(280 days)
No
The device is described as a lateral flow immunochromatographic assay, which is a traditional biochemical test method. There is no mention of AI or ML in the description, intended use, or performance studies.
No
This device is an in-vitro diagnostic test used to detect drug substances in urine, not to treat any condition.
Yes
The device is an "immunochromatographic one-step in-vitro test intended for the qualitative detection of up to ten or eleven different drug substances... in human urine." This qualifies it as a diagnostic device because it identifies the presence of specific substances (drug metabolites) in a biological sample to aid in the detection or diagnosis of conditions (drug use).
No
The device is described as an immunochromatographic one-step in-vitro test cup, which is a physical device for analyzing urine samples. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the devices are "immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances... in human urine". The term "in-vitro" directly indicates it's for testing outside of the body.
- Device Description: The description further clarifies that the devices are "competitive binding, lateral flow immunochromatographic iv-vitro assays for the qualitative and simultaneous detection of..." various substances in human urine samples. Again, "in-vitro" is used.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device fits that definition perfectly as it tests urine samples for the presence of various drug substances.
N/A
Intended Use / Indications for Use
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device.
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Product codes
DIO, DIS, DJG, DJR, DKZ, JXM, LAF, LCM, LDJ
Device Description
The Rapid Diagnostics MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are competitive binding, lateral flow immunochromatographic iv-vitro assays for the qualitative and simultaneous detection of amphetamines, barbiturates, benzodiazenines, buprenorphine, cocaine, methadone, methamphetamine, opiates, oxycodone and phencyclidine, in human urine samples. MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup detects each of the analytes on separate strips. A positive urine sample will not generate a colored line for the specific drug tested in the designated region. A negative urine sample containine, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine, methamphetamine, opiates, oxycodone or phencyclidine below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored line will always appear at the control region. Drug substances detected and cut-off levels are included in the following table:
| Drug Identifier | Cut-off Level (ng/ml) |
|---|---|
| Amphetamine (AMP) | 1000 |
| Barbiturates (BAR) | 300 |
| Benzodiazepine (BZD) | 300 |
| Buprenorphine (BUP) | 10 |
| Cannabinoids (THC) | 50 |
| Cocaine (COC) | 300 |
| Methadone (MTD) | 300 |
| Methamphetamine (MAMP) | 1000 |
| Opiates | 300 |
| Opiates II | 2000 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
Configurations of the MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup can consist of any combination of up to 10 or 11 drug analyte test strips respectively, depending on the cup size. The test provides only preliminary test results and a more specific alternative chemical method must be used in order to obtain a confirmed analytical results. GC/MS is the preferred confirmatory method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care (POC) setting
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)
A comparison study was conducted to verify that there is no performance difference of the DOA Test Strips and DOA Test Cups when exposed to a human urine specimen for 20 seconds vs. 5 minutes. For each device format, three lots of product were tested over three drug cut-off concentration levels (-50%, + 50%, +300%) including a negative specimen. Testing was conducted utilizing three device formats; DOA Test Strips, DOA-10 Panel Test Cup and DOA-11 Panel Test Cups. During the conduct of this comparison study there were no observed test failures. 432/432 of the drug test strips passed, 360/360 of the MP DOA-10 Panel Test Cups passed and 396/396 of the MP DOA-11 Panel Test Cups passed per the pre-defined study acceptance criteria. An interfering drug analyte study was conducted using 198 MP DOA-11 Panel Test Cups (divided in 2 groups) and 180 MP DOA-10 Panel Test Cups (divided in 2 groups) over 3 lots of DOA Test Cups. Cut-off concentrations (-50%, +50%, +300%) for each drug analyte were assessed for interference. Following the addition of specimen at the 3 different concentrations, results at 5 and 10 minutes demonstrated no interference. Additional performance data of precision, reproducibility, interference, sensitivity and specific analytes and test devices were reported in previously cleared 510(k) Pre-Market Notifications belonging to Rapid Diagnostics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 862.3250 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).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2017
MP Biomedicals, LLC Sean R. Gemmill, MS. RAC Director of Regulatory Affairs 1429 Rollins Road Burlingame, California 94010
Re: K162395
Trade/Device Name: MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO, DIS, DJG, DJR, DKZ, JXM, LAF, LCM, LDJ Dated: May 9, 2017 Received: May 10, 2017
Dear Mr. Gemmill:
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 and Part 809); medical device reporting (reporting of
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 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.
