(322 days)
Not Found
No
The device description details a standard enzyme immunoassay (HEIA) process based on chemical reactions and spectrophotometric measurement. There is no mention of AI, ML, or any computational algorithms used for interpretation or analysis beyond the direct measurement of absorbance changes. The performance studies focus on comparing the HEIA results to LC/MS/MS, a standard analytical technique, not on validating an AI/ML model.
No
The device is described as an "in vitro diagnostic device" for the detection of drugs in hair, which is used for diagnostic purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This is an in vitro diagnostic device intended exclusively for Psychemedics use only."
No
The device description clearly outlines physical reagents (R1 and R2) and a spectrophotometric measurement process, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: 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 for sale to anyone."
- Nature of the Test: The device performs a test on a biological sample (human hair) in vitro (outside of the living body) to detect the presence of substances (amphetamines) for the purpose of identifying drug use. This aligns with the definition of an in vitro diagnostic device.
- Device Description: The description details a laboratory-based assay using reagents and spectrophotometric measurement, which is typical of IVD tests.
N/A
Intended Use / Indications for Use
The Psychemedics homogeneous enzyme immunoassay (HEIA) for amphetamines in hair is an enzyme immunoassay system for the preliminary qualitative detection of methamphetamine in human head and body hair using a methamphetamine calibrator at 3 ng methamphetamine/10 mg hair or 5 ng methamphetamine/10 mg hair for the purpose of identifying methamphetamine use, and for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng amphetamine/10 mg hair for the purpose of identifying amphetamine use.
This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not for sale to anyone. The Psychemedics HEIA for amphetamines in hair 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.
Product codes (comma separated list FDA assigned to the subject device)
LAF, DKZ
Device Description
The test consists of two parts; a pre-analytical hair treatment procedure (to extract amphetamines from the solid hair matrix to a measurable liquid matrix) and the screening assay, the Psychemedics Amphetamines 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 Amphetamines HEIA consists of reagents R1 (anti-methamphetamine monoclonal antibody with substrate) and R2 (methamphetamine labeled recombinant G6PDH) for the detection of methamphetamine, and reagents R1 (anti-amphetamine monoclonal antibody with substrate) and R2 (amphetamine labeled recombinant G6PDH) for the detection of amphetamine.
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 amphetamines in hair samples stored at room temperature has been shown for at least seven months. Amphetamines in samples shipped coast-to-coast twice was stable.
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
This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing Summary: Precision studies were performed by spiking negative hair with previously LC/MS/MS validated calibrator and control solutions to achieve concentrations of negative, the cutoff calibrator of 3 ng methamphetamine/10 mg hair, 5 ng methamphetamine/10 mg hair, or 3 ng amphetamine/10 mg hair, and +/- 75%, +/-50% and +/-25% of the cutoff calibrator.
Methamphetamine Intra-Assay and Inter-Assay Precision Summary, 3 ng Methamphetamine/10 mg Hair Calibrator:
For Intra-Assay Precision (8 samples per level): -100%, -75%, -50%, -25% levels were all Negative (8 Negative, 0 Positive). +25%, +50, +75%, +100% levels were all Positive (0 Negative, 8 Positive).
For Inter-Assay Precision (80 samples per level): -100%, -75%, -50%, -25% levels were all Negative (80 Negative, 0 Positive). +25%, +50, +75%, +100% levels were all Positive (0 Negative, 80 Positive).
Methamphetamine Intra-Assay and Inter-Assay Precision Summary, 5 ng Methamphetamine/10 mg Hair Calibrator:
For Intra-Assay Precision (8 samples per level): -100%, -75%, -50%, -25% levels were all Negative (8 Negative, 0 Positive). +25%, +50, +75%, +100% levels were all Positive (0 Negative, 8 Positive).
For Inter-Assay Precision (80 samples per level): -100%, -75%, -50%, -25% levels were all Negative (80 Negative, 0 Positive). +25%, +50, +75%, +100% levels were all Positive (0 Negative, 80 Positive).
Amphetamine Intra-Assay and Inter-Assay Precision Summary, 3 ng Amphetamine/10 mg Hair Calibrator:
For Intra-Assay Precision (8 samples per level): -100%, -75%, -50%, -25% levels were all Negative (8 Negative, 0 Positive). +25%, +50, +75%, +100% levels were all Positive (0 Negative, 8 Positive).
For Inter-Assay Precision (80 samples per level): -100%, -75%, -50%, -25% levels were all Negative (80 Negative, 0 Positive). +25%, +50, +75%, +100% levels were all Positive (0 Negative, 80 Positive).
Cross Reactivity Summary:
Evaluated minimum concentration for cross-reactivity equivalent to 3.0 ng methamphetamine/10 mg hair and 5.0 ng methamphetamine/10 mg hair cutoffs.
- MDMA: 81% cross-reactivity at 3.7 ng (3 ng cutoff), 83% at 6 ng (5 ng cutoff).
- Para-Methoxy Methamphetamine: 50% at 6.0 ng (3 ng cutoff), 50% at 10 ng (5 ng cutoff).
- 1R, 2S Ephedrine: 20% at 15 ng (3 ng cutoff), 20% at 25 ng (5 ng cutoff).
- MDEA: 12% at 25 ng (3 ng cutoff), 10% at 50 ng (5 ng cutoff).
- R-Methamphetamine: 2% at 150 ng (3 ng cutoff), 2% at 175 ng (5 ng cutoff).
- D-Amphetamine, L-Amphetamine, MDA, Para-methoxy Amphetamine: 300 ng (3 ng cutoff) and >500 ng (5 ng cutoff).
No cross-reactivity was shown for various other compounds.
Evaluated minimum concentration for cross-reactivity equivalent to 3.0 ng amphetamine/10 mg hair cutoff.
- MDA: 100% cross-reactivity at 3.0 ng.
- Phentermine: 25% at 12 ng.
- D-Methamphetamine, MDMA, Phenmetrazine, 1R, 2S Ephedrine: 300 ng.
No cross-reactivity was shown for various other compounds in the Amphetamine assay.
Interference: Various compounds showed no interference in the methamphetamine and amphetamine assays.
Sample Shipping Stability During Storage: 9 methamphetamine positive samples remained positive after approximately 8 months in storage and after shipping twice coast-to-coast. 9 amphetamine positive samples remained positive after approximately 6 months in storage and after shipping twice coast-to-coast.
Recovery: Recovery of methamphetamine and amphetamine in the method was shown on average to be approximately 100% complete after extraction for 3 hours using a phosphate buffer extraction procedure.
Cosmetic Treatments:
- 5 methamphetamine-negative head hair samples treated with perm, dye, shampoo, and relaxer remained negative.
- 4 methamphetamine-positive head hair samples treated with perm, dye, shampoo, and relaxer remained positive.
- 5 amphetamine-negative head hair samples treated with dye, shampoo, and relaxer remained negative; 4 amphetamine-negative hair samples treated with perm remained negative.
- 4 amphetamine-positive head hair samples treated with perm, dye, shampoo, and relaxer remained positive.
Comparison Studies:
Methamphetamine, 3 ng methamphetamine/10 mg hair calibrator:
- Sample size: 114 individual hair samples collected anonymously from a workplace setting. 58 negative and 56 positive samples identified by the test device.
- Comparison with LC/MS/MS:
- HEIA Positive: 0 samples 4.50 ng/10 mg hair.
- HEIA Negative: 53 samples 4.50 ng/10 mg hair.
- Discordant Results (Positive HEIA/Negative LC/MS/MS): 2 samples had positive HEIA but negative LC/MS/MS upon washing (LC/MS/MS results of 2.43 ng/10 mg hair and 2.46 ng/10 mg hair after washing, from unwashed results of 4.70 and 4.80 ng/10 mg hair).
Methamphetamine, 5 ng methamphetamine/10 mg hair calibrator:
- Sample size: 94 individual hair samples collected anonymously from a workplace setting. 49 negative and 45 positive samples identified by the test device.
- Comparison with LC/MS/MS:
- HEIA Positive: 0 samples 7.50 ng/10 mg hair.
- HEIA Negative: 45 samples 7.50 ng/10 mg hair.
- Discordant Results (Positive HEIA/Negative LC/MS/MS): 2 samples had positive HEIA but negative LC/MS/MS upon washing (LC/MS/MS results of 4.28 ng/10 mg hair and 4.56 ng/10 mg hair after washing, from unwashed results of 6.18 and 5.57 ng/10 mg hair).
Amphetamine, 3 ng Amphetamine/10 mg hair calibrator:
- Sample size: 96 individual hair samples collected anonymously from a workplace setting. 48 negative and 48 positive samples identified by the test device.
- Comparison with LC/MS/MS:
- HEIA Positive: 0 samples 4.50 ng/10 mg hair.
- HEIA Negative: 42 samples 4.50 ng/10 mg hair.
- Discordant Results (Positive HEIA/Negative LC/MS/MS): 2 samples had positive HEIA but negative LC/MS/MS upon washing (LC/MS/MS results of 2.51 ng/10 mg hair and 2.73 ng/10 mg hair after washing, from unwashed results of 3.18 and 5.82 ng/10 mg hair).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not explicitly stated as Sensitivity, Specificity, PPV, NPV. Precision data is provided as NEG/POS counts across various concentration levels. Calibration comparison studies against LC/MS/MS provide counts for HEIA result vs. LC/MS/MS result ranges, which can be used to infer these metrics. For example, for Methamphetamine 3 ng calibrator:
- True Positives (HEIA POS, LC/MS/MS >= 3.0): 19 + 35 = 54
- False Positives (HEIA POS, LC/MS/MS = 3.0): 0 + 0 = 0
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.
Psychemedics Microplate EIA for Methamphetamine in Hair, K111927; Psychemedics Microplate EIA for Amphetamine in Hair, K130811
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
§ 862.3610 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).
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Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2021
Psychemedics Corporation Neil Stowe Principal Scientist 5832 Uplander Way Culver City, California 90230
Re: K210212
Trade/Device Name: Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: LAF, DKZ Dated: September 13, 2021 Received: September 15, 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.
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
1
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 (OPEQ) Center for Devices and Radiologial Health (CDRH)
Enclosure
2
Indications for Use
510(k) Number (if known) K210212
Device Name
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
Indications for Use (Describe)
The Psychemedics homogeneous enzyme immunoassay (HEIA) for amphetamines in hair is an enzyme immunoassay system for the preliminary qualitative detection of methamphetamine in human head and body hair using a methamphetamine calibrator at 3 ng methamphetamine/10 mg hair or 5 ng methamphetamine/10 mg hair for the purpose of identifying methamphetamine use, and for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng amphetamine/10 mg hair for the purpose of identifying amphetamine use.
This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not for sale to anyone. The Psychemedics HEIA for amphetamines in hair 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.
| 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) | X |
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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: | K210212 |
|---|---|
| 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: | |
| Device Trade Name: | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair |
| Predicate Device: | Psychemedics Microplate EIA for Methamphetamine in Hair, K111927; |
| Psychemedics Microplate EIA for Amphetamine in Hair, K130811 | |
| Product Code: | LAF (Methamphetamine Test System), DKZ (Amphetamine Test System) |
| Device/Classification Name: | 21 CFR 862.3610 Methamphetamine Test System, Classification II, 21 CFR |
| 862.3100 Amphetamine Test System, Classification II | |
| Intended Use: | The Psychemedics homogeneous enzyme immunoassay (HEIA) for |
| amphetamines in hair is an enzyme immunoassay system for the preliminary | |
| qualitative detection of methamphetamine in human head and body hair using a | |
| methamphetamine calibrator at 3 ng methamphetamine/10 mg hair or 5 ng | |
| methamphetamine/10 mg hair for the purpose of identifying methamphetamine | |
| use, and for the preliminary qualitative detection of amphetamine in human head | |
| and body hair using an amphetamine calibrator at 3 ng amphetamine/10 mg hair | |
| for the purpose of identifying amphetamine use. This is an in vitro diagnostic | |
| device intended exclusively for Psychemedics use only and is not for sale to | |
| anyone. | |
| The Psychemedics HEIA Amphetamines Assay provides only a preliminary | |
| analytical test result. A more specific alternative chemical method must be used | |
| in order to obtain a confirmed analytical test result. Liquid | |
| Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) is the | |
| preferred confirmatory method. | |
| Device Description: | The test consists of two parts; a pre-analytical hair treatment procedure (to |
| extract amphetamines from the solid hair matrix to a measurable liquid matrix) | |
| and the screening assay, the Psychemedics Amphetamines 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 Amphetamines HEIA consists of reagents R1 (anti- | |
| methamphetamine monoclonal antibody with substrate) and R2 | |
| (methamphetamine labeled recombinant G6PDH) for the detection of | |
| methamphetamine, and reagents R1 (anti-amphetamine monoclonal antibody | |
| with substrate) and R2 (amphetamine labeled recombinant G6PDH) for the | |
| detection of amphetamine. | |
| 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 amphetamines in hair | |
| samples stored at room temperature has been shown for at least seven months. | |
| Amphetamines in samples shipped coast-to-coast twice was stable. | |
| Materials Required: | Hair sample collection kit, HEIA for Amphetamines, automated clinical |
| chemistry analyzer, LC/MS/MS for confirmation. |
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Comparison with Predicate Devices:
| Item | Proposed Device | Psychemedics Methamphetamine Assay, K111927 |
|---|---|---|
| Indications/Intended Use | The Psychemedics HEIA is an enzyme immunoassay system for the preliminary qualitative detection of methamphetamine in human head and body hair using a methamphetamine calibrator of 3 ng methamphetamine/10 mg hair or 5 ng methamphetamine/10 mg hair for the purpose of identifying methamphetamine use. This is an in-vitro diagnostic device intended exclusively for Psychemedics use only and is not for sale to anyone. The enzyme immunoassay system provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method such as LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgement must be applied to the interpretation of any drug-of-abuse test result. | The Psychemedics Microplate EIA for Methamphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng/10 mg hair cutoff for the purpose of identifying methamphetamine use. This product is intended exclusively for in-house professional use and not for sale to anyone. The test is not intended for over-the-counter sale to non-professionals. The Psychemedics EIA Methamphetamine Assay provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method such as LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgement must be applied to the interpretation of any drug-of-abuse test result. |
| Product Code | LAF | LAF |
| Measurand | Methamphetamine | Methamphetamine |
| Test System | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Psychemedics Microplate EIA for Methamphetamine in Hair |
| Sample Matrix | Human Hair | Human Hair |
| Method of Measurement | Automated Clinical Chemistry Analyzer at 340 nm | Microplate Reader at 450 nm |
| Type of Test | Enzyme Immunoassay | Enzyme Immunoassay |
| Extraction Method | Acidic aqueous buffer | Patented Digestion Method |
| Confirmation Method | LC/MS/MS | LC/MS/MS |
| Item | Proposed Device | Psychemedics Amphetamine |
| Assay, K130811 | ||
| Indications/Intended Use | The Psychemedics HEIA is an | |
| enzyme immunoassay system for | ||
| the preliminary qualitative detection | ||
| of amphetamine in human head and | ||
