InstaStrip Fentanyl Rapid Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL. The test is intended for over-the-counter (OTC) use. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The InstaStrip Fentanyl Dipstick Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Device Description

InstaStrip Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each InstaStrip Fentanyl Test device consists of a Test Strip, a Test Tube, a Dropper and a package insert. Each Test Strip is sealed with sachets of desiccant in an aluminum pouch.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the InstaStrip Fentanyl Rapid Test (Urine) / InstaStrip Fentanyl Dipstick Test (Urine):

1. Acceptance Criteria and Reported Device Performance:

The document indicates a cutoff value of 1.0 ng/mL for fentanyl detection. The performance data is primarily presented through precision studies and a lay-user study, focusing on the device's ability to correctly identify positive and negative samples around this cutoff. While explicit acceptance criteria (e.g., minimum sensitivity/specificity percentages) are not explicitly stated as "acceptance criteria," the reported performance demonstrates the device's accuracy in these studies.

Metric (Implicit Acceptance Criteria)	Reported Device Performance
Precision (True Negatives) (No positive results for concentrations at or below -50% cutoff)	-100% cutoff (0 ng/mL): 60-/0+ across 3 lots -75% cutoff (0.19 ng/mL): 60-/0+ across 3 lots -50% cutoff (0.50 ng/mL): 60-/0+ across 3 lots
Precision (Near Cutoff Negatives) (Majority negative results for concentrations between -50% and -25% cutoff, with some tolerance for false positives due to inherent variability near cutoff)	-25% cutoff (0.69 ng/mL): Lot 1: 54-/6+ Lot 2: 55-/5+ Lot 3: 55-/5+
Precision (Near Cutoff Positives) (Majority positive results for concentrations between +25% and +50% cutoff, with some tolerance for false negatives)	+25% cutoff (1.15 ng/mL): Lot 1: 60+/0- Lot 2: 60+/0- Lot 3: 60+/0-
Precision (True Positives) (All positive results for concentrations at or above +50% cutoff)	+50% cutoff (1.44 ng/mL): 60+/0- across 3 lots +75% cutoff (1.69 ng/mL): 60+/0- across 3 lots +100% cutoff (2.0 ng/mL): 60+/0- across 3 lots
Lay-user Accuracy (True Negatives) (100% correct negative identification)	-100% Cutoff (0 ng/mL): 100% correct (0 positive, 20 negative) -75% Cutoff (0.19 ng/mL): 100% correct (0 positive, 20 negative) -50% Cutoff (0.50 ng/mL): 100% correct (0 positive, 20 negative)
Lay-user Accuracy (Near Cutoff Negative) (High percentage of correct negative identification allowed for some false positives)	-25% Cutoff (0.69 ng/mL): 95% correct (1 positive, 19 negative)
Lay-user Accuracy (True Positives) (100% correct positive identification)	+25% Cutoff (1.15 ng/mL): 100% correct (20 positive, 0 negative) +50% Cutoff (1.44 ng/mL): 100% correct (20 positive, 0 negative) +75% Cutoff (1.69 ng/mL): 100% correct (20 positive, 0 negative)
Specificity (Non-interfering substances)	No interference observed for a wide range of common substances at specified concentrations (summarized in tables).
Specificity (Cross-reactivity)	Detailed cross-reactivity with various fentanyl analogs and other opioids provided, indicating varying levels of cross-reactivity or no cross-reactivity.
Stability	Stable at room temperature for 24 months (based on accelerated stability study).
Effect of Urine Specific Gravity and pH	All samples at or above +50% Cut-Off were positive; all samples at or below -50% Cut-Off were negative across tested pH (4-9) and specific gravity (1.000-1.035) ranges.

2. Sample Size and Data Provenance (Test Set):

Precision Studies:
- Sample Size: 60 tests per lot for each of 9 concentration levels (6 tests/day for 10 days per lot). Total: 9 concentrations * 60 tests/lot * 3 lots = 1620 tests.
- Data Provenance: Samples were prepared by spiking fentanyl into negative samples. The origin of the initial negative samples is not specified (e.g., country of origin). The study design implies a laboratory-controlled setting, likely retrospective preparation of spiked samples.
Comparison Studies (Method Comparison):
- Sample Size: 85 unaltered clinical samples (42 negative and 43 positive).
- Data Provenance: "clinical samples." The specific country of origin, whether retrospective or prospective, is not mentioned.
Lay-user Study:
- Sample Size: 140 lay persons and 140 individual test samples.
- Data Provenance: Urine samples were prepared by spiking fentanyl into drug-free pooled urine specimens. This indicates a laboratory-controlled, simulated-use setting rather than direct patient samples.

