← Product Code [LDJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ) · K223162

# Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (K223162)

_Healgen Scientific,, LLC · LDJ · Mar 17, 2023 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ/K223162

## Device Facts

- **Applicant:** Healgen Scientific,, LLC
- **Product Code:** [LDJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ.md)
- **Decision Date:** Mar 17, 2023
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3870
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The Healgen® Accurate Oral Fluid Drug Test COT is a lateral flow chromatographic immunoassay for the qualitative detection of COT in oral fluid at the cut-off concentration 30 ng/mL. This assay provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid at the cutoff concentrations listed below and their metabolites. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography mass spectrometry (GC/MS) and liquid chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.

## Device Story

Lateral flow chromatographic immunoassay; detects Cotinine and Marijuana (THC) in human oral fluid. Principle: competitive binding; drug in sample competes with drug conjugate for antibody binding sites. Negative sample: antibody binds drug conjugate, forming visible test line. Positive sample: drug saturates antibody, preventing test line formation. Control line confirms proper wicking. Used for preliminary drug screening; results require laboratory confirmation via GC/MS or LC/MS. Operated by layusers (OTC) or professionals (prescription). Provides rapid qualitative visual output; aids in identifying potential drug use; facilitates subsequent confirmatory testing.

## Clinical Evidence

No clinical trials performed. Evidence consists of analytical performance studies (precision, specificity, cross-reactivity, read time, sample volume) and method comparison studies. Method comparison against LC-MS/MS involved 427 samples for COT and 126 for THC. Layuser study included 362 participants. Pharmacokinetic study supported the 30 ng/mL cotinine cut-off. All results demonstrate substantial equivalence to predicate performance.

## Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding principle. Qualitative visual output. Specimen: human oral fluid. Stability: 4-30°C for 24 months. No electronic components, software, or connectivity.

## Regulatory Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

## Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

- LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls ([K141320](/device/K141320.md))
- LabOne Micro-Plate Cotinine EIA (Oral Fluid) ([K033601](/device/K033601.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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

K223162

B Applicant

Healgen Scientific LLC

C Proprietary and Established Names

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  LDJ | Class II | 21 CFR 862.3870 - Cannabinoid Test System | Toxicology  |
|  MKU | Class I | 21 CFR 862.3220 - Carbon monoxide test system | Toxicology  |

## II Submission/Device Overview:

A Purpose for Submission:

New Device

B Measurand:

Cotinine and marijuana

C Type of Test:

Lateral flow chromatographic immunoassay

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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K223162 - Page 2 of 12

# 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 COT is a lateral flow chromatographic immunoassay for the qualitative detection of COT in oral fluid at the cut-off concentration 30 ng/mL.

This assay provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test.

The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid at the cutoff concentrations listed below and their metabolites.

|  Test | Calibrator | Cut-off (ng/mL)  |
| --- | --- | --- |
|  Cotinine (COT) | (-) Cotinine | 30  |
|  Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40  |

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography mass spectrometry (GC/MS) and liquid chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.

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

Rx and OTC

Healgen® Accurate Oral Fluid Drug Test COT is for OTC use only.

Healgen® Accurate Oral Fluid Drug Test is for Rx use only.

## D Special Instrument Requirements:

Not Applicable.

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K223162 - Page 3 of 12

## IV Device/System Characteristics:

### A Device Description:

The Healgen® Accurate Oral Fluid Drug Test is a lateral flow chromatographic immunoassay for the qualitative detection of marijuana and cotinine in oral fluids at cut-off concentrations of 40 ng/mL and 30 ng/mL respectively for prescription use only. The Healgen® Accurate Oral Fluid Drug Test COT is also a lateral flow chromatographic immunoassay for the qualitative detection of cotinine in oral fluids at a cut-off concentration of 30 ng/mL for over-the-counter use only. Both assays provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography mass spectrometry (GC/MS) and liquid chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.

