(62 days)
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No
The device is described as an immunochromatographic assay (lateral flow system) for qualitative determination. The description of the technology, performance studies, and metrics do not mention any AI or ML components. The analysis relies on visual interpretation of lines on a test strip/cassette/cup.
No
This device is an in vitro diagnostic test designed to detect the presence of specific drugs (Oxazepam and Morphine) in human urine. It is explicitly stated for "in vitro diagnostic use only" and provides "preliminary test results," indicating that its purpose is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." It also describes the device as an "immunochromatographic assay for the qualitative determination of Oxazepam...in human urine" and "morphine...in human urine," which are common descriptions for diagnostic tests to detect substances in the body.
No
The device is described as an immunochromatographic assay available in physical formats (Strip, Cassette, Dip Card, Cup) and involves the qualitative determination of substances in human urine, indicating a physical test kit rather than software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the Oxazepam and Morphine tests clearly states: "For in vitro diagnostic use only."
- Device Description: The "Device Description" section also states: "The products are in vitro diagnostic devices..."
- Nature of the Test: The test is designed to analyze a biological sample (human urine) in vitro (outside the body) to detect the presence of specific substances (Oxazepam and Morphine) for diagnostic purposes (identifying the presence of these drugs).
N/A
Intended Use / Indications for Use
Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. 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 Oxazepam 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 oxazepam 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.
Healgen Morphine Test is an immunochromatographic assay for the qualitative determination of morphine (a drug in the opiate class) in human urine at a Cut-Off concentration of 2000 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 presult 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)
JXM, DJG
Device Description
Healgen Oxazepam Test and Healgen Morphine Test are immunochromatographic assays for Oxazepam and Morphine. Each assay test is a lateral flow system for the qualitative detection of Oxazepam and Morphine (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
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
For in vitro diagnostic use only. It is intended for 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
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)
1. Analytical Performance
a. Precision: Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +50% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blind labeled and randomized. For each concentration, tests were performed two runs per day for 25 days.
b. 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 Oxazepam and Morphine.
Cut-off for Oxazepam Test: 300 ng/mL.
Cut-off for Morphine Test: 2000 ng/mL.
c. 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 were summarized in tables.
d. 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.
e. Effect of Urine Specific Gravity and Urine pH: To investigate the effect of urine specific gravity and urine pH, urine samples with of 1.000 to 1.035 specific gravity or urine samples with pH 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. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off.
2. Comparison Studies
The method comparison studies for the Oxazepam Test, and the Morphine Test were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results.
Oxazepam Results (per viewer, total 3 viewers):
- Strip format: Between 0 and 2 discordant results near cutoff for negative samples, and between 2 and 4 discordant results near cutoff for positive samples.
- Cassette format: 3 discordant results near cutoff for positive samples for each viewer.
- Cup format: 2 discordant results near cutoff for positive samples for each viewer.
- Dip Card format: Between 2 and 4 discordant results near cutoff for positive samples for each viewer.
Morphine Results (per viewer, total 3 viewers):
- Strip format: 4 discordant results near cutoff for positive samples for Viewer A and B, and 2 for Viewer C.
- Cassette format: Between 3 and 4 discordant results near cutoff for positive samples for each viewer.
- Dip Card format: Between 4 and 5 discordant results near cutoff for positive samples for each viewer.
- Cup format: Between 2 and 4 discordant results near cutoff for positive samples for each viewer.
Lay-user study: A lay user study was performed at three intended user sites with 140 lay persons testing the Oxazepam devices and another set of 140 persons testing the morphine devices. A total of 44 females and 96 males tested the Oxazepam samples, and 41 females and 99 males tested the Morphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device.
Lay person results for Oxazepam (e.g., Strip format):
-100%, -75%, -50% Cutoff: 100% correct negative results.
-25% Cutoff: 95% correct negative results (1 positive, 19 negative).
+25% Cutoff: 95% correct positive results (19 positive, 1 negative).
+50%, +75% Cutoff: 100% correct positive results.
Similar results presented for Cassette, DipCard, and Cup formats for Oxazepam, and for all formats for Morphine. Lay-users indicated that device instructions can be easily followed. A Flesch-Kincaid reading analysis showed a reading Grade Level of 7 for each package insert.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K052115 First Check Multi Drug Cup 12
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 features a stylized representation of three human profiles facing to the right, arranged in a cascading manner. The profiles are depicted in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile images.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2014
HEALGEN SCIENTIFIC LLC C/O JOE SHIA LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE., SUITE F GAITHERSBURG MD 20877
Re: K142280
Trade/Device Name: Healgen Oxazepam Test (Strip, Cassette, Cup, Dio Card): Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: II Product Code: JXM, DJG Dated: August 12, 2014 Received: August 15, 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 (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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142280
Device Name
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card) Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
Indications for Use (Describe)
Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. 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 Oxazepam 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 oxazepam 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.
