Healgen THC One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 50 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 mAMP One Step Methamphetamine Test is an immunochromatographic assay for the qualitative determination of methamphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

Device Description

Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

AI/ML Overview

The provided document describes the performance characteristics of the Healgen THC One Step Marijuana Test and the Healgen mAMP One Step Methamphetamine Test, and concludes that they are substantially equivalent to a predicate device.

Here's an analysis of the acceptance criteria and the studies that support it:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by the results of the performance studies presented, primarily focused on their ability to correctly identify drug presence/absence at and around the specified cutoff concentrations. The studies demonstrate that for samples at or above +25% of the cutoff, the devices consistently show positive results, and for samples at or below -25% of the cutoff, they consistently show negative results. At the cutoff concentration, there is some variability, which is expected for qualitative tests.

Healgen THC One Step Marijuana Test (Cut-off: 50 ng/mL)

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision	Consistent results at defined concentrations (100% agreement for -100%/-75%/-50%, +25%/+50%/+75%/+100% cut off)	THC Strip Format: -100%, -75%, -50% cut off: 50-/0+ (100% negative)+25%, +50%, +75%, +100% cut off: 50+/0- (100% positive)Cut off: 12-/38+THC Cassette Format: Similar results (e.g., 18-/32+ at cut off) THC Cup Format: Similar results (e.g., 14-/36+ at cut off) THC Dipcard Format: Similar results (e.g., 20-/30+ at cut off)
Cut-off Verification	All positive at and above +25% Cut-off; all negative at and below -25% Cut-off.	THC: All positive at and above +25% Cut-off; all negative at and below -25% Cut-off.
Interference	No interference from common physiological/pathological substances at specified concentrations.	No interference from a long list of compounds at 100 µg/mL.
Specificity	Predictable cross-reactivity with related compounds.	THC: 11-nor-Δ9-THC-9-COOH (100% at 50 ng/mL), Delta-9-THC (0.1% at 50,000 ng/mL), 11-nor-delta-9-THC-carboxyglucuronide (67% at 75 ng/mL), 11-Hydroxy-Δ9-THC (1% at 5,000 ng/mL), etc.
Effect of Urine Specific Gravity and pH	No impact on results at defined range.	All positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off within pH 4-9 and specific gravity 1.000-1.035.
Method Comparison (Clinical Samples)	Agreement with GC/MS (concordance)	THC Strip, Cassette, Cup, Dip Card: High concordance for "Negative" and "High Positive" samples. Some discordant results (false negatives) for samples "Near Cutoff Positive" (52-53 ng/mL, i.e., slightly above the 50 ng/mL cutoff).
Lay User Study	High percentage of correct results, especially for samples further from the cutoff.	THC: 100% correct for -100%, -75%, -50%, +50%, +75% Cutoff samples. 95% correct for -25% Cutoff (1 false positive) and +25% Cutoff (1 false negative).

Healgen mAMP One Step Methamphetamine Test (Cut-off: 1000 ng/mL)

