(31 days)
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 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 drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone 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 Methadone, Phencyclidine, and Oxycodone 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.
The provided text describes the performance characteristics and studies for the "First Sign® Drug of Abuse Cup Test" and "First Sign® Drug of Abuse Dip Card Test" for Methadone, Phencyclidine, and Oxycodone.
The acceptance criteria for each drug are implicitly defined by the reported performance, specifically in the precision, cut-off verification, and comparison studies. For instance, in the precision study, at -100% to -25% of the cut-off, all results were expected to be negative, and at +25% to +100% of the cut-off, all results were expected to be positive, with some allowance for variation at the exact cut-off concentration.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a separate table. However, the performance tables demonstrate the device's adherence to the expected behavior around the cut-off concentrations. The "Precision" section's implied criteria are 100% correct negatives for concentrations below -25% of the cut-off, 100% correct positives for concentrations above +25% of the cut-off, and a high percentage of correct results at +/-25% and at the cut-off values. The "Cut-off" section verifies the stated cut-off values.
Table: Acceptance Criteria (Implied from Precision and Cut-off Studies) and Reported Device Performance
| Drug | Concentration Range | Implied Acceptance: Expected Result | Reported Performance (Precision Study: Examples from Lot 1/3) |
|---|---|---|---|
| Methadone (Cut-off: 300 ng/mL) | -100% to -25% Cut-off (0-225 ng/mL) | Negative | 50-/0+ (100% Negative) |
| Cut-off (300 ng/mL) | Mix of Positive/Negative | 3-/47+ or 1-/49+ (mostly Positive) | |
| +25% to +100% Cut-off (375-600 ng/mL) | Positive | 50+/0- (100% Positive) | |
| Phencyclidine (Cut-off: 25 ng/mL) | -100% to -25% Cut-off (0-18.75 ng/mL) | Negative | 50-/0+ (100% Negative) |
| Cut-off (25 ng/mL) | Mix of Positive/Negative | 3-/47+ or 2-/48+ (mostly Positive) | |
| +25% to +100% Cut-off (31.25-50 ng/mL) | Positive | 50+/0- (100% Positive) | |
| Oxycodone (Cut-off: 100 ng/mL) | -100% to -25% Cut-off (0-75 ng/mL) | Negative | 50-/0+ (100% Negative) |
| Cut-off (100 ng/mL) | Mix of Positive/Negative | 4-/46+ or 3-/47+ (mostly Positive) | |
| +25% to +100% Cut-off (125-200 ng/mL) | Positive | 50+/0- (100% Positive) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision Study:
- Sample Size: For each drug and each format (Dip Card/Cup), 8 concentrations were tested across 3 lots, with samples run 2 times per day for 25 days by 3 different operators. This is not a simple count of unique clinical samples. It uses spiked samples. Each individual concentration point (e.g., -100% cut-off) had 50 measurements (2 tests/day * 25 days by each of 3 lots, but the values are given as 50-/0+ or 50+/0- for each lot, suggesting 50 replicates per lot at each concentration).
- Data Provenance: The samples were "prepared by spiking drug in negative samples." The document does not specify the country of origin, but the testing was conducted "in-house." These are prospective, laboratory-prepared samples.
- Cut-off Verification Study:
- Sample Size: 150 samples ("equally distributed at concentrations of -50% cut-off; cut-off; +25% cut-off; +50% cut-off"). These were tested using three different lots of each device by three different operators.
- Data Provenance: Similar to precision study, these were laboratory-prepared samples ("spiked drug in negative samples"). No country of origin is specified.
- Comparison Studies (Clinical Samples):
- Sample Size: 80 "unaltered clinical samples" for each drug (40 negative and 40 positive). This means 80 samples for Methadone, 80 for Phencyclidine, and 80 for Oxycodone, for both Dip Card and Cup formats (though the tables suggest the same samples were likely used for both formats for a given viewer).
- Data Provenance: "in-house" studies, using "unaltered clinical samples." The origin of these clinical samples is not specified (e.g., country, retrospective/prospective).
- Lay-user Study:
- Sample Size: 280 lay persons for Methadone, 280 for Phencyclidine, and 280 for Oxycodone devices. Each participant received 1 blind-labeled sample. The samples themselves were prepared at 7 different concentrations, with 20 samples per concentration. This means a total of 140 samples for each drug (7 concentrations * 20 samples/concentration) were tested by the lay-users.
