(277 days)
Not Found
No
The device is a lateral flow immunoassay that provides visual, qualitative results without the use of an instrument. There is no mention of any computational analysis, algorithms, or learning processes.
No.
Explanation: The device is an in vitro diagnostic test for the detection of drugs of abuse and their metabolites in urine, not a device used for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine." The "Device Description" also mentions its use "as in vitro diagnostics." These phrases indicate that the device is used to identify a condition (presence of drugs/metabolites) based on in vitro testing of human samples, which falls under the definition of a diagnostic device.
No
The device is described as a lateral flow immunochromatographic competitive binding assay in various physical formats (Cassette, Dip Card, Cup) that are visually read. It is an in vitro diagnostic test that uses physical components and chemical reactions to detect substances in urine. There is no mention of software being the primary or sole component performing the medical function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "qualitative detection of multiple drugs of abuse and/or their metabolites in human urine". This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of drugs).
- Device Description: The "Device Description" section further clarifies that it is used as "in vitro diagnostics to visually and qualitatively detect some of the most common drugs of abuse and/or their metabolites in human urine specimens."
- Mechanism: The description of the device as a "lateral flow immunochromatographic competitive binding assay" and its use of "anti-drug antibody to selectively detect elevated levels of multi-drugs and/or their metabolites in urine" confirms that it is performing a diagnostic test on a biological sample.
- Regulatory Context: The mention of "prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use" and "CLIA Waived use" indicates that this device is subject to regulatory oversight for diagnostic devices.
- Performance Studies: The inclusion of performance studies evaluating accuracy, precision, and lay-user results, often required for IVDs, further supports its classification as a diagnostic device.
Therefore, based on the provided information, the Advin Multi-Drug Screen Test clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels:
Amphetamine (AMP) Calibrator: d-Amphetamine, Cutoff Level: 500 ng/mL
Barbiturates (BAR) Calibrator: Secobarbital, Cutoff Level: 300 ng/mL
Benzodiazepines (BZO) Calibrator: Oxazepam, Cutoff Level: 300 ng/mL
Buprenorphine (BUP) Calibrator: Buprenorphine, Cutoff Level: 10 ng/mL
Cocaine (COC) Calibrator: Benzoylecgnine, Cutoff Level: 150 ng/mL
EDDP Calibrator: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Cutoff Level: 300 ng/mL
Ecstasy (MDMA) Calibrator: Methylenedioxymethamphetamine, Cutoff Level: 500 ng/mL
Methamphetamine (MET) Calibrator: d-Methamphetamine, Cutoff Level: 500 ng/mL
Methadone (MTD) Calibrator: Methadone, Cutoff Level: 300 ng/mL
Morphine (MOR300) Calibrator: Morphine, Cutoff Level: 300 ng/mL
Opiates (OPI) Calibrator: Morphine, Cutoff Level: 2,000 ng/mL
Oxycodone (OXY) Calibrator: Oxycodone, Cutoff Level: 100 ng/mL
Phencyclidine (PCP) Calibrator: Phencyclidine, Cutoff Level: 25 ng/mL
Propoxyphene (PPX) Calibrator: Propoxyphene, Cutoff Level: 300 ng/mL
Tricyclic-antidepressant (TCA) Calibrator: Nortriptynine, Cutoff Level: 1,000 ng/mL
Marijuana (THC) Calibrator: 11-nor-Δ9-THC-9-COOH, Cutoff Level: 50 ng/mL
The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dip Card and a Cup, which may be configured in any combination of the drug analytes listed in the above table.
Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use.
The Advin Multi-Drug Screen Test will yield preliminary positive results when prescription drugs TCA, Barbiturates and Benzodiazepine, Methadone, Buprenorphine and Opiates are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for TCA, Barbiturates and Benzodiazepine in urine.
The Advin Multi-Drug Screen Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography-(HPLC)-are the-preferred-confirmatory-methods-Glinical-consideration and professional judgment should be applied to any drug of abuse test result, particularly in the evaluation of a preliminary positive test result.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DJC, DIS, JXM, DJG, LDJ, DIO, DJR, LFG, JXN, LCM
Device Description
The Advin Multi-Drug Screen Test is a lateral flow immunochromatographic competitive binding assay and is intended for prescription use, CLIA Waived use and OTC use. It is used as in vitro diagnostics to visually and qualitatively detect some of the most common drugs of abuse and/or their metabolites in human urine specimens. The test is based on the principle of competitive binding antigen-antibody immunochemistry. It utilizes anti-drug antibody to selectively detect elevated levels of multi-drugs and/or their metabolites in urine at a specified cutoff for each drug. These visual read tests are performed without the use of an instrument.
A drug-Positive urine specimen will not generate a colored-line in the designated test region, while a drug-Negative urine specimen or a urine specimen containing drug(s) at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of urine specimen has been added and membrane wicking has occurred.
