Healgen COC One Step Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

Healgen MOP One Step Morphine Test is an immunochromatographic assay for the qualitative determination of morphine in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GO/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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

Device Description

Healgen COC One Step Cocaine Test and Healgen MOP One Step Morphine Test are immunochromatographic assays for Cocaine and Morphine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine and Morphine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: Strips, Cassettes, DipCards, or Cups. It contains a Test Device (in one of the four formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

AI/ML Overview

The sponsor, HEALGEN SCIENTIFIC LLC, submitted a 510(k) premarket notification (K141647) for the Healgen COC One Step Cocaine Test and Healgen MOP One Step Morphine Test. Both devices are immunochromatographic assays intended for the qualitative determination of Benzoylecgonine and Morphine, respectively, in human urine at a cut-off concentration of 300 ng/mL. They are available in Strip, Cassette, Dip Card, and Cup formats for in vitro diagnostic use, intended for both over-the-counter and prescription use. The predicate device is the K052115 First Check Multi Drug Cup 12.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity or specificity percentages to be achieved). However, the performance characteristics studies (precision, cut-off, interference, specificity, and method comparison) are presented to demonstrate the device's acceptable performance and substantial equivalence to the predicate. The "acceptance criteria" can be inferred from the positive results observed in these studies, particularly the concordance with GC/MS and the high percentage of correct results from lay users around the cut-off.

Healgen COC One Step Cocaine Test Performance (Summary from provided data):

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision	Consistent results across lots and runs for samples at specified concentrations relative to cut-off.	Cocaine (COC) Strip, Cassette, Dip Card, Cup Formats: -100% to -25% Cut-off: 100% negative results (e.g., 50-/0+ for 3 lots, 2 runs/day for 25 days, totaling 150 tests/lot) +25% to +100% Cut-off: 100% positive results (e.g., 50+/0- for 3 lots, 2 runs/day for 25 days, totaling 150 tests/lot) Cut-off: Mixed results, indicating sensitivity around the cut-off (e.g., Strip: 18-/32+, Cassette: 22-/28+, Dip Card: 20-/30+, Cup: 18-/32+ for 3 lots).
Cut-off	Correctly identify positive/negative at and around the cut-off (300 ng/mL).	All samples at or above +25% cut-off (e.g., 375 ng/mL) were positive. All samples at or below -25% cut-off (e.g., 225 ng/mL) were negative.
Interference	No significant interference from common substances found in urine.	Numerous compounds (e.g., 4-Acetamidophenol, Aspirin, Ibuprofen, Methadone, etc.) at 100 µg/mL showed no interference in drug-free urine or urine spiked at 25% above cut-off levels.
Specificity (Cross-reactivity)	Limited cross-reactivity to ensure accurate detection of the target analyte.	Cocaethylene: 100% cross-reactivity (positive at 300 ng/mL). Cocaine HCl: 100% cross-reactivity (positive at 300 ng/mL).
Effect of Urine Specific Gravity and pH	Consistent results across a range of urine specific gravity and pH.	Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% cut-off, across specific gravity 1.000-1.035 and pH 4-9.
Method Comparison (Clinical Samples)	High concordance with GC/MS results, especially for samples further from the cut-off.	COC Strip Format: Out of 80 clinical samples (40 negative, 40 positive), for Viewer A: 0 false positives, 1 false negative (GC/MS 303 ng/mL, device negative) COC Cassette Format: For Viewer B: 0 false positives, 0 false negatives. Similar high concordance across all formats and viewers, with a few discordant results near the cut-off (e.g., 303 ng/mL or 305 ng/mL GC/MS concentrations read as negative by the device).
Lay-User Study	High percentage of correct results by lay users, demonstrating ease of use and interpretability.	COC Strip: 90% correct at -25% Cut-off, 95% correct at +25% Cut-off, 100% at other concentrations. Overall high accuracy. Users indicated instructions were easily followed (Flesch-Kincaid Grade Level 7).