Healgen Morphine Test is an immunochromatographic assay for the qualitative determination of morphine (a drug in the opiate class) in human urine at a Cut-Off concentration of 2000 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 presult 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) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) SUMMARY
| 1. Date: | October 6, 2014 |
|---|---|
| 2. Submitter: | HEALGEN SCIENTIFIC LLC |
| 5213 Maple St | |
| Bellaire, TX77401 | |
| 3. Contact person: | Jianqiu Fang |
| HEALGEN SCIENTIFIC LLC | |
| 5213 Maple St | |
| Bellaire, TX77401 | |
| Telephone: 713-733-8088 |
Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com
-
- Device Name: Healgen Oxazepam Test (Strip, Cassette. Cup, Dip Card) Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
Classification:
| Product
| Code | CFR # | Panel |
|---|---|---|
| JXM | 21 CFR, 862.3170 Benzodiazepine Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
-
- Predicate Devices:
K052115 First Check Multi Drug Cup 12
- Predicate Devices:
-
- Intended Use
Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.
- Intended Use
The test may yield preliminary positive results even when prescription drug Oxazepam 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 oxazepam 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
4
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 Morphine Test is an immunochromatographic assay for the qualitative determination of morphine (a drug in the opiate class) in human urine at a Cut-Off concentration of 2000 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.
7. Device Description
Healgen Oxazepam Test and Healgen Morphine Test are immunochromatographic assays for Oxazepam and Morphine. Each assay test is a lateral flow system for the qualitative detection of Oxazepam and Morphine (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.
8. Substantial Equivalence Information
A summary comparison of features of the Healgen Oxazepam Test and Healgen Morphine Test and the predicate device is provided in Table 1 & Table 2.
| Item | Device | Predicate -
K052115 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended Use | For the qualitative determination of drugs
of abuse in human urine. | Same |
| Drug Analyte | Oxazepam | Benzodiazepine
Drug Class |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
Table 1: Features Comparison of Healgen Oxazepam Test and the Predicate Device
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| Item | Device | Predicate -
K052115 |
|------------------------|------------------------------------------------|---------------------------------|
| Intended
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 Morphine 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 | Morphine | Opiate Drug Class |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based | ||
| on the principle of antigen antibody | ||
| immunochemistry. | Same | |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 2000 ng/mL | Same |
| Intended | ||
| For over-the-counter and prescription | For over-the-counter | |
| Population | uses. | use. |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |
9. Test Principle
Healgen Oxazepam Test and Healgen Morphine Test are rapid tests for the qualitative detection of Oxazepam and Morphine 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.
10. Performance Characteristics
6
1. Analytical Performance
a.Precision
Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +50% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blind labeled and randomized. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:
Oxazepam
| | 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: 1201001 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1201002 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1201003 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Strip Format
Cassette Format
| Result -100% | -75% - | -50% | -25% | +25% +50% +75% +100% | |||
|---|---|---|---|---|---|---|---|
| Drug | Cut-off Cut-off Cut-off Cut-off | Cut-off | Cut-off Cut-off Cut-off Cut-off | ||||
| Lot: 1201004 | 50-10+ | 50-/0+ 50-/0+ 50-/0+ 24-/26+ 50+/0- 50+/0- 50+/0- 50+/0- | |||||
| Lot: 1201005 | 50-10+ | 50-/0+ 50-/0+ 50-/0+ 24-/26+ 50+/0- 50+/0- 50+/0- 50+/0- | |||||
| Lot: 1201006 | 50-/0+ 50-/0+ 50-/0+ 50-/0+ 24-/26+ 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: 1201007 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1201008 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1201009 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 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: 1201010 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1201011 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1201012 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Morphine
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: 1112001 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1112002 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1112003 | 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: 1112004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:1112005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot: 1112006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 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: 1112007 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1112008 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1112009 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 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: 1112010 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1112011 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: 1112012 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity
Not applicable.
c.Stability
The devices are stable at 4-30℃ for 24 months based on the accelerated stability study at 45℃ and real time stability determination at both 4 ℃ and 30℃.