Some of the Advin Multi-Drug Screen Test will be sold with either one or two adulteration test strips for the detection of adulterants added to the urine specimen. Each Adulteration strip consists of one to three reagent pads which consist of tests for oxidant, specific gravity, pH, glutaraldehyde, creatinine and nitrite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Accuracy: Forty drug-free urine specimens collected from presumed non-user volunteers were tested with Advin Multi-Drug Screen Test. Of these 40 negative specimens tested, all were correctly identified as negative. 10% of these negative specimens were confirmed with GC/MS as drug negative urine specimens. At least 40 drug positive urine specimens for each drug test were obtained from reference labs throughout the United States. The drug concentration in each of the positive specimen was confirmed with GC/MS and LC/MS (for TCA analysis).
Precision: The precision of Advin Multi-Drug Screen Test was evaluated at 3 Physician's Office Laboratory sites and 100 lay persons. The lay person user study tested drug-free urine specimens together with spiked urine specimens with different drug concentrations at +/- 50% cutoff and +/- 25% cutoff. Each level of the drug solutions was randomly tested with at least 20 replicates. The results were compared to GC/MS analysis results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy
Study Type: Accuracy study comparing Advin Multi-Drug Screen Test to GC/MS analysis data.
Sample Size: 40 drug-free urine specimens and at least 40 drug-positive urine specimens for each drug test.
Key Results:
The accuracy results are summarized in tables for Cassette, Dipcard, and Cup formats. The tables show the number of negative and positive results compared to GC/MS analysis data across different concentration ranges.
For negative results, agreement percentages range from 93.2% to 97.7%.
For positive results, agreement is 100% across all drug tests and formats.
Precision
Study Type: Precision study conducted at 3 Physician's Office Laboratory sites and with 100 lay persons.
Key Results:
Data from these sites indicated that correct test results could be obtained when urine specimens with drug concentrations at +/-50% cutoff levels were tested.
Lay-Users Study:
The agreement between the testing results from lay persons and GC/MS analysis results was over 99% for concentrations at +/-50% cutoff levels and 65% to 86% for concentrations near the cutoff levels.
The statistic analysis indicated that lay persons can follow the product package insert and perform Advin Multi-Drug Screen Test Cassette, Dip Card, and Cup similar to professionals at POL sites with reasonable accuracy.
Tables for discordant results are provided for each device format (Cassette, Dipcard, Cup) from the lay person study compared to GC/MS or LCMS analysis. These tables show the number of discordant results out of total results for positive and negative tests, along with the corresponding GC/MS or LCMS concentrations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (agreement) percentages are provided for positive and negative concordance with GC/MS.
Negative agreement: 93.2% to 97.7%
Positive agreement: 100%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Innovacon Spectrum II Test Card and Test Card with Integrated Test Cup (K061718)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).
0
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) number is: K122809
Submitter:
Advin Biotech 6861 Nancy Ridge Dr., Suite #D, San Diego, CA 92121.
Tel.: 858-866-8382 Fax: 858-866-8382
Date:
April 21, 2013
Contact Person:
Edward Tung, Ph.D.
Tel. 858-668-8305 (Cell)
Product Names:
Advin Multi-Drug Screen Test Cassette Advin Multi-Drug Screen Test Dipcard Advin Multi-Drug Screen Test Cup
Common Name:
Immunochromatographic test for the qualitative detection of multi-drugs and/or their metabolites in human urine.
Device Classification:
The Advin Multi-Drug Screen Test Cassette, Dipcard and Cup are similar to other FDAcleared devices for the qualitative detection of following drugs in urine specimens:
| Drug Test | Calibrator | Cutoff |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 ng/mL |
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 150 ng/mL |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3- | |
| diphenylpyrrolidine | 300 ng/mL |
1
| Drug Test | Calibrator | Cutoff |
|---|---|---|
| Ecstasy (MDMA) | Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | d-Methamphetamine | 500 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Morphine (MOR300) | Morphine | 300 ng/mL |
| Opiates (OPI) | Morphine | 2,000 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | Propoxyphene | 300 ng/mL |
| Tricyclic-antidepressant | ||
| (TCA) | Nortriptyline | 1,000 ng/mL |
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
These tests are used to provide only preliminary test results. The test systems have been classified as Class II devices with moderate complexity.
Classification Name:
Amphetamine Test System Methamphetamine Test System Barbiturates Test System Benzodiazepine Test system Antidepressant test system Opiate Test System Cannabinoids Test System Cocaine and cocaine metabolite Test System Methadone Test System Tricyclic Antidepressants Test System Methadone Test System Propoxyphene test system
Intended Use:
The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection
of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels:
| Drug Test | Calibrator | Cutoff |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 500 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Benzodiazepines | Oxazepam | 300 |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Cocaine (COC) | Benzoylecgnine | 150 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3- | 300 |
| Ecstasy (MDMA) | Methylenedioxymethamphetamine | 500 |
2
| Methamphetamine | d-Methamphetamine | 500 |
|---|---|---|
| Methadone (MTD) | Methadone | 300 |
| Morphine (MOR300) | Morphine | 300 |
| Opiates (OPI) | Morphine | 2,000 |
| Oxycodone (OXY) | Oxycodone | 100 |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | Propoxyphene | 300 |
| Tricyclic- | ||
| antidepressant | Nortriptynine | 1,000 |
| ng/mL | ||
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dipcard and a Cup format, which may be configured in any combination of the drugs analytes listed in the above table.
Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use.
This test does not distinguish between drugs of abuse and certain medications. It will yield preliminary positive results when prescription drugs TCA, Barbiturates, Benzodiazepine, Methadone, Buprenorphine and Opiates drugs are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for these prescription drugs in urine.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory methods.
Clinical considerations and professional judgment should always be applied to interpret any drug of abuse test result, particularly in evaluating a preliminary positive test result.
Description:
The Advin Multi-Drug Screen Test is a lateral flow immunochromatographic competitive binding assay and is intended for prescription use, CLIA Waived use and OTC use. It is used as in vitro diagnostics to visually and qualitatively detect some of the most common drugs of abuse and/or their metabolites in human urine specimens. The test is based on the principle of competitive binding antigen-antibody immunochemistry. It utilizes anti-drug antibody to selectively detect elevated levels of multi-drugs and/or their metabolites in urine at a specified cutoff for each drug. These visual read tests are performed without the use of an instrument.
A drug-Positive urine specimen will not generate a colored-line in the designated test region, while a drug-Negative urine specimen or a urine specimen containing drug(s) at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a
3
colored-line will always appear at the control region, indicating that proper volume of urine specimen has been added and membrane wicking has occurred.
Some of the Advin Multi-Drug Screen Test will be sold with either one or two adulteration test strips for the detection of adulterants added to the urine specimen. Each Adulteration strip consists of one to three reagent pads which consist of tests for oxidant, specific gravity, pH, glutaraldehyde, creatinine and nitrite.
Predicate Devices and 510(k) Numbers:
Innovacon Spectrum II Test Card and Test Card with Integrated Test Cup (K061718)
Comparison to a Predicate Device:
The ADVIN Multi-Drug Screen Test (Cassette, Dipcard and Cup) have following similarities compared to the above predicate devices:
- All tests are assays intended for the qualitative detection of drugs in urine samples. .
- All tests are intended as a screening method that provides a preliminary qualitative . analytical test result.
- . All tests are immunochromatographic, lateral flow, competitive binding assays for the rapid detection of drug and drug metabolites with a visual, qualitative end result.
- . All tests utilize the same basic immunoassay principles that rely on antigen/ antibody interaction to indicate a positive or a negative result.
- All tests have the same cutoff for each of drugs with the exception of Amphetamine test. ●
| Feature | Advin Multi-Drug Screen Test | Predicate devices |
|---|---|---|
| Indication of use | A rapid chromatographic | |
| immunoassay for the qualitative | ||
| detection of multiple | ||
| drugs/metabolites in human urine. | A rapid chromatographic | |
| immunoassay for the qualitative and | ||
| simultaneous detection of multiple | ||
| drugs and metabolites in human | ||
| urine. | ||
| Cutoff | ||
| Concntrations | ||
| (ng/mL) | Amphetamine 500 | |
| Barbiturates 300 | ||
| Benzodiazepines 300 | ||
| Buprenorphine 10 | ||
| Cocaine 150 | ||
| Methadone 300 | ||
| MDMA 500 | ||
| THC 50 | ||
| Methamphetamine 500 | ||
| morphine 300, or opiates 2,000 | ||
| Oxycodone 100 | ||
| Phencyclidine 25 | ||
| Propoxyphene 300 | ||
| Tricyclic antidepressants 1,000, | ||
| EDDP 300 | Amphetamine 1000 or 300 | |
| Barbiturates 300 | ||
| Benzodiazepines 300 | ||
| Buprenorphine 10 | ||
| Cocaine 150 or 300 | ||
| Methadone 300 | ||
| MDMA 500 | ||
| THC 50 | ||
| Methamphetamine 500 or 1,000 | ||
| morphine 300, or opiates 2,000 | ||
| Oxycodone 100 | ||
| Phencyclidine 25 | ||
| Propoxyphene 300 | ||
| Tricyclic antidepressants 1,000 | ||
| EDDP 300 |
4
