(59 days)
AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine 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 |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
| AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination |
est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination 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 when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. 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 Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine 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) | 1-nor-Δ9-THC-9 COOH | 50 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Fentanyl(FYL) | Fentanyl | 1 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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 and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device Name: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Test Cup
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by the performance characteristics demonstrated in the studies, particularly the agreement/precision at and around the cutoff concentrations, and the specificity. Since this is an in vitro diagnostic (IVD) device, the "performance" here refers to its accuracy in detecting the target analytes and its overall reliability in a diagnostic context. This is fundamentally about how well the device matches a known, established ground truth.
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| Precision/Reproducibility | For Tramadol (TRA), Propoxyphene (PPX), Fentanyl (FYL), and 6-monoacetylmorphine (6-MAM), results at -100%, -75%, -50% cut-off were 100% negative calls. For +100%, +75%, +50% cut-off, results were 100% positive calls (with a few exceptions for PPX Lot 3 at +25% cutoff, and 6-MAM Lot 2 at +25% cutoff). At the exact cutoff, performance ranged from 22-28 positive/negative calls out of 50 total tests, showing expected variability around the cutoff. This demonstrates the device's ability to consistently provide the expected result across multiple runs and lots at various concentrations relative to the cutoff. |
| Linearity/Assay Reportable Range | Not applicable, as the device is intended for qualitative use only. |
| Stability | Stable at 2-30°C for 24 months based on real-time stability study. |
| Analytical Specificity/Interference | Cross-Reactivity: Demonstrated varying degrees of cross-reactivity for structurally related compounds (e.g., N-Desmethyl-cis-tramadol for TRA, Norpropoxyphene for PPX, Acetyl fentanyl, Acrylfentanyl for FYL, Diacetylmorphine for 6-MAM). Specificity was shown by very low or no cross-reactivity (<0.01% - 0.1%) for a large panel of non-structurally related drugs and common endogenous/exogenous substances. Non-Interference: pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 were shown not to affect assay results. |
| Method Comparison (Clinical Concordance) | For TRA, PPX, 6-MAM, and FYL, when compared against LC-MS/MS: - Drug-Free, Low Negative (-50%), Near Cutoff Negative (between -50% and Cutoff): The device typically reported 0 positive and high negative counts, indicating good agreement for negatives. - Near Cutoff Positive (between Cutoff and +50%), High Positive (>+50%): The device typically reported high positive counts and 0 negative counts, indicating good agreement for positives. Small numbers of discordant results (e.g., a sample near the cutoff called positive by LC/MS/MS but negative by the device, or vice-versa) were observed consistently with the nature of qualitative cutoff tests. |
| Lay Person Study Agreement | For all tested drugs (AMP, BAR, BZO, BUP, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, TCA, THC, TRA, PPX, FYL, 6-MAM) across two configurations: - Agreement at -100%, -75%, -50% Cutoff: Generally 100% negative agreement. - Agreement at +50%, +75% Cutoff: Generally 100% positive agreement. - Agreement at -25% and +25% Cutoff: Ranged from 85.0% to 95.0% negative/positive agreement, respectively, demonstrating expected variability around the cutoff. All participants found the instructions easy to understand and follow (Flesch-Kincaid Grade Level 7). |
2. Sample Size Used for the Test Set and Data Provenance
-
Precision/Reproducibility Study:
- Sample Size: For each drug and each concentration (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100% of cutoff), tests were performed in 2 runs per day for 25 days, using 3 lots of test cups. This means for each concentration and drug, there were 50 tests per lot (2 runs/day * 25 days) and 150 tests across 3 lots.
- Data Provenance: Urine samples spiked with target drugs into drug-free urine. The drug concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study, not from actual patients.
-
Analytical Specificity/Interference Study:
- Sample Size: Not explicitly stated as a total number, but drugs and interfering compounds were spiked into drug-free urine samples and tested using 3 lots of devices for each interference condition.
- Data Provenance: Laboratory prepared urine samples (drug-free urine spiked with various compounds).
-
Method Comparison Study:
- Sample Size: 80 unaltered urine clinical samples (40 negative and 40 positive) for each drug.
- Data Provenance: Unaltered clinical urine samples. The country of origin is not specified but it is an in-house study.
-
Lay Person Study:
- Sample Size: 280 lay persons.