8
Control materials are not provided with the device. The labeling provides information on how to obtain control materials.
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 Oxazepam and Morphine. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off
(ng/mL) |
|---------------|------------|--------------------|
| Oxazepam Test | Oxazepam | 300 |
| Morphine Test | Morphine | 2000 |
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.
| 4-Acetamidophenol | Doxylamine | Oxolinic acid |
|---|---|---|
| Acetophenetidin | Ecaonine dydrochloride | Pentobarbital |
| N-Acetylprocainamide | Ecgonine methylester | Perphenazine |
| Acetylsalicylic acid | (-)-Ψ-Ephedrine | Phencyclidine |
| Aminoprine | Fenoprofen | Phenelzine |
| Amitriptyline | Furosemide | Phenobarbital |
| Amorbarbital | Gentisic acid | Phentermine |
| Amoxicillin | Hemoglobin | L-Phenylephrine |
| Ampicillin | Hydrocortisone | Phenylethylamine |
| 1-Ascorbic Acid | O-Hydroxyhippuric acid | Phenylpropanotamine |
| D.L-Amphetamine | p-Hydroxy- | |
| methamphetamine | Prednisone | |
| Aporphine | 3-Hydroxytyramine | D.L-Propanolol |
Oxazepam
9
| Aspartame | Ibuprofen | D-Propoxyphene |
|---|---|---|
| Atropine | Imipramine | D-Pseudoephedrine |
| Benzillic acid | Iproniazid | Quinine |
| Benzoic acid | (±)Isoproterenol | Ranitidine |
| Benzoylecaonine | Isoxsuprine | Salicylic acid |
| Benzphetamine | Ketamine | Secobarbital |
| Bilirubin | Ketoprofen | Serotonin |
| (5-Hydroxytyramine) | ||
| (±) Chlorpheniramine | Labetalol | Sertraline |
| Caffeine | Loperamide | Sulfamethazine |
| Cannabidiol | Maprotiline | Sulindac |
| Chloralhydrate | Meperidine | Tetrahydrocortisone,3 Acetate |
| Chloramphenicol | Meprobamate | Tetrahydrocortisone,(β-D |
| glucuronide) | ||
| Chlorothiazide | Methadone | Tetrahydrozoline |
| (±)Chlorpheniramine | Methoxyphenamine | Thiamine |
| Chlorpromazine | (+) 3,4-Methylenedioxy- | |
| amphetamine | Thioridazine | |
| Chlorquine | (+)3,4-Methylenedioxy- | |
| methamphetamine | D.L-Tyrosine | |
| Cholesterol | Nalidixic acid | Tolbutamide |
| Clomipramine | Nalorphine | Triamterene |
| Clonidine | Naloxone | Trifluoperazine |
| Cocaine hydrochloride | Naltrexone | Trimethoprim |
| Cortisone | Naproxen | Tryptamine |
| (-)cotinine | Niacinamide | D.L-Tryptophan |
| Creatinine | Nifedipine | Tyramine |
| Dextromethlorphan | Norethindrone | Uric acid |
| Diclolrfenac | D-Norpropoxyphene | Verapamil |
| Diflunisal | Noscapine | Zomepirac |
| Diaoxin | D.L-Octopamine | |
| Diphenhydramine | Oxalic acid |
Morphine
| 4-Acetamidophenol | Ecgonine methylester | Oxolinic acid |
|---|---|---|
| Acetophenetidin | (-) -Y -Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | β-Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Pentazocine |
| Amitryptyline | Ethyl-p-aminobenzoate | Pentobarbital |
| Amobarbital | Fenoprofen | Perphenazine |
| Amoxicillin | Furosemide | Phencyclidine |
| Ampicillin | Gentisic acid | Phenelzine |
| Ascorbic acid | Hemoglobin | Phenobarbital |
| D,L-Amphetamine | Hydralazine | Phentermine |
| Apomorphine | Hydrochlorothiazide | L-Phenylephrine |
| Aspartame | Hydrocortisone | β-Phenylethylamine |
| Atropine | O-Hydroxyhippuric acid | Phenylpropanolamine |
| Benzilic acid | p-Hydroxy methamphetamine | Prednisone |
| Benzoic acid | 3-Hydroxytyramine | D,L-Propanolol |
| Benzoylecgonine | Ibuprofen | D-Propoxyphene |
