(31 days)
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Oxazepam , Methamphetamine, and Morphine in human urine at cut-off concentrations of 300 ng/mL, and 2000 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.
The tests 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 tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.
First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Oxazepam , Methamphetamine , and Morphine in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in terms of specific quantitative benchmarks (e.g., "sensitivity must be >90%"). Instead, it describes performance characteristics and then presents the results of studies to demonstrate that the device performs acceptably. The implied acceptance criterion for these qualitative drug tests is that they generally agree with GC/MS results, especially at and significantly above/below cut-off values.
Based on the provided performance characteristics, here's a summary:
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Consistent results at various concentrations relative to the cut-off. | Oxazepam, Methamphetamine, Morphine (Dip/Cup): Samples at -100%, -75%, -50%, -25% cut-off showed 100% negative results. Samples at +25%, +50%, +75%, +100% cut-off showed 100% positive results (with very few exceptions noted at the exact cut-off concentration, e.g., 3-4/46-47 +/-). |
| Cut-off | Correct qualitative determination (positive/negative) around the defined cut-off. | Oxazepam (300 ng/mL), Methamphetamine (1000 ng/mL), Morphine (2000 ng/mL): All devices (all lots, all formats) were positive at and above +25% cut-off and negative at and below -25% cut-off. |
| Interference | No interference from common physiological substances at specified concentrations. | Numerous compounds (e.g., Acetamidophenol, Ibuprofen, Caffeine for all drugs; specific examples listed for each drug) showed no interference at 100 µg/mL. |
| Specificity | Cross-reactivity minimized for non-target drugs; appropriate reactivity for metabolites. | Oxazepam: Showed expected cross-reactivity with some benzodiazepine metabolites/analogs (e.g., Alprazolam 240%, Clonazepam 3%, Triazolam 12%). No detection of Methamphetamine or Morphine. Methamphetamine: Showed cross-reactivity with some related compounds (e.g., (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) 2%, (+/-)3,4-Methylenedioxymethamphetamine (MDMA) 13%, L-Methamphetamine 10%). No detection of Morphine or Oxazepam. Morphine: Showed cross-reactivity with Codeine (200%), Ethylmorphine (357%), Hydrocodone (40%), Hydromorphone (27%), σ-Monoacetylmorphine (200%), Morphine 3-b-D-glucuronide (154%). No detection of Oxazepam or Methamphetamine. (Note: % cross-reactivity values are relative to the drug's own cut-off concentration). |
| Urine Specific Gravity & pH | Performance unaffected by normal variations in urine specific gravity and pH. | Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off across a specific gravity range of 1.000-1.035 and a pH range of 4-9. |
| Method Comparison (Professional User) | High concordance with GC/MS results, especially for clearly positive/negative samples. | Oxazepam Dip/Cup: For 40 negative (incl. low and near cut-off) and 40 positive (incl. near cut-off and high) samples, there were very few discordant results (e.g., 2-4 negative calls for samples slightly above cut-off, or 1 negative call for a sample slightly above cut-off per viewer/format). Overall high agreement. Methamphetamine Dip/Cup: Similar high concordance, with few discordant results (e.g., 1-2 negative calls for samples slightly above cut-off per viewer/format). Morphine Dip/Cup: Similar high concordance, with few discordant results (e.g., 1 negative call for a sample slightly above cut-off per viewer/format). |
| Lay-user Study | High percentage of correct results by lay users, clear instructions. | Oxazepam (Dip/Cup): 100% correct for negative samples, 90-100% correct for positive samples, with minor discrepancies (-25% cutoff for cup, +25% cutoff for dip card). Methamphetamine (Dip/Cup): 100% correct for negative samples, 95-100% correct for positive samples, with minor discrepancies (+25% cutoff). Morphine (Dip/Cup): 95-100% correct for negative samples (one false positive at -25% Cutoff for dip card), 95-100% correct for positive samples (one false negative at +25% Cutoff for cup/dip card). All lay users could easily follow instructions. |
2. Sample Size and Data Provenance (Test Set)
- Sample Size (Trained Professionals, Method Comparison):
- For each of the three drugs (Oxazepam, Methamphetamine, Morphine) and each format (Dip Card, Cup), 80 clinical samples were used.
- Total samples for method comparison: 3 drugs * 2 formats * 80 samples/drug/format = 480 samples.