| Intended use | Prescription use, CLIA-waived
laboratory and Over-the-Counter
use | Professionals and point of care sites |
|--------------------|-------------------------------------------------------------------------|-------------------------------------------------|
| Intended specimen | Urine | Urine |
| Endpoint | Colored Lines | Same |
| Materials provided | Test Devices (Cassette, Dipcard,
Cup)
Package Insert | Test Devices (Test Card, Cup)
Package Insert |
| Methodology | Membrane Particle Assay | Same |
| Test Time | 5 minutes | Same |
| Format | Immunochemical Antigen/Antibody
Immunoassay | Same |
Safety and Effectiveness Data:
Accuracy
The accuracy of Advin Multi-Drug Screen Test was evaluated in comparison to GC/MS analysis data. Forty drug-free urine specimens collected from presumed non-user volunteers were tested with Advin Multi-Drug Screen Test. Of these 40 negative specimens tested, all were correctly identified as negative. 10% of these negative specimens were confirmed with GC/MS as drug negative urine specimens. At least 40 drug positive urine specimens for each drug test were obtained from reference labs throughout the United States. The drug concentration in each of the positive specimen was confirmed with GC/MS and LC/MS (for TCA analysis). Summary of accuracy results on Advin Multi-Drug Screen Test Cassette, Dipcard and Cup are shown in tables below:
| Drug Test | Test
Result | Drug-
free | Compared to GC/MS Analysis Data | | | | | %
agreement |
|-----------|----------------|---------------|---------------------------------|---------------------|--------------------|--------------------------|--------------|----------------|
| | | | -50% C/O to
+25% C/O
to +50% C/O | >+50%
C/O | |
| AMP | Neg | 40 | 3 | 0 | 0 | 0 | 0 | 97.7% |
| 500 | Pos | 0 | 0 | 1 | 2 | 2 | 45 | 100% |
| BAR | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.2% |
| 300 | Pos | 0 | 0 | 2 | 5 | 2 | 36 | 100% |
| BUP | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% |
| 10 | Pos | 0 | 0 | 2 | 8 | 0 | 32 | 100% |
| BZO | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| 300 | Pos | 0 | 0 | 3 | 1 | 6 | 34 | 100% |
| COC | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% |
| 150 | Pos | 0 | 0 | 1 | 4 | 1 | 53 | 100% |
| EDDP | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| 300 | Pos | 0 | 0 | 3 | 5 | 2 | 33 | 100% |
| MDMA | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% |
| 500 | Pos | 0 | 0 | 2 | 5 | 1 | 34 | 100% |
| MET | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| 500 | Pos | 0 | 0 | 3 | 1 | 3 | 51 | 100% |
| MOR | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| 300 | Pos | 0 | 0 | 3 | 4 | 0 | 53 | 100% |
| MTD | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% |
| 300 | Pos | 0 | 0 | 2 | 4 | 0 | 37 | 100% |
| OPI | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
A. Summary of Accuracy Results on Advin Multi-Drug Screen Test Cassette:
5
| 2,000 | Pos | 0 | 0 | 2 | 4 | 3 | 40 | 100% |
|---|---|---|---|---|---|---|---|---|
| OXY | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| 100 | Pos | 0 | 0 | 3 | 7 | 1 | 33 | 100% |
| PCP | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7 |
| 25 | Pos | 0 | 0 | 1 | 3 | 8 | 33 | 100% |
| PPX | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 95.3% |
| 300 | Pos | 0 | 0 | 2 | 5 | 2 | 33 | 100% |
| TCA | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% |
| 1,000 | Pos | 0 | 0 | 2 | 5 | 7 | 28 | 100% |
| THC | Neg | 40 | 1 | 2 | 0 | 0 | 0 | 97.7% |
| 50 | Pos | 0 | 0 | 1 | 4 | 7 | 44 | 100% |
.
・
B. Summary of Accuracy Results on Advin Multi-Drug Screen Test Dipcard:
:
:
| Drug Test
with Cutoff
(ng/mL) | Test
Result | Drug-free | Compared to GC/MS Analysis Data | | | | | |
|-------------------------------------|----------------|-----------|---------------------------------|---------------------|-----------|--------------------------|--------------|-----------|
| | | | -50% C/O to
+25% C/O
to +50% C/O | >+50%
C/O | Drug-free |
| AMP
500 | Neg | 40 | 3 | 0 | 0 | 0 | 0 | 97.7% |
| 500 | Pos | 0 | 0 | 1 | 2 | 2 | 45 | 100% |
| BAR
