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K Number
K153050
Device Name
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
Manufacturer
Co-Innovation Biotech Co., Ltd
Date Cleared
2016-04-26

(189 days)

Product Code
DJG,DIO,DIS,DJC,DJR,DKZ,DNK,JXM,JXN,LAF,LCM,LDJ,LFG
Regulation Number
862.3650
Type
Special
Panel
Toxicology
Reference & Predicate Devices
K140748,K142800
Predicate For
K180349,K182530,K222955,K232228
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

TestCalibratorCut-off level
Marijuana (THC)Delta-9-THC-COOH50 ng/mL
Cocaine (COC)Benzoylecgonine300 ng/mL
Amphetamine (AMP)D-Amphetamine1000 ng/mL
Methamphetamine (MET)D-Methamphetamine1000 ng/mL
Morphine 2000 (MOP)Morphine2000 ng/mL
Barbiturates (BAR)Secobarbital300 ng/mL
Benzodiazepines (BZO)Oxazepam300 ng/mL
Methylenedioxymethamphetamine (MDMA)3,4-Methylenedioxymethamphetamine500 ng/mL
Methadone (MTD)Methadone300 ng/mL
Oxycodone (OXY)Oxycodone100 ng/mL
Phencyclidine (PCP)Phencyclidine25 ng/mL
Buprenorphine(BUP)Buprenorphine10ng/mL
2-ethylidene-1, 5-dimethyl-3,2-ethylidene-1, 5-dimethyl-3,300 ng/mL
3-diphenylpyrrolidine(EDDP)3-diphenylpyrrolidine
Morphine(MOP300)Morphine300 ng/mL
Propoxyphene(PPX)Propoxyphene300 ng/mL
Tri-cyclic Antidepressants (TCA)Nortriptyline1000 ng/mL

The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use.

The tests will vield preliminary positive results when prescription drugs Barbiturates. Benzodiazenine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no unformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine.

This assay provides only a preliminary analytical test result. Gas Chromatography Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result. particularly when preliminary positive results are indicated.

Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaines, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument. Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

AI/ML Overview

Here's an analysis of the acceptance criteria and study findings for the "Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard" device, based solely on the provided text:

This document is a 510(k) Premarket Notification summary to the FDA, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, not necessarily showcasing comprehensive clinical trials for novel devices. Therefore, the "study" described focuses on demonstrating equivalence rather than proving novel clinical utility with large-scale, multi-reader, or outcomes-based studies.

Acceptance Criteria and Reported Device Performance

The core acceptance criteria are based on the ability to qualitatively detect specific drugs and their metabolites in human urine at predefined cut-off concentrations. The performance data demonstrates agreement with these cut-off concentrations, indicating the device meets the intended detection capability.

Table of Acceptance Criteria and Reported Device Performance (Specificity and Sensitivity implicitly)

For each drug, the acceptance criteria are to correctly identify negative samples and positive samples relative to the specified cut-off. The performance is reported in terms of the number of positive/negative results at various concentrations around these cut-offs during precision and accuracy studies.

Precision Study (Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC)

The precision study aimed for accurate detection at concentrations:

  • 0 ng/mL: All negative
  • -75% cutoff: All negative or predominantly negative
  • -50% cutoff: All negative or predominantly negative
  • -25% cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
  • Cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
  • +25% cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
  • +50% cutoff, +75% cutoff, +100% cutoff: All positive or predominantly positive

Observed Performance (Summarized from Precision Tables)

For all drugs tested (AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC) across three lots for both the Test Cup and Test Dipcard:

  • At 0 ng/mL, -75% cutoff, and -50% cutoff: All (or overwhelmingly almost all) reported results were negative. This indicates good specificity below the cutoff.
  • At +50% cutoff, +75% cutoff, and +100% cutoff: All (or overwhelmingly almost all) reported results were positive. This indicates good sensitivity above the cutoff.
  • At -25% cutoff, cutoff, and +25% cutoff: A mixed distribution of positive and negative results was consistently observed, demonstrating the device's ability to differentiate samples around the cut-off concentration, as expected for a qualitative assay. For instance, at the exact cutoff, typically around 30-40 positive and 20-30 negative results were seen out of 60 determinations per lot, for most analytes.

Accuracy Study (Clinical Specimens - Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC)

The accuracy study categorizes samples into five groups based on GC/MS or HPLC reference:

  • Drug free
  • Less than half the cutoff
  • Near cutoff negative (between 50% below cutoff and cutoff)
  • Near cutoff positive (between cutoff and 50% above cutoff)
  • High positive (greater than 50% above cutoff)

The acceptance criteria here are that results from the Rapid Multi-drug Test Cup/Dipcard should align with the GC/MS or HPLC classifications.

Observed Performance (Summarized from Accuracy Tables)

For both the Test Cup and Test Dipcard:

  • Drug-free, Less than half the cutoff, Near Cutoff Negative samples: Overwhelmingly resulted in negative reports from the device. A very small number of "false positives" (e.g., 1 or 2 positive results in the "Near Cutoff Negative" category for some drugs) were noted, and some "false negatives" for Buprenorphine, Morphine, Methadone, Oxycodone, TCA, and THC in the "Near Cutoff Negative" or "Near Cutoff Positive" categories when compared to the reference methods. The "Analysis of Discordant Results" section details these specific discrepancies.
  • Near Cutoff Positive and High Positive samples: Overwhelmingly resulted in positive reports from the device. Similar to above, a very small number of discordant results (e.g., some "Near Cutoff Positive" samples were reported negative by the device) were observed, which are explicitly detailed in the "Analysis of Discordant Results" tables.

Overall Conclusion on Acceptance Criteria: The studies presented generally demonstrate that the device performs as expected for a qualitative immunoassay, showing good agreement with GC/MS/HPLC results for samples significantly above or below the cut-off. The mixed results near the cut-off are typical for such tests.

