(29 days)
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
Configuration of the CLUNGENE® 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 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 in vitro diagnostic use only.
CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone. Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs 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 alternical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
The CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The CLUNGENE Multi-Drug Test Dip Card kit contains a Dip Card device, a package insert and a urine cup for sample collection. The CLUNGENE Multi-Drug Test Easy Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
Based on the provided text, the device in question is the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of various drugs in human urine.
Here's an analysis of the acceptance criteria and the studies performed:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a separate, quantitative table with pass/fail thresholds before presenting the results. However, the performance data presented implies the criteria for "acceptable performance" for each test type. The precision study for concentrations near the cut-off would be a key indicator for quantitative acceptance. For the qualitative tests, the performance at concentrations above and below the cutoff demonstrates the criteria.
Implied Acceptance Criteria and Reported Performance from Precision Studies (for Secobarbital)
The precision study for Secobarbital demonstrates expected performance around the cut-off (300 ng/mL). A device is expected to consistently classify samples below the cut-off as negative and above as positive. At the exact cut-off, a roughly 50/50 split is typical, reflecting the analytical variation.
| Test Parameter / Concentration (ng/mL) | Acceptance Criteria (Implied) | Reported Device Performance (CLUNGENE Multi-Drug Test Dip Card - Secobarbital) | Reported Device Performance (CLUNGENE Multi-Drug Test Easy Cup - Secobarbital) | Outcome |
|---|---|---|---|---|
| Secobarbital (Cut-off: 300 ng/mL) | ||||
| 0 (100% below) | 100% Negative | 50-/0+ (All negative across 3 lots) | 50-/0+ (All negative across 3 lots) | Pass |
| 69 (75% below) | 100% Negative | 50-/0+ (All negative across 3 lots) | 50-/0+ (All negative across 3 lots) | Pass |
| 147 (50% below) | 100% Negative | 50-/0+ (All negative across 3 lots) | 50-/0+ (All negative across 3 lots) | Pass |
| 226 (25% below) | 100% Negative | 50-/0+ (All negative across 3 lots) | 50-/0+ (All negative across 3 lots) | Pass |
| 286 (Cut-off) | Mixed results expected | Lot 1: 22-/28+, Lot 2: 26-/24+, Lot 3: 27-/23+ (Mixed positive/negative) | Lot 1: 26-/24+, Lot 2: 27-/23+, Lot 3: 21-/29+ (Mixed positive/negative) | Pass |
| 370 (25% above) | 100% Positive | 50+/0- (All positive across 3 lots) | 50+/0- (All positive across 3 lots) | Pass |
| 457 (50% above) | 100% Positive | 50+/0- (All positive across 3 lots) | 50+/0- (All positive across 3 lots) | Pass |
| 510 (75% above) | 100% Positive | 50+/0- (All positive across 3 lots) | 50+/0- (All positive across 3 lots) | Pass |
| 559 (100% above) | 100% Positive | 50+/0- (All positive across 3 lots) | 50+/0- (All positive across 3 lots) | Pass |
Similar tables and outcomes are provided for Methadone and Oxycodone, and referenced for other drugs (Amphetamine, Oxazepam, Cocaine, Methamphetamine, Morphine, Marijuana) in previous submissions (K153741 and K161251).
Lay-User Study Performance:
The lay-user study also demonstrates adherence to an implicit acceptance criterion that a high percentage of correct results should be obtained, especially for samples significantly above or below the cutoff. For samples at +/- 25% of the cutoff, a slight reduction in accuracy is observed and expected due to the nature of qualitative assays at the analytical threshold.
| Drug | % of Cut-off | Expected Outcome | Reported % of Correct Results | Outcome |
|---|---|---|---|---|
| AMP | -100% to -50% | 100% Negative | 100% | Pass |
| -25% | High % Negative | 95% Negative | Pass | |
| +25% | High % Positive | 95% Positive | Pass | |
| +50% to +75% | 100% Positive | 100% | Pass | |
| BAR, COC, BZO, MTD, MOP, OXY, THC (similar patterns across drugs) | -100% to -50% | 100% Negative | Mostly 100% | Pass |
| -25% | High % Negative | 90-100% | Pass | |
| +25% | High % Positive | 90-100% | Pass | |
| +50% to +75% | 100% Positive | 100% | Pass |
2. Sample size used for the test set and the data provenance
-
Precision Study:
- Sample Size: For each drug and concentration, "tests were performed two runs per day for 25 days per device," which equates to 50 individual tests per concentration per lot. With 9 concentrations tested and 3 lots, this is 50 * 9 * 3 = 1350 tests per drug type. This study was carried out for Secobarbital, Methadone, and Oxycodone. Data for other drugs were reported previously.