- Data Provenance: Urine samples prepared by spiking drug(s) into drug-free pooled urine specimens. The concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study designed to evaluate user comprehension and ease of use, not true clinical performance with patient samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
-
Precision/Reproducibility, Analytical Specificity/Interference, Lay Person Study: Ground truth was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and standardized analytical method for drug concentration determination. No human experts were explicitly stated to establish this ground truth, as it's an objective chemical analysis.
-
Method Comparison Study: Ground truth was established by LC-MS/MS. Similar to the above, this is an objective analytical method.
4. Adjudication Method for the Test Set
- For the Method Comparison Study, the device results were compared directly to the LC-MS/MS results. There is no mention of an adjudication process (e.g., 2+1, 3+1 expert review) for the ground truth itself, as LC-MS/MS is considered the definitive truth.
- For the Lay Person Study, the "ground truth" for the expected positive/negative call was based on the known spiked concentrations confirmed by LC-MS/MS. The participants' interpretations of the device results were then compared to this established truth. There was no adjudication of the lay person's reading, but rather an assessment of their accuracy against the known sample content.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done.
- This device is a qualitative lateral flow immunochromatographic assay ("rapid test cup") for in vitro diagnostic use, intended for direct reading by a user (either professionals or lay persons). It does not involve AI or human readers interpreting complex images or data assisted by AI.
- The closest analogy is the "Lay Person Study," which assesses how well lay users can interpret the results without assistance on complex outputs, but there is no AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, the analytical performance studies (precision, specificity, stability) and the LC-MS/MS ground truth in the method comparison study represent "standalone" performance. The device itself (the immunochromatographic strip) is the "algorithm," and its chemical reactions are assessed according to established scientific principles, independent of human interpretation prior to result line formation.
- However, the final reading of the lines on the rapid test cup is still a human-in-the-loop step, even for laboratory personnel in the precision and method comparison studies, and especially for lay users in their study. The intent of these "rapid test" types of devices is precisely for direct human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The primary ground truth used across all analytical and method comparison studies was LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and quantitative laboratory method used for definitive drug detection and concentration measurement.
8. The Sample Size for the Training Set
- This submission describes a premarket notification (510(k)) for an in vitro diagnostic device. Unlike AI/ML devices, these types of products typically do not involve "training sets" in the machine learning sense.
- The manufacturing process, antibody selection, and assay design for these immunochromatographic tests are developed and refined through internal R&D, often using a range of samples and iterations. The document does not describe a formal 'training set' analogous to those used for AI algorithms. The data presented are for validation and verification of the finished device.
9. How the Ground Truth for the Training Set was Established
- As noted above, a "training set" in the AI/ML context is not applicable here. The development of the reagents and test design would have relied on standard laboratory practices for developing highly specific and sensitive immunoassays, with positive and negative controls and calibration against known concentrations, usually verified by gold-standard analytical methods like LC-MS/MS.
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February 27, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Hangzhou Alltest Biotech Co., Ltd % Jenny Xia Director LSI International Inc. 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K244043
Trade/Device Name: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: NFT, PTH, NGL, NFV, NFY, PTG, NGG, QBF, NGM, QAW, NFW, NGI Dated: December 28, 2024 Received: December 30, 2024
Dear Jenny Xia:
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 mediation-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-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Joseph A. Joseph A. Kotarek -S Date: 2025.02.27 Kotarek -S 10:58:43 -05'00'
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
EF
510(k) Number (if known) K244043
Device Name
AllTest Multi-Drug Rapid Test Cup : AllTest Multi-Drug Test Cup
Indications for Use (Describe)
AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine 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 |
| Tramadol (TRA) | 100 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Fentanyl(FYL) | 1 ng/mL |
| 6-monoacetylmorphine (6-MAM) | 10 ng/mL |
| AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination |
est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination 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 when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. 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 Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine 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 |
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| 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) | 1-nor-Δ9-THC-9 COOH | 50 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Fentanyl(FYL) | Fentanyl | 1 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. 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.