- Breakdown of 80 samples: 10 Negative, 10 Low Negative, 20 Near Cutoff Negative, 15 Near Cutoff Positive, 25 High Positive.
- Sample Size (Lay User Study):
- 280 lay persons for Oxazepam devices.
- 280 lay persons for Methamphetamine devices.
- 280 lay persons for Morphine devices.
- Each lay person tested 1 blind labeled sample and a device.
- Total samples tested by lay users: Roughly 280 samples/drug * 3 drugs = 840 samples.
- Data Provenance (Method Comparison): "unaltered clinical samples" - implies retrospective collection, origin unknown based on the text.
- Data Provenance (Lay User Study): "Urine samples were prepared... by spiking drugs into drug free-pooled urine specimens." This indicates the samples were synthesized or spiked rather than naturally occurring clinical samples, and then blind-labeled.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts:
- Method Comparison (Professional User): "three different laboratory assistants for each format of the device." Total of 6 unique readers (3 for dip card, 3 for cup) if they were distinct, or 3 if the same 3 read both formats (the wording "Different set of operators tested each format" in the precision study suggests distinct operators, but here it states "for each format", which could mean the same set of 3 rotated). The data is presented as Viewer A, B, C for each.
- Lay User Study: 280 lay persons per drug. Not "experts" in the traditional sense, but the intended users.
- Qualifications of Experts: The "three different laboratory assistants" are not further qualified (e.g., radiologist with 10 years of experience).
4. Adjudication Method (Test Set)
- None specified for the professional user readings. The raw results from each "Viewer" (laboratory assistant) are presented individually, and then compared against the GC/MS result. They are not pooled or adjudicated to form a single "device" result.
- For the Lay User Study: There is no "adjudication" between lay users. Each lay user's individual result is recorded and compared to the GC/MS confirmed concentration.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done to measure human reader improvement with AI vs. without AI assistance. This device is a standalone qualitative diagnostic test (immunochromatographic assay), not an AI-assisted interpretation tool for human readers.
6. Standalone Performance (Algorithm Only)
- Yes, a standalone performance was done, but it's not an "algorithm" in the typical AI sense. The device itself (the immunochromatographic assay) is designed to provide a result (positive/negative) based on a chemical reaction, which can then be visually interpreted. The precision studies, cut-off studies, interference, specificity, and specific gravity/pH studies all demonstrate the standalone performance of the device without explicit human interpretation variability considered (though a human reads the test line).
- The "Method Comparison" and "Lay-user study" then introduce the human element (laboratory assistants and lay users, respectively) reading these standalone device results.
7. Type of Ground Truth Used (Test Set)
- Gas Chromatography/Mass Spectrometry (GC/MS) was explicitly used as the preferred confirmatory method for establishing ground truth for both the professional method comparison study and for confirming the concentrations of the spiked samples in the lay user study and precision/cut-off studies.
8. Sample Size for the Training Set
- The document describes performance characteristics and equivalence to a predicate device, but does not specify a separate "training set" for the development of the device itself or for any AI/algorithmic component (as there isn't one). The studies described are performance validation studies.
9. How the Ground Truth for the Training Set was Established
- Not applicable as no "training set" is mentioned in the context of device development. The ground truth for all performance evaluation studies (precision, cut-off, method comparison, lay user) was established using GC/MS.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads.
February 26, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
W.H.P.M., INC. JOHN WAN 5358 IRWINDALE AVENUE IRWINDALE CA 91706
Re: K150162 Trade/Device Name: First Sign® Drug Of Abuse Cup Test First Sign® Drug Of Abuse Dip Card Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, JXM, DJG Dated: January 19, 2015 Received: January 26, 2015
Dear Mr. John Wan:
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/Resourcesfor You/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 -A
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
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Indications for Use
510(k) Number (if known) K150162
Device Name First Sign® Drug of Abuse Cup Test First Sign® Drug of Abuse Dip Card Test
Indications for Use (Describe)
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Oxazepam , Methamphetamine, and Morphine in human urine at cut-off concentrations of 300 ng/mL, and 2000 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.