Study Details

  1. Sample size used for the test set and the data provenance:

    • Precision Study: For each drug, there were 9 concentrations tested. For each concentration, 60 determinations were made (3 lots x 3 runs/day x 10 days = 90 determinations per concentration, but the table indicates 60 determinations per lot for each concentration, which suggests (2 operators * 3 aliquots tested per lot per day = 6 determinations per lot per day) * 10 days leads to 60 determinations per lot). With 16 drugs, this means roughly 16 x 9 x 60 = 8,640 determinations for the precision study (excluding the implicit number of lots).
    • Accuracy Study (Clinical Samples): 80 clinical urine specimens per drug were used for both the Multi-drug Test Cup and Multi-drug Test Dipcard. With 16 drugs, this amounts to 16 x 80 = 1,280 samples per device format (Cup and Dipcard), so a total of 2,560 unique clinical specimens.
      • Data Provenance: The document does not specify the country of origin but states "Clinical urine specimens." It also states these were "retrospective" as they were analyzed by GC/MS/HPLC prior to testing with the device, and then retrospectively analyzed against the device results. The absence of details on where these clinical samples were collected typically means their origin is unknown or not considered relevant for this type of submission (often laboratory-sourced for drug testing evaluations).
    • Lay User Study: 1720 lay users participated. Each participant performed 1 test. Urine samples were prepared at 0, +/- 50% cutoff, +/- 25% cutoff, and +100% cutoff. This study does not explicitly state the number of unique urine samples used but rather the number of user interactions with a test sample. For each drug and each concentration, there were 10 or 30 or 360 determinations across two lots (one for Cup, one for Dipcard, it seems implied).
      • Data Provenance: Not specified, but involved "lay users" performing tests, implying a prospective collection for this specific study.
    • Interference Study: For each drug, 4 concentrations (0, -50% cutoff, +50% cutoff, +100% cutoff), 3 lots, and 15 determinations per lot per concentration. This amounts to 16 x 4 x 3 x 15 = 2,880 determinations.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Ground Truth Method: For the accuracy studies, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC). These are analytical chemistry "gold-standard" methods, not expert human interpretation.
    • Number/Qualifications of Experts: Not applicable in the context of GC/MS or HPLC as ground truth. The results are based on analytical measurements, not human interpretation of images or observations.

  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • No formal adjudication method is described for establishing ground truth, as the ground truth relies on quantitative analytical methods (GC/MS, HPLC) rather than subjective human assessment.
    • For the precision study, results were based on multiple determinations (e.g., 60 per lot per concentration), and for the lay user study, the "agreement" was calculated based on the collective results of the lay users against the known spiked concentrations. Discordant results in the accuracy study are individually listed, implying a comparison against the GC/MS/HPLC result without further adjudication panels described for the device's outcome.

  4. 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 MRMC comparative effectiveness study was performed or described. This device is a rapid diagnostic test (Test Cup/Dipcard) for drug screening, not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply to this specific device. The closest equivalent is the "Lay User Study," which assesses how well lay users can interpret the test independently using the provided instructions. Their agreement rates for correctly classifying samples are provided.

  5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Yes, in essence, standalone performance was assessed in the "Precision" and "Accuracy" studies if "standalone" is interpreted as the device's intrinsic ability to detect drugs in controlled and clinical samples when read by trained operators. The device itself (the dipcard or cup) produces a visual qualitative result (lines appearing or not appearing), which is then read. The "precision study" and "accuracy study" data (Table 8.5, 8.6) represent this "algorithm only" (device only) performance when operated and interpreted by presumably trained personnel. The "Lay User Study" (Table 8.7) assesses reading by an untrained human-in-the-loop, demonstrating usability rather than optimal device performance.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • The ground truth for the accuracy studies was established by analytical chemistry methods: Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC). These methods provide quantitative measurements of drug concentrations, which are considered the definitive "ground truth" for drug screening device validation. For spiked samples in precision, lay user, and interference studies, the ground truth was the known spiked concentration of the drug.

  7. The sample size for the training set:

    • This document describes a 510(k) submission, which is for a traditional in-vitro diagnostic device (a rapid test cup/dipcard with reagent strips). There is no "training set" in the context of machine learning or AI models, as this device does not utilize such technologies. The studies described are for validation and performance assessment of the physical chemical assay.

  8. How the ground truth for the training set was established:

    • As there is no "training set" in the AI/ML sense, this question is not applicable to the device described. The studies involve testing the device against samples with known drug concentrations (either spiked or determined by reference analytical methods) to evaluate its performance.

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, stacked on top of each other, forming a stylized wing shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 26, 2016

CO-INNOVATION BIOTECH Co., LTD HONG FENG PRODUCT MANAGER NO. 13, YANYUAN ROAD, TIANHE DISTRICT, GUANGZHOU 510507, CHINA

Re: K153050

Trade/Device Name: Rapid Single/multi-drug Test Cup, Rapid Single/multi-drug Test Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DKZ, LFG, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR, JXN Dated: March 28, 2016 Received: March 28, 2016

Dear Hong Feng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K153050

Device Name

Rapid Single/Multi-drug test Dipcard Rapid Single/Multi-drug test Cup

Indications for Use (Describe)

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

TestCalibratorCut-off level
Marijuana (THC)Delta-9-THC-COOH50 ng/mL
Cocaine (COC)Benzoylecgonine300 ng/mL
Amphetamine (AMP)D-Amphetamine1000 ng/mL
Methamphetamine (MET)D-Methamphetamine1000 ng/mL
Morphine 2000 (MOP)Morphine2000 ng/mL
Barbiturates (BAR)Secobarbital300 ng/mL
Benzodiazepines (BZO)Oxazepam300 ng/mL
Methylenedioxymethamphetamine (MDMA)3,4-Methylenedioxymethamphetamine500 ng/mL
Methadone (MTD)Methadone300 ng/mL
Oxycodone (OXY)Oxycodone100 ng/mL
Phencyclidine (PCP)Phencyclidine25 ng/mL
Buprenorphine(BUP)Buprenorphine10ng/mL
2-ethylidene-1, 5-dimethyl-3,2-ethylidene-1, 5-dimethyl-3,300 ng/mL
3-diphenylpyrrolidine(EDDP)3-diphenylpyrrolidine
Morphine(MOP300)Morphine300 ng/mL
Propoxyphene(PPX)Propoxyphene300 ng/mL
Tri-cyclic Antidepressants (TCA)Nortriptyline1000 ng/mL

The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use.

The tests will vield preliminary positive results when prescription drugs Barbiturates. Benzodiazenine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no unformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine.

