(28 days)
CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine is a rapid test for the qualitative detection of Phencyclidine and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 25ng/mL and 500ng/mL. respectively.
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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
The CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine test uses immunochromatographic assays for phencyclidine and methylenedioxymethamphetamine. The test is a lateral flow, one step system for the qualitative detection of phencyclidine and methylenedioxymethamphetamine in human urine.
The provided document describes the performance characteristics of the "CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine" device, a rapid test for the qualitative detection of Phencyclidine (PCP) and Methylenedioxymethamphetamine (MDMA) in human urine.
Here's an analysis based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or overall agreement. However, it presents the results of several performance studies that demonstrate the device's capabilities, particularly around the established cut-off concentrations.
For the purpose of this analysis, we can infer the "acceptance criteria" from the performance reported in the "Precision" and "Lay-user study" sections, generally looking for high agreement around non-cutoff concentrations and a predictable range of positive/negative results at the cutoff.
Implied Acceptance Criteria and Reported Performance:
| Study Type / Metric | Acceptance Criteria (Inferred from common practice for drug tests) | Reported Device Performance (PCP) | Reported Device Performance (MDMA) |
|---|---|---|---|
| Precision Study | |||
| -100% Cut-off | 100% Negative | 50/0+ (50 Negative, 0 Positive) across 3 lots | 50/0+ (50 Negative, 0 Positive) across 3 lots |
| -75% Cut-off | 100% Negative | 50/0+ across 3 lots | 50/0+ across 3 lots |
| -50% Cut-off | 100% Negative | 50/0+ across 3 lots | 50/0+ across 3 lots |
| -25% Cut-off | 100% Negative (or very high percentage negative) | 50/0+ across 3 lots | 50/0+ across 3 lots |
At Cut-off (25 ng/mL for PCP, 500 ng/mL for MDMA) | Expected to show a mix of positive and negative results, demonstrating sensitivity at the cutoff, but no specific ratio is typically set as an acceptance criterion; rather, it should demonstrate the cutoff is truly a discrimination point. | 42+/8- (Lot 1 & 2), 43+/7- (Lot 3) for 50 tests | 42+/8- (Lot 1), 43+/7- (Lot 2 & 3) for 50 tests |
| +25% Cut-off | 100% Positive (or very high percentage positive) | 50+/0- across 3 lots | 50+/0- across 3 lots |
| +50% Cut-off | 100% Positive | 50+/0- across 3 lots | 50+/0- across 3 lots |
| +75% Cut-off | 100% Positive | 50+/0- across 3 lots | 50+/0- across 3 lots |
| +100% Cut-off | 100% Positive | 50+/0- across 3 lots | 50+/0- across 3 lots |
| Lay-User Study | |||
| Drug-free (-100%) | 100% Agreement with GC/MS (Negative) | 100% | Not applicable (combined drug-free for both) |
| -75% Cut-off | 100% Agreement with GC/MS (Negative) | 100% | 100% |
| -50% Cut-off | 100% Agreement with GC/MS (Negative) | 100% | 100% |
| -25% Cut-off | High Agreement with GC/MS (Negative), ideally >95% | 85% | 90% |
| +25% Cut-off | High Agreement with GC/MS (Positive), ideally >95% | 85% < | 85% |
| +50% Cut-off | 100% Agreement with GC/MS (Positive) | 100% | 100% |
| +75% Cut-off | 100% Agreement with GC/MS (Positive) | 100% | 100% |
Summary of Device Performance:
The device demonstrates excellent precision at concentrations significantly above and below the cut-off. At the cut-off, it shows a mix of positive and negative results, which is expected for a qualitative assay designed to discriminate at that concentration. The lay-user study shows strong agreement (100%) at concentrations well outside the cutoff range, with a slight decrease in agreement (85-90%) at concentrations near the +/-25% cut-off, indicating some variability at those boundary concentrations.