- Data Provenance: Samples were "prepared by spiking drug in negative urine samples." This indicates controlled laboratory conditions. The text does not specify the country of origin of the urine samples themselves, but the manufacturer is Hangzhou Clongene Biotech Co.,Ltd. in China. The study is prospective in the sense that samples were prepared and then tested.
-
Comparison Studies (Clinical Samples):
- Sample Size: "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug." This was done for Secobarbital, Methadone, and Oxycodone. Similar studies for the other drugs were referenced in previous submissions.
- Data Provenance: "unaltered clinical samples." The origin (e.g., country) is not specified. The study design sounds retrospective, as samples were collected clinically and then processed for the study.
-
Lay-user Study:
- Sample Size: "A lay user study was performed at three intended user sites with 300 lay persons for each device format." Each participant tested one sample. The samples included negative and various levels around the cut-off. For each drug, the total number of samples tested with the device by lay users corresponds to the sum of samples across all concentrations (e.g., for AMP, 20+20+160+20+20+40+20 = 300 samples). This implies 300 samples per drug per device format. Given there are 9 drugs, this means 300 * 9 tests per device format.
- Data Provenance: Urine samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." This indicates controlled laboratory-prepared samples. The study was prospective in its execution. The "three intended user sites" are not specified geographically.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Precision Study: The ground truth for the prepared samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate analytical method, and no human experts are noted for establishing this specific ground truth.
- Comparison Studies (Clinical Samples): The ground truth for the clinical samples was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is explicitly stated as "The samples were blind labeled and compared to GC/MS results." No human experts are mentioned for establishing the ground truth, as GC/MS is an objective chemical analysis method.
- Lay-user Study: The ground truth for the prepared samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). No human experts are noted for establishing this specific ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For the device's reading: In the comparison studies, "three laboratory assistants" for each device (Dip Card and Easy Cup) seem to have visually read the results. The document provides tables breaking down positive/negative calls by "Viewer A, Viewer B, Viewer C". There is no explicit mention of an adjudication process (like 2+1 or 3+1) if these viewers disagreed. The data shows individual viewer results, and discordant results are listed separately, implying that their individual interpretations were recorded.
- For the ground truth: As the ground truth for all studies was established by chemical analytical methods (LC/MS or GC/MS), no human adjudication method was needed for the ground truth itself.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not performed in the context of AI assistance. This document describes the performance of a point-of-care, visually interpreted immunochromatographic device (dip card/easy cup drug test). The "viewers" are laboratory assistants reading the visual results, not radiologists interpreting medical images with or without AI.
- The study is a direct comparison of the device's results against a gold standard (GC/MS or LC/MS), and a lay-user study to assess comprehensibility and ease of use. There is no AI component or human-in-the-loop AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a lateral flow immunoassay that produces a visual result inherently requiring human interpretation (either by a lay user or laboratory assistant). There is no "algorithm" in the sense of software interpreting results without human input described for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for all studies (Precision, Comparison, Lay-user) was established using objective chemical analytical methods: LC/MS and GC/MS. These are considered gold standards for drug concentration determination. No expert consensus, pathology, or outcomes data were used as ground truth for this type of diagnostic device.
8. The sample size for the training set
- This information is not provided in the document. The document describes performance testing of the final device, not the development or training of a software algorithm. For an immunochromatographic assay, the "training set" would refer to the samples used during the assay development and optimization phase to establish the device's characteristics (e.g., antibody selection, membrane properties, cutoff optimization), which is distinct from the formal performance validation studies presented here.
9. How the ground truth for the training set was established
- This information is not provided in the document, as it pertains to the device's development phase rather than its validation. However, it can be inferred that similar analytical methods (LC/MS/GC/MS) would have been used during development to characterize drug concentrations in samples used for internal optimization.