This assay provides only a preliminary analytical test result. Gas Chromatography Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result. particularly when preliminary positive results are indicated.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5 - 510(k) Summary

Date of Summary Preparation: 26/4/2016

1. Submitter's Identifications

Submitter: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285 2. Correspondent's Identifications

Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

3. Name of the Device

Recommended classification regulation:

21 CFR 862.3100 Amphetamine test system 21 CFR 862.3150 Barbiturate test system 21 CFR 862.3650 Opiate test system 21 CFR 862.3170 Benzodiazepine test system 21 CFR 862.3250 Cocaine test system 21 CFR 862.3620 Methadone test system 21 CFR 862.3610 Methamphetamine test system 21 CFR 862.3640 Morphine test system Unclassified, Enzyme immunoassay, phencyclidine test system 21 CFR 862.3700 Propoxyphene test system 21 CFR 862.3910 Tri-cyclic Antidepressants drug test system 21 CFR 862.3870 Cannabinoid test system

Device class: Class II Panel: Toxicology (91) Product code: DKZ,DJC.DIO,LDJ,DNK,DIS,JXM,DJR,DJG,LCM,JXN,LFG Common Name:

Amphetamine (AMP) Test System Barbiturates (BAR) Test System Buprenorphine(BUP) Test System

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Benzodiazepines (BZO) Test System Cocaine (COC) Test System 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP) Test System Methylenedioxymethamphetamine (MDMA) Test System Methamphetamine (MET) Test System Morphine (MOP300) Test System Morphine(MOP2000) Test System Methadone (MTD) Test System Oxycodone (OXY) Test System Phencyclidine (PCP) Test System Propoxyphene(PPX) Test System Tri-cyclic Antidepressants (TCA)Test System Cannabinoid (THC) Test System

Proprietary names:

Rapid Single/Multi-drug Test Cup Rapid Single/Multi-drug Test Dipcard

4. The Predicate Devices

K140748One Step Single/Multi-drug Test Cup
One Step Single/Multi-drug Test Dipcard
K142800Rapid Single/Multi-drug Test Cup
Rapid Single/Multi-drug Test Dipcard

5. Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaines, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument. Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

6. Intended Use of Device

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test for the qualitatively detection of drugs and drug metabolites in human urine. Drug test cut-off concentrations are listed below:

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TestCalibratorCut-off level
Amphetamine (AMP)D-Amphetamine1000 ng/mL
Barbiturates (BAR)Secobarbital300 ng/mL
Buprenorphine(BUP)Buprenorphine10ng/mL
Benzodiazepines (BZO)Oxazepam300 ng/mL
Cocaine (COC)Benzoylecgonine300 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP)2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine300 ng/mL
Methylenedioxymethamphetamine (MDMA)3,4-Methylenedioxymethamphetamine500 ng/mL
Methamphetamine (MET)D-Methamphetamine1000 ng/mL
Morphine300(MOP300)Morphine300 ng/mL
Morphine2000(MOP2000)Morphine2000 ng/mL
Methadone (MTD)Methadone300 ng/mL
Oxycodone (OXY)Oxycodone100 ng/mL
Phencyclidine (PCP)Phencyclidine25 ng/mL
Propoxyphene(PPX)Propoxyphene300 ng/mL
Tri-cyclic Antidepressants (TCA)Nortriptyline1000 ng/mL
Marijuana (THC)Delta-9-THC-COOH50 ng/mL

The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use.

The tests will yield preliminary positive results when prescription drugs Barbiturates, Buprenorphine, Benzodiazepine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

7. Comparison to Predicate Devices:

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Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are a modified product format derived from the previously FDA-cleared Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard, One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard. A summary comparison of features of the Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard and the predicate devices is provided in the following Table.

ItemDevicePredicate(K140748, K142800)
Indication for useQualitative detection of drugs-of-abuse inurine (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 ofdrugs detected different)
Intended UsersOver the Counter (OTC) Use andPrescription UseSame
SpecimenUrineSame
CutoffAmphetamine:1000 ng/mLBarbiturates:300 ng/mLBuprenorphine:10 ng/mLBenzodiazepines:300 ng/mLCocaine:300 ng/mLEDDP:300 ng/mLMethylenedioxymethamphetamine:500ng/mLMethamphetamine:1000 ng/mLMorphine:300 ng/mLMorphine:2000 ng/mLMethadone:300 ng/mLOxycodone:100 ng/mLPhencyclidine:25 ng/mLPropoxyphene:300 ng/mLTri-cyclic Antidepressants:1000 ng/mLMarijuana:50 ng/mLSame
Read time5 minutesSame
Storage4 ~ 30 °CSame
ResultsQualitativeSame
MethodologyCompetitive binding, Lateral flowSame
immunochromatographic assay based on
the principle of antigen antibody
immunochemistry
ConfigurationDipcard and CupSame

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Remark:

  • 1、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.

8. Performance Data:

8.1 Cross-reactivity with structurally similar compounds

To test the cross reactivity of the test, 2 lots of test Dipcard and one lot of test Cup was used to test with drug metabolites and drug structurally similar compounds in urine. All the components were added to drug-free normal human urine. Each sample was tested in 5 replicates using 3 lots of Test Cup and Test Dipcard. If any positive result was observed, the compounds were further diluted with known drug-free urine specimen sequentially to different concentrations and tested in quintuplicate, until the highest concentration that generates a negative result was identified. The cross reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table below.