Both tests contain mouse monoclonal antibody coupled particles and corresponding drug-protein conjugates. A goat antibody is employed in each control line.

Kit Contents for Both Devices:
- Test device – Holder cartridge with cup insert, test strips and reagent pads
- Security seal labels
- Saliva collectors
- Package insert

### B Principle of Operation:

Both tests are rapid immunoassays based on the principle of competitive inhibition binding. 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.

In the absence of THC and/or COT in the oral fluid specimen the colloidal gold-labeled antibody complex moves with the oral fluid by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the test area, The formation of two (2) visible lines (control and test lines) occurs when the test is negative or below the cut-off for the drug.

When THC and/or COT are present in the oral fluid specimen, the drug or metabolites will compete with the immobilized drug conjugate in the test area for the antibody binding sites on the colloidal gold-labeled antibody complex. If a sufficient amount of drug analyte is present it will fill the available binding sites, thus preventing attachment of the drug labeled antibody to the drug conjugate. The formation of one (1) visible line (control line, no test line) is indicative of a preliminary positive result for the drug.

### V Substantial Equivalence Information:

### A Predicate Device Name(s):

LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls

LabOne Micro-Plate Cotinine EIA

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B Predicate 510(k) Number(s):

K141320, K033601

# C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K223162 | K141320  |
| --- | --- | --- |
|  Device Trade Name | Healgen® Accurate Oral Fluid Drug Test | LZI Oral Fluid Cannabinoids Enzyme Immunoassay  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | Preliminary Drug screening test for the qualitative detection of drug analytes in oral fluid (human saliva) For In Vitro Diagnostic Use, Prescription Use | Same  |
|  Specimen Type | Human Oral Fluid | Same  |
|  General Device Characteristic Differences |  |   |
|  Analytes | Delta-9-Tetrahydrocannabinol (THC) Cotinine (COT) | Delta-9-Tetrahydrocannabinol (THC)  |
|  Device & Predicate Device(s): | K223162 | K033601  |
| --- | --- | --- |
|  Device Trade Name | Healgen® Accurate Oral Fluid Drug Test COT | LabOne Micro-Plate Cotinine EIA  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | For the qualitative determination of cotinine in human oral fluid. | Same  |
|  Calibrator | Cotinine | Same  |
|  Specimen Type | Human Oral Fluid | Same  |

K223162 - Page 4 of 12

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K223162 - Page 5 of 12

|  General Device Characteristic Differences |  |   |
| --- | --- | --- |
|  Methodology | Competitive binding, lateral flow immunochromatographic assay | A solid phase competitive enzyme-linked immunoassay  |
|  Assay Result | Qualitative | Qualitative and Semi-Quantitative  |

VI Standards/Guidance Documents Referenced:

ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
ISO 10993-10:2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-12:2012: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Precision-Reproducibility-Cut-Off studies were performed using the Healgen® Accurate Oral Fluid Drug Test at three POC testing sites by three healthcare professionals. 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 were prepared by spiking cotinine or marijuana in negative oral fluid samples. Each cotinine or marijuana concentration was confirmed by LC/MS/MS. All sample aliquots were tested in a blinded fashion. For each concentration, tests were performed on two runs per day for 25 days per device lot in a randomized order. A total of 50 determinations by each operator at each concentration were made.

Cotinine (COT)

|  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  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0-  |
|  Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0-  |

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Marijuana (THC)

|  Result
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  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot 1: | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 24-/26+ | 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+ | 24-/26+ | 47+/3- | 50+/0- | 50+/0- | 50+/0-  |

2. Linearity:

Not Applicable.