- Data Provenance: "Urine samples were prepared... by spiking drugs into drug free-pooled urine specimens." The study was performed "at three intended user sites." No country of origin is specified. These are prospective, laboratory-prepared samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Precision, Cut-off, and Lay-user Studies (Spiked Samples): The ground truth was established by the precise spiking of drugs into negative urine samples at known concentrations, confirmed by GC/MS (Gas Chromatography/Mass Spectrometry). This is an analytical chemistry method, and implicitly, the expertise lies in the laboratory personnel conducting these precise preparations and GC/MS confirmations. No further expert qualifications are provided.
- Comparison Studies (Clinical Samples): The ground truth was established by GC/MS results for each of the 80 unaltered clinical samples per drug. No details on the number or qualifications of the GC/MS experts are provided, but GC/MS is the "preferred confirmatory method" for drug of abuse tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Precision Study: "All sample aliquots were blind-labeled and randomized by the person who prepared samples and did not take part in the sample testing." Tests were performed by "three different operators." The results are aggregated, but no specific adjudication method among operators is explicitly described. It appears each operator's results were simply recorded.
- Cut-off Verification Study: Tested by "three different operators." Similar to precision study, results are aggregated, no specific adjudication is mentioned.
- Comparison Studies: "three different laboratory assistants" ("Viewer A, B, C") tested the samples. The tables show individual viewer results, followed by a list of "Discordant Results." This implies that there wasn't a formal adjudication method (like 2+1 or 3+1) in place to yield a single "device" result, but rather a comparison of each viewer's interpretation against the GC/MS ground truth.
- Lay-user Study: Each "participant was provided with the package insert, 1 blind labeled sample and a device." The results appear to be individual lay person interpretations compared to the GC/MS ground truth, with no inter-lay user adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study involving AI assistance was not done.
- The studies involved human readers (laboratory assistants, lay-users) interpreting the device results, and these devices are immunochromatographic assays (lateral flow tests), not AI software. Therefore, there is no "AI vs without AI assistance" component to these studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm-only performance study was not done. The devices are physical tests interpreted by humans (either trained laboratory personnel or lay-users). They do not involve an algorithm separate from human interpretation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For all studies (Precision, Cut-off, Comparison, Lay-user), the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) of the spiked or clinical urine samples. GC/MS is a highly accurate analytical method considered the gold standard for confirming drug concentrations.
8. The sample size for the training set
- The document implies that these studies (precision, cut-off, comparison, lay-user) represent the validation of the device. It does not mention a separate "training set" in the context of machine learning or algorithm development, as this medical device is an immunoassay, not an AI/ML product. The development process for such a test would involve internal R&D and optimization, but the specific term "training set" as used in AI/ML is not applicable here.
9. How the ground truth for the training set was established
- As a traditional immunoassay device, there is no "training set" in the AI/ML sense. The ground truth for the analytical and clinical performance studies was established using GC/MS of urine samples with known (spiked) or confirmed (clinical) drug concentrations.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2015
W.H.P.M., INC. C/O JOE SHIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877
Re: K151441
Trade/Device Name: First Sign® Drug Of Abuse Cup Test, First Sign® Drug Of Abuse Dip Card Test Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, LCM, DJG Dated: May 22, 2015 Received: May 29, 2015
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For :
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151441
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 Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, and 100 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 drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| 区 Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 区 Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K151441
| 1. Date: | June 26, 2015 |
|---|---|
| 2. Submitter | W.H.P.M., Inc.5358 Irwindale Ave.Irwindale, CA 91706 |
| 3. Contact person: | John WanW.H.P.M., Inc.5358 Irwindale Ave.Irwindale, CA 91706Telephone: 626-443-8480 |
Fax: 626-443-8065 Email: johnwan@whpm.com
-
- Device Name: First Sign® Drug of Abuse Cup Test First Sign® Drug of Abuse Dip Card Test
| Product Code | Class | CFR # | Panel |
|---|---|---|---|
| DJR | Class II | 21 CFR, 862.3620 Methadone Test System | Toxicology |
| LCM | Unclassified | Phencyclidine | Toxicology |
| DJG | Class II | 21 CFR, 862.3650 Opiate Test System | Toxicology |
-
- Predicate Devices: K052115 First Check Multi Drug Cup 12
-
- Intended Use
First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 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 drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone 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
{4}------------------------------------------------
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.