2. Sample size used for the test set and the data provenance
Precision Study:
- Sample Size: For each drug (PCP and MDMA), 9 concentration levels were tested. For each concentration, tests were performed two runs per day for 25 days, totaling 50 tests per concentration level. Since there were 3 different lots used, this means 150 tests per concentration level (50 tests/level * 3 lots). Overall, 1350 tests per drug (9 conc. levels * 150 tests/level).
- Data Provenance: Not explicitly stated, but implies laboratory-prepared samples. It does not mention country of origin or whether it's retrospective or prospective, but the controlled nature of the study (prepared samples, masked, randomized) suggests a prospective, in-house laboratory setting.
Cut-off Study:
- Sample Size: 125 phencyclidine samples and 125 methylenedioxymethamphetamine samples. These were equally distributed at concentrations of -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs. This results in 25 samples per concentration level per drug.
- Data Provenance: Not explicitly stated, but implies laboratory-prepared samples. "labeled by a person who prepared them and would not participate in the sample testing." Suggests an in-house laboratory study.
Interference and Specificity Studies:
- Sample Size: Not specified in terms of distinct sample numbers, but interference testing involved adding various substances to 'drug-free urine' and 'urine containing target drugs at 25% below and 25% above the cut-off'. Specificity testing used "drug metabolites and other components that are likely to be present in urine samples". Each condition was tested using three batches of the device by three different operators.
- Data Provenance: Not explicitly stated, implied to be laboratory-prepared samples.
Comparison Studies (with GC/MS):
- Sample Size: 80 "unaltered clinical samples" (40 negative and 40 positive) for PCP and separately for MDMA. This means a total of 160 clinical samples were used (80 for PCP + 80 for MDMA).
- Data Provenance: "clinical samples". No country of origin is mentioned. The collection method (e.g., retrospective or prospective) is not stated, but they were "unaltered," "masked and randomized," suggesting a controlled clinical study environment.
Lay-User Study:
- Sample Size: 260 lay persons. Of these, 20 tested drug-free samples, 120 tested phencyclidine samples, and 120 tested methylenedioxymethamphetamine samples. The drug samples were further divided into 6 concentration levels (20 samples per concentration level for each drug).
- Data Provenance: "Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-25% of the cut-off by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS." These were likely laboratory-prepared "spiked" samples, not entirely real patient samples, although they were processed to simulate varying drug concentrations within urine. Data provenance is not explicitly stated in terms of country or retrospective/prospective outside of this description.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Comparison Studies (with GC/MS): The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry) results. GC/MS is a highly accurate and widely accepted gold-standard method for drug confirmation testing in urine. Therefore, no human "experts" were used to establish this ground truth; the analytical method itself is the gold standard.
- Precision, Cut-off, Interference, Specificity, Lay-User Studies: The ground truth for these studies was established by preparing samples with known concentrations of the target drugs/substances, often confirmed by an analytical method like GC/MS (as mentioned for the lay-user study). Again, the "ground truth" here is the known chemical composition and concentration, not expert human interpretation.
4. Adjudication method for the test set
- Comparison Studies (with GC/MS): The device results were directly compared to the GC/MS results, meaning GC/MS served as the definitive ground truth. Discrepancies were noted in discordant tables. There was no mention of human adjudication of discordant results; GC/MS was considered final.
- Precision, Cut-off, Interference, Specificity Studies: The results from the device were assessed against the known concentrations of the prepared samples.
- Lay-User Study: The lay-user results were compared against the GC/MS confirmed concentrations of the prepared (spiked) samples.
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
This is not applicable. The device is a rapid in-vitro diagnostic (urine drug test cup) that produces a visual qualitative result (colored lines). It does not involve AI assistance, human imaging interpretation, or complex multi-reader analysis in the way an MRMC study for AI would typically be conducted. The "readers" for this device are the users themselves (laboratory assistants in comparison studies, lay-users in the lay-user study), interpreting the visual lines to determine a positive or negative result.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a qualitative rapid immunoassay, which inherently requires human observation of the test lines to interpret the result ("human-in-the-loop"). There is no "algorithm only" component that operates without human interpretation of the visual output.
