(90 days)
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Oxazepam (OXA) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Morphine (MOR) | 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs oxazepan and oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific altemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone, in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, and Oxycodone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
The provided document describes the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, and Oxycodone in human urine.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a table format with corresponding performance metrics like sensitivity, specificity, or accuracy for the device as a whole. Instead, it provides the cut-off levels for each drug, which serve as a critical component of the device's performance specification.
The performance characteristics are implied by the statement: "Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates." This suggests that the device's performance was deemed adequate during verification studies. However, specific values for sensitivity, specificity, etc., for the new multi-drug device are not presented.
A table of the specified cut-off levels is provided in the document:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL |
| Oxazepam (OXA) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Morphine (MOR) | 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "verification studies" and "interference studies and a lay-user study" were conducted. However, the exact sample size for the test set is not explicitly provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The device is a diagnostic test, not an AI-assisted diagnostic tool, so this type of study is not relevant in this context.
6. Standalone (Algorithm Only) Performance Study
As this is a lateral flow immunoassay device, it does not involve algorithms in the sense of AI or software. Therefore, a standalone (algorithm only) performance study is not applicable and not reported. The device's performance is driven by its biological and chemical components.
7. Type of Ground Truth Used
The document states that a "more specific analytical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method." This indicates that chromatography-mass spectrometry (GC/MS or LC/MS) is the intended gold standard/ground truth for confirming the preliminary results of the device. It is highly probable that similar analytical methods were used to establish the ground truth in the verification studies, although not explicitly stated for the studies performed.
8. Sample Size for the Training Set
The document does not mention or specify a training set sample size. As a lateral flow immunoassay device, it does not typically involve machine learning with separate training and testing datasets in the way an AI diagnostic algorithm would. Its development relies on biochemical optimization and validation.
9. How Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of machine learning, the method for establishing its ground truth is not applicable and not described. Ground truth for assay development would typically involve precisely prepared samples with known drug concentrations, confirmed by highly accurate analytical methods like GC/MS or LC/MS.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2015
HEALGEN SCIENTIFIC LLC C/O JOE SHIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877
Re: K150356
Trade/Device Name: Healgen Multi-Drug Urine Test Cup. Healgen Multi-Drug Urine Test Dip Card Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: II Product Code: JXM, DJG, DIO, LDJ, LAF, DKZ Dated: April 14, 2015 Received: April 17, 2015
Dear Mr. Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150356
Device Name Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card
Indications for Use (Describe)
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Oxazepam (OXA) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Morphine (MOR) | 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs oxazepan and oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific altemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
| 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) | |||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||||
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | ||||
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov | ||||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." |
FORM FDA 3881 (8/14)
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- Date: May 8, 2015 HEALGEN SCIENTIFIC LLC 2. Submitter: 5213 Maple St
-
- Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401 Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com
-
- Device Name: Healgen Multi-Drug Urine Test Cup Healgen Multi-Drug Urine Test Dip Card
| Classification: Class II | ||
|---|---|---|
| Product Code | Regulation Section | Panel |
| DKZAmphetamine | 21 CFR § 862.3100, Amphetamine Test System | Toxicology |
| LDJCannabinoids | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology |
| DIOCocaine | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology |
| LAFMethamphetamine | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology |
| DJGMorphine | 21 CFR § 862.3650, Opiate Test System | Toxicology |
| JXMOxazepam | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology |
| DJGOxycodone | 21 CFR § 862.3650, Opiate Test System | Toxicology |
Classification: Class II
Bellaire, TX77401
5. Description of the device:
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone, in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containine, Oxazepam, Cocaine,
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Cannabinoids, Methamphetamine, Morphine, and Oxycodone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
-
- Predicate Devices:
K142280; Healgen Oxazepam and Morphine Tests (Strip, Cassette, Dip Card, Cup) K143187; Healgen Amphetamine and Oxycodone Tests (Strip, Cassette, Dip Card, Cup) K141647; Healgen Cocaine and Morphine Tests (Strip, Cassette, Dip Card, Cup) K140546; Healgen Marijuana and Methamphetamine Tests (Strip, Cassette, Dip Card, Cup)
- Predicate Devices:
-
- Intended Use / Indications for Use
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone in human urine at the cutoff concentrations of:
- Intended Use / Indications for Use
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Oxazepam (OXA) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Morphine (MOR) | 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs oxazepam and oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
-
- Substantial Equivalence Information
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are a modified product format derived from the previously FDA-cleared Healgen single DOA Tests. A summary comparison of
- Substantial Equivalence Information
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features of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card and the predicate devices is provided in the following Table
| Item | New Devices | Predicate devices (K142280, K143187, K141647, K140546) |
|---|---|---|
| Indication(s) for use | For the qualitative determination ofAmphetamine (AMP), Oxazepam (OXA),Cocaine (COC), Cannabinoids (THC),Methamphetamine (MET), Morphine (MOR),Oxycodone(OXY) in human urine.The configurations of the New Devices areavailable in any combination of the abovetests. | For the qualitative determination ofAmphetamine, Oxazepam, Cocaine,Cannabinoids, Methamphetamine,Morphine, Oxycodone, in humanurine.The configurations of the Predicatedevices are only available in singledrug test. |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on the | Same |
| Type Of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive or | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 1,000 ng/mlOxazepam (OXA):300 ng/mlCocaine(COC): 300 ng/mlCannabinoids (THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (MOR): 2000 ng/mlOxycodone(OXY) : 100 ng/ml | Same |
| Configurations | Cup, Dip Card | Same |
| Intended Use | OTC Use & Prescription Use | Same |
Healgen Multi-Drug Urine Test Cup is a multi-drug test that offers any combination from 2 to 7 drugs of abuse tests while the predicate devices are single-drug test. And the Healgen Multi-Drug Urine Test Dip Card is the same as the test dip card format of the predicate devices except that the Healgen Multi-Drug Urine Test Dip Card is a multi-drug test that offers any combination from 2 to 7 drugs of abuse tests while the predicate devices are single-drug test.
9. Conclusion
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Verification studies were conducted in support of the modification to have a multi-drug test cup and test card test, including interference studies and a lay-user study. Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).