AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethy-3.3-diphenylpvrrolidine. Methylenedioxymethamphetamine. Morphine. Methadone. Oxycodone. Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level ng/mL
Amphetamine (AMP)	500 or 1000 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Benzodiazepines (BZO)	300 ng/mL
Cocaine (COC)	150 or 300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 or 1000 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP/OPI)	300 or 2000 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level ng/mL
Amphetamine (AMP)	500 or 1000 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Benzodiazepines (BZO)	300 ng/mL
Cocaine (COC)	150 or 300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 or 1000 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP/OPI)	300 or 2000 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses, It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone. Oxycodone, Phencycligine and Mariiuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Calibrator	Cut-off (ng/mL)
Amphetamine (AMP)	d-Amphetamine	500 or 1000
Buprenorphine (BUP)	Buprenorphine	10
Secobarbital (BAR)	Secobarbital	300
Benzodiazepines (BZO)	Oxazepam	300
Cocaine (COC)	Benzoylecgonine	150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Methamphetamine (MET)	d-Methamphetamine	500 or 1000
Methylenedioxymethamphetamine (MDMA)	d,l-Methylenedioxymethamphetamine	500
Morphine (MOP/OPI)	Morphine	300 or 2000
Methadone (MTD)	Methadone	300
Oxycodone (OXY)	Oxycodone	100
Phencyclidine (PCP)	Phencyclidine	25
Nortriptyline (TCA)	Nortriptyline	1000
Marijuana (THC)	11-nor-A9-THC-9 COOH	50

AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Calibrator	Cut-off (ng/mL)
Amphetamine (AMP)	d-Amphetamine	500 or 1000
Buprenorphine (BUP)	Buprenorphine	10
Secobarbital (BAR)	Secobarbital	300
Benzodiazepines (BZO)	Oxazepam	300
Cocaine (COC)	Benzoylecgonine	150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Methamphetamine (MET)	d-Methamphetamine	500 or 1000
Methylenedioxymethamphetamine (MDMA)	d.l-Methylenedioxymethamphetamine	500
Morphine (MOP/OPI)	Morphine	300 or 2000
Methadone (MTD)	Methadone	300
Oxycodone (OXY)	Oxycodone	100
Phencyclidine (PCP)	Phencyclidine	25
Nortriptyline (TCA)	Nortriptyline	1000
Marijuana (THC)	11-nor-Δ9-THC-9 COOH	50

AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may vield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Description

The AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The AllTest Multi-Drug Rapid Test kit contains a Cup or a Panel device, a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

AI/ML Overview

The provided document describes the acceptance criteria and the studies conducted for the AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel for the detection of various drugs in human urine. The submission primarily focuses on the three new analytes: Amphetamine 1000, Cocaine 300, and Methamphetamine 1000, while referencing a previous submission (K182738) for other analytes.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests typically revolve around the ability to correctly identify samples above and below the specified cut-off concentrations. The precision study results implicitly serve as the performance criteria, showing the percentage of correct identifications at various concentrations relative to the cut-off.

Acceptance Criterion: The device should consistently provide correct positive results for samples at or above the cut-off concentration and correct negative results for samples significantly below the cut-off concentration. For samples near the cut-off, a certain degree of variability is expected but needs to be within acceptable ranges (e.g., majority of results correctly identified).

Reported Device Performance (from Precision Studies - 3 lots, 25 replicates each, total 75 tests per concentration level):

Drug (Cut-off ng/mL)	Concentration (% of Cut-off)	Cup: % Correct Negative (Expected Negative)	Cup: % Correct Positive (Expected Positive)	Panel: % Correct Negative (Expected Negative)	Panel: % Correct Positive (Expected Positive)
AMP 1000	-100% (0 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-75% (250 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-50% (500 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-25% (750 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	Cut-off (1000 ng/mL)	20-25% (19/75-25/75) Negative	75-80% (50/75-56/75) Positive	16-21% (12/75-16/75) Negative	79-84% (59/75-63/75) Positive
	+25% (1250 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+50% (1500 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+75% (1750 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+100% (2000 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
COC 300	-100% (0 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-75% (75 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-50% (150 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-25% (225 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	Cut-off (300 ng/mL)	17-21% (13/75-16/75) Negative	79-83% (59/75-62/75) Positive	20-21% (15/75-16/75) Negative	79-80% (59/75-60/75) Positive
	+25% (375 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+50% (450 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+75% (525 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+100% (600 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
MET 1000	-100% (0 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-75% (250 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-50% (500 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	-25% (750 ng/mL)	100% (75/75)	N/A	100% (75/75)	N/A
	Cut-off (1000 ng/mL)	19-27% (14/75-20/75) Negative	73-81% (55/75-61/75) Positive	16-21% (12/75-16/75) Negative	79-84% (59/75-63/75) Positive
	+25% (1250 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+50% (1500 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+75% (1750 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)
	+100% (2000 ng/mL)	N/A	100% (75/75)	N/A	100% (75/75)