7. The type of ground truth used
- GC/MS (Gas Chromatography/Mass Spectrometry): Used as the confirmatory method and the gold standard for the "Comparison Studies" with clinical samples and for verifying the concentrations of spiked samples in the "Lay-User Study."
- Known/Spiked Concentrations: For the "Precision," "Cut-off," "Interference," and "Specificity" studies, samples were prepared with predetermined concentrations of the target analytes. This constitutes the ground truth for these analytical performance characteristics.
8. The sample size for the training set
This is not applicable. The device is an immunoassay (lateral flow, one-step system) that operates based on antigen-antibody reactions. It is not an algorithm or AI model that requires a "training set" in the computational sense. Its performance is determined by its biochemical and physical design.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for an immunoassay device. The scientific principles of immunology (antibody-antigen binding) and chromatography govern its function.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE., SUITE F GAITHERSBURG MD 20878
August 25, 2014
Re: K142044
Trade/Device Name: CR3 Keyless Split Sample Cup Phencyclidine-Methylenedioxymethamphetamine Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, LCM Dated: July 24, 2014 Received: July 28, 2014
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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,
Katherine Serrano -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
CR3 Kevless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine
Indications for Use (Describe)
CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamine is a rapid test for the qualitative detection of Phencyclidine and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 25ng/mL and 500ng/mL. respectively.
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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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FORM FDA 3881 (1/14)
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510(k) SUMMARY
| 1. Date: | August 21, 2014 |
|---|---|
| 2. Submitter: | Guangzhou Wondfo Biotech Co., Ltd.No.8 Lizhishan Road, Science City, Luogang DistrictGuangzhou, P.R. China 510663 |
| 3. Contact person: | Joe ShiaLSI International Inc.504 East Diamond Ave., Suite FGaithersburg, MD 20878Telephone: 240-505-7880Fax: 301-916-6213Email: shiajl@yahoo.com |
| 4. Device Name: | CR3 Keyless Split Sample Cup Phencyclidine –Methylenedioxymethamphetamine |
| Classification: | Product Code CFR #LCM UnclassifiedLAF 21CFR 862.3610 |
| 5. Predicate Devices: | K130665Wondfo Multi-Drug Urine Test CupWondfo Multi-Drug Urine Test Panel |
-
- Intended Use
CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine is a rapid test for the qualitative detection of Phencyclidine and Methylenediox ymethamphetamine in human urine at a cutoff concentration of 25ng/mL and 500ng/mL, respectively.
- Intended Use
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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
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For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
-
- Device Description
The CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine test uses immunochromatographic assays for phencyclidine and methylenedioxymethamphetamine. The test is a lateral flow, one step system for the qualitative detection of phencyclidine and methylenedioxymethamphetamine in human urine.
- Device Description
| Item | Device | Predicate |
|---|---|---|
| Indication(s) for use | For the qualitative determination of Phencyclidine andMethylenedioxymethamphetamine in human urine | Same, but also detects other drugs in human urine |
| Methodology | Competitive binding, lateral flowimmunochromatographic assaysbased on the principle of antigenantibody immunochemistry. | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Phencyclidine: 25ng/mlMethylenedioxymethamphetamine: 500ng/ml | Same for Phencyclidine andMethylenedioxymethamphetamine |
| Configurations | Cup | Cup, Panel |
| Conditions for Use | Over-the-Counter & Prescription Use | Same |
-
- Substantial Equivalence Information
9. Test Principle
The CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine test is a rapid test for the qualitative detection of phencyclidine and methylenedioxymethamphetamine in urine samples and contains lateral flow chromatographic immunoassays for phencyclidine and methylenedioxymethamphetamine. Each assay uses a mouse monoclonal anti-drug antibody-dye conjugate, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibodies coated on the test membranes. When the absorbent end of the test is immersed into a urine sample, the urine is absorbed into the
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device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentrations below the target cut-off, antibody-dye conjugates bind to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored test line that indicates a negative result. When analyte concentration is above the cut-off, analyte molecules bind to the antibody-dye conjugate, preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. No colored band shows in the test region, indicating a potentially positive result. A band should form in the control region (C) of the device regardless of the presence of drug or metabolite in the sample.