Type of Use (Select one or both, as applicable)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K244043
- December 28, 2024 1. Date: Hangzhou AllTest Biotech Co., Ltd. Submitter: 2. Plant Bldg. 3, 4, 5, No. 550 Yinhai Street, Baiyang Street, Hangzhou ETDZ, Jianggan District 3. Contact person: Jenny Xia LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 301-525-6856 Email: jxia@lsi-consulting.org
- Device Name: AllTest Multi-Drug Rapid Test Cup 4. AllTest Multi-Drug Test Cup Classification: Class II ਹੈ.
| Product Code | Regulation Section | Panel |
|---|---|---|
| Target Drug | ||
| NFTAmphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| PTHSecobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NGLBuprenorphine (BUP)Fentanyl (FYL)Morphine (MOP/OPI)Oxycodone (OXY)6-Monoacetylmorphine(6-MAM)Tramadol (TML) | 862.3650, Opiate Test System | Toxicology |
| NGIMorphine (MOP/OPI) | 862.3640, Morphine Test System | Toxicology |
| NFVOxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFYCocaine (COC) | 862.3250, Cocaine and cocainemetabolite test system | Toxicology |
| PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGGMethylenedioxymethamphetamine(MDMA) | 862.3610,Methamphetamine Test System | Toxicology |
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| Methamphetamine (MET) | ||
|---|---|---|
| QBF | 862.3700 Propoxyphene test system. | Toxicology |
| Propoxyphene(PPX) | ||
| NGM | Unclassified | Toxicology |
| Phencyclidine (PCP) | ||
| QAW | 862.3910 Tricyclic antidepressant drugstest system | Toxicology |
| Nortriptyline (TCA) | ||
| NFW | 862.3870, Cannabinoids Test System | Toxicology |
| Cannabinoids (THC) |
6. Predicate Devices:
AllTest Multi-Drug Rapid Test Cup (K233019)
Intended Use 7.
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, Marijuana, Tramadol , Propoxyphene , Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off (ng/mL) |
|---|---|
| Amphetamine (AMP) | 500 or 1000 |
| Buprenorphine (BUP) | 10 |
| Secobarbital (BAR) | 300 |
| Benzodiazepines (BZO) | 300 |
| Cocaine (COC) | 150 or 300 |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 |
| Methamphetamine (MET) | 500 or 1000 |
| Methylenedioxymethamphetamine (MDMA) | 500 |
| Morphine (MOP/OPI) | 300 or 2000 |
| Methadone (MTD) | 300 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
| Nortriptyline (TCA) | 1000 |
| Marijuana (THC) | 50 |
| Tramadol (TRA) | 100 |
| Propoxyphene (PPX) | 300 |
| Fentanyl (FYL) | 1 |
| 6-monoacetylmorphine (6-MAM) | 10 |
AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
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The tests may yield positive results for the prescription drugs 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 is the recommended confirmatory method.
AllTest Multi-Drug 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, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine 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 |
| 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 |
| Tramadol (TRA) | Tramadol | 100 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Fentanyl (FYL) | Fentanyl | 1 |
| 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 |
AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs 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 is the recommended confirmatory method.
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8. Device Description
AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
9. Substantial Equivalence Information
| Similarities | |||
|---|---|---|---|
| Item | Device | Predicate (K233019) | |
| Intended use | Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use | Same. | |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | Same | |
| Type of Test | Qualitative | Same | |
| Specimen Type | Human urine | Same | |
| Target Drug and Cut Off Values | Target Drugs | Cutoff (ng/mL) | Same except that no |
| Amphetamine(AMP) | 1000 or 500 | FYL | |
| Secobarbital (BAR) | 300 | TRA | |
| Buprenorphine (BUP) | 10 | 6-MAAM | |
| Oxazepam (BZO) | 300 | PPX | |
| Cocaine (COC) | 150 | ||
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 | ||
| Methylenedioxymethamphetamine (MDMA) | 500 | ||
| Methamphetamine (MET) | 1000 or 500 | ||
| Morphine (MOP300/OPI2000) | 2000 or 300 | ||
| Methadone (MTD) | 300 | ||
| Oxycodone (OXY) | 100 | ||
| Phencyclidine (PCP) | 25 | ||
| Propoxyphene(PPX) | 300 | ||
| Nortriptyline (TCA) | 1000 | ||
| Cannabinoids (THC) | 50 | ||
| 6-Monoacetylmorphine(6-MAM) | 10 | ||
| Fentanyl (FYL) | 1 | ||
| Tramadol (TRA) | 100 | ||
| Differences | |||
| Configurations | Test cup | Test cup & Test Dip Card |
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10. Standard/Guidance Document Reference (if applicable)
None referenced.
