← Product Code LCM · K142044
# CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE (K142044)
_Guangzhou Wondfo Biotech Co., Ltd. · LCM · Aug 25, 2014 · CH · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K142044
## Device Facts
- **Applicant:** Guangzhou Wondfo Biotech Co., Ltd.
- **Product Code:** LCM
- **Decision Date:** Aug 25, 2014
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** CH
## Intended Use
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.
## Device Story
Lateral flow immunochromatographic assay for qualitative detection of Phencyclidine and Methylenedioxymethamphetamine in human urine; competitive binding principle. Device consists of a split sample cup; user immerses absorbent end into urine sample. Capillary action draws urine across membrane pre-coated with drug-protein conjugates and mouse monoclonal anti-drug antibody-dye conjugates. Analyte below cutoff allows antibody-dye to bind to test region (colored line = negative); analyte above cutoff binds antibody-dye, preventing test line formation (no line = positive). Control line confirms proper flow. Used in point-of-care or home settings by lay users or clinicians. Results provide preliminary screening; positive results require confirmation via GC/MS. Assists in identifying potential drug use; clinical judgment required for interpretation.
## Clinical Evidence
Bench testing only. Precision studies (25 days, 2 runs/day) confirmed performance across concentrations. Interference testing evaluated 100+ compounds with no interference at 100µg/mL. Specificity/cross-reactivity tested against metabolites. Method comparison against GC/MS performed with 80 clinical samples. Lay-user study (n=260) across three sites demonstrated high agreement with GC/MS (85-100% depending on concentration relative to cutoff).
## Technological Characteristics
Lateral flow immunochromatographic assay. Components: mouse monoclonal anti-drug antibody-dye conjugate, fixed drug-protein conjugates, anti-mouse IgG polyclonal antibodies. Form factor: split sample cup. No electronic components; purely chemical/mechanical sensing via capillary action. Stable at 4-30°C for 18 months.
## Submission Summary (Full Text)
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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)
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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 District
Guangzhou, P.R. China 510663 |
| 3. Contact person: | Joe Shia
LSI International Inc.
504 East Diamond Ave., Suite F
Gaithersburg, MD 20878
Telephone: 240-505-7880
Fax: 301-916-6213
Email: shiajl@yahoo.com |
| 4. Device Name: | CR3 Keyless Split Sample Cup Phencyclidine –
Methylenedioxymethamphetamine |
| Classification: | Product Code CFR #
LCM Unclassified
LAF 21CFR 862.3610 |
| 5. Predicate Devices: | k130665
Wondfo Multi-Drug Urine Test Cup
Wondfo Multi-Drug Urine Test Panel |
- 6. 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.
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.
- 7. 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.
| Item | Device | Predicate |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Indication(s) for use | For the qualitative determination of Phencyclidine and
Methylenedioxymethamphetamine in human urine | Same, but also detects other drugs in human urine |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays
based on the principle of antigen
antibody immunochemistry. | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Phencyclidine: 25ng/ml
Methylenedioxymethamphetamine: 500ng/ml | Same for Phencyclidine and
Methylenedioxymethamphetamine |
| Configurations | Cup | Cup, Panel |
| Conditions for Use | Over-the-Counter & Prescription Use | Same |
- 8. 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
- 1. 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:
| Result
PCP | -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
| Result
MDMA | -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.
- 2. 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:
# Phencyclidine
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| Group
Operators | | 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%) |
|--------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| 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
{12}------------------------------------------------
| Group
Operators | | 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%) |
|--------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| 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 | | Number
of
samples | OTC user | | % Agreement
With
GC/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.
- 3. Clinical Studies
Not applicable
- 11. 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.
---
**Source:** [https://fda.innolitics.com/device/K142044](https://fda.innolitics.com/device/K142044)
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