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, at the cut-off, +25% cut-off, +50% cut-off , +75% cut-off and +100% cut-off. For each concentration, tests were performed two runs per day for 25 days. All sample aliquots were masked and randomized. The results obtained are summarized in the following tables:
| ResultPCP | -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 |
|---|---|---|---|---|---|---|---|---|---|
| W11810501CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| W11810502CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| W11810503CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
A. For Phencyclidine (PCP) testing
B. For Methylenedioxymethamphetamine (MDMA) testing
| ResultMDMA | -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 |
|---|---|---|---|---|---|---|---|---|---|
| W11810501CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| W11810502CU5 | 50-/0+ | 50-10+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| W11810503CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
- b. Linearity
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Not applicable.
- c. Stability
The CR3 Keyless Split Sample Cup Phencyclidine -Methylenedioxymethamphetamine is stable at 4-30°C for 18 months as determined by conducting accelerated and real-time stability testing.
Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
- d. Cut-off
A total of 125 phencyclidine samples and 125 methylenedioxymethamphetamine samples equally distributed at concentrations of -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs were labeled by a person who prepared them and would not participate in the sample testing. These samples were tested using three different lots by three different operators. Results were all positive at +25% and +50% cut-off and all negative at -25% and -50% cut-off for both phencyclidine and methylenedioxymethamphetamine. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off(ng/ml) |
|---|---|---|
| Phencyclidine (PCP) | phencyclidine | 25 |
| Methylenedioxymethamphetamine (MDMA) | methylenedioxymethamphetamine | 500 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and to urine containing target drugs (phencyclidine or methylenedioxymethamphetamine) at 25% below and 25% above the cut-off. These urine samples were tested using three batches of the CR3Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine by three different operators. Compounds that showed no interference at a concentration of 100µg/mL are summarized below:
Phencyclidine
| Acetaminophen | (-) Y Ephedrine | Oxycodone |
|---|---|---|
| Acetophenetidin | Erythromycin | Oxymetazoline |
| N-Acetylprocainamide | β-Estradiol | Papaverine |
| Acetylsalicylic acid | Estrone-3-sulfate | Penicillin-G |
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Aminopyrine Amitryptyline Amobarbital Amoxicillin Ampicillin Ascorbic acid D.L-Amphetamine Apomorphine acid Aspartame Atropine Benzilic acid Benzoic acid Benzoylecgonine Benzphetamine Bilirubin Brompheniramine Caffeine Cannabidiol Cannabinol Chloralhydrate Chloramphenicol Chlordiazepoxide Chlorothiazide (±) Chlorpheniramine Chlorpromazine Chlorquine Cholesterol Clomipramine Clonidine Cocaine hydrochloride Codeine Cortisone (-) Cotinine Creatinine Deoxycorticosterone Dextromethorphan Diazepam Diclofenac Diflunisal Digoxin
Ethyl-p-aminobenzoate Fenoprofen Furosemide Gentisic acid Hemoglobin Hydralazine Hydrochlorothiazide Hydrocodone Hydrocortisone O-Hydroxyhippuric p-Hydroxymethamphetamine 3-Hydroxytyramine Ibuprofen Imipramine Iproniazid (±) - Isoproterenol Isoxsuprine Ketamine Ketoprofen Labetalol Loperamide Maprotiline Meperidine Meprobamate Methadone Methoxyphenamine (+) 3,4-Methylenedioxyamphetamine (+)3,4-Methylenedioxymethamphetamine Morphine-3-B-D glucuronide Morphine Sulfate Nalidixic acid Naloxone Naltrexone Naproxen Niacinamide Nifedipine Norcodein Norethindrone D-Norpropox yphene Noscapine