11. Test Principle
AllTest Multi-Drug Rapid Test Cup or AllTest Multi-Drug Test Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.
When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.
12. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. The results obtained are summarized in the following table for Tramadol (TRA), Propoxyphene (PPX), Fentanyl(FYL) and 6-monoacetylmorphine (6-MAM). The rest data were reported in the cleared AllTest submission of K233019.
TRA
| Concentration(ng/mL) | +100%cutoff | +75%cutoff | +50%cutoff | +25%cutoff | Cutoff | -25%cutoff | -50%cutoff | -75%cutoff | -100%cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 193 | 175.0 | 152.5 | 129.1 | 101.5 | 74.3 | 49.2 | 25.6 | 0 |
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| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | |
|---|---|---|---|---|---|---|---|---|---|
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
PPX
| Concentration | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|---|---|---|---|---|---|---|---|---|---|
| (ng/mL) | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cut-off | |
| Lot Number | 613.3 | 528.7 | 435.4 | 371.3 | 304.6 | 229.7 | 146.9 | 79.9 | 0 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
FYL
| Concentration(ng/mL) | +100%cutoff | +75%cutoff | +50%cutoff | +25%cutoff | Cutoff | -25%cutoff | -50%cutoff | -75%cutoff | -100%cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot Number | 2.05 | 1.79 | 1.53 | 1.21 | 0.96 | 0.71 | 0.48 | 0.26 | 0 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
6-MAM
| Concentration | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|---|---|---|---|---|---|---|---|---|---|
| (ng/mL) | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cut-off | |
| Lot Number | 20.6 | 17.0 | 15.3 | 12.2 | 9.8 | 7.0 | 5.3 | 2.6 | 0 |
| Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device is stable at 2-30°C for 24 months based on real time stability study.
d. Analytical specificity/Interference:
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device. The results obtained are summarized in the following table for Tramadol (TRA),
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Propoxyphene (PPX), Fentanyl(FYL) and 6-monoacetylmorphine (6-MAM). The rest data were reported in the cleared AllTest submission of K233019.
Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100. If no cross-reactivity was observed, the highest concentration tested is shown.
| Drug/Cutoff | Compound | Minimumconcentrationrequired to obtaina positive result(ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| TRA 100 | Tramadol | 100 | 100% |
| TRA 100 | N-Desmethyl-cis-tramadol | 200 | 50% |
| TRA 100 | O-Desmethyl-cis-tramadol | 1000 | 10% |
| TRA 100 | Venlafaxine | 100000 | 0.1% |
| TRA 100 | (±)-O-Desmethylvenlafaxine | 100000 | 0.1% |
| PPX 300 | (+)-Propoxyphene | 300 | 100% |
| PPX 300 | (+)-Norpropoxyphene | 500 | 60% |
| 6-MAM 10 | 6-Monoacetylmorphine | 10 | 100% |
| 6-MAM 10 | Hydrocodone | >100000 | <0.01% |
| 6-MAM 10 | Hydromorphone | >100000 | <0.01% |
| 6-MAM 10 | Morphine | >100000 | <0.01% |
| 6-MAM 10 | Oxymorphone | >100000 | <0.01% |
| 6-MAM 10 | Procaine | >100000 | <0.01% |
| 6-MAM 10 | Thebaine | >100000 | <0.01% |
| 6-MAM 10 | Diacetylmorphine (heroin) | 300 | 3.3% |
| 6-MAM 10 | Acetylcodeine | >100000 | <0.01% |
| 6-MAM 10 | Buprenorphine | >100000 | <0.01% |
| 6-MAM 10 | Dihydrocodeine | >100000 | <0.01% |
| 6-MAM 10 | Nalorphine | >100000 | <0.01% |
| 6-MAM 10 | Mitragynine (kratom) | >100000 | <0.01% |
| 6-MAM 10 | Norbuprenorphine | >100000 | <0.01% |
| 6-MAM 10 | s-Monoacetylmorphine | 10 | 100% |
| 6-MAM 10 | Codeine | >100000 | <0.01% |