3. Analytical Specificity/Interference:

**Interference**

Potential interfering substances were added to either drug-free oral fluid or oral fluid containing the target drugs cotinine (COT) and marijuana (THC) with concentrations at 50% below and 50% above cut-off levels. These oral fluid samples were tested using three lots of the Healgen® Accurate Oral Fluid Drug Test. Compounds that showed no interference for marijuana (THC) or cotinine (COT) at a concentration of 100μg/mL are summarized in the following table.

|  Acetaminophen | Diacetylmorphine | Naltrexone  |
| --- | --- | --- |
|  (IR,2S)-(-)Ephedrine Hydrochloride | Diazepam | Naproxen  |
|  Acetylcodeine | Digoxin | Niacinamide  |
|  Acetylsalicylic Acid | Dihydrocodeine | Nicotinamide  |
|  Allobarbital | Diltiazem HCl | Niordiazepan  |
|  Alprazolam | Diphenhydramine HCl | Noscapine  |
|  Amobarbital | DL-Methadone | Omeprazole  |
|  Ampicillin | DL-Propranolol | Papaverine  |
|  Apomorphine | Doxylamine | Penicillin  |
|  ascorbic acid | Ecgonine Hydrochloride | Pentazocine  |
|  Atenolol | Ecgonine methylester | Pentobarbital  |
|  Atropine | Estradiol | Phencyclidine (PCP)  |
|  Baclofen | Estrone | Phenobarbital  |
|  Benzocaine | Fenoprofen | Phentermine  |
|  Benzoylecgonine | Fluconazole | Phenylephrine  |
|  beta-Phenethylamine | Furosemide | Phenylpropanolamine  |
|  Bilirubin | Gemfibrozil | Phenytoin  |

K223162 - Page 6 of 12

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|  Butabarbital | Gentisic Acid | Pioglitazone HCl  |
| --- | --- | --- |
|  Butalbital | Heroin hydrochloride | Prednisolone  |
|  Caffeine | Hexobarbital | Prednisone  |
|  Carbamazepine | Hydrochlorothiazide | Procainamide HCl  |
|  Chlordiazepoxide | Hydrocodone | Procaine HCL  |
|  Chlorpromazine | Hydromorphone | Promethazine  |
|  Cimetidine | Ibuprofen | Pseudoephedrine  |
|  Citalopram HBr | Imipramine | Quinidine  |
|  Clobazam | L-Ephedrine | Quinine HCl  |
|  Clomipramine | L-Methamphetamine | R,R(-)-Pseudoephedrine  |
|  Clonazepam | L-Thyroxine | Salicylic Acid  |
|  Clonidine | Lamotrigine | Sertraline HCL  |
|  Clopidogrel bisulfate | Levetiracetam | Simvastin  |
|  Clorazepate | Lidocaine | Temazepam  |
|  Cocaethylene | Lormetazepam | Theophylline  |
|  Cocaine | Meperidine | Theophylline  |
|  Codeine | Metformin HCl | Thiamine  |
|  Cortisol | Methylphenidate HCl | Topiramate  |
|  D-Amphetamine | Metoprolol | Valproic Acid  |
|  D-Methamphetamine | Metronidazole | Verapamil  |
|  d,l-Salbutamol | Montelukast sodium salt | Zomepirac  |
|  Deoxycorticosterone | Morphine Sulfate | Zonisamide  |
|  Deta-9-THC (except for THC test) | Nalorphine |   |
|  Dextromethorphan | Naloxone |   |

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 cut-off levels to a concentration of 5%. None of the substances showed interference.

Hemoglobin showed no interference at 10mg/dL.

K223162 - Page 7 of 12

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K223162 - Page 8 of 12

# Cross-Reactivity

To test specificity, drug metabolites and other components that are likely to interfere in oral fluid samples were tested using three lots of the Healgen device by three lab technicians. Results were as follows:

COT

|  (-) Cotinine
(Cut-off=30 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity  |
| --- | --- | --- |
|  (-) Cotinine | 30 | 100%  |
|  S(-)-Nicotine | 3000 | 1%  |
|  Trans-3-hydroxycotinine | 10 | 300%  |
|  (+)-anabasine | 1,350,000 | 0.002%  |
|  (+/-)-nornicotine | 150,000 | 0.02%  |
|  Niacinamide | >100,000 | < 0.03%  |

THC

|  Marijuana
(Cut-off=40 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity  |
| --- | --- | --- |
|  Δ9-Tetrahydrocannabinol | 40 | 100%  |
|  Δ8-Tetrahydrocannabinol | 80 | 50%  |
|  11-nor-Δ9-THC-9 COOH | 4 | 1000%  |
|  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%  |

# Effect of Oral Fluid pH

To investigate the effect of oral fluid pH, oral fluid samples with pH ranging from 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% of the cut-off and all negative for samples at and below -50% of the cut-off.