Pentazocine hydrochloride Pentobarbital Perphenazine Phenelzine Phenobarbital Phentermine L-Phenylephrine ß-Phenylethylamine Phenylpropanolamine Prednisolone Prednisone Procaine Promazine Promethazine D.L-Propanolol D-Propoxyphene D-Pseudoephedrine Ouinidine Ouinine Ranitidine Salicylic acid Secobarbital Serotonin (5-Hydroxytyramine) Sulfamethazine Sulindac Temazepam Tetracycline Tetrahydrocortisone, 3acetate Tetrahydrocortisone3 (ß-D glucuronide) Tetrahydrozoline Thiamine Thioridazine D, L-Tyrosine Tolbutamide Triamterene Trifluoperazine Trimethoprim Trimipramine Tryptamine D, L-Tryptophan
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Diphenhydramine Doxylamine Ecgonine hydrochloride Ecgonine methylester
D.L-Octopamine Oxalic acid Oxazepam Oxolinic acid
Methylenedioxymethamphetamine
- 4-Acetamidophenol Acetophenetidin N-Acetylprocainamide Acetylsalicylic acid Aminopyrine Amitryptyline
Amobarbital Amoxicillin Ampicillin L-Ascorbic acid Apomorphine Aspartame Atropine Benzilic acid Benzoic acid Benzoylecgonine Bilirubin (±) - Brompheniramine Buspiron Caffeine Cannabidiol Cannabinol Chloralhydrate Chloramphenicol
Chlordiazepoxide Chlorothiazide (±) - Chlorpheniramine Chlorpromazine Chlorquine Methylphenidate Cholesterol
Clomipramine
(L) – Epinephrine Erythromycin ß-Estradiol Estrone-3-sulfate Ethyl-p-aminobenzoate Fenoprofen
Furosemide Gentisic acid Hemoglobin Hydralazine Hydrochlorothiazide Hydrocodone Hydrocortisone O-Hydroxyhippuric acid 3-Hydroxytyramine Ibuprofen Imipramine Iproniazid (±) — Isoproterenol Isoxsuprine Ketamine Ketoprofen Labetalol Levorphanol
Loperamide Maprotiline Meperidine Meprobamate Methadone
Morphine-3-β-Dglucuronide
Morphine sulfate
Tyramine Uric acid Verapamil Zomepirac
Perphenazine Phencyclidine Phenelzine Phenobarbital Phentermine Trans-2-phenylcyclopropyl amine hydrochloride L-Phenylephrine ß-Phenylethylamine Phenylpropanolamine Prednisolone Prednisone Procaine Promazine Promethazine DL-Propranolol D-Propox vphene D-Pseudoephedrine Ouinacrine Quinidine Quinine Ranitidine Salicylic acid Secobarbital Serotonin (5-Hydroxytyramine) Sulfamethazine Sulindac Sustiva Temazepam Tetracycline Tetrahydrocortisone, 3-acetate Tetrahydrocortisone 3-(ß-Dglucuronide)
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| Clonidine | Nalidixic acid | Tetrahydrozoline |
|---|---|---|
| Cocaethylene | Naloxone | Thebaine |
| Cocaine hydrochloride | Naltrexone | Theophylline |
| Codeine | Naproxen | Thiamine |
| Cortisone | Niacinamide | Thioridazine |
| (-) Cotinine | Nifedipine | Tolbutamide |
| Creatinine | Nimesulidate | Trans-2-phenylcyclopropylamine |
| Deoxycorticosterone | Norcodein | Trazodone |
| Dextromethorphan | Norethindrone | Triamterene |
| Diclofenac | D-Norpropoxyphene | DL-Tyrosine |
| Diazepam | Noscapine | Trifluoperazine |
| Diflunisal | D,L-Octopamine | Trimethoprim |
| Digoxin | Oxalic acid | Trimipramine |
| Dicylomine | Oxazepam | Tryptamine |
| Diphenhydramine | Oxolinic acid | D L-Tryptophan |
| 5,5 - Diphenylhydantoin | Oxycodone | Tyramine |
| Doxylamine | Oxymetazoline | Uric acid |
| Ecgonine hydrochloride | Papaverine | Verapamil |
| Ecgonine methylester | Penicillin-G | Zomepirac |
| (-) – Ψ-Ephedrine | Pentazocinehydrochloride | |
| 1R,2S Ephedrine | Pentobarbital |
- f. Specificity
To test the specificity, drug metabolites and other components that are likely to be present in urine samples were tested. The target drug (Phencyclidine or Methylenedioxymethamphetamine), its drug metabolites and the related compounds were studied. These samples were tested using three batches of the CR3Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine by three different operators. The drug metabolites and other components were tested at different concentrations. The obtained lowest detectable concentration was used to calculate the cross-reactivity. Results are shown in the following tables.