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision	Consistent results at defined concentrations (100% agreement for -100%/-75%/-50%, +25%/+50%/+75%/+100% cut off)	MET Strip Format: -100%, -75%, -50% cut off: 50-/0+ (100% negative)+25%, +50%, +75%, +100% cut off: 50+/0- (100% positive)Cut off: 14-/36+MET Cassette, Dip Card, Cup Formats: Similar results (e.g., 20-/30+ at cut off, 24-/26+ at cut off, 22-/28+ at cut off respectively)
Cut-off Verification	All positive at and above +25% Cut-off; all negative at and below -25% Cut-off.	MET: All positive at and above +25% Cut-off; all negative at and below -25% Cut-off.
Interference	No interference from common physiological/pathological substances at specified concentrations.	No interference from a long list of compounds at 100 µg/mL.
Specificity	Predictable cross-reactivity with related compounds.	MET: D-Methamphetamine (100% at 1000 ng/mL), MDEA (5% at 20,000 ng/mL), Procaine (1.7% at 60,000 ng/mL), MDMA (40% at 2500 ng/mL), Ephedrine (1% at 100,000 ng/mL), etc.
Effect of Urine Specific Gravity and pH	No impact on results at defined range.	All positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off within pH 4-9 and specific gravity 1.000-1.035.
Method Comparison (Clinical Samples)	Agreement with GC/MS (concordance)	MET Strip, Cassette, Dip Card, Cup: High concordance for "Negative" and "High Positive" samples. Some discordant results (false negatives) for samples "Near Cutoff Positive" (1003-1008 ng/mL, i.e., slightly above the 1000 ng/mL cutoff).
Lay User Study	High percentage of correct results, especially for samples further from the cutoff.	MET: 100% correct for -100%, -75%, -50%, +50%, +75% Cutoff samples. 90% correct for -25% Cutoff (2 false positives) and 95% correct for +25% Cutoff (1 false negative).

2. Sample Sizes and Data Provenance

Precision Study: For each drug (THC and MET) and each format (Strip, Cassette, Cup, Dip Card), 8 concentrations (-100% cut off to +100% cut off) were tested. For each concentration, tests were performed two runs per day for 25 days. This implies 50 individual tests per concentration per lot, and 3 lots were used for each format.
- Example for THC Strip: 8 concentrations x 50 tests/concentration x 3 lots = 1200 tests.
- Data Provenance: The document does not explicitly state the country of origin but implies an in-house laboratory setting (referred to as "in-house" for comparison studies, and "prepared by spiking drug in negative samples" for precision, cut-off, and interference studies). The data is retrospective in the sense that samples were prepared and then tested. The urine samples were "negative samples" (for spiking) or "drug-free urine" (for interference), suggesting they were sourced specifically for testing purposes.
Cut-off Verification Study: 150 samples were used, equally distributed at concentrations of -50%, -25%, Cut-Off, +25%, +50% Cut-Off. So, 30 samples per concentration.
- Data Provenance: Similar to precision, prepared by spiking.
Interference Study: Urine samples (drug-free and spiked with target drugs +/-25% Cut-Off) were used for testing various interfering substances. The number of samples per substance is not specified, but it was tested using three batches of each device for all formats.
- Data Provenance: Assumed to be artificially created/spiked samples.
Method Comparison Study: For each drug and each format, 80 unaltered clinical urine samples were used (40 negative, 40 positive).
- Data Provenance: The samples are described as "clinical samples," suggesting real-world patient samples. The country of origin is not specified, but the study was performed "in-house." This is retrospective data.
Lay-user Study: 140 lay persons participated. Urine samples were prepared at 7 different concentrations (negative, +/-75%, +/-50%, +25% of cutoff). For each concentration, 20 samples were prepared.
- Data Provenance: Artificially prepared by spiking into drug-free pooled urine specimens.

3. Number of Experts and Qualifications for Ground Truth

Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH:
- The ground truth for these analytical performance studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted gold standard method for quantifying drug concentrations in urine.
- The document states that "Each drug concentration was confirmed by GC/MS" and that the "concentrations of the samples were confirmed by GC/MS." No human experts are explicitly mentioned for establishing ground truth from GC/MS results, as GC/MS is an objective analytical method.
Method Comparison Study:
- The ground truth for the 80 clinical samples was established by GC/MS results.
- No specific number or qualifications of human experts are mentioned for interpreting the GC/MS results or establishing the ground truth from them.
Lay-user Study:
- Ground truth was established by GC/MS for the spiked urine samples.