| Benzphetamine | Imipramine | D-Pseudoephedrine |
| Bilirubin (±) | Iproniazid | Quinidine |
| Brompheniramine | Isoproterenol | Quinine |
| Caffeine | Isoxsuprine | Ranitidine |
| Cannabidiol | Ketamine | Salicylic acid |
| Chloralhydrate | Ketoprofen | Secobarbital |
| Chloramphenicol | Labetalol | Serotonin (5- |
| Hydroxytyramine) | ||
| Chlordiazepoxide | Loperamide | Sulfamethazine |
| Chlorothiazide | Maprotiline | Sulindac |
| (±) Chlorpheniramine | Meperidine | Temazepam |
| Chlorpromazine | Meprobamate | Tetracycline |
| Chlorquine | Methadone | Tetrahydrocortisone, 3 |
| Acetate | ||
| Cholesterol | Methoxyphenamine | Tetrahydrocortisone3 (ß-D |
| glucuronide) | ||
| Clomipramine | (+) 3,4-Methylenedioxy- | |
| amphetamine | Tetrahydrozoline | |
| Clonidine | (+)3,4-Methylenedioxy- | |
| methamphetamine | Thiamine | |
| Cocaine hydrochloride | Nalidixic acid | Thioridazine |
| Cortisone | Nalorphine | D, L-Tyrosine |
| (-) Cotinine | Naloxone | Tolbutamide |
| Creatinine | Naltrexone | Triamterene |
| Deoxycorticosterone | Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Trimethoprim |
| Diazepam | Nifedipine | Trimipramine |
| Diclofenac | Norethindrone | Tryptamine |
| Diflunisal | D-Norpropoxyphene | D, L-Tryptophan |
| Digoxin | Noscapine | Tyramine |
| Diphenhydramine | D,L-Octopamine | Uric acid |
| Doxylamine | Oxalic acid | Verapamil |
| Ecgonine hydrochloride | Oxazepam | Zomepirac |
10
11
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.
| | Result | %
Cross-Reactivity |
|---------------------------------|-------------------------|-----------------------|
| Oxazepam
(Cut-off=300 ng/mL) | Positive at 300 ng/mL | 100% |
| Alprazolam | Positive at 200 ng/mL | 150% |
| Bromazepam | Positive at 1560 ng/mL | 19% |
| Chlordiazepoxide HCL | Positive at 1560 ng/mL | 19% |
| Clobazam | Positive at 100 ng/mL | 300% |
| Clonazepam | Positive at 780 ng/mL | 38% |
| Clorazepate Dipotassium | Positive at 200 ng/mL | 150% |
| Delorazepam | Positive at 1560 ng/mL | 19% |
| Desalkylflurazepam | Positive at 400 ng/mL | 75% |
| Diazepam | Positive at 200 ng/mL | 150% |
| Estazolam | Positive at 2500 ng/mL | 12% |
| Flunitrazepam | Positive at 400 ng/mL | 75% |
| a-Hydroxyalprazolam | Positive at 1260 ng/mL | 24% |
| (±) Lorazepam | Positive at 1560 ng/mL | 19% |
| RS-Lorazepam glucuronide | Positive at 160 ng/mL | 188% |
| Midazolam | Positive at 12500 ng/mL | 2.4% |
| Nitrazepam | Positive at 100 ng/mL | 300% |
| Norchlordiazepoxide | Positive at 200 ng/mL | 150% |
| Nordiazepam | Positive at 400 ng/mL | 75% |
| Temazepam | Positive at 100 ng/mL | 300% |
| Triazolam | Positive at 2500 ng/mL | 12% |
12
| Result | % Cross-Reactivity | |
|---|---|---|
| Morphine | ||
| (Cut-off=2000 ng/mL) | Positive at 2000 ng/mL | 100% |
| O6-Acetylmorphine | Positive at 2500 ng/mL | 80% |
| Codeine | Positive at 1000 ng/mL | 200% |
| EthylMorphine | Positive at 250 ng/mL | 800% |
| Heroin | Positive at 5000 ng/mL | 40% |
| Hydromorphone | Positive at 2500 ng/mL | 80% |
| Hydrocodone | Positive at 5000 ng/mL | 40% |
| Oxycodone | Positive at 75000 ng/mL | 3% |
| Thebaine | Positive at 13,000 ng/mL | 15% |
g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples with of 1.000 to 1.035 specific gravity or urine samples with pH 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. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different formats.
