(434 days)
No
The device description and performance studies detail a standard enzyme immunoassay (HEIA) process based on chemical reactions and spectrophotometric measurement. There is no mention of AI, ML, or any computational analysis beyond basic data processing of absorbance changes.
No.
This device is an in vitro diagnostic device used for the preliminary qualitative detection of opiates and oxycodone in human hair, identifying substance use, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone."
No
The device description clearly outlines a homogeneous enzyme immunoassay (HEIA) test that involves a pre-analytical hair treatment procedure and a screening assay based on chemical reactions and spectrophotometric measurement. This involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone." This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Psychemedics homogeneous enzyme immunoassay (HEIA) for opiates in hair is an enzyme immunoassay for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng morphine/10 mg hair for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics homogeneous enzyme immunoassay for opiates in hair provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/ MS/MS) is the preferred confirmatory method.
The Psychemedics homogeneous enzyme immunoassay (HEIA) for oxycodone in hair is an enzyme immunoassay for the preliminary qualitative detection of oxycodone in human head and body hair using an oxycodone calibrator at 2 ng oxycodone/10 mg hair for the purpose of identifying opioid use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics homogeneous enzyme immunoassay for oxycodone in hair provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The homogeneous enzyme immunoassay (HEIA) test consists of two parts; a pre-analytical hair treatment procedure (to extract opioids from the solid hair matrix to form a measurable liquid matrix) and the screening assay, the Psychemedics Opiates HEIA and the Psychemedics Oxycodone HEIA. The screening portion of the test system is based on competition for antibody binding sites between drug in the measurable liquid matrix and drug-labeled recombinant glucose-6-phosphate dehydrogenase (G6PDH). As the antibody binds labeled G6PDH, enzyme activity decreases. In the presence of drug, enzyme activity increases in direct proportion to the drug concentration. Active enzyme reduces nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically.
The Psychemedics Opiates HEIA consists of reagents R1 (anti-opiates monoclonal antibody with substrate) and R2 (morphine labeled recombinant G6PDH). The Psychemedics Oxycodone HEIA consists of reagents R1 (anti-oxycodone monoclonal antibody with substrate) and R2 (oxycodone labeled recombinant G6PDH).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human head and body hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
For Opiates HEIA: The test device (assay) has been validated using 230 individual hair samples collected anonymously from a workplace setting. The stored hair samples were then tested using Psychemedics' LC/MS/MS confirmatory assay, to compare the Psychemedics HEIA results with the LC/MS/MS results. The studies comparing the HEIA with LC/MS/MS documented the source of hair (head or body) and other demographics as available.
For Oxycodone HEIA: The test device (assay) has been validated using 219 individual hair samples collected anonymously from a workplace setting. The stored hair samples were then tested using Psychemedics' LC/MS/MS confirmatory assay, to compare the Psychemedics HEIA results with the LC/MS/MS results. The studies comparing the HEIA with LC/MS/MS documented the source of hair (head or body) and other demographics as available.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision studies:
Performed by spiking negative hair with previously validated LC/MS/MS validated calibrator and control solutions to achieve concentrations of negative, the cutoff calibrator of 2 ng morphine/10 mg hair or 2 ng oxycodone/10 mg hair, and +/-75%, +/-50% and +/-25% of the cutoff calibrator. Results were identical for both immunoassays.
Intra-Assay Precision (8 samples per level):
-100%, -75%, -50%, -25% levels: 8 Negative, 0 Positive
+25%, +50%, +75%, +100% levels: 0 Negative, 8 Positive
Inter-Assay Precision (80 samples per level):
-100%, -75%, -50%, -25% levels: 80 Negative, 0 Positive
+25%, +50%, +75%, +100% levels: 0 Negative, 80 Positive
Cross Reactivity:
Opiates HEIA: Evaluated by determining minimum concentration for equivalent to 2.0 ng morphine/10 mg hair cutoff.