| 6-MAM 10 | Ethylmorphine | >100000 | <0.01% |
| 6-MAM 10 | Levorphanol tartrate | >100000 | <0.01% |
| Morphine-3-β-D-glucuronide | >100000 | <0.01% | |
| Norcodeine | >100000 | <0.01% | |
| Normorphine | >100000 | <0.01% | |
| Oxycodone | >100000 | <0.01% | |
| Dextromethorphan | >100000 | <0.01% | |
| Imipramine hydrochloride | >100000 | <0.01% | |
| Levacetylmethadol (LAAM) | >100000 | <0.01% | |
| Meperidine | >100000 | <0.01% | |
| (±)-Methadone | >100000 | <0.01% | |
| Naloxone hydrochloride | >100000 | <0.01% | |
| Naltrexone hydrochloride | >100000 | <0.01% | |
| Naproxen | >100000 | <0.01% | |
| Noroxycodone HCL | >100000 | <0.01% | |
| Noroxymorphone HCL | >100000 | <0.01% | |
| (+)-Norpropoxyphene maleate | >100000 | <0.01% | |
| Oxymorphone-3β-D-glucuronide | >100000 | <0.01% | |
| Tapentadol HCl | >100000 | <0.01% | |
| Tramadol hydrochloride | >100000 | <0.01% | |
| Chlordiazepoxide | >100000 | <0.01% | |
| Clobazam | >100000 | <0.01% | |
| D-Amphetamine | >100000 | <0.01% | |
| (±)-Amphetamine | >100000 | <0.01% | |
| FYL 1 | Fentanyl | 1 | 100% |
| Acetyl fentanyl | 1 | 100% | |
| Acrylfentanyl | 1 | 100% | |
| ω-1-Hydroxyfentanyl | 20000 | 0.005% | |
| Isobutyryl fentanyl | 1 | 100% | |
| Ocfentanil | 2.5 | 40% | |
| Butyryl fentanyl | 2.5 | 40% | |
| Furanyl fentanyl | 5 | 20% | |
| Valeryl fentanyl | 10 | 10% | |
| (±) β-hydroxythiofentanyl | 2 | 50% | |
| 4-Fluoro-isobutyrylfentanyl | 50 | 2% | |
| Para-fluorobutyryl fentanyl | 4 | 25% | |
| Para-fluoro fentanyl | 3 | 33.3% | |
| (±)-3-cis-methyl fentanyl | 50 | 2% | |
| Carfentanil | 2 | 50% | |
| Sufentanil | 10 | 10% | |
| Alfentanil | 5000 | 0.02% | |
| Cyclopropylfentanyl | 3 | 33.3% | |
| Despropionyl fentanyl (4-ANPP) | 2500 | 0.04% | |
| Isotonitaze | >100000 | <0.001% | |
| AH-7921 HCL | >100000 | <0.001% | |
| Remifentanil | >100000 | <0.001% | |
| Norfentanyl | >100000 | <0.001% | |
| Acetyl norfentanyl | >100000 | <0.001% | |
| Norcarfentanil | >100000 | <0.001% | |
| 6-Acetyl morphine | >100000 | <0.001% | |
| Amphetamine | >100000 | <0.001% | |
| Buprenorphine | >100000 | <0.001% | |
| Buprenorphineglucuronide | >100000 | <0.001% | |
| Codeine | >100000 | <0.001% | |
| Dextromethorphan | >100000 | <0.001% | |
| Dihydrocodeine | >100000 | <0.001% | |
| EDDP | >100000 | <0.001% | |
| EMDP | >100000 | <0.001% | |
| Fluoxetine | >100000 | <0.001% | |
| Heroin | >100000 | <0.001% | |
| Hydrocodone | >100000 | <0.001% | |
| Hydromorphone | >100000 | <0.001% | |
| Ketamine | >100000 | <0.001% | |
| Levorphanol | >100000 | <0.001% | |
| Meperidine | >100000 | <0.001% | |
| Methadone | >100000 | <0.001% | |
| Morphine | >100000 | <0.001% | |
| Morphine-3-glucuronide | >100000 | <0.001% | |
| Naloxone | >100000 | <0.001% | |
| Naltrexone | >100000 | <0.001% |
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{13}------------------------------------------------
{14}------------------------------------------------
| Norbuprenorphine | >100000 <0.001% |
|---|---|
| Norcodeine | >100000 <0.001% |
| Norketamine | >100000 <0.001% |
| Normeperidine | >100000 <0.001% |
| Normorphine | >100000 <0.001% |
| Noroxycodone | >100000 <0.001% |
| Oxycodone | >100000 <0.001% |
| Oxymorphone | >100000 <0.001% |
| Pentazocine (Talwin) | >100000 <0.001% |
| Pipamperone | >100000 <0.001% |
| Risperidone | >100000 <0.001% |
| Tapentadol | >100000 <0.001% |
| Thioridazine | >100000 <0.001% |
| Tilidine | >100000 <0.001% |
| Tramadol | >100000 <0.001% |
| Tramadol-O-Desmethyl | >100000 <0.001% |
| Tramadol-N-Desmethyl | >100000 <0.001% |
To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 50% below and 50% above each corresponding cutoff.
