(47 days)
Wondfo Cocaine Urine Test (COC 100) is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care 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.
Wondfo Cannabinoids Urine Test (THC 40) is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 40 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care 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.
Immunochromatograph assays for Cocaine and Cannabinoids Urine Tests use a lateral flow, for the for step system qualitative detection of Benzoylecgonine and one 11-nor-A9-THC-9-COOH (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.
This document describes the performance of the Wondfo Cocaine Urine Test (COC 100) and Wondfo Cannabinoids Urine Test (THC 40). The acceptance criteria and the study results are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in terms of specific percentages for agreement, sensitivity, or specificity. However, the precision studies and comparison studies implicitly demonstrate the expected performance around the cut-off values. For the purpose of this summary, we will interpret the demonstrated ability to correctly identify positive and negative samples, particularly around the cut-off, as the acceptance criteria.
COC 100 (Cocaine Urine Test) - Cup Format
| Performance Characteristic | Acceptance Criteria (Implied from Study Design) | Reported Device Performance (Worst Case for a single Viewer) |
|---|---|---|
| Precision (Analytical) | All negative samples below -25% Cut-Off should be negative. All positive samples above +25% Cut-Off should be positive. Cut-Off samples may show mixed results. | -100% to -25% Cut-Off: All 50 samples per lot/concentration were negative (50-/0+).+25% to +100% Cut-Off: All 50 samples per lot/concentration were positive (50+/0-).At Cut-Off: Viewer C: 47+/3- (47 positive, 3 negative out of 50) |
| Comparison Study | High agreement with GC/MS for drug-free, low negative, and high positive samples. Reasonable agreement near cut-off. | Drug-free: All 10 samples were negative.Low Negative: All 15 samples were negative.Near Cut-Off Negative: 13 or 14 negative, 1 or 2 positive.Near Cut-Off Positive: All 27 samples were positive.High Positive: All 13 samples were positive. |
COC 100 (Cocaine Urine Test) - Dip Card Format
| Performance Characteristic | Acceptance Criteria (Implied from Study Design) | Reported Device Performance (Worst Case for a single Viewer) |
|---|---|---|
| Precision (Analytical) | All negative samples below -25% Cut-Off should be negative. All positive samples above +25% Cut-Off should be positive. Cut-Off samples may show mixed results. | -100% to -25% Cut-Off: All 50 samples per lot/concentration were negative (50-/0+).+25% to +100% Cut-Off: All 50 samples per lot/concentration were positive (50+/0-).At Cut-Off: Viewer A and C: 45+/5- (45 positive, 5 negative out of 50) |
| Comparison Study | High agreement with GC/MS for drug-free, low negative, and high positive samples. Reasonable agreement near cut-off. | Drug-free: All 10 samples were negative.Low Negative: All 15 samples were negative.Near Cut-Off Negative: 12 or 13 negative, 2 or 3 positive.Near Cut-Off Positive: All 27 samples were positive.High Positive: All 13 samples were positive. |
THC 40 (Cannabinoids Urine Test) - Cup Format
| Performance Characteristic | Acceptance Criteria (Implied from Study Design) | Reported Device Performance (Worst Case for a single Viewer) |
|---|---|---|
| Precision (Analytical) | All negative samples below -25% Cut-Off should be negative. All positive samples above +25% Cut-Off should be positive. Cut-Off samples may show mixed results. | -100% to -25% Cut-Off: All 50 samples per lot/concentration were negative (50-/0+).+25% to +100% Cut-Off: All 50 samples per lot/concentration were positive (50+/0-).At Cut-Off: Viewer A and B: 45+/5- (45 positive, 5 negative out of 50) |
| Comparison Study | High agreement with GC/MS for drug-free, low negative, and high positive samples. Reasonable agreement near cut-off. | Drug-free: All 10 samples were negative.Low Negative: All 13 samples were negative.Near Cut-Off Negative: 14, 15 or 16 negative, 1, 2 or 3 positive.Near Cut-Off Positive: All 20 samples were positive.High Positive: All 20 samples were positive. |
THC 40 (Cannabinoids Urine Test) - Dip Card Format
| Performance Characteristic | Acceptance Criteria (Implied from Study Design) | Reported Device Performance (Worst Case for a single Viewer) |
|---|---|---|
| Precision (Analytical) | All negative samples below -25% Cut-Off should be negative. All positive samples above +25% Cut-Off should be positive. Cut-Off samples may show mixed results. | -100% to -25% Cut-Off: All 50 samples per lot/concentration were negative (50-/0+).+25% to +100% Cut-Off: All 50 samples per lot/concentration were positive (50+/0-).At Cut-Off: Viewer B and C: 45+/5- (45 positive, 5 negative out of 50) |
| Comparison Study | High agreement with GC/MS for drug-free, low negative, and high positive samples. Reasonable agreement near cut-off. | Drug-free: All 10 samples were negative.Low Negative: All 13 samples were negative.Near Cut-Off Negative: 14 or 15 negative, 2 or 3 positive.Near Cut-Off Positive: All 20 samples were positive.High Positive: All 20 samples were positive. |
2. Sample size used for the test set and the data provenance
-
Precision Studies (Analytical Performance):
- For each drug (COC 100 and THC 40), for each format (Cup and Dip Card), and for each of 3 lots:
- 9 concentrations were tested (-100%, -75%, -50%, -25%, Cut-Off, +25%, +50%, +75%, +100% of cut-off).