4. Adjudication Method for the Test Set

Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH: For these analytical studies, GC/MS was the objective reference. The testing was done by unspecified personnel; "sample aliquots were blinded labeled by the person who prepared the samples and won't take part in the sample testing" (precision study). This suggests a blinding mechanism but no explicit multi-reader adjudication process for the actual device results.
Method Comparison Study: Three laboratory assistants were the "operators" who ran the devices and presumably interpreted the results. The comparison was against GC/MS. The individual results of each viewer are reported, and then discordant results are listed. There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus among the three viewers) to arrive at a single device result per sample if their interpretations differed. Each viewer's interpretation is compared independently to the GC/MS ground truth.
Lay-user Study: The study involved "140 lay persons" each testing "1 blind labeled sample and a device." The "Lay person results" table shows aggregate counts of positive/negative results. It does not describe an adjudication process for discordant interpretations among lay users on a single sample, as each lay user tested a unique sample (or set of samples for the overall study) and their individual interpretation was the data point.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was described. The studies focused on the performance of the device itself, observed by laboratory assistants (method comparison) or lay users (lay-user study), against an objective ground truth (GC/MS). There is no comparison of "human readers improve with AI vs without AI assistance" because the device is a simple, qualitative immunochromatographic assay, not an AI-powered diagnostic system requiring human interpretation of complex AI outputs.

6. Standalone Performance Study (Algorithm Only)

The device itself is a standalone, qualitative diagnostic test (immunochromatographic assay). All the performance studies (precision, cut-off, interference, specificity, method comparison, lay-user study) assess the standalone performance of the device without human interpretation being the primary variable. The "human-in-the-loop" component is essentially the reading and interpretation of the colored lines on the test strip as positive or negative, which is intrinsic to this type of device. There isn't an "algorithm" in the sense of a sophisticated computational model that could be evaluated separately from the physical test.

7. Type of Ground Truth Used

The primary and consistently used ground truth for all analytical and comparative studies was GC/MS (Gas Chromatography/Mass Spectrometry). This is an objective, highly accurate analytical method for drug concentration determination.

8. Sample Size for the Training Set

The document does not describe the development of an "algorithm" or "AI" system that would typically require a training set. This is an immunochromatographic assay, which relies on chemical and biological reactions rather than machine learning algorithms. Therefore, there is no "training set" in the context of AI. The product validation data described (precision, cut-off, interference, specificity, method comparison) serves to demonstrate the device's performance, not to "train" it.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of AI/algorithm development for this device, this question is not applicable. The device's inherent design and manufacturing processes are validated by the performance studies using GC/MS as the ground truth.

Summary

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.K140546

JUN 0 6 2014

510(k) SUMMARY

1. Date:
  May 29, 2014

Submitter: 2.

HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401

1. Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401 Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com
1. Device Name:

Healgen mAMP One Step Methamphetamine Test

Healgen THC One Step Marijuana Test

Classification:

Product Code	CFR #	Panel
LDJ	21 CFR, 862.3870 Cannabinoid Test System	Toxicology
LAF	21 CFR, 862.3610 Methamphetamine Test System	Toxicology

1. Predicate Devices:
  K052115

FIRST CHECK DIAGNOSTICS LLC

6. Intended Use

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

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

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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.

1. Device Description
  Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

8. Substantial Equivalence Information

A summary comparison of features of the Healgen THC One Step Marijuana Test and Healgen mAMP One Step Methamphetamine Test and the predicate devices is provided in Table 1 & Table 2.

Item	Device	Predicate -K052115
Indication(s) forUse	For the qualitative determination of11-nor-Δ9-THC-9-COOH in human urine.	Same (but thenumber of drugsdetected is different)
Calibrator	11-nor-Δ9-THC-9-COOH	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative to indicate positive or negativeresult	Same
Specimen Type	Human Urine	Same
Cut-Off Values	50 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	For over-the-counteruse.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

Table 1: Features Comparison of Healgen THC One Step Marijuana Test and the Predicate Devices

Table 2: Features Comparison of Healgen mAMP One Step Methamphetamine Test and the Predicate Devices

ltem	Device	Predicate - K052115
Indication(s) forUse	For the qualitative determination ofMethamphetamine in human urine.	Same(but the numberof drugs detected isdifferent)
Calibrator	Methamphetamine	Same

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Item	Device	Predicate - K052115
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative to indicate positive or negativeresult	Same
Specimen Type	Human Urine	Same
Cut-Off Values	1000 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	For over-the-counteruse.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

1. Test Principle
  It is a rapid test for the qualitative detection of 11-nor-A9-THC-9-COOH and Methamphetamine in urine samples. It is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific 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.

10. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled by the person who prepared the samples and won't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.

Drug	Result	-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	cut off	+25%cutoff	+50%cutoff	+75%cut+100%cutt off
Lot:THC1110001	50-/0+	50-/0+	50-/0+	50-/0+	12-/38+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:THC1110002	50-/0+	50-/0+	50-/0+	50-/0+	12-/38+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:THC1110003	50-/0+	50-/0+	50-/0+	50-/0+	12-/38+	50+/0-	50+/0-	50+/0-	50+/0-
	Result	-100% cutoff	-75%cutoff	-50%cutoff	-25%cutoff	cut off	+25%cutoff	+50%cutoff	+75%cutoff	+100%cutt off
Drug	Lot:THC1110004	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:THC1110005	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:THC1110006	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
THC Cup Format	Result	-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	cut off	+25%cutoff	+50%cutoff	+75%cutoff	+100%cutt off
Drug	Lot:THC1110007	50-/0+	50-/0+	50-/0+	50-/0+	14-/36+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:THC1110008	50-/0+	50-/0+	50-/0+	50-/0+	14-/36+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:THC1110009	50-/0+	50-/0+	50-/0+	50-/0+	14-/36+	50+/0-	50+/0-	50+/0-	50+/0-
THC Dipcard Format	Result	-100% cutoff	-75%cutoff	-50%cutoff	-25%cutoff	cut off	+25%cutoff	+50%cutoff	+75%cutoff	+100%cutt off
Drug	Lot:THC1110010	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:THC1110011	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:THC1110012	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
MET Strip Format	Result	-100% cutoff	-75%cutoff	-50%cutoff	-25%cutoff	cut off	+25%cutoff	+50%cutoff	+75%cutoff	+100%cutt off
Drug	Lot:MET1110001	50-/0+	50-/0+	50-/0+	50-/0+	14-/36+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MET1110002	50-/0+	50-/0+	50-/0+	50-/0+	14-/36+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MET1110003	50-/0+	50-/0+	50-/0+	50-/0+	14-/36+	50+/0-	50+/0-	50+/0-	50+/0-
MET Cassette Format	Result	-100% cutoff	-75%cutoff	-50% cutoff	-25%cutoff	cut off	+25%cutoff	+50%cutoff	+75%cutoff	+100%cutt off
Drug	Lot:MET1110004	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MET1110005	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MET1110006	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
MET Dip Card Format	Result	-100% cutoff	-75%cutoff	-50%cutoff	-25%cutoff	cut off	+25%cutoff	+50%cutoff	+75%cutoff	+100%cutt off
Drug	Lot:MET1110007	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MET1110008	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MET1110009	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
MET CUP Format	Result	-100% cutoff	-75%cutoff	-50% cutoff	-25%cutoff	cut off	+25%cutoff	+50%cutoff	+75%cutoff	+100%cutt off
Drug	Lot:MET1110010	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MET1110011	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-

THC Strip Format

THC Cassette Format

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b.Linearity

Not applicable, this is a visually read device

c. Stability
It is stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 ℃ and real time stability determination at both 4 ℃ and 30 ℃.

d.Cut-off

Total 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 below -25% Cut-off for both Marijuana and Methamphetamine. The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off (ng/mL)
One Step Marijuana Test	11-nor-Δ9-THC-9-COOH	50
One Step Methamphetamine Test	Methamphetamine	1000

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% below and 25% above Cut-Off level respectively. These urine samples were tested using three batches of each device for all formats.

Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed for different formats.

4-Acetamidophenol	Estrone-3-sulfate	Penicillin-G
Acetophenetidin	Ethyl-p-aminobenzoate	Pentazocine
N-Acetylprocainamide	Fenoprofen	Pentobarbital
Acetylsalicylic acid	Furosemide	Perphenazine
Aminopyrine	Gentisic acid	Phencyclidine
Amitryptyline	Hemoglobin	Phenelzine
Amobarbital	Hydralazine	Phenobarbital
Amoxicillin	Hydrochlorothiazide	Phentermine
Ampicillin	Hydrocodone	L-Phenylephrine
Ascorbic acid	Hydrocortisone	ß-Phenylethlamine
D,L-Amphetamine	O-Hydroxyhippuric acid	ß-Phenyllethylamine
L-Amphetamine	3-Hydroxytyramine	Phenylpropanolamine
Apomorphine	Ibuprofen	Prednisolone
Aspartame	Imipramine	Prednisone
Atropine	Iproniazid	Procaine
Benzilic acid	(-) Isoproterenol	Promazine
Benzoic acid	Isoxsuprine	Promethazine
Benzoylecgonine	Ketamine	D,L-Propanolol
Benzphetamine	Ketoprofen	D-Propoxyphene
Bilirubin	Labetalol	D-Pseudoephedrine

THC:

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Brompheniramine	Levorphanol	Quinidine
Caffeine	Loperamide	Quinine
Chloralhydrate.	Maprotiline	Ranitidine
Chloramphenicol	Meprobamate	Salicylic acid
Chlordiazepoxide	Methadone	Secobarbital
Chlorothiazide	Methoxyphenamine	Serotonin (5-Hydroxytyramine)
(±) Chlorpheniramine	(+) 3,4-Methylenedioxyamphetamine	Sulfamethazine
Chlorpromazine	(+)3,4-Methylenedioxymethamphetamine	Sulindac
Chlorquine	Methylphenidate	Temazepam
Cholesterol	Methyprylon	Tetracycline
Clomipramine	Morphine-3-β-Dglucuronide	Tetrahydrocortisone, 3 Acetate
Clonidine	Nalorphine	Tetrahydrocortisone3(5-Dglucuronide)
Cocaine hydrochloride	Naloxone	Tetrahydrozoline
Codeine	Nalidixic acid	Thebaine
Cortisone	Naltrexone	Thiamine
(-) Cotinine	Naproxen	Thioridazine
Creatinine	Niacinamide	D, L-Thyroxine
Deoxycorticosterone	Nifedipine ·	Tolbutamine
Dextromethorphan	Norcodein	Triamterene
Diazepam	Norethindrone	Trifluoperazine
Diclofenac	D-Norpropoxyphene	Trimethoprim
Diflunisal	Noscapine	Trimipramine
Digoxin	D, L-Octopamine	Tryptamine
Diphenhydramine	Oxalic acid	D, L-Tryptophan
Doxylamine	Oxazepam	Tyramine
Ecgonine hydrochloride	Oxolinic acid	PrD, L-Tyrosine
Ecgonine methylester	Oxycodone	Uric acid
(-) Y Ephedrine	Oxymetazoline	Verapamil
Erythromycin	p-Hydroxymethamphetamine	Zomepirac
β-Estradiol	Papaverine

МЕТ

4-Acetamidophenol	(-) Y Ephedrine	Penicillin-G
Acetophenetidin	Erythromycin	Pentazocaine
N-Acetylprocainamide	ß-Estradiol	Pentobarbital
Acetylsalicylic acid	Estrone-3-sulfate	Perphenazine
Aminopyrine	Ethyl-p-aminobenzoate	Phencyclidine
Amitryptyline	Fenfluramine	Phenelzine
Amobarbital	Fenoprofen	Phendimetrazine
Amoxicillin	Furosemide	Phenobarbital
Ampicillin	Gentisic acid	Phetoin
Ascorbic acid	Hemoglobin	L-Phenylephrine