Healgen MOP One Step Morphine Test Performance (Summary from provided data):

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision	Consistent results across lots and runs for samples at specified concentrations relative to cut-off.	Morphine (MOP) Strip, Cassette, Dip Card, Cup Formats: -100% to -25% Cut-off: 100% negative results (e.g., 50-/0+ for 3 lots, 2 runs/day for 25 days, totaling 150 tests/lot) +25% to +100% Cut-off: 100% positive results (e.g., 50+/0- for 3 lots, 2 runs/day for 25 days, totaling 150 tests/lot) Cut-off: Mixed results, indicating sensitivity around the cut-off (e.g., Strip: 16-/34+, Cassette: 18-/32+, Dip Card: 22-/28+, Cup: 20-/30+ for 3 lots).
Cut-off	Correctly identify positive/negative at and around the cut-off (300 ng/mL).	All samples at or above +25% cut-off (e.g., 375 ng/mL) were positive. All samples at or below -25% cut-off (e.g., 225 ng/mL) were negative.
Interference	No significant interference from common substances found in urine.	Numerous compounds (e.g., Acebutolol, Aspirin, Ibuprofen, Cocaine hydrochloride, etc.) at 100 µg/mL showed no interference in drug-free urine or urine spiked at 25% above cut-off levels.
Specificity (Cross-reactivity)	Limited cross-reactivity to ensure accurate detection of the target analyte.	6-Acetylmorphine: 75% cross-reactivity (positive at 400 ng/mL). Codeine: 100% cross-reactivity (positive at 300 ng/mL). Various other opiate-related compounds showed varying degrees of cross-reactivity (e.g., Heroin 50%, Hydromorphone 10%).
Effect of Urine Specific Gravity and pH	Consistent results across a range of urine specific gravity and pH.	Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% cut-off, across specific gravity 1.000-1.035 and pH 4-9.
Method Comparison (Clinical Samples)	High concordance with GC/MS results, especially for samples further from the cut-off.	MOP Strip Format: Out of 80 clinical samples (40 negative, 40 positive), for Viewer A: 0 false positives, 1 false negative (GC/MS 307 ng/mL, device negative). Viewer B showed one false positive (GC/MS 298 ng/mL) and one false negative (GC/MS 328 ng/mL). Similar high concordance across all formats and viewers, with a few discordant results near the cut-off.
Lay-User Study	High percentage of correct results by lay users, demonstrating ease of use and interpretability.	MOP Strip: 90% correct at -25% Cut-off, 95% correct at +25% Cut-off, 100% at other concentrations. Overall high accuracy. Users indicated instructions were easily followed.

