(211 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunochromatographic assay, which relies on chemical reactions and visual interpretation of lines, not AI/ML for analysis or interpretation.
No.
This device is an in-vitro diagnostic test used to detect the presence of drugs in human urine. It is not intended for therapy or treatment.
Yes
Explanation: The device is designed for the qualitative detection of various drugs in human urine, which provides information about the presence or absence of these substances, making it a diagnostic device. The "Intended Use" section explicitly states it is for "qualitative and simultaneous detection" of drugs.
No
The device is described as a "competitive binding, lateral flow immunochromatographic assay" in both cup and dip card formats, which are physical test kits that detect substances in urine. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the "qualitative and simultaneous detection of [various drugs] in human urine". This clearly indicates it is used to test a biological sample (urine) in vitro (outside the body) to obtain diagnostic information (presence or absence of drugs).
- Device Description: It describes the device as a "competitive binding, lateral flow immunochromatographic assay" that detects analytes in "human urine samples". This further confirms its use with biological samples in vitro.
- Performance Studies: The document details performance studies involving testing urine samples with known concentrations of drugs, comparing results to LC/MS (a confirmatory method), and evaluating performance with lay users. These are typical studies conducted for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a predicate device (K153050; Rapid Single/Multi-drug test Cup Rapid Single/Multi-drug test Dipcard) which is also a drug test in urine, strongly suggests that this device falls under the same regulatory category, which for such tests is IVD.
The fact that it is intended for both "Over-the-counter use" and "Prescription use only" doesn't change its classification as an IVD; it simply indicates different regulatory pathways or intended user populations within the IVD category.
N/A
Intended Use / Indications for Use
Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|---|---|---|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Opzaepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug UrineTest Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
For over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DIO, LDJ, LCM, JXM, LAF, DKZ, DIS, DJR, JXN
Device Description
The subject device will be sold in two formats: Multi-drug Urine Test Dip Card and Multi-drug Urine Test Cup.
Multi-Drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Multi-Drug Urine Test devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use; Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A lay user study were performed at three intended user sites with 603 laypersons for Test Cup and 300 laypersons for Test Dip Card).They should have diverse educational and professional backgrounds and ranged in age from 21 to 50. Urine samples are prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cut off by spiking 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. They will be asked to fill out an English questionnaire after finishing the test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
10.1 Comparison Study:
Different operators to test the same sample, the results are consistent. The Multi-drug Urine Test Cup/ Test Dip Card has good comparison. The Summarize/results are as follows:
Cup:
Amphetamine: % agreement among positives: 98.3%, % agreement among negatives: 100.0%
Secobarbital: % agreement among positives: 98.3%, % agreement among negatives: 100.0%
Buprenorphine: % agreement among positives: 98.3%, % agreement among negatives: 100.0%
Oxazepam: % agreement among positives: 98.3%, % agreement among negatives: 100.0%
Cocaine: % agreement among positives: 97.5%, % agreement among negatives: 100.0%
Methylenedioxy-methamphetamine: % agreement among positives: 95.8%, % agreement among negatives: 100.0%
Methamphetamine: % agreement among positives: 95.8%, % agreement among negatives: 100.0%
Morphine: % agreement among positives: 97.5%, % agreement among negatives: 100.0%
Methadone: % agreement among positives: 97.5%, % agreement among negatives: 100.0%
Oxycodone: % agreement among positives: 99.2%, % agreement among negatives: 100.0%
Phencyclidine: % agreement among positives: 95.8%, % agreement among negatives: 100.0%
Marijuana: % agreement among positives: 99.2%, % agreement among negatives: 100.0%
Card:
Amphetamine: % agreement among positives: 98.3%, % agreement among negatives: 100.0%
Secobarbital: % agreement among positives: 100.0%, % agreement among negatives: 100.0%
Buprenorphine: % agreement among positives: 100.0%, % agreement among negatives: 100.0%
Oxazepam: % agreement among positives: 98.3%, % agreement among negatives: 100.0%
Cocaine: % agreement among positives: 98.3%, % agreement among negatives: 100.0%
Methylenedioxy-methamphetamine: % agreement among positives: 98.3%, % agreement among negatives: 100.0%
Methamphetamine: % agreement among positives: 99.2%, % agreement among negatives: 100.0%
Morphine: % agreement among positives: 99.2%, % agreement among negatives: 100.0%
Methadone: % agreement among positives: 97.5%, % agreement among negatives: 100.0%
Oxycodone: % agreement among positives: 96.7%, % agreement among negatives: 100.0%
Phencyclidine: % agreement among positives: 99.2%, % agreement among negatives: 100.0%
Marijuana: % agreement among positives: 99.2%, % agreement among negatives: 100.0%
10.2 Cross Reactivity:
Cross reactivity study is complemented, the result showed when there are substances of the corresponding concentration in the urine, the Test Cup and Test Dip Card may produce false positive results.
