 105 | Negative |

b. Matrix comparison:

Not applicable. The assays are intended to be used with urine samples only.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

A lay user study was performed at three sites where 1120 lay persons tested one of

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the four formats (Strip, Cassette, Dip Card, Cup) of the Healgen Amphetamine Test and the Healgen Oxycodone Test (140 readers across three sites x 4 formats x 2 analytes = 1120). The participants had diverse educational and professional backgrounds and ranged in age from 21 to 63 years. Urine samples were prepared at the following concentrations; negative, ±75%, ±50%, ±25% of the cutoff by spiking drug into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers, blind-labeled, and randomized prior to testing. Each participant was provided with the package insert, one masked sample and a device. The results are summarized below.

Strip Format

| Drug | Cutoff | Conc. by GC/MS (ng/mL) | n | Lay Person Results | | % Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | Negative | Positive | |
| Amphetamine | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 250 | 20 | 0 | 20 | 100% |
| | -50% | 500 | 20 | 0 | 20 | 100% |
| | -25% | 750 | 20 | 2 | 18 | 90% |
| | +25% | 1250 | 20 | 19 | 1 | 95% |
| | +50% | 1500 | 20 | 20 | 0 | 100% |
| | +75% | 1750 | 20 | 20 | 0 | 100% |
| Oxycodone | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 25 | 20 | 0 | 20 | 100% |
| | -50% | 50 | 20 | 0 | 20 | 100% |
| | -25% | 75 | 20 | 2 | 18 | 90% |
| | +25% | 125 | 20 | 18 | 2 | 90% |
| | +50% | 150 | 20 | 20 | 0 | 100% |
| | +75% | 175 | 20 | 20 | 0 | 100% |

Cassette Format

| Drug | Cutoff | Conc. by GC/MS (ng/mL) | n | Lay Person Results | | % Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | Negative | Positive | |
| Amphetamine | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 250 | 20 | 0 | 20 | 100% |
| | -50% | 500 | 20 | 0 | 20 | 100% |
| | -25% | 750 | 20 | 1 | 19 | 95% |
| | +25% | 1250 | 20 | 19 | 1 | 95% |
| | +50% | 1500 | 20 | 20 | 0 | 100% |
| | +75% | 1750 | 20 | 20 | 0 | 100% |

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21

| Oxycodone | -100% | 0 | 20 | 0 | 20 | 100% |
| --- | --- | --- | --- | --- | --- | --- |
| | -75% | 25 | 20 | 0 | 20 | 100% |
| | -50% | 50 | 20 | 0 | 20 | 100% |
| | -25% | 75 | 20 | 1 | 19 | 95% |
| | +25% | 125 | 20 | 19 | 1 | 95% |
| | +50% | 150 | 20 | 20 | 0 | 100% |
| | +75% | 175 | 20 | 20 | 0 | 100% |

Cup Format

| Drug | Cutoff | Conc. by GC/MS (ng/mL) | n | Lay Person Results | | %Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | Negative | Positive | |
| Amphetamine | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 250 | 20 | 0 | 20 | 100% |
| | -50% | 500 | 20 | 0 | 20 | 100% |
| | -25% | 750 | 20 | 1 | 19 | 95% |
| | +25% | 1250 | 20 | 20 | 0 | 100% |
| | +50% | 1500 | 20 | 20 | 0 | 100% |
| | +75% | 1750 | 20 | 20 | 0 | 100% |
| Oxycodone | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 25 | 20 | 0 | 20 | 100% |
| | -50% | 50 | 20 | 0 | 20 | 100% |
| | -25% | 75 | 20 | 1 | 19 | 95% |
| | +25% | 125 | 20 | 19 | 1 | 95% |
| | +50% | 150 | 20 | 20 | 0 | 100% |
| | +75% | 175 | 20 | 20 | 0 | 100% |

Dip Card Format

| Drug | Cutoff | Conc. by GC/MS (ng/mL) | n | Lay Person Results | | %Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | Negative | Positive | |
| Amphetamine | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 250 | 20 | 0 | 20 | 100% |
| | -50% | 500 | 20 | 0 | 20 | 100% |
| | -25% | 750 | 20 | 1 | 19 | 95% |
| | +25% | 1250 | 20 | 18 | 2 | 90% |
| | +50% | 1500 | 20 | 20 | 0 | 100% |
| | +75% | 1750 | 20 | 20 | 0 | 100% |

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22

| | -100% | 0 | 20 | 0 | 20 | 100% |
| --- | --- | --- | --- | --- | --- | --- |
| Oxycodone | -75% | 25 | 20 | 0 | 20 | 100% |
| | -50% | 50 | 20 | 0 | 20 | 100% |
| | -25% | 75 | 20 | 2 | 18 | 90% |
| | +25% | 125 | 20 | 18 | 2 | 90% |
| | +50% | 150 | 20 | 20 | 0 | 100% |
| | +75% | 175 | 20 | 20 | 0 | 100% |

The labeling is rated at 7th grade reading level per Flesch-Kincaid Methodology. All participants (100%) indicated on the questionnaire that the labeling instructions were clear or very clear and that they did not find the tests difficult to operate.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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