Lay User Study Performance (Cup & Panel combined, n=20 per concentration level per drug):

Drug (Cutoff ng/mL)	Concentration (% of Cut-off)	% Correct Negative	% Correct Positive
AMP 500	-100%, -75%, -50%	100%	N/A
	-25%	95%	5%
	+25%	10%	90%
	+50%, +75%	N/A	100%
AMP 1000	-100%, -75%, -50%	100%	N/A
	-25%	90%	10%
	+25%	5-10%	90-95%
	+50%, +75%	N/A	100%
COC 150	-100%, -75%, -50%	100%	N/A
	-25%	90%	10%
	+25%	10%	90%
	+50%, +75%	N/A	100%
COC 300	-100%, -75%, -50%	100%	N/A
	-25%	90%	10%
	+25%	5-10%	90-95%
	+50%, +75%	N/A	100%
MET 500	-100%, -75%, -50%	100%	N/A
	-25%	90%	10%
	+25%	10%	90%
	+50%, +75%	N/A	100%
MET 1000	-100%, -75%, -50%	100%	N/A
	-25%	95%	5%
	+25%	5%	95%
	+50%, +75%	N/A	100%

(Note: The table only includes performance for the new analytes (AMP 1000, COC 300, MET 1000) for precision, and for all listed analytes in the lay user study, which implicitly includes the other cut-off values for AMP, COC, and MET, as well as the other drugs reported in K182738.)

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

Precision Studies (Laboratory Testing):

Sample Size: For each of the three new analytes (Amphetamine 1000, Cocaine 300, Methamphetamine 1000), 9 concentration levels were tested. For each concentration, 5 replicates were performed per day for 5 days, across 3 lots.
- This equates to: 9 concentrations * 5 replicates/day * 5 days * 3 lots = 675 total tests per analyte for the precision study using spiked urine samples.
Data Provenance: The document states, "These samples were prepared by spiking drug in negative urine samples." This indicates the data is from prospective, laboratory-controlled experiments using spiked urine samples. The country of origin for the samples themselves is not explicitly stated beyond being "negative urine samples," but the submitting company is Hangzhou Alltest Biotech Co.,Ltd. in China, suggesting the studies likely occurred there or with materials sourced globally.

Comparison Studies (Clinical Samples):

Sample Size: For each of the three new analytes (Amphetamine 1000, Cocaine 300, Methamphetamine 1000), 80 unaltered clinical urine samples were used (40 negative and 40 positive).
- This totals 80 samples per analyte (Cup and Panel results are reported on the same sample set).
Data Provenance: The document states, "unaltered clinical samples." This suggests these were retrospective clinical samples. The country of origin is not specified.

Lay User Study:

Sample Size: 560 lay persons participated. Urine samples were prepared at 7 concentration levels (negative, +/-25%, +/-50%, +/-75%, +100% of cut-off) for each drug. Each participant was provided with 1 blind labeled sample and a device.
- For each of the approximately 14 drugs/cut-off concentrations evaluated, there were 7 concentration levels. Each concentration level had 20 tests (Agreement (%) is based on 20 total for each row). So, at minimum, 14 drugs * 7 concentrations * 20 tests/concentration = 1960 total tests were performed by lay users, distributed across the 560 participants.
Data Provenance: The samples were "prepared by spiking drugs into drug free-pooled urine specimens," indicating prospective, laboratory-controlled experiments using spiked urine samples. The study was performed at "three intended user sites" but the country/region is not specified.

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

Precision Studies and Lay User Studies:

Ground Truth Establishment: The ground truth for these studies was established by spiking known concentrations of drugs into negative urine samples and confirming them by LC/MS. This is a chemical/analytical method, not expert opinion.
Number of Experts & Qualifications: Not applicable, as the ground truth was determined analytically.