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February 28, 2018
Hangzhou Clongene Biotech Co.,Ltd. % Jesse Xia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K180255
Trade/Device Name: CLUNGENE Multi-Drug Test Dip Card CLUNGENE Multi-Drug Test Easy Cup Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate Test System Regulatory Class: Class II Product Code: PTH, PTG, NGL, NGG, NFT, NFW, NFY, NFV Dated: January 25, 2018 Received: January 30, 2018
Dear Jesse Xia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
for 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) K180255
Device Name
CLUNGENE® Multi-Drug Test Dip Card CLUNGENE® Multi-Drug Test Easy Cup
Indications for Use (Describe)
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
Configuration of the CLUNGENE® 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 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 in vitro diagnostic use only.
CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone. Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
{3}------------------------------------------------
Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs 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 alternical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K180255
-
- Date: February 28, 2018
- Hangzhou Clongene Biotech Co., Ltd. 2. Submitter: 20 Longquan Road Hangzhou 311121, China
-
- Contact person: Zheng Shujian Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: 86 571 88262120 Email: frank@clongene.com.
-
- Device Name: CLUNGENE Multi-Drug Test Dip Card
CLUNGENE Multi-Drug Test Easy Cup
| Classification: | Class 2 | ||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| NFTAmphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| NFWCannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| NFYCocaine | II | 21 CFR § 862.3250, Cocaine Test System | Toxicology (91) |
| NGGMethamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| NGLMorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| NFVOxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| NGLOxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| PTHSecobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| PTGMethadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
5. Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
-
- Intended Use
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of:
- Intended Use
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
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| Oxazepam | Oxazepam | 300 ng/mL |
|---|---|---|
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-Δ⁹-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
Configuration of the CLUNGENE® 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 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 or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs 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 or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
-
- Device Description
The CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of
- Device Description
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Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The CLUNGENE Multi-Drug Test Dip Card kit contains a Dip Card device, a package insert and a urine cup for sample collection. The CLUNGENE Multi-Drug Test Easy Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
-
- Substantial Equivalence Information A summary comparison of features of the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup and the predicate devices is provided in following tables.
| Table 1: Features Comparison of CLUNGENE Multi-Drug Test Dip Card and the | |||
|---|---|---|---|
| Predicate Devices | |||
| D J . L T 1 1001 | |||
| Item | Device | Predicate - K142396 | |
| Indication(s)for Use | For the qualitative determination of drugs ofabuse in human urine. | Same (but the number ofdrugs detected is different) | |
| Calibrator andCut-Off Values | Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (MOR): 300ng/mLOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/ml | Same | |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry. | Same | |
| Type of Test | Qualitative | Same | |
| Specimen Type | Human Urine | Same | |
| Intended Use | For over-the-counter | Same | |
| Configurations | Dip Card | Same |
Table 2: Features Comparison of CLUNGENE Multi-Drug Test Easy Cup Tests and the Predicate Devices
| Item | Device | Predicate - K142396 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofdrugs of abuse in human urine. | Same (but the number ofdrugs detected is different) |
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| Calibrator and Cut-OffValues | Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/ml11-Nor-Δ9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (MOR): 300ng/mLOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/ml | Same |
|---|---|---|
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Cup | Dip Card |
9. Test Principle
The CLUNGENE Multi-Drug Test Dip Card, and CLUNGENE Multi-Drug Test Easy Cup are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
10. Performance Characteristics
-
- Analytical Performance
a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the
{8}------------------------------------------------
following tables for Secobarbital, Methadone and Oxycodone. The data for Methamphetamine, Morphine and Marijuana were reported in K153741; and the data for Amphetamine, Oxazepam and Cocaine were reported in K161251.
