AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL.

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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

The AllSource Drug Detector Fentanyl Test is a rapid, one-step immunoassay for the qualitative detection of fentary] in human urine at the cutoff concentrations of 1 ng/mL.

This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GCMS is the preferred confirmatory method. Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated. It is for in vitro diagnostic use only.

Device Description

AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllSource Drug Detector Fentanyl Test device consists of a Test Dip Card and a package insert. Each Test Dip Card is sealed with sachets of desiccant in an aluminum pouch.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the AllSource Drug Detector Fentanyl Test:

Device: AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
Indications for Use: Qualitative detection of Fentanyl in human urine at the cutoff concentration of 1 ng/mL. Provides preliminary test results, requiring further confirmatory methods (GC/MS or LC/MS). For in vitro diagnostic use only. For Over-The-Counter Use.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined table with numerical targets for each performance characteristic. Instead, device performance is presented and implicitly deemed acceptable by the FDA for substantial equivalence. The following table synthesizes the performance characteristics presented in the document:

Performance Characteristic	Acceptance Criteria (Implicit from FDA Clearing)	Reported Device Performance
Precision	Consistent results around cutoff.	For each of 3 lots: -100% to -50% cut off: 60-/0+ (100% negative) +25% to +100% cut off: 60+/0- (100% positive) -25% cut off: 44-46 negative, 14-16 positive Cut off: 28-30 positive, 30-32 negative
Stability	Demonstrated stability over time.	Stable at 2-30 °C for 24 months (based on accelerated stability study).
Interference	No significant interference from common substances at specified concentrations.	Many compounds showed no interference at 100µg/mL or specified concentrations (e.g., Acetone, Ethanol, Albumin, Glucose, etc.). See source for extensive list.
Specificity (Cross-Reactivity)	Limited cross-reactivity with structurally similar compounds, and no cross-reactivity with unrelated opioids/drugs below specified concentrations.	Fentanyl (Cutoff=1ng/mL): - Acetyl fentanyl: 1 ng/mL (100% cross-reactivity) - Isobutyryl fentanyl, Butyryl fentanyl: 2.5 ng/mL (40% cross-reactivity) - Norfentanyl, 4-Fluoro-isobutyrylfentanyl: 50 ng/mL (2% cross-reactivity) - Acrylfentanyl, Ocfentanil, Valeryl fentanyl, Para-fluorobutyrylfentanyl (p-FBF), (±)-3-cis-methylfentanyl, Acetyl norfentanyl: 10 ng/mL (10% cross-reactivity) - Furanyl fentanyl: 7.5 ng/mL (13.3% cross-reactivity) - (±) β-hydroxythiofentanyl: 5 ng/mL (20% cross-reactivity) - Despropionyl fentanyl (4-ANPP): 2500 ng/mL (0.04% cross-reactivity) - Carfentanil, Sufentanil, Remifentanil, Alfentanil: 10000 ng/mL (0.01% cross-reactivity) - ω-1-Hydroxyfentanyl: 20000 ng/mL (0.005% cross-reactivity) - Norcarfentanil: 100000 ng/mL (<0.001% cross-reactivity) No cross-reactivity (negative results) at 100 µg/mL for: 6-Acetyl morphine, Amphetamine, Buprenorphine, Codeine, Dextromethorphan, Hydrocodone, Morphine, Naloxone, Oxymorphone, Tramadol, etc. (see source for extensive list).
Effect of Urine Specific Gravity & pH	Consistent results across a physiological range for urine specific gravity and pH.	All positive samples at/above +50% Cut-Off were positive; all negative samples at/below -50% Cut-Off were negative for urine specific gravity (1.000 to 1.035) and pH (4 to 9).
Method Comparison (Clinical Samples)	High concordance with confirmatory method (LC/MS).	Site 1: 40 positive (22 Near Cutoff Pos, 17 High Pos, 1 Near Cutoff Neg), 39 negative (10 Low Neg, 9 Near Cutoff Neg, 20-1-1 = 18 total neg. from row) Site 2: 44 positive (21 Near Cutoff Pos, 17 High Pos, 6 Near Cutoff Neg, 0 Low Neg), 36 negative (10 Low Neg, 7 Near Cutoff Neg, 2 Near Cutoff Pos, 0 High Pos) Site 3: 44 positive (21 Near Cutoff Pos, 17 High Pos, 6 Near Cutoff Neg, 0 Low Neg), 36 negative (10 Low Neg, 7 Near Cutoff Neg, 2 Near Cutoff Pos, 0 High Pos) Combined (Approx. from table): High percentage of agreement with LC/MS across low negative, near cutoff, and high positive samples. (e.g., 60 Low Negative samples were 100% negative by device; 51 High Positive samples were 100% positive by device).
Lay-User Study	High percentage of correct results by untrained users; clear and understandable instructions.	100% correct results for -100%, -75%, -50% Cutoff, +25%, +50%, +75% Cutoff samples. 75% correct for -25% Cutoff. All lay users found instructions easy to follow. Flesch-Kincaid score < 7th-grade level.

