HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
Device Facts
| Record ID | K141647 |
|---|---|
| Device Name | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) |
| Applicant | Healgen Scientific,, LLC |
| Product Code | DIO · Clinical Toxicology |
| Decision Date | Jul 17, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3250 |
| Device Class | Class 2 |
Intended Use
Healgen COC One Step Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 300 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 MOP One Step Morphine Test is an immunochromatographic assay for the qualitative determination of morphine in human urine at a Cut-Off concentration of 300 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.
Device Story
Lateral flow immunochromatographic assay for qualitative detection of Benzoylecgonine or morphine in human urine. Input: urine sample; process: competitive binding immunoassay where target drug competes with drug-conjugate for limited antibody binding sites; output: visual colored line (negative) or absence of line (positive) in test region. Used in point-of-care or home settings by lay users or clinicians. Provides preliminary screening results; positive results require confirmatory testing via GC/MS. Assists in clinical decision-making regarding drug abuse status.
Clinical Evidence
No clinical studies performed. Evidence based on bench testing: precision studies (25 days, 2 runs/day), analytical specificity/cross-reactivity, interference testing, and method comparison against GC/MS (80 samples per format). Lay-user study (n=140 per drug) confirmed ease of use and performance across diverse demographics (ages 21 to >50).
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Formats: Strip, Cassette, Dip Card, Cup. Single-use. Visual read. Stable at 4-30°C for 24 months. No electronic components or software.
Indications for Use
Indicated for qualitative detection of Benzoylecgonine (cocaine metabolite) or morphine in human urine at 300 ng/mL cut-off. Intended for OTC and prescription use in adults and adolescents. Provides preliminary results; requires confirmatory testing (GC/MS).
Regulatory Classification
Identification
A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
Special Controls
*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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).
Related Devices
- K032903 — ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE · ACON Laboratories, Inc. · Feb 17, 2004
- K121166 — WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL · Guangzhou Wondfo Biotech Co., Ltd. · May 8, 2012
- K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Mar 21, 2019
- K994398 — INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST · Alfa Scientific Designs, Inc. · Jul 27, 2000
- K150356 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card · Healgen Scientific,, LLC · May 13, 2015
Submission Summary (Full Text)
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K141647
#### 510(k) SUMMARY
- 1. Date: July 15, 2014
JUL 1 7 2014
- 2. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX7740İ
- 3. Contact person: Jiangiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401 Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com
- 4. Device Name: Healgen COC One Step Cocaine Test (Strip, Cassette, Cup. Dip Card) Healgen MOP One Step Morphine Test (Strip, Cassette, Cup, Dip Card)
Classification:
ં પ્રે
| Product<br>Code | CFR # | Panel |
|-----------------|--------------------------------------|------------|
| DIO | 21 CFR, 862.3250 Cocaine Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
- 5. Predicate Devices: K052115 First Check Multi Drug Cup 12
- 6. Intended Use
Healgen COC One Step Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 300 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.
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Healgen MOP One Step Morphine Test is an immunochromatographic assay for the qualitative determination of morphine in human urine at a Cut-Off concentration of 300 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. GO/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.
- 7. Device Description
Healgen COC One Step Cocaine Test and Healgen MOP One Step Morphine Test are immunochromatographic assays for Cocaine and Morphine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine and Morphine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: Strips, Cassettes, DipCards, or Cups. It contains a Test Device (in one of the four formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.
## 8. Substantial Equivalence Information
A summary comparison of features of the One Step Cocaine Test and One Step Morphine Test and the predicate device is provided in Table 1 & Table 2.
| Item | Device | Predicate -<br>K052115 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>Benzoylecgonine in human urine. | Same |
| Calibrator | Benzoylecgonine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended<br>Population | For over-the-counter and prescription<br>uses. | For<br>over-the-counter<br>use. |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |
#### Table 1: Features Comparison of Healgen COC One Step Cocaine Test and the Predicate Device
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Table 2: Features Comparison of Healgen MOP One Step Morphine Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>Morphine in human urine. | Same |
| Calibrator | Morphine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
| Intended<br>Population | For over-the-counter and prescription<br>uses. | For over-the-counter<br>use. |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |
#### 9. Test Principle
Healgen COC One Step Cocaine Test and Healgen MOP One Step Morphine Test are rapid tests for the qualitative detection of Benzoylecgonine and Morphine in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (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.