10.3 Interference:
Potential interfering substances were added to drug-free urine samples with target drugs of ±25% cutoff level.The substances in the table up did not affect the Test Dip Card/Test Cup at concentrations of 100ug/ml.All samples with a concentration of -25% cutoff and drug free test results are aegative, and all samples with a concentration of+25% cutoff test results are positive.
10.4 Interference of Different pH:
The results are all positive for samples at +50% cutoff and all negative for samples at -50% cutoff. The results show that when the pH of samples are in the range of 4-9, there is no effect on the test results.
10.5 Interference of Specific Gravity:
The results all positive for samples at +50% cutoff and all negative for samples at -50% cutoff. The results show that when the gravity is in the range of 1.000-1.035, there is no effect on the test results.
10.7 Precision:
As the results ,all the results of drug free,-75%Cut off,-50%Cut off are negative, and all the results of +100% cutoff,+75%Cut off,+50%Cut off are positive, and cutoff coincidence rate of the test results is 79%(>55%),±25% cutoff coincidence rate of the test results is 88%(>84%),so the Precision of kit is qualified.
10.8 Lay User Study:
Lay user study was performed with 603 laypersons for Test Cup and 300 laypersons for Test Dip Card). Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff and confirmed by LC/MS.
For Test Cup:
Amphetamine: 100% agreement for negative samples, 95.0% for +25% cutoff, 100.0% for +50% and +75% cutoff.
Secobarbital: 100% agreement for negative samples and all positive cutoffs.
Buprenorphine: 100% agreement for negative samples and all positive cutoffs.
Oxazepam: 100% agreement for negative samples, 95.0% for +25% cutoff, 100.0% for +50% and +75% cutoff.
Cocaine: 100% agreement for negative samples and all positive cutoffs.
Methylenedioxy-methamphetamine: 100% agreement for negative samples and all positive cutoffs.
Methamphetamine: 100% agreement for negative samples and all positive cutoffs.
Morphine: 100% agreement for negative samples and all positive cutoffs.
Methadone: 100% agreement for negative samples, 95.0% for +25% cutoff, 100.0% for +50% and +75% cutoff.
Oxycodone: 100% agreement for negative samples and all positive cutoffs.
Phencyclidine: 100% agreement for negative samples and all positive cutoffs.
Marijuana: 100% agreement for negative samples and all positive cutoffs.
For Test Dip Card:
Amphetamine: 100% agreement for negative samples and all positive cutoffs.
Secobarbital: 100% agreement for negative samples and all positive cutoffs.
Buprenorphine: 100% agreement for negative samples, 95.0% for +25% cutoff, 100.0% for +50% and +75% cutoff.
Oxazepam: 100% agreement for negative samples and all positive cutoffs.
Cocaine: 100% agreement for negative samples and all positive cutoffs.
Methylenedioxy-methamphetamine: 100% agreement for negative samples and all positive cutoffs.
Methamphetamine: 100% agreement for negative samples and all positive cutoffs.
Morphine: 100% agreement for negative samples and all positive cutoffs.
Methadone: 100% agreement for negative samples and all positive cutoffs.
Oxycodone: 100% agreement for negative samples and all positive cutoffs.
Phencyclidine: 100% agreement for negative samples and all positive cutoffs.
Marijuana: 100% agreement for negative samples and all positive cutoffs.
"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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
Shanghai Accurature Diagnostics Co., Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Re: K23228
Trade/Device Name: Multi-drug Urine Test Cup Multi-drug Urine Test Dip Card Accurature Multi-drug Urine Test Cup Accurature Multi-drug Urine Test Dip Card Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DIO, LDJ, LCM, JXM, LAF, DKZ, DIS, DJR, JXN, Dated: January 22, 2024 Received: January 22, 2024
Dear Eva Li:
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).
1
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 Joseph |
| Kotarek -S | A. Kotarek -S |
| Date: 2024.02.23 17:32:56 | |
| -05'00' | |
| Joseph Kotarek | |
| 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 |
2
Indications for Use
510(k) Number (if known) K232228
Device Name
Accurature Multi-drug Urine Test Cup AccuratureMulti-drug Urine Test Dip Card
Indications for Use (Describe)
Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|---|---|---|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Opzaepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug UrineTest Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
For over-the-counter use.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K232228
Device Name
Multi-drug Urine Test Cup Multi-drug Urine Test Dip Card
Indications for Use (Describe)
Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|---|---|---|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Opzaepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.