| Concentration byLC/MS (ng/mL) | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | Cut-off+25% | Cut-off+50% | Cut-off+75% | Cut-off+100% |
|---|---|---|---|---|---|---|---|---|---|
| LotNumber | 0 | 69 | 147 | 226 | 286 | 370 | 457 | 510 | 559 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Secobarbital CLUNGENE Multi-Drug Test Dip Card
CLUNGENE Multi-Drug Test Easy Cup
| Concentration byLC/ MS (ng/mL) | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | Cut-off+25% | Cut-off+50% | Cut-off+75% | Cut-off+100% |
|---|---|---|---|---|---|---|---|---|---|
| LotNumber | 0 | 69 | 147 | 226 | 286 | 370 | 457 | 510 | 559 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Methadone CLUNGENE Multi-Drug Test Dip Card
| Concentration byLC/MS (ng/mL) | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
|---|---|---|---|---|---|---|---|---|---|
| LotNumber | 0 | 76 | 140 | 235 | 297 | 377 | 431 | 507 | 631 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CLUNGENE Multi-Drug Test Easy Cup
| Concentration byLC/MS (ng/mL) | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Lot | |||||||||
| Number | 0 | 76 | 140 | 235 | 297 | 377 | 431 | 507 | 631 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Oxycodone
CLUNGENE Multi-Drug Test Dip Card
| Concentration byLC/MS (ng/mL) | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
|---|---|---|---|---|---|---|---|---|---|
| LotNumber | 0 | 25 | 48 | 72 | 101 | 119 | 142 | 164 | 187 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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| Concentration byLC/MS (ng/mL)Lot | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
|---|---|---|---|---|---|---|---|---|---|
| Number | 0 | 25 | 48 | 72 | 101 | 119 | 142 | 164 | 187 |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Concentration byLC/MS (ng/mL)Lot | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off |
| Number | 0 | 25 | 48 | 72 | 101 | 119 | 142 | 164 | 187 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
The following cut-off values are verified.
| Drug(Identifier) | Cut-off level |
|---|---|
| Secobarbital (BAR) | 300 ng/mL |
| Methadone (MTD ) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
-
b. Linearity
Not applicable. -
c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C. Real time stability studies are ongoing. -
d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three lots of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
| Acetominophen (4-Acetamidophenol) | Ecgonine methyl ester | D,L-Octopamine |
|---|---|---|
| Acetophenetidin | EMDP | Oxalic acid |
| N-Acetylprocainamide | Erythromycin | Oxolinic acid |
| Acetylsalicylic acid | β-Estradiol | Oxymetazoline |
| Albumin | Fenoprofen | Papaverine |
| Aminopyrine | Furosemide | Penicillin-G |
| Amoxicillin | Gentisic acid | Perphenazine |
| Ampicillin | Hemoglobin | Phenelzine |
| Apomorphine | Hydralazine | Prednisone |
| Ascorbic acid | Hydrochlorothiazide | DL-Propranolol |
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| Aspartame | Hydrocortisone | D-Pseudoephedrine |
|---|---|---|
| Atropine | O-Hydroxyhippuric acid | Quinine |
| Benzilic acid | 3-Hydroxytyramine | Ranitidine |
| Benzoic acid | Ibuprofen | Salicylic acid |
| Bilirubin | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Chloralhydrate | Isoxsuprine | Sulfamethazine |
| Chloramphenicol | Ketamine | Sulindac |
| Chlorothiazide | Ketoprofen | Tetrahydrocortisone, 3-acetate |
| Chlorpromazine | Labetalol | Tetrahydrocortisone 3-(β- |
| Cholesterol | Loperamide | Dglucuronide) |
| Clonidine | Maprotiline | Tetrahydrozoline |
| Cortisone | Meperidine | Thiamine |
| (-) Cotinine | Meprobamate | Thioridazine |
| Creatinine | Methoxyphenamine | Triamterene |
| Deoxycorticosterone | Nalidixic acid | DL-Tyrosine |
| Dextromethorphan | Naloxone | Trifluoperazine |
| Diclofenac | Naltrexone | Trimethoprim |
| Diflunisal | Naproxen | D L-Tryptophan |
| Digoxin | Niacinamide | Tyramine |
| Diphenhydramine | Nifedipine | Uric acid |
| Disopyramide | Norethindrone | Verapamil |
| EDDP | Noscapine | Zomepirac |
To demonstrate that there are no interference from each of the nine drug analytes on the other eight drug strips, devices in both CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup were tested using standard drug urine solutions at three fold cut-off drug concentrations of each drug analyte. Tests showed positive result only for each target drug and negative result for other drugs.