Comparison Studies (Clinical Samples):

Ground Truth Establishment: The ground truth for the clinical samples was established using LC/MS (Liquid Chromatography-Mass Spectrometry), which is the recommended confirmatory method as stated in the Indications for Use.
Number of Experts & Qualifications: Not applicable, as the ground truth was determined via a definitive analytical method, not human expert consensus. "Three laboratory assistants" ran the device tests, but they were not establishing the ground truth.

4. Adjudication Method for the Test Set

Precision Studies and Lay User Studies:

Adjudication Method: Not applicable. The ground truth was based on known spiked concentrations confirmed by LC/MS. The device's result was compared directly to this analytical ground truth.

Comparison Studies (Clinical Samples):

Adjudication Method: Not explicitly described in terms of human adjudication. However, the document states: "The samples were blind labeled and compared to LC/MS results." This implies a direct comparison against a definitive analytical method (LC/MS) for ground truth, rather than an adjudication process involving multiple human interpretations of the ground truth. The "Discordant Results" tables show discrepancies between the viewer (device interpreter) results and the LC/MS result, indicating the LC/MS was the adjudicating method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a typical MRMC comparative effectiveness study was not explicitly described in the context of human readers improving with AI vs. without AI assistance.
The document describes a "Comparison Studies" section, but this compares the device's performance to LC/MS results. It also mentions three "Viewer" (likely laboratory assistants or technicians) evaluating the device results against LC/MS, but it's not a study about human readers improving with AI assistance. It's a study of the device's performance when interpreted by human users against a gold standard.
The device itself is a rapid test cup/panel, not an AI software.

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

Not applicable. The device is an immunochromatographic assay (a physical test strip/cup), not an algorithm or AI software. Its performance inherently involves human-in-the-loop for result interpretation (reading the lines). The "Precision" study and the "Comparison Studies" evaluate the device's standalone analytical performance, but its practical use and reported performance include human interpretation of its visual output. The "Lay User Study" specifically evaluates performance with human-in-the-loop (lay users interpreting the results).

7. The Type of Ground Truth Used

Precision Studies & Lay User Studies: The ground truth was established by spiking known concentrations of drugs into drug-free urine samples, with these concentrations confirmed by LC/MS. This is an analytically derived ground truth.
Comparison Studies (Clinical Samples): The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is considered a definitive analytical gold standard for drug detection.

8. The Sample Size for the Training Set

The document does not describe the development of an algorithm or AI model that would require a "training set." This device is a rapid diagnostic test based on immunochromatography. Therefore, the concept of a training set as used in machine learning is not applicable here.

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

As noted above, there is no mention of a training set for an algorithm or AI model. The device operates on chemical and immunological principles, not machine learning.

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue.

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

Re: K233019

Trade/Device Name: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Cup Rx, AllTest Multi-Drug Rapid Test Panel, AllTest Multi-Drug Rapid Test Panel Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ, NFT, DIS, JXM, DJG, PTH, DIO. DJR, NFV. LAF, DJC, LDJ, NGL, NFY, DNK, LCM, PTG, LFG, NGG, NFW, NGI, NGM, QAW Dated: September 21, 2023 Received: September 22, 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 (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: 2023.12.13 Joseph Kotarek, Ph.D. Toxicology 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

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Indications for Use

510(k) Number (if known)

K233019

Device Name AllTest Multi-Drug Rapid Test Cup AllTest Multi-Drug Rapid Test Panel

Indications for Use (Describe)

Cut-off level

ng/mL

Drug (Identifier)

Amphetamine (AMP)	500 or 1000 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Benzodiazepines (BZO)	300 ng/mL
Cocaine (COC)	150 or 300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 or 1000 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP/OPI)	300 or 2000 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	500 or 1000 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Benzodiazepines (BZO)	300 ng/mL
Cocaine (COC)	150 or 300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 or 1000 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP/OPI)	300 or 2000 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL

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Nortriptyline (TCA) Marijuana (THC)

1000 ng/mL 50 ng/mL

AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method.

