(83 days)
Not Found
No
The device is described as an immunochromatographic assay (lateral flow system), which is a traditional biochemical test method. There is no mention of AI, ML, image processing, or any computational analysis of the results. The performance studies focus on the analytical characteristics of the biochemical reaction and user interpretation, not on algorithmic performance.
No
This device is an in vitro diagnostic test used to detect the presence of Amphetamine and Oxycodone in human urine. It is for diagnostic purposes, not for treatment or therapy.
Yes.
The "Healgen Amphetamine Test" and "Healgen Oxycodone Test" are described as "immunochromatographic assays for the qualitative determination of Amphetamine/Oxycodone in human urine" and explicitly stated to be "For in vitro diagnostic use only." The device description identifies them as "in vitro diagnostic devices."
No
The device is an in vitro diagnostic test that comes in physical formats (Strips, Cassettes, DipCards, or Cups) and relies on immunochromatographic assay technology, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For in vitro diagnostic use only." in the Intended Use / Indications for Use section for both the Amphetamine and Oxycodone tests.
- "The products are in vitro diagnostic devices..." in the Device Description section.
N/A
Intended Use / Indications for Use
Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
Healgen Oxycodone Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test may yield preliminary positive results even when prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DJG
Device Description
Healgen Amphetamine Test and Healgen Oxycodone Test are immunochromatographic assays for Amphetamine and Oxycodone. Each assay test is a lateral flow system for the qualitative detection of Amphetamine and Oxycodone (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
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
over-the-counter and for prescription 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance - Precision: The precision performance was evaluated using 3 lots for each format (Strip, Cassette, Cup, Dip Card) of the device. Each lot was evaluated by a different operator, analyzing samples in 2 runs per day for 25 days (n = 50 per lot). Drug-free urine samples were spiked to achieve concentrations at 100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, +25% cutoff, +50% cutoff, +75% cutoff, and +100% cutoff. All sample aliquots were blind labeled and randomized, and each drug concentration was confirmed by GC/MS.
Analytical Performance - Cut-off: A total of 150 samples equally distributed at concentrations of -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and below -25% cut-off for both Amphetamine and Oxycodone.
Analytical Performance - Interference: Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats. No interference was observed for listed compounds at 100µg/mL.
Analytical Performance - Specificity: Specificity was tested against drug metabolites and other components that are likely to interfere in urine samples, using three batches of each device for all formats. Cross-reactivity was calculated based on the lowest detectable concentration.
Analytical Performance - Effect of Urine Specific Gravity and Urine pH: Urine samples with specific gravity from 1.000 to 1.035 or pH from 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three batches of each device for all formats. All results were positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off.
Comparison Studies (Professional User): Method comparison studies were performed in-house with three different laboratory assistants for each device format. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. Samples were blind labeled and compared to GC/MS results.
Lay-user study: A lay user study was performed at three intended user sites with 140 lay persons testing each format of the Amphetamine devices and another set of 140 persons testing each format of the Oxycodone devices. Total of 1120 individuals performed the study. A total of 230 females and 330 males tested the Amphetamine samples, and 226 females and 334 males tested the Oxycodone samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug-free pooled urine specimens. Concentrations were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant received the package insert, one blind-labeled sample, and a device.
Key results for Amphetamine (Strip, Cassette, DipCard, Cup) and Oxycodone (Strip, Cassette, DipCard, Cup) in lay-user study indicated high percentages of correct results across various cutoff concentrations. For -100%, -75%, -50% cutoff, 100% correct negative results were achieved. For -25% cutoff, correct negative results were 90-95%. For +25% cutoff, correct positive results were 90-100%. For +50% and +75% cutoff, 100% correct positive results were achieved. Lay-users also indicated the device instructions were easily followed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Specific sensitivity, specificity, PPV, NPV values are not explicitly stated, but raw data is provided in comparison studies for calculation.)
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.
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2015
HEALGEN SCIENTIFIC LLC JOE SHIA LSI INTERNATIONAL INC 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877
Re: K143187
Trade/Device Name: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DJG Dated: October 31, 2014 Received: November 5, 2014
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 (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.