Amphetamine (AMP)LowestConcentration(ng/mL)% Cross-reactivityMethamphetamine (MET)LowestConcentration (ng/mL)% Cross-reactivity
d-Amphetamine1,000100%3,4- Methylenedioxyethylamphetamine(MDEA)50,0002%
d.l-Amphetamine2,50040%d-Amphetamine> 100,000Notdetected
1-Amphetamine50,0002%l-Amphetamine> 100,000Notdetected
3,4-Methylenedioxyamphetamine(MDA)2,00050%3,4-methylenedioxyamphetamine (MDA)> 100,000Notdetected
d-methamphetamine> 100,000NotdetectedMorphine300(MOP300)
l-methamphetamine> 100,000NotdetectedMorphine300100%
3,4-Methylenedioxumethamphetamine(MDMA)> 100,000NotdetectedCodeine300100%
Methylenedioxyethylamphetamine(MDEA)> 100,000NotdetectedHydrocodone200015%
Barbiturates (BAR)Hydromorphone150020%
Secobarbital300100%6-Monoacetylmorphine(6-MAM )75040%
Amobarbital50060%Morphine 3-b-D-glucuronide300100%
Alphenal150200%Ethylmorphine35008.6%
Aprobarbital200150%Levorphanol50006%
Butabarbital75400%Heroin300100%
Butalbital1,50020%Norcodeine75004%
Butethal100300%Oxycodone1000000.3%
Cyclopentobarbital60050%Thebain80003.8%
Pentobarbital70042.9%Morphine2000(MOP2000)
Phenobarbital300100%Morphine2,000100%
Buprenorphine(BUP)Codeine2,000100%
Buprenorphine10100%Hydrocodone15,00013.3%
Norbuprenorphine2050%Hydromorphone10,00020%
Buprenorphine 3-D-glucuronide1566.7%6-Monoacetylmorphine5,00040%
Norbuprenorphine 3-D-glucuronide2005%Morphine 3-b-D-glucuronide2,000100%
Benzodiazepines (BZO)Oxycodone>1000002%
Oxazepam300100%Methadone (MTD)
Alprazolam200150%Methadone300100%
α-Hydroxyalprazolam110027.3%(±)2-Ethy1-1,5-dimethy1-3,3-diphenylpyrrolinium500000.6%
Bromazepam100030%Doxylamine500000.6%
Chlordiazepoxide200015%Oxycodone (OXY)
Clobazam100300%Oxycodone100100%
Clonazepam80037.5%Naloxone500000.2%
Clorazepate200150%Naltrexone500000.2%
Delorazepam160018.8%Morphine 3-β-D-glucuronide500000.2%
Desalkylflurazepam40075%Hydrocodone30003.3%
Diazepam200150%Hydromorphone750000.1%
Estazolam100030%Oxymorphone100010%
Flunitrazepam35085.7%Phencyclidine (PCP)
Lorazepam120025%Phencyclidine25100%
Midazolam250012%4-Hydroxyphencyclidine150000.2%
Nitrazepam100300%Propoxyphene (PPX)
Nordiazepam40075%d-Propoxyphene300100%
Temazepam120250%d-Norpropoxyphene300100%
Triazolam100030%Tri-cyclic Antidepressants(TCA)
Cocaine (COC)Nortriptyline1000100%
Benzoylecgonine300100%Nordoxepin1000100%
Cocaine80037.5%Trimipramine500020%
Cocaethylene12,5002.4%Promazine300033.3%
Ecgonine HCI35,0000.9%Desipramine1000100%
2-ethylidene-1, 5-dimethyl-3,3-diphenylpyrrolidine (EDDP)Imipramine1000100%
EDDP300100%Clomipramine125008%
Methylenedioxymethamphetamine(MDMA)Doxepin200050%
(+/-)3,4-Methylenedioxymethamphetamine (MDMA)500100%Maprotiline200050%
3,4-Methylenedioxyamphetamine(MDA)220022.7%Amitriptyline1000100%
3,4-Methylenedioxyethylamphetamine (MDEA)240208%Promethazine250004%
D-methamphetamine(MAMP)1000000.5%Cannabinoids (THC)
D-Amphetamine>100000Notdetected11-nor-Δ9-THC-9-COOH50100%
L-Amphetamine>100000Notdetected11-nor-Δ8-THC-9-COOH50100%
L-Methamphetamine>100000NotdetectedΔ8- Tetrahydrocannabinol10,0000.5%
Methamphetamine (MET)Δ9- Tetrahydrocannabinol15,0000.3%
3,4- Methylenedioxyethylamphetamine(MDEA)50,0002%Cannabinol20,0000.3%
L(-)-Methamphetamine8,00012.5%Cannabidiol> 100,000Notdetected
(+/-)3,4-Methylenedioxumethamphetamine(MDMA)2,00050%
p-hydroxymethamphetamine30,0003.3%

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

8.2 Interference

Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine or drug positive urine containing AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, PPX, TCA or THC with the concentration 50% below the cutoff and the concentration 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100μg/mL (All concentrations of the drugs were confirmed with GC/MS, or LC/MS,HPLC). The urine specimens were tested with two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard.

{10}------------------------------------------------

None of the compounds listed below were shown to interfere.

AcetaminophenEstrone-3-sulfated,l-Octopamine
AcetophenetidinEthyl-p-aminobenzoateOxalic acid
AmoxicillinErythromycinOxolinic acid
AmpicillinFenoprofenOxymetazoline
AspirinFlucloxacillinOxytetracycline
AtenololFluoxetinePapaverine
AtorvastatinFurosemidePenicillin-G
AzlocillinGentisic acidPentazocine
Benzilic acidHemoglobinPerphenazine
BenzylpenicillinHydralazinePhenelzine
Benzoic acidHydrochlorothiazidePrednisolone
BilirubinHydrocortisonePrednisone
Benzydamineo-Hydroxyhippuric acidd,l-Propranolol
Caffeinep-Hydroxytyramined-Pseudoephedrine
CarbamazepineIbuprofenQuinacrine
CephalexinIndomethacinQuinine
ChloralhydrateIproniazidQuinidine
Chloramphenicold,l-IsoproterenolRanitidine
ChlorothiazideIsoxsuprineSalicylic acid
ChlorpheniramineKetamineSerotonin
d,l-ChlorpromazineKetoprofenSulfamethazine
CholesterolLabetalolSulindac
ClonidineLisinoprilTetracycline
CimetidineLoperamideTetrahydrozoline
CitalopramMeperidineThiamine
CortisoneMeprobamateThioridazine
CreatinineMethoxyphenamined, 1-Thyroxine
DeoxycorticosteroneMethylphenidateTolbutamine
DexamethasoneNadololTolbutamide
DextromethorphanNalidixic acidTrifluoperazine
DiclofenacNaproxenTryptamine
DiflunisalNiacinamideUric acid
DigoxinNicotineVerapamil
DiphenhydramineNifedipineZomepirac
EphedrineNorethindrone
β-EstradiolNoscapine

8.3 Effect of urinary pH

The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (All concentrations were confirmed with GC/MS, or LC/MS, HPLC). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. The results

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

demonstrate that varying ranges of pH do not interfere with the performance of the test.

8.4 Effect of Urinary specific gravity

The specific gravity studies were conducted on different specific gravity including 1.002,1.010, 1.020, 1.030, 1.040 specimens with drug free urine containing AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP, MTD, OXY, PCP, PPX, TCA or THC at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS, or LC/MS, HPLC). Each sample was tested by two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result.

8.5 Precision

Precision studies were performed using the multi-drug test formats. Drug free specimens were spiked with analytes at 0, ±75% cutoff, ±50% cutoff and +100% cutoff of The concentrations of the target drugs were confirmed with GC/MS, or LC/MS, drug. HPLC. Each concentration of the urine specimen was then divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test dipcard format and the second operator tested the test cup format. There were 1620 observations by 3 sites at 9 concentrations.