# Drug Recovery Study

Negative oral fluid samples were spiked with target drugs to concentrations of -50% and +50% of the cut-offs. The samples were transferred to Healgen devices and stored at room temperature (20 to 25°C), frozen at -20°C, and stored at 40°C. Samples were also tested after overnight shipment during the summer and winter. For room temperature, testing was done at Day 0 and Day 2. For -20°C, testing was done at Day 0 and Day 90 (3 months). For 40°C, testing was done at Day 0 and Day 1. The drug concentration was confirmed by LC-MS/MS.

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All data show that the average recoveries are over 90% and that oral fluid samples can be stored in the device at -20°C for at least 90 days, at 40°C for 2 days, and at room temperature (20 to 25°C) for 2 days with no leakage observed. Oral fluid samples can be shipped overnight in the device for LC-MS/MS confirmation.

## Sample Volume Study

A sample volume study was conducted to show that the Healgen devices captured a consistent volume of oral fluid sample and to determine the average duration of time to saturation. Professional operators used the Healgen devices to collect oral fluid specimens from study volunteers (71 smokers or drug users and 86 normal non-smoker and non-drug-use volunteers). Using the provided collection swab, operators swept the inside of the volunteer's mouth (cheek, gums, and tongue), using a timer to record how long the swab was held in their mouth until color appeared on the saturation strip in the indicator window. The results showed that the saturation indicator appears within 7 minutes and the average sample volume is 0.98±0.13mL for smokers/drug users and 1.0±0.10mL for non-smokers/non-drug-users. These results demonstrate the reproducibility of adequate sample volume collection by the device within the recommended 7 minute timeframe described in the instructions for use.

## Read Time Study

COT Standards with concentrations of 15ng/mL, 45ng/mL and 60ng/mL in negative oral fluid samples, THC Standards with concentrations of 40ng/mL, 60ng/mL and 80ng/mL in negative oral fluid samples, and negative oral fluid from drug-free people were tested using three lots of the device by three different operators according to procedures in the product insert at different reading times of 3, 4, 5, 8, 10, 12, 15, 20, 30, 40, 60 and 120 minutes. False positives were observed for read times up to 8 minutes. Expected results were observed for all concentrations tested at reading times greater than 8 minutes and up to 120 minutes. These results support the recommended 10 minute read time described in the instructions for use.

4. Assay Reportable Range:

Not Applicable.

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

The device is traceable to commercial reference standards.

6. Detection Limit:

Refer to the precision section VII.A.1.

7. Assay Cut-Off:

Refer to the precision section VII.A.1 for information about the assays' cut-offs.

K223162 - Page 9 of 12

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B Comparison Studies:

1. Method Comparison with Predicate Device:

Method comparison studies for the Healgen device were performed at three testing sites for each target drug with one operator at each site. Operators tested a total of 427 samples for COT and 126 samples for THC. The obtained test results were compared to LC/MS/MS results. The results are presented in the tables below.