| PCP(Phencyclidine,Cut-off=25 ng/mL) | Result | %Cross-Reactivity |
|---|---|---|
| Phencyclidine | Positive at 25 ng/mL | 100% |
| 4-Hydroxyphencyclidine | Positive at 12,500 ng/mL | 0.2% |
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| MDMA(Methylenedioxymethamphetamine,Cut-off=500 ng/mL) | Result | % Cross-Reactivity |
|---|---|---|
| Methylenedioxymethamphetamine | Positive at 500 ng/mL | 100% |
| 3,4-Methylenedioxyamphetamine HCl(MDA) | Positive at 3000 ng/mL | 16.7% |
| 3,4-Methylenedioxyethylamphetamine(MDEA) | Positive at 300 ng/mL | 167% |
| d-methamphetamine | >100,000 | Not detected |
| d-amphetamine | >100,000 | Not detected |
g. Effect of Urinary Density and pH
Twelve urine samples of normal, high, and low specific density ranges (1.000 to 1.035) were collected and spiked with either phencyclidine or methylenedioxymethamphetamine at 25% below and 25% above the corresponding cut-off level. These samples were tested using three batches of the CR3Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine by three different operators.
The pH of an aliquot negative urine pool was adjusted to pH ranges of 4.00 to 9.00 in 1 pH unit increments and spiked with phencyclidine or methylenedioxymethamphetamine at 25% below and 25% above the corresponding cut-off levels. These samples were tested using three batches of the CR3Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine by three different operators.
The device performance was found not affected by varying urine density and pH.
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- Comparison Studies
The method comparison for the CR3 Keyless Split Sample Cup Phencyclidine -Methylenedioxymethamphetamine was performed in-house with three laboratory assistants. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were masked and randomized. The obtained test results are compared to GC/MS results. The results are presented in the table below:
- Comparison Studies
Phencyclidine
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| GroupOperators | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 3 | 17 | 20 |
| Negative | 10 | 18 | 9 | 3 | 0 | |
| Viewer B | Positive | 0 | 0 | 3 | 16 | 20 |
| Negative | 10 | 18 | 9 | 4 | 0 | |
| Viewer C | Positive | 0 | 0 | 3 | 17 | 20 |
| Negative | 10 | 18 | 9 | 3 | 0 |
Discordant table:
| Viewer | Sample number | GC/MS result | Viewer result |
|---|---|---|---|
| Viewer A | PCPC1061 | 24 | positive |
| Viewer A | PCPC1062 | 24 | positive |
| Viewer A | PCPC1064 | 23 | positive |
| Viewer A | PCPC1063 | 26 | negative |
| Viewer A | PCPC1065 | 25 | negative |
| Viewer A | PCP1214 | 25 | negative |
| Viewer B | PCPC1061 | 24 | positive |
| Viewer B | PCPC1062 | 24 | positive |
| Viewer B | PCPC1064 | 23 | positive |
| Viewer B | PCPC1063 | 26 | negative |
| Viewer B | PCPC1065 | 25 | negative |
| Viewer B | PCP1213 | 27 | negative |
| Viewer B | PCP1214 | 25 | negative |
| Viewer C | PCPC1034 | 21 | positive |
| Viewer C | PCPC1062 | 24 | positive |
| Viewer C | PCPC1064 | 23 | positive |
| Viewer C | PCPC1065 | 25 | negative |