300 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.2% |
| 300 | Pos | 0 | 0 | 2 | 5 | 2 | 36 | 100% |
| BUP
10 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% |
| 10 | Pos | 0 | 0 | 2 | 8 | 0 | 32 | 100% |
| BZO
300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| 300 | Pos | 0 | 0 | 3 | 1 | 6 | 34 | 100% |
| COC
150 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% |
| 150 | Pos | 0 | 0 | 1 | 4 | 1 | 53 | 100% |
| EDDP
300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| 300 | Pos | 0 | 0 | 3 | 5 | 2 | 33 | 100% |
| MDMA
500 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% |
| 500 | Pos | 0 | 0 | 2 | 5 | 1 | 34 | 100% |
| MET
500 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| 500 | Pos | 0 | 0 | 3 | 1 | 3 | 51 | 100% |
| MOR
300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% |
| 300 | Pos | 0 | 0 | 3 | 4 | 0 | 53 | 100% |
| MTD
300 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% |
| 300 | Pos | 0 | 0 | 2 | 4 | 0 | 37 | 100% |
| OPI
2,000 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| 2,000 | Pos | 0 | 0 | 2 | 4 | 3 | 40 | 100% |
| OXY
100 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% |
| 100 | Pos | 0 | 0 | 3 | 7 | 1 | 33 | 100% |
| PCP
25 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% |
| 25 | Pos | 0 | 0 | 1 | 3 | 8 | 33 | 100% |
| PPX
300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 95.3% |
| 300 | Pos | 0 | 0 | 2 | 5 | 2 | 33 | 100% |
| TCA
1,000 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% |
| 1,000 | Pos | 0 | 0 | 2 | 5 | 7 | 28 | 100% |
| THC
50 | Neg | 40 | 1 | 2 | 0 | 0 | 0 | 97.7% |
| 50 | Pos | 0 | 0 | 1 | 4 | 7 | 44 | 100% |
:
,
6
| Drug Test
with
Cutoff
(ng/mL) | Test
Result | Drug-
free | Compared to GC/MS Analysis Data | | | | | | %
agreement |
|----------------------------------------|----------------|---------------|---------------------------------|--------------------|--------------------|--------------------------|--------------|-------|----------------|
| | | | -50% C/O
to
+25% C/O
to +50% C/O | >+50%
C/O | | |
| AMP
500 | Neg | 40 | 3 | 0 | 0 | 0 | 0 | 97.7% | |
| AMP
500 | Pos | 0 | 0 | 1 | 2 | 2 | 45 | 100% | |
| BAR
300 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.2% | |
| BAR
300 | Pos | 0 | 0 | 2 | 5 | 2 | 36 | 100% | |
| BUP
10 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% | |
| BUP
10 | Pos | 0 | 0 | 2 | 8 | 0 | 32 | 100% | |
| BZO
300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% | |
| BZO
300 | Pos | 0 | 0 | 3 | 1 | 6 | 34 | 100% | |
| COC
150 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% | |
| COC
150 | Pos | 0 | 0 | 1 | 4 | 1 | 53 | 100% | |
| EDDP
300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% | |
| EDDP
300 | Pos | 0 | 0 | 3 | 5 | 2 | 33 | 100% | |
| MDMA
500 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% | |
| MDMA
500 | Pos | 0 | 0 | 2 | 5 | 1 | 34 | 100% | |
| MET
500 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | |
| MET
500 | Pos | 0 | 0 | 3 | 1 | 3 | 51 | 100% | |
| MOR
300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% | |
| MOR
300 | Pos | 0 | 0 | 3 | 4 | 0 | 53 | 100% | |
| MTD
300 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% | |
| MTD
300 | Pos | 0 | 0 | 2 | 4 | 0 | 37 | 100% | |
| OPI
2,000 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | |
| OPI
2,000 | Pos | 0 | 0 | 2 | 4 | 3 | 40 | 100% | |
| OXY
100 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | |
| OXY
100 | Pos | 0 | 0 | 3 | 7 | 1 | 33 | 100% | |
| PCP
25 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% | |
| PCP
25 | Pos | 0 | 0 | 1 | 3 | 8 | 33 | 100% | |
| PPX
300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 95.3% | |
| PPX
300 | Pos | 0 | 0 | 2 | 5 | 2 | 33 | 100% | |
| TCA
1,000 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% | |
| TCA
1,000 | Pos | 0 | 0 | 2 | 5 | 7 | 28 | 100% | |
| THC
50 | Neg | 40 | 1 | 2 | 0 | 0 | 0 | 97.7% | |
| THC
50 | Pos | 0 | 0 | 1 | 4 | 7 | 44 | 100% | |
C. Summary of Accuracy Results on Advin Multi-Drug Screen Test Cup:
Analytical Specificity
