Healgen® Accurate Oral Fluid Drug Test
Device Facts
| Record ID | K253705 |
|---|---|
| Device Name | Healgen® Accurate Oral Fluid Drug Test |
| Applicant | Healgen Scientific,, LLC |
| Product Code | DJC · Clinical Toxicology |
| Decision Date | Mar 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Indications for Use
The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone, and Phencyclidine in human oral fluid at the cutoff concentrations listed below and their metabolites: Test Calibrator Cutoff (ng/mL) Amphetamine (AMP) d-Amphetamine 50 Cocaine (COC) Benzoylecgonine 20 Marijuana (THC) Delta-9-Tetrahydrocannabinol 40 Methadone (MTD) Methadone 30 Methamphetamine (MET) d-Methamphetamine 50 Opiates (OPI) Morphine 40 Oxycodone (OXY) Oxycodone 20 Phencyclidine (PCP) Phencyclidine 10 This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to distinguish between prescription use or abuse of the drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Device Story
Lateral flow immunochromatographic assay; detects drugs of abuse in human oral fluid. Principle: competitive binding; drug in sample competes with drug conjugate for antibody binding sites. Negative sample: colored line forms at test region (no drug competition). Positive sample: no colored line (drug saturates antibody). Control line confirms proper wicking. Used in clinical/professional settings; results are preliminary; requires LC-MS/MS confirmation. Benefits: rapid screening for multiple drug classes.
Clinical Evidence
No clinical trials performed. Evidence consists of analytical performance studies including precision/reproducibility, interference, specificity, and method comparison. Method comparison tested 1430 samples across six sites, comparing device results to LC-MS/MS. Results showed high concordance for all analytes. Recovery studies confirmed sample stability and volume adequacy for confirmatory testing.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Components: membrane strip with immobilized drug conjugate, colloidal gold-labeled antibody complex. Visual readout. Standalone, single-use device. No electronic components or software. Materials: collection sponge, rectangular prism housing.
Indications for Use
Indicated for qualitative, simultaneous detection of Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine and their metabolites in human oral fluid. For prescription use only. Not intended to distinguish between prescription use or abuse.
Regulatory Classification
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Special Controls
*Classification.* Class II (special controls). A methamphetamine 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
- Premier Biotech OralTox® Oral Fluid Drug Test (k181305)
Related Devices
- K171403 — OralTox Oral Fluid Drug Test · Premier Biotech, Inc. · Feb 2, 2018
- K242498 — Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC · Aicheck Biotech, Inc. · Oct 1, 2024
- K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card · Shanghai Accurature Diagnostics Co., Ltd. · Feb 23, 2024
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K253705
B Applicant
Healgen Scientific, LLC
C Proprietary and Established Names
Healgen® Accurate Oral Fluid Drug Test
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 21CFR 862.3100, Amphetamine Test System | Toxicology (91) |
| DIO | Class II | 21 CFR 862.3250, Cocaine and metabolites TEST System | Toxicology (91) |
| LDJ | Class II | 21 CFR 862.3870, Cannabinoids Test System | Toxicology (91) |
| DJC | Class II | 21 CFR 862.3610, Methamphetamine Test System | Toxicology (91) |
| LCM | Class II | Unclassified, Enzyme immunoassay Phencyclidine | Toxicology (91) |
| DJG | Class II | 21 CFR 862.3650, Opiate Test System | Toxicology (91) |
| DJR | Class II | 21 CFR, 862.3610 Methadone Test System | Toxicology (91) |
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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## II Submission/Device Overview:
A Purpose for Submission: New device.
B Measurands: Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone and Phencyclidine
C Type of Test: Qualitative, lateral flow immunochromatographic
## III Intended Use/Indications for Use:
A Intended Use(s): See Indications for Use below.