3. Number of Experts and Qualifications (Ground Truth for Test Set):

Precision, Comparison, and Lay-user Studies: The ground truth for fentanyl concentrations in all test samples (spiked or clinical) was established using LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and widely accepted analytical method for drug confirmation.
- Number of Experts: Not specified. LC/MS analysis is typically performed by trained laboratory technicians or chemists, not clinical "experts" like radiologists. Their "qualification" is their expertise in performing and interpreting LC/MS results.
- Qualifications: Expertise in LC/MS analysis.

4. Adjudication Method (Test Set):

The document implies that for the precision, comparison, and lay-user studies, the LC/MS results served as the definitive ground truth reference standard against which the device's qualitative results (positive/negative) were compared. There is no mention of a human expert adjudication process (e.g., 2+1, 3+1) for the actual test results from the device itself.

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

No, a MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images or complex diagnostic data with and without AI assistance to measure the effect size of AI. The InstaStrip Fentanyl Test is a rapid, qualitative immunoassay where the interpretation is typically straightforward (presence/absence of a line) and not subject to the same kind of reader variability or AI assistance as image interpretation.

6. Standalone Performance (Algorithm Only):

Yes, standalone performance was evaluated. The device itself (the immunoassay strip) performs the detection without active human-in-the-loop decision-making beyond visual interpretation of the result. The precision studies and comparison studies directly assess this standalone performance against the LC/MS ground truth. The lay-user study then evaluates the standalone performance combined with user interpretation.

7. Type of Ground Truth Used:

The primary ground truth used throughout the studies (precision, comparison, specificity, cross-reactivity, lay-user) was LC/MS (Liquid Chromatography-Mass Spectrometry), a gold standard analytical method for confirming drug concentrations.

8. Sample Size for the Training Set:

Not applicable / Not specified. This device is a rapid immunoassay, not a machine learning or AI-based device that typically requires a large "training set" in the same way. The performance characteristics are based on the biochemical reactions and design of the test strip, which are validated through the described analytical and clinical performance studies, not by training a computational model.

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

Not applicable. As stated above, there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the development and validation of the immunoassay itself would be based on established analytical chemistry principles and controlled spiking experiments to ensure the antibodies and reagents react appropriately at the desired cutoff.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Instanosis Inc % Joe Shia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K240295

Trade/Device Name: InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL Dated: January 24, 2024 Received: February 1, 2024

Dear 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

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product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2024.03.2 Date: 2024.03.28

Joseph Kotarek Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240295

Device Name InstaStrip Fentanyl Rapid Test (Urine)

InstaStrip Fentanyl Dipstick Test (Urine)

Indications for Use (Describe)

InstaStrip Fentanyl Rapid Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL. The test is intended for over-the-counter (OTC) use.

The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The InstaStrip Fentanyl Dipstick Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL.

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)

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510(k) SUMMARY K240295

March 25, 2024 1. Date: 2. Submitter: Instanosis Inc. 1004 w 9th Avenue, Suite 10 King of Prussia, PA 19406 3. Contact person: Joe Shia LSI International Inc. 504E Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com
1. Device Names: InstaStrip Fentany1 Rapid Test (Urine) InstaStrip Fentanyl Dipstick Test (Urine)

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
NGL	II	21 CFR § 862.3650Opiate Test System	Toxicology (91)

1. Predicate Devices:
  AllTest Fentanyl Urine Test Cassette (K233417)
1. Indications for Use
  InstaStrip Fentanyl Rapid Test (Urine) is intended for the qualitative detection of fentany] in human urine at the cutoff value of 1.0 ng/mL. The test is intended for over-the-counter (OTC) use. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The InstaStrip Fentanyl Dipstick Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL.

1. Device Description
  InstaStrip Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each InstaStrip Fentanyl Test device consists of a Test Strip, a Test Tube, a Dropper and a package insert. Each Test Strip is sealed with sachets of desiccant in an aluminum pouch.
1. Substantial Equivalence Information
  A summary comparison of features of the InstaStrip Fentany] Test and the predicate devices is provided in following table.