2. Sample Sizes and Data Provenance

Test Set (Clinical Samples for Method Comparison):
- Sample Size: 80 "unaltered clinical samples" per site, tested at three different testing sites. This implies a total of 240 samples (80 samples * 3 sites). Each set of 80 consisted of 40 negative and 40 positive samples.
- Data Provenance: The document does not explicitly state the country of origin. It indicates they were "unaltered clinical samples," suggesting they were collected from human subjects. It does not specify whether they were retrospective or prospective, but the term "unaltered clinical samples" often implies retrospectively collected samples that were then blinded for the study.
Test Set (Lay-User Study):
- Sample Size: 140 "lay persons" tested with aliquoted and blinded samples. The table shows 20 samples per concentration level, for a total of 7 concentration levels ( -100%, -75%, -50%, -25%, +25%, +50%, +75% Cutoff). It's somewhat ambiguous if each of the 140 lay persons tested 1 sample, or if the sample count of 20 per concentration implies 20 unique samples tested across the 140 participants. Given "Each participant was provided with ... 1 blind labeled sample," it suggests 140 samples were tested in total across the lay users, with 20 samples falling into each defined concentration range.
- Data Provenance: Not explicitly stated, but implies U.S. participants, likely prospective collection for the study.
Test Set (Precision Study):
- Sample Size: 9 concentration levels, tested 2 tests per day for 10 days per device lot, across 3 device lots. This equals 9 concentrations * 2 tests/day * 10 days * 3 lots = 540 individual tests.
- Data Provenance: Samples were "prepared by spiking fentanyl in negative samples," meaning they were artificially created samples.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

For the Method Comparison Study and Lay-User Study, the ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an objective, gold-standard analytical chemistry method, not reliant on expert human interpretation. For the Precision Study, the samples were "prepared by spiking fentanyl in negative samples" and "confirmed by LC/MS," meaning the ground truth for concentration was analytically derived.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

For all performance studies detailed (Method Comparison, Precision, Lay-User), the "results" of the device were compared against an objective analytical ground truth (LC/MS confirmation of spiked or real sample concentrations), rather than human interpretation. Therefore, no multi-reader adjudication method was necessary or performed.

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

Was an MRMC study done? No.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device is a qualitative chemical immunoassay, not an AI-based diagnostic image or data interpretation system. It does not involve human readers interpreting complex medical data with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Was a standalone study done? Yes, in essence. The studies conducted (Precision, Interference, Specificity, Effect of Urine Specific Gravity & pH, Method Comparison, Lay-User Study) all assessed the performance of the device itself (the "algorithm" in the context of an immunoassay) against established ground truth or reference standards. While "algorithm" might typically refer to software, here it refers to the intrinsic analytical process of the immunoassay device. The results are reported as the device's accuracy in detecting fentanyl.

7. Type of Ground Truth Used

Clinical Samples (Method Comparison): LC/MS results. This is an analytical gold-standard method for precise quantification of substances in a sample.
Spiked Samples (Precision, Interference, Specificity, Effect of Urine Specific Gravity & pH): Prepared concentrations confirmed by LC/MS. This is a highly controlled, analytically derived ground truth.
Lay-User Study: LC/MS results of the prepared and blinded samples.

8. Sample Size for the Training Set

Sample Size: Not applicable.

This device is a lateral flow immunoassay. It is not an AI/machine learning device that requires a "training set" in the conventional sense of computational models learning from data. Its performance is based on the inherent chemical and immunological properties built into the device design.

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

How Ground Truth Established: Not applicable.

As mentioned above, this is not an AI/ML device, so there is no training set or associated ground truth establishment process for a machine learning model. The "training" of such a device is in its chemical formulation and manufacturing process ensuring consistent and accurate reactivity.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

AllSource Screening Solutions % Joe Shia Director LSI International Inc 504 E Diamond Ave. Gaithersburg, Maryland 20877

Re: K234006

Trade/Device Name: AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL Dated: February 9, 2024 Received: February 12, 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).