- Codeine: 100% cross-reactivity, 2.0 ng
- 6-Acetylmorphine: 80% cross-reactivity, 2.5 ng
- Hydrocodone: 20% cross-reactivity, 10 ng
- Hydromorphone: 13% cross-reactivity, 15 ng
- Buprenorphine: 10% cross-reactivity, 20 ng
- Oxycodone: 100 ng
- Oxymorphone: 100 ng
Many other compounds showed no cross-reactivity.
Oxycodone HEIA: Evaluated by determining minimum concentration for equivalent to 2.0 ng oxycodone/10 mg hair cutoff.
- Hydrocodone: 80% cross-reactivity, 2.5 ng
- Codeine: 67% cross-reactivity, 3.0 ng
- 6-Acetylmorphine: 27% cross-reactivity, 7.5 ng
- Morphine: 27% cross-reactivity, 7.5 ng
- Buprenorphine: 13% cross-reactivity, 15 ng
- Hydromorphone: 10% cross-reactivity, 20 ng
- Oxymorphone: 5% cross-reactivity, 40 ng
- Imipramine: 2% cross-reactivity, 100 ng
Many other compounds showed no cross-reactivity.
Interference:
No interference in opiates and oxycodone assay with most tested compounds, exception is imipramine. Imipramine shown to be an interferent in the oxycodone and hydrocodone assay at >= 100 ng imipramine/10 mg hair.
Sample Shipping and Stability During Storage:
Opiate positive samples (7) remained positive after ~2 months storage and shipping twice coast-to-coast in opiates HEIA.
Opioid positive samples (6) remained positive after ~5 months storage and shipping twice coast-to-coast in oxycodone and hydrocodone HEIA.
Recovery:
Opiates HEIA: Average recovery >94% complete after 3 hours.
Oxycodone and hydrocodone HEIA: Average recovery >85% complete after 3 hours.
Cosmetic Treatments:
Opiate HEIA: 15 opiate-negative hair samples treated with perm, dye, shampoo, relaxer remained negative. 10 opiate-positive samples remained positive after treatments.
Oxycodone HEIA: 15 opioid-negative hair samples treated with perm, dye, shampoo, relaxer remained negative. 10 opioid-positive samples remained positive after treatments.
Comparison Studies:
Opiates HEIA: 230 individual hair samples compared against Psychemedics opiates microplate assay (K111926) and LC/MS/MS.
- Opiates HEIA Positive results: 43 samples with washed LC/MS/MS 3.0 ng.
- Opiates HEIA Negative results: 118 samples with washed LC/MS/MS 3.0 ng.
Discordant results showed presence of codeine, 6-AM, and morphine by LC-MS/MS contributing to positive screening results.
Oxycodone HEIA: 219 individual hair samples compared against Psychemedics oxycodone microplate assay (K123799) or opiates microplate assay (K111926) and LC/MS/MS.
- Oxycodone HEIA Positive results: 48 samples with washed LC/MS/MS 3.0 ng.
- Oxycodone HEIA Negative results: 103 samples with washed LC/MS/MS 3.0 ng.
Discordant results showed presence of hydrocodone by LC-MS/MS contributing to positive screening results.
Conclusion: Substantially equivalent to predicate based on performance studies including precision, specificity, and interference (cosmetic effects).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Raw counts provided, not summarized as metrics)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
July 27, 2021
Psychemedics Corporation Neil Stowe Principal Scientist 5832 Uplander Way Culver City, California 90230
Re: K201326
Trade/Device Name: Psychemedics Homogeneous Enzyme Immunoassay for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay for Oxycodone in Hair Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: January 5, 2021 Received: January 6, 2021
Dear Neil Stowe:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201326
Device Name
Psychemedics Homogeneous Enzyme Immunoassay for Opiates in Hair Psychemedics Homogeneous Enzyme Immunoassay for Oxycodone in Hair
Indications for Use (Describe)
The Psychemedics homogeneous enzyme immunoassay (HEIA) for opiates in hair is an enzyme immunoassay for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng morphine/10 mg hair for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics homogeneous enzyme immunoassay for opiates in hair provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/ MS/MS) is the preferred confirmatory method.