#### 10. Performance Characteristics
- 1. Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled and randomized.
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For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot:COC1111001 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:COC1111002 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:COC1111003 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Cocaine (COC) Strip Format
#### COC Cassette Format
| | Result | | | | | | | | |
|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
| Lot:COC1111004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:COC1111005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:COC1111006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### COC Dip Card Format
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot:COC1111007 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:COC1111008 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:COC1111009 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### COC CUP Format
| | Result -100% | -75% | -50% | -25% | | +25% | +50% +75% +100%} | |
|----------------------------------------------------------------------------------------|----------------|-----------------------------------------|------|------|---------|------|---------------------------------------|--|
| Drug | | Cut-off Cut-off Cut-off Cut-off Cut-off | | | Cut-off | | Cut-off Cut-off Cut-off Cut-off | |
| Lot:COC1111010 50-/0+ 50-/0+ 50-/0+ 50-/0+ 18-/32+ 50+/0- 50+/0- 50+/0- | | | | | | | | |
| Lot:COC1111011 50-/0+ 50-/0+ 50-/0+ 50-/0+ 18-/32+ 50+/0- 50+/0- 50+/0- | | | | | | | | |
| Lot:COC1111012 50-10+ 50-10+ 50-10+ 50-10+ 50+/0- 50+/0- 50+/0- 50+/0- | | | | | | | | |
## Morphine (MOP) Strip Format
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot:MOP1110001 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MOP1110002 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
රි
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| Drug | Result | -100% | -75% | -50% | -25% | Cut-off | +25% | +50% | +75% | +100% |
|----------------|--------|---------|---------|---------|---------|---------|---------|---------|---------|---------|
| | | Cut-off | Cut-off | Cut-off | Cut-off | | Cut-off | Cut-off | Cut-off | Cut-off |
| Lot:MOP1110003 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### MOP Cassette Format
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot:MOP1110004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MOP1110005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MOP1110006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### MOP Dip Card Format
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|----------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot:MOP1110007 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MOP1110008 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot:MOP1110009 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### MOP CUP Format
| | Result | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------|----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot:MOP1110010 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MOP1110011 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MOP1110012 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### b. Linearity
Not applicable, these are visually read devices.
#### c. Stability
The devices are stable at 4-30°C for 24 months based on the accelerated stability study at 45°C and real time stability determination at both 4 ℃ and 30℃.
Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
#### d. Cut-off
A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and
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The following cut-off values for the test below -25% cut-off for both Cocaine and Morphine. devices have been verified.
| Test | Calibrator | Cut-off (ng/mL) |
|------------------------|------------------|-----------------|
| One Step Cocaine Test | Benzoylecogonine | 300 |
| One Step Morphine Test | Morphine | 300 |
#### e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.
ﺎ
Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different formats.