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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 product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS 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 (OS) 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, Joseph A. Digitally signed by Kotarek - S Date: 2024.03.21 Joseph Kotarek Branch Chief for Toxicology Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K234006

Device Name

AllSource Drug Detector FenTest AllSource Drug Detector Fentanyl Test

Indications for Use (Describe)

AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL.

The AllSource Drug Detector Fentany] Test is a rapid, one-step immunoassay for the qualitative detection of fentary] in human urine at the cutoff concentrations of 1 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 K234006

March 7, 2024 1. Date: 2. Submitter: AllSource Screening Solutions 1401 Pontiac Court Export, PA 15632 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: AllSource Drug Detector FenTest AllSource Drug Detector Fentanyl Test

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
  AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AllSource Drug Detector Fentanyl Test is a rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine at the cutoff concentrations of 1 ng/mL.

Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated.

It is for in vitro diagnostic use only.

1. Device Description
  AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllSource Drug Detector Fentanyl Test device consists of a Test Dip Card and a package insert. Each Test Dip Card is sealed with sachets of desiccant in an aluminum pouch.

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1. Substantial Equivalence Information
  A summary comparison of features of the AllSource Drug Detector Fentanyl Test and the predicate devices is provided in following table.

Table 1: Features Comparison of AllSource Drug Detector Fentanyl Test and the Predicate Device

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	Dip Card	Cassette
Storage	4-30°C	Same

1. Test Principle
  AllSource Drug Detector Fentanyl Test is a competitive and immunochromatography assay, and uses monoclonal antibody as the indicator marker to qualitatively detect fentanyl in human urine. The test cassette contains fentanyl test strip. The nitrocellulose membrane test area (T) of the test strip is correspondingly coated with fentanyl-bovine serum albumin conjugate, and the quality control area (C) is coated with goat anti-rabbit IgG polyclonal antibody. When the concentration of fentanyl in the sample is higher than or equal to the cut-off of the product, it will compete with the corresponding conjugate coated on the test area (T) to bind to the monoclonal antibody, the test line is inhibited and the result is positive; while when the sample does not contain fentanyl or its concentration is lower than the cut-off of the product, the corresponding conjugate on the test line reacts with sufficient monoclonal antibodies, the test line will be visible and the result is negative. 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
  - Precision a.

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

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sample testing. For each concentration, tests were performed two 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+	46-/14+	28+/32-	60+/0-	60+/0-	60+/0-	60+/0-
Lot 2	60-/0+	60-/0+	60-/0+	44-/16+	28+/32-	60+/0-	60+/0-	60+/0-	60+/0-
Lot 3	60-/0+	60-/0+	60-/0+	45-/15+	30+/30-	60+/0-	60+/0-	60+/0-	60+/0-

c. Stability

The devices are stable at 2-30 ℃ 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	Doxepin	Nortriptyline
Acetone (1000mg/dL)	Ecgonine methyl ester	Noscapine
Acetophenetidin	Ephedrine	O-Hydroxyhippuric acid
Acetylsalicylic acid	Erythromycin	Octopamine
Albumin (100mg/dL)	Ethanol (1%)	Oxalic acid (100 mg/dL)
Albuterol	Fenoprofen	Oxazepam
Aminopyrine	Fluphenazine	Oxolinic acid
Amitriptyline	Furosemide	Oxymetazoline
Amobarbital	Galactose (10mg/dL)	Papaverine
Amoxicillin	Gamma Globulin (500mg/dL)	Penicillin G
Ampicillin	Gentisic acid	Perphenazine
Apomorphine	Glucose (3000mg/dL)	Phencyclidine
Ascorbic acid	Hemoglobin	Phenelzine
Aspartame	Hydralazine	Phenobarbital
Atropine	Hydrochlorothiazide	Prednisone
Benzilic acid	Hydrocortisone	Propoxyphene (50ug/ml)
Benzoic acid	Hydroxytyramine	Propranolol
Benzoylecgonine	Ibuprofen	Pseudoephedrine
Bilirubin	Imipramine	Quinine
Boric Acid (1%)	Isoproterenol	Ranitidine
Bupropion	Isoxsuprine	Riboflavin (10mg/dL)
Caffeine	Ketamine	Salicylic acid
Carbamazepine	Ketoprofen	Secobarbital
Chloral hydrate	Labetalol	Serotonin (5-Hydroxytyramine)
Chloramphenicol	Lidocaine	Sulfamethazine
Chlorothiazide	Loperamide	Sulindac
Chlorpromazine	Maprotiline	Tetrahydrocortisone 3-(β-Dglucuronide)
Cholesterol	Meperidine	Tetrahydrocortisone 3-acetate
Clomipramine	Meprobamate	Tetrahydrozoline
Clonidine	Methapyrilene	Thiamine
Cortisone	Methaqualone	Thioridazine
Cotinine	Methoxyphenamine	Triamterene