The tests 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 tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are 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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510(k) SUMMARY K150162
-
February 24, 2015 1. Date: 2. Submitter W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706 3. Contact person:
John Wan W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706 Telephone: 626-443-8480 Fax: 626-443-8065 Email: johnwan@whpm.com -
First Sign® Drug of Abuse Cup Test 4. Device Name: First Sign® Drug of Abuse Dip Card Test
Classification: Class II
| ProductCode | CFR # | Panel |
|---|---|---|
| LAF | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology |
| 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:
{4}------------------------------------------------
6. Intended Use
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Oxazepam , Methamphetamine , and Morphine in human urine at cut-off concentrations of 300 ng/mL, 1000 ng/mL, and 2000 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.
The tests 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 tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.
-
- Device Description
First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Oxazepam , Methamphetamine , and Morphine in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the First Sign™ Drug of Abuse Test and the predicate device is provided in Table 1, Table 2 & Table 3.
- Substantial Equivalence Information
| Item | Device | Predicate -K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofOxazepam in human urine. | Same |
| Calibrator | Oxazepam | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL | Same |
Table 1: Features Comparison of First Sign™ Oxazepam Test and the Predicate Device
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| Item | Device | Predicate -K052115 |
|---|---|---|
| IntendedPopulation | For over-the-counter and prescriptionuses. | Forover-the-counteruse. |
| Configurations | Cup, Dip Card | Cup |
Table 2: Features Comparison of First Sign™ Methamphetamine Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s) for Use | For the qualitative determination of methamphetamine in human urine. | Same |
| Calibrator | D-methamphetamine | 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 |
| Intended Population | For over-the-counter and prescription uses. | For over-the-counter use. |
| Configurations | Cup, Dip Card | Cup |
Table 3: Features Comparison of First Sign™ Morphine Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofmorphine in human urine. | For the qualitativedetermination ofopiates in humanurine, includingmorphine. |
| Calibrator | Morphine | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibody | Same |
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| Item | Device | Predicate - K052115 |
|---|---|---|
| immunochemistry. | ||
| 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 | Cup, Dip Card | Cup |
9. Test Principle
First Sign™ Drug of Abuse Tests are rapid tests for the qualitative detection of Oxazepam . Methamphetamine , 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
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, +75% 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 by the person who prepared samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days by three different operators for each format of devices. Different set of operators tested each format. The results obtained are summarized in the following tables:
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Oxazepam 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: D4010558 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot: D4010560 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot: D4010562 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Oxazepam 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: D4010559 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010561 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010563 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Methamphetamine (mAMP) 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: D4010558 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot: D4010560 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010562 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
(mAMP) 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: D4010559 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010561 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010563 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Morphine 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: D4010558 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010560 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010562 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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| 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: D4010559 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010561 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot: D4010563 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Morphine Cup Format
b. Linearity
Not applicable.
c. Stability
The devices are stable at 4-30°C (39-86°F) for 24 months based on the accelerated stability study at 50°C. 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 Oxazepam, Methamphetamine and Morphine. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| One Step Oxazepam Test | Oxazepam | 300 |
| One Step Methamphetamine Test | D-methamphetamine | 1000 |
| One Step Morphine Test | Morphine | 2000 |
e. Interference
Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and to urine containing target drugs at 25% below and 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.