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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Indications for Use

510(k) Number (if known)

K233019

Device Name

AllTest Multi-Drug Rapid Test Cup Rx AllTest Multi-Drug Rapid Test Panel Rx

Indications for Use (Describe)

Drug (Identifier)	Calibrator	Cut-off (ng/mL)
Amphetamine (AMP)	d-Amphetamine	500 or 1000
Buprenorphine (BUP)	Buprenorphine	10
Secobarbital (BAR)	Secobarbital	300
Benzodiazepines (BZO)	Oxazepam	300
Cocaine (COC)	Benzoylecgonine	150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Methamphetamine (MET)	d-Methamphetamine	500 or 1000
Methylenedioxymethamphetamine (MDMA)	d,l-Methylenedioxymethamphetamine	500
Morphine (MOP/OPI)	Morphine	300 or 2000
Methadone (MTD)	Methadone	300
Oxycodone (OXY)	Oxycodone	100
Phencyclidine (PCP)	Phencyclidine	25
Nortriptyline (TCA)	Nortriptyline	1000
Marijuana (THC)	11-nor-A9-THC-9 COOH	50

AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Drug (Identifier)	Calibrator	Cut-off (ng/mL)
Amphetamine (AMP)	d-Amphetamine	500 or 1000
Buprenorphine (BUP)	Buprenorphine	10
Secobarbital (BAR)	Secobarbital	300
Benzodiazepines (BZO)	Oxazepam	300
Cocaine (COC)	Benzoylecgonine	150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Methamphetamine (MET)	d-Methamphetamine	500 or 1000
Methylenedioxymethamphetamine	d.l-Methylenedioxymethamphetamine	500

{5}------------------------------------------------

(MDMA)
Morphine (MOP/OPI)	Morphine	300 or 2000
Methadone (MTD)	Methadone	300
Oxycodone (OXY)	Oxycodone	100
Phencyclidine (PCP)	Phencyclidine	25
Nortriptyline (TCA)	Nortriptyline	1000
Marijuana (THC)	11-nor-Δ9-THC-9 COOH	50

AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

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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{6}------------------------------------------------

510(k) SUMMARY K233019

The purpose of this submission is to add analytes Amphetamine 1000, Cocaine 300, Methamphetamine 1000, to previously cleared devices (K182738). These three new analytes were evaluated in this submission. For other analytes, please refer to K182738 for Buprenorphine, Secobarbital, Benzodiazepines, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Nortriptyline and Marijuana.

1. Date:	November 3, 2023
2. Submitter:	Hangzhou Alltest Biotech Co.,Ltd.#550, Yinhai StreetHangzhou 310018, China
3. Contact person:	Joe ShiaLSI International Inc504E Diamond Ave., Suite HGaithersburg, MD 20877Telephone: 240-505-7880Email: shiajl@yahoo.com
4. Device Name:	AllTest Multi-Drug Rapid Test CupAllTest Multi-Drug Rapid Test Cup RxAllTest Multi-Drug Rapid Test PanelAllTest Multi-Drug Rapid Test Panel Rx

Classification: Class 2

ProductCodes	Class	RegulationSection	Regulation Name	Panel
DKZ, NFT	II	862.3100	Amphetamine Test system	Toxicology
DIS, PTH	II	862.3150	Barbiturate Test system	(91)
JXM, NFV	II	862.3170	Benzodiazepines Test System
DIO, NFY	II	862.3250	Cocaine and metabolites Test System
DJR, PTG	II	862.3620	Methadone Test system
LAF, DJC,NGG	II	862.3610	Methamphetamine Test System
LDJ, NFW	II	862.3870	Cannabinoids Test System
DNK, NGI	II	862.3640	Morphine Test System
DJG, NGL	II	862.3650	Opiate Test System
LCM, NGM	II	Unclassified	Enzyme immunoassay Phencyclidine
LFG, QAW	II	862.3910	Tricyclic Antidepressant Drugs Test System

1. Predicate Devices: K182738
  The AllTest Single and Multi-Drug Rapid Test Cup (Urine)

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

1. Intended Use
  AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	500 or 1000 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Benzodiazepines (BZO)	300 ng/mL
Cocaine (COC)	150 or 300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 or 1000 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP/OPI)	300 or 2000 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Calibrator	Cut-off (ng/mL)
Amphetamine (AMP)	d-Amphetamine	500 or 1000
Buprenorphine (BUP)	Buprenorphine	10
Secobarbital (BAR)	Secobarbital	300
Benzodiazepines (BZO)	Oxazepam	300
Cocaine (COC)	Benzoylecgonine	150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Methamphetamine (MET)	d-Methamphetamine	500 or 1000