DrugtestApproximate% of cutoffNumber ofResult
concentrationdeterminatiLot 1Lot 2Lot 3
of sampleons per lotPositiveNegativePositiveNegativePositiveNegative
0ng/mlNegative60060060060
250ng/ml-75%cutoff60060060060
AMP500ng/ml-50%cutoff60060060060
750ng/ml-25%cutoff608528521050
1000ng/mlcutoff60342634263228
1250ng/ml+25%cutoff605285010546
1500ng/ml+50%cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100%cutoff60600600600
BAR0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff608526541050
300ng/mlcutoff60382236243822
375ng/ml+25%cutoff60564564546
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
2.5ng/ml-75%cutoff60060060060
5ng/ml-50%cutoff60060060060
7.5ng/ml-25%cutoff60852654654
BUP10ng/mlcutoff60342632283426
12.5ng/ml+25%cutoff60501048125010
15ng/ml+50%cutoff60600600600
17.5ng/ml+75%cutoff60600600600
20ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60456654852
BZO300ng/mlcutoff60362434263426
375ng/ml+25%cutoff60528546528
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60654852654
COC300ng/mlcutoff60382236243822
375ng/ml+25%cutoff60546564528
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
EDDP225ng/ml-25%cutoff60456456654
300ng/mlcutoff60362436243822
375ng/ml+25%cutoff60546564528
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
MDMA0ng/mlNegative60060060060
125ng/ml-75%cutoff60060060060
250ng/ml-50%cutoff60060060060
375ng/ml-25%cutoff60852654456
500ng/mlcutoff60322834263426
625ng/ml+25%cutoff6052848125010
750ng/ml+50%cutoff60600600600
875ng/ml+75%cutoff60600600600
1000ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
250ng/ml-75%cutoff60060060060
500ng/ml-50%cutoff60060060060
750ng/ml-25%cutoff608521050852
MET1000ng/mlcutoff60362434263822
1250ng/ml+25%cutoff605465285010
1500ng/ml+50%cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60105010501248
MOP300ng/mlcutoff60382240203822
300375ng/ml+25%cutoff60564546564
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
500ng/ml-75%cutoff60060060060
1000ng/ml-50%cutoff60060060060
MOP1500ng/ml-25%cutoff60654852456
20002000ng/mlcutoff60362434263228
2500ng/ml+25%cutoff60564546546
3000ng/ml+50%cutoff60600600600
3500ng/ml+75%cutoff60600600600
4000ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
MTD75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60852456654
300ng/mlcutoff60382236243624
375ng/ml+25%cutoff60564546528
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
OXY0ng/mlNegative60060060060
25ng/ml-75%cutoff60060060060
50ng/ml-50%cutoff60060060060
75ng/ml-25%cutoff60456654654
100ng/mlcutoff60362438223624
125ng/ml+25%cutoff60546582564
150ng/ml+50%cutoff60600600600
175ng/ml+75%cutoff60600600600
200ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
6.3ng/ml-75%cutoff60060060060
12.5ng/ml-50%cutoff60060060060
18.8ng/ml-25%cutoff60456456654
PCP25ng/mlcutoff60382234263426
31.3ng/ml+25%cutoff60564546564
37.5ng/ml+50%cutoff60600600600
43.8ng/ml+75%cutoff60600600600
50ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60456654654
PPX300ng/mlcutoff60342632283228
375ng/ml+25%cutoff60546528564
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
250ng/ml-75%cutoff60060060060
500ng/ml-50%cutoff60060060060
750ng/ml-25%cutoff60852654456
TCA1000ng/mlcutoff60342636243624
1250ng/ml+25%cutoff605285010546
1500ng/ml+50%cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100%cutoff60600600600
THC0ng/mlNegative60060060060
12.5ng/ml-75%cutoff60060060060
25ng/ml-50%cutoff60060060060
37.5ng/ml-25%cutoff60456654654
50ng/mlcutoff60382238223624
62.5ng/ml+25%cutoff60546564546
75ng/ml+50%cutoff60600600600
87.5ng/ml+75%cutoff60600600600
100ng/ml+100%cutoff60600600600

Multi-drug Test Cup:

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

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

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

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

Multi-drug Test Dipcard:

ApproximateNumber ofResultLot 2Lot 3
Drugconcentration% of cutoffdeterminatiLot 1
testof sampleons per lotPositiveNegativePositiveNegativePositiveNegative
AMP250ng/ml-75%cutoff60060060060
500ng/ml-50%cutoff60060060060
750ng/ml-25%cutoff60852654654
1000ng/mlcutoff60322834263624
1250ng/ml+25%cutoff6050105285010
1500ng/ml+50%cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100%cutoff60600600600
250ng/ml-75%cutoff60060060060
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
BAR225ng/ml-25%cutoff6010508521050
300ng/mlcutoff60362438223624
375ng/ml+25%cutoff60528546564
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
2.5ng/ml-75%cutoff60060060060
5ng/ml-50%cutoff60060060060
7.5ng/ml-25%cutoff60456852654
BUP10ng/mlcutoff60322832283426
12.5ng/ml+25%cutoff6052850104812
15ng/ml+50%cutoff60600600600
17.5ng/ml+75%cutoff60600600600
20ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
BZO225ng/ml-25%cutoff60654852456
300ng/mlcutoff60342636243228
375ng/ml+25%cutoff605465010528
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
COC0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60456456852
300ng/mlcutoff60362438223426
375ng/ml+25%cutoff60546528528
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
EDDP0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff60654456654
300ng/mlcutoff60382238223624
375ng/ml+25%cutoff60564546546
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
MDMA0ng/mlNegative60060060060
125ng/ml-75%cutoff60060060060
250ng/ml-50%cutoff60060060060
375ng/ml-25%cutoff60654456852
500ng/mlcutoff60342632283228
625ng/ml+25%cutoff6050104812528
750ng/ml+50%cutoff60600600600
875ng/ml+75%cutoff60600600600
1000ng/ml+100%cutoff60600600600
MET0ng/mlNegative60060060060
250ng/ml-75%cutoff60060060060
500ng/ml-50%cutoff60060060060
750ng/ml-25%cutoff601050852654
1000ng/mlcutoff60362434263624
1250ng/ml+25%cutoff60528528546
1500ng/ml+50%cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100%cutoff60600600600
MOP3000ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
225ng/ml-25%cutoff6012481050852
300ng/mlcutoff60362438224020
375ng/ml+25%cutoff60546546564
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
MOP20000ng/mlNegative60060060060
500ng/ml-75%cutoff60060060060
1000ng/ml-50%cutoff60060060060
1500ng/ml-25%cutoff60852852654
2000ng/mlcutoff60342632283426
2500ng/ml+25%cutoff60546528564
3000ng/ml+50%cutoff60600600600
3500ng/ml+75%cutoff60600600600
4000ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
150ng/ml-50%cutoff60060060060
MTD225ng/ml-25%cutoff60654456852
300ng/mlcutoff60362434263822
375ng/ml+25%cutoff60564564546
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
25ng/ml-75%cutoff60060060060
50ng/ml-50%cutoff60060060060
OXY75ng/ml-25%cutoff60654456456
100ng/mlcutoff60382236243822
125ng/ml+25%cutoff60546546564
150ng/ml+50%cutoff60600600600
175ng/ml+75%cutoff60600600600
200ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
6.3ng/ml-75%cutoff60060060060
12.5ng/ml-50%cutoff60060060060
18.8ng/ml-25%cutoff60456654258
PCP25ng/mlcutoff60362438223426
31.3ng/ml+25%cutoff60546564528
37.5ng/ml+50%cutoff60600600600
43.8ng/ml+75%cutoff60600600600
50ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
PPX75ng/ml-75%cutoff60060060060
0ng/mlNegative60060060060
75ng/ml-75%cutoff60060060060
225ng/ml-25%cutoff60654456852
300ng/mlcutoff60342636243228
375ng/ml+25%cutoff60564528528
450ng/ml+50%cutoff60600600600
525ng/ml+75%cutoff60600600600
600ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
250ng/ml-75%cutoff60060060060
500ng/ml-50%cutoff60060060060
750ng/ml-25%cutoff60654456654
TCA1000ng/mlcutoff60322834263624
1250ng/ml+25%cutoff605010528546
1500ng/ml+50%cutoff60600600600
1750ng/ml+75%cutoff60600600600
2000ng/ml+100%cutoff60600600600
0ng/mlNegative60060060060
12.5ng/ml-75%cutoff60060060060
THC25ng/ml-50%cutoff60060060060
37.5ng/ml-25%cutoff60654852456
50ng/mlcutoff60342636243822
62.5ng/ml+25%cutoff60528546564
75ng/ml+50%cutoff60600600600
87.5ng/ml+75%cutoff60600600600
100ng/ml+100%cutoff60600600600

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

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

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

8.6 Accuracy

Multi-drug Test Cup:

80 clinical urine specimens for each drug were analyzed by GC/MS, or HPLC and by one lot of the corresponding Rapid Multi-drug Test Cup. Samples were divided by concentration into five categories: drug free, less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:

DrugTestCo-InnovationResultDrug freebyGC/MSanalysisLess than half thecutoffconcentration byGC/MS analysisNear CutoffNegative (Between50% below thecutoff and the cutoffconcentration)Near Cutoff Positive(Between the cutoffand 50% above thecutoff concentration)High Positive(greater than 50%above the cutoffconcentration)Total
AMP+00063480
-332500
BAR+00073380
-341500
BUP+00063380
-340610

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

BZO+00163480
-312600
COC+00053580
-331600
EDDP+00053580
-350500
MDMA+00073380
-350500
MET+00153580
-303600
MOP300+00053480
-332510
MOP2000+00163480
-304500
MTD+00073280
-350510
OXY+00053480
-332510
PCP+00053580
-340600
PPX+00153580
-330600
TCA+00153580
-331500
THC+00063380
-341510

Analysis of Discordant Results with Rapid Multi-drug Test Cup

Rapid Multi-drug Test CupGC/MS Analysis
Drug TestCutoff(ng/mL)Test ResultDrugConcentration(ng/mL)Drug in Urine
BUP**10Negative11.7Buprenorphine
BZO300Positive286Oxazepam
MET1000Positive867Methamphetamine
MOP300300Negative356Morphine
MOP20002000Positive1742Morphine
MTD300Negative328Methadone
OXY100Negative122Oxycodone
PPX300Positive248Propoxyphene
TCA*1000Positive861Nortriptyline
THC50Negative6111-nor-A9--THC-9-COOH

(TCA*:TCA was based on HPLC data.BUP**:BUP was based on LC/MS data.)

Multi-drug Test Dipcard

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

80 clinical urine specimens for each drug were analyzed by GC/MS, or HPLC and by one lot of the corresponding Rapid Multi-drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:

Drug TestCo-Innovation ResultDrug free by GC/MS analysisLess than half the cutoff concentration by GC/MS analysisNear Cutoff Negative (Between 50% below the cutoff and the cutoff concentration)Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration)High Positive (greater than 50% above the cutoff concentration)Total
AMP+00063480
-332500
BAR+00073380
-341500
BUP+00063380
-340610
BZO+00163480
-312600
COC+00053580
-331600
EDDP+00053580
-350500
MDMA+00073380
-350500
MET+00153580
-303600
MOP300+00053480
-332510
MOP2000+00163480
-304500
MTD+00073280
-350510
OXY+00053480
-332510
PCP+00053580
-340600
PPX+00153580
-330600
TCA+00153580
-331500
THC+00063380

Analysis of Discordant Results with Rapid Multi-drug Test Dipcard

Rapid Multi-drug Test DipcardGC/MS Analysis
Drug TestCutoff(ng/mL)Test ResultDrug Concentration (ng/mL)Drug in Urine
BUP**10Negative11.7Buprenorphine
BZO300Positive286Oxazepam
MET1000Positive867Methamphetamine

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

MOP300300Negative356Morphine
MOP20002000Positive1742Morphine
MTD300Negative328Methadone
OXY100Negative122Oxycodone
PPX300Positive248Propoxyphene
TCA*1000Positive861Nortriptyline
THC50Negative6111-nor-Δ9--THC-9-COOH

(TCA*:TCA was based on HPLC data.BUP**:BUP was based on LC/MS data.)