7. Device Description
First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Methadone, Phencyclidine, and Oxycodone 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 Each test device is sealed with a desiccant in an aluminum pouch. collection.
8. 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.
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofMethadone in human urine. | Same |
| Calibrator | Methadone | 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 |
| IntendedPopulation | For over-the-counter and prescriptionuses. | For over-the-counter use. |
| Configurations | Cup, Dip Card | Cup |
Table 1: Features Comparison of First Sign™ Methadone Test and the Predicate Device
Table 2: Features Comparison of First Sign™ Phencyclidine Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofPhencyclidine in human urine. | Same |
| Calibrator | Phencyclidine | Same |
| Methodology | Competitive binding, lateral flow | Same |
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| Item | Device | Predicate - K052115 |
|---|---|---|
| immunochromatographic assays basedon the principle of antigen antibodyimmunochemistry. | ||
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 25 ng/mL | Same |
| IntendedPopulation | For over-the-counter and prescriptionuses. | For over-the-counteruse. |
| Configurations | Cup, Dip Card | Cup |
Table 3: Features Comparison of First Sign™ Oxycodone Test and the Predicate Device
| Item | Device | Predicate - K052115 |
|---|---|---|
| Indication(s)for Use | For the qualitative determination ofOxycodone in human urine. | Same |
| Calibrator | Oxycodone | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 100 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 Methadone, Phencyclidine, and Oxycodone in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff 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.
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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:
| Result | -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off | |
|---|---|---|---|---|---|---|---|---|---|---|
| Drug | ||||||||||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 1-/49+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Methadone Dip Card Format
Methadone Cup Format
| Drug | -100% Cut-off | -75% Cut-off | -50% Cut-off | -25% Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off |
|---|---|---|---|---|---|---|---|---|
| Lot 4 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 6 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- |
Phencyclidine 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 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Phencyclidine 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 4 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 6 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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| Drug | Result | Cut-off | |||||||
|---|---|---|---|---|---|---|---|---|---|
| -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off | ||
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Oxycodone Cup Format | |||||||||
| Drug | Result | Cut-off | |||||||
| -100%Cut-off | -75%Cut-off | -50%Cut-off | -25%Cut-off | +25%Cut-off | +50%Cut-off | +75%Cut-off | +100%Cut-off | ||
| Lot 4 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 6 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Oxycodone Dip Card 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; cutoff; +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 Methadone, Phencyclidine and Oxycodone. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| First Sign™ Methadone Test | Methadone | 300 |
| First Sign™ Phencyclidine Test | Phencyclidine | 25 |
| First Sign™ Oxycodone Test | Oxycodone | 100 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological 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.