2. Comparison Studies
The method comparison studies for the Oxazepam Test, and the Morphine Test were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
| Oxazepam | ||||||
|---|---|---|---|---|---|---|
| Strip format | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| Negative | 10 | 15 | 15 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| Negative | 10 | 15 | 15 | 3 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| Negative | 10 | 15 | 15 | 2 | 0 |
Oxazepam
13
| Viewer | Sample Number | GC/MS Result | Strip Format
Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 549 | 306 | Negative |
| Viewer A | 523 | 303 | Negative |
| Viewer B | 549 | 306 | Negative |
| Viewer B | 523 | 303 | Negative |
| Viewer B | 579 | 312 | Negative |
| Viewer C | 549 | 306 | Negative |
| Viewer C | 523 | 303 | Negative |
Discordant Results of Oxazepam Strip
| Cassette
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near
Cutoff
Negative
by GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|--------------------|----------|----------|----------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| | Positive | 0 | 0 | 0 | 13 | 24 |
| Viewer A | Negative | 10 | ાં ર | ાં ર | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | ા ર | ા ર | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 24 |
| | Negative | 10 | ા ર | ા ર | 3 | 0 |
Discordant Results of Oxazepam Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | 549 | 306 | Negative |
| Viewer A | 523 | 303 | Negative |
| Viewer A | 579 | 312 | Negative |
| Viewer B | 549 | 306 | Negative |
| Viewer B | 523 | 303 | Negative |
| Viewer B | 579 | 312 | Negative |
| Viewer C | 549 | 306 | Negative |
| Viewer C | 523 | 303 | Negative |
| Viewer C | 579 | 312 | Negative |
14
| Cup format | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 24 |
| Negative | 10 | 15 | 15 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 24 |
| Negative | 10 | 15 | 15 | 2 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| Negative | 10 | 15 | 15 | 2 | 0 |
Discordant Results of Oxazepam Cup
| Viewer | Sample Number | GC/MS Result | Cup Format
Viewer Results |
|----------|---------------|--------------|------------------------------|
| Viewer A | 549 | 306 | Negative |
| Viewer A | 523 | 303 | Negative |
| Viewer B | 523 | 303 | Negative |
| Viewer B | 579 | 312 | Negative |
| Viewer C | 549 | 306 | Negative |
| Viewer C | 523 | 303 | Negative |
| Dip Card
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 12 | 24 |
| | Negative | 10 | 15 | 15 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 24 |
| | Negative | 10 | 15 | 15 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 14 | 24 |
| | Negative | 10 | 15 | 15 | 2 | 0 |
Discordant Results of OxazepamDip Card
| Discordant Results of OxazepamDip Card | |||||
|---|---|---|---|---|---|
| Viewer | Sample Number | Dip Card Format | |||
| GC/MS Result | |||||
| Viewer Results | |||||
| Viewer A | રે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ | 315 | Negative | ||
| Viewer A | 549 | 306 | Negative |
15
| Viewer | Sample Number | GC/MS Result | Dip Card Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | 523 | 303 | Negative |
| Viewer A | 579 | 312 | Negative |
| Viewer B | 505 | 315 | Negative |
| Viewer B | 549 | 306 | Negative |
| Viewer B | 523 | 303 | Negative |
| Viewer B | 579 | 312 | Negative |
| Viewer C | 549 | 306 | Negative |
| Viewer C | 523 | 303 | Negative |
Morphine
| Strip
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|-----------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 16 | 14 | 2 | 0 |
Discordant Results of Morphine Strip
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|---|---|---|---|
| Viewer A | 468 | 2036 | Negative |
| Viewer A | 466 | 2019 | Negative |
| Viewer A | 453 | 2066 | Negative |
| Viewer A | 449 | 2005 | Negative |
| Viewer B | 468 | 2036 | Negative |
| Viewer B | 466 | 2019 | Negative |
| Viewer B | 453 | 2066 | Negative |
| Viewer B | 449 | 2005 | Negative |
| Viewer C | 466 | 2019 | Negative |
16
| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|---|---|---|---|
| Viewer C | 449 | 2005 | Negative |
| Cassette
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 23 |
| | Negative | 10 | 16 | 14 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
Discordant Results of Morphine Cassette
| Viewer | Sample Number | GC/MS Result | Cassette Format Viewer Results |
|---|---|---|---|
| Viewer A | 468 | 2036 | Negative |
| Viewer A | 466 | 2019 | Negative |
| Viewer A | 449 | 2005 | Negative |
| Viewer B | 405 | 2053 | Negative |
| Viewer B | 468 | 2036 | Negative |
| Viewer B | 466 | 2019 | Negative |
| Viewer B | 449 | 2005 | Negative |
| Viewer C | 405 | 2053 | Negative |
| Viewer C | 468 | 2036 | Negative |
| Viewer C | 466 | 2019 | Negative |
| Viewer C | 449 | 2005 | Negative |
17
| Dip Card
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|--------------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 23 |
| Viewer A | Negative | 10 | 16 | 14 | 4 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 23 |
