AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only.

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.

Device Description

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the AllTest Fentanyl Rapid Test (Urine), based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are generally inferred from the positive and negative agreement with the LC/MS reference method, especially around the cutoff concentration. While explicit numerical acceptance criteria are not stated as "acceptance criteria," the performance in the method comparison study demonstrates the device's ability to classify samples correctly.

Acceptance Criteria (Inferred)	Reported Device Performance (Aggregate from 3 Sites)
For Negative Samples (LC/MS < Cutoff): High agreement for definitively negative samples and samples below -50% of cutoff.	Negative Samples: 90/90 (100%) correctly identified as negative (Low Negative) 36/45 (80%) correctly identified as negative (Near Cutoff Negative)
For Positive Samples (LC/MS >= Cutoff): High agreement for definitively positive samples and samples above +50% of cutoff.	Positive Samples: 63/63 (100%) correctly identified as positive (High Positive) 65/69 (94.2%) correctly identified as positive (Near Cutoff Positive)
Overall Agreement with LC/MS: Demonstrate substantial equivalence to the predicate and accurate qualitative detection of fentanyl.	Overall Performance: See detailed breakdown in "Discordant Results" for samples around the cutoff. The device shows strong performance for samples well above or below the cutoff.
Precision: Consistent results across different lots and concentrations around the cutoff.	For -25% Cutoff: - Lot 1: 58-/2+ - Lot 2: 59-/1+ - Lot 3: 60-/0+ For Cutoff: - Lot 1: 35+/25- - Lot 2: 28+/32- - Lot 3: 26+/34- For +25% Cutoff: - All lots 60+/0-
Interference: No interference from common endogenous or exogenous substances at specified concentrations.	Over 80 tested compounds showed no interference at 100 µg/mL or specified concentrations (except Trazodone with 0.1% cross-reactivity).
Specificity (Cross-reactivity): Limited cross-reactivity with structurally similar compounds. Other opioids show no cross-reactivity.	Detailed cross-reactivity provided for 17 fentanyl analogs; 21 other opioid compounds showed no cross-reactivity.
Effect of Urine Specific Gravity and pH: Accurate results across a range of urine specific gravities and pH levels.	Consistent results (positive for +50% Cut-Off and above, negative for -50% Cut-Off and below) over specific gravity 1.000-1.035 and pH 4-9.

Study Details

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Operators ran 80 unaltered clinical samples at each of the three testing sites. This means a total of 240 tests were performed on the clinical samples (80 samples * 3 sites). Each sample was characterized by LC/MS results (40 negative and 40 positive for fentanyl).
Data Provenance: The document states "unaltered clinical samples." The country of origin is not specified, but the device manufacturer is based in Hangzhou, Zhejiang, China. The study appears to be prospective in the sense that the device was used to test these clinical samples, and the results were then compared to LC/MS.

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

Ground Truth Establishment: The ground truth for the test set was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug testing, rather than human experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as the ground truth was industrial standard LC/MS. Discordant results were identified by direct comparison to the LC/MS reference.

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

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly done. The study compares the device's performance against a gold standard (LC/MS), not against human readers with and without AI assistance. The device itself is an immunoassay, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Standalone Performance: Yes, the described method comparison study is a standalone (algorithm only without human-in-the-loop performance) study, as it evaluates the device's ability to detect fentanyl in urine samples independently and compares its results to LC/MS. Human operators ran the tests, but their interpretation was based on the test line development, which is an intrinsic function of the device's chemistry.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used was established by LC/MS/MS results, specifically for fentanyl concentration, with a cutoff of 1.0 ng/mL. LC/MS is a highly accurate and sensitive analytical chemistry technique considered the gold standard for confirming the presence and quantity of drugs in biological samples.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay and relies on chemical reactions, not on an algorithm that requires a training set. The various analytical performance studies (precision, interference, specificity) are internal validation studies that support the device's design and analytical capability, but these are not typically referred to as "training sets" in the same way as in AI/ML development.

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

Ground Truth for Training Set: Not applicable, as there is no explicitly defined "training set" for this immunoassay device in the context of AI/ML. All samples used in the analytical performance studies (precision, interference, specificity) involved prepared samples with known concentrations of fentanyl or interfering substances, often confirmed by LC/MS, or drug-free urine.

Summary

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Hangzhou AllTest Biotech Co., Ltd. % Joe Shia Director LSI International Inc 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K231698

Trade/Device Name: AllTest Fentanyl Rapid Test (Urine) Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: June 11, 2023 Received: June 12, 2023

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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
Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2023.07.31
12-04-00' Joseph Kotarek, Ph.D. 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)

K231698

Device Name AllTest Fentanyl Rapid Test (Urine)

Indications for Use (Describe)

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 (K231698)

1. Date:	June 11, 2023
2. Submitter:	Hangzhou Alltest Biotech Co.,Ltd#550, Yinhai StreetHangzhou, zhejiang, China 310018
3. Contact person:	Joe ShiaLSI International Inc.504E Diamond Ave., Suite HGaithersburg, MD 20877Telephone: 240-505-7880Email: shiajl@yahoo.com

AllTest Fentanyl Rapid Test (Urine) 4. Device Names:

Product Code	Classification	Regulation Section	Panel
DJG	II	21 CFR § 862.3650Opiate Test System	Toxicology (91)

1. Predicate Devices:
  Superbio Fentanyl Urine Detection Kit (K220046)
1. Indications for Use
  AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only.