2. Sample Size Used for the Test Set and Data Provenance:

Precision Study Test Set: For each drug (Cocaine and Morphine) and each format, 3 lots were tested. For each lot, 9 concentration levels were tested. For each concentration, tests were performed two runs per day for 25 days.
- This implies 3 lots * 9 concentrations * (2 runs/day * 25 days/run) = 3 * 9 * 50 = 1350 tests per lot per concentration type (e.g., Cocaine Strip).
- The results are reported as "X-/Y+" (Negative/Positive) out of 50 total readings per lot, meaning 50 tests were performed per lot per concentration level. So, 3 lots * 9 concentrations * 50 tests/concentration = 1350 tests were conducted for each device format (Strip, Cassette, Dip Card, Cup) for both Cocaine and Morphine.
- Data Provenance: The samples were "prepared by spiking drug in negative samples." The document does not specify the country of origin, but it implies a controlled laboratory setting (in-house) rather than collected human samples for this specific study. It is retrospective in the sense that the concentrations were known and confirmed by GC/MS beforehand.
Cut-off Verification Test Set: A total of 150 samples (equally distributed at -50%, -25%, cut-off, +25%, +50% cut-off concentrations) were tested. These were tested using three different lots of each device by three different operators.
- Data Provenance: Samples were "spiking drug in negative samples." No country of origin is mentioned, likely in-house.
Interference and Specificity Test Set: No specific sample size is given beyond "three batches of each device for all formats." The concentrations of interfering substances or cross-reactants were tested against drug-free urine and urine spiked at 25% above cut-off levels.
- Data Provenance: Not specified, likely in-house laboratory.
Method Comparison Studies (Clinical Samples Test Set): 80 unaltered clinical samples were used for each target drug (Cocaine and Morphine) and each device format (Strip, Cassette, Dip Card, Cup). Specifically, these were 40 negative and 40 positive samples.
- Data Provenance: "unaltered clinical samples". Country of origin is not specified, but the study was performed "in-house." These were retrospective/archived samples as their GC/MS results were already known and they were blind-labeled.
Lay-User Study Test Set: 140 lay persons tested the cocaine devices, and another 140 lay persons tested the morphine devices. Each participant was provided with 1 blind-labeled sample. For each drug, urine samples were prepared at 7 concentration levels (negative, +/-75%, +/-50%, +/-25% of the cutoff). The tables show 20 samples per concentration level, totaling 7 * 20 = 140 samples per drug group which corresponds to the number of lay users.
- Data Provenance: Urine samples were prepared by "spiking drugs into drug free-pooled urine specimens." Country of origin is not specified. The study involved human participants, making it a prospective study in terms of user interaction, but the samples themselves were prepared in a controlled manner.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Precision, Cut-off, Interference, Specificity, Lay-User Studies: The ground truth for these studies was established by GC/MS confirmation of the spiked drug concentrations in the urine samples. GC/MS (Gas Chromatography/Mass Spectrometry) is a highly accurate and accepted method for drug confirmation. No human experts are explicitly mentioned for establishing ground truth as GC/MS is the gold standard.
Method Comparison Studies (Clinical Samples): The ground truth was established by GC/MS results. The study states: "compared to GC/MS results." Again, no human experts are explicitly mentioned for interpreting these GC/MS results as they are quantitative and serve as the definitive ground truth for drug concentration.

4. Adjudication Method for the Test Set:

Precision, Cut-off, Interference, Specificity Studies: No explicit adjudication method is mentioned beyond the initial GC/MS confirmation of sample concentrations. The device results were presumably compared directly to these known concentrations.
Method Comparison Studies (Clinical Samples): Three "laboratory assistants" (referred to as Viewer A, Viewer B, Viewer C) independently interpreted the results of the rapid tests. The discordant results (where the rapid test device result did not match the GC/MS ground truth) are listed individually for each viewer and sample. This indicates that while there were multiple readers (viewers), their results were not adjudicated against each other to form a consensus before comparison to GC/MS. Instead, individual performance against GC/MS was reported.
Lay-User Study: Results from individual lay persons were compared against the GC/MS confirmed concentrations of the samples they tested. No adjudication between lay readers is mentioned; each reader's accuracy was assessed independently.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

This device is an immunochromatographic assay for drug detection in urine, which is a rapid, visually-read test. It does not utilize AI. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed and is not applicable to this type of device. The studies involved human readers (laboratory assistants and lay users) interpreting the results of a non-AI-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a manual, visually-read immunochromatographic test. There is no algorithm component to perform standalone testing. The performance characteristics represent the device's inherent analytical capabilities when used as intended.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The primary ground truth used for all performance studies (precision, cut-off, interference, specificity, and method comparison) was GC/MS (Gas Chromatography/Mass Spectrometry). This is considered a highly accurate and quantitative analytical method, serving as an objective gold standard for drug concentration in urine. For the lay-user study, the ground truth was also GC/MS confirmed drug concentrations in the prepared samples.

8. The Sample Size for the Training Set:

This is a rapid diagnostic test, not a machine learning or AI-based device, so the concept of a "training set" in the context of algorithm development is not applicable. The device's formulation and manufacturing processes are likely developed through R&D and optimization, not through training on a dataset in the AI sense.

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

As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable.