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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.
| Aminopyrine | Ethyl-p-aminobenzoate | Papaverine |
|---|---|---|
| Amitryptyline | Fenoprofen | Penicillin-G |
| Amobarbital | Furosemide | Pentazocine hydrochloride |
| Amoxicillin | Gentisic acid | Pentobarbital |
| Ampicillin | Hemoglobin | Perphenazine |
| L-Ascorbic acid | Hydralazine | Phencyclidine |
| DL-Amphetamine sulfate | Hydrochlorothiazide | Phenelzine |
| Apomorphine | Hydrocodone | Phenobarbital |
| Aspartame | Hydrocortisone | Phentermine |
| Atropine | O-Hydroxyhippuric acid | L-Phenylephrine |
| Benzilic acid | p-Hydroxyamphetamine | β-Phenylethylamine |
| Benzoic acid | p-Hydroxymethamphetamine | Phenylpropanolamine |
| Benzoylecgonine | 3-Hydroxytyramine | Prednisolone |
| Benzphetamine | Ibuprofen | Prednisone |
| Bilirubin | Imipramine | Procaine |
| Caffeine | Iproniazid | Promazine |
| Cannabidiol | (±) - Isoproterenol | Promethazine |
| Cannabinol | Isoxsuprine | DL-Propranolol |
| Chloralhydrate | Ketamine | D-Propoxyphene |
| Chloramphenicol | Ketoprofen | D-Pseudoephedrine |
| Chlorothiazide | Labetalol | Quinacrine |
| Chlorpromazine | Levorphanol | Quinidine |
| Chlorquine | Loperamide | Quinine |
| Cholesterol | Maprotiline | Ranitidine |
| Clomipramine | Meperidine | Salicylic acid |
| Clonidine | Meprobamate | Secobarbital |
| Cocaethylene | Methamphetamine | Serotonin |
| Temazepam | Methoxyphenamine | Sulfamethazine |
| Cocaine hydrochloride | (±)-3,4-Methylenedioxy- amphetamine hydrochloride | Sulindac |
| Codeine | (±)-3,4-Methylenedioxy- methamphetamine hydrochloride | Tetracycline |
| Cortisone | Morphine-3-β-D glucuronide | Tetrahydrocortisone 3- (β-D-glucuronide) |
| (-) Cotinine | Morphine Sulfate | Tetrahydrozoline |
| Creatinine | Nalidixic acid | Thebaine |
| Deoxycorticosterone | Naloxone | Thiamine |
| Dextromethorphan | Naltrexone | Thioridazine |
| Diazepam | Naproxen | DL-Tyrosine |
| Diclofenac | Niacinamide | Tolbutamide |
| Diflunisal | Nifedipine | Triamterene |
| Digoxin | Norcodein | Trifluoperazine |
| Diphenhydramine | Norethindrone | Trimethoprim |
| Ecgonine hydrochloride | D-Norpropoxyphene | Trimipramine |
| Ecgonine methyl ester | Noscapine | Tryptamine |
| (-) -Ψ -Ephedrine | DL-Octopamine | DL-Tryptophan |
| [1R,2S] (-) Ephedrine | Oxalic acid | Tyramine |
| (L) - Epinephrine | Oxazepam | Uric acid |
| Erythromycin | Oxolinic acid | Verapamil |
| β-Estradiol | Oxycodone | Zomepirac |
| Estrone-3-sulfate | Oxymetazoline |
{9}------------------------------------------------
Phencyclidine
| Acetaminophen | (+) Ephedrine | Oxycodone |
|---|---|---|
| Acetophenetidin | Erythromycin | Oxymetazoline |
| N-Acetylprocainamide | β-Estradiol | Papaverine |
| Acetylsalicylic acid | Estrone-3-sulfate | Penicillin-G |
| Aminopyrine | Ethyl-p-aminobenzoate | Pentazocine hydrochloride |
| Amitryptyline | Fenoprofen | Pentobarbital |
| Amobarbital | Furosemide | Perphenazine |
| Amoxicillin | Gentisic acid | Phenelzine |
| Ampicillin | Hemoglobin | Phenobarbital |
| Ascorbic acid | Hydralazine | Phentermine |
| D,L-Amphetamine | Hydrochlorothiazide | L-Phenylephrine |
| Apomorphine acid | Hydrocodone | β-Phenylethylamine |
| Aspartame | Hydrocortisone | Phenylpropanolamine |
| Atropine | O-Hydroxyhippuric | Prednisolone |
| Benzilic acid | p-Hydroxymethamphetamine | Prednisone |
| Benzoic acid | 3-Hydroxytyramine | Procaine |
| Benzoylecgonine | Ibuprofen | Promazine |
| Benzphetamine | Imipramine | Promethazine |
| Bilirubin | Iproniazid | D,L-Propanolol |
| Brompheniramine | (±) - Isoproterenol | D-Propoxyphene |
| Caffeine | Isoxsuprine | D-Pseudoephedrine |
| Cannabidiol | Ketamine | Quinidine |
| Cannabinol | Ketoprofen | Quinine |
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| Chloralhydrate | Labetalol | Ranitidine |
|---|---|---|
| Chloramphenicol | Loperamide | Salicylic acid |
| Chlordiazepoxide | Maprotiline | Secobarbital |