The Psychemedics homogeneous enzyme immunoassay (HEIA) for oxycodone in hair is an enzyme immunoassay for the preliminary qualitative detection of oxycodone in human head and body hair using an oxycodone calibrator at 2 ng oxycodone/10 mg hair for the purpose of identifying opioid use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics homogeneous enzyme immunoassay for oxycodone in hair provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method.
| 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K201326
| Submitted By: | Psychemedics Corporation |
|---|---|
| 5832 Uplander Way | |
| Culver City, CA 90230 | |
| TEL: 310 216 7776 | |
| FAX: 310 216 6662 | |
| Submission Contact: | Neil Stowe |
| Date Prepared: | July 26, 2021 |
| Device Trade Name: | Psychemedics Homogeneous Enzyme Immunoassay for Opiates in |
| Hair | |
| Psychemedics Homogeneous Enzyme Immunoassay for Oxycodone | |
| in Hair | |
| Predicate Device: | Psychemedics Microplate EIA for Opiates in Hair, K111926 and |
| Psychemedics Microplate EIA for Oxycodone in Hair, K123799 | |
| Product Code: | DJG |
| Device/Classification | |
| Name: | 21 CFR 862.3650 Opiate Test System, Classification II |
| Intended Use: | The Psychemedics homogeneous enzyme immunoassay (HEIA) for |
| opiates in hair is an enzyme immunoassay for the preliminary | |
| qualitative detection of opiates in human head and body hair using a | |
| morphine calibrator at 2 ng morphine/10m mg hair for the purpose of | |
| identifying opiate use. This is an in vitro diagnostic device intended | |
| exclusively for Psychemedics use only and is not intended for sale to | |
| anyone. The Psychemedics homogeneous enzyme immunoassay | |
| provides only a preliminary analytical test result. A more specific | |
| alternative chemical method must be used in order to obtain a | |
| confirmed analytical result. Liquid Chromatography/Mass | |
| Spectrometry/Mass Spectrometry (LC/MS/MS) is the preferred | |
| confirmatory method. | |
| The Psychemedics homogeneous enzyme immunoassay (HEIA) for | |
| oxycodone in hair is an enzyme immunoassay for the preliminary | |
| qualitative detection of oxycodone in human head and body hair | |
| using an oxycodone calibrator at 2 ng oxycodone/10 mg hair for the | |
| purpose of identifying opioid use. This is an in vitro diagnostic | |
| device intended exclusively for Psychemedics use only and is not | |
| intended for sale to anyone. The Psychemedics homogeneous | |
| enzyme immunoassay provides only a preliminary analytical test | |
| result. A more specific alternative chemical method must be used in | |
| order to obtain a confirmed analytical result. Liquid | |
| Chromatography/Mass Spectrometry/Mass Spectrometry | |
| (LC/MS/MS) is the preferred confirmatory method. | |
| Device Description: | The homogeneous enzyme immunoassay (HEIA) test consists of |
| two parts; a pre-analytical hair treatment procedure (to extract | |
| opioids from the solid hair matrix to form a measurable liquid | |
| matrix) and the screening assay, the Psychemedics Opiates HEIA | |
| and the Psychemedics Oxycodone HEIA. The screening portion of | |
| the test system is based on competition for antibody binding sites | |
| between drug in the measurable liquid matrix and drug-labeled | |
| recombinant glucose-6-phosphate dehydrogenase (G6PDH). As the | |
| antibody binds labeled G6PDH, enzyme activity decreases. In the | |
| presence of drug, enzyme activity increases in direct proportion to | |
| the drug concentration. Active enzyme reduces nicotinamide | |
| adenine dinucleotide (NAD) to NADH in the presence of glucose-6- | |
| phosphate (G6P), resulting in an absorbance change that is measured | |
| spectrophotometrically. | |