Compounds that show no interference at a concentration of 100µg/mL or specified concentrations are summarized in the following table.
| Acetaminophen | D-Pseudoephedrine | Norfentanyl |
|---|---|---|
| Acetone (1000mg/dL) | Duloxetine | Noscapine |
| Acetophenetidin | 4-Dimethyl-aminoantipyrine | (+)-Naproxen |
| Acetylsalicylic Acid | 5, 5-Diphenylhydantoin | 19-Norethindrone |
| Acyclovir | Ecgonine methyl ester | Octopamine |
| Albumin (100mg/dL) | EMDP | O-Hydroxyhippuric acid |
| Albuterol sulfate (Proair HFA) | Ephedrine | Olanzapine |
| Alpha Methadol | Erythromycin | Omeprazole |
| Aminophylline | Esomeprazole Magnesium (exceptMTD test) | Oxalic acid (100 mg/dL) |
| Aminopyrine | Estradiol | Oxolinic acid |
| Amoxicillin | Estrone | Oxymetazoline |
| Ampicillin | Ethanol (1%) | Paliperidone |
| Aripiprazole | Fenofibrate | Papaverine |
| Aspartame | Fenoprofen | Penicillin-G |
| Aspirin | Fentanyl(except FYL test) | PenicillinV Potassium |
| Atomoxetine | Fluoxetine Hydrochloride | Perphenazine |
| Atorvastatin Calcium | Fluphenazine | Phenacetin |
| Atropine | Fotemustine | Phenelzine |
| Azithromycin | Furosemide | Phenethylamine |
| Baclofen | Gabapentin | Phenylethylamine |
| Benzilic acid | Galactose (10mg/dL) | Phenylpropanolamine |
| Benzocaine | Gamma Globulin(500mg/dL) | Prednisone |
| Benzoic Acid | Gatifloxacin | Pregablin |
| Benzphetamine | Gemfibrozil | Procaine |
| Bilirubin | Gentisic acid | Promazine |
| Boric Acid (1%) | Glucose (3000mg/dL) | Promethazine |
| Bupropion | Guaiacol glyceryl ether | Propoxyphene (except PPX test) |
| Caffeine | Hemoglobin | Propranolol |
| Cannabidiol | Hydralazine | Pseudoephedrine |
| Captopril | Hydrochlorothiazide | Pyridoxine |
| Carbamazepine | Hydrocortisone | Pyrilamine |
| Carfentanil (except FYL test) | 3-Hydroxytyramine | Pyrogallol |
| Carisoprodol | Ibuprofen | Quetiapine |
| Cefradine | Isoxsuprine | Quinine |
| Cephalexin | (+/-)-Isoproterenol | Quinolinic Acid |
| Chloralhydrate | Ketamine | R-(-)-Apomorphine |
| Chloramphenicol | Ketoprofen | Ranitidine |
| Chlordiazepoxide (except BZO test) | LAAM HCl | Riboflavin (10mg/dL) |
| Chloroquine (except MET test) | Labetalol | Rifampicin |
| Chlorothiazide | L-Ascorbic Acid | Risperidone |
| Chlorpromazine | L-Ephedrine | Salicylic Acid |
| Cholesterol | L-Epinephrine | Serotonin(5- Hydroxytyramine) |
| Ciprofloxacin Hydrochloride | Levofloxacin Hydrochloride | Sertraline |
| Citalopram | Levonorgestrel | Sildenafil Citrate |
| Clarithromycin | Levothyroxine Sodium | Simvastatin |
| Clonidine | Lidocaine Hydrochloride | Sulfamethazine |
| Clozapine | Lisinopril | Sulindac |
| Conjugated Estrogens | Loperamide | Telmisartan |
| Cortisone | Loratadine | Tetracycline |
| Creatine Hydrate | L-phenylephrine | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Creatinine | Magnesium | Tetrahydrocortisone, 3-acetate |
| Cyclobenzaprine | Maprotiline | Tetrahydrozoline |
| Cyclodextrin | Meperidine | Theophylline |