- Each concentration was tested by performing 2 runs per day for 25 days.
- Total samples per lot/concentration: 2 runs/day * 25 days = 50 samples.
- Total samples for precision study: 2 drugs * 2 formats * 3 lots * 9 concentrations * 50 samples/concentration = 5400 samples.
- Data Provenance: The samples were "prepared by spiking drug in negative samples" and confirmed by GC/MS. This indicates controlled laboratory conditions, likely in China (country of origin of the submitter). Given the preparation method, this is considered a prospective study for analytical precision.
- For each drug (COC 100 and THC 40), for each format (Cup and Dip Card), and for each of 3 lots:
-
Comparison Studies:
- COC 100: 80 "unaltered clinical samples" were tested.
- THC 40: 80 "unaltered clinical samples" were tested.
- Total samples for comparison study: 160 samples (80 for COC 100, 80 for THC 40).
- Data Provenance: The samples are described as "unaltered clinical samples." The country of origin is not explicitly stated, but given the submitter, it is likely China. These are retrospective samples as they were clinical samples already collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Ground Truth for Analytical Performance (Precision): The ground truth was established by preparing samples with known concentrations by spiking negative samples and confirming them with GC/MS. No human experts were involved in establishing this ground truth beyond the laboratory personnel performing the spiking and GC/MS confirmation.
- Ground Truth for Comparison Studies: The ground truth for the 160 clinical samples was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is the "preferred confirmatory method" as stated in the intended use. No human experts interpreted the GC/MS results for the purpose of establishing ground truth for the comparison study itself, as GC/MS is an objective analytical method.
4. Adjudication method for the test set
- Analytical Performance (Precision): Not applicable. The results were observations of whether a test line appeared or not, based on known spiked concentrations.
- Comparison Studies: The "Wondfo Result" for each clinical sample was determined by three "laboratory assistants" (Viewer A, B, C). Their readings were then compared against the GC/MS ground truth. There is no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) among the three viewers to decide a single "device result" when their readings differed. Instead, the results for each viewer are presented individually in the tables, and discordant results for each viewer are also listed separately. This suggests individual reader performance was being assessed against the GC/MS, rather than a single adjudicated device reading.
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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly done in the context of comparing human readers with and without AI assistance. This device is a rapid diagnostic test where the result (presence/absence of a line) is interpreted directly by a human viewer. The "viewers" in the comparison study are reading the device's output, not interpreting medical images or complex data. The study compares the device's performance (as read by individual human viewers) against GC/MS, not human readers' diagnostic accuracy with vs. without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm-only performance study was not done. This device is an immunochromatographic assay that produces a visual result (a line) that requires a human to interpret as positive or negative. It is not an automated analytical instrument or an AI system that provides its own output. The "Wondfo Result" in the comparison study is the human interpretation of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For both the precision studies and the comparison studies, the ground truth was based on analytical chemical methods.
- Precision Studies: Known concentrations of drugs spiked into negative urine, verified by GC/MS.