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,
Katherine Serrano -S
For : 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
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) K143187
Device Name
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card) Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
Indications for Use (Describe)
Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
Healgen Oxycodone Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test may yield preliminary positive results even when prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Amphetamine Test (Strip, Cassette, Cup, Dip Card) and Oxycodone Test (Strip, Cassette, Cup, Dip Card
3
-
- Date: January 21, 2014
-
- Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401
-
- 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 Amphetamine Test (Strip, Cassette, Cup, Dip Card) Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
- Classification:
| Product
| Code | CFR # | Panel |
|---|---|---|
| DKZ | 21 CFR, 862.3100 Amphetamine Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
-
- Predicate Devices: K052115 First Check Multi Drug Cup 12
-
- Intended Use / Indications for Use
Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
4
Healgen Oxycodone Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
The test may yield preliminary positive results even when prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
-
- Device Description
Healgen Amphetamine Test and Healgen Oxycodone Test are immunochromatographic assays for Amphetamine and Oxycodone. Each assay test is a lateral flow system for the qualitative detection of Amphetamine and Oxycodone (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the Healgen Amphetamine Test and Healgen Oxycodone Test and the predicate device is provided in Table 1 & Table 2.
- Substantial Equivalence Information
| Item | Device | Predicate -
K052115 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Intended Use | For the qualitative determination of drugs
of abuse in human urine. | Same |
| Drug Analyte | Amphetamine | Same |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 1000 ng/mL | Same |
Table 1: Features Comparison of Healgen Amphetamine Test and the Predicate Device
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| Intended Use
Population | For over-the-counter and
prescription uses. | For
over-the-counter
use. |
|----------------------------|------------------------------------------------|---------------------------------|
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |
Table 2: Features Comparison of Healgen Oxycodone Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|---|---|---|
| Intended Use | For the qualitative determination of | |
| drugs of abuse in human urine. | Same | |
| Drug Analyte | Oxycodone | Same |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based | ||
| on the principle of antigen antibody | ||
| immunochemistry. | Same | |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 100 ng/mL | Same |
| Intended | ||
| Population | For over-the-counter and prescription | |
| uses. | For over-the-counter | |
| use. | ||
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |
9. Test Principle
Healgen Amphetamine Test and Healgen Oxycodone Test are rapid tests for the qualitative detection of Amphetamine and Oxycodone in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the test has been performed properly.
10. Performance Characteristics
-
- Analytical Performance
- a. Precision
The precision performance of the Healgen Amphetamine and Oxycodone tests was evaluated using 3 lots for each format (Strip, Cassette, Cup, Dip Card) of the device. Each lot was evaluated by a
6
different operator. The testing consisted of analyzing samples in 2 runs per day for 25 days (n = 50 per lot) and by spiking drug free urine samples to achieve 100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off drug The samples were prepared by spiking drug into negative samples. All sample concentrations. aliquots were blind labeled and randomized and each drug concentration was confirmed by GC/MS. Results are summarized below for each lot and device.
Amphetamine
Strip Format
| Drug | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cassette Format
| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 4 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 6 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card Format
| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot 7 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 8 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 9 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CUP Format
| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|--------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot 10 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 11 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 12 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Oxycodone
Strip Format
| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cassette Format
| Drug | Result | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off |
|---|---|---|---|---|---|---|---|---|---|---|
| Lot 4 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 6 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card Format
| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | | | | | | | | | | |
| Lot 7 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 8 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 9 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CUP Format
| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 10 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 11 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot 12 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 16-/34+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity
Not applicable.
- c. Stability
The devices are stable at 4-30°C for 24 months based on the accelerated stability study at 45°C and real time stability determination at both 4℃ and 30℃.
Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
8
d. Cut-off
A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and below -25% cut-off for both Amphetamine and Oxycodone. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off
(ng/mL) |
|------------------|-------------|--------------------|
| Amphetamine Test | Amphetamine | 1000 |
| Oxycodone Test | Oxycodone | 100 |
e. Interference
Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.
Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different formats.