Summary

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K141647

510(k) SUMMARY

1. Date: July 15, 2014
  JUL 1 7 2014
1. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX7740İ
1. Contact person: Jiangiu 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 COC One Step Cocaine Test (Strip, Cassette, Cup. Dip Card) Healgen MOP One Step Morphine Test (Strip, Cassette, Cup, Dip Card)

Classification:

ં પ્રે

ProductCode	CFR #	Panel
DIO	21 CFR, 862.3250 Cocaine Test System	Toxicology
DJG	21 CFR, 862.3650 Opiate Test System	Toxicology

1. Predicate Devices: K052115 First Check Multi Drug Cup 12
1. Intended Use

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

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

1. Device Description
  Healgen COC One Step Cocaine Test and Healgen MOP One Step Morphine Test are immunochromatographic assays for Cocaine and Morphine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine and Morphine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: Strips, Cassettes, DipCards, or Cups. It contains a Test Device (in one of the four formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

8. Substantial Equivalence Information

A summary comparison of features of the One Step Cocaine Test and One Step Morphine Test and the predicate device is provided in Table 1 & Table 2.

Item	Device	Predicate -K052115
Indication(s)for Use	For the qualitative determination ofBenzoylecgonine in human urine.	Same
Calibrator	Benzoylecgonine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	Forover-the-counteruse.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

Table 1: Features Comparison of Healgen COC One Step Cocaine Test and the Predicate Device

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Table 2: Features Comparison of Healgen MOP One Step Morphine Test and the Predicate Device

Item	Device	Predicate - K052115
Indication(s)for Use	For the qualitative determination ofMorphine in human urine.	Same
Calibrator	Morphine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	For over-the-counteruse.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

9. Test Principle

Healgen COC One Step Cocaine Test and Healgen MOP One Step Morphine Test are rapid tests for the qualitative detection of Benzoylecgonine and Morphine in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample.

10. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled and randomized.

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For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:

	Result	-100%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
Drug	Lot:COC1111001	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:COC1111002	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:COC1111003	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-

Cocaine (COC) Strip Format

COC Cassette Format

	Result
Drug	-100%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:COC1111004	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:COC1111005	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:COC1111006	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-

COC Dip Card Format

	-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
Drug
Lot:COC1111007	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:COC1111008	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:COC1111009	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

COC CUP Format

	-75%		+50% +75% +100%}
Drug	Cut-off Cut-off Cut-off Cut-off Cut-off	Cut-off	Cut-off Cut-off Cut-off Cut-off
Lot:COC1111010 50-/0+ 50-/0+ 50-/0+ 50-/0+ 18-/32+ 50+/0- 50+/0- 50+/0-
Lot:COC1111011 50-/0+ 50-/0+ 50-/0+ 50-/0+ 18-/32+ 50+/0- 50+/0- 50+/0-
Lot:COC1111012 50-10+ 50-10+ 50-10+ 50-10+ 50+/0- 50+/0- 50+/0- 50+/0-

Morphine (MOP) Strip Format

	-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
Drug
Lot:MOP1110001	50-/0+	50-/0+	50-/0+	50-/0+	16-/34+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MOP1110002	50-/0+	50-/0+	50-/0+	50-/0+	16-/34+	50+/0-	50+/0-	50+/0-	50+/0-

රි

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Drug	Result	-100%	-75%	-50%	-25%	Cut-off	+25%	+50%	+75%	+100%
		Cut-off	Cut-off	Cut-off	Cut-off		Cut-off	Cut-off	Cut-off	Cut-off
Lot:MOP1110003		50-/0+	50-/0+	50-/0+	50-/0+	16-/34+	50+/0-	50+/0-	50+/0-	50+/0-

MOP Cassette Format

	Result	-100%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
Drug	Lot:MOP1110004	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MOP1110005	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MOP1110006	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-

MOP Dip Card Format

	-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
Drug
Lot:MOP1110007	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MOP1110008	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MOP1110009	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-

MOP CUP Format

	Result	-100%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
Drug	Lot:MOP1110010	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MOP1110011	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:MOP1110012	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

b. Linearity

Not applicable, these are visually read devices.

c. Stability

The devices are stable at 4-30°C for 24 months based on the accelerated stability study at 45°C and real time stability determination at both 4 ℃ and 30℃.

Control materials are not provided with the device. The labeling provides information on how to obtain control materials.

d. Cut-off

A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and

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The following cut-off values for the test below -25% cut-off for both Cocaine and Morphine. devices have been verified.