| Chlorothiazide | Meperidine | Serotonin (5-Hydroxytyramine) |
| (+) Chlorpheniramine | Meprobamate | Sulfamethazine |
| Chlorpromazine | Methadone | Sulindac |
| Chlorquine | Methoxyphenamine | Temazepam |
| Cholesterol | (+) 3,4-Methylenedioxy-amphetamine | Tetracycline |
| Clomipramine | (+)3,4-Methylenedioxy-methamphetamine | Tetrahydrocortisone3 (β-Dglucuronide) |
| Clonidine | Morphine-3-β-D glucuronide | Tetrahydrozoline |
| Cocaine hydrochloride | Morphine Sulfate | Thiamine |
| Codeine | Nalidixic acid | Thioridazine |
| Cortisone | Naloxone | D, L-Tyrosine |
| (-) Cotinine | Naltrexone | Tolbutamide |
| Creatinine | Naproxen | Triamterene |
| Deoxycorticosterone | Niacinamide | Trifluoperazine |
| Dextromethorphan | Nifedipine | Trimethoprim |
| Diazepam | Norcodein | 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 |
| Ecgonine methylester | Oxolinic acid |
Oxycodone
| Acetophenetidin | Ethyl-p-aminobenzoate | Papaverine |
|---|---|---|
| Acetylsalicylic acid | β-Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Perphenazine |
| Amoxicillin | Erythromycin | Phenelzine |
| Ampicillin | Fenoprofen | L-Phenylephrine |
| Apomorphine | Furosemide | β-Phenylethylamine |
| Aspartame | Gentisic acid | Phenylpropanolamine |
| Atropine | Hemoglobin | Prednisone |
| Benzilic acid | Hydralazine | Loperamide |
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| Benzoic acid | Hydrochlorothiazide | Quinine |
|---|---|---|
| Benzphetamine | Hydrocortisone | Quinidine |
| Bilirubin | O-Hydroxyhippuric acid | Ranitidine |
| Deoxycorticosterone | 3-Hydroxytyramine | Salicylic acid |
| Caffeine | Labetalol | Serotonin |
| Chloralhydrate | D, L-Isoproterenol | Sulfamethazine |
| Chloramphenicol | Meprobamate | Sulindac |
| Chlorothiazide | Methoxyphenamine | Tetracycline |
| D,L-Chlolrpheniramine | Nalidixic acid | Tetrahydrocortisone |
| Chlorpromazine | Naloxone | Morphine-3-β-D-glucuronide |
| Chlorquine | Naltrexone | Tetrahydrozoline |
| Cholesterol | Naproxen | Thiamine |
| Clonidine | Niacinamide | Thioridazine |
| L-Cotinine | Nifedipine | D,L-Tyrosine |
| Cortisone | Isoxsuprine | Tolbutamide |
| Creatinine | D,L-Propanolol | Triamterene |
| D-Pseudoephedrine | Ketoprofen | Trifluoperazine |
| Dextromethorphan | Norethindrone | Trimethoprim |
| Diclofenac | D-Norpropoxyphene | Tyramine |
| Diflunisal | Noscapine | D,L-Tryptophan |
| Digoxin | D,L-Octopamine | Urine acid |
| Diphenhydramine | Oxalic acid | Verapamil |
| L-Ephedrine | Oxolinic acid | Zomepirac |
| Ecgonine methylester | Oxymetazoline |
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.
| MethadoneCut-off=300 ng/mL | Result | %Cross-Reactivity |
|---|---|---|
| Methadone | Positive at 300 ng/mL | 100% |
| LAAM | Positive at 10000 | 3% |
| Alpha Methadol | Negative at 100000 | Not Detected |
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| Doxylamine | Negative at 100000 | Not Detected |
|---|---|---|
| EMDP | Negative at 100000 | Not Detected |
| EDDP | Negative at 100000 | Not Detected |
| PhencyclidineCut-off=25 ng/mL) | Result | % Cross-Reactivity |
|---|---|---|
| Phencyclidine | Positive at 25 ng/mL | 100% |
| 4-Hydroxyphencyclidine | Positive at 250 ng/mL | 10% |
| Phencyclidine Morpholine | Positive at 625 ng/mL | 4% |
| Oxycodone | Result | % Cross- |
|---|---|---|
| Cut-off=100 ng/mL | Reactivity | |
| Oxycodone | Positive at 100 ng/mL | 100% |
| Dihydrocodeine | Positive at 50000 ng/mL | 0.2% |
| Hydrocodone | Positive at 10000 ng/mL | 1% |
| Heroin | Negative at 100000 | Not Detected |
| Morphine-3-b-glucuronide | Negative at 100000 | Not Detected |
| Codeine | Negative at 100000 | Not Detected |
| Hydromorphone | Negative at 100000 | Not Detected |
| Morphine | Negative at 100000 | Not Detected |
| Acetylmorphine | Negative at 100000 | Not Detected |
| Buprenorphine | Negative at 100000 | Not Detected |
| Ethylmorphine | Negative at 100000 | 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.