| Acetophenetidin | Fenoprofen | Phenelzine |
|---|---|---|
| N-Acetylprocainamide | Furosemide | Phenobarbital |
| Acetylsalicylic Acid | ||
| (Aspirin) | Gentisic acid | Phenylephrine-L |
| Aminopyrine | Hemoglobin | Phenylethylamine |
| Amitriptyline | Hydralazine | Phenylpropanolamine |
| Amoxicillin | Hydrochlorothiazide | Prednisolone Acetate |
| Amobarbital | Hydrocodone | Prednisone |
| Ampicinine(Ampicillin) | Hydrocortisone | Procaine(Novocaine) |
| Apomorphine | a -Hydroxyhippuric acid | Promazine |
| L-Ascorbic Acid | p-Hydroxymethamphetamine | Promethazine |
| Aspartame | Ibuprofen | Propoxyphene,d- |
| Atropine | Imipramine | Propranolol |
| Benzilic acid | Isoxsuprine | Pseudoephedrine HCL |
| Benzphetamine | Isoproterenol-(+/-) | Quinidine |
| Bezoic Acid | Ketamine | Quinine |
| Bilirubin | Labetalol | Ranitidine(Zantac) |
| Caffeine | Levorphanol | Salicylic Acid |
| Chloramphenicol | Loperamide | Secobarbital |
Amphetamine
9
| Chlordiazepoxide
| HCL | Maprotiline | Serotonin |
|---|---|---|
| Chloroquine | Meprobamate | Sulfamethazine |
| Chlorothiazide | Methadone | Sulindac |
| Chlorpheniramine | Methoxyphenamine | Temazepam |
| Chlorpromazine | Methylphenidate | 11-Nor-Δ9-Tetrahydrocannabinol |
| Cholesterol | Nalbuphine | Tetracycline |
| Clomipramine | Nalidixic acid | Tetrahydrozoline |
| Clonidine hydrochloride | Naloxone hydrochloride | Thebaine |
| Codeine | Naltrexone hydrochloride | Thiamine |
| Cortisone | Naproxen | L-Thyroxine |
| Cotinine(-) | Niacinamide | ThioridazineHydrochloride |
| Creatinine | Nifedipine | Triamterene |
| Deoxyepinephrine | Norethindrone | Triflupromazine |
| Hydrochloride | ||
| Dextromethorphan | Norpropoxyphene | Trimethoprim |
| Diazepam | Noscapine | Trimipramine |
| Diflunisal | Oxazepam | Tryptamine |
| Digoxin | Oxycodone | DL-Tryptophan |
| Doxylamine | Oxymetazoline | Tyramine |
| Ecgonine methylester | Papaverine | D/L-Tyrosine |
| R(-)-Epinephrine | Penicillin | Uric Acid |
| Erythromycin | Pentobarbital | Verapamil |
| Estrone-3-sulfate | Perphenazine | Zomepirac |
| Ethyl-p-aminobenzoate | Phencyclidine |
Oxycodone
| Acetophenetidin | Ethyl-p-aminobenzoate | Phencyclidine |
|---|---|---|
| N-Acetylprocainamide | Fenoprofen | Phenelzine |
| Acetylsalicylic Acid | ||
| (Aspirin) | Furosemide | Phenobarbital |
| Aminopyrine | Gentisic acid | Phentermine |
| Amitriptyline | Hemoglobin | Phenylephrine-L |
| Amoxicillin | Hydralazine | Phenylethylamine |
| Amobarbital | (+/-)-4-Hydroxyamphetamine | |
| HCL | Phenylpropanolamine | |
| D-Amphetamine | Hydrochlorothiazide | Prednisolone Acetate |
| L-Amphetamine | Hydrocodone | Prednisone |
| Amphetamine Sulfate | Hydrocortisone | Procaine(Novocaine) |
| Ampicinine(Ampicillin) | a -Hydroxyhippuric acid | Promazine |
10
| Apomorphine | p-Hydroxymethamphetamine | Promethazine |
|---|---|---|
| L-Ascorbic Acid | Ibuprofen | Propoxyphene,d- |
| Aspartame | Imipramine | Propranolol |
| Atropine | Isoxsuprine | Pseudoephedrine HCL |
| Benzilic acid | Isoproterenol-(+/-) | Quinidine |
| Benzphetamine | Ketamine | Quinine |
| Benzoic Acid | Labetalol | Ranitidine(Zantac) |
| Bilirubin | Levorphanol | Salicylic Acid |
| Caffeine | Loperamide | Secobarbital |
| Chloramphenicol | Maprotiline | Serotonin |
| Chlordiazepoxide HCL | Meprobamate | Sulfamethazine |
| Chloroquine | Methadone | Sulindac |
| Chlorothiazide | Methoxyphenamine | Temazepam |
| Chlorpheniramine | (+/-)-Methylenedioxyamphetamine(MDA) | 11-Nor-Δ9-Tetrahydrocannabinol |
| Chlorpromazine | Methylphenidate | Tetracycline |
| Cholesterol | Nalbuphine | Tetrahydrozoline |
| Clomipramine | Nalidixic acid | Thiamine |
| Clonidine hydrochloride | Naloxone hydrochloride | L-Thyroxine |
| Cortisone | Naltrexone hydrochloride | Thioridazine Hydrochloride |
| Cotinine(-) | Naproxen | Triamterene |
| Creatinine | Niacinamide | Triflupromazine |
| Hydrochloride | ||
| Deoxyepinephrine | Nifedipine | Trimethoprim |
| Dextromethorphan | Norethindrone | Trimipramine |
| Diazepam | Norpropoxyphene | Tryptamine |
| Diflunisal | Noscapine | DL-Tryptophan |
| Digoxin | Oxazepam | Tyramine |
| Doxylamine | Oxymetazoline | D/L-Tyrosine |
| Ecgonine methylester | Papaverine | Uric Acid |
| R(-)-Epinephrine | Penicillin | Verapamil |
| Erythromycin | Pentobarbital | Zomepirac |
| Estrone-3-sulfate | Perphenazine |
f. Specificity
To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.