- Comparison Studies: GC/MS (Gas Chromatography/Mass Spectrometry) results for "unaltered clinical samples." GC/MS is considered the gold standard for confirming drug presence and concentration.
8. The sample size for the training set
- This document describes performance characteristics of a rapid diagnostic test, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development. The device's design and manufacturing processes are developed through internal R&D, not by training on a dataset in the way an AI algorithm would be.
9. How the ground truth for the training set was established
- As there is no training set for an AI/ML algorithm described, this question is not applicable.
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K 131757
510(k) SUMMARY
| 1. Date: | July 28, 2013 | JUL 3 1 2013 |
|---|---|---|
| 2. Submitter: | Guangzhou Wondfo Biotech Co., Ltd.South China University of TechnologyGuangzhou, P.R. China 510641 | |
| 3. Contact person: | Joe ShiaLSI International Inc.504 East Diamond Ave., Suite FGaithersburg, MD 20878Telephone: 240-505-7880Fax: 301-916-6213Email: shiajl@yahoo.com |
-
- Device Name: Wondfo Cocaine Urine Test (COC100) Wondfo Cannabinoids Urine Test (THC40)
Classification:
- Device Name: Wondfo Cocaine Urine Test (COC100) Wondfo Cannabinoids Urine Test (THC40)
| Product Code | CFR # | Panel |
|---|---|---|
| DIO | 21 CFR, 862.3250 Cocaine Test System | Toxicology |
| LDJ | 21 CFR, 862.3870 Cannabinoid Test System | Toxicology |
-
- Predicate Devices:
K050394
- Predicate Devices:
Medtox Diagnostics Sure-Screen
6. Intended Use
Wondfo Cocaine Urine Test (COC 100) is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care 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.
Wondfo Cannabinoids Urine Test (THC 40) is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 40 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care 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
{1}------------------------------------------------
confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
7. Device Description
Immunochromatograph assays for Cocaine and Cannabinoids Urine Tests use a lateral flow, for the for step system qualitative detection of Benzoylecgonine and one 11-nor-A9-THC-9-COOH (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.
8. Substantial Equivalence Information
A summary comparison of features of the Wondfo Cocaine Urine Test (COC 100) and Wondfo Cannabinoids Urine Test (THC 40) and the predicate devices is provided in Table 1 & Table 2.
Table 1: Features Comparison of Wondfo Cocaine Urine Test (COC 100) and the Predicate Devices
| Item | Device | Predicate -K050394 |
|---|---|---|
| Indication(s) forUse | For the qualitative determination ofBenzoylecgonine in human urine. Forprescription use. | Same (but thenumber of drugsdetected is different) |
| Calibrator | Benzoylecgonine | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry. | Same |
| Type of Test | Qualitative to indicate positive or negativeresult | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 100 ng/mL | Same |
| Configurations | Cup, Dip Card | Cup |
Table 2: Features Comparison of Wondfo Cannabinoids Urine Test (THC 40) and the Predicate Devices
| Item | Device | Predicate - K050394 |
|---|---|---|
| Indication(s) forUse | For the qualitative determination of11-nor-Δ9-THC-9-COOH in human urine. | Same (but the numberof drugs detected isdifferent) |
| Calibrator | 11-nor-Δ9-THC-9-COOH | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibody | Same |
{2}------------------------------------------------
| Item | Device | Predicate - K050394 |
|---|---|---|
| immunochemistry. | ||
| Type of Test | Qualitative to indicate positive or negativeresult | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 40 ng/mL | Same |
| Configurations | Cup, Dip Card | Cup |
9. Test Principle
It is a rapid test for the qualitative detection of Benzoylecgonine and
11-nor-A9-THC-9-COOH in urine samples. It is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a urine sample, the urine is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentration 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 cutoff, 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.
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, +25% cut off, +50% cut off , +75% cut off and +100%cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled by the person who prepared the samples and that person did not take part in the For each concentration, tests were performed two runs per day for 25 sample testing. days. The results obtained are summarized in the following table.