1. Device Description
  AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
1. Substantial Equivalence Information
  A summary comparison of features of the AllTest Fentanyl Rapid Test (Urine) and the predicate devices is provided in following table.

					Table 1: Features Comparison of AllTest Fentanyl Rapid Test (Urine) and the Predicate Devices
--	--	--	--	--	-----------------------------------------------------------------------------------------------

Item	Device	Predicate - K220046
------	--------	---------------------

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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 prescription use	Same
Configurations	Cassette	Dip Card
Platform Required	None	Fluorescence analyzer
Storage	4-30°C	Same

9. Test Principle

AllTest Fentanyl Rapid Test (Urine) 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.

10. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, 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 two tests per day for 10 days per device lot in a randomized order.

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cut off		+25%cut off	+50%cut off	+75%cut off	+100%cut off
---------------	------------------	-----------------	-----------------	-----------------	--	-----------------	-----------------	-----------------	------------------

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Lot 1	60-/0+	60-/0+	60-/0+	58-/2+	35+/25-	60+/0-	60+/0-	60+/0-
Lot 2	60-/0+	60-/0+	60-/0+	59-/1+	28+/32-	60+/0-	60+/0-	60+/0-
Lot 3	60-/0+	60-/0+	60-/0+	60-/0+	26+/34-	60+/0-	60+/0-	60+/0-

c. Stability

The devices are stable at 2-30 ℃ for 24 months based on the real time stability.

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
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)

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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
Acetyl fentanyl	1	100
Acrylfentanyl	1	100
ω-1-Hydroxyfentanyl	20000	0.005
Isobutyryl fentanyl	1	100
Ocfentanil	2.5	40.00
Butyryl fentanyl	2.5	40.00
Furanyl fentanyl	5	20.00
Valeryl fentanyl	10	10.00
(±) ß-hydroxythiofentanyl	2	50.00
4-Fluoro-isobutyrylfentanyl	50	2.00
Para-fluorobutyryl fentanyl	4	25.00
Para-fluoro fentanyl	3	33.33
(±)-3-cis-methyl fentanyl	50	2.00
Carfentanil	2	50.00
Sufentanil	7.5	13.33
Alfentanil	5000	0.02
Despropionyl fentanyl (4-ANPP)	2500	0.04
Remifentanil	>100000	/
Norfentanyl	>100000	/
Acetyl norfentanyl	>100000	/
Norcarfentanil	>100000	/

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 Alltest Fentanyl Rapid Test (Urine).

6-Acetyl morphine	Naloxone
Amphetamine	Naltrexone
Buprenorphine	Norbuprenorphine
Buprenorphineglucuronide	Norcodeine
Codeine	Norketamine
Dextromethorphan	Normeperidine
Dihydrocodeine	Normorphine
EDDP	Noroxycodone
EMDP	Oxycodone

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Fluoxetine	Oxymorphone
Heroin	Pentazocine (Talwin)
Hydrocodone	Pipamperone
Hydromorphone	Risperidone
Ketamine	Tapentadol
Levorphanol	Thioridazine
Meperidine	Tilidine
Methadone	Tramadol
Morphine	Tramadol-O- Desmethyl
Morphine-3-glucuronide	Tramadol-N- Desmethyl

Trazodone showed 0.1% cross-reactivity as a positive result was observed at 1000 ng/mL.

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 Alltest Fentanyl Rapid Test (Urine) 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. The results are presented in the tables below.

		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%)
Site1	Positive	0	0	3	22	16
Site1	Negative	9	16	12	2	0
Site2	Positive	0	0	3	22	16
Site2	Negative	9	16	12	2	0
Site3	Positive	0	0	2	21	16
Site3	Negative	9	16	13	3	0

Discordant Results

Site	Sample Number	LC-MS/MS Result	ALLTEST Result
Site 1	M41	1.079	Negative
Site 1	M40	0.906	Positive
Site 1	M2	1.013	Negative
Site 1	M58	0.822	Positive
Site 1	M59	0.920	Positive
Site 2	M14	1.015	Negative
Site 2	M2	1.013	Negative
Site 2	M63	0.917	Positive
Site 2	M59	0.920	Positive

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Site	Sample Number	LC-MS/MS Result	ALLTEST Result
Site 2	M49	0.842	Positive
Site 3	M41	1.079	Negative
Site 3	M59	0.920	Positive
Site 3	M2	1.013	Negative
Site 3	M14	1.015	Negative
Site 3	M63	0.917	Positive

3. Clinical Studies

Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, and method comparison 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).