B Indication(s) for Use: The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone, and Phencyclidine in human oral fluid at the cutoff concentrations listed below and their metabolites:
| Test | Calibrator | Cutoff (ng/mL) |
| --- | --- | --- |
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 |
| Methadone (MTD) | Methadone | 30 |
| Methamphetamine (MET) | d-Methamphetamine | 50 |
| Opiates (OPI) | Morphine | 40 |
| Oxycodone (OXY) | Oxycodone | 20 |
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| Phencyclidine (PCP) | Phencyclidine | 10 |
| --- | --- | --- |
This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to distinguish between prescription use or abuse of the drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
## Special Conditions for Use Statement(s):
For prescription point-of-care use only
## C Special Instrument Requirements:
Not applicable; the device is a visually read single use device.
## IV Device/System Characteristics:
### A Device Description:
The Healgen Accurate Oral Fluid Drug Test is a rapid immunoassay based on the principle of competitive inhibition binding. Therefore, drugs that may be present in the oral fluid specimen compete for antibody binding sites with drugs or metabolites which may be present in the oral fluid specimen.
The test strip consists of a membrane strip with an immobilized drug conjugate. A colloidal gold labeled antibody complex is dried to one end of the membrane. A control line comprised of a different antibody/antigen reaction is present on the membrane strip. The control line is not influenced by the presence or absence of a drug analyte in the oral fluid and therefore it should be present in all reactions.
### B Principle of Operation:
The Healgen® oral fluid drug test device is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody. During testing, a portion of the oral fluid specimen migrates upward by capillary action. A drug, if present in the oral fluid specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration in the oral fluid specimen will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. A drug-positive oral fluid specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative oral fluid specimen will generate a line in the test line
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region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
V Substantial Equivalence Information:
A Predicate Device Name(s): Premier Biotech OralTox® Oral Fluid Drug Test,
B Predicate 510(k) Number(s): k181305
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K253705 | K181305 |
| --- | --- | --- |
| Device Trade Name | Healgen® Accurate Oral Fluid Drug Test | Premier Biotech OralTox® Oral Fluid Drug Test |
| General Device Characteristic Similarities | K253705 | K181305 |
| Intended Use/Indications For Use | For the qualitative determination of drug analytes in human oral fluid. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Oral fluid | Same |
| Cut-Off Values | AMP 50 ng/mL
COC 20 ng/mL
THC 40 ng/mL
MET 50 ng/mL
OPI 40 ng/mL
PCP 10 ng/mL
OXY 20 ng/mL
MTD 30 ng/mL | Same |
| Intended Use | For prescription use | Same |
| General Device Characteristic Differences | | |
| Device Format | Rectangular prism shaped | Half cylinder-shaped |
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VI Standards/Guidance Documents Referenced:
None referenced.
VII Performance Characteristics:
A Analytical Performance:
1. Precision/Reproducibility:
Precision-Reproducibility-Cut-Off studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Testing was performed across three sites by 3 healthcare professionals at each site.
The samples were prepared by spiking target drug in negative oral fluid samples. Each drug concentration was confirmed by LC/MS/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device lot in a randomized order.
The following are summaries:
AMP
| Results Device Lot | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| LC-MS | 0 | 12.2 | 26.0 | 37.1 | 51.0 | 64.6 | 77.1 | 87.8 | 101.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
COC
| Results Device Lot | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| LC-MS (ng/mL) | 0 | 5.3 | 10.2 | 16.2 | 21.3 | 26.8 | 31.9 | 35.2 | 40.7 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
MET
| Results Device Lot | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| LC-MS (ng/mL) | 0 | 12.2 | 25.3 | 36.7 | 50.2 | 62.3 | 78.0 | 87.0 | 99.1 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 28-/22+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
MTD
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| Results Device Lot | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| LC-MS (ng/mL) | 0 | 7.8 | 15.8 | 23.4 | 31.6 | 38.2 | 44.5 | 52.9 | 59.7 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 27-/23+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 27-/23+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
OPI
| Results Device Lot | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| LC-MS (ng/mL) | 0 | 10.4 | 20.7 | 30.4 | 40.1 | 51.4 | 61.2 | 70.8 | 81.7 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
OXY
| Results Device Lot | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| LC-MS (ng/mL) | 0 | 5.4 | 10.6 | 15.7 | 20.4 | 25.2 | 32.8 | 37.8 | 43.6 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
PCP
| Results Device Lot | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| LC-MS (ng/mL) | 0 | 2.7 | 5.3 | 8.0 | 10.7 | 13.2 | 16.0 | 18.8 | 21.5 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 27-/23+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
THC
| Result Device Lot | -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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| LC-MS (ng/mL) | 0 | 10.3 | 20.7 | 30.8 | 41.3 | 51.1 | 60.7 | 72.8 | 80.2 |
| Lot 1: | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2: | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 28-/22+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3: | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- |
2. Linearity:
Not applicable. These devices are intended for qualitative use only.