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Apomorphine	Hydralazine	β-Phenylethlamine
Aspartame	Hydrochlorothiazide	Phenylpropanolamine
Atropine	Hydrocodone	Prednisolone
Benzilic acid	Hydrocortisone	Prednisone
Benzoic acid	O-Hydroxyhippuric acid	Procaine
Benzoylecgonine	3-Hydroxytyramine	Promazine
Bilirubin	Ibuprofen	Promethazine
Brompheniramine	Imipramine	D,L-Propanolol
Caffeine	(-) Isoproterenol	Propiomazine
Cannabidiol	Isoxsuprine	D-Propoxyphene
Cannabinol	Ketamine	Quinidine
Chloralhydrate	Ketoprofen	Quinine
Chloramphenicol	Labetalol	Ranitidine
Chlordiazepoxide	Levorphanol	Salicylic acid
Chlorothiazide	Loperamide	Secobarbital
(±) Chlorpheniramine	Maprotiline	Serotonin
Chlorpromazine	Meperidine	Sulfamethazine
Chlorquine	Meprobamate	Sulindac
Cholesterol	Methadone	Temazepam
Clomipramine	Methylphenidate	Tetracycline
Clonidine	Morphine-3-Dglucuronide	Tetrahydrocortisone
Cocaine hydrochloride	Nalidixic acid	Tetrahydrozoline
Codeine	Naloxone	Δ9-THC-COOH
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	Noscapine	Trimethoprim
Digoxin	D,L-Octopamine	Trimipramine
Diphenhydramine	Oxalic acid	Tryptamine
Doxylamine	Oxazepam	D, L-Tyrosine
Ecgonine hydrochloride	Oxolinic acid	Uric acid
Ecgonine methylester	Oxycodone	Verapamil
(IR,2S)-(-)-Ephedrine	Oxymetazoline	Zomepirac
l-Ephedrine	Papaverine	Acebutolol

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. Compounds that produced positive results are listed below. There were no differences observed for different formats.

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THC	Result	% Cross-Reactivity
(11-nor-Δ9-THC-9-COOH, Cutoff=50 ng/mL)	Positive at 50 ng/mL	100%
Delta-9-Tetrahydrocannabinol	Positive at 50,000 ng/mL	0.1%
11-nor-delta-9-THC-carboxyglucuronide	Positive at 75 ng/mL	67%
(-)-11-nor-9-carboxy-delta9-THC	Positive at 75 ng/mL	67%
11-Nor-Δ9-Tetrahydrocannabinol	Positive at 50 ng/mL	100%
11-Hydroxy-Δ9-Tetrahydrocannabinol	Positive at 5,000 ng/mL	1%
11-Nor-Δ8-Tetrahydrocannabinol	Positive at 50 ng/mL	100%
Δ8-THC-COOH	Positive at 50,000 ng/mL	0.1%

MET	Result	% Cross-Reactivity
(D-Methamphetamine, Cutoff=1000 ng/mL)	Positive at 1000 ng/mL	100%
(+/-) 3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	Positive at 20,000 ng/mL	5%
Procaine (Novocaine)	Positive at 60,000 ng/mL	1.7%
Trimethobenzamide	Positive at 20,000 ng/mL	5%
Methamphetamine	Positive at 1000 ng/mL	100%
Ranitidine (Zantac)	Positive at 50,000 ng/mL	2%
(+/-) 3,4-Methylenedioxymethamphetamine (MDMA)	Positive at 2500 ng/mL	40%
Chloroquine	Positive at 50,000 ng/mL	2%
Ephedrine	Positive at 100,000 ng/mL	1%
Fenfluramine	Positive at 50,000 ng/mL	2%
p-Hydroxymethamphetamine	Positive at 10,000 ng/mL	10%

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, the urine samples, with 1.000~~1.035 specific gravity or urine samples with pH 4~~9 were spiked with target drugs at 25% below and 25% above Cut-Off level, respectively. 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.