For prescription use only.
| Type of Use (Select one or both , as applicable) | |
|---|---|
| ---------------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
510(K)Summary(K232228)
| 1. Prepared date: | Jan 14, 2024 |
|---|---|
| 2. Submitter: | Shanghai Accurature Diagnostics Co.,Ltd. |
| Building 1,No.168 Banqiao East Road, Shanyang Town, | |
| Jinshan District, Shanghai 201508, P.R.China | |
| 3. Contact person: | Shuang He |
| +86-21-33691818 | |
| hes@kangliyixue.com | |
| 4. Device Name*: | OTC use: Accurature Multi-drug Urine Test Dip Card |
| Accurature Multi-drug Urine Test Cup | |
| Rx use: Multi-drug Urine Test Dip Card | |
| Multi-drug Urine Test Cup | |
| 5. Classification: | II |
*The Device for OTC and Rx are exact same, only have different name.
Hereafter, Multi-drug Urine Test Dip card and Multi-drug Urine Test Cup represented both OTC and Rx use.
| Product Code | Regulation Section | Panel |
|---|---|---|
| DKZ | 21 CFR § 862.3100, Amphetamine | |
| Test System | Toxicology | |
| LDJ | 21 CFR § 862.3870, Cannabinoids | |
| Test System | ||
| DIO | 21 CFR § 862.3250, Cocaine and | |
| Cocaine Metabolites Test System | ||
| LAF | 21 CFR § 862.3610, | |
| Methamphetamine Test System | ||
| DJG | 21 CFR § 862.3650, Opiate Test | |
| System | ||
| JXM | 21 CFR § 862.3170, | |
| Benzodiazepine Test System | ||
| DJG | 21 CFR § 862.3650, Opiate Test | |
| System | ||
| DIS | 21 CFR § 862.3150, Barbiturate | |
| Test System | ||
| DJG | 21 CFR § 862.3650, Opiate Test | |
| System | ||
| LAF | 21 CFR § 862.3610, | |
| Methylenedioxy- | ||
| methamphetamine Test System | ||
| LCM | Enzyme Immunoassay | |
| Phencyclidine | ||
| DJR | 21 CFR § 862.3620, Methadone | |
| Test System |
6. Description of the device:
The subject device will be sold in two formats: Multi-drug Urine Test Dip Card and Multi-drug Urine Test Cup.
7
Multi-Drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Multi-Drug Urine Test devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
7. The Predicate Devices:
K153050 Device name: Rapid Single/Multi-drug test Cup Rapid Single/Multi-drug test Dipcard Co-Innovation Biotech Co.,Ltd.
8. Indication for use:
Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|---|---|---|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Oxazepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For prescription use only.
8
Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|---|---|---|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Oxazepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug urineTest Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For over-the-counter use.
9. Substantial Equivalence Information
A summary comparison of features of the subject device and the predicate devices is provided in the following Table
| Item | Subject device | Predicate device
K153050 | Comparison |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Indication(s) for use | Qualitative detection of drugs-of-abuse in human urine (Amphetamine, Secobarbital , Buprenorphine, Oxazepam , Cocaine, Methylenedioxy-methamphetamine, Methamphetamine 、Morphine, Methadone, Oxycodone , Phencyclidine, Marijuana) | Qualitative detection of drugs-of-abuse in human urine (Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana) | Same (but the number of drugs detected different) |
| Intended Users | Over the Counter (OTC) Use and Prescription Use | Over the Counter (OTC) Use and Prescription Use | Same |
9
| Methodology | Competitive binding, lateral flow
immunochromatographic assays
based on the principle of antigen
antibody immunochemistry. | Competitive binding, lateral flow
immunochromatographic
assays
based on the principle of antigen
antibody immunochemistry. | Same |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Specimen | Human Urine | Human Urine | Same |
| Cutoff | Amphetamine:1000ng/mL
Secobarbital:300ng/mL
Buprenorphine:10ng/mL
Oxazepam:300ng/mL
Cocaine:300 ng/mL
Methylenedioxymethamphetami
ne:500 ng/mL
Methamphetamine:1000ng/mL
Morphine:300ng/mL
Methadone:300ng/mL
Oxycodone:100ng/mL
Phencyclidine:25ng/mL
Marijuana:50 ng/mL | Amphetamine:1000ng/mL
Barbiturates:300ng/mL
Buprenorphine:10ng/mL
Benzodiazepines:300ng/mL
Cocaine:300 ng/mL
EDDP:300ng/mL
Methylenedioxymethamphetamine:5
00 ng/mL
Methamphetamine:1000ng/mL
Morphine:300ng/mL
Morphine:2000ng/mL
Methadone:300ng/mL
Oxycodone:100ng/mL
Phencyclidine:25ng/mL
Propoxyphene:300 ng/mL
Tri-cyclic Antidepressants:1000 ng/mL
Marijuana:50 ng/mL | Same |
| Configurations | Dipcard and Cup | Dipcard and Cup | Same |
Remark:
The subject devices have all features of the predicate device except the number of drugs detected. These differences do not affect the performance characteristics of the subject devices.