| (-)-Cotinine | Meprobamate | Thiamine |
| (+)-Chlorpheniramine | Methapyrilene | Thioridazine |
| D,L-Epinephrine | Methaqualone | Tramadol (except TRA test) |
| D,L-Octopamine | Methoxyphenamine (except AMP/MET test) | Triamterene |
| d,l-Propranolol | Methylphenidate | Trifluoperazine |
| D,L-Tryptophan | Metoprolol Tartrate | Trimethobenzamide |
| D,L-Tyrosine | Metronidazole (300ug/ml) | Trimethoprim |
| Delorazepam (except BZO test) | Mifepristone | Tryptamine |
| Deoxycorticosterone | N-Acetylprocainamide | Tyramine |
| Desloratadine | NaCl(4000mg/dL) | Urea (2000mg/dL) |
| Dextromethorphan | Nalidixic Acid | Uric Acid |
| Diclofenac | Naloxone hydrochloride (except OXY test) | Valproic acid (250ug/ml) |
{15}------------------------------------------------
{16}------------------------------------------------
| Diflunisal | Naltrexone | Venlafaxine HCl (except TRA test) |
|---|---|---|
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine HCl | Nicotine | Vitamin B2 |
| Disopyramide (except MTD test) | Nicotinic Acid | Vitamin C |
| Dopamine HCl | Nifedipine | Zaleplon |
| Doxepin | Nitroglycerin | Zomepirac sodium salt |
| Doxylamine | Nordoxepin |
Interference by pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 50% below and 50% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.
B. Method comparison study
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. The results are presented in the table below for Tramadol (TRA), Propoxyphene (PPX), Fentanyl(FYL) and 6-monoacetylmorphine (6-MAM). The rest data were reported in the cleared AllTest submission of K233019.
| Drugtest | Test CupResult | Drug-Free | LowNegative byLC-MS/MS(less than -50%) | Near CutoffNegative byLC-MS/MS(Between -50% and theCutoff) | Near CutoffPositive byLC-MS/MS(Betweenthe cutoffand +50%) | High Positiveby LC-MS/MS(greater than+50%) | |
|---|---|---|---|---|---|---|---|
| TRA | Operator | + | 0 | 0 | 1 | 11 | 29 |
| TRA | A | - | 12 | 14 | 13 | 0 | 0 |
| TRA | Operator | + | 0 | 0 | 0 | 10 | 29 |
| TRA | B | - | 12 | 14 | 14 | 1 | 0 |
| TRA | Operator | + | 0 | 0 | 1 | 10 | 29 |
| TRA | C | - | 12 | 14 | 13 | 1 | 0 |
| PPX | Operator | + | 0 | 0 | 1 | 10 | 30 |
| PPX | A | - | 12 | 13 | 14 | 0 | 0 |
| PPX | Operator | + | 0 | 0 | 1 | 10 | 30 |
| PPX | B | - | 12 | 13 | 14 | 0 | 0 |
| PPX | Operator | + | 0 | 0 | 0 | 9 | 30 |
| PPX | C | - | 12 | 13 | 15 | 1 | 0 |
| 6-MAM | Operator | + | 0 | 0 | 1 | 14 | 26 |
| 6-MAM | A | - | 12 | 11 | 16 | 0 | 0 |
| 6-MAM | Operator | + | 0 | 0 | 1 | 13 | 26 |
| 6-MAM | B | - | 12 | 11 | 16 | 1 | 0 |
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| Operator | + | 0 | 0 | 2 | 13 | 26 | |
|---|---|---|---|---|---|---|---|
| C | - | 12 | 11 | 15 | 1 | 0 | |
| FYL | Operator | + | 0 | 0 | 2 | 22 | 16 |
| A | - | 12 | 13 | 13 | 2 | 0 | |
| Operator | + | 0 | 0 | 3 | 22 | 16 | |
| B | - | 12 | 13 | 12 | 2 | 0 | |
| Operator | + | 0 | 0 | 2 | 22 | 16 | |
| C | - | 12 | 13 | 13 | 2 | 0 |
Discordant Results are summarized below.