Test	Calibrator	Cut-off (ng/mL)
One Step Cocaine Test	Benzoylecogonine	300
One Step Morphine Test	Morphine	300

e. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.

ﺎ

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

COC
4-Acetamidophenol	Fenoprofen	Pentazocine
Acetophenetidin	Furosemide	Pentobarbital
N-Acetylprocainamide	Gentisic acid	Perphenazine
Acetylsalicylic acid	Hemoglobin	Phencyclidine
Aminopyrine	Hydralazine	Phenelzine
Amitryptyline	Hydrochlorothiazide	Phenobarbital
Amobarbital	Hydrocodone	Phentermine
Amoxicillin	Hydrocortisone	L-Phenylephrine
Ampicillin	O-Hydroxyhippuric acid	β-Phenylethlamine
Ascorbic acid	3-Hydroxytyramine	β-Phenylethylamine
D,L-Amphetamine	Ibuprofen	Phenylpropanolamine
L-Amphetamine	Imipramine	Prednisolone
Apomorphine	Iproniazid	Prednisone
Aspartame	(-) Isoproterenol	Procaine
Atropine	Isoxsuprine	Promazine
Benzilic acid	Ketamine	Promethazine
Benzoic acid	Ketoprofen	D,L-Propanolol
Benzphetamine	Labetalol	D-Propoxyphene
Bilirubin	Levorphanol	D-Pseudoephedrine
Brompheniramine	Loperamide	Quinidine
Caffeine	Maprotiline	Quinine
Chloralhydrate	Meprobamate	Ranitidine
Chloramphenicol	Methadone	Salicylic acid

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Chlordiazepoxide	Methoxyphenamine	Secobarbital
Chlorothiazide	(+)3,4-Methylenedioxyamphetamine	Serotonin(5-Hydroxytyramine)
(±) Chlorpheniramine	(+)3,4-Methylenedioxymethamphetamine	Sulfamethazine
Chlorpromazine	Methylphenidate	Sulindac
Chlorquine	Methyprylon	Temazepam
Cholesterol	Morphine-3-β-Dglucuronide	Tetracycline
Clomipramine	Nalorphine	Tetrahydrocortisone, 3 Acetate
Clonidine	Naloxone	Tetrahydrocortisone3(5-Dglucuronide)
Codeine	Nalidixic acid	Tetrahydrozoline
Cortisone	Naltrexone	Thebaine
(-) Cotinine	Naproxen	Thiamine
Creatinine	Niacinamide	Thioridazine
Deoxycorticosterone	Nifedipine	D, L-Thyroxine
Dextromethorphan	Norcodein	Tolbutamine
Diazepam	Norethindrone	Triamterene
Diclofenac	D-Norpropoxyphene	Trifluoperazine
Diflunisal	11-nor-Δ9-THC-9-COOH	Trimethoprim
Digoxin	Noscapine	Trimipramine
Diphenhydramine	D,L-Octopamine	Tryptamine
Doxylamine	Oxalic acid	D, L-Tryptophan
Ecgonine hydrochloride	Oxazepam	Tyramine
Ecgonine methylester	Oxolinic acid	D, L-Tyrosine
(-) Y Ephedrine	Oxycodone	Uric acid
Erythromycin	Oxymetazoline	Verapamil
β-Estradiol	p-Hydroxymethamphetamine	Zomepirac
Estrone-3-sulfate	Papaverine
Ethyl-p-aminobenzoate	Penicillin-G