-
performance Data
-
1 Comparison Study
Different operators to test the same sample, the results are consistent. The Multi-drug Urine Test Cup/ Test
Dip Card has good comparison. The Summarize/results are as follows:
| Cup | Card | |||
|---|---|---|---|---|
| Amphetamine | Result | Amphetamine | Result | |
| % agreement among positives: | 98.3% | Qualified | 98.3% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Secobarbital | Result | Secobarbital | Result | |
| % agreement among positives: | 98.3% | Qualified | 100.0% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Buprenorphine | Result | Buprenorphine | Result | |
| % agreement among positives: | 98.3% | Qualified | 100.0% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Oxazepam | Result | Oxazepam | Result | |
| % agreement among positives: | 98.3% | Qualified | 98.3% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Cocaine | Result | Cocaine | Result |
10
| % agreement among positives: | 97.5% | Qualified | 98.3% | Qualified |
|---|---|---|---|---|
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Methylenedioxy- | ||||
| methamphetamine | Result | Methylenedioxy- | ||
| methamphetamine | Result | |||
| % agreement among positives: | 95.8% | Qualified | 98.3% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Methamphetamine | Result | Methamphetamine | Result | |
| % agreement among positives: | 95.8% | Qualified | 99.2% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Morphine | Result | Morphine | Result | |
| % agreement among positives: | 97.5% | Qualified | 99.2% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Methadone | Result | Methadone | Result | |
| % agreement among positives: | 97.5% | Qualified | 97.5% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Oxycodone | Result | Oxycodone | Result | |
| % agreement among positives: | 99.2% | Qualified | 96.7% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Phencyclidine | Result | Oxycodone | Result | |
| % agreement among positives: | 95.8% | Qualified | 99.2% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
| Marijuana | Result | Marijuana | Result | |
| % agreement among positives: | 99.2% | Qualified | 99.2% | Qualified |
| % agreement among negatives : | 100.0% | Qualified | 100.0% | Qualified |
10.2 Cross Reactivity
Cross reactivity study is complemented, the result showed when there are substances of the corresponding concentration in the urine, the Test Cup and Test Dip Card may produce false positive results.
| Drug | concentration (ng/mL) |
|---|---|
| Amphetamine | |
| D-Amphetamine | 1,000 |
| D,L-Amphetamine (Amphetamine | |
| Sulfate) | 1,000 |
| Phentermine | 1,300 |
| (+/-)-4-Hydroxyamphetamine HCL | 700 |
| 1-Amphetamine | 50,000 |
| Methylenedioxyethylamphetamine | 100,000 |
| Secobarbital | |
| Secobarbital | 300 |
| Amobarbital | 300 |
| Aprobarbital | 300 |
| Phenobarbital | 300 |
| Oxazepam | |
| Buprenorphine | 10 |
| Buprenorphine -3-D-Glucuronide | 10 |
| Chlordiazepoxide | 2000 |
| Clorazepate | 200 |
| Oxazepam | |
| Alprazolam | 200 |
| Bromazepam | 1,500 |
| Chlordiazepoxide HCL | 1,500 |
| Clobazam | 100 |
| Clonazepam | 750 |
| Clorazepate Dipotassium | 200 |
| Delorazepam | 1,500 |
| Desalkylflurazepam | 400 |
| Diazepam | 200 |
| Estazolam | 2,500 |
| Flunitrazepam | 400 |