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Item	Device	Predicate – K233417
Indication(s)for Use	For the qualitative determination offentanyl in human urine.	Same
Calibrator and Cut-OffValues	Fentanyl (FTY)1 ng/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For OTC use	Same
Configurations	Strip	Cassette
Storage	15-30°C	4-30°C

Table 1: Features Comparison of InstaStrip Fentanyl Test and the Predicate Device

1. Test Principle
  The InstaStrip-Fentanyl Rapid Test is an immunoassay technique that is based on competitive lateral flow immunoassay to detect the presence of fentanyl in human urine samples. The urine sample is added to a provided test tube containing dried rabbit monoclonal antibody-gold nanoparticle (Ab-AuNP) conjugates. This mixture is applied to the InstaStrip-Fentanyl test strip. The pre-immobilized fentanyl-BSA on the test line competes with fentanyl in the urine sample for binding to the Ab-AuNPs. The device is designed so that when the fentanyl concentration in the urine sample exceeds 1 ng/mL, the test line is no longer visible. The test line will be visible and the result is negative when the fentanyl concentration in the urine sample is less than 1 ng/mL. No matter whether the sample contains the corresponding analyte or not, the quality control area (C) will develop a colored line, which is the criteria for judging whether the chromatography process is normal or not.
1. 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, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking fentanyl in negative samples. Each fentanyl concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed six tests per day for 10 days per device lot in a randomized order.

Lot Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	cut off	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	60-/0+	60-/0+	60-/0+	54-/6+	32+/28-	60+/0-	60+/0-	60+/0-	60+/0-

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Lot 2	60-/0+	60-/0+	60-/0+	55-/5+	30+/30-	60+/0-	60+/0-	60+/0-
Lot 3	60-/0+	60-/0+	60-/0+	55-/5+	34+/26-	60+/0-	60+/0-	60+/0-

c. Stability

The devices are stable at room temperature for 24 months based on the accelerated stability study.

d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drug fentanyl urine with concentrations at 50% below and 50% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL or specified concentrations are summarized in the following tables.

Acetaminophen (500 µg/mL)	Doxepin	Nortriptyline
Acetone (1000 mg/dL)	Ecgonine methyl ester	Noscapine
Acetophenetidin	Ephedrine	O-Hydroxyhippuric acid
Acetylsalicylic acid	Erythromycin	Octopamine
Albumin (500 mg/dL)	Ethanol (1%)	Oxalic acid (100 mg/dL)
Albuterol	Fenoprofen	Oxazepam
Aminopyrine	Fluphenazine	Oxolinic acid
Amitriptyline	Furosemide	Oxymetazoline
Amobarbital	Galactose (10 mg/dL)	Papaverine
Amoxicillin	Gamma globulin (500 mg/dL)	Penicillin G
Ampicillin	Gentisic acid	Perphenazine
Apomorphine	Glucose (3000 mg/dL)	Phencyclidine
Ascorbic Acid (560 mg/dL)	Hemoglobin (500 mg/dL)	Phenelzine
Aspartame	Hydralazine	Phenobarbital
Atropine	Hydrochlorothiazide	Prednisone
Benzilic acid	Hydrocortisone	Propoxyphene
Benzoic acid	Hydroxytyramine	Propranolol
Benzoylecgonine	Ibuprofen (500 µg/mL)	Pseudoephedrine
Bilirubin	Imipramine	Quinine (15 µg/mL)
Boric acid (1% w/v)	Isoproterenol	Ranitidine
Bupropion	Isoxsuprine (20 µg/mL)	Riboflavin (10 mg/dL)
Caffeine	Ketamine	Salicylic acid
Carbamazepine	Ketoprofen	Secobarbital
Chloral hydrate	Labetalol (15 µg/mL)	Serotonin (5-hydroxytyramine)
Chloramphenicol	Lidocaine	Sulfamethazine
Chlorothiazide	Loperamide	Sulindac
Chlorpromazine	Maprotiline	Tetrahydrocortisone 3-(β-D-glucuronide)
Cholesterol	Meperidine	Tetrahydrocortisone 3-acetate
Clomipramine	Meprobamate	Tetrahydrozoline
Clonidine	Methapyrilene	Thiamine
Cortisone	Methaqualone	Thioridazine
Cotinine	Methoxyphenamine	Triamterene
Creatinine (500 mg/dL)	Metronidazole (300 µg/mL)	Trifluoperazine
Cyclobenzaprine	N-Acetylprocainamide	Trimethoprim
Deoxycorticosterone	NaCl (4000 mg/dL)	Tyramine

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Desipramine	Nalidixic acid	Urea (2000 mg/dL)
Dextromethorphan	Naloxone	Uric acid
Diclofenac	Naltrexone	Valproic acid (250 $\mu$ g/mL)
Diflunisal	Naproxen	Venlafaxine
Digoxin	Niacinamide	Verapamil (20 $\mu$ g/mL)
Diphenhydramine	Nicotine	Zomepirac
DL-Tryptophan	Nifedipine	$\beta$ -Estradiol
DL-Tyrosine	Norethindrone

e.Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of device. The lowest concentration that caused a positive result for each compound are listed below.