| COC | | |
|----------------------|------------------------|---------------------|
| 4-Acetamidophenol | Fenoprofen | Pentazocine |
| Acetophenetidin | Furosemide | Pentobarbital |
| N-Acetylprocainamide | Gentisic acid | Perphenazine |
| Acetylsalicylic acid | Hemoglobin | Phencyclidine |
| Aminopyrine | Hydralazine | Phenelzine |
| Amitryptyline | Hydrochlorothiazide | Phenobarbital |
| Amobarbital | Hydrocodone | Phentermine |
| Amoxicillin | Hydrocortisone | L-Phenylephrine |
| Ampicillin | O-Hydroxyhippuric acid | β-Phenylethlamine |
| Ascorbic acid | 3-Hydroxytyramine | β-Phenylethylamine |
| D,L-Amphetamine | Ibuprofen | Phenylpropanolamine |
| L-Amphetamine | Imipramine | Prednisolone |
| Apomorphine | Iproniazid | Prednisone |
| Aspartame | (-) Isoproterenol | Procaine |
| Atropine | Isoxsuprine | Promazine |
| Benzilic acid | Ketamine | Promethazine |
| Benzoic acid | Ketoprofen | D,L-Propanolol |
| Benzphetamine | Labetalol | D-Propoxyphene |
| Bilirubin | Levorphanol | D-Pseudoephedrine |
| Brompheniramine | Loperamide | Quinidine |
| Caffeine | Maprotiline | Quinine |
| Chloralhydrate | Meprobamate | Ranitidine |
| Chloramphenicol | Methadone | Salicylic acid |
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| Chlordiazepoxide | Methoxyphenamine | Secobarbital |
|------------------------|------------------------------------------|------------------------------------------|
| Chlorothiazide | (+)<br>3,4-Methylenedioxyampheta<br>mine | Serotonin<br>(5-Hydroxytyramine) |
| (±) Chlorpheniramine | (+)3,4-Methylenedioxymetha<br>mphetamine | Sulfamethazine |
| Chlorpromazine | Methylphenidate | Sulindac |
| Chlorquine | Methyprylon | Temazepam |
| Cholesterol | Morphine-3-β-Dglucuronide | Tetracycline |
| Clomipramine | Nalorphine | Tetrahydrocortisone, 3 Acetate |
| Clonidine | Naloxone | Tetrahydrocortisone3<br>(5-Dglucuronide) |
| Codeine | Nalidixic acid | Tetrahydrozoline |
| Cortisone | Naltrexone | Thebaine |
| (-) Cotinine | Naproxen | Thiamine |
| Creatinine | Niacinamide | Thioridazine |
| Deoxycorticosterone | Nifedipine | D, L-Thyroxine |
| Dextromethorphan | Norcodein | Tolbutamine |
| Diazepam | Norethindrone | Triamterene |
| Diclofenac | D-Norpropoxyphene | Trifluoperazine |
| Diflunisal | 11-nor-Δ9-THC-9-COOH | Trimethoprim |
| Digoxin | Noscapine | Trimipramine |
| Diphenhydramine | D,L-Octopamine | Tryptamine |
| Doxylamine | Oxalic acid | D, L-Tryptophan |
| Ecgonine hydrochloride | Oxazepam | Tyramine |
| Ecgonine methylester | Oxolinic acid | D, L-Tyrosine |
| (-) Y Ephedrine | Oxycodone | Uric acid |
| Erythromycin | Oxymetazoline | Verapamil |
| β-Estradiol | p-Hydroxymethamphetamine | Zomepirac |
| Estrone-3-sulfate | Papaverine | |
| Ethyl-p-aminobenzoate | Penicillin-G | |
# MOP
| Acebutolol | (-) Y Ephedrine | p-Hydroxymethamphetamine |
|------------------------|--------------------------------------|------------------------------------------|
| Acetopromazine - d6 | Erythromycin | Papaverine |
| 4-Acetamidophenol | β-Estradiol | Penicillin-G |
| Acetophenetidin | Estrone-3-sulfate | Pentazocaine |
| N-Acetylprocainamide | Ethyl-p-aminobenzoate | Pentobarbital |
| Acetylsalicylic acid | Fenoprofen | Perphenazine |
| D,L-Amphetamine | Furosemide | Phencyclidine |