3. a. Interference:
Potential interfering substances were added to drug-free oral fluid and target drugs oral fluid with concentrations at 50% below and 50% above Cut-Off levels. These oral fluid
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samples were tested using three batches of the Healgen device. Compounds that showed no interference for drugs at a concentration of 100 µg/mL are summarized in the following tables.
| Acetaminophen | Deoxycorticosterone | Naproxen |
| --- | --- | --- |
| Acetylcodeine | Dextromethorphan | Nicotinamide |
| Allobarbital | Digoxin | Nicotine |
| Alprazolam | Diltiazem HCl | Noscapine |
| Amobarbital | Diphenhydramine HCl | Omeprazole |
| Apomorphine | DL-Propranolol | Papaverine |
| Atenolol | Estradiol | Pentazocine |
| Atropine | Estrone | Phenytoin |
| Baclofen | Fluconazole | Pioglitazone HCl |
| Benzocaine | Furosemide | Prednisolone |
| Butabarbital | Hexobarbital | Prednisone |
| Caffeine | Hydrochlorothiazide | Procainamide HCl |
| Carbamazepine | Ibuprofen | Promethazine |
| Chlordiazepoxide | Imipramine | Quinine HCl |
| Chlorpromazine | Lamotrigine | R,R(-)-Pseudoephedrine |
| Cimetidine | Levetiracetam | Salicylic Acid |
| Citalopram HBr | Lidocaine | Sertraline HCL |
| Clobazam | Lormetazepam | Simvastin |
| Clomipramine | L-Thyroxine | Theophylline |
| Clonazepam | Metformin HCl | Thiamine |
| Clonidine | Methylphenidate HCl | Topiramate |
| Clopidogrel bisulfate | Metoprolol | Valproic Acid |
| Cortisol | Metronidazole | Verapamil |
| Cotinine | Montelukast sodium salt | Zonisamide |
| d,l-Salbutamol | Naltrexone HCl (except for OXY) | Dihydrocodeine (except for OPI & OXY) |
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| Doxylamine | Ecgonine methylester (except for COC) | Phentermine (except for AMP) |
| --- | --- | --- |
| Naloxone HCl (except for OXY | | |
Food items such as methanol cough drops, cough syrup, cola, mouthwash, coffee, tea, milk, sugar, chewing gum, alcohol, baking soda, salt, cranberry juice, orange juice, food coloring (red, blue, green), toothpaste, tomatoes and MSG were added in either drug-free oral fluid or oral fluid containing the target drugs with concentrations of 50% below and 50% above cutoff levels to a concentration of 5%. No discrepant results were observed.
Hemoglobin was added to drug-free oral fluid and oral fluid containing the target drugs AMP, COC, THC, MTD, MET, OPI, OXY and PCP with concentration of 50% below and 50% above cutoff levels to a concentration of 10mg/dL. Hemoglobin showed no interference at 10mg/dL.
Potential interference from cigarette smoking was evaluated by asking a participant to smoke a cigarette and after 15 minutes an oral fluid sample was collected and spiked with drugs at concentrations +/-50% of cutoff. No interference was observed.