2. Comparison Studies
The method comparison studies for the First Sign™ Drug Tests (Cup and Dip Card) for Methadone, Phencyclidine, and Oxycodone 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
{13}------------------------------------------------
samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
| Methadone | ||||||
|---|---|---|---|---|---|---|
| Dip Cardformat | 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 | 12 | 26 |
| Negative | 10 | 10 | 20 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 26 |
| Negative | 10 | 10 | 19 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results of Methadone Dip Card
| Viewer | Sample Number | GC/MS Result | Dipcard FormatViewer Results |
|---|---|---|---|
| Viewer A | 83001724 | 325 | Negative |
| Viewer A | 83001691 | 337 | Negative |
| Viewer B | 94639074 | 353 | Negative |
| Viewer B | 83001695 | 274 | Positive |
| Viewer C | 83002140 | 366 | Negative |
| Viewer C | 83002176 | 289 | Positive |
| 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 | 1 | 13 | 26 |
| Negative | 10 | 10 | 19 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 26 |
| Negative | 10 | 10 | 19 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 12 | 26 |
| Negative | 10 | 10 | 19 | 2 | 0 |
Discordant Results of Methadone Cup
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| Viewer | Sample Number | GC/MS Result | Cup FormatViewer Results |
|---|---|---|---|
| Viewer A | 83001695 | 274 | Positive |
| Viewer A | 83001691 | 337 | Negative |
| Viewer B | 83002176 | 289 | Positive |
| Viewer B | 83001707 | 331 | Negative |
| Viewer C | 83002164 | 242 | Positive |
| Viewer C | 83001724 | 325 | Negative |
| Viewer C | 94639074 | 353 | Negative |
Phencyclidine
| Dip Cardformat | 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 | 1 | 13 | 26 |
| Negative | 10 | 10 | 19 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 26 |
| Negative | 10 | 10 | 19 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 12 | 26 |
| Negative | 10 | 10 | 20 | 2 | 0 |
Discordant Results of Phencyclidine DipCard
| Viewer | Sample Number | GC/MS Result | DipCard FormatViewer Results |
|---|---|---|---|
| Viewer A | 83002015 | 20.6 | Positive |
| Viewer A | 83002085 | 27.9 | Negative |
| Viewer B | 83001968 | 21.4 | Positive |
| Viewer B | 83002029 | 28.3 | Negative |
| Viewer C | 83002085 | 27.9 | Negative |
| Viewer C | 83002062 | 28.7 | Negative |
| Cupformat | Negative | LowNegativeby GC/MS(less than -50%) | Near CutoffNegative byGC/MS(Between -50% andcut-off) | NearCutoffPositive byGC/MS | HighPositive byGC/MS(greaterthan +50%) | |
|---|---|---|---|---|---|---|
| --------------- | -- | ---------- | ----------------------------------------------------- | -------------------------------------------------------------------------- | ---------------------------------------- | -------------------------------------------------------- |
{15}------------------------------------------------
| (Betweenthe cut-offand +50%) | ||||||
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 2 | 13 | 26 |
| Negative | 10 | 10 | 18 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 26 |
| Negative | 10 | 10 | 20 | 2 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 26 |
| Negative | 10 | 10 | 20 | 1 | 0 |
Discordant Results of Phencyclidine Cup
| Viewer | Sample Number | GC/MS Result | Cup FormatViewer Results |
|---|---|---|---|
| Viewer A | 83002015 | 20.6 | Positive |
| Viewer A | 83001780 | 21.3 | Positive |
| Viewer A | 83002077 | 29.3 | Negative |
| Viewer B | 83002085 | 27.9 | Negative |
| Viewer B | 83002029 | 28.3 | Negative |
| Viewer C | 83001978 | 27.7 | Negative |
Oxycodone
| DipCardformat | Negative | LowNegativeby GC/MS(less than -50%) | Near CutoffNegative byGC/MS(Between -50% and cut-off) | Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%) | HighPositive byGC/MS(greaterthan+50%) | |
|---|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 0 | 2 | 13 | |
| Negative | 10 | 10 | 18 | 1 | 0 | |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 26 |
| Negative | 10 | 10 | 20 | 2 | 0 | |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results of Oxycodone DipCard
| Viewer | Sample Number | GC/MS Result | DipCard FormatViewer Results |
|---|---|---|---|
| Viewer A | 83002095 | 89 | Positive |
| Viewer A | 83002040 | 99 | Positive |
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| Viewer A | 83001639 | 120 | Negative |
|---|---|---|---|
| Viewer B | 83001639 | 120 | Negative |
| Viewer B | 83002092 | 116 | Negative |
| Viewer C | 94639011 | 85 | Positive |
| Viewer C | 83002092 | 116 | Negative |
| 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 | 1 | 12 | 26 |
| Negative | 10 | 10 | 19 | 2 | 0 | |
| Viewer B | Positive | 0 | 0 | 2 | 13 | 26 |
| Negative | 10 | 10 | 18 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 0 | 12 | 26 |