| L-Amphetamine | Gentisic acid | Phenelzine |
| Aminopyrine | Hemoglobin | Phenobarbital |
| Amitryptyline | Hydralazine | Phentermine |
| Amobarbital | Hydrochlorothiazide | β-Phenylethylamine |
| Amoxicillin | Hydrocortisone | L-Phenylephrine |
| Ampicillin | O-Hydroxyhippuric acid | β-Phenylethlamine |
| Ascorbic acid | 3-Hydroxytyramine | Phenylpropanolamine |
| Apomorphine | Ibuprofen | Prednisolone |
| Aspartame | Imipramine | Prednisone |
| Atropine | Iproniazid | Promazine |
| Benzilic acid | (-) Isoproterenol | Promethazine |
| Benzoic acid | Isoxsuprine | D,L-Propanolol |
| Benzoylecgonine | Ketamine | D-Propoxyphene |
| Benzphetamine | Ketoprofen | D-Pseudoephedrine |
| Bilirubin | Labetalol | Quinidine |
| Brompheniramine | Loperamide | Quinine |
| Caffeine | Maprotiline | Salicylic acid |
| Chloramphenicol | Meprobamate | Secobarbital |
| Chlordiazepoxide | Methoxyphenamine | Serotonin |
| Chlorothiazide | (+) 3,4-Methylenedioxyamphetamine | Sulfamethazine |
| (±) Chlorpheniramine | (+)3,4-Methylenedioxymethamphetamine | Sulindac |
| Chlorpromazine | Methadone | Temazepam |
| Chlorquine | Methylphenidate | Tetracycline |
| Cholesterol | Methyprylon | Tetrahydrozoline |
| Clomipramine | Nalorphine | Tetrahydrocortisone,3 Acetate |
| Clonidine | Nalidixic acid | Tetrahydrocortisone3<br>(5-Dglucuronide) |
| Cocaine hydrochloride | Naloxone | Thiamine |
| Cortisone | Naltrexone | Thioridazine |
| (-) Cotinine | Naproxen | D,L-Thyroxine |
| Creatinine | Niacinamide | Tolbutamine |
| Deoxycorticosterone | Nifedipine | Triamterene |
| Dextromethorphan | Norcodein | Trifluoperazine |
| Diazepam | Norethindrone | Trimethoprim |
| Diclofenac | D-Norpropoxyphene | Trimipramine |
| Digoxin | D,L-Octopamine | D, L-Tyrosine |
| Diphenhydramine | Oxalic acid | Uric acid |
| Doxylamine | Oxazepam | Verapamil |
| Ecgonine hydrochloride | Oxolinic acid | Zomepirac |
| Ecgonine methylester | Oxymetazoline | |
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#### f. Specificity
To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.
| COC<br>(Benzoylecogonine,<br>Cut-off=300 ng/mL) | Result | %<br>Cross-Reactivity |
|-------------------------------------------------|-----------------------|-----------------------|
| Cocaethylene | Positive at 300 ng/mL | 100% |
| Cocaine HCl | Positive at 300 ng/mL | 100% |
| MOP<br>(Morphine, Cut-off=300 ng/mL) | Result | %<br>Cross-Reactivity |
|--------------------------------------|--------------------------|-----------------------|
| 6-Acetylmorphine | Positive at 400 ng/mL | 75% |
| Codeine | Positive at 300 ng/mL | 100% |
| EthylMorphine | Positive at 6240 ng/mL | 5% |
| Heroin | Positive at 600 ng/mL | 50% |
| Hydromorphone | Positive at 3120 ng/mL | 10% |
| Hydrocodone | Positive at 50000 ng/mL | 0.6% |
| Levorphanol | Positive at 1500 ng/mL | 20% |
| Oxycodone | Positive at 30,000 ng/mL | 1% |
| Procaine | Positive at 15,000 ng/mL | 2% |
| Thebaine | Positive at 6240 ng/mL | 5% |
- g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples with of 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 cut-off levels. These samples were tested using three batches of each device for all formats. 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 for different formats.