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Oxazepam 4-Acetamidophenol Diphenhydramine D.L-Octopamine Acetophenetidin Doxylamine Oxalic acid N-Acetvprocainamide Ecaonine dydrochloride Oxolinic acid Acetvsalicvlic acid Ecqonine methylester Pentobarbital Aminopvrine (-)-Y-Ephedrine Perphenazine Amityptvline Fenoprofen Phencyclidine Amorbarbital Phenelzine Furosemide Amoxicillin Gentisic acid Phenobarbital Ampicillin Hemoglobin Phentermine l-Ascorbic Acid Hydrocortisone L-Phenylephrine O-Hydroxyhippuric acid B-Phenylethylamine D.L-Amphetamine p-Hydroxy-Apormorphine methamphetamine Phenylpropanotamine Aspartame 3-Hydroxytyramine Prednisone Atropine Ibuprofen D.L-Propanolol Benzillic acid Imipramine D-Pseudoephedrine Benzoic acid Iproniazid Quinine Benzoylecaonine (±)Isoproterenol Ranitidine Benzphetamine Isoxsuprine Salicylic acid Bilirubin Ketamine Secobarbital Serotonin (±) Chlorpheniramine Ketoprofen (5-Hydroxytyramine) Caffeine Labetalol Sertraline Cannabidiol Loperamide Sulfamethazine Chloralhvdrate Maprotiline Sulindac Tetrahydrocortisone,(b-D Chloramphenicol Meperidine glucuronide) Chlorothiazide Meprobamate Tetrahydrozoline (±)Chlorpheniramine Thiamine Methadone Methoxyphenamine Thioridazine Chlorpromazine (+) 3,4-Methylenedioxy-Chlorquine amphetamine D.L-Tyrosine (+)3,4-Methylenedioxy-Cholesterol Tolbutamide methamphetamine Clomipramine Nalidixic acid Triamterene Clonidine Nalorphine Trifluoperazine Cocaine hydrochloride Naloxone Trimethoprim Cortisone Naltrexone Triyptamine D.L-Tryptophan (-)cotinine Naproxen
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| Creatinine | Niacinamide | Tyramine |
|---|---|---|
| Dextromethlorphan | Nifedipine | Uric acid |
| Diclolrfenac | Norethindrone | Verapamil |
| Diflunisal | D-Norpropoxyphene | Zomepirac |
| Diaoxin | Noscapine |
Methamphetamine
| Acetamidophen | Gentisic acid | Oxycodone |
|---|---|---|
| Acetophenetidin | Glucuronide | Oxymetazoline |
| N-Acetylprocainamide | Glutethimide | Papaverine |
| Acetylsalicylate | Guaifenesin | Penicillin-G |
| Aminopyrine | Hippuric acid | Pentazocine |
| Amitryptyline | Hydralazine | Pentobarbital |
| Amobarbital | Hydrochlorothiazide | Perphenazine |
| Amoxicillin | Hydrocodone | Phencyclidine |
| Ampicillin | Hydrocortisone | Phenelzine |
| Apomorphine | O-Hydroxyhippuric acid | Phenobarbital |
| Aspartame | 3-Hydroxytyramine | Prednisolone |
| Atropine | Ibuprofen | Phenylpropanolamine |
| Benzilic acid | Imipramine | Prednisone |
| Benzoic acid | (-) Isoproterenol | Procaine |
| Benzoylecgonine | Isoxsuprine | Promazine |
| Butabartital | Ketamine | Promethazine |
| Cannabidiol | Ketoprofen | D,L-Propanolol |
| Chloralhydrate | Labetalol | D-Propoxyphene |
| Chloramphenicol | Levorphanol | D-Pseudoephedrine |
| Chlordiazepoxide | Loperamide | Quinidine |
| Chlorothiazide | Loxapine succinate | Quinine |
| Chlorpromazine | Maprotiline | Ranitidine |
| Cholesterol | Meperidine | Salicylic acid |
| Clomipramine | Meprobamate | Secobarbital |
| Clonidine | Methadone | Serotonin (5-Hydroxytyramine) |
| Cocaine hydrochloride | Methaqualone | Sulfamethazine |
| Codeine | Methylphenidal | Sulindac |
| Cortisone | Methyprylon | Temazepam |
| (-) Cotinine | Morphine-3- $\beta$ -Dglucuronide | Tetracycline |
| Creatinine | Nalidixic acid | Tetrahydrocortisone |
| Deoxycorticosterone | Nalorphine | 3 ( $\beta$ -D glucuronide) |
| Tetrahydrozoline |
{11}------------------------------------------------
| Dextromethorphan | Naloxone | Thebaine |
|---|---|---|
| Diazepam | Naltrexone | Thiamine |
| Diclofenac | Naproxen | Thioridazine |
| Diflunisal | Niacinamide | Tolbutamine |
| Digoxin | Nifedipine | Triamterene |
| Diphenhydramine | Norcodein | Trifluoperazine |
| Doxylamine | Norethindrone | Trimethoprim |
| Ecgonine hydrochloride | Noroxymorphone | Trimipramine |
| Ecgonine methyl ester | D-Norpropoxyphene | D, L-Tryptophan |
| Erythromycin | Noscapine | Tyramine |
| β-Estradiol | Nylidrin | D, L-Tyrosine |
| Estrone-3-sulfate | D,L-Octopamine | Uric acid |
| Ethyl-p-aminobenzoate | Oxalic acid | Verapamil |
| Fenoprofen | Oxazepam | Zomepirac |
| Furosemide | Oxolinic acid |
Morphine
| 4-Acetamidophenol | Ecgonine methylester | Oxolinic acid |
|---|---|---|
| Acetophenetidin | (-) -Y -Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | ẞ-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 | ẞ-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 |