b. Analytic specificity
To test specificity, drug metabolites and other components that are likely to interfere in oral fluid samples were tested using three batches of the Healgen device. The following are summaries:
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| Drug | Concentration (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| AMPHETAMINE (AMP) | | |
| D-Amphetamine | 50 | 100% |
| l-Amphetamine | 2,500 | 2% |
| d/l-Amphetamine | 100 | 50% |
| Methylenedioxyamphetamine (MDA) | 62.5 | 80% |
| 3-Hydroxy Tyramine | 2,500 | 2% |
| d,l-Phenylpropanolamine | 10,000 | 0.5% |
| Phenethylamine | 1,000 | 5% |
| Phentermine | 12,500 | 0.4% |
| d-Methamphetamine | 50,000 | 0.1% |
| l-Methamphetamine | 50,000 | 0.1% |
| Hydroxyamphetamine | 12,500 | 0.4% |
| Dimethylamylamine (DMAA) | 50,000 | 0.1% |
| Methoxyamphetamine | 200 | 25% |
| Benzodioxolylbutanamine(BDB) | 10,000 | 0.5% |
| d,l-p-Chloramphetamine | 300 | 16.7% |
| Methylenedioxyethylamphetamine | >100,000 | <0.05% |
| Methylenedioxymethamphetamine | >100,000 | <0.05% |
| Methylbenzodioxolylbutanamine | >100,000 | <0.05% |
| para-Methoxymethamphetamine | >100,000 | <0.05% |
| Phendimetrazine | >100,000 | <0.05% |
| Phenmetrazine | >100,000 | <0.05% |
| Ephedrine (d-,or l-,or d-l form) | >100,000 | <0.05% |
| d-Pseudoephedrine | >100,000 | <0.05% |
| Isoxsuprine | >100,000 | <0.05% |
| l-Pseudoephedrine | >100,000 | <0.05% |
| Fenfluramine | >100,000 | <0.05% |
| Mephentermine | >100,000 | <0.05% |
| COCAINE (COC) | | |
| Benzoylecgonine | 20 | 100% |
| Cocaine | 20 | 100% |
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| Cocaethylene | 25 | 80% |
| --- | --- | --- |
| Ecgonine methylester | 12,500 | 0.16% |
| Norcocaine | 500 | 4% |
| Procaine | >100,000 | <0.02% |
| MARIJUANA (THC) | | |
| Δ⁹-Tetrahydrocannabinol | 40 | 100% |
| 11-nor-Δ⁹-THC-9 COOH | 4 | 1000% |
| Δ⁸-Tetrahydrocannabinol | 80 | 50% |
| 11-hydroxy-Δ⁹-THC | 45 | 89% |
| Cannabinol | 200 | 20% |
| Cannabidiol (CBD) | 2,200 | 1.8% |
| 11-Nor-Δ⁹-THC-carboxy-glucuronide | 60 | 66.7% |
| (+)-11-nor-9-carboxy-Δ⁹-THC | 50 | 80% |
| 11-nor-Δ⁸-THC-9-COOH | 20 | 200% |
| 8-beta-11-dihydroxy-Δ⁹-THC | 200 | 20% |
| 8-beta-hydroxy-Δ⁹-THC | 200 | 20% |
| Exo-THC | 75 | 53.3% |
| 1-11-Nor-Δ⁹-THC-9-Carboxylic Acyl-Glucuronide | 15 | 266.7% |
| Δ⁸-THC Carboxylic Acid | 20 | 200% |
| Δ⁹-THC Carboxylic Acid | 4 | 1000% |
| (-)-Δ⁹-THC-D3 | 3,000 | 1.3% |
| 11-Nor-9beta-hydroxyhexahydrocannabinol
(11-Nor-9beta-HHC) solution | 125 | 32% |
| METHADONE (MTD) | | |
| Methadone | 30 | 100% |
| Phencyclidine | 5,000 | 0.6% |
| LAAM | 10,000 | 0.3% |
| Alpha-Methadol | 150 | 20% |
| Doxylamine | >100,000 | <0.03% |
| 2-Ethylidene-1,5-dimethyl-3,3-diphenyl(EDDP) pyrrolidine(EDDP) | >100,000 | <0.03% |
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| 2-Ethyl-5-methyl-3,3-diphenyl pyrrolidine(EMDP) | >100,000 | <0.03% |
| --- | --- | --- |
| **METHAMPHETAMINE (MET)** | | |
| d-Methamphetamine | 50 | 100% |
| l-Methamphetamine | 1,250 | 4% |
| Methoxymethamphetamine | 25 | 200% |
| Ephedrine | 800 | 6.25% |
| Phenylephrine | 4,000 | 1.25% |
| Procaine | 2,000 | 2.5% |
| Methylephedrine | 5,000 | 1% |
| Methylenedioxyethylamphetamine | 250 | 20% |
| 3,4-methylenedioxy-methamphetamine(MDMA) | 50 | 100% |