Cup Format
| COC 100 | Result | -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 W1070901CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| LOT W1070902CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| LOT W1070903CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| الي سال ا | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Result -100% | -75% | -50% | -25% | Cut-Off | +25% | +50% | +75% | +100% | ||
| ITHC 40 | Cut-Off Cut-Off Cut-Off Cut-Off | Cut-Off Cut-Off Cut-Off Cut-Off | ||||||||
| LOT W1970901CU2 | 50-10+ | 50-10+ | 50-10+ | 50-10+ | 45+/5- | , 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| LOT W1970902CU2 | 50-10+ | 50-10+ | 50-10+ | 50-10+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
THE AD.
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| Result | -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 | |
|---|---|---|---|---|---|---|---|---|---|---|
| THC 40LOT W1970903CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card Format
| COC 100 | Result | -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 W1070901P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1070902P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1070903P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| THC 40: | ||||||||||
| THC 40 | Result | -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 W1970901P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| LOT W1970902P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| LOT W1970903P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
COC 100:
b. Linearity
Not applicable
-
c. Stability
Stable at 4-30°C for 18 months based on the accelerated stability study at 50°C and real time stability determination at both 4℃ and 30℃. -
d. Cut-off
Total 150 samples equally distributed at concentrations of -50% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for both cocaine and cannabinoids. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Wondfo Cocaine Urine Test (COC 100) | Benzoylecgonine | 100 |
| Wondfo Cannabinoids Urine Test (THC 40) | 11-nor-Δ9-THC-9-COOH | 40 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% below and 25% above Cut-Off level respectively. These urine samples were tested using three batches of each device for both Dip Card and Cup formats.
Compounds that show no interference at a concentration of 100 µg/mL are summarized in the following tables. There are no differences observed for both Dip Card and Cup formats.
| Acetominophen | Estrone-3-sulfate | Papaverine |
|---|---|---|
| Acetophenetidin | Ethyl-p-aminobenzoate | Penicillin-G |
| N-Acetylprocainamide | Fenoprofen | Pentobarbital |
| Acetylsalicylic acid | Furosemide | Perphenazine |
| Aminopyrine | Gentisic acid | Phencyclidine |
| Amitriptyline | Hemoglobin | Phenelzine |
| Amobarbital | Hydralazine | Phenobarbital |
| Amoxicillin | Hydrochlorothiazide | Phentermine |
| Ampicillin | Hydrocodone | L-Phenylephrine |
| L-Ascorbic acid | Hydrocortisone | β-Phenylethylamine |
| DL-Amphetamine Sulfate | O-Hydroxyhippuric acid | Phenylpropanolamine |
| Apomorphine | p-Hydroxymethamphetamine | Prednisolone |
| Aspartame | 3-Hydroxytyramine | Prednisone |
| Atropine | Ibuprofen | Procaine |
| Benzilic acid | Imipramine | Promazine |
| Benzoic acid | Iproniazid | Promethazine |
| Benzphetamine | (±) - Isoproterenol | DL-Propranolol |
| Bilirubin | Isoxsuprine | D-Propoxyphene |
| (±) -Brompheniramine | Ketamine | D-Pseudoephedrine |
| Caffeine | Ketoprofen | Quinidine |
| Cannabidiol | Labetalol | Quinine |
| Cannabinol | Levorphanol | Ranitidine |
| Chloralhydrate | Loperamide | Salicylic acid |
| Chloramphenicol | Maprotiline | Secobarbital |
| Chlordiazepoxide | Meperidine | Serotonin |
| Chlorothiazide | Meprobamate | Sulfamethazine |
| (±) -Chlorpheniramine | Methadone | Sulindac |
| Chlorpromazine | Methoxyphenamine | Temazepam |
| Chlorquine | (±)-3,4-Methylenedioxyamphetamine | Tetracycline |
| Cholesterol | hydrochloride(±)-3,4-Methylene-dioxymethamphetaminehydrochloride | Tetrahydrocortisone, 3-Acetate |
| Clomipramine | Morphine-3-B-D glucuronide | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Clonidine | Morphine Sulfate | Tetrahydrozoline |
| Codeine | Nalidixic acid | Thebaine |
| Cortisone | Naloxone | Thiamine |
| (-) Cotinine | Naltrexone | Thioridazine |
| Creatinine | Naproxen | DL-Tyrosine |
| Deoxycorticosterone | Niacinamide | Tolbutamide |
| Dextromethorphan | Nifedipine | Triamterene |
| Diazepam | Norcodein | Trifluoperazine |
| Diclofenac | Norethindrone | Trimethoprim |
| Diflunisal | D-Norpropoxyphene | Trimipramine |
| Digoxin | Noscapine | Tryptamine |
| Diphenhydramine | DL-Octopamine | DL-Tryptophan |
| Doxylamine | Oxalic acid | Tyramine |
| Ecgonine methylester | Oxazepam | Uric acid |
| (-) - Ψ-Ephedrine | Oxolinic acid | Verapamil |
| Erythromycin | Oxycodone | Zomepirac |
| ß-Estradiol | Oxymetazoline |
COC 100
{4}------------------------------------------------
and the comments of the comments of the comments of
:
·
{5}------------------------------------------------
- .