Courtney H. Lias -S
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) K162395
Device Name MP DOA-10 Panel Test Cup MP DOA-11 Panel Test Cup
Indications for Use (Describe)
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device.
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
510(k) Summary
This summary of 510(k) safety and effectiveness is submitted in accordance with 21 CFR 807.92.
The assigned 510(k) number is: K162395
| 1. Date: | May 24, 2017 |
|---|---|
| 2. Submitter: | Rapid Diagnostics |
| Division of MP Biomedicals, LLC | |
| 1429 Rollins Road | |
| Burlingame, CA 94010 USA | |
| Tel: (650) 558-0395 | |
| FAX: (650) 558-0397 | |
| 3. Contact Person: | Sean Gemmill, MS, RAC, |
| Director of Regulatory Affairs | |
| MP Biomedicals, LLC | |
| 3 Hutton Centre Dr. #100 | |
| Santa Ana, CA 92707 | |
| Tel: (949) 833-2500 | |
| FAX: (949) 859-5010 | |
| 4. Establishment Registration #: | 2954282 |
| 5. Device Name: | |
| Common Name: | |
| Trade or Proprietary Name: | Multi Drugs of Abuse Test Cup |
| MP DOA-10 Panel Test Cup | |
| MP DOA-11 Panel Test Cup |
-
- Classification:
Class II medical as defined by FDA product codes and the Code of Federal Regulations (CFRs):
- Classification:
| Product
Code | Regulatory Description | Device
Class | Regulation
Section | Review Panel |
|-----------------|-----------------------------------------------|-----------------|-----------------------|-----------------|
| DKZ | Amphetamine test system | II | 862.3100 | Toxicology (91) |
| DIS | Barbiturate test system | II | 862.3150 | Toxicology (91) |
| JXM | Benzodiazepine test system | II | 862.3170 | Toxicology (91) |
| LDJ | Cannabinoid test system | II | 862.3870 | Toxicology (91) |
| DIO | Cocaine and cocaine metabolite test
system | II | 862.3250 | Toxicology (91) |
| DJR | Methadone test system | II | 862.3620 | Toxicology (91) |
| LAF | Methamphetamine test system | II | 862.3610 | Toxicology (91) |
| LCM | Amphetamine test system,
Phencyclidine | II | 862.3100 | Toxicology (91) |
| DJG | Opiate test system | II | 862.3650 | Toxicology (91) |
4
7. Description of the Device:
The Rapid Diagnostics MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are competitive binding, lateral flow immunochromatographic iv-vitro assays for the qualitative and simultaneous detection of amphetamines, barbiturates, benzodiazenines, buprenorphine, cocaine, methadone, methamphetamine, opiates, oxycodone and phencyclidine, in human urine samples. MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup detects each of the analytes on separate strips. A positive urine sample will not generate a colored line for the specific drug tested in the designated region. A negative urine sample containine, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine, methamphetamine, opiates, oxycodone or phencyclidine below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored line will always appear at the control region. Drug substances detected and cut-off levels are included in the following table:
| Drug Identifier | Cut-off Level (ng/ml) |
|---|---|
| Amphetamine (AMP) | 1000 |
| Barbiturates (BAR) | 300 |
| Benzodiazepine (BZD) | 300 |
| Buprenorphine (BUP) | 10 |
| Cannabinoids (THC) | 50 |
| Cocaine (COC) | 300 |
| Methadone (MTD) | 300 |
| Methamphetamine (MAMP) | 1000 |
| Opiates | 300 |
| Opiates II | 2000 |
| Oxycodone (OXY) | 100 |
| Phencyclidine (PCP) | 25 |
Configurations of the MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup can consist of any combination of up to 10 or 11 drug analyte test strips respectively, depending on the cup size. The test provides only preliminary test results and a more specific alternative chemical method must be used in order to obtain a confirmed analytical results. GC/MS is the preferred confirmatory method.