MOP

Acebutolol	(-) Y Ephedrine	p-Hydroxymethamphetamine
Acetopromazine - d6	Erythromycin	Papaverine
4-Acetamidophenol	β-Estradiol	Penicillin-G
Acetophenetidin	Estrone-3-sulfate	Pentazocaine
N-Acetylprocainamide	Ethyl-p-aminobenzoate	Pentobarbital
Acetylsalicylic acid	Fenoprofen	Perphenazine
D,L-Amphetamine	Furosemide	Phencyclidine
L-Amphetamine	Gentisic acid	Phenelzine
Aminopyrine	Hemoglobin	Phenobarbital
Amitryptyline	Hydralazine	Phentermine
Amobarbital	Hydrochlorothiazide	β-Phenylethylamine
Amoxicillin	Hydrocortisone	L-Phenylephrine
Ampicillin	O-Hydroxyhippuric acid	β-Phenylethlamine
Ascorbic acid	3-Hydroxytyramine	Phenylpropanolamine
Apomorphine	Ibuprofen	Prednisolone
Aspartame	Imipramine	Prednisone
Atropine	Iproniazid	Promazine
Benzilic acid	(-) Isoproterenol	Promethazine
Benzoic acid	Isoxsuprine	D,L-Propanolol
Benzoylecgonine	Ketamine	D-Propoxyphene
Benzphetamine	Ketoprofen	D-Pseudoephedrine
Bilirubin	Labetalol	Quinidine
Brompheniramine	Loperamide	Quinine
Caffeine	Maprotiline	Salicylic acid
Chloramphenicol	Meprobamate	Secobarbital
Chlordiazepoxide	Methoxyphenamine	Serotonin
Chlorothiazide	(+) 3,4-Methylenedioxyamphetamine	Sulfamethazine
(±) Chlorpheniramine	(+)3,4-Methylenedioxymethamphetamine	Sulindac
Chlorpromazine	Methadone	Temazepam
Chlorquine	Methylphenidate	Tetracycline
Cholesterol	Methyprylon	Tetrahydrozoline
Clomipramine	Nalorphine	Tetrahydrocortisone,3 Acetate
Clonidine	Nalidixic acid	Tetrahydrocortisone3(5-Dglucuronide)
Cocaine hydrochloride	Naloxone	Thiamine
Cortisone	Naltrexone	Thioridazine
(-) Cotinine	Naproxen	D,L-Thyroxine
Creatinine	Niacinamide	Tolbutamine
Deoxycorticosterone	Nifedipine	Triamterene
Dextromethorphan	Norcodein	Trifluoperazine
Diazepam	Norethindrone	Trimethoprim
Diclofenac	D-Norpropoxyphene	Trimipramine
Digoxin	D,L-Octopamine	D, L-Tyrosine
Diphenhydramine	Oxalic acid	Uric acid
Doxylamine	Oxazepam	Verapamil
Ecgonine hydrochloride	Oxolinic acid	Zomepirac
Ecgonine methylester	Oxymetazoline

{7}------------------------------------------------

{8}------------------------------------------------

f. Specificity

To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.

COC(Benzoylecogonine,Cut-off=300 ng/mL)	Result	%Cross-Reactivity
Cocaethylene	Positive at 300 ng/mL	100%
Cocaine HCl	Positive at 300 ng/mL	100%

MOP(Morphine, Cut-off=300 ng/mL)	Result	%Cross-Reactivity
6-Acetylmorphine	Positive at 400 ng/mL	75%
Codeine	Positive at 300 ng/mL	100%
EthylMorphine	Positive at 6240 ng/mL	5%
Heroin	Positive at 600 ng/mL	50%
Hydromorphone	Positive at 3120 ng/mL	10%
Hydrocodone	Positive at 50000 ng/mL	0.6%
Levorphanol	Positive at 1500 ng/mL	20%
Oxycodone	Positive at 30,000 ng/mL	1%
Procaine	Positive at 15,000 ng/mL	2%
Thebaine	Positive at 6240 ng/mL	5%

g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples with of 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three batches of each device for all formats. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different formats.
1. Comparison Studies

{9}------------------------------------------------

The method comparison studies for the One Step Cocaine Test, and the One Step Morphine Test were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

COC
Stripformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	0	15	24
	Negative	10	17	13	1	0
Viewer B	Positive	0	0	0	14	24
	Negative	10	17	13	2	0
Viewer C	Positive	0	0	0	15	24
	Negative	10	17	13	1	0

Discordant Results of COC Strip

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	370	303	Negative
Viewer B	370	303	Negative
Viewer B	302	305	Negative
Viewer C	302	305	Negative