- 2. Comparison Studies
{9}------------------------------------------------
The method comparison studies for the One Step Cocaine Test, and the One Step Morphine Test were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
| COC | | | | | | |
|-----------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------|
| Strip<br>format | | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near<br>Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 17 | 13 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 17 | 13 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 17 | 13 | 1 | 0 |
#### Discordant Results of COC Strip
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 370 | 303 | Negative |
| Viewer B | 370 | 303 | Negative |
| Viewer B | 302 | 305 | Negative |
| Viewer C | 302 | 305 | Negative |
| Cassette<br>format | | Negative | Low Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative<br>by GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) |
|--------------------|----------|----------|-------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 17 | 13 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 16 | 24 |
| | Negative | 10 | 17 | 13 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 17 | 13 | 2 | 0 |
Discordant Results of COC Cassette
{10}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 370 | 303 | Negative |
| Viewer C | 370 | 303 | Negative |
| Viewer C | 302 | 305 | Negative |
| Cup | | | Low | Near Cutoff | Near Cutoff | High |
|----------|----------|----------|------------|-------------|-------------|-------------|
| format | | Negative | Negative | Negative by | Positive by | Positive by |
| | | | by GC/MS | GC/MS | GC/MS | GC/MS |
| | | | (less than | (Between | (Between | (greater |
| | | | -50%) | -50% and | the cut-off | than |
| | | | | cut-off) | and +50%) | +50%) |
| Viewer A | Positive | 0 | 0 | 0 | ાં ર | 24 |
| | Negative | 1 0 | 17 | । ਤੇ | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | । ୧ | 24 |
| | Negative | 1 0 | 17 | । 3 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 1 0 | 17 | 13 | 2 | 0 |
Discordant Results of COC Cup
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 370 | 303 | Negative |
| Viewer C | 370 | 303 | Negative |
| Viewer C | 302 | 305 | Negative |
| Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
|-----------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 17 | 13 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| | Negative | 10 | 17 | 13 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 17 | 13 | 2 | 0 |
# Discordant Results of COC Dip Card
{11}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 370 | 303 | Negative |
| Viewer B | 370 | 303 | Negative |
| Viewer C | 370 | 303 | Negative |
| Viewer C | 302 | 305 | Negative |
| • |
|---|
|---|
| Strip format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
|--------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 15 | 15 | 0 | 0 |
## Discordant Results of MOP Strip
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 36 | 307 | Negative |
| Viewer B | 60 | 298 | Positive |
| Viewer B | 38 | 328 | Negative |
| Cassette format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
|-----------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 25 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 25 |
.
14
{12}------------------------------------------------
| Negative | 10 | 15 | 15 | 1 | 0 |
|------------------------------------|---------------|--------------|-----------------------------|---|---|
| Discordant Results of MOP Cassette | | | | | |
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results | | |
| Viewer A | 36 | 307 | Negative | | |
| Viewer A | 12 | 310 | Negative | | |
| Viewer B | 36 | 307 | Negative | | |
| Viewer C | 36 | 307 | Negative | | |
| Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
|-----------------|----------|----------|----------------------------------------|----------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|
| | Viewer A | Positive | 0 | 0 | 0 | 13 |
| Negative | | 10 | 15 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 25 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
# Discordant Results of MOP Dip Card
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 36 | 307 | Negative |
| Viewer A | 12 | 310 | Negative |
| Viewer B | 36 | 307 | Negative |
| Viewer C | 36 | 307 | Negative |
| Viewer C | 12 | 310 | Negative |
| Cup<br>format | Negative | Low<br>Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cut-off) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than<br>+50%) | |
|---------------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|----|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 25 |
{13}------------------------------------------------
| | Negative | | | | | |
|----------|----------|----|----|----|----|----|
| Viewer B | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 15 | 15 | 0 | 0 |
#### Discordant Results of MOP Cup
| Viewer | Sample Number | GC/MS Result | Strip Format<br>Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 36 | 307 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 140 lay persons testing the cocaine devices and another set of 140 persons testing the morphine devices. A total of 56 females and 84 males tested the Cocaine samples, and 53 females and 87 males tested the Morphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/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. The results are summarized below.
| % of Cutoff | Number of samples | COC Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
|-------------|-------------------|------------------------------------|--------------------|-----------------|---------------------------------------|
| -100%Cutoff | 20 | 0 | No. of Positive | No. of Negative | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
#### Comparison between GC/MS and Lay Person Results (COC Strin)
Comparison between GC/MS and Lay Person Results (COC Cassette)
| % of Cutoff | Number of samples | COC Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
|-------------|-------------------|------------------------------------|--------------------|-----------------|---------------------------------------|