| A-Hydroxyalprazolam | 1260 |
| (±) Lorazepam | 1,500 |
| RS-Lorazepam glucuronide | 160 |
| Midazolam | 12,500 |
| Nitrazepam | 100 |
| Norchlordiazepoxide | 200 |
| Nordiazepam | 400 |
| Oxazepam | 300 |
| Temazepam | 100 |
| Triazolam | 2,500 |
| Cocaine | |
| Benzoylecogonine | 300 |
| Cocaethylene | 300 |
| CocaineHCl | 300 |
| Ecgonine HCl | 35000 |
| Methylenedioxy-methamphetamine | |
| D,L-3,4- | |
| Methylenedioxymethamphetamine | |
| (MDMA) | 500 |
| Methamphetamine | |
| D-Methamphetamine | 1,000 |
| Methamphetamine | 1000 |
| L(-)-Methamphetamine | 8000 |
| d-Amphetamine | 100,000 |
| 3,4-methylenedioxyampheta mine | |
| (MDA) | 100,000 |
| Morphine | |
| Morphine | 300 |
| Codeine | 300 |
| Norcodeine | 7500 |
| Morphine 3-b-D-glucuronide | 300 |
| Methadone | |
| Methadone | 300 |
| (±)2-Ethyl-1,5-dimethyl-3,3- | |
| diphenylpyrrolinium | 50000 |
| Oxycodone | |
| Oxycodone | 100 |
| Naloxone | 50000 |
| Naltrexone | 50000 |
| Morphine 3- β-D-glucuronide | 50000 |
| Phencyclidine | |
| Phencyclidine | 25 |
| Marijuana | |
| 11-nor-Δ9-THC-9-COOH | 50 |
| 11-Nor-Δ9-Tetrahydrocannabinol | 50 |
| 11-Nor-Δ8-Tetrahydrocannabinol | 50 |
| Cannabidiol | 100,000 |
| Δ8- Tetrahydrocannabinol | 10,000 |
11
12
10.3 Interference
Potential interfering substances were added to drug-free urine samples with target drugs of ±25% cutoff level.The substances in the table up did not affect the Test Dip Card/Test Cup at concentrations of 100ug/ml.All samples with a concentration of -25% cutoff and drug free test results are aegative, and all samples with a concentration of+25% cutoff test results are positive.
Interference of Different pH 10.4
The results are all positive for samples at +50% cutoff and all negative for samples at -50% cutoff. The results
show that when the pH of samples are in the range of 4-9, there is no effect on the test results.
10:5 Interference of Specific Gravity
The results all positive for samples at +50% cutoff and all negative for samples at -50% cutoff. The results show that when the gravity is in the range of 1.000-1.035, there is no effect on the test results.
10.6 Cut-off
The cut-off value is
| Calibrator | Cut-off (ng/mL) |
|---|---|
| Amphetamine | 1000 |
| Secobarbital | 300 |
| Buprenorphine | 10 |
13
| Oxazepam | 300 |
|---|---|
| Cocaine | 300 |
| Methylenedioxy- | |
| methamphetamine | 500 |
| Methamphetamine | 1000 |
| Morphine | 300 |
| Methadone | 300 |
| Oxycodone | 100 |
| Phencyclidine | 25 |
| Marijuana | 50 |
10.7 Precision
As the results ,all the results of drug free,-75%Cut off,-50%Cut off are negative, and all the results of +100% cutoff,+75%Cut off,+50%Cut off are positive, and cutoff coincidence rate of the test results is 79%(>55%),±25% cutoff coincidence rate of the test results is 88%(>84%),so the Precision of kit is qualified.
10.8 Lay User Study
A lay user study were performed at three intended user sites with 603 laypersons for Test Cup and 300 laypersons for Test Dip Card).They should have diverse educational and professional backgrounds and ranged in age from 21 to 50. Urine samples are prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cut off by spiking 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. They will be asked to fill out an English questionnaire after finishing the test.