The following compounds are detected positive in urine by the Advin Multi- Drug Screen Test Cassette, Dip card, and Cup; the concentration of each cross-reactive compound which produced a positive result is in ng/mL and the percentage of the cross-reactivity relative to
the calibrator is in parenthesis:
| Compounds | Concentration (%) | Compounds | Concentration (%) |
|---|---|---|---|
| AMP | |||
| D-Amphetamine | |||
| MDA | 500 (100%) | ||
| 8,000 (6.5%) | L-amphetamine | ||
| Phentermine | 50,000 (1%) | ||
| 45,000 (1.1%) | |||
| BAR | |||
| Secobarbital | |||
| Aprobarbital | 300 (100%) | ||
| 500 (60%) | Amobarbital | ||
| Butabarbital | 2,500 (12%) | ||
| 100 (300%) | |||
| Butalbital | |||
| Phenobarbital | 300 (100%) | ||
| 300 (100%) | Cyclopentobarbital | ||
| Phentobarbital | 500 (60%) | ||
| 250 (120%) | |||
| BUP | |||
| Buprenorphine | 10 (100%) | ||
| BZO | |||
| Oxazepam | |||
| Alprazolam | |||
| Clobazam | |||
| Desalkyflurazepam | |||
| Flunitrazepam | |||
| Nitrazepam | |||
| Nordiazepam | |||
| Temazepam | |||
| Triazolam | 300 (100%) | ||
| 200 (150%) | |||
| 200 (150%) | |||
| 1,200 (25%) | |||
| 250 (120%) | |||
| 250 (120%) | |||
| 390 (76.9%) | |||
| 150 (200%) | |||
| 2,500 (12%) | Alpha-hydroxyalprazolam | ||
| Bromazepam | |||
| Clorazepam | |||
| Diazepam | |||
| Lorazepam | |||
| Lorazepam-glucuronide | |||
| Nordiazepam | |||
| Norchlordiazepoxide | 1,900 (15.8%) | ||
| 1,000 (30%) | |||
| 750 (40%) | |||
| 1,000 (30%) | |||
| 3,900 (7.7%) | |||
| 5,000 (6%) | |||
| 400 (75%) | |||
| 500 (60%) | |||
| COC | |||
| Benzoylecgonine | |||
| Cocaethylene | 150 (100%) | ||
| 50,000 (0.3%) | Cocaine | ||
| Ecgonine | 5,000 (3%) | ||
| 50,000 (0.3%) | |||
| EDDP | |||
| EDDP | 300 (100%) | ||
| MET | |||
| d-Methamphetamine | |||
| d-Amphetamine | |||
| MDEA | |||
| MDMA | 500 (100%) | ||
| 50,000 (1%) | |||
| 30,000 (1.7%) | |||
| 3,500 (14.3%) | 1R,2S(-) -Ephedrine | ||
| L-Amphetamine | |||
| Mephentermine | 100,000 (0.5%) | ||
| 50,000 (1%) | |||
| 75,000 (0.7%) | |||
| MDMA | |||
| (+/-) - MDMA | |||
| (+/-)- MDEA | 500 (100%) | ||
| 500 (100%) | (+/-)-MDA | 3,900 (12.8%) | |
| MTD | |||
| Methadone | 300 (100%) | ||
| MOR | |||
| Morphine | |||
| Ethylmorphine | |||
| Hydrocodone | |||
| Levophenol | |||
| Norcodeine | |||
| Thebaine | 300 (100%) | ||
| 100 (300%) | |||
| 1,250 (24%) | |||
| 50,000 (0.6%) | |||
| 6,000 (1.9%) | |||
| 90,000 (0.3%) | Codeine | ||
| Heroine | |||
| Hydromorphone | |||
| Morphine 3-glucuronide | |||
| Oxycodone | 100 (300%) | ||
| 8,000 (37.5%) | |||
| 2,500 (12%) | |||
| 400 (75%) | |||
| 75,000 (0.4%) | |||
| PCP | |||
| Phencyclidine | 25 (100%) | 4-hydroxy-PCP | 1,500 (1.7%) |
| OPI | |||
| Morphine | |||
| Codeine | |||
| Ethylmorphine | |||
| Hydromorphone | |||
| Heroine | 2,000 (100%) | ||
| 1,800 (111.1%) | |||
| 1500 (133.3%) | |||
| 5,000 (40%) | |||
| 11,000 (18.2%) | Oxycodone | ||
| Morphine-3-glucuronide | |||
| Hydrocodone | |||
| Thebaine | 70,000 (2.9%) | ||
| 2,600 (76.9%) | |||
| 5,000 (40%) | |||
| 95,000 (2.1%) | |||
| OXY | |||
| Oxycodone | |||
| Hydrocodone | |||
| Ethylmorphine | 100 (100%) | ||
| 5,000 (2%) | |||
| 50,000 (0.2%) | Hydromorphone | ||
| Oxymorphone | |||
| Codeine | 25,000 (0.4%) | ||
| 12,500 (0.8) | |||
| 50,000 (0.2%) | |||
| PPX | |||
| Propoxyphene | 300 (100%) | Nor-propoxyphen | 300 (100%) |
| TCA | |||
| Nortriptyline | 1,000 (100%) | Amitriptyline | 4,000 (25%) |
| Clomipramine | 2,000 (50%) | Doxepine | 1,000 (100%) |
| Desipramine | 500 (200%) | Imipramine | 1,000 (100%) |
| Promethazine | 1,000 (100%) | Trimipramine | 5,000 (20%) |
| THC | |||
| 11-nor-Δ9-THC-9-COOH | 50 (100%) | (+/-)11-hydroxy-Δ9-THC | 5,000 (1%) |
| (-)- Δ8-THC | 20,000 (0.3%) | (-)-Δ9-THC | 20,000 (0.3%) |
7
・
8
Precision:
The precision of Advin Multi-Drug Screen Test was evaluated at 3 Physician's Office Laboratory sites and 100 lay persons. Data obtained from these sites indicate that correct test results can be obtained when urine specimen with drug concentrations at +/-50% cutoff levels are tested with Advin Multi-Drug Test Cassette, Dipcard, and Cup.