11
| Amphetamine (Cut-off=1000 ng/mL) | Result | % Cross-Reactivity |
|---|---|---|
| D,L - Amphetamine | ||
| (Amphetamine Sulfate) | Positive at 1000 ng/mL | 100% |
| Phentermine | Positive at 1250 ng/mL | 80% |
| (+/-)-4-Hydroxyamphetamine HCL | Positive at 600 ng/mL | 167% |
| L-Amphetamine | Positive at 20000 ng/mL | 5% |
| (+/-)-Methylenedioxyamphetamine(MDA) | Positive at 1500 ng/mL | 67% |
| d-Methamphetamine | Positive at >100000 ng/mL | 100000 ng/mL |
18
| Comparison between GC/MS and Lay Person Results (Amphetamine Strip) | |||||
|---|---|---|---|---|---|
| % of Cutoff | Number | ||||
| of | |||||
| samples | Amphetamine | ||||
| Concentration by GC/MS | |||||
| (ng/mL) | Lay person results | The | |||
| percentage of | |||||
| correct results | |||||
| (%) | |||||
| No. of | |||||
| Positive | No. of | ||||
| Negative | |||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 1250 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Amphetamine Strip)
Comparison between GC/MS and Lay Person Results (Amphetamine Cassette)
| % of Cutoff | Number of samples | Amphetamine Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | No. of Positive 0 | No. of Negative 20 | 100% |
| -75% Cutoff | 20 | 250 | No. of Positive 0 | No. of Negative 20 | 100% |
| -50% Cutoff | 20 | 500 | No. of Positive 0 | No. of Negative 20 | 100% |
| -25% Cutoff | 20 | 750 | No. of Positive 1 | No. of Negative 19 | 95% |
| +25% Cutoff | 20 | 1250 | No. of Positive 19 | No. of Negative 1 | 95% |
| +50% Cutoff | 20 | 1500 | No. of Positive 20 | No. of Negative 0 | 100% |
| +75% Cutoff | 20 | 1750 | No. of Positive 20 | No. of Negative 0 | 100% |
Comparison between GC/MS and Lay Person Results (Amphetamine DipCard)
| % of Cutoff | Number
of
samples | Amphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |
19
| % of Cutoff | Number of samples | Amphetamine
Concentration by GC/MS
(ng/mL) | Lay person results
No. of Positive | Lay person results
No. of Negative | The
percentage of
correct results
(%) |
|--------------|-------------------|--------------------------------------------------|---------------------------------------|---------------------------------------|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 1250 | 20 | 0 | 100% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Amphetamine Cup)
Comparison between GC/MS and Lay Person Results (Oxycodone Strip)
| % of Cutoff | Number of samples | Oxycodone Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 50 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 75 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 125 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 150 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 175 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Oxycodone Cassette)
| % of Cutoff | Number of samples | Oxycodone
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------|------------------------------------------------|--------------------|-----------------|------------------------------------------------|
| -100% Cutoff | 20 | 0 | No. of Positive | No. of Negative | 100% |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 50 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 75 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 125 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 150 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 175 | 20 | 0 | 100% |
20
| % of Cutoff | Number of samples | Oxycodone Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| No. of Positive | No. of Negative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 50 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 75 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 125 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 150 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 175 | 20 | 0 | 100% |
Comparison between GC/MS and Lav Person Results (Oxycodone DipCard)
Comparison between GC/MS and Lay Person Results (Oxycodone Cup)
| % of Cutoff | Number
of
samples | Oxycodone
Concentration by GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 25 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 50 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 75 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 125 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 150 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 175 | 20 | 0 | 100% |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
-
- Clinical Studies
Not applicable.
- Clinical Studies
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the Healgen Amphetamine Test, and Healgen Oxycodone Test are substantially equivalent to the predicate.