| The Psychemedics Opiates HEIA consists of reagents R1 (anti- | |
| opiates monoclonal antibody with substrate) and R2 (morphine | |
| labeled recombinant G6PDH). The Psychemedics Oxycodone | |
| HEIA consists of reagents R1 (anti-oxycodone monoclonal | |
| antibody with substrate) and R2 (oxycodone labeled recombinant | |
| G6PDH). | |
| Sample Collection | |
| and Stability: | A sample of hair should be cut as close as possible to the skin. The |
| hair is placed in a V-shaped aluminum foil sample holder with the | |
| root end of the hair protruding beyond the slanted edge of the foil. | |
| The aluminum foil is crimped around the sample, securing the hair | |
| specimen firmly into place within the foil. The hair sample, crimped | |
| within the foil, is placed in a sample acquisition card envelope and | |
| the envelope is sealed with a tamper-evident seal. Hair specimens are | |
| kept at ambient temperature in a secure location until they are | |
| shipped without refrigeration to the laboratory. Stability of opiates in | |
| hair samples stored at room temperature has been shown for | |
| approximately 2 months. Opiates in samples shipped coast-to-coast | |
| twice was stable. | |
| Materials Required: | Hair sample HEIA for Opiates, HEIA for Oxycodone, automated |
| clinical chemistry analyzer, LC/MS/MS for confirmation. |
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Comparison with Predicate:
| Device & Predicate
| Device(s): | K201326 | K111926 |
|---|---|---|
| Device Trade Name | Psychemedics Homogeneous Enzyme | |
| Immunoassay for Opiates in Hair | Psychemedics Microplate | |
| EIA for Opiates in Hair | ||
| General Device | ||
| Characteristic | ||
| Similarities | ||
| Intended | ||
| Use/Indications For | ||
| Use | The Psychemedics homogeneous enzyme | |
| immunoassay (HEIA) for opiates is an enzyme | ||
| immunoassay for the preliminary qualitative | ||
| detection of opiates in human head and body hair | ||
| using a morphine calibrator at 2 ng morphine/10 | ||
| mg hair for the purpose of identifying opiate use. | ||
| This is an in vitro diagnostic device intended | ||
| exclusively for Psychemedics use only and is not | ||
| intended for sale to anyone. The Psychemedics | ||
| homogeneous enzyme immunoassay provides | ||
| only a preliminary analytical test result. A more | ||
| specific alternative chemical method must be | ||
| used in order to obtain a confirmed analytical | ||
| result. Liquid Chromatography/Mass | ||
| Spectrometry/Mass Spectrometry (LC/MS/MS) is | ||
| the preferred confirmatory method. | The Psychemedics Microplate | |
| EIA for Opiates is an enzyme | ||
| immunoassay (EIA) for the | ||
| preliminary qualitative | ||
| detection of opiates in human | ||
| head and body hair samples | ||
| using a morphine calibrator at | ||
| 2 ng/10 mg hair cutoff for the | ||
| purpose of identifying opiate | ||
| use. | ||
| Sample Matrix | Human Hair | Same |
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| General Device
Characteristic
| Differences | ||
|---|---|---|
| Method of | ||
| Measurement | Automated Clinical Chemistry | |
| Analyzer at 340 nm | Microplate Reader at 450 nm | |
| Antibody | Mouse monoclonal | Rabbit polyclonal |
| Device & Predicate
| Device(s): | K201326 | K123799 |
|---|---|---|
| Device Trade Name | Psychemedics Homogeneous Enzyme | |
| Immunoassay for Oxycodone in Hair | Psychemedics Microplate EIA | |
| for Oxycodone in Hair | ||
| General Device | ||
| Characteristic | ||
| Similarities | ||
| Intended | ||
| Use/Indications For | ||
| Use | The Psychemedics homogeneous enzyme | |
| immunoassay (HEIA) for oxycodone is an | ||
| enzyme immunoassay for the preliminary | ||
| qualitative detection of oxycodone in human | ||