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Creatinine	Metronidazole (300ug/ml)	Trifluoperazine
Cyclobenzaprine	N-Acetylprocainamide	Trimethoprim
Deoxycorticosterone	NaCl (4000mg/dL)	Tyramine
Desipramine	Nalidixic acid	Urea (2000mg/dL)
Dextromethorphan	Naloxone	Uric acid
Diclofenac	Naltrexone	Valproic acid (250ug/ml)
Diflunisal	Naproxen	Venlafaxine
Digoxin	Niacinamide	Verapamil
Diphenhydramine	Nicotine	Zomepirac
DL-Tryptophan	Nifedipine	ß-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
Norfentanyl	50	2%
Acetyl fentanyl	1	100%
Acrylfentanyl	10	10%
Isobutyryl fentanyl	2.5	40%
Ocfentanil	10	10%
Butyryl fentanyl	2.5	40%
Furanyl fentanyl	7.5	13.3%
Valeryl fentanyl	10	10%
(±) β-hydroxythiofentanyl	5	20%
Para-fluorobutyrylfentanyl (p-FBF)	10	10%
Para-fluoro fentanyl	1	100%
(±)-3-cis-methylfentanyl	10	10%
Carfentanil	10000	0.01%
Sufentanil	10000	0.01%
Norcarfentanil	100000	<0.001%
Acetyl norfentanyl	10	10%
Remifentanil	10000	0.01%
Alfentanil	10000	0.01%
ω-1-Hydroxyfentanyl	20000	0.005%
4-Fluoro-isobutyrylfentanyl	50	2%
Despropionyl fentanyl (4-ANPP)	2500	0.04%

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 AllSource Drug Detector Fentanyl Test

6-Acetyl morphine	Naltrexone
Amphetamine	Norbuprenorphine
Buprenorphine	Norcodeine

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Buprenorphineglucuronide	Norketamine
Codeine	Normeperidine
Dextromethorphan	Normorphine
Dihydrocodeine	Noroxycodone
EDDP	Oxycodone
EMDP	Oxymorphone
Fluoxetine	Pentazocine (Talwin)
Heroin	Pipamperone
Hydrocodone	Risperidone
Hydromorphone	Tapentadol
Ketamine	Thioridazine
Levorphanol	Tilidine
Meperidine	Tramadol
Methadone	Tramadol-O-Desmethyl
Morphine	Tramadol-N-Desmethyl
Morphine-3-glucuronide	Trazodone
Naloxone

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 AllSource Drug Detector Fentanyl Test were performed at three different testing sites. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results are presented in the tables below.

		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%)
Site1	Positive	0	4	22	17
Site1	Negative	10	9	1	0
Site2	Positive	0	6	21	17
Site2	Negative	10	7	2	0
Site3	Positive	0	6	21	17
Site3	Negative	10	7	2	0

Discordant Results

Site	Sample Number	LC-MS/MS Result	AllSource Result
Site 1	CP167	0.835	Positive
Site 1	CP322	0.937	Positive
Site 1	CP298	0.941	Positive

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Site	Sample Number	LC-MS/MS Result	AllSource Result
Site 1	CP127	0.967	Positive
Site 1	CP365	1.059	Negative
Site 2	CP352	0.792	Positive
Site 2	CP167	0.835	Positive
Site 2	CP322	0.937	Positive
Site 2	CP318	0.957	Positive
Site 2	CP127	0.967	Positive
Site 2	CP191	0.98	Positive
Site 2	CP365	1.059	Negative
Site 2	CP279	1.036	Negative
Site 3	CP308	0.818	Positive
Site 3	CP294	0.838	Positive
Site 3	CP298	0.941	Positive
Site 3	CP318	0.957	Positive
Site 3	CP127	0.967	Positive
Site 3	CP191	0.98	Positive
Site 3	CP253	1.099	Negative
Site 3	CP365	1.059	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%, +/-50%, +/-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 ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	0.31	0	20	100
-50% Cutoff	20	0.48	0	20	100
-25% Cutoff	20	0.77	5	15	75
+25% Cutoff	20	1.22	20	0	100
+50% Cutoff	20	1.42	20	0	100
+75% Cutoff	20	1.78	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.

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

11. 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).