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

Methylenedioxymethamphetamine(MDMA)	d,l-Methylenedioxymethamphetamine	500
Morphine (MOP/OPI)	Morphine	300 or 2000
Methadone (MTD)	Methadone	300
Oxycodone (OXY)	Oxycodone	100
Phencyclidine (PCP)	Phencyclidine	25
Nortriptyline (TCA)	Nortriptyline	1000
Marijuana (THC)	11-nor-Δ9-THC-9 COOH	50

AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	500 or 1000 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Benzodiazepines (BZO)	300 ng/mL
Cocaine (COC)	150 or 300 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 or 1000 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP/OPI)	300 or 2000 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Benzodiazepines, Secobarbital, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result,

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

particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethyl-3,3dipheny|pyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Calibrator	Cut-off (ng/mL)
Amphetamine (AMP)	d-Amphetamine	500 or 1000
Buprenorphine (BUP)	Buprenorphine	10
Secobarbital (BAR)	Secobarbital	300
Benzodiazepines (BZO)	Oxazepam	300
Cocaine (COC)	Benzoylecgonine	150 or 300
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300
Methamphetamine (MET)	d-Methamphetamine	500 or 1000
Methylenedioxymethamphetamine(MDMA)	d,1-Methylenedioxymethamphetamine	500
Morphine (MOP/OPI)	Morphine	300 or 2000
Methadone (MTD)	Methadone	300
Oxycodone (OXY)	Oxycodone	100
Phencyclidine (PCP)	Phencyclidine	25
Nortriptyline (TCA)	Nortriptyline	1000
Marijuana (THC)	11-nor-A9-THC-9 COOH	50

AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

7. Device Description

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1. Substantial Equivalence Information
  A summary comparison of features of the AllTest Multi-Drug Rapid Tests and the predicate devices is provided in following tables.

Table 1: Features Comparison of AllTest Multi-Drug Rapid Test Cup/Panel and the Predicate Devices

Item	Device	Predicate - K182738
Indication(s)for Use	For the qualitative determination of drugs ofabuse in human urine.	Same
Calibrator andCut-Off Values	Amphetamine (AMP): 500 or 1000 ng/mlBenzodiazepines (BZO):300 ng/mlCocaine (COC): 150 or 300 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 500 or 1000 ng/mlMorphine (MOP/OPI): 300 or 2000 ng/mLOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlBuprenorphine (BUP): 10 ng/mlD.L-Methylenedioxymethamphetamine(MDMA): 500 ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/ml2-ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine (EDDP): 300 ng/ml	Same exceptAMP 500MET 500COC 150
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For prescription use and over-the-counter	Same
Configurations	Cup and Panel	Same

9. Test Principle

The AllTest Multi-Drug Rapid Test Cup/Panel tests for the qualitative detection of target drug or drug metabolites in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody

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

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 to indicate that the tests have been performed properly.

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 drug in negative urine samples. Each drug 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 5 replicates per day for 5 days per device in a randomized order. The results obtained are summarized in the following tables for Amphetamine 1000, Cocaine 300, and Methamphetamine 1000. The rest data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Benzodiazepines, EDDP, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana were reported in K182738.

AMP Cup
Concentration byLC/MS (ng/mL)LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100 %
Lot 1	25-/0+	25-/0+	25-/0+	25-/0+	19+/6-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 2	25-/0+	25-/0+	25-/0+	25-/0+	19+/6-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 3	25-/0+	25-/0+	25-/0+	25-/0+	20+/5-	25+/0-	25+/0-	25+/0-	25+/0-

Concentration byLC/MS (ng/mL)LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100 %
Lot 1	25-/0+	25-/0+	25-/0+	25-/0+	20+/5-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 2	25-/0+	25-/0+	25-/0+	25-/0+	19+/6-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 3	25-/0+	25-/0+	25-/0+	25-/0+	21+/4-	25+/0-	25+/0-	25+/0-	25+/0-

AMP Panel

COC Cup

Concentration byLC/MS (ng/mL)LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
Lot 1	25-/0+	25-/0+	25-/0+	25-/0+	20+/5-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 2	25-/0+	25-/0+	25-/0+	25-/0+	19+/6-	25+/0-	25+/0-	25+/0-	25+/0-