The results of the lay user method comparison (Test Cup)
Amphetamine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage agreement
(%) |
|------------------------------------|-----------------------------------|--------------------|--------------------|---------------------------------|
| | | No. of
Positive | No. of
Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 253.8674 | 0 | 20 | 100.0% |
| -50%Cut off | 508.5452 | 0 | 161 | 100.0% |
| -25%Cut off | 736.2487 | 0 | 20 | 100.0% |
| +25%Cut off | 1197.5758 | 19 | 1 | 95.0% |
| +50%Cut off | 1501.0527 | 42 | 0 | 100.0% |
| +75%Cut off | 1678.9382 | 20 | 0 | 100.0% |
| Secobarbital | | | | |
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage agreement
(%) |
| | | No. of
Positive | No. of
Negative | |
| | | | | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 71.5804 | 0 | 20 | 100.0% |
| -50%Cut off | 147.7771 | 0 | 161 | 100.0% |
| -25%Cut off | 226.3641 | 0 | 20 | 100.0% |
| +25%Cut off | 364.0221 | 20 | 0 | 100.0% |
| +50%Cut off | 419.027 | 42 | 0 | 100.0% |
| +75%Cut off | 515.8795 | 20 | 0 | 100.0% |
| Buprenorphine | | | | |
| | | Lay person results | | |
| % of Cutoff | Concentration by
LC/MS (ng/mL) | No. of
Positive | No. of
Negative | The percentage agreement
(%) |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 2.4489 | 0 | 20 | 100.0% |
| -50%Cut off | 4.731 | 0 | 161 | 100.0% |
| -25%Cut off | 7.2609 | 0 | 20 | 100.0% |
| +25%Cut off | 11.7585 | 20 | 0 | 100.0% |
| +50%Cut off | 14. 2329 | 42 | 0 | 100.0% |
| +75%Cut off | 16.8724 | 20 | 0 | 100.0% |
| Oxazepam | | | | |
| | | Lay person results | | |
| % of Cutoff | Concentration by
LC/MS (ng/mL) | No. of
Positive | No. of
Negative | The percentage agreement
(%) |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 70.446 | 0 | 20 | 100.0% |
| -50%Cut off | 151.3073 | 0 | 161 | 100.0% |
| -25%Cut off | 220.6369 | 0 | 20 | 100.0% |
| +25%Cut off | 389.9653 | 19 | 1 | 95.0% |
| +50%Cut off | 461.6992 | 42 | 0 | 100.0% |
| +75%Cut off | 502.0942 | 20 | 0 | 100.0% |
| Cocaine | | | | |
| | | Lay person results | | |
| % of Cutoff | Concentration by
LC/MS (ng/mL) | No. of
Positive | No. of
Negative | The percentage
agreement (%) |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 70.446 | 0 | 20 | 100.0% |
| -50%Cut off | 151.3073 | 0 | 161 | 100.0% |
| -25%Cut off | 220.6369 | 0 | 20 | 100.0% |
| +25%Cut off | 389.9653 | 20 | 0 | 100.0% |
| +50%Cut off | 461.6992 | 42 | 0 | 100.0% |
| +75%Cut off | 502.0942 | 20 | 0 | 100.0% |
| Methylenedioxy-
methamphetamine | | | | |
| | | Lay person results | | |
| % of Cutoff | Concentration by
LC/MS (ng/mL) | No. of
Positive | No. of
Negative | The percentage
agreement (%) |
| 0 | 0.00 | 0 | 20 | 100.0% |
| | | | | |
| -75%Cut off | 114. 1879 | 0 | 20 | 100.0% |
| -50%Cut off | 257.9109 | 0 | 161 | 100.0% |
| -25%Cut off | 359.2816 | 0 | 20 | 100.0% |
| +25%Cut off | 613.3061 | 20 | 0 | 100.0% |
| +50%Cut off | 692.4385 | 42 | 0 | 100.0% |
| +75%Cut off | 918.3664 | 20 | 0 | 100.0% |
14
15
Methamphetamine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|--------------------|---------------------------------|
| | | No. of
Positive | No. of
Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 257.2811 | 0 | 20 | 100.0% |
| -50%Cut off | 519.5908 | 0 | 161 | 100.0% |
| -25%Cut off | 780.8035 | 0 | 20 | 100.0% |
| +25%Cut off | 1127.6588 | 20 | 0 | 100.0% |
| +50%Cut off | 1435.7586 | 42 | 0 | 100.0% |
| +75%Cut off | 1795.7356 | 20 | 0 | 100.0% |
Morphine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|--------------------|---------------------------------|
| | | No. of
Positive | No. of
Negative | |