| Viewer B | Negative | 10 | 16 | 14 | 5 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 12 | 23 |
| Viewer C | Negative | 10 | 16 | 14 | 5 | 0 |
Discordant Results of Morphine Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Format
Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | 405 | 2053 | Negative |
| Viewer A | 468 | 2036 | Negative |
| Viewer A | 466 | 2019 | Negative |
| Viewer A | 449 | 2005 | Negative |
| Viewer B | 405 | 2053 | Negative |
| Viewer B | 468 | 2036 | Negative |
| Viewer B | 466 | 2019 | Negative |
| Viewer B | 449 | 2005 | Negative |
| Viewer B | 429 | 2067 | Negative |
| Viewer C | 405 | 2053 | Negative |
| Viewer C | 468 | 2036 | Negative |
| Viewer C | 466 | 2019 | Negative |
| Viewer C | 449 | 2005 | Negative |
| Viewer C | 429 | 2067 | Negative |
18
| Cup
format | | Negative | Low
Negative
by GC/MS
(less than
-50%) | Near Cutoff
Negative by
GC/MS
(Between
-50% and
cut-off) | Near Cutoff
Positive by
GC/MS
(Between
the cut-off
and +50%) | High
Positive by
GC/MS
(greater
than
+50%) |
|---------------|----------|----------|----------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 15 | 23 |
| | Negative | 10 | 16 | 14 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 23 |
| | Negative | 10 | 16 | 14 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 23 |
| | Negative | 10 | 16 | 14 | 4 | 0 |
Discordant Results of Morphine Cup
| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Results |
|---|---|---|---|
| Viewer A | 466 | 2019 | Negative |
| Viewer A | 449 | 2005 | Negative |
| Viewer B | 468 | 2036 | Negative |
| Viewer B | 466 | 2019 | Negative |
| Viewer B | 449 | 2005 | Negative |
| Viewer C | 405 | 2053 | Negative |
| Viewer C | 468 | 2036 | Negative |
| Viewer C | 466 | 2019 | Negative |
| Viewer C | 449 | 2005 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 140 lay persons testing the Oxazepam devices and another set of 140 persons testing the morphine devices. A total of 44 females and 96 males tested the Oxazepam samples, and 41 females and 99 males tested the Morphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
19
| % of Cutoff | Number of samples | Oxazepam 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 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Oxazepam Strip)
Comparison between GC/MS and Lay Person Results (Oxazepam Cassette)
| Number | Oxazepam Concentration | Lay person results | The | ||
|---|---|---|---|---|---|
| % of Cutoff | of | ||||
| samples | by GC/MS | ||||
| (ng/mL) | No. of | ||||
| Positive | No. of | ||||
| Negative | percentage of | ||||
| correct results | |||||
| (%) | |||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Oxazepam DipCard)
| | Number
of
samples | Oxazepam Concentration
by GC/MS
(ng/mL) | Lay person results | | The |
|--------------|-------------------------|-----------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
20
| | Number
of
samples | Oxazepam Concentration
by GC/MS
(ng/mL) | Lay person results | | The |
|--------------|-------------------------|-----------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Oxazepam Cup)
Comparison between GC/MS and Lay Person Results (Morphine Strip)
| % of Cutoff | Number of samples | MOP Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 1000 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 1500 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 2500 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 3000 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 3500 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Morphine Cassette)
| | Number
of
samples | MOP Concentration by
GC/MS
(ng/mL) | Lay person results | | The |
|-------------|-------------------------|------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 500 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 1000 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 1500 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 2500 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 3000 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 3500 | 20 | 0 | 100% |
21
| % of Cutoff | Number
of
samples | MOP 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 | 500 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 1000 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 1500 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 2500 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 3000 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 3500 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Morphine DipCard)
Comparison between GC/MS and Lay Person Results (Morphine Cup)
| % of Cutoff | Number
of
samples | MOP Concentration by
GC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 1000 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 1500 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 2500 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 3000 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 3500 | 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 Oxazepam Test, and Healgen Morphine Test are substantially equivalent to the predicate.