e. Specificity
To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Secobarbital, Methadone and Oxycodone. The data for Methamphetamine, Morphine and Marijuana were reported in K153741; and the data for Amphetamine, Oxazepam and Cocaine were reported in K161251. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
| Secobarbital | Result | % Cross-Reactivity |
|---|---|---|
| (Cut-off=300 ng/mL) | Positive at (ng/mL) | |
| Secobarbital | 300 | 100% |
| Amobarbital | 300 | 100% |
| Alphenol | 150 | 200% |
| Aprobarbital | 200 | 150% |
| Butabarbital | 75 | 400% |
| Butathal | 100 | 300% |
| Butalbital | 2500 | 12% |
| Cyclopentobarbital | 600 | 50% |
| Pentobarbital | 300 | 100% |
| Phenobarbital | 100 | 300% |
| Methadone(Cut-off=300 ng/mL) | ResultPositive at(ng/ml) | % Cross-Reactivity |
|---|---|---|
| ---------------------------------- | ------------------------------ | -------------------- |
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| Methadone | 300 | 100% |
|---|---|---|
| Doxylamine | 5000 | 6% |
| LAAM HCl | >100000 | <0.3% |
| Alpha Methadol | >100000 | <0.3% |
| EDDP | >100000 | <0.3% |
| EMDP | >100000 | <0.3% |
| Oxycodone(Cut-off=100 ng/mL) | ResultPositive at(ng/ml) | % Cross-Reactivity |
|---|---|---|
| Oxycodone | 100 | 100% |
| Codeine | 50000 | 0.2% |
| Dihydrocodeine | 12500 | 0.8% |
| Ethylmorphine | 25000 | 0.4% |
| Hydrocodone | 1562 | 6.4% |
| Hydromorphone | 12500 | 0.8% |
| Oxymorphone | 1562 | 6.4% |
| Thebaine | 50000 | 0.2% |
f. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
2. Comparison Studies
Method comparison studies for the CLUNGENE Multi-Drug Test Dip Card and the CLUNGENE Multi-Drug Test Easy Cup were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below for Secobarbital, Methadone and Oxycodone. The data for Methamphetamine, Morphine and Marijuana were reported in K153741; and the data for Amphetamine, Oxazepam and Cocaine were reported in K161251.
| CLUNGENEMulti-DrugTest Dip Card | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 1 | 19 | 20 |
| ViewerA | Negative | 10 | 15 | 14 | 1 | 0 |
| ViewerB | Positive | 0 | 0 | 0 | 20 | 20 |
| ViewerB | Negative | 10 | 15 | 15 | 0 | 0 |
| ViewerC | Positive | 0 | 0 | 1 | 20 | 20 |
| ViewerC | Negative | 10 | 15 | 14 | 0 | 0 |
Discordant Results
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| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
|---|---|---|---|
| Viewer A | BAR79 | 298 | Positive |
| Viewer C | BAR29 | 294 | Positive |
| Viewer A | BAR14 | 316 | Negative |
| CLUNGENEMulti-DrugTest EasyCup | Negative | Low Negative by GC/MS(less than -50%) | Near Cutoff Negative by GC/MS(Between -50% and cutoff) | Near Cutoff Positive by GC/MS(Between the cutoff and +50%) | High Positive by GC/MS(greater than +50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 1 | 19 | 20 |
| Negative | 10 | 15 | 14 | 1 | 0 | |
| ViewerB | Positive | 0 | 0 | 2 | 18 | 20 |
| Negative | 10 | 15 | 13 | 2 | 0 | |
| ViewerC | Positive | 0 | 0 | 1 | 19 | 20 |
| Negative | 10 | 15 | 14 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | GC/MS Result | Easy CupViewer Results |