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

Concentration byLC/MS (ng/mL)Lot Number	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100 %
Lot 3	25-/0+	25-/0+	25-/0+	25-/0+	21+/4-	25+/0-	25+/0-	25+/0-	25+/0-

COC Panel
Concentration byLC/MS (ng/mL)LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
Lot 1	25-/0+	25-/0+	25-/0+	25-/0+	20+/5-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 2	25-/0+	25-/0+	25-/0+	25-/0+	20+/5-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 3	25-/0+	25-/0+	25-/0+	25-/0+	20+/5-	25+/0-	25+/0-	25+/0-	25+/0-

MET Cup

Concentration byLC/MS (ng/mL)LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
Lot 1	25-/0+	25-/0+	25-/0+	25-/0+	19+/6-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 2	25-/0+	25-/0+	25-/0+	25-/0+	19+/6-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 3	25-/0+	25-/0+	25-/0+	25-/0+	20+/5-	25+/0-	25+/0-	25+/0-	25+/0-

MET Panel

Concentration byLC/MS (ng/mL)LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
Lot 1	25-/0+	25-/0+	25-/0+	25-/0+	20+/5-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 2	25-/0+	25-/0+	25-/0+	25-/0+	21+/4-	25+/0-	25+/0-	25+/0-	25+/0-
Lot 3	25-/0+	25-/0+	25-/0+	25-/0+	21+/4-	25+/0-	25+/0-	25+/0-	25+/0-

The following cut-off values are verified.

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL
Cocaine (COC)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL

b. Linearity

Not applicable.

c. Stability and Traceability

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

The devices are stable at 2-30 ℃ for 24 months based on real time stability studies. All drug calibrators of the device are traceable to available commercial reference materials.

d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three lots of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. No differences were observed for different device format.

Acetylsalicylic Acid	5, 5-Diphenylhydantoin	19-Norethindrone
Albumin (100mg/dL)	Erythromycin	Noscapine
Amoxicillin	Estradiol	Octopamine
Ampicillin	Estrone	Papaverine
Aspartame	Ethanol (1%)	Penicillin-G
Aspirin	Fenofibrate	Perphenazine
Atropine	Fentanyl	Phenelzine
Baclofen	Fotemustine	Phenylethylamine
Benzocaine	Furosemide	Promazine
Benzoic Acid	Gemfibrozil	Promethazine
Bilirubin	Gentisic acid	Pyridoxine
Carisoprodol	Glucose	Pyrilamine
Chloramphenicol	Guaiacol glyceryl ether	Pyrogallol
Chlordiazepoxide	Hemoglobin	Quinine
(+)-Chlorpheniramine	Hydralazine	Quinolinic Acid
Chlorpromazine	Hydrocortisone	R-(-)-Apomorphine
Cholesterol	3-Hydroxytyramine	Ranitidine
Clonidine	(+/-)-Isoproterenol	Salicylic Acid
Cortisone	Ketamine	Sulindac
(-)-Cotinine	L-Ascorbic Acid	Tetracycline
Creatine Hydrate	Meprobamate	Tetrahydrozoline
Creatinine	Methylphenidate	Thiamine
Cyclodextrin	Nalidixic Acid	Thioridazine
d,l-Propranolol	Naltrexone	Tramadol
Deoxycorticosterone	(+)-Naproxen	Trifluoperazine
Dextromethorphan	Niacinamide	Tryptamine
Diclofenac	Nicotinic Acid	Uric Acid
4-Dimethyl-aminoantipyrine	Nifedipine	Zomepirac sodium salt

e. Specificity

To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Amphetamine 1000, Cocaine 300, Methamphetamine 1000. No differences were observed for different device format. The rest data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Benzodiazepines, Morphine, Methadone, Oxycodone, Phencyclidine, EDDP, Nortriptyline and Marijuana were reported in K182738.