Cassetteformat		Negative	Low Negativeby GC/MS(less than-50%)	Near CutoffNegativeby GC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
Viewer A	Positive	0	0	0	15	24
	Negative	10	17	13	1	0
Viewer B	Positive	0	0	0	16	24
	Negative	10	17	13	0	0
Viewer C	Positive	0	0	0	14	24
	Negative	10	17	13	2	0

Discordant Results of COC Cassette

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

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	370	303	Negative
Viewer C	370	303	Negative
Viewer C	302	305	Negative

Cup			Low	Near Cutoff	Near Cutoff	High
format		Negative	Negative	Negative by	Positive by	Positive by
			by GC/MS	GC/MS	GC/MS	GC/MS
			(less than	(Between	(Between	(greater
			-50%)	-50% and	the cut-off	than
				cut-off)	and +50%)	+50%)
Viewer A	Positive	0	0	0	ાં ર	24
	Negative	1 0	17	। ਤੇ	1	0
Viewer B	Positive	0	0	0	। ୧	24
	Negative	1 0	17	। 3	0	0
Viewer C	Positive	0	0	0	14	24
	Negative	1 0	17	13	2	0

Discordant Results of COC Cup

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	370	303	Negative
Viewer C	370	303	Negative
Viewer C	302	305	Negative

Dip Card format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cut-off)	Near Cutoff Positive by GC/MS (Between the cut-off and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	0	15	24
	Negative	10	17	13	1	0
Viewer B	Positive	0	0	0	15	24
	Negative	10	17	13	1	0
Viewer C	Positive	0	0	0	14	24
	Negative	10	17	13	2	0

Discordant Results of COC Dip Card

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

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	370	303	Negative
Viewer B	370	303	Negative
Viewer C	370	303	Negative
Viewer C	302	305	Negative

•
---

Strip format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cut-off)	Near Cutoff Positive by GC/MS (Between the cut-off and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	0	14	25
	Negative	10	15	15	1	0
Viewer B	Positive	0	0	1	14	25
	Negative	10	15	14	1	0
Viewer C	Positive	0	0	0	15	25
	Negative	10	15	15	0	0

Discordant Results of MOP Strip

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	36	307	Negative
Viewer B	60	298	Positive
Viewer B	38	328	Negative

Cassette format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cut-off)	Near Cutoff Positive by GC/MS (Between the cut-off and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	0	13	25
	Negative	10	15	15	2	0
Viewer B	Positive	0	0	0	14	25
	Negative	10	15	15	1	0
Viewer C	Positive	0	0	0	14	25

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

Negative	10	15	15
Discordant Results of MOP Cassette
Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	36	307	Negative
Viewer A	12	310	Negative
Viewer B	36	307	Negative
Viewer C	36	307	Negative

Dip Card format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cut-off)	Near Cutoff Positive by GC/MS (Between the cut-off and +50%)	High Positive by GC/MS (greater than +50%)
	Viewer A	Positive	0	0	0	13
Negative		10	15	15	2	0
Viewer B	Positive	0	0	0	14	25
	Negative	10	15	15	1	0
Viewer C	Positive	0	0	0	13	25
	Negative	10	15	15	2	0

Discordant Results of MOP Dip Card

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	36	307	Negative
Viewer A	12	310	Negative
Viewer B	36	307	Negative
Viewer C	36	307	Negative
Viewer C	12	310	Negative

Cupformat	Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
Viewer A	Positive	0	0	0	14	25

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

	Negative
Viewer B	Positive	0	0	0	15	25
	Negative	10	15	15	1	0
Viewer C	Positive	0	0	0	15	25
	Negative	10	15	15	0	0

Discordant Results of MOP Cup

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	36	307	Negative

Lay-user study

A lay user study was performed at three intended user sites with 140 lay persons testing the cocaine devices and another set of 140 persons testing the morphine devices. A total of 56 females and 84 males tested the Cocaine samples, and 53 females and 87 males tested the Morphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