Lay-Users Study
A total of over one hundred male and female persons age 18 or older participated in the lay person user study with Advin Multi -Drug Screen Test following product package insert. The drug-free urine specimens together with spiked urine specimens with different drug concentrations at +/- 50% cutoff and +/- 25% cutoff were tested by the participants. Each level of the drug solutions was randomly tested with at least 20 replicates.
The lay person user study results indicates that the agreement between the testing results from lay person and GC/MS analysis results is from over 99% for the concentrations at +/-50% cutoff levels and 65% to 86% for the concentrations near the cutoff levels and. The statistic analysis indicates that a lay person can follow the product package insert and perform Advin Multi-Drug Screen Test Cassette, Dip Card and Cup similar to professionals at POL sites with reasonable accuracy.
A Summary of the lay person user study results are listed in the tables below:
Analysis of Discordant Results with Advin Multi-drug Screen Cassette by Lay Person vs. GC/MS Analysis
| Drug test cutoff
(ng/mL) | Number of tests
(discordant
results/total results) | Result of Advin
Multi-drug Test
Cassette | GC/MS or LCMS
(ng/mL) |
|-----------------------------|----------------------------------------------------------|------------------------------------------------|--------------------------|
| AMP 500 | 12/136 | Positive | 366 |
| | 7/86 | Negative | 555 |
| BAR 300 | 5/65 | Positive | 227 |
| | 4/44 | Negative | 394 |
| BUP 10 | 6/66 | Positive | 6.9 |
| | 6/44 | Negative | 11.3 |
9
| BZO 300 | 6/65 | Positive | 209 |
|---|---|---|---|
| 4/41 | Negative | 374 | |
| COC 150 | 6/68 | Positive | 113 |
| 4/42 | Negative | 186 | |
| EDDP | 5/66 | Positive | 212 |
| 6/42 | Negative | 406 | |
| MET 500 | 6/62 | Positive | 394 |
| 5/44 | Negative | 646 | |
| MDMA 500 | 6/62 | Positive | 368 |
| 6/46 | Negative | 624 | |
| MTD 300 | 7/64 | Positive | 218 |
| 3/44 | Negative | 412 | |
| MOR 300 | 5/62 | Positive | 255 |
| 6/47 | Negative | 318 | |
| OPI 2000 | 5/64 | Positive | 1465 |
| 4/44 | Negative | 2135 | |
| OXY | 6/70 | Positive | 67 |
| 3/42 | Negative | 112 | |
| PCP 25 | 7/68 | Positive | 17.2 |
| 3/41 | Negative | 35.2 | |
| TCA 1000 | 6/68 | Positive | 784 |
| 4/42 | Negative | 1210 | |
| THC 50 | 6/62 | Positive | 34.1 |
| 5/48 | Negative | 57.1 |
. . . . .
. . . . . . . ・
.
.
: 上
:
.
:
··
Analysis of Discordant Result with Advin Multi-drug Screen Dipcard by Lay Person vs. GC/MS Analysis . .
| Drug test cutoff
(ng/mL) | Number of tests
(discordant
results/total results) | Result of Advin
Multi-drug Test
Dipcard | GC/MS or LCMS
(ng/mL) |
|-----------------------------|----------------------------------------------------------|-----------------------------------------------|--------------------------|
| AMP 500 | 12/126 | Positive | 366 |
| | 7/86 | Negative | 555 |
| BAR 300 | 5/66 | Positive | 227 |
| | 6/40 | Negative | 394 |
| BUP 10 | 4/63 | Positive | 6.9 |
| | 4/42 | Negative | 11.3 |
| BZO 300 | 4/63 | Positive | 209 |
| | 4/42 | Negative | 374 |
| COC 150 | 5/64 | Positive | 113 |
| | 4/45 | Negative | 186 |
| EDDP 300 | 5/62 | Positive | 212 |
| | 6/43 | Negative | 406 |
| MET 500 | 6/65 | Positive | 394 |
| | 4/40 | Negative | 646 |
| MDMA 500 | 5/63 | Positive | 368 |
| | 6/41 | Negative | 624 |
| MTD 300 | 6/63 | Positive | 218 |
| | 5/42 | Negative | 412 |
| MOR 300 | 5/65 | Positive | 255 |
:
. .
10
| 4/44 | Negative | 318 | |
|---|---|---|---|
| OPI 2000 | 5/63 | Positive | 1465 |
| 5/41 | Negative | 2125 | |
| OXY 100 | 5/62 | Positive | 67 |
| 4/41 | Negative | 112 | |
| PCP 25 | 5/64 | Positive | 17.2 |
| 4/42 | Negative | 35.2 | |
| TCA 1000 | 5/62 | Positive | 784 |
| 4/43 | Negative | 1210 | |
| THC 50 | 6/65 | Positive | 34.1 |
| 4/44 | Negative | 57.1 |
.