| d-Amphetamine | 25,000 | 0.2% |
| 3,4-methylenedioxyamphetamine | 25,000 | 0.2% |
| (±)-Amphetamine | 10,000 | 0.5% |
| l-Amphetamine | >100,000 | <0.05% |
| **OPIATES (OPI)** | | |
| Morphine | 40 | 100% |
| Acetylmorphine | 50 | 80% |
| Codeine | 10 | 400% |
| Ethylmorphine | 24 | 166.7% |
| Heroin(diacetylmorphine) | 50 | 80% |
| Hydromorphone | 100 | 40% |
| Thebaine | 1,500 | 2.67% |
| Norcodeine | 1,500 | 2.67% |
| Oxycodone | 25,000 | 0.16% |
| Oxymorphone | 25,000 | 0.16% |
| Nalorphine | 10,000 | 0.4% |
| Hydrocodone | 100 | 40% |
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| 6-monoacetylmorphine(6-AM) | 25 | 160% |
| --- | --- | --- |
| Morphine 3- β-d-glucuronide | 50 | 80% |
| Bilirubin | 3,500 | 1.14% |
| Dihydrocodeine | 50 | 80% |
| Normorphine | 12,500 | 0.32% |
| Morphine-6-β-d-glucuronide | 100 | 40% |
| OXYCODONE (OXY) | | |
| Oxycodone | 20 | 100% |
| Hydrocodone | 1,562.5 | 1.28% |
| Hydromorphone | 750 | 2.67% |
| Naloxone HCl | 5,000 | 0.4% |
| Oxymorphone | 48.8 | 40.98% |
| Dihydrocodeine | 3,125 | 0.64% |
| Naltrexone HCl | 2,000 | 1% |
| Heroin(diacetymorphine) | 12,500 | 0.16% |
| Buprenorphine | >100,000 | <0.02% |
| Codeine | >100,000 | <0.02% |
| Morphine | >100,000 | <0.02% |
| Morphine 3- β-d-glucuronide | >100,000 | <0.02% |
| Ethylmorphine | >100,000 | <0.02% |
| 6-monoacetylmorphine(6-AM) | >100,000 | <0.02% |
| PHENCYCLIDINE (PCP) | | |
| Phencyclidine | 10 | 100% |
| Cyclizine | 5,000 | 0.2% |
| Venlafaxine | 50,000 | 0.02% |
| Tenocyclidine (TCP) | 2,000 | 0.5% |
| 1-(1-phenylcyclohexyl) morpholine | 15 | 66.7% |
| 4-hydroxyphencyclidine | 10 | 100% |
| Hydrocodone | >100,000 | <0.01% |
| Hydromorphone | >100,000 | <0.01% |
| Nalorphine | >100,000 | <0.01% |
| EDDP | >100,000 | <0.01% |
| Ketamine | >100,000 | <0.01% |
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| Prazepam | >100,000 | <0.01% |
| --- | --- | --- |
| Amitriptyline | >100,000 | <0.01% |
| (+) Brompheniramine | >100,000 | <0.01% |
| (+) Chlorphenamine | >100,000 | <0.01% |
| Desmethylvenlafaxine | >100,000 | <0.01% |
| Chlorpromazine | >100,000 | <0.01% |
| Clomipramine | >100,000 | <0.01% |
| Cyclobenzaprine | >100,000 | <0.01% |
| Dextromethorphan | >100,000 | <0.01% |
| Doxepin | >100,000 | <0.01% |
| Doxylamine | >100,000 | <0.01% |
| Imipramine | >100,000 | <0.01% |
| Thioridazine | >100,000 | <0.01% |
| Dexbrompheniramine | >100,000 | <0.01% |
{13}
c. Effect of Oral fluid pH
To investigate the effect of oral fluid pH, oral fluid samples with pH 4 to 9 were spiked with target drugs at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of the device. Results were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off.
d. Drug Recovery Study
Volume Recovery
A sample volume recovery study was conducted to confirm that adequate sample volume could be extracted from the device for confirmatory testing after collection and shipping. Operators collected samples from volunteers at the study site. Three lots of the Healgen® test device was used on a total of 150 subjects (53 normal volunteers and 67 drug users) following the device's instructions for use. The results showed that the saturation indicator appeared within 7 minutes and that the average sample volume was 2.2±0.2mL.