COT

|  Concentration Range (by LC-MS/MS) | Test Results  |   |
| --- | --- | --- |
|   |  No. of Positive | No. of Negative  |
|  Drug-Free | 0 | 112  |
|  Less than Half the Cut-off Concentration | 0 | 93  |
|  Near Cut-off Negative | 5 | 35  |
|  Near Cut-off Positive | 28 | 4  |
|  High Positive | 150 | 0  |

Discordant Results

|  Sample Number | LC/MS Result | Test Results  |
| --- | --- | --- |
|  CM-098 | 23.43 | Positive  |
|  CM-003 | 27.70 | Positive  |
|  LH-140 | 24.62 | Positive  |
|  LH-161 | 28.88 | Positive  |
|  LS-007 | 29.32 | Positive  |
|  CM-096 | 30.38 | Negative  |
|  LH-069 | 32.64 | Negative  |
|  LS-082 | 30.75 | Negative  |
|  LS-002 | 31.84 | Negative  |

THC

|  Concentration Range (by LC-MS/MS) | Test Results  |   |
| --- | --- | --- |
|   |  No. of Positive | No. of Negative  |
|  Drug-Free | 0 | 35  |
|  Less than Half the Cut-off Concentration | 0 | 13  |
|  Near Cut-off Negative | 2 | 5  |

K223162 - Page 10 of 12

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|  Concentration Range (by LC-MS/MS) | Test Results  |   |
| --- | --- | --- |
|   |  No. of Positive | No. of Negative  |
|  Near Cut-off Positive | 6 | 4  |
|  High Positive | 61 | 0  |

Discordant Results

|  Sample Number | LC/MS Result | Test Results  |
| --- | --- | --- |
|  S0665123 | 38.3 | Positive  |
|  S0665139 | 38.7 | Positive  |
|  S0583367 | 40.6 | Negative  |
|  S0583363 | 42.2 | Negative  |
|  S0583368 | 46.0 | Negative  |
|  S0583371 | 47.0 | Negative  |

2. Layuser Studies:

Layuser studies for the Healgen® Accurate Oral Fluid Drug Test COT were performed at three testing sites. A total of 362 layusers with diverse educational and professional backgrounds performed tests based on the product insert. The layuser results were compared to COT LC/MS/MS results. The results are presented in the tables below.

|  Concentration Range (by LC-MS/MS) | Test Results  |   |
| --- | --- | --- |
|   |  No. of Positive | No. of Negative  |
|  Drug-Free | 0 | 95  |
|  Less than Half the Cut-off Concentration | 0 | 39  |
|  Near Cut-off Negative | 4 | 31  |
|  Near Cut-off Positive | 34 | 5  |
|  High Positive | 154 | 0  |

Discordant Results

|  Sample Number | LC/MS Result | Test Results  |
| --- | --- | --- |
|  NX-032 | 27.97 | Positive  |
|  PH-012 | 23.54 | Positive  |
|  PH-028 | 29.77 | Positive  |
|  AJ-096 | 29.89 | Positive  |
|  NX-010 | 30.53 | Negative  |
|  NX-010 | 38.64 | Negative  |
|  PH-083 | 35.80 | Negative  |
|  AJ-019 | 30.26 | Negative  |

K223162 - Page 11 of 12

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|  Sample Number | LC/MS Result | Test Results  |
| --- | --- | --- |
|  AJ-016 | 32.54 | Negative  |

Layusers were given surveys on the ease of understanding the instructions for use. All layusers indicated that the device’s instructions are easy to understand and follow. A Flesch-Kincaid reading analysis was performed on the package insert and the scores revealed a reading Grade Level of 7.

2. Matrix Comparison:
Not Applicable.

C Clinical Studies:

1. Clinical Sensitivity:
Not Applicable.

2. Clinical Specificity:
Not Applicable.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
To support their proposed cutoff of 30 ng/mL for detection of cotinine, the sponsor provided a pharmacokinetic study. Oral fluid samples in this study were evaluated both by the sponsor’s device as well as confirmatory LC-MS/MS testing. The sponsor additionally provided a description of the smoking habits and history of subjects in their lay user study. After review, it was determined that the sponsor’s proposed cut-off was clinically valid for the intended use of the device.

D Clinical Cut-Off:
Not applicable.

E Expected Values/Reference Range:
Not applicable.

VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

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

K223162 - Page 12 of 12

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ/K223162](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ/K223162)

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