| 0 | 0.00 | 0 | 20 | 100.0 % |
| -75%Cut off | 74.9251 | 0 | 20 | 100.0 % |
| -50%Cut off | 148.7061 | 0 | 161 | 100.0 % |
| -25%Cut off | 210.2795 | 0 | 20 | 100.0 % |
| +25%Cut off | 354.7366 | 20 | 0 | 100.0 % |
| +50%Cut off | 420.8013 | 42 | 0 | 100.0 % |
| +75%Cut off | 476.5929 | 20 | 0 | 100.0 % |
Methadone
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|--------------------|---------------------------------|
| | | No. of
Positive | No. of
Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 76.2488 | 0 | 20 | 100.0% |
| -50%Cut off | 157.0163 | 0 | 161 | 100.0% |
| -25%Cut off | 206.975 | 0 | 20 | 100.0% |
| +25%Cut off | 356.5922 | 19 | 1 | 95.0% |
| +50%Cut off | 454.0655 | 42 | 0 | 100.0% |
| +75%Cut off | 519.0941 | 20 | 0 | 100.0% |
0xycodone
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|--------------------|---------------------------------|
| | | No. of
Positive | No. of
Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 22.5121 | 0 | 20 | 100.0% |
| -50%Cut off | 45.9304 | 0 | 161 | 100.0% |
16
| -25%Cut off | 70.8923 | 0 | 20 | 100.0% |
|---|---|---|---|---|
| +25%Cut off | 131.2278 | 20 | 0 | 100.0% |
| +50%Cut off | 144.5957 | 42 | 0 | 100.0% |
| +75%Cut off | 174.6656 | 20 | 0 | 100.0% |
Phencyclidine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|--------------------|---------------------------------|
| | | No. of
Positive | No. of
Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 5.6551 | 0 | 20 | 100.0% |
| -50%Cut off | 11.8659 | 0 | 161 | 100.0% |
| -25%Cut off | 19.3029 | 0 | 20 | 100.0% |
| +25%Cut off | 29.5142 | 20 | 0 | 100.0% |
| +50%Cut off | 38.0936 | 42 | 0 | 100.0% |
| +75%Cut off | 41.2136 | 20 | 0 | 100.0% |
Marijuana
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage |
|-------------|-----------------------------------|--------------------|----------|----------------|
| | | No. of | No. of | agreement (%) |
| | | Positive | Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 12.9481 | 0 | 20 | 100.0% |
| -50%Cut off | 23.5849 | 0 | 161 | 100.0% |
| -25%Cut off | 36.2969 | 0 | 20 | 100.0% |
| +25%Cut off | 59.5132 | 20 | 0 | 100.0% |
| +50%Cut off | 74.5304 | 42 | 0 | 100.0% |
| +75%Cut off | 90.3451 | 20 | 0 | 100.0% |
17
The results of the lay user method comparison (Test Dip Card)
Amphetamine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 253.8674 | 0 | 19 | 100.0% |
| -50%Cut off | 508.5452 | 0 | 160 | 100.0% |
| -25%Cut off | 736.2487 | 0 | 20 | 100.0% |
| +25%Cut off | 1197.5758 | 20 | 0 | 100.0% |
| +50%Cut off | 1501.0527 | 41 | 0 | 100.0% |
| +75%Cut off | 1678.9382 | 20 | 0 | 100.0% |
Secobarbital
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 71.5804 | 0 | 19 | 100.0% |
| -50%Cut off | 147.7771 | 0 | 160 | 100.0% |
| -25%Cut off | 226.3641 | 0 | 20 | 100.0% |
| +25%Cut off | 364.0221 | 20 | 0 | 100.0% |
| +50%Cut off | 419.027 | 41 | 0 | 100.0% |
| +75%Cut off | 515.8795 | 20 | 0 | 100.0% |
Buprenorphine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 2.4489 | 0 | 19 | 100.0% |
| -50%Cut off | 4.731 | 0 | 160 | 100.0% |
| -25%Cut off | 7.2609 | 0 | 20 | 100.0% |
| +25%Cut off | 11.7585 | 19 | 1 | 95.0% |
| +50%Cut off | 14.2329 | 41 | 0 | 100.0% |
| +75%Cut off | 16.8724 | 20 | 0 | 100.0% |
Oxazepam
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 70.446 | 0 | 19 | 100.0% |
| -50%Cut off | 151.3073 | 0 | 160 | 100.0% |
| -25%Cut off | 220.6369 | 0 | 20 | 100.0% |
18
Shanghai Accurature Diagnostics Co., Ltd. Building 1,No.168 Banqiao East Road, Shanyang Town, Jinshan District, Shanghai 201508,P.R.China
| +25%Cut off | 389. 9653 | 20 | 0 | 100.0% |
|---|---|---|---|---|