Deoxycorticosterone
| 4-Acetamidophenol | Estrone-3-sulfate | Penicillin-G |
|---|---|---|
| Acetophenetidin | Ethyl-p-aminobenzoate | Pentazocine |
| N-Acetylprocainamide | Fenoprofen | Pentobarbital |
| Acetylsalicylic acid | Furosemide | Perphenazine |
| Aminopyrine | Gentisic acid | Phencyclidine |
| Amitryptyline | Hemoglobin | Phenelzine |
| Amobarbital | Hydralazine | Phenobarbital |
| Amoxicillin | Hydrochlorothiazide | Phentermine |
| Ampicillin | Hydrocodone | L-Phenylephrine |
| Ascorbic acid | Hydrocortisone | β-Phenylethlamine |
| D,L-Amphetamine | O-Hydroxyhippuric acid | β-Phenyllethylamine |
| L-Amphetamine | 3-Hydroxytyramine | Phenylpropanolamine |
| Apomorphine | Ibuprofen | Prednisolone |
| Aspartame | Imipramine | Prednisone |
| Atropine | Iproniazid | Procaine |
| Benzilic acid | (-) Isoproterenol | Promazine |
| Benzoic acid | Isoxsuprine | Promethazine |
| Benzoylecgonine | Ketamine | D,L-Propanolol |
| Benzphetamine | Ketoprofen | D-Propoxyphene |
| Bilirubin | Labetalol | D-Pseudoephedrine |
| Brompheniramine | Levorphanol | Quinidine |
| Caffeine | Loperamide | Quinine |
| Chloralhydrate | Maprotiline | Ranitidine |
| Chloramphenicol | Meprobamate | Salicylic acid |
| Chlordiazepoxide | Methadone | Secobarbital |
| Chlorothiazide | Methoxyphenamine | Serotonin (5-Hydroxytyramine) |
| (±) Chlorpheniramine | (+)3,4-Methylenedioxyamphetamine | Sulfamethazine |
| Chlorpromazine | (+)3,4-Methylenedioxymethamphetamine | Sulindac |
| Chlorquine | Methylphenidate | Temazepam |
| Cholesterol | Methyprylon | Tetracycline |
| Clomipramine | Morphine-3-β-Dglucuronide | Tetrahydrocortisone, 3 Acetate |
| Clonidine | Nalorphine | Tetrahydrocortisone3(5-Dglucuronide) |
| Cocaine hydrochloride | Naloxone | Tetrahydrozoline |
| Codeine | Nalidixic acid | Thebaine |
| Cortisone | Naltrexone | Thiamine |
| (-) Cotinine | Naproxen | Thioridazine |
| Creatinine | Niacinamide | D,L-Thyroxine |
Nifedipine
.
Tolbutamine
.
{6}------------------------------------------------
| Dextromethorphan | Norcodein | Triamterene |
|---|---|---|
| Diazepam | Norethindrone | Trifluoperazine |
| Diclofenac | D-Norpropoxyphene | Trimethoprim |
| Diflunisal | Noscapine | Trimipramine |
| Digoxin | D,L-Octopamine | Tryptamine |
| Diphenhydramine | Oxalic acid | D, L-Tryptophan |
| Doxylamine | Oxazepam | Tyramine |
| Ecgonine hydrochloride | Oxolinic acid | PrD, L-Tyrosine |
| Ecgonine methylester | Oxycodone | Uric acid |
| (-) Y Ephedrine | Oxymetazoline | Verapamil |
| Erythromycin | p-Hydroxymethamphetamine | Zomepirac |
| β-Estradiol | Papaverine |
f. Specificity
To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for both Dip Card and Cup formats. Compounds that produced positive results are listed below. There are no differences observed for both Dip Card and Cup formats.