Fentanyl (Cutoff=1ng/mL)	Minimumconcentration requiredto obtain a positiveresult (ng/mL)	% Cross-Reactivity
Acetyl fentanyl	1	100
Acetyl norfentanyl	>10000	<0.01
Acrylfentanyl	1.8	56
Alfentanil	>10000	<0.01
Benzodioxole fentanyl	4.8	21
Butyryl fentanyl	1	100
Carfentanil	>10000	<0.01
Crotonyl fentanyl	1	100
Despopionyl 2' fluoro-ortho-	>10000	<0.01
Despropionyl fentanyl (4-ANPP)	10000	0.01
Furanyl fentanyl	1.9	53
(±) β-hydroxythiofentanyl	7.5	13
Isobutyryl fentanyl	1.7	59
N-benzyl furanyl norfentanyl	>10000	<0.01
N-benzyl parafluoro cyclopropyl	>10000	<0.01
(±)-3-cis-methyl fentanyl	9.2	11
Norcarfentanil	>10000	<0.01
Norfentanyl	>10000	<0.01
o-Fluorofentanyl	1	100
4-Fluoro-isobutyryl fentanyl	1	100
Ocfentanil	2.2	45
Para-chloroisobutyrul fentanyl	1.8	56
Para-fluoro fentanyl	2.8	36
Para-fluorobutyryl fentanyl (p-FBF)	2.5	40
Remifentanil	>10000	<0.01
Sufentanil	>10000	<0.01
Tetrahydrofyranyl fentanyl	2.3	43
Valeryl fentanyl	2.9	34
β-hydroxyfentanyl	7.5	13

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ω-1-Hydroxyfentanyl	7.5	13
---------------------	-----	----

compounds using the InstaStrip Fentanyl Test.
6-Acetyl morphine	Morphine
Amphetamine	Morphine-3-glucuronide
Buprenorphine	Naloxone
Buprenorphine glucuronide	Naltrexone
Ceftriaxone	Norbuprenorphine
M-Chlorophenylpiperazine	Norcodeine
Ciprofloxacin	Norketamine
Cocaine	Normeperidine
Codeine	Normorphine
Dextromethorphan	Noroxycodone
Dihydrocodeine	Ofloxacin
Diphehydramine	Oxycodone
Duloxetine	Oxymorphone
EDDP	Pentazocine (Talwin)
EMDP	Pipamperone
Fluoxetine	1-(3-chlorophenyl)Piperazine (hydrochloride)
Haloperidol	Quinidine
Heroin	Risperidone
Hydrocodone	Tapentadol
Hydromorphone	Thioridazine
Ketamine	Tilidine
Levorphanol	Tramadol
MDMA	Tramadol-O- Desmethyl
Meperidine	Tramadol-N- Desmethyl
Methadone	Trazodone
Methamphetamine

The following opioids compounds were tested at a concentration of 100ug/mL. Negative results were obtained for all these compounds. There is no cross-reactivity for these compounds using the InstaStrip Fentany] Test

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target fentanyl at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of device. Results were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off.

2. Comparison Studies

Method comparison studies for the InstaStrip Fentanyl Test were performed using three different lots of the device. Operators ran 85 (42 negative and 43 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below.

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		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Lot	Positive	0	0	1	7	36
1	Negative	11	21	9	0	0
Lot	Positive	0	0	0	7	36
2	Negative	11	21	10	0	0
Lot	Positive	0	0	0	6	36
3	Negative	11	21	10	1	0

Discordant Results

Lot	Sample Number	LC-MS/MS Result	InstaStrip Result
Lot 1	310-13724	0.9	Positive
Lot 3	280-06705	1.0	Negative

3. Lay-user study

A lay user study was performed at three intended user sites with 140 lay persons. They had diverse educational and professional backgrounds and ranged in age from 18 to >50 years. Urine samples were prepared at the following concentrations: - 100%, +/- 75%, +/- 25% of the cut-off by spiking fentanyl into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below:

% of Cutoff	Numberofsamples	Fentanyl Concentrationby LC/MS(ng/mL)	Lay person results		Thepercentage of
			No. ofPositive	No. ofNegative	correct results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	0.19	0	20	100
-50% Cutoff	20	0.50	0	20	100
-25% Cutoff	20	0.69	1	19	95
+25% Cutoff	20	1.15	20	0	100
+50% Cutoff	20	1.44	20	0	100
+75% Cutoff	20	1.69	20	0	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 the package insert and the score revealed a reading grade level of less than 7.

1. Clinical Studies
  Not applicable.
1. Conclusion
  Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison and Lay-user studies of the devices, it's concluded a substantial equivalence decision.

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).