% of Cutoff	Number of samples	COC Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100%Cutoff	20	0	No. of Positive	No. of Negative	100%
-75%Cutoff	20	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	2	18	90%
+25% Cutoff	20	375	19	1	95%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

Comparison between GC/MS and Lay Person Results (COC Strin)

Comparison between GC/MS and Lay Person Results (COC Cassette)

% of Cutoff	Number of samples	COC Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	75	0	20	100%

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

-50% Cutoff	20	। ૨૦	0	20	100%
-25% Cutoff	20	225	l	19	તે તે જેની જેવી જેવી સવલતો પ્રાપ્
+25% Cutoff	20	375	।	-	તે જેટી જેવી જેવી સાચાર તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્
450% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%
Comparison between GC/MS and Lay Person Results (COC DipCard)
	Number	COC Concentration byGC/MS(ng/mL)	Lay person results		The

% of Cutoff	ofsamples		No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	75	0	20	100%
-50% Cutoff	20	। ২০	0	20	100%
-25% Cutoff	20	225	1	19	તે જેવી જેવી સવલતો પ્રતિષ્ઠા તેમ જ દૂધની ડેરી જેવી સવલતો પ્રતિષ્ઠા તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની ખેતી કરવામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની તેમ

+50% Cutoff

+75% Cutoff

Comparison between GC/MS and Lay Person Results (COC Cup)

100%

% of Cutoff	Numberofsamples	COC Concentration byGC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	1	19	95%
+25% Cutoff	20	375	20	0	100%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

Comparison between GC/MS and Lay Person Results (MOP Strip)

% of Cutoff	Number of samples	MOP Concentration by GC/MS (ng/mL)	Lay person results No. of Positive	Lay person results No. of Negative	The percentage of correct results (%)
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	75	0	20	100%

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

-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	2	18	90%
+25% Cutoff	20	375	19	1	95%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

Comparison between GC/MS and Lay Person Results (MOP Cassette)

% of Cutoff	Number of samples	MOP Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	1	19	95%
+25% Cutoff	20	375	19	1	95%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

Comparison between GC/MS and Lay Person Results (MOP DipCard)

% of Cutoff	Numberofsamples	MOP Concentration byGC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
-100%Cutoff	20	0	No. ofPositive	No. ofNegative
-75%Cutoff	20	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	0	20	100%
+25% Cutoff	20	375	1	19	95%
+50% Cutoff	20	450	17	3	85%
+75% Cutoff	20	525	20	0	100%
			20	0	100%

Comparison between GC/MS and Lay Person Results (MOP Cup)

% of Cutoff	Number of samples	MOP Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	1	19	95%

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

-75%2uton	195	A M F)	.CSeal V		.100%
+50% C00"Itor-			AC1	A concession and the charges and a	100%------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
、アニックCutoff		- AND AND LA - A CARD - A CARD - CALL CREAN - A CLAIMER - A CLAIMER - A CLAIMER - CALL - CLAIMER - CLAIM - CALL - CLAIMER - CLAIM - CALL - CLAIMER - CALL - CLAIM - CALL - CLAcarand land with	t1		100%

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

1. Clinical Studies
  Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the Healgen COC One Step Cocaine Test, and Healgen MOP One Step Morphine Test are substantially equivalent to the predicate.

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines extending from its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

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

July 17, 2014

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

Re: K141647

Trade/Device Name: Healgen COC One Step Cocaine Test (Strip, Cassette, Dip Card, Cup) Healgen MOP One Step Morphine Test (Strip. Cassette, Dip Card, Cup) Regulation Number: 21 CFR 862.3250

Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO, DJG Dated: June 16, 2014 Received: June 19, 2014

Dear Mr. Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable. the

{18}------------------------------------------------

Page 2-Mr. Shia

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Katherine Serrano -S

For : Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{19}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K141647

Device Name

Healgen MOP One Step Morphine Test (Strip, Cassette, Dip Card, Cup) Healgen COC One Step Cocaine Test (Strip, Cassette, Dip Card, Cup)

Indications for Use (Describe)

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCMS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive, For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional iudement should be exercised with any drug of abuse test result particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Denise Johnson-lyles -S

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).