Analyte Recovery
To confirm that preliminary positive results can be adequately measured via confirmation testing after being subject to the temperature conditions required for shipping and storage, negative oral fluid samples in glass bottles were spiked with target drugs, Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone to concentrations approximately -50% and +50% of the cutoff. Samples were spiked using known standards. Each drug concentration was confirmed by LC-MS/MS. The samples were transferred to Healgen devices using the collection sponges soaked into the spiked sample for up to 7 minutes. The 7 minutes was choosing because the saturation indicator appeared within 7 minutes during sample volume study.
For each of 3 storage conditions (2-8°C, at -20°C and at 40°C) 12 devices were used (4 devices from each of 3 lots). For each device, drug was measured by LC-MS/MS at time zero and the devices containing the specimens were stored under the specified condition. Drug in the devices stored at 2-8°C was measured by LC-MS/MS at 0, 3, 7, and 10 days, drug in the devices stored at -20°C was measured by LC-MS/MS at 0 and 100 days, and drug in the devices stored at 40°C, measured at 0 and 1 day.
Over 90% recoveries were observed for the drugs in the Healgen devices. Oral fluid samples can be stored in the device at -20°C for at least 100 days. Oral fluid samples can be shipped overnight in the device for LC-MS confirmation
The minimum and maximum recovery from the 12 devices per lot per storage condition is shown below:
Room Temperature (20 to 25°C) (3-day storage)
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| -50% cutoff | AMP 25 | COC 10 | MET 25 | MTD 15 | OPI 20 | OXY 10 | PCP 5 | THC 20 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| MAX | 107.05% | 98.13% | 109.77% | 102.80% | 105.55% | 109.55% | 97.51% | 106.12% |
| MIN | 93.32% | 91.16% | 93.58% | 98.67% | 91.19% | 97.06% | 91.54% | 93.81% |
| +50% cutoff | AMP 75 | COC 30 | MET 75 | MTD 45 | OPI 60 | OXY 30 | PCP 15 | THC 60 |
| MAX | 109.38% | 109.47% | 109.66% | 107.71% | 105.76% | 108.91% | 98.00% | 108.44% |
| MIN | 102.87% | 95.44% | 104.06% | 100.46% | 92.56% | 101.85% | 92.67% | 94.44% |
-20°C (100-day storage)
| -50% cutoff | AMP 25 | COC 10 | MET 25 | MTD 15 | OPI 20 | OXY 10 | PCP 5 | THC 20 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| MAX | 109.27% | 98.81% | 108.91% | 100.00% | 108.28% | 98.04% | 105.58 % | 106.12% |
| MIN | 98.31% | 90.26% | 91.13% | 92.72% | 96.18% | 91.18% | 91.54% | 100.00% |
| +50% cutoff | AMP 75 | COC 30 | MET 75 | MTD 45 | OPI 60 | OXY 30 | PCP 15 | THC 60 |
| MAX | 95.63% | 103.07% | 108.95% | 101.96% | 103.82% | 100.68% | 103.65% | 108.90% |
| MIN | 92.62% | 95.00% | 97.92% | 96.30% | 91.74% | 93.19% | 92.67% | 92.57% |
40°C (1-day storage)
| -50% cutoff | AMP 25 | COC 10 | MET 25 | MTD 15 | OPI 20 | OXY 10 | PCP 5 | THC 20 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| MAX | 108.30% | 105.83% | 109.58% | 105.12% | 105.01% | 104.90% | 106.67% | 109.37% |
| MIN | 95.44% | 94.29% | 92.83% | 98.05% | 93.61% | 96.45% | 98.46% | 96.29% |
| +50% cutoff | AMP 75 | COC 30 | MET 75 | MTD 45 | OPI 60 | OXY 30 | PCP 15 | THC 60 |
| MAX | 103.68% | 107.00% | 109.76% | 104.55% | 102.43% | 102.42% | 109.03% | 107.12% |
| MIN | 99.12% | 99.75% | 106.56% | 99.67% | 95.84% | 93.73% | 103.60% | 92.0% |
4. Detection Limit and Assay Reportable Range:
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Refer to Precision/Reproducibility section under VII A.1 above
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The device is traceable to commercial standards. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims that the devices are stable at 2-30 °C for 24 months based on the real time stability study at 2°C and 30°C.