8. Indications for Use
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic onestep in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml.; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device.
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
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9. Predicate Devices
The following 510(k) cleared devices belong to Rapid Diagnostics; Rapid Drugs of Abuse Single and Multiple Test Panels (K003809), MICROMEDIC Drugs of Abuse Panel Test (K033566) and RapidBUP Test Strip / RapidOXY Test Strip (K051958). These previously cleared drugs of abuse test strip and drugs of abuse test panels are predicate devices to the MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cups of this Pre-Market Notification.
10. Substantial Equivalence Information
The MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are a "modified" product format derived from previously FDA cleared single and multi-panel DOA tests. The modification of the subject device, MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup offers the previously 510(k) cleared drugs of abuse tests in a test cup format. The following 510(k) cleared devices; Rapid Drugs of Abuse Single and Multiple Test Panels (K003809), MICROMEDIC Drugs of Abuse Panel Test (K033566) and RapidBUP Test Strip/RapidOXY Test Strip (K051958), to which substantial equivalence is claimed, belong to Rapid Diagnostics. The subject devices in its modified format of this submission are substantially equivalent to the previously cleared Rapid Diagnostics drugs of abuse tests.
11. Performance
A comparison study was conducted to verify that there is no performance difference of the DOA Test Strips and DOA Test Cups when exposed to a human urine specimen for 20 seconds vs. 5 minutes. For each device format, three lots of product were tested over three drug cut-off concentration levels (-50%, + 50%, +300%) including a negative specimen. Testing was conducted utilizing three device formats; DOA Test Strips, DOA-10 Panel Test Cup and DOA-11 Panel Test Cups. During the conduct of this comparison study there were no observed test failures. 432/432 of the drug test strips passed, 360/360 of the MP DOA-10 Panel Test Cups passed and 396/396 of the MP DOA-11 Panel Test Cups passed per the pre-defined study acceptance criteria. An interfering drug analyte study was conducted using 198 MP DOA-11 Panel Test Cups (divided in 2 groups) and 180 MP DOA-10 Panel Test Cups (divided in 2 groups) over 3 lots of DOA Test Cups. Cut-off concentrations (-50%, +50%, +300%) for each drug analyte were assessed for interference. Following the addition of specimen at the 3 different concentrations, results at 5 and 10 minutes demonstrated no interference. Additional performance data of precision, reproducibility, interference, sensitivity and specific analytes and test devices were reported in previously cleared 510(k) Pre-Market Notifications belonging to Rapid Diagnostics as outlined in the following table:
| Rapid Diagnostics Drugs of Abuse Tests - Performance Data References | ||
|---|---|---|
| Drug Identifier | Cut-off Level (ng/ml) | 510(k) Reference |
| Amphetamine | 1000 | K033566, K003809 |
| Barbiturates (secobarbital) | 300 | K033566, K030211 |
| Benzodiazepine (oxezepam) | 300 | K033566, K003809 |
| Buprenorphine | 10 | K051958 |
| Cannabinoids | 50 | K033566, K003809 |
| Cocaine | 300 | K033566, K003809 |
| Methadone | 300 | K033566, K023252 |
| Methamphetamine | 1000 | K033566, K003809 |
| Opiates | 300 | K033566, K003809 |
| Opiates II | 2000 | K033566, K020716 |
| Oxycodone | 100 | K051958 |
| Phencyclidine | 25 | K033566, K003809 |