{12}------------------------------------------------
| Chloramphenicol | Labetalol | Serotonin (5-Hydroxytyramine) |
|---|---|---|
| Chlordiazepoxide | Loperamide | Sulfamethazine |
| Chlorothiazide | Maprotiline | Sulindac |
| (±) Chlorpheniramine | Meperidine | Temazepam |
| Chlorpromazine | Meprobamate | Tetracycline |
| Chlorquine | Methadone | Tetrahydrocortisone3 (β-Dglucuronide) |
| Cholesterol | Methoxyphenamine | Tetrahydrozoline |
| Clomipramine | (+) 3,4-Methylenedioxy-amphetamine | Thiamine |
| Clonidine | (+)3,4-Methylenedioxy-methamphetamine | Thioridazine |
| Cocaine hydrochloride | Nalidixic acid | D, L-Tyrosine |
| Cortisone | Nalorphine | Tolbutamide |
| (-) Cotinine | Naloxone | Triamterene |
| Creatinine | Naltrexone | Trifluoperazine |
| Deoxycorticosterone | Naproxen | Trimethoprim |
| Dextromethorphan | Niacinamide | Trimipramine |
| Diazepam | Nifedipine | Tryptamine |
| Diclofenac | Norethindrone | D, L-Tryptophan |
| Diflunisal | D-Norpropoxyphene | Tyramine |
| Digoxin | Noscapine | Uric acid |
| Diphenhydramine | D,L-Octopamine | Verapamil |
| Doxylamine | Oxalic acid | Zomepirac |
| Ecgonine hydrochloride | Oxazepam |
- 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.
{13}------------------------------------------------
| Oxazepam | Result | %Cross-Reactivity |
|---|---|---|
| Cut-off=300 ng/mL | ||
| Oxazepam | Positive at 300 ng/mL | 100% |
| Alprazolam | Positive at 125 ng/mL | 240% |
| a-Hydroxyalprazolam | Positive at 2500 ng/mL | 12% |
| Bromazepam | Positive at 1565 ng/mL | 19% |
| Chlordiazepoxide | Positive at 1560 ng/mL | 19% |
| Clobazam | Positive at 65 ng/mL | 462% |
| Clonazepam | Positive at 10000 ng/mL | 3% |
| Clorazepate dipotassium | Positive at 195ng/mL | 154% |
| Delorazepam | Positive at 1560 ng/mL | 19% |
| Desalkylflurazepam | Positive at 1560 ng/mL | 19% |
| Diazepam | Positive at 115 ng/mL | 261% |
| Estazolam | Positive at 165 ng/mL | 182% |
| Flunitrazepam | Positive at 166 ng/mL | 181% |
| Midazolam | Positive at 6500 ng/mL | 5% |
| Nitrazepam | Positive at 300 ng/mL | 100% |
| Norchlordiazepoxide | Positive at 250 ng/mL | 120% |
| Nordiazepam | Positive at 400 ng/mL | 75% |
| Temazepam | Positive at 100 ng/mL | 300% |
| Triazolam | Positive at 2500 ng/mL | 12% |
| D,L-Lorazepam | Negative at ≤ 105 ng/mL | Not Detected |
| Methamphetamine | Negative at ≤ 105 ng/mL | Not Detected |
| Morphine | Negative at ≤ 105 ng/mL | Not Detected |
{14}------------------------------------------------
| mAMP(Methamphetamine,Cut-off=1000 ng/mL) | Result | %Cross-Reactivity |
|---|---|---|
| D-Methamphetamine | Positive at 1000 ng/mL | 100% |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | Positive at 41600 ng/mL | 2% |
| D/L-Methamphetamine | Positive at 1000 ng/mL | 100% |
| p-Hydroxymethamphetamine | Positive at 27000 ng/mL | 4% |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | Positive at 8000 ng/mL | 13% |
| L-Methamphetamine | Positive at 10000 ng/mL | 10% |
| Trimethobenzamide | Negative at ≤ 105 ng/mL | Not Detected |
| Chloroquine | Negative at ≤ 105 ng/mL | Not Detected |
| Ephedrine | Negative at ≤ 105 ng/mL | Not Detected |
| Fenfluramine | Negative at ≤ 105 ng/mL | Not Detected |
| Procaine (Novocaine) | Negative at ≤ 105 ng/mL | Not Detected |
| Ranitidine (Zantac) | Negative at ≤ 105 ng/mL | Not Detected |
| D-amphetamine | Negative at ≤ 105 ng/mL | Not Detected |
| L-amphetamine | Negative at ≤ 105 ng/mL | Not Detected |
| Morphine | Negative at ≤ 105 ng/mL | Not Detected |
| Oxazepam | Negative at ≤ 105 ng/mL | Not Detected |
{15}------------------------------------------------
| MorphineCut-off=2000 ng/mL | Result | %Cross-Reactivity |
|---|---|---|
| Morphine | Positive at 2000 ng/mL | 100% |
| Codeine | Positive at 1000 ng/mL | 200% |
| Ethylmorphine | Positive at 560 ng/mL | 357% |
| Hydrocodone | Positive at 5000 ng/mL | 40% |
| Hydromorphone | Positive at 7315 ng/mL | 27% |
| Levorphanol | Positive at 16000 ng/mL | 13% |
| σ-Monoacetylmorphine | Positive at 1000 ng/mL | 200% |
| Morphine 3-b-D-glucuronide | Positive at 1300 ng/mL | 154% |
| Thebaine | Negative at ≤ 105 ng/mL | Not Detected |
| Norcodeine | Negative at ≤ 105 ng/mL | Not Detected |
| Normorphone | Negative at ≤ 105 ng/mL | Not Detected |