| head and body hair using an oxycodone | ||
| calibrator at 2 ng oxycodone/10 mg hair for the | ||
| purpose of identifying opioid use. This is an in | ||
| vitro diagnostic device intended exclusively for | ||
| Psychemedics use only and is not intended for | ||
| sale to anyone. The Psychemedics homogeneous | ||
| enzyme immunoassay provides only a | ||
| preliminary analytical test result. A more | ||
| specific alternative chemical method must be | ||
| used in order to obtain a confirmed analytical | ||
| result. Liquid Chromatography/Mass | ||
| Spectrometry/Mass Spectrometry (LC/MS/MS) | ||
| is the preferred confirmatory method. | The Psychemedics Microplate | |
| EIA for Oxycodone is an | ||
| enzyme immunoassay (EIA) | ||
| for the preliminary qualitative | ||
| detection of oxycodone in | ||
| human head and body hair | ||
| samples using an oxycodone | ||
| calibrator at 2 ng/10 mg hair | ||
| cutoff for the purpose of | ||
| identifying oxycodone use. | ||
| Sample Matrix | Same | Human hair |
| General Device | ||
| Characteristic | ||
| Differences | ||
| Method of | ||
| Measurement | Automated Clinical Chemistry | |
| Analyzer at 340 nm | Microplate Reader at 450 nm | |
| Antibody | Mouse monoclonal | Rabbit polyclonal |
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Performance Testing Summary:
Precision studies were performed by spiking negative hair with previously validated LC/MS/MS validated calibrator and control solutions to achieve concentrations of negative, the cutoff calibrator of 2 ng morphine/10 mg hair or 2 ng oxycodone/10 mg hair, and +/-75%, +/-50% and +/-25% of the cutoff calibrator. The results were identical for both immunoassays and are summarized below:
| Summary Intra-Assay
Precision | | | Summary Inter-Assay
Precision | | |
|----------------------------------|-----|-----|----------------------------------|-----|-----|
| Level | NEG | POS | Level | NEG | POS |
| -100% | 8 | 0 | -100% | 80 | 0 |
| -75% | 8 | 0 | -75% | 80 | 0 |
| -50% | 8 | 0 | -50% | 80 | 0 |
| -25% | 8 | 0 | -25% | 80 | 0 |
| +25% | 0 | 8 | +25% | 0 | 80 |
| +50 | 0 | 8 | +50 | 0 | 80 |
| +75% | 0 | 8 | +75% | 0 | 80 |
| +100% | 0 | 8 | +100% | 0 | 80 |
Cross Reactivity
Summary:
The cross reactivity of the following metabolites and opiate structural analogs was evaluated by determining the minimum concentration that would result approximately equivalent to the 2.0 ng morphine/10 mg hair cutoff.
| Opiates HEIA: Cross Reactivities of Structurally Related
| Compounds and Metabolites | ||
|---|---|---|
| Compound | % Cross | |
| Reactivity | Concentration | |
| Equivalent to2.0 ng | ||
| Morphine/10 mg Hair | ||
| Codeine | 100 | 2.0 |
| 6-Acetylmorphine | 80 | 2.5 |
| Hydrocodone | 20 | 10 |
| Hydromorphone | 13 | 15 |
| Buprenorphine | 10 | 20 |
| Oxycodone | 100 | |
| Oxymorphone | 100 |
The following compounds were shown to have no cross reactivity in the Opiates assay.
Lisinopril Dihydrate, Atropine, Bupropion, Cotinine, Cannabinol, Chlorpheniramine Maleate, O-Desmethylvenlafaxine, Desipramine, Doxylamine Succinate, 1S, 2R-Ephedrine, Amitriptyline, Dextromethorphan, Lidocaine, Methocarbamol, Nordoxepin,
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Pentazocine, Phenylephrine, Triamterene, Naproxen, Nicotine, Nortriptyline, Propoxyphene, R,R- Pseudoephedrine, Thioridazine, Cis-Tramadol, Venlafaxine HC1, 8-(-)11-nor-9- carboxy-delta 9 THC, 11-nor-9-carboxy-delta 9 THC, Amoxicillin, Propranolol, Promethazine, Phenmetrazine, Phendimetrazine, Benzocaine, Dimenhydrinate, Carbamazepine, Diazepine, Nordiazepam, Oxazepam, Acetaminophen, Caffeine, Dyphylline, Methaqualone, Theophylline, Amphetamine, Cetirizine DiHCl, Imipramine, Methamphetamine, Phencyclidine, Phenylpropanolamine, Amitriptyline, Bupivacaine