(77 days)
No
The device description and performance studies indicate a traditional lateral flow immunoassay technology, with no mention of AI or ML.
No.
This device is an in vitro diagnostic device used to detect the presence of drugs in human urine. It is not designed to treat or alleviate a medical condition.
Yes
Explanation: The "Device Description" section explicitly states, "The Chemtrue® DOA Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices..."
No
The device is described as a "colloidal gold based lateral flow immunoassay" and comes in physical formats like "dip card, cup, or cassette," indicating it is a hardware-based diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: The document explicitly states, "The tests are single-use, in vitro diagnostic devices..."
- Intended Use: The tests are designed for the "qualitative detection of... drugs in human urine." This involves testing a biological sample (urine) outside of the body to gain information about a person's health status (presence of drugs). This is a core characteristic of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Chemtrue® Multi-Panel DOA Dip Card Tests:
The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP / MET | d-Methamphetamine | 1000 |
| Morphine | MOR | Morphine | 300 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemtrue® Multi-Panel DOA Dip Card Tests panel can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the prefered confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests:
The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines. Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP /MET | d-Methamphetamine | 1000 |
| Opiates | OPI | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemrue® Multi-Panel DOA Dip Card with OP1 2000 Tests can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Product codes
DKZ, LCM, DIO, LDJ, LAF, DJG, DIS, JXM, DJC, DJR, DNK
Device Description
The Chemtrue® DOA Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in the formats of dip card, cup, or cassette, as indicated by the test name.
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 (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All the drugs of abuse analytes of the candidate devices (AMP, COC, MAMP, OPI, MOR, PCP, THC, BZO, BAR, MDMA, MTD, and OXY) were previously cleared under K102203, K111322, K121339, and K123080. Test strips, sample matrix, test format, and cut-off concentrations for these drugs of abuse analytes are identical to those cleared under K102203, K111322, K121339, and K123080. See K102203, K111322, K121339, and K123080 for additional precision, specificity, interference, method comparison, stability and lay-user study information.
Verification and validation activities were conducted to support combining the test strips to create the multi-panel candidate devices, including interference studies and usability testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102203, K111322, K121339, K123080
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2014
CHEMTRON BIOTECH, INC. JANE ZHANG QA/RA DIRECTOR 9245 BROWN DEER ROAD, SUITE B SAN DIEGO CA 92121
Re: K142580
Trade/Device Name: Chemtrue® Multi Panel DOA Dip Card Tests Chemtrue® Multi Panel DOA Dip Card with OPI 2000 Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, LCM, DIO, LDJ, LAF, DJG, DIS, JXM, DJC, DJR, DNK Dated: November 3, 2014 Received: November 4, 2014
Dear Ms. Jane Zhang:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Courtney
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
2
Indications for Use
510(k) Number (if known) K142580
Device Name
Chemtrue® Multi-Panel DOA Dip Card Tests Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests
Indications for Use (Describe)
Chemtrue® Multi-Panel DOA Dip Card Tests:
The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP / MET | d-Methamphetamine | 1000 |
| Morphine | MOR | Morphine | 300 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemtrue® Multi-Panel DOA Dip Card Tests panel can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the prefered confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests:
The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines. Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP /MET | d-Methamphetamine | 1000 |
| Opiates | OPI | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
FORM FDA 3881 (8/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
|---|---|---|---|
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemrue® Multi-Panel DOA Dip Card with OP1 2000 Tests can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
AS REQUIRED BY 21 CFR 807.92(c)
A. SUBMITTER: Chemtron Biotech, Inc. 9245 Brown Deer Road, Suite B, San Diego, CA
- TEL: 858-450-0044; FAX: 858-450-0046
Contact Person: Jane Zhang, Director of QA/RA
Official FDA Correspondent 9245 Brown Deer Road, Suite B San Diego, CA 92121 Office: (858) 450-0044; FAX: (858) 450-0046 Email: jane@uschemtronbio.com
Date Prepared: November 20, 2014
B. DEVICE
Trade or Proprietary Name: Chemtrue® Multi-Panel DOA Dip Card Tests Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests
Common Name: Multi-Drug Urine Test Panel
Regulatory Class: Class II