| Oxycodone | Negative at ≤ 105 ng/mL | Not Detected |
| Oxymorphine | Negative at ≤ 105 ng/mL | Not Detected |
| Procaine | Negative at ≤ 105 ng/mL | Not Detected |
| Oxazepam | Negative at ≤ 105 ng/mL | Not Detected |
| Methamphetamine | Negative at ≤ 105 ng/mL | Not Detected |
g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples with a range of 1.000 to 1.035 specific gravity or urine samples with a range of 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.
{16}------------------------------------------------
2. Comparison Studies
The method comparison studies for the First Sign™ Drug Tests (Cup and Dip Card) for Oxazepam , Methamphetamine , and Morphine 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 for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
| 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 | 25 |
| Negative | 10 | 10 | 20 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 25 |
| Negative | 10 | 10 | 20 | 2 | 0 |
Discordant Results of Oxazepam Dip Card
| Viewer | Sample Number | GC/MS Result | Dipcard FormatViewer Results |
|---|---|---|---|
| Viewer A | 94638975 | 324 | Negative |
| Viewer A | 83001567 | 325 | Negative |
| Viewer B | 94638975 | 324 | Negative |
| Viewer C | 83002215 | 326 | Negative |
| Viewer C | 94639027 | 328 | Negative |
{17}------------------------------------------------
| Cupformat | Negative | LowNegativeby GC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcut-off) | NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 14 | 25 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 25 |
| Negative | 10 | 10 | 20 | 2 | 0 |
Discordant Results of Oxazepam Cup
| Viewer | Sample Number | GC/MS Result | Cup FormatViewer Results |
|---|---|---|---|
| Viewer A | 83002215 | 326 | Negative |
| Viewer B | 83001567 | 325 | Negative |
| Viewer C | 83001567 | 325 | Negative |
| Viewer C | 94639027 | 328 | Negative |
Methamphetamine
| Dip Card | Low | Near | ||||
|---|---|---|---|---|---|---|
| format | Negative | Negativeby GC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcut-off) | CutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
| Viewer A | Positive | 0 | 0 | 0 | 18 | 21 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 18 | 21 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 17 | 21 |
| Negative | 10 | 10 | 20 | 2 | 0 |
{18}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | DipCard Format Viewer Results |
|---|---|---|---|
| Viewer A | 83000530 | 1156 | Negative |
| Viewer B | 83001807 | 1094 | Negative |
| Viewer C | 83001811 | 1065 | Negative |
| Viewer C | 83001807 | 1094 | Negative |
Discordant Results of Methamphetamine DipCard
| Cupformat | Negative | LowNegativeby GC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcut-off) | NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 18 | 21 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 18 | 21 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 17 | 21 |
| Negative | 10 | 10 | 20 | 2 | 0 |
Discordant Results of Methamphetamine Cup
| Viewer | Sample Number | GC/MS Result | Cup FormatViewer Results |
|---|---|---|---|
| Viewer A | 83001821 | 1079 | Negative |
| Viewer B | 83001807 | 1094 | Negative |
| Viewer C | 83001821 | 1079 | Negative |
| Viewer C | 83001807 | 1094 | Negative |
{19}------------------------------------------------
Morphine
| DipCardformat | Morphine | |||||
|---|---|---|---|---|---|---|
| Negative | Low Negativeby GC/MS(less than -50%) | Near CutoffNegative byGC/MS(Between -50% andcut-off) | Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%) | High Positive byGC/MS(greaterthan +50%) | ||
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 24 |
| Negative | 10 | 10 | 20 | 1 | 0 |
Discordant Results of Morphine DipCard
| Viewer | Sample Number | GC/MS Result | DipCard FormatViewer Results |
|---|---|---|---|
| Viewer A | 94639012 | 2119 | Negative |
| Viewer B | 94639012 | 2119 | Negative |
| Viewer C | 83000219 | 2325 | Negative |
| Cupformat | Negative | LowNegativeby GC/MS(less than-50%) | Near CutoffNegative byGC/MS(Between-50% andcut-off) | Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan+50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 0 | 15 | 24 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 15 | 24 |
| Negative | 10 | 10 | 20 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 15 | 24 |