HC1, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, Phenylephrine, Triamterene, Ethosuximide, Alpha-methyl-alpha-propyl succinimide, Metharbital, Barbital, Methsuximide, Phensuximide, N-Normethsuximide, Mephyton, Ethotoin, Mephobarbital, PEMA, Phenobarbital, Methyl PEMA, 10, 11- Dihydrocarbamazepine, Primidone, 5,5-Diphenylhydantoin, 4-Methylprimidone, Butabarbital, Amobarbital, Secobarbital, Hexobarbital, Azithromycin Dihydrate, Glutethimide, Methaqualone, Diazepam, Chlorpromazine, Flurazepam, AM-2201, JWH-019, JWH-081, JWH-122, CP47,497 (+/-), CP47, 497 (+/-), C8 Homologue, HU-211, JWH-200, JWH-250, Ibuprofen, Ephinephrine (+/-), Norephenephrine (+/-), Metanephrine (+/-), Normetanephrine (+/-), Vanilmandelic Acid (+/-), 5-Hydroxyindole-3-acetic acid, Homovanillic acid. Alprazolam. Cimetidine. Citalopram HBr, Clonazepam, Clopidogrel bisulfate, Fluconazole, Hydrochlorothiazide, Lamotrigine, L-Thyroxine, Methylphenidate HCl, Omeprazole, Levetiracetam, Sertraline HCl, Topiramate, Zolpidem Tartrate, Zonisamide, Amlodipine Besylate Atorvastatin Calcium Salt.
The cross reactivity of the following metabolites, opioid structural analogs and the tricyclic antidepressant imipramine was evaluated by determining the minimum concentration that would result approximately equivalent to the 2.0 ng oxycodone/10 mg hair cutoff.
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| Compounds and Metabolites | ||
|---|---|---|
| Compound | % Cross | |
| Reactivity | Concentration Equivalent | |
| to 2.0 ng Oxycodone/10 | ||
| mg Hair | ||
| Hydrocodone | 80 | 2.5 |
| Codeine | 67 | 3.0 |
| 6-Acetylmorphine | 27 | 7.5 |
| Morphine | 27 | 7.5 |
| Buprenorphine | 13 | 15 |
| Hydromorphone | 10 | 20 |
| Oxymorphone | 5 | 40 |
| Imipramine | 2 | 100 |
| Oxycodone HEIA: Cross Reactivities of Structurally Related
The following compounds were shown to have no cross reactivity in the Oxycodone assay.
Lisinopril Dihydrate, Atropine, Bupropion, Cotinine, Cannabinol, Chlorpheniramine Maleate, O-Desmethylvenlafaxine, Desipramine, Doxylamine Succinate, 1S, 2R-Ephedrine, Amitriptyline, Dextromethorphan, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, Phenylephrine, Triamterene, Naproxen, Nicotine, Nortriptyline, Propoxyphene, R,R- Pseudoephedrine, Thioridazine, Cis-Tramadol, Venlafaxine HC1, 8-(-)11-nor-9- carboxy-delta 9 THC, 11-nor-9-carboxy-delta 9 THC, Amoxicillin, Propranolol, Promethazine, Phenmetrazine, Phendimetrazine, Benzocaine, Dimenhydrinate, Carbamazepine, Diazepine, Nordiazepam, Oxazepam, Acetaminophen, Caffeine, Dyphylline, Methaqualone, Theophylline, Amphetamine, Cetirizine DiHCl, Methamphetamine, Phencyclidine, Phenylpropanolamine, Amitriptyline, Bupivacaine HCl, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, Phenylephrine, Triamterene, Ethosuximide, Alpha-methyl-alphapropyl succinimide, Metharbital, Barbital, Methsuximide, Phensuximide, N-Normethsuximide, Mephenytoin, Ethotoin, Mephobarbital, PEMA, Phenobarbital, Methyl PEMA, 10, 11-Dihydrocarbamazepine, Primidone, 5,5-Diphenylhydantoin, 4-Methylprimidone, Butabarbital, Amobarbital, Secobarbital, Hexobarbital, Azithromycin Dihydrate, Glutethimide, Methaqualone, Diazepam, Chlorpromazine, Flurazepam, AM-2201, JWH-019, JWH-081, JWH-122, CP47,497 (+/-), CP47, 497 (+/-),
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| C8 Homologue, HU-211, JWH-200, JWH-250, Ibuprofen,
Epinephrine (+/-), Norepinephrine (+/-), Metanephrine (+/-),
Normetanephrine (+/-), Vanilmandelic Acid (+/-), 5-
Hydroxyindole-3-acetic acid, Homovanillic acid, Alprazolam,
Cimetidine, Citalopram HBr, Clonazepam, Clopidogrel bisulfate,
Fluconazole, Hydrochlorothiazide, Lamotrigine, L-Thyroxine,
Methylphenidate HCl, Omeprazole, Levetiracetam, Sertraline HCl,