| Drug | Operator | Sample Number | LC/MS/MSResult (ng/mL) | Accurate Result |
|---|---|---|---|---|
| TRA | A, C | S2148 | 91.6 | + |
| B, C | S2157 | 103.0 | - | |
| PPX | A | S2052 | 286.3 | + |
| B | S2017 | 280.6 | + | |
| C | S2018 | 319.8 | - | |
| 6-MAM | A, C | S2249 | 9.5 | + |
| B, C | S2236 | 9.6 | + | |
| B, C | S2228 | 10.2 | - | |
| FYL | A, C | S1425 | 1.02 | - |
| A | S1420 | 0.87 | + | |
| A, B | S1447 | 1.01 | - | |
| A, B | S1442 | 0.91 | + | |
| B, C | S1402 | 0.92 | + | |
| B | S1422 | 1.08 | - | |
| B | S1465 | 0.92 | + | |
| C | S1453 | 0.82 | + | |
| C | S1439 | 1.02 | - |
C. Lay person study
A lay user study was performed at three intended user sites with 280 lay persons. 121 male and 159 female tested AllTest Multi-Drug Rapid Test Cup. They had diverse educational and professional backgrounds and their age range from 20 to > 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug freepooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
Result of AllTest Multi-Drug Rapid Test Cup: Configuration 1
| Drug | Cutoff | Results | Concentration |
|---|---|---|---|
| ------ | -------- | --------- | --------------- |
{18}------------------------------------------------
| (ng/mL) | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff | ||
|---|---|---|---|---|---|---|---|---|---|
| AMP | 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| 1000 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 1000 | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| 300 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 300 | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| 300 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | |
| 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 300 | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | |
| BUP | 10 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| 10 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | |
| 10 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 10 | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | |
| COC | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| 300 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 300 | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| 300 | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 300 | Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |
| MDMA | 500 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| 500 | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | |
| 500 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 500 | Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | |
| MET | 1000 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| 1000 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |
| 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 1000 | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | |
| MOP | 2000 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| 2000 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |
| 2000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 2000 | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | |
| MTD | 300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| 300 | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |
| 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| 300 | Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | |
| OXY | 100 | 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% | 95.0% | 90.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | ||
| PCP | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |
| 25 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | ||
| TCA | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | ||
| THC | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |
| 50 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | ||
| TRA | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |
| 100 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | ||
| PPX | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | |
| 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 17 | 0 | 0 | 0 | ||
| FYL | Positive | 0 | 0 | 0 | 3 | 20 | 20 | 20 | |
| 1 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 85.0% | 100.0% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 | ||
| 6-MAM | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 | |
| 10 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% | ||
| Concentration | |||||||||
| Result of AllTest Multi-Drug Rapid Test Cup: Configuration 2 |
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| Drug | Cutoff(ng/mL) | Concentration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Results | -100%cutoff | -75%cutoff | -50%cutoff | -25%cutoff | +25%cutoff | +50%cutoff | +75%cutoff | |||
| AMP | 500 | Negative | 20 | 20 | 20 | 18 | ||||
| Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |||
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | |||
| BAR | 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% | 95.0% | 90.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |||
| BZO | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |||
| BUP | 10 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 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% | 90.0% | 95.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | |||
| EDDP | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 | |||
| MDMA | 500 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 90.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |||
| MET | 500 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |||
| MOP | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 | |||
| MTD | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 90.0% | 95.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |||
| OXY | 100 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |||
| PCP | 25 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |||
| Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |||
| Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |||
| TCA | 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Agreement (%) | 100% | 100% | 100% | 95.0% | 95.0% | 100% | 100% | |||
| THC | 50 | 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% | 90.0% | 95.0% | 100% | 100% | |||
| TRA | 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 | |||
| Agreement (%) | 100% | 100% | 100% | 90.0% | 90.0% | 100% | 100% | |||
| PPX | 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% | 90.0% | 90.0% | 100% | 100% | |||
| FYL | 1 | 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% | 90.0% | 95.0% | 100% | 100% | |||
| 6-MAM | 10 | 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% | 90.0% | 90.0% | 100% | 100% |
{20}------------------------------------------------
{21}------------------------------------------------
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
Clinical Studies: Not applicable.
13. Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are substantially equivalent to the predicate device.
§ 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).