1. Comparison Studies
  The method comparison for the One Step Marijuana Test, and the One Step Methamphetamine Test was performed in-house with three laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the table below:

Stripformat	Negative	THC
		LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%)	HighPositive byGC/MS(greaterthan +50%)

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Viewer		0	0	0	13	26
Viewer A	Positive	0	0	0	13	26
	Negative	10	16	16	1	0
Viewer B	Positive	0	0	0	12	26
	Negative	10	16	16	2	0
Viewer C	Positive	0	0	0	12	26
	Negative	10	16	16	2	0

Discordant Results of THC Strip

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	223	52	Negative
Viewer B	207	53	Negative
Viewer B	223	52	Negative
Viewer C	207	53	Negative
Viewer C	223	52	Negative

Cassetteformat		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%)	HighPositive byGC/MS(greaterthan +50%)
ViewerA	Positive	0	0	0	12	26
	Negative	10	16	16	2	0
ViewerB	Positive	0	0	0	11	26
	Negative	10	16	16	3	0
ViewerC	Positive	0	0	0	11	26
	Negative	10	16	16	3	0

Discordant Results of THC Casette

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	223	52	Negative
Viewer A	247	53	Negative
Viewer B	207	53	Negative
Viewer B	247	53	Negative
Viewer B	223	52	Negative
Viewer C	207	53	Negative
Viewer C	247	53	Negative
Viewer C	223	52	Negative

Cupformat	Negative	LowNegative byGC/MS(less than -50%)	Near CutoffNegative byGC/MS(Between -50% and	Near CutoffPositive byGC/MS(Between the cutoff	HighPositive byGC/MS(greater than +50%)

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				cutoff)	and +50%)
Viewer	Positive	0	0	0	12	26
A	Negative	10	16	16	2	0
Viewer	Positive	0	0	0	11	26
B	Negative	10	16	16	3	0
Viewer	Positive	0	0	0	12	26
C	Negative	10	16	16	2	0

Discordant Results of THC Cup

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	223	52	Negative
Viewer A	247	53	Negative
Viewer B	207	53	Negative
Viewer B	247	53	Negative
Viewer B	223	52	Negative
Viewer C	207	53	Negative
Viewer C	247	53	Negative

DipCardformat	Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%)	HighPositive byGC/MS(greaterthan +50%)
ViewerA	Positive	0	0	0	13	26
ViewerA	Negative	10	16	16	1	0
ViewerB	Positive	0	0	0	12	26
ViewerB	Negative	10	16	16	2	0
ViewerC	Positive	0	0	0	12	26
ViewerC	Negative	10	16	16	2	0

Discordant Results of THC Dip Card

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	223	52	Negative
Viewer B	207	53	Negative
Viewer B	223	52	Negative
Viewer C	207	53	Negative
Viewer C	247	53	Negative

{10}------------------------------------------------

Stripformat		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer	Positive	0	0	0	12	27
A	Negative	10	19	15	1	0
Viewer	Positive	0	0	0	11	27
B	Negative	10	19	15	2	0
Viewer	Positive	0	0	0	12	27
C	Negative	10	19	15	1	0

Discordant Results of MET Strip

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	133	1008	Negative
Viewer B	123	1003	Negative
Viewer B	133	1008	Negative
Viewer C	133	1008	Negative

Cassetteformat		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%)	HighPositive byGC/MS(greaterthan +50%)
ViewerA	Positive	0	0	0	11	27
	Negative	10	19	15	2	0
ViewerB	Positive	0	0	0	12	27
	Negative	10	19	15	1	0
ViewerC	Positive	0	0	0	11	27
	Negative	10	19	15	2	0