| COC 100 | ||
|---|---|---|
| COC(Cocaine)(Benzoylecgonine, Cut-off=100 ng/mL) | Minimum ConcentrationRequired to Obtain a PositiveResult (ng/mL) | % Cross-Reactivity |
| Benzoylecgonine | 100 | 100% |
| Cocaine HCI | 250 | 40.0% |
| Cocaethylene | 4000 | 2.5% |
| Ecgonine | 10000 | 1% |
| THC 40 | |
|---|---|
| -------- | -- |
| THC(11-nor-Δ9-THC-9-COOH)(11-nor-Δ9-THC-9-COOH, Cut-off=40 ng/mL) | Minimum ConcentrationRequired to Obtain a PositiveResult (ng/mL) | % Cross-Reactivity |
|---|---|---|
| 11-nor-Δ9-THC-9-COOH | 40 | 100% |
| 11-nor-Δ8-THC-9-COOH | 20 | 200% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 2000 | 2% |
| Δ 8-Tetrahydrocannabinol | 6000 | <1% |
| Δ 9-Tetrahydrocannabinol | 8000 | <1% |
| Cannabinol | 80000 | <1% |
| Cannabidiol | 80000 | <1% |
g.Effect of Urine Specified Gravity and Urine pH
To investigate the effect of urine specified gravity and urine pH, the urine samples, with 1.0001.035 specified gravity or urine samples with pH 49 were spiked with target drugs at 25% below and 25% above Cut-Off level, respectively. These samples
7
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were tested using three batches of each device for both Dip Card and Cup formats. 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 for both Dip Card and Cup formats.·
-
- Comparison Studies
The method comparison for the Wondfo Cocaine Urine Test (COC100), Wondfo Cannabinoids Urine Test (THC40) was performed in-house with three laboratory assistants. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the table below:
- Comparison Studies
COC 100:
Cup Format
| Wondfo Result | Drug-free | Low Negative by GC/MS (Less than -50%) | Near Cut-Off Negative by GC/MS (Between -50% and Cut-Off) | Near Cut-Off Positive by GC/MS (Between the Cut-Off and +50%) | High Positive by GC/MS (Greater than +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 2 | 27 | 13 |
| Negative | 10 | 15 | 13 | 0 | 0 | |
| Viewer B | Positive | 0 | 0 | 2 | 27 | 13 |
| Negative | 10 | 15 | 13 | 0 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 27 | 13 |
| Negative | 10 | 15 | 14 | 0 | 0 |
Dip Card Format
| Wondfo Result | Drug-free | Low Negative byGC/MS(Less than -50%) | Near Cut-OffNegative byGC/MS(Between -50%and Cut-Off) | Near Cut-OffPositive by GC/MS(Between theCut-Off and +50%) | High Positive byGC/MS (Greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 2 | 27 | 13 |
| Viewer A | Negative | 10 | 15 | 13 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 27 | 13 |
| Viewer B | Negative | 10 | 15 | 12 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 27 | 13 |
| Viewer C | Negative | 10 | 15 | 13 | 0 | 0 |
Discordant Results of COC 100
| Viewer | Sample Number | GC/MS Result | Cup Format Viewer |
|---|---|---|---|
| Result | |||
| Viewer A | COC1063 | 90 | Positive |
| Viewer A | COC1065 | રેવે | Positive |
| Viewer B | COC1065 | ਰੁਭ | Positive |
| Viewer B | COC1217 | કેટ | Positive |
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| Viewer | Sample Number | GC/MS Result | Cup Format ViewerResult |
|---|---|---|---|
| Viewer C | COC1063 | 90 | Positive |
| Viewer | Sample Number | GC/MS Result | Dip Card FormatViewer Results |
|---|---|---|---|
| Viewer A | COC1065 | 99 | Positive |
| Viewer A | COC1217 | 86 | Positive |
| Viewer B | COC1063 | 90 | Positive |
| Viewer B | COC1065 | 99 | Positive |
| Viewer B | COC1217 | 86 | Positive |
| Viewer C | COC1031 | 78 | Positive |
| Viewer C | COC1063 | 90 | Positive |
THC 40:
Cup Format
| Wondfo Result | Drug-free | Low Negative byGC/MS(Less than -50%) | Near Cut-OffNegative byGC/MS(Between -50%and Cut-Off) | Near Cut-OffPositive by GC/MS(Between theCut-Off and +50%) | High Positive byGC/MS (Greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 2 | 20 | 20 |
| Negative | 10 | 13 | 15 | 0 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 20 | 20 |