| +50%Cut off | 461.6992 | 41 | 0 | 100.0% |
| +75%Cut off | 502. 0942 | 20 | 0 | 100.0% |
Cocaine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 70.446 | 0 | 19 | 100.0% |
| -50%Cut off | 151.3073 | 0 | 160 | 100.0% |
| -25%Cut off | 220.6369 | 0 | 20 | 100.0% |
| +25%Cut off | 389.9653 | 20 | 0 | 100.0% |
| +50%Cut off | 461.6992 | 41 | 0 | 100.0% |
| +75%Cut off | 502.0942 | 20 | 0 | 100.0% |
Methylenedioxy-
methamphetamine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 114. 1879 | 0 | 19 | 100.0% |
| -50%Cut off | 257. 9109 | 0 | 160 | 100.0% |
| -25%Cut off | 359. 2816 | 0 | 20 | 100.0% |
| +25%Cut off | 613. 3061 | 20 | 0 | 100.0% |
| +50%Cut off | 692. 4385 | 41 | 0 | 100.0% |
| +75%Cut off | 918. 3664 | 20 | 0 | 100.0% |
Methamphetamine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0 % |
| -75%Cut off | 257.2811 | 0 | 19 | 100.0 % |
| -50%Cut off | 519.5908 | 0 | 160 | 100.0 % |
| -25%Cut off | 780.8035 | 0 | 20 | 100.0 % |
| +25%Cut off | 1127.6588 | 20 | 0 | 100.0 % |
| +50%Cut off | 1435.7586 | 41 | 0 | 100.0 % |
| +75%Cut off | 1795.7356 | 20 | 0 | 100.0 % |
Morphine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| 0 | 0.00 | No. of
Positive | No. of Negative | 100.0% |
| -75%Cut off | 74.9251 | 0 | 19 | 100.0% |
19
Shanghai Accurature Diagnostics Co., Ltd. Building 1,No.168 Banqiao East Road, Shanyang Town, Jinshan District, Shanghai 201508,P.R.China
| -50%Cut off | 148.7061 | 0 | 160 | 100.0% |
|---|---|---|---|---|
| -25%Cut off | 210.2795 | 0 | 20 | 100.0% |
| +25%Cut off | 354.7366 | 20 | 0 | 100.0% |
| +50%Cut off | 420.8013 | 41 | 0 | 100.0% |
| +75%Cut off | 476.5929 | 20 | 0 | 100.0% |
Methadone
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 76.2488 | 0 | 19 | 100.0% |
| -50%Cut off | 157.0163 | 0 | 160 | 100.0% |
| -25%Cut off | 206.975 | 0 | 20 | 100.0% |
| +25%Cut off | 356.5922 | 20 | 0 | 100.0% |
| +50%Cut off | 454.0655 | 41 | 0 | 100.0% |
| +75%Cut off | 519.0941 | 20 | 0 | 100.0% |
0xycodone
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 22.5121 | 0 | 19 | 100.0% |
| -50%Cut off | 45.9304 | 0 | 160 | 100.0% |
| -25%Cut off | 70.8923 | 0 | 20 | 100.0% |
| +25%Cut off | 131.2278 | 20 | 0 | 100.0% |
| +50%Cut off | 144.5957 | 41 | 0 | 100.0% |
| +75%Cut off | 174.6656 | 20 | 0 | 100.0% |
Phencyclidine
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| | | No. of
Positive | No. of Negative | |
| 0 | 0.00 | 0 | 20 | 100.0% |
| -75%Cut off | 5.6551 | 0 | 19 | 100.0% |
| -50%Cut off | 11.8659 | 0 | 160 | 100.0% |
| -25%Cut off | 19.3029 | 0 | 20 | 100.0% |
| +25%Cut off | 29.5142 | 20 | 0 | 100.0% |
| +50%Cut off | 38.0936 | 41 | 0 | 100.0% |
| +75%Cut off | 41.2136 | 20 | 0 | 100.0% |
Marijuana
| % of Cutoff | Concentration by
LC/MS (ng/mL) | Lay person results | | The percentage
agreement (%) |
|-------------|-----------------------------------|--------------------|-----------------|---------------------------------|
| 0 | 0.00 | No. of
Positive | No. of Negative | 100.0% |
| | | 0 | 20 | |
20
| -75%Cut off | 12.9481 | 0 | 19 | 100.0% |
|---|---|---|---|---|
| -50%Cut off | 23.5849 | 0 | 160 | 100.0% |
| -25%Cut off | 36.2969 | 0 | 20 | 100.0% |
| +25%Cut off | 59.5132 | 20 | 0 | 100.0% |
| +50%Cut off | 74.5304 | 41 | 0 | 100.0% |
| +75%Cut off | 90.3451 | 20 | 0 | 100.0% |
Shanghai Accurature Diagnostics Co., Ltd. Building 1,No.168 Banqiao East Road, Shanyang Town, Jinshan District, Shanghai 201508,P.R.China
"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."
11. Conclusion
The data collected in the performance and comparison studies demonstrate that subject devices are substantially equivalent to the predicate.