Discordant Results of MET Cassette

Viewer	Sample Number	GC/MS Result	Results
Viewer A	123	1003	Negative
Viewer A	133	1008	Negative
Viewer B	123	1003	Negative
Viewer C	123	1003	Negative
Viewer C	133	1008	Negative

・

{11}------------------------------------------------

DipCardformat		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%)	HighPositive byGC/MS(greaterthan +50%)
ViewerA	Positive	0	0	0	11	27
	Negative	10	19	15	2	0
ViewerB	Positive	0	0	0	11	27
	Negative	10	19	15	2	0
ViewerC	Positive	0	0	0	11	27
	Negative	10	19	15	2	0

Discordant Results of MET Dip Card

Viewer	Sample Number	GC/MS Result	Strip Format ViewerResults
Viewer A	123	1003	Negative
Viewer A	133	1008	Negative
Viewer B	123	1003	Negative
Viewer B	133	1008	Negative
Viewer C	123	1003	Negative
Viewer C	133	1008	Negative

Cup format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cutoff)	Near Cutoff Positive by GC/MS (Between the cutoff and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	0	12	27
Viewer A	Negative	10	19	15	1	0
Viewer B	Positive	0	0	0	12	27
Viewer B	Negative	10	19	15	1	0
Viewer C	Positive	0	0	0	11	27
Viewer C	Negative	10	19	15	2	0

Discordant Results of MET Cup

Viewer	Sample Number	GC/MS Result	Strip Format ViewerResults
Viewer A	123	1003	Negative
Viewer B	123	1003	Negative
Viewer C	123	1003	Negative
Viewer C	133	1008	Negative

Lay-user study

A lay user study was performed at three intended user sites with 140 lay persons. For a typical Strip device study, participants were 54 females and 86 males tested the Marijuana samples, and

{12}------------------------------------------------

54 females and 86 males tested the Methamphetamine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-25% of the cutoff by spiking drug(s) 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 samples and a device. The typical results are summarized below. There are no statistic differences of layperson results between different formats of the devices.

% of Cutoff	Number of samples	THC 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	12.5	0	20	100%
-50% Cutoff	20	25	0	20	100%
-25% Cutoff	20	37.5	1	19	95%
+25% Cutoff	20	62.5	19	1	95%
+50% Cutoff	20	75	20	0	100%
+75% Cutoff	20	87.5	20	0	100%

Typical Comparison between GC/MS and Lay Person Results (THC)

Typical Comparison between GC/MS and Lay Person Results (MET)

% of Cutoff	Number of samples	MET 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	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	2	18	90%
+25% Cutoff	20	1250	19	1	95%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

1. Clinical Studies
  Not applicable
1. 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 THC One Step Marijuana Test, and Healgen mAMP One Step Methamphetamine Test are substantially equivalent to the predicate.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the HHS symbol, which is a stylized representation of a human figure embracing the world. The symbol is composed of three curved lines that form the shape of a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 6, 2014

HEALGEN SCIENTIFIC, LLC C/O JOE SHIA 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877

Rc: K140546

Trade/Device Name: Healgen THC One Step Marijuana Test Healgen mAMP One Step Methamphetamine Test Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, LAF Dated: April 17, 2014 Received: April 18, 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 the 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). and conment of control the device, subject to the general controls provisions of the Act. The I ou may on on on 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.

1f your device is classified (see above) into either 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, Paris 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 or any I vatual 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{14}------------------------------------------------

Page 2-Mr. Joe Shia

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 yours,

Courtney H. Lias -S

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

{15}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k} Number (if known) K140546

Device Name

Healgen THC One Step Marijuana Test Healgen mAMP One Step Methamphetamine Test

Indications for Use (Describe)

Healgen THC One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of II-nor-49-THC-9-COOH in human urine at a Cut-Off concentration of 50 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{16}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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ﺎ ﺍﻟﻌﺎﻡ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
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 includedelta -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.(b)
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).