| Negative | 10 | 13 | 16 | 0 | 0 | |
| Viewer C | Positive | 0 | 0 | 2 | 20 | 20 |
| Negative | 10 | 13 | 15 | 0 | 0 |
Dip Card Format
| Dip Card Format | ||||||
|---|---|---|---|---|---|---|
| Wondfo Result | Drug-free | Low Negative byGC/MS(Less than -50%) | Near Cut-OffNegative byGC/MS(Between -50%and Cut-Off) | Near Cut-OffPositive by GC/MS(Between theCut-Off and +50%) | High Positive byGC/MS (Greaterthan +50%) | |
| Viewer A | Positive | 0 | 0 | 2 | 20 | 20 |
| Negative | 10 | 13 | 15 | 0 | 0 | |
| Viewer B | Positive | 0 | 0 | 2 | 20 | 20 |
| Negative | 10 | 13 | 15 | 0 | 0 | |
| Viewer C | Positive | 0 | 0 | 3 | 20 | 20 |
| Negative | 10 | 13 | 14 | 0 | 0 |
Discordant Results of THC 40
| Viewer | Sample Number | GC/MS Result | Cup Format ViewerResult |
|---|---|---|---|
| Viewer A | THC4033 | 33 | Positive |
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| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Result |
|---|---|---|---|
| Viewer A | THC4217 | 36 | Positive |
| Viewer B | THC4033 | 33 | Positive |
| Viewer C | THC4032 | 33 | Positive |
| Viewer C | THC4217 | 36 | Positive |
| Viewer | Sample Number | GC/MS Result | Dip Card FormatViewer Results |
|---|---|---|---|
| Viewer A | THC4032 | 33 | Positive |
| Viewer A | THC4217 | 36 | Positive |
| Viewer B | THC4032 | 33 | Positive |
| Viewer B | THC4033 | 33 | Positive |
| Viewer C | THC4032 | 33 | Positive |
| Viewer C | THC4033 | 33 | Positive |
| Viewer C | THC4217 | 36 | Positive |
-
- Clinical Studies
Not applicable
- Clinical Studies
-
- Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that Wondfo Cocaine Urine Test (COC 100), and Wondfo Cannabinoids Urine Test (THC 40) are substantially equivalent to the predicate.
- Conclusion
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Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2013
Guangzhou Wondfo Biotech Co., Ltd. C/O Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F GAITHERSBURG MD 20878
Re: K131754
Trade/Device Name: Wondfo Cocaine Urine Test (COC100) Wondfo Cannabinoids Urine Test (THC40) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO, LDJ Dated: July 2, 2013 Received: July 8, 2013
Dear Mr. 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 Part 801); 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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Page 2-Mr. Shia
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safcty/ReportalProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDeviecs/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias, Ph.D.
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): K131754
Device Name: Wondfo Cocaine Urine Test (COC 100) Wondfo Cannabinoids Urine Test (THC 40)
Indications for Use:
Wondfo Cocaine Urine Test (COC 100)
Wondfo Cocaine Urine Test (COC 100) is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care 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.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.07.31 08:07:53 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K131754 510(k)
{13}------------------------------------------------
Indications for Use
510(k) Number (if known): K131754
Device Name: Wondfo Cocaine Urine Test (COC 100) Wondfo Cannabinoids Urine Test (THC 40)
Indications for Use:
Wondfo Cannabinoids Urine Test (THC 40)
Wondfo Cannabinoids Urine Test (THC 40) is an immunochromatographic assay for the qualitative determination of II-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 40 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care 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.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.07.31 08:08:17 -04'00' Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K131754 510(k)
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).