| Negative | 10 | 10 | 20 | 1 | 0 |
Discordant Results of Morphine Cup
| Viewer | Sample Number | GC/MS Result | Cup FormatViewer Results |
|---|---|---|---|
| Viewer A | 83000219 | 2325 | Negative |
| Viewer B | 83000572 | 2227 | Negative |
| Viewer C | 94639012 | 2119 | Negative |
{20}------------------------------------------------
Lay-user study
A lay user study was performed at three intended user sites with 280 lay persons testing the Oxazepam devices, 280 lay persons testing the Methamphetamine devices and 280 lay persons testing the Morphine devices. A total of 139 females and 141 males tested the Oxazepam samples, 138 females and 142 males tested Methamphetamine samples, and 137 females and 143 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.
| Numberofsamples | Oxazepam Concentrationby GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | ||
|---|---|---|---|---|---|
| % of Cutoff | No. ofPositive | No. ofNegative | |||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 145 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 222 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 384 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 468 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 542 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Oxazepam DipCard)
Comparison between GC/MS and Lay Person Results (Oxazepam Cup)
| % of Cutoff | Numberofsamples | Oxazepam Concentrationby GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 76 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 145 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 222 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 384 | 20 | 0 | 100% |
| +50% Cutoff | 20 | 468 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 542 | 20 | 0 | 100% |
{21}------------------------------------------------
| Numberofsamples | MethamphetamineConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | ||
|---|---|---|---|---|---|
| % of Cutoff | No. ofPositive | No. ofNegative | |||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 245 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 488 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 729 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 1212 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 1441 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1666 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Methamphetamine DipCard)
Comparison between GC/MS and Lay Person Results (Methamphetamine Cup)
| % of Cutoff | Numberofsamples | MethamphetamineConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | ||||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 245 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 488 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 729 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 1212 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 1441 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1666 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Morphine DipCard)
| % of Cutoff | Numberofsamples | Morphine Concentrationby GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 527 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 1053 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 1573 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 2652 | 20 | 0 | 100% |
| +50% Cutoff | 20 | 3254 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 3711 | 20 | 0 | 100% |
{22}------------------------------------------------
| % of Cutoff | Numberofsamples | Morphine Concentrationby GC/MS(ng/mL) | Lay person results | The | |
|---|---|---|---|---|---|
| No. ofPositive | No. ofNegative | percentage ofcorrect results(%) | |||
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 527 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 1053 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 1573 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 2652 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 3254 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 3711 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Morphine Cup)
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 First Sign™ Drug of Abuse Dip Card Test and First Sign™ Drug of Abuse Cup Test are substantially equivalent to the predicate.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).