6. Assay Cut-Off:
Characterization of how the device performs analytically around the claimed cut-off concentration appears in the precision section VII. A.1 above.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Method comparison studies for the Healgen® Accurate Oral Fluid Drug Test were performed, testing a total of 1430 samples at six testing sites from nine lots. The number of operators at each site varied between one and thirteen health care professionals. Four sites were within the US, while 2 sites were OUS.
Device results were compared to LC/MS/MS results. Samples were collected and stored with the candidate device for the confirmatory LC-MS/MS testing.
The results are presented in the tables below:
AMP
| Concentration range by LC/MS | Number of samples | Number of Negative | Number of Positive | The percentage of correct result |
| --- | --- | --- | --- | --- |
| Drug free (0 %) | 833 | 833 | 0 | 100% |
| < -50% Cut off | 261 | 261 | 0 | 100% |
| -50% Cut off ~ Cut off | 31 | 30 | 1 | 97% |
| Cut off ~ +50% Cut off | 14 | 2 | 12 | 86% |
| > -50% Cut off | 95 | 0 | 95 | 100% |
Discordant Results
| Sample # | LC/MS Concentration (ng/mL) | Healgen Test Results |
| --- | --- | --- |
| HA02-043 | 41.377 | Pos |
| HA03-096 | 52.62 | Neg |
| HA01-188 | 56.82 | Neg |
COC
| Concentration range by LC/MS | Number of samples | Number of Negative | Number of Positive | The percentage |
| --- | --- | --- | --- | --- |
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| | | | | of correct result |
| --- | --- | --- | --- | --- |
| Drug free | 833 | 833 | 0 | 100% |
| < -50% Cut off | 176 | 176 | 0 | 100% |
| -50% Cut off ~ Cut off | 21 | 17 | 4 | 81% |
| Cut off ~ +50% Cut off | 23 | 2 | 21 | 91% |
| > -50% Cut off | 181 | 0 | 181 | 100% |
## Discordant Results
| Sample # | LC/MS Concentration (ng/mL) | Healgen Test Results |
| --- | --- | --- |
| HA02B-020 | 16.55 | Pos |
| HA02-075 | 16.788 | Pos |
| HA03-026 | 17.037 | Pos |
| HA02-038 | 19.574 | Pos |
| HA01-121 | 22.596 | Neg |
| HA02B-104 | 22.60 | Neg |
## MTD
| Concentration range by LC/MS | Number of samples | Number of Negative | Number of Positive | The percentage of correct result |
| --- | --- | --- | --- | --- |
| Drug free | 1040 | 1040 | 0 | 100% |
| < -50% Cut off | 223 | 223 | 0 | 100% |
| -50% Cut off ~ Cut off | 19 | 18 | 1 | 95% |
| Cut off ~ +50% Cut off | 11 | 1 | 10 | 91% |
| > -50% Cut off | 32 | 0 | 32 | 100% |
## Discordant Results
| Sample # | LC/MS Concentration (ng/mL) | Healgen Test Results |
| --- | --- | --- |
| WA011 | 28.8 | Pos |
| HA01-297 | 33.04 | Neg |
## MET
| Concentration range by LC/MS | Number of samples | Number of Negative | Number of Positive | The percentage of correct result |
| --- | --- | --- | --- | --- |
| Drug free | 838 | 838 | 0 | 100% |
| < -50% Cut off | 296 | 296 | 0 | 100% |
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| -50% Cut off ~ Cut off | 30 | 29 | 1 | 97% |
| --- | --- | --- | --- | --- |
| Cut off ~ +50% Cut off | 17 | 0 | 17 | 100% |
| > -50% Cut off | 55 | 0 | 55 | 100% |