Topiramate, Zolpidem Tartrate, Zonisamide, Amlodipine Besylate,
| Atorvastatin Calcium Salt |
|---|
| Interference: The following compounds were shown to have no interference in the |
| opiates and oxycodone assay with the exception of imipramine. |
| Imipramine was shown to be an interferent in the oxycodone and |
| hydrocodone assay at a concentration of $\ge$ 100 ng imipramine/10 mg |
| hair. |
| Atropine, Bupropion, Cotinine, Cannabinol, Chlorpheniramine |
| maleate, O- Desmethylvenlafaxine, Desipramine, Doxylamine |
| Succinate, 1S, 2R Ephedrine, Anhydroecgonine methyl ester, |
| Naproxen, Nicotine, Nortriptyline, Propoxyphene, R,R- |
| Pseudoephedrine, Thioridazine, Cis-Tramadol, Venlafaxine HCl, 8- |
| (-)-11-nor-9-carboxy-delta-9 THC, 11-nor-9-carboxy-delta 9 THC, |
| Amoxicillin, Propranolol, Promethazine, Phenmetrazine, |
| Phendimetrazine, Benzocaine, Ecgonine, Glutethimide, |
| Meprobamate, Methyprylon, Carbamazepine, Diazepam, |
| Nordiazepam, Oxazepam, Acetaminophen, Caffeine, Dyphylline, |
| Methaqualone, Theophylline, Amitriptyline, Dextromethorphan, |
| Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, |
| Phenylephrine, Triamterene, Ethosuximde, α-Methyl- α- |
| Propylsuccinimde, Metharbital, Barbital, Methsuximide, |
| Phensuximide, N- Normethylsuximde, Mephenytoin, Ethotoin, |
| Mephobarbital, PEMA, Phenobarbital, Methyl PEMA, 10, 11- |
| Dihydrocarbamazepine, Primidone, Carbamazepine, 5,5- |
| Diphenylhydantoin, 4-Methylprimidone, Glutethimide, |
| Methaqualone, Chlorpromazine, Flurazepam, AM-2201, JWH-019, |
| JWH-081, JWH-122, CP47, 497 (±), CP 47, 497 (±) C8 |
| Homologue, HU-211, JWH-200, JWH-250, Acetaminophen, |
| Caffeine, Chlorpheniramine, Ibuprofen, Naproxen, R,R-(-)- |
| Pseudoephedrine, Epinephrine (±), Metanephrine (±), |
| Normetanephrine (±), Alprazolam, Cimetidine, Citalopram HBr |
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| | Clonazepam, Clopidogrel Bisulfate, Fluconazole,
Hydrochlorothiazide, Lamotrigine, L-Thyroxine, Methylphenidate
HCl, Omeprazole, Amlodipine Besylate, Atorvastatin Calcium Salt,
Azithromycin Dihydrate, Bupivacaine HCl Monohydrate, Cetirizine
Di- HCl, Dimenhydrinate, Lisinopril Dihydrate, Benzocaine. |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibrator: | Psychemedics prepares calibrators and control materials using
drug stocks purchased from a commercial vendor. Each lot of
drug is received with its specific certificate of analysis. The
commercially obtained stock is made into calibrators and
controls to the desired concentrations. The concentrations are
confirmed by LC/MS/MS. |
| Sample Shipping and
Stability During
Storage: | Seven opiate positive samples remained positive after approximately
two months in storage and after shipping twice coast-to-coast in the
opiates HEIA. Six opioid positive samples remained positive after
approximately five months in storage and after shipping twice coast-
to-coast in the oxycodone and hydrocodone HEIA. |
| Recovery: | The hair sample preparation for the screening HEIA is an acidic
phosphate buffer extraction procedure. Recovery of opiates in the
opiates HEIA was shown on average to be at least 94% complete
after 3 hours. Recovery of opioids in the oxycodone and
hydrocodone HEIA was shown on average to be at least 85%
complete after 3 hours. |
| Cosmetic Treatments: | Fifteen opiate-negative head hair samples were treated with perm,
dye, shampoo and relaxer and the results compared to the same
samples without treatments. In each case of the fifteen samples
treated with a type of cosmetic treatment, all samples remained
negative in the opiates HEIA after the treatments. |
| | Ten opiate-positive head hair samples were treated with perm, dye,