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

AMP 1000	Result	%Cross-
(Cut-off=1000 ng/mL)	Positive at (ng/ml)	Reactivity
d-Amphetamine	1000	100%
Methylenedioxyethylamphetamine(MDEA)	>100000	<1%
d,l-Methamphetamine	>100000	<1%
Phenylephrine	>100000	<1%
d-Methamphetamine	>100000	<1%
l-Methamphetamine	>100000	<1%
d,l - Methylenedioxymethamphetamine	>100000	<1%
l-Amphetamine	1000	100%
Ephedrine	>100000	<1%
Pseudoephedrine	>100000	<1%
d, 1-Amphetamine	1000	100%
d,l-3,4-Methylenedioxyamphetamine(MDA)	50	2000%
Phentermine	1000	100%

COC 300(Cut-off=300 ng/mL)	ResultPositive at (ng/ml)	%Cross-Reactivity
Benzoylecgonine	300	100%
Cocaine	250	120%
Cocaethylene	500	60%
Ecgonine	>100000	<0.3%
Norcocaine	>100000	<0.3%

MET 1000(Cut-off=1000 ng/mL)	ResultPositive at (ng/ml)	%Cross-Reactivity
d-Methamphetamine	1000	100%
l-Methamphetamine	25000	4%
d,l-Amphetamine	500	200%
Phentermine	>100000	<1%
d,l-Methamphetamine	500	200%
d-Amphetamine	>100000	<1%
l-Amphetamine	>100000	<1%
Ephedrine	>100000	<1%
Phenylephrine	>100000	<1%
Pseudoephedrine	>100000	<1%
3,4- Methylenedioxymethamphetamine (MDMA)	2500	40%
d,l- Methylenedioxyethylamphetamine (MDEA)	12500	8.0%
d,l-3,4-Methylenedioxyamphetamine(MDA)	>100000	<1%

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

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

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 lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off.

1. Comparison Studies
  Method comparison studies for the AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel were performed in-house with three laboratory assistants. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Amphetamine 1000, Cocaine 300, and Methamphetamine 1000. The rest data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Benzodiazepines, Morphine, Methadone, Oxycodone, Phencyclidine, EDDP, Nortriptyline and Marijuana were reported in K182738.

AMP Cup
AllTestMulti-DrugTest Cup		Negative	Low Negative 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%)
ViewerA	Positive	0	0	1	13	26
	Negative	12	12	15	1	0
ViewerB	Positive	0	0	0	13	26
	Negative	12	12	16	1	0
ViewerC	Positive	0	0	1	14	26
	Negative	12	12	15	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Viewer Results
Viewer A	SN165	896.471	+
Viewer A	SN175	1070.815	-
Viewer B	SN044	1149.522	-
Viewer C	SN128	838.956	+

AMP Panel

AllTestMulti-DrugTest Panel		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%)
ViewerA	Positive	0	0	0	13	26
ViewerA	Negative	12	12	16	1	0
ViewerB	Positive	0	0	1	14	26
ViewerB	Negative	12	12	15	0	0

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

Viewer	Positive	0	0	2	13	26
C	Negative	12	12	14	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Viewer Results
Viewer A	SN044	1149.522	-
Viewer B	SN062	833.996	+
Viewer C	SN036	922.995	+
Viewer C	SN120	987.795	+
Viewer C	SN150	1181.731	-

COC Cup

AllTestMulti-DrugTest Cup		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%)
ViewerA	Positive	0	0	0	9	30
	Negative	12	10	18	1	0
ViewerB	Positive	0	0	1	10	30
	Negative	12	10	17	0	0
ViewerC	Positive	0	0	1	10	30
	Negative	12	10	17	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Viewer Results
Viewer A	SN174	324.6	-
Viewer B	SN070	297.0	+
Viewer C	SN079	297.7	+

COC Panel

AllTestMulti-DrugTest Panel		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%)
ViewerA	Positive	0	0	1	8	30
	Negative	12	10	17	2	0
ViewerB	Positive	0	0	1	10	30
	Negative	12	10	17	0	0
ViewerC	Positive	0	0	0	8	30
	Negative	12	10	18	2	0

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

Discordant Results
Viewer	Sample Number	LC/MS Result	Viewer Results
Viewer A	SN079	297.7	+
Viewer A	SN142	352.1	-
Viewer A	SN174	324.6	-
Viewer B	SN012	292.7	+
Viewer C	SN084	312.9	-
Viewer C	SN142	352.1	-