|---|---|---|---|
| Viewer A | BAR79 | 298 | Positive |
| Viewer B | BAR30 | 296 | Positive |
| Viewer B | BAR79 | 298 | Positive |
| Viewer C | BAR29 | 294 | Positive |
| Viewer A | BAR33 | 330 | Negative |
| Viewer B | BAR14 | 316 | Negative |
| Viewer B | BAR35 | 349 | Negative |
| Viewer C | BAR14 | 316 | Negative |
Methadone
| CLUNGENEMulti-DrugTest Dip Card | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 0 | 19 | 20 |
| ViewerA | Negative | 10 | 15 | 15 | 1 | 0 |
| ViewerB | Positive | 0 | 0 | 1 | 20 | 20 |
| ViewerB | Negative | 10 | 15 | 14 | 0 | 0 |
| ViewerC | Positive | 0 | 0 | 1 | 20 | 20 |
| ViewerC | Negative | 10 | 15 | 14 | 0 | 0 |
Discordant Results
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| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
|---|---|---|---|
| Viewer B | MTD28 | 297 | Positive |
| Viewer C | MTD14 | 292 | Positive |
| Viewer A | MTD29 | 308 | Negative |
| CLUNGENEMulti-DrugTest EasyCup | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| Viewer | Positive | 0 | 0 | 2 | 19 | 20 |
| A | Negative | 10 | 15 | 13 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 20 | 20 |
| B | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 19 | 20 |
| C | Negative | 10 | 15 | 14 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | GC/MS Result | Easy CupViewer Results |
|---|---|---|---|
| Viewer A | MTD14 | 292 | Positive |
| Viewer A | MTD28 | 297 | Positive |
| Viewer B | MTD28 | 297 | Positive |
| Viewer C | MTD14 | 292 | Positive |
| Viewer A | MTD29 | 308 | Negative |
| Viewer C | MTD76 | 313 | Negative |
Oxycodone
| CLUNGENEMulti-DrugTest Dip Card | Negative | Low Negative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 0 | 20 | 20 |
| ViewerA | Negative | 10 | 15 | 15 | 0 | 0 |
| ViewerB | Positive | 0 | 0 | 1 | 19 | 20 |
| ViewerB | Negative | 10 | 15 | 14 | 1 | 0 |
| ViewerC | Positive | 0 | 0 | 0 | 19 | 20 |
| ViewerC | Negative | 10 | 15 | 15 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | GC/MS Result | Dip CardViewer Results |
|---|---|---|---|
| Viewer B | OXY66 | 92 | Positive |
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| Viewer B | OXY39 | 101 | Negative |
|---|---|---|---|
| Viewer C | OXY30 | 102 | Negative |
| CLUNGENEMulti-DrugTest EasyCup | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Between thecutoff and+50%) | High Positiveby GC/MS(greater than+50%) | |
|---|---|---|---|---|---|---|
| ViewerA | Positive | 0 | 0 | 0 | 19 | 20 |
| ViewerA | Negative | 10 | 15 | 15 | 1 | 0 |
| ViewerB | Positive | 0 | 0 | 1 | 20 | 20 |
| ViewerB | Negative | 10 | 15 | 14 | 0 | 0 |
| ViewerC | Positive | 0 | 0 | 0 | 19 | 20 |
| ViewerC | Negative | 10 | 15 | 15 | 1 | 0 |
Discordant Results
| Viewer | Sample Number | GC/MS Result | Easy CupViewer Results |
|---|---|---|---|
| Viewer B | OXY66 | 92 | Positive |
| Viewer A | OXY39 | 101 | Negative |
| Viewer C | OXY30 | 102 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 300 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Results are shown below.