8.7 Lay User Study

1720 lay users from age 18 to 65 years participated in the study. Urine samples were prepared at the following concentrations: 0, +/- 50% cutoff,+/- 25% cutoff and +100% cutoff by spiking drug into drug free urine specimens. Each sample contain different drugs and the different concentrations. The concentrations of target drugs were confirmed with GC/MS, or LC/MS, HPLC. Each participant performed only 1 test on provided specimen with one format of Rapid Multi- drug Test (Dipcard, Cup) using the English package insert as guide to perform the test. They were asked to fill out an English questionnaire after finishing the test. Results were as follows:

Multi-drug Test Cup:

Drug testApproximateconcentration ofsample% of cutoffNumber ofdeterminationsper lotLayer user ResultsAgreement(%)
Lot1Lot2
AMP0ng/mlNegative36003600360100%
500ng/ml-50%cutoff10010010100%
750ng/ml-25%cutoff10192885%
1250ng/ml+25%cutoff10829185%
1500ng/ml+50%cutoff30300300100%
2000ng/ml+100%cutoff10100100100%
BAR0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
225ng/ml-25%cutoff10191990%
375ng/ml+25%cutoff101009195%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
BUP0ng/mlNegative36003600360100%
5ng/ml-50%cutoff10010010100%
7.5ng/ml-25%cutoff10192885%
12.5ng/ml+25%cutoff10919190%
15ng/ml+50%cutoff30300300100%
20ng/ml+100%cutoff10100100100%
BZO0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
225ng/ml-25%cutoff100101995%
375ng/ml+25%cutoff10919190%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
225ng/ml-25%cutoff100101995%
COC375ng/ml+25%cutoff101008290%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
EDDP225ng/ml-25%cutoff101901095%
375ng/ml+25%cutoff10829185%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
250ng/ml-50%cutoff10010010100%
MDM375ng/ml-25%cutoff10191990%
A625ng/ml+25%cutoff10829185%
750ng/ml+50%cutoff30300300100%
1000ng/ml+100%cutoff10100100100%
MET0ng/mlNegative36003600360100%
500ng/ml-50%cutoff10010010100%
750ng/ml-25%cutoff10281985%
1250ng/ml+25%cutoff108210090%
1500ng/ml+50%cutoff30300300100%
2000ng/ml+100%cutoff10100100100%
0ng/mlNegative3100310100%
150ng/ml-50%cutoff10010100%
MOP225ng/ml-25%cutoff601990%
300375ng/ml+25%cutoff609190%
450ng/ml+50%cutoff30300100%
600ng/ml+100%cutoff10100100%
0ng/mlNegative3100310100%
1000ng/ml-50%cutoff10010100%
MOP1500ng/ml-25%cutoff601990%
20002500ng/ml+25%cutoff609190%
3000ng/ml+50%cutoff30300100%
4000ng/ml+100%cutoff10100100%
0ng/mlNegative36003600360100%
MTD150ng/ml-50%cutoff10010010100%
225ng/ml-25%cutoff10192885%
375ng/ml+25%cutoff10829185%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
50ng/ml-50%cutoff10010010100%
75ng/ml-25%cutoff10191990%
OXY125ng/ml+25%cutoff108210090%
150ng/ml+50%cutoff30300300100%
200ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
12.5ng/ml-50%cutoff10010010100%
18.8ng/ml-25%cutoff10281985%
PCP31.3ng/ml+25%cutoff10919190%
37.5ng/ml+50%cutoff30300300100%
50ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
225ng/ml-25%cutoff101901095%
PPX375ng/ml+25%cutoff10919190%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
500ng/ml-50%cutoff10010010100%
750ng/ml-25%cutoff100102890%
TCA1250ng/ml+25%cutoff108210090%
1500ng/ml+50%cutoff30300300100%
2000ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
25ng/ml-50%cutoff10010010100%
37.5ng/ml-25%cutoff10192885%
THC62.5ng/ml+25%cutoff108210090%
75ng/ml+50%cutoff30300300100%
100ng/ml+100%cutoff10100100100%

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

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

Multi-drug Test Dipcard:

Drug testApproximateconcentrationof sample% of cutoffNumber ofdeterminationsper lotLayer user ResultsAgreement(%)
Lot1Lot2
PositiveNegativePositiveNegative
AMP0ng/mlNegative36003600360100%
AMP500ng/ml-50%cutoff10010010100%
750ng/ml-25%cutoff10191990%
1250ng/ml+25%cutoff109110095%
1500ng/ml+50%cutoff30300300100%
2000ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
225ng/ml-25%cutoff100101995%
BAR375ng/ml+25%cutoff10919190%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
5ng/ml-50%cutoff10010010100%
BUP7.5ng/ml-25%cutoff10192885%
12.5ng/ml+25%cutoff101009195%
15ng/ml+50%cutoff3010090100%
20ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
BZO225ng/ml-25%cutoff10191990%
375ng/ml+25%cutoff108210090%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
COC225ng/ml-25%cutoff10191990%
375ng/ml+25%cutoff10919190%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
EDDP225ng/ml-25%cutoff10281985%
375ng/ml+25%cutoff10919190%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
250ng/ml-50%cutoff10010010100%
375ng/ml-25%cutoff10192885%
MDMA625ng/ml+25%cutoff101009195%
750ng/ml+50%cutoff30300300100%
1000ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
MET500ng/ml-50%cutoff10010010100%
750ng/ml-25%cutoff101901095%
1250ng/ml+25%cutoff101009195%
1500ng/ml+50%cutoff30300300100%
2000ng/ml+100%cutoff10100100100%
0ng/mlNegative3100310100%
150ng/ml-50%cutoff10010100%
225ng/ml-25%cutoff60010100%
MOP300375ng/ml+25%cutoff609190%
450ng/ml+50%cutoff30300100%
600ng/ml+100%cutoff10100100%
0ng/mlNegative31000310100%
1000ng/ml-50%cutoff100010100%
1500ng/ml-25%cutoff601990%
MOP20002500ng/ml+25%cutoff609190%
3000ng/ml+50%cutoff30300100%
4000ng/ml+100%cutoff10100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
225ng/ml-25%cutoff102801090%
MTD375ng/ml+25%cutoff101008290%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
50ng/ml-50%cutoff10010010100%
75ng/ml-25%cutoff10281985%
OXY125ng/ml+25%cutoff10919190%
150ng/ml+50%cutoff30300300100%
200ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
12.5ng/ml-50%cutoff10010010100%
18.8ng/ml-25%cutoff100102890%
PCP31.3ng/ml+25%cutoff10829185%
37.5ng/ml+50%cutoff30300300100%
50ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
150ng/ml-50%cutoff10010010100%
225ng/ml-25%cutoff10192885%
PPX375ng/ml+25%cutoff10829185%
450ng/ml+50%cutoff30300300100%
600ng/ml+100%cutoff10100100100%
0ng/mlNegative36003600360100%
500ng/ml-50%cutoff10010010100%
TCA750ng/ml-25%cutoff10281985%
1250ng/ml+25%cutoff10919190%
1500ng/ml+50%cutoff30300300100%
2000ng/ml+100%cutoff10100100100%
THC0ng/mlNegative36003600360100%
25ng/ml-50%cutoff10010010100%
37.5ng/ml-25%cutoff100102890%
62.5ng/ml+25%cutoff10918285%
75ng/ml+50%cutoff30300300100%
100ng/ml+100%cutoff10100100100%