MET Cup

AllTestMulti-DrugTest Cup		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%)
		Viewer	Positive	0	0	1
	A	Negative	12	11	16	1
	Positive	0	0	0	10	29
B	Negative	12	11	17	1	0
	Positive	0	0	2	10	29
C	Negative	12	11	15	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Viewer Results
Viewer A	SN108	974.577	+
Viewer A	SN043	1194.980	-
Viewer B	SN043	1194.980	-
Viewer C	SN054	919.834	+
Viewer C	SN188	841.261	+
Viewer C	SN197	1167.315	-

MET Panel

AllTestMulti-DrugTest Panel		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%)
ViewerA	Positive	0	0	1	9	29
ViewerA	Negative	12	11	16	2	0
ViewerB	Positive	0	0	1	10	29
ViewerB	Negative	12	11	16	1	0

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

Viewer	Positive	0	0	0	10	29
C	Negative	12	11	17	1	0

Viewer	Sample Number	LC/MS Result	Viewer Results
Viewer A	SN159	882.244	+
Viewer A	SN043	1194.980	-
Viewer A	SN186	1138.254	-
Viewer B	SN159	882.244	+
Viewer B	SN186	1138.254	-
Viewer C	SN197	1167.315	-

Discordant Results

Lay User Study

A lay user study was performed at three intended user sites with 560 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 20 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 LC/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. Each device was tested. Results are shown below.

Results for Low Cutoff Cup
----------------------------	--	--	--	--

Drug	Cutoff (ng/mL)	Results	Concentration
			-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50 % cutoff	+75 % cutoff
AMP	500	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
BAR	300	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
BZO	300	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
BUP	10	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%

		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
COC	150	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
EDDP	300	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
MDMA	500	Agreement(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
MET	500	Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
MOP	300	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
MTD	300	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
OXY	100	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
PCP	25	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
TCA	1000	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
THC	50	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%

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

{20}------------------------------------------------

Results for High Cutoff Cup

			Concentration
	Cutoff		-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	+25%cutoff	+50%cutoff	+75%cutoff
Drug	(ng/mL)	Results						f	f
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
AMP	1000	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
BAR	300	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
BZO	300	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	2	0	0
BUP	10	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
COC	300	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
EDDP	300	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
MDMA	500	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	19	1	0	0
MET	1000	Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	95%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
OPI	2000	Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
		(%)
MTD	300	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	95%	95%	100%	100%
OXY	100	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	95%	100%	100%
PCP	25	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	95%	90%	100%	100%
TCA	1000	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%
THC	50	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	95%	90%	100%	100%

{21}------------------------------------------------

Results for Low Cutoff Panel

			Concentration
Drug	Cutoff(ng/mL)	Results	-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	+25%cutoff	+50%cutoff	+75%cutoff
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
AMP	500	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
BAR	300	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
BZO	300	Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
BUP	10	Positive	0	0	0	2	18	20	20
			Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
COC	150	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
EDDP	300	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
		Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
MDMA	500	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
		Negative	20	20	20	18	1	0	0
	500	Positive	0	0	0	2	19	20	20
MET		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
	300	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
MOP		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
	300	Negative	20	20	20	18	1	0	0
		Positive	0	0	0	2	19	20	20
MTD		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	95%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
OXY	100	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
PCP	25	Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
		Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
	1000	Total	20	20	20	20	20	20	20
TCA		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
THC	50	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement(%)	100%	100%	100%	90%	90%	100%	100%

{22}------------------------------------------------

{23}------------------------------------------------

Results for High Cutoff Panel

Drug	Cutoff(ng/mL)	Results	Concentration
			-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	+25%cutoff	+50%cutoff	+75%cutoff

AMP	1000	Negative	20	20	20	18	0	0	0
		Positive	0	0	0	2	20	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	100%	100%	100%
BAR	300	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
BZO	300	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
BUP	10	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
COC	300	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
EDDP	300	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%
MDMA	500	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
MET	1000	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
OPI	2000	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
MTD	300	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
OXY	100	Negative	20	20	20	19	1	0	0
		Positive	0	0	0	1	19	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	95%	100%	100%
PCP	25	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
TCA	1000	Negative	20	20	20	18	2	0	0
		Positive	0	0	0	2	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	90%	90%	100%	100%
THC	50	Negative	20	20	20	19	2	0	0
		Positive	0	0	0	1	18	20	20
		Total	20	20	20	20	20	20	20
		Agreement (%)	100%	100%	100%	95%	90%	100%	100%

{24}------------------------------------------------

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, method comparison, and lay-user studies of the devices, it's concluded that the AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).