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
・
.
・
Analysis of Discordant Result with Advin Multi-drug Screen Cup by Lay Person vs. GC/MS Analysis ·
·
| Drug test cutoff
(ng/mL) | Number of tests
(discordant
results/total results) | Result of Advin
Multi-drug Test Cup | GC/MS or LCM
(ng/mL) |
|-----------------------------|----------------------------------------------------------|----------------------------------------|-------------------------|
| AMP 500 | 23/256 | Positive | 366 |
| | 22/176 | Negative | 555 |
| BAR 300 | 5/193 | Positive | 227 |
| | 6/42 | Negative | 394 |
| BUP 10 | 4/191 | Positive | 6.9 |
| | 6/44 | Negative | 11.3 |
| BZO 300 | 6/196 | Positive | 209 |
| | 6/41 | Negative | 374 |
| COC 150 | 6/194 | Positive | 113 |
| | 5/43 | Negative | 186 |
| EDDP 300 | 6/194 | Positive | 212 |
| | 5/43 | Negative | 406 |
| MET 500 | 6/195 | Positive | 394 |
| | 5/42 | Negative | 646 |
| MDMA 500 | 5/191 | Positive | 368 |
| | 6/43 | Negative | 624 |
| MTD 300 | 5/193 | Positive | 218 |
| | 6/44 | Negative | 412 |
| MOR 300 | 6/127 | Positive | 255 |
| | 5/42 | Negative | 381 |
| OPI 2000 | 5/129 | Positive | 1465 |
| | 4/41 | Negative | 2125 |
| OXY 100 | 7/194 | Positive | 67 |
| | 5/43 | Negative | 112 |
| PCP 25 | 6/194 | Positive | 17.2 |
| | 4/41 | Negative | 35.2 |
| TCA 1000 | 5/192 | Positive | 784 |
| | 6/43 | Negative | 1210 |
| THC 50 | 6/195 | Positive | 34.1 |
| | 5/42 | Negative | 57.1 |
11
Conclusion:
.
From data collected in the accuracy and precision studies, it was demonstrated that Advin Multi-Drug Screen Test is safe and effective to use when compared to predicate devices already marketed in the United States.
:
12
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2013
Advin Biotech C/O Edward Tung 6861 Nancy Ridge Dr., Suite #D SAN DIEGO CA 92121
Re: K122809
Trade/Device Name: Advin Multi-Drug Screen Test Cassette Advin Multi-Drug Screen Test Dipcard Advin Multi-Drug Screen Test Cup
Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DJC, DIS, JXM, DJG, LDJ, DIO, DJR, LFG, JXN, LCM Dated: June 03, 2013 Received: June 06, 2013
Dear Dr. Tung:
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.
13
Page 2-Dr. Tung
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/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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney @was, 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
14
Indications for Use
510(k) Number (if known): K122809
Device Name: Advin Multi-Drug Screen Test Cassette Advin Multi-Drug Screen Test Dip Card Advin Multi-Drug Screen Test Cup
:
Indications for Use:
The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels:
| Drug Test | Calibrator | Cutoff Level |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine. | 500 ng/mL |
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Cocaine (COC) | Benzoylecgnine | 150 ng/mL |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 ng/mL |
| Ecstasy (MDMA) | Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | d-Methamphetamine | 500 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Morphine (MOR300) | Morphine | 300 ng/mL |
| Opiates (OPI) | Morphine | 2,000 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | Propoxyphene | 300 ng/mL |
| Tricyclic-antidepressant (TCA) | Nortriptynine | 1,000 ng/mL |
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
Prescription Use X (21 CFR Part 801 Subpart D) .And/Or ・・
Over the Counter Use X (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)
Ruth A. ሬ🇿e͡§ler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k) K122809
15
Indications for Use
510(k) Number (if known): K122809
Device Name: Advin Multi-Drug Screen Test Cassette Advin Multi-Drug Screen Test Dip Card Advin Multi-Drug Screen Test Cup
Indications for Use:
The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dip Card and a Cup, which may be configured in any combination of the drug analytes listed in the above table.
Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use.
The Advin Multi-Drug Screen Test will yield preliminary positive results when prescription drugs TCA, Barbiturates and Benzodiazepine, Methadone, Buprenorphine and Opiates are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for TCA, Barbiturates and Benzodiazepine in urine.
The Advin Multi-Drug Screen Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography-(HPLC)-are the-preferred-confirmatory-methods-Glinical-consideration and professional judgment should be applied to any drug of abuse test result, particularly in the evaluation of a preliminary positive test result.
Prescription Use X (21 CFR Part 801 Subpart D)
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chester -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k) K122809