| Drugs | % of Cut-off | Numberofsamples | Concentration byLC/MS(ng/mL) | Lay person resultsNo. ofPositive | Lay person resultsNo. ofNegative | Thepercentageof correctresults(%) |
|---|---|---|---|---|---|---|
| AMP | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 250 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 500 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 750 | 1 | 19 | 95 | |
| +25% Cut-off | 20 | 1250 | 19 | 1 | 95 | |
| +50% Cut-off | 40 | 1500 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 1750 | 20 | 0 | 100 | |
| BAR | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 225 | 0 | 20 | 100 | |
| +25% Cut-off | 20 | 375 | 18 | 2 | 90 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| -100% Cut-off | 20 | 0 | 0 | 20 | 100 | |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| COC | -25% Cut-off | 20 | 225 | 1 | 19 | 95 |
| +25% Cut-off | 20 | 375 | 19 | 1 | 95 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| -100% Cut-off | 20 | 0 | 0 | 20 | 100 | |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| BZO | -25% Cut-off | 20 | 225 | 0 | 20 | 100 |
| +25% Cut-off | 20 | 375 | 19 | 1 | 95 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| -100% Cut-off | 20 | 0 | 0 | 20 | 100 | |
| -75% Cut-off | 20 | 250 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 500 | 0 | 160 | 100 | |
| MET | -25% Cut-off | 20 | 750 | 1 | 19 | 95 |
| +25% Cut-off | 20 | 1250 | 20 | 0 | 100 | |
| +50% Cut-off | 40 | 1500 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 1750 | 20 | 0 | 100 | |
| -100% Cut-off | 20 | 0 | 0 | 20 | 100 | |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| MTD | -25% Cut-off | 20 | 225 | 0 | 20 | 100 |
| +25% Cut-off | 20 | 375 | 18 | 2 | 90 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| -100% Cut-off | 20 | 0 | 0 | 20 | 100 | |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| MOP | -25% Cut-off | 20 | 225 | 2 | 18 | 90 |
| +25% Cut-off | 20 | 375 | 20 | 0 | 100 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| -100% Cut-off | 20 | 0 | 0 | 20 | 100 | |
| OXY | -75% Cut-off | 20 | 25 | 0 | 20 | 100 |
| -50% Cut-off | 160 | 50 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 75 | 1 | 19 | 95 | |
| +25% Cut-off | 20 | 125 | 20 | 0 | 100 | |
| +50% Cut-off | 40 | 150 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 175 | 20 | 0 | 100 | |
| -100% Cut-off | 20 | 0 | 0 | 20 | 100 | |
| -75% Cut-off | 20 | 12.5 | 0 | 20 | 100 | |
| THC | -50% Cut-off | 160 | 25 | 0 | 160 | 100 |
| -25% Cut-off | 20 | 37.5 | 0 | 20 | 100 | |
| +25% Cut-off | 20 | 62.5 | 18 | 2 | 90 | |
| +50% Cut-off | 40 | 75 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 87.5 | 20 | 0 | 100 | |
| Drugs | % of Cut-off | Numberofsamples | Concentration byLC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
| AMP | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 250 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 500 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 750 | 1 | 19 | 95 | |
| +25% Cut-off | 20 | 1250 | 18 | 2 | 90 | |
| +50% Cut-off | 40 | 1500 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 1750 | 20 | 0 | 100 | |
| BAR | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 225 | 0 | 20 | 100 | |
| +25% Cut-off | 20 | 375 | 18 | 2 | 90 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| COC | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 225 | 0 | 20 | 100 | |
| +25% Cut-off | 20 | 375 | 19 | 1 | 95 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| BZO | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 225 | 1 | 19 | 95 | |
| +25% Cut-off | 20 | 375 | 19 | 1 | 95 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| MET | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 250 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 500 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 750 | 2 | 18 | 90 | |
| +25% Cut-off | 20 | 1250 | 20 | 0 | 100 | |
| +50% Cut-off | 40 | 1500 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 1750 | 20 | 0 | 100 | |
| MTD | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 225 | 0 | 20 | 100 | |
| +25% Cut-off | 20 | 375 | 19 | 1 | 95 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| MOP | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 75 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 150 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 225 | 1 | 19 | 95 | |
| +25% Cut-off | 20 | 375 | 20 | 0 | 100 | |
| +50% Cut-off | 40 | 450 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 525 | 20 | 0 | 100 | |
| OXY | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| -75% Cut-off | 20 | 25 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 50 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 75 | 1 | 19 | 95 | |
| +25% Cut-off | 20 | 125 | 20 | 0 | 100 | |
| +50% Cut-off | 40 | 150 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 175 | 20 | 0 | 100 | |
| THC | -100% Cut-off | 20 | 0 | 0 | 20 | |
| -75% Cut-off | 20 | 12.5 | 0 | 20 | 100 | |
| -50% Cut-off | 160 | 25 | 0 | 160 | 100 | |
| -25% Cut-off | 20 | 37.5 | 0 | 20 | 100 | |
| +25% Cut-off | 20 | 62.5 | 19 | 1 | 95 | |
| +50% Cut-off | 40 | 75 | 40 | 0 | 100 | |
| +75% Cut-off | 20 | 87.5 | 20 | 0 | 100 |
CLUNGENE Multi-Drug Test Dip Card
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CLUNGENE Multi-Drug Test Easy Cup
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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.
3. Clinical Studies
Not applicable.
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are substantially equivalent to the predicate.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).