shampoo and relaxer and the results compared to the same samples
without the treatments. In each case, the samples remained positive
in the opiates HEIA after the treatments. |
| | Fifteen opioid-negative head hair samples were treated with perm,
dye, shampoo and relaxer and the results compared to the same
samples without treatments. In each case of the 15 samples treated
with a type of cosmetic treatment all samples remained negative in |
| | the oxycodone HEIA after the treatments. |
| | Ten opioid-positive head hair samples were treated with perm, dye, shampoo and relaxer and the results compared to the same samples without the treatments. In each case, the samples remained positive in the oxycodone HEIA after the treatments. |
| Comparison Studies: | Samples positive or negative for opiates were identified using the Psychemedics opiates microplate assay (K111926), and then tested with the test device, the Psychemedics HEIA for opiates in hair. The test device (assay) has been validated using 230 individual hair samples collected anonymously from a workplace setting. |
| | The stored hair samples were then tested using Psychemedics' LC/MS/MS confirmatory assay, to compare the Psychemedics HEIA results with the LC/MS/MS results. The studies comparing the HEIA with LC/MS/MS documented the source of hair (head or body) and other demographics as available. The comparison of the Psychemedics Opiates HEIA with LC/MS/MS is shown in the following tables. |
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| Opiates HEIA
Result | Washed LC/MS/MS Result, ng Morphine/10 mg hair (% of cutoff
calibrator) | | | |
|------------------------|----------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------|-------------------------------|
| | 3.0 (> 50%
above cutoff) |
| Positive | 43 | 3 | 14 | 42 |
| Negative | 118 | 10 | 0 | 0 |
The presence of codeine, 6-AM, and morphine was detected by LC-MS/MS in the discordant results observed, and the presence of these analytes contributed to the positive results observed by the screening assay.
Samples positive or negative for opioids were identified using the Psychemedics oxycodone microplate assay (K123799) or opiates microplate assay (K111926), and then tested with the test device, the Psychemedics HEIA for oxycodone in hair. The test device (assay) has been validated using 219 individual hair samples collected anonymously from a workplace setting.
The stored hair samples were then tested using Psychemedics' LC/MS/MS confirmatory assay, to compare the Psychemedics HEIA results with the LC/MS/MS results. The studies comparing
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the HEIA with LC/MS/MS documented the source of hair (head or body) and other demographics as available. The comparison of the Psychemedics Oxycodone HEIA with LC/MS/MS is shown in the following tables.
| Oxycodone
HEIA Result | 3.0 (> 50%
above cutoff) |
|--------------------------|-------------------------------|-------------------------------------------------|-----------------------------------------------|-------------------------------|
| Positive | 48 | 8 | 15 | 31 |
| Negative | 103 | 14 | 0 | 0 |
The presence of hydrocodone was detected by LC-MS/MS in the discordant results observed, and the presence of this analyte contributed to the positive results observed by the screening assay.
The Psychemedics HEIA for opiates in hair is substantially Conclusion: equivalent to the predicate based on performance studies, including precision, specificity and interference (including cosmetic effects).
The Psychemedics HEIA for oxycodone in hair is substantially equivalent to the predicate based on performance studies, including precision, specificity and interference (including cosmetic effects).