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

{25}------------------------------------------------

{26}------------------------------------------------

1720 questionnaires were distributed collected. The results show that the test is easy to be used and the instruction insert is clear.

Evaluation of the readability of the labeling

The entire package insert readability was assessed. We choose 30 chain sentences from Instructions Insert at OTC user read. According to SMOG Conversion Table of Appendix B the SMOG Readability Formula of "Labeling of Home-Use In Vitro Testing Products: Approved Guideline: GP-14A5", the reading level belong to 7th degree.

8.7 Interference study

Interference studies were performed using the multi-drug test formats. Drug free specimens were spiked with single drug at 0, ±50% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS, or LC/MS, HPLC. Each concentration of the urine divided into aliquots. Each aliquot was specimen was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to The study was conducted by 6 operators at 3 Point-of-Care sites. Operators tested 3 testing. aliquots at each concentration for each lot per day (3runs/day ) and lasted for 5 non-consecutive days. A total of 15 determinations were made by each site at each concentration. There were 180 observations by 3 sites at 4 concentrations.

Drug testApproximateconcentration ofsample% of cutoffNumber ofdeterminations per lotResultLot2Lot3
Lot1
PositiveNegativePositiveNegativePositive
AMP0ng/mlNegative15015015015
500ng/ml-50%cutoff15015015015
1500ng/ml+50%cutoff15150150150
2000ng/ml+100%cutoff15150150150
BAR0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
BUP0ng/mlNegative15015015015
5ng/ml-50%cutoff15015015015
15150150150
BZO15ng/ml+50%cutoff15150150150
20ng/ml+100%cutoff15150150150
0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
COC0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
EDDP0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
MDMA0ng/mlNegative15015015015
250ng/ml-50%cutoff15015015015
750ng/ml+50%cutoff15150150150
1000ng/ml+100%cutoff15150150150
MET0ng/mlNegative15015015015
500ng/ml-50%cutoff15015015015
1500ng/ml+50%cutoff15150150150
2000ng/ml+100%cutoff15150150150
MOP3000ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
MOP20000ng/mlNegative15015015015
1000ng/ml-50%cutoff15015015015
3000ng/ml+50%cutoff15150150150
4000ng/ml+100%cutoff15150150150
MTD0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
OXY0ng/mlNegative15015015015
50ng/ml-50%cutoff15015015015
150ng/ml+50%cutoff15150150150
200ng/ml+100%cutoff15150150150
PCP0ng/mlNegative15015015015
12.5ng/ml-50%cutoff15015015015
37.5ng/ml+50%cutoff15150150150
50ng/ml+100%cutoff15150150150
PPX0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
TCA0ng/mlNegative15015015015
500ng/ml-50%cutoff15015015015
1500ng/ml+50%cutoff15150150150
2000ng/ml+100%cutoff15150150150
THC0ng/mlNegative15015015015
25ng/ml-50%cutoff15015015015
75ng/ml+50%cutoff15150150150
100ng/ml+100%cutoff15150150150

Multi-drug Test Cup:

{27}------------------------------------------------

{28}------------------------------------------------

Multi-drug Test Dipcard:

Drug testApproximateconcentration ofsample% of cutoffNumber ofdeterminations per lotLot1Lot2Lot3
PositiveNegativePositiveNegativePositiveNegative
AMP0ng/mlNegative15015015015
500ng/ml-50%cutoff15015015015
1500ng/ml+50%cutoff15150150150
2000ng/ml+100%cutoff15150150150
BAR0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
BUP0ng/mlNegative15015015015
5ng/ml-50%cutoff15015015015
15ng/ml+50%cutoff15150150150
20ng/ml+100%cutoff15150150150
BZO0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
COC0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
EDDP0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
MD0ng/mlNegative15015015015
MA250ng/ml-50%cutoff15015015015
750ng/ml+50%cutoff15150150150
1000ng/ml+100%cutoff15150150150
MET0ng/mlNegative15015015015
500ng/ml-50%cutoff15015015015
1500ng/ml+50%cutoff15150150150
2000ng/ml+100%cutoff15150150150
0ng/mlNegative15015015015
MOP150ng/ml-50%cutoff15015015015
300450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
0ng/mlNegative15015015015
MOP1000ng/ml-50%cutoff15015015015
20003000ng/ml+50%cutoff15150150150
4000ng/ml+100%cutoff15150150150
0ng/mlNegative15015015015
MTD150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
OXY0ng/mlNegative15015015015
50ng/ml-50%cutoff15015015015
150ng/ml+50%cutoff15150150150
200ng/ml+100%cutoff15150150150
PCP0ng/mlNegative15015015015
12.5ng/ml-50%cutoff15015015015
37.5ng/ml+50%cutoff15150150150
50ng/ml+100%cutoff15150150150
PPX0ng/mlNegative15015015015
150ng/ml-50%cutoff15015015015
450ng/ml+50%cutoff15150150150
600ng/ml+100%cutoff15150150150
TCA0ng/mlNegative15015015015
500ng/ml-50%cutoff15015015015
1500ng/ml+50%cutoff15150150150
2000ng/ml+100%cutoff15150150150
THC0ng/mlNegative15015015015
25ng/ml-50%cutoff15015015015
75ng/ml+50%cutoff15150150150
100ng/ml+100%cutoff15150150150

{29}------------------------------------------------

9. Conclusion:

{30}------------------------------------------------

The data collected in the performance and accuracy studies demonstrate that the Rapid Single/Multi Drug test cup and dipcard are substantially equivalent to the predicate device.

--- End of this section ---

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).