This 510(k) has been submitted for clearance of new drugs of abuse dip card devices that combines drugs of abuse test strips from previously FDA cleared Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (K102203, K111322, K121339, and K123080). These tests have been previously cleared for prescription use (K102203 and K111322) and over-the-counter use (K121339 and K123080) for the following drugs of abuse analytes in the table below. The new devices are intended for over-the-counter and prescription use:
| Drug of Abuse | Product Code | Panel | Regulation Section |
|---|---|---|---|
| Amphetamine | DKZ | Toxicology 91 | 21CFR 862.3100, Amphetamine Test System |
| Cocaine | DIO | Toxicology 91 | 21 CFR 862.3250, Cocaine and metabolites Test System |
| Methamphetamine | LAF | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Opiates | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
| Phencyclidine | LCM | Toxicology 91 | Unclassified, Enzyme immunoassay Phencyclidine |
| Marijuana | LDJ | Toxicology 91 | 21 CFR 862.3870, Cannabinoids Test System |
| Benzodiazepines | JXM | Toxicology 91 | 21 CFR 862.3170, Benzodiazepines Test System |
| Barbiturates | DIS | Toxicology 91 | 21 CFR 862.3150, Barbiturates Test System |
| Ecstasy (MDMA) | DJC | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Methadone | DJR | Toxicology 91 | 21 CFR 862.3620, Methadone Test System |
| Oxycodone | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
| Morphine | DNK | Toxicology 91 | 21 CFR 862.3640, Morphine Test System |
5
C. PREDICATE DEVICES
510(k): K102203, K111322, K121339 and K123080. Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests
D. INDICATIONS FOR USE:
Device Name: Chemtrue® Multi-Panel DOA Dip Card Tests
Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests
Chemtrue® Multi-Panel DOA Dip Card Tests:
The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration
(ng/mL) |
|-----------------|--------------|-----------------------------------|---------------------------------|
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP /MET | d-Methamphetamine | 1000 |
| Morphine | MOR | Morphine | 300 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ⁹-THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemtrue® Multi-Panel DOA Dip Card Tests panel can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests:
The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Opiates
6
- Methamphetamine, Phencyclidine, Benzodiazepines, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP/MET | d-Methamphetamine | 1000 |
| Opiates | OPI | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor- $\Delta^{9}$ -THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
E. DEVICE DESCRIPTION
The Chemtrue® DOA Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in the formats of dip card, cup, or cassette, as indicated by the test name.
F. SUBSTANTIAL EQUIVALENCE INFORMATION
Comparison with the predicate devices is outlined below:
| Item | Candidate Devices | Predicates |
|---|---|---|
| Indication(s) for use | For qualitative detection of drugs of abuse in human urine | Same |
| Specimen Type | Human urine | Same |
7
| Methodology /Technological | Lateral flow, competitive binding immunoassay based on
the principle of antigen and antibody immunochemistry. | Same |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Characteristics | | |
| Results | Qualitative | Same |
| Cut Off | Amphetamine 1000 ng/mL
Cocaine 300 ng/mL
Methamphetamine 1000 ng/mL
Morphine 300 ng/mL
Opiates 2000 ng/mL
PCP 25 ng/mL
THC 50 ng/mL
Benzodiazepines 300 ng/mL
Barbiturates 300 ng/mL
Ecstasy (MDMA) 500 ng/mL
Methadone 300 ng/mL
Oxycodone 100 ng/mL | Same |
| Configurations | Dip Card | Same |
| Intended Use | Prescription and OTC Use | Same |
G. TEST PRINCIPLE
The Chemtrue® DOA Tests are rapid lateral flow immunoassays in which chemically modified drugs (drug-protein conjugates) compete with drugs that may be present in urine. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band indicates a negative result. If the target drug level exceeds its cut-off concentration, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result.
A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.
Monoclonal anti-drug antibodies are used on the AMP/COC/MET/MOR/OPI/ PCP/THC/ BAR/MDMA/MTD/OXY Test devices which are derived from mouse. The polyclonal antidrug antibodies are used on BZO Test devices which are derived from sheep/mouse.
8
H. PERFORMANCE CHARACTERISTICS
All the drugs of abuse analytes of the candidate devices (AMP, COC, MAMP, OPI, MOR, PCP, THC, BZO, BAR, MDMA, MTD, and OXY) were previously cleared under K102203, K111322, K121339, and K123080. Test strips, sample matrix, test format, and cut-off concentrations for these drugs of abuse analytes are identical to those cleared under K102203, K111322, K121339, and K123080. See K102203, K111322, K121339, and K123080 for additional precision, specificity, interference, method comparison, stability and lay-user study information.
Verification and validation activities were conducted to support combining the test strips to create the multi-panel candidate devices, including interference studies and usability testing.
I. CONCLUSION:
Based on the test principle and performance characteristics of the candidate device, it is concluded that the candidate devices are substantially equivalent to the predicate device.