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
{14}------------------------------------------------
| -50% Cutoff | 20 | । ૨૦ | 0 | 20 | 100% | | |
|---------------------------------------------------------------|---------------|------------------------------------------|--------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| -25% Cutoff | 20 | 225 | l | 19 | તે તે જેની જેવી જેવી સવલતો પ્રાપ્ | | |
| +25% Cutoff | 20 | 375 | । | - | તે જેટી જેવી જેવી સાચાર તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્ | | |
| 450% Cutoff | 20 | 450 | 20 | 0 | 100% | | |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% | | |
| Comparison between GC/MS and Lay Person Results (COC DipCard) | | | | | | | |
| | Number | COC Concentration by<br>GC/MS<br>(ng/mL) | Lay person results | | The | | |
| | | | | | | | |
| % of Cutoff | of<br>samples | | No. of<br>Positive | No. of<br>Negative | percentage of<br>correct results<br>(%) | | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% | | |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% | | |
| -50% Cutoff | 20 | । ২০ | 0 | 20 | 100% | | |
| -25% Cutoff | 20 | 225 | 1 | 19 | તે જેવી જેવી સવલતો પ્રતિષ્ઠા તેમ જ દૂધની ડેરી જેવી સવલતો પ્રતિષ્ઠા તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની ખેતી કરવામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની તેમ | | |
+50% Cutoff
+75% Cutoff
Comparison between GC/MS and Lay Person Results (COC Cup)
100%
100%
| % of Cutoff | Number<br>of<br>samples | COC Concentration by<br>GC/MS<br>(ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
|-------------|-------------------------|------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 20 | 0 | 100% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
#### Comparison between GC/MS and Lay Person Results (MOP Strip)
| % of Cutoff | Number of samples | MOP Concentration by GC/MS (ng/mL) | Lay person results No. of Positive | Lay person results No. of Negative | The percentage of correct results (%) |
|-------------|-------------------|------------------------------------|------------------------------------|------------------------------------|---------------------------------------|
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
{15}------------------------------------------------
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
|-------------|----|-----|----|----|------|
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
## Comparison between GC/MS and Lay Person Results (MOP Cassette)
| % of Cutoff | Number of samples | MOP Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
|-------------|-------------------|------------------------------------|--------------------|-----------------|---------------------------------------|
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
## Comparison between GC/MS and Lay Person Results (MOP DipCard)
| % of Cutoff | Number<br>of<br>samples | MOP Concentration by<br>GC/MS<br>(ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
|-------------|-------------------------|------------------------------------------|--------------------|--------------------|------------------------------------------------|
| -100%Cutoff | 20 | 0 | No. of<br>Positive | No. of<br>Negative | |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 375 | 1 | 19 | 95% |
| +50% Cutoff | 20 | 450 | 17 | 3 | 85% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
| | | | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (MOP Cup)
| % of Cutoff | Number of samples | MOP Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
|-------------|-------------------|------------------------------------|--------------------|-----------------|---------------------------------------|
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
{16}------------------------------------------------
| -75%<br>2<br>uton | 195 | A M F<br>) | .<br>C<br>Seal V | | .<br>100% |
|------------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| +50% C<br>00<br>"Itor- | | | AC<br>1 | A concession and the charges and a | 100%<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 、アニック<br>Cutoff | | - AND AND LA - A CARD - A CARD - CALL CREAN - A CLAIMER - A CLAIMER - A CLAIMER - CALL - CLAIMER - CLAIM - CALL - CLAIMER - CLAIM - CALL - CLAIMER - CALL - CLAIM - CALL - CLA<br>car<br>and land with | t<br>1 | | 100% |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
- 3. Clinical Studies
Not applicable.
#### 11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the Healgen COC One Step Cocaine Test, and Healgen MOP One Step Morphine Test are substantially equivalent to the predicate.
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines extending from its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2014
HEALGEN SCIENTIFIC. LLC C/O JOE SHIA LSI INTERNATIONAL INC 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877
Re: K141647
Trade/Device Name: Healgen COC One Step Cocaine Test (Strip, Cassette, Dip Card, Cup) Healgen MOP One Step Morphine Test (Strip. Cassette, Dip Card, Cup) Regulation Number: 21 CFR 862.3250
Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO, DJG Dated: June 16, 2014 Received: June 19, 2014
Dear Mr. Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable. the
{18}------------------------------------------------
Page 2-Mr. Shia
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
# Katherine Serrano -S
For : Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{19}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) k141647
#### Device Name
Healgen MOP One Step Morphine Test (Strip, Cassette, Dip Card, Cup) Healgen COC One Step Cocaine Test (Strip, Cassette, Dip Card, Cup)
#### Indications for Use (Describe)
Healgen COC One Step Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 300 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. GCMS 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 MOP One Step Morphine Test is an immunochromatographic assay for the qualitative determination of morphine in human urine at a Cut-Off concentration of 300 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 iudement 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
# Denise Johnson-lyles -S