| Negative | 10 | 10 | 20 | 2 | 0 |
Discordant Results of Oxycodone Cup
| Viewer | Sample Number | GC/MS Result | Cup FormatViewer Results |
|---|---|---|---|
| Viewer A | 83002095 | 89 | Positive |
| Viewer A | 83001639 | 120 | Negative |
| Viewer A | 83002092 | 116 | Negative |
| Viewer B | 83002096 | 85 | Positive |
| Viewer B | 83002040 | 99 | Positive |
| Viewer B | 83001638 | 117 | Negative |
| Viewer C | 83001639 | 120 | Negative |
| Viewer C | 83001638 | 117 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 280 lay persons testing the Methadone devices, 280 lay persons testing the Phencyclidine devices and 280 lay persons testing the Oxycodone devices. A total of 136 females and 144 males tested the Methadone samples, 141 females and 139 males tested Phencyclidine samples, and 141 females and 139 males tested the Oxycodone samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at 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
{17}------------------------------------------------
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.
| % of Cutoff | Numberofsamples | MethadoneConcentration 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 | 74 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 148 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 222 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 378 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 452 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 530 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Methadone DipCard)
Comparison between GC/MS and Lay Person Results (Methadone Cup)
| % of Cutoff | Number of samples | Methadone Concentration by GC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | No. of Positive 0 | No. of Negative 20 | 100% |
| -75% Cutoff | 20 | 74 | No. of Positive 0 | No. of Negative 20 | 100% |
| -50% Cutoff | 20 | 148 | No. of Positive 0 | No. of Negative 20 | 100% |
| -25% Cutoff | 20 | 222 | No. of Positive 1 | No. of Negative 19 | 95% |
| +25% Cutoff | 20 | 378 | No. of Positive 19 | No. of Negative 1 | 95% |
| +50% Cutoff | 20 | 452 | No. of Positive 20 | No. of Negative 0 | 100% |
| +75% Cutoff | 20 | 530 | No. of Positive 20 | No. of Negative 0 | 100% |
Comparison between GC/MS and Lay Person Results (Phencyclidine DipCard)
| Number | PhencyclidineConcentration by GC/MS(ng/mL) | Lay person results | The | ||
|---|---|---|---|---|---|
| % of Cutoff | ofsamples | No. ofPositive | No. ofNegative | percentage ofcorrect results(%) | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 6 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 12.2 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 19 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 31.3 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 37 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100% |
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| % of Cutoff | Number of samples | PhencyclidineConcentration by GC/MS(ng/mL) | Lay person results | Thepercentage ofcorrect results(%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 6 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 12.2 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 19 | 0 | 20 | 100% |
| +25% Cutoff | 20 | 31.3 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 37 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 44 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Phencyclidine Cup)
Comparison between GC/MS and Lay Person Results (Oxycodone DipCard)
| NumberOxycodone | Lay person results | The | |||
|---|---|---|---|---|---|
| % of Cutoff | ofsamples | Concentration by GC/MS(ng/mL) | No. ofPositive | No. ofNegative | percentage ofcorrect results(%) |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 24 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 49 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 74 | 1 | 19 | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો |
| +25% Cutoff | 20 | 124 | 19 | 1 | તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી ત |
| +50% Cutoff | 20 | 148 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 173 | 20 | 0 | 100% |
Comparison between GC/MS and Lay Person Results (Oxycodone Cup)
| % of Cutoff | Numberofsamples | OxycodoneConcentration 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 | 24 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 49 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 74 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 124 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 148 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 173 | 20 | 0 | 100% |
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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.
-
- 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.
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).