| Viewer C | PCP1213 | 27 | negative |
| Viewer C | PCP1214 | 25 | negative |
Methylenedioxymethamphetamine
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| GroupOperators | Negative | LowNegative byGC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcutoff) | Near CutoffPositive byGC/MS(Betweenthe cutoffand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 4 | 16 | 20 |
| Negative | 10 | 10 | 16 | 4 | 0 | |
| Viewer B | Positive | 0 | 0 | 3 | 17 | 20 |
| Negative | 10 | 10 | 17 | 3 | 0 | |
| Viewer C | Positive | 0 | 0 | 4 | 17 | 20 |
| Negative | 10 | 10 | 16 | 3 | 0 |
Discordant table:
| Viewer | Sample number | GC/MS result | viewer results |
|---|---|---|---|
| Viewer A | MDMA5213 | 498 | positive |
| Viewer A | MDMA5216 | 482 | positive |
| Viewer A | MDMA5223 | 494 | positive |
| Viewer A | MDMA5224 | 478 | positive |
| Viewer A | MDMAC5061 | 532 | negative |
| Viewer A | MDMAC5062 | 544 | negative |
| Viewer A | MDMAC5063 | 509 | negative |
| Viewer A | MDMAC5064 | 521 | negative |
| Viewer B | MDMA5216 | 482 | positive |
| Viewer B | MDMA5223 | 494 | positive |
| Viewer B | MDMA5224 | 478 | positive |
| Viewer B | MDMAC5061 | 532 | negative |
| Viewer B | MDMAC5063 | 509 | negative |
| Viewer B | MDMAC5064 | 521 | negative |
| Viewer C | MDMA5213 | 498 | positive |
| Viewer C | MDMA5213 | 498 | positive |
| Viewer C | MDMA5223 | 494 | positive |
| Viewer C | MDMA5216 | 482 | positive |
| Viewer C | MDMAC5061 | 532 | negative |
| Viewer C | MDMAC5063 | 509 | negative |
| Viewer C | MDMAC5064 | 521 | negative |
Lay-user study
A lay user study was performed at three intended user sites with 260 lay persons, of which, 20 tested for drug-free samples, 120 for phencyclidine samples, 120 for methylenedioxymethamphetamine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to
{13}------------------------------------------------
50 years. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-25% of the cut-off by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below:
| Cup format | Numberofsamples | OTC user | % AgreementWithGC/MS | ||
|---|---|---|---|---|---|
| Drug | Concentration | Negative | Positive | ||
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| Phencyclidine | -75% | 20 | 20 | 0 | 100% |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 17 | 3 | 85% | |
| +25% | 20 | 3 | 17 | 85% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% | |
| Methylenedioxy-methamphetamine | -75% | 20 | 20 | 0 | |
| -50% | 20 | 20 | 0 | 100% | |
| -25% | 20 | 18 | 2 | 90% | |
| +25% | 20 | 3 | 17 | 85% | |
| +50% | 20 | 0 | 20 | 100% | |
| +75% | 20 | 0 | 20 | 100% |
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 the package insert and the score revealed a reading grade level of less than 7.
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- Clinical Studies
Not applicable
- Clinical Studies
-
- Conclusion
Based on the test principle and performance characteristics of the device, it's concluded that CR Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine is substantially equivalent to the predicate.
- Conclusion
N/A