## Discordant Results
| Sample # | LC/MS Concentration (ng/mL) | Healgen Test Results |
| --- | --- | --- |
| HA01-149 | 41.36 | Pos |
## OPI
| Concentration range by LC/MS | Number of samples | Number of Negative | Number of Positive | The percentage of correct result |
| --- | --- | --- | --- | --- |
| Drug free | 799 | 799 | 0 | 100% |
| < -50% Cut off | 233 | 233 | 0 | 100% |
| -50% Cut off ~ Cut off | 28 | 27 | 1 | 96% |
| Cut off ~ +50% Cut off | 12 | 1 | 11 | 92% |
| > -50% Cut off | 162 | 0 | 162 | 100% |
## Discordant Results
| Sample # | LC/MS Concentration (ng/mL) | Healgen Test Results |
| --- | --- | --- |
| HA02-119 | 33.62 | Pos |
| HA01-201 | 42.81 | Neg |
## OXY
| Concentration range by LC/MS | Number of samples Total | Number of Negative | Number of Positive | The percentage of correct result |
| --- | --- | --- | --- | --- |
| Drug free | 854 | 854 | 0 | 100% |
| < -50% Cut off | 269 | 269 | 0 | 100% |
| -50% Cut off ~ Cut off | 16 | 16 | 0 | 100% |
| Cut off ~ +50% Cut off | 39 | 1 | 38 | 97% |
| > -50% Cut off | 56 | 0 | 56 | 100% |
## Discordant Results
| Sample # | LC/MS Concentration (ng/mL) | Healgen Test Results |
| --- | --- | --- |
| HA03-344 | 22.53 | Neg |
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PCP
| Concentration range by LC/MS | Number of samples Total | Number of Negative | Number of Positive | The percentage of correct result |
| --- | --- | --- | --- | --- |
| Drug free | 1023 | 1023 | 0 | 100% |
| < -50% Cut off | 233 | 233 | 0 | 100% |
| -50% Cut off ~ Cut off | 23 | 23 | 0 | 100% |
| Cut off ~ +50% Cut off | 15 | 0 | 15 | 100% |
| > -50% Cut off | 47 | 0 | 47 | 100% |
THC
| Concentration range by LC/MS | Number of samples Total | Number of Negative | Number of Positive | The percentage of correct result |
| --- | --- | --- | --- | --- |
| Drug free | 725 | 725 | 0 | 100% |
| < -50% Cut off | 252 | 252 | 0 | 100% |
| -50% Cut off ~ Cut off | 91 | 87 | 4 | 96% |
| Cut off ~ +50% Cut off | 25 | 11 | 14 | 56% |
| > -50% Cut off | 141 | 0 | 141 | 100% |
Discordant Results
| Sample # | LC/MS Concentration (ng/mL) | Healgen Test Results |
| --- | --- | --- |
| HA01-288 | 35.42 | Pos |
| HA03-097 | 37.094 | Pos |
| HA03-103 | 38.145 | Pos |
| HA02-071 | 38.982 | Pos |
| HA01-141 | 40.67 | Neg |
| HA03-030 | 40.680 | Neg |
| HA02-100 | 40.95 | Neg |
| HA03-145 | 43.409 | Neg |
| HA02-166 | 43.91 | Neg |
| HA01-081 | 44.868 | Neg |
| HA01-035 | 45.231 | Neg |
| HA02B-244 | 45.27 | Neg |
| HA03-163 | 47.22 | Neg |
| HA01-221 | 49.26 | Neg |
| HA01-144 | 49.75 | Neg |
2. Matrix comparison:
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Not applicable. These devices are of use with oral fluid samples only.
## C Clinical Studies:
1. Clinical Sensitivity: Not applicable.
2. Clinical Specificity: Not applicable.
3. Clinical Cut-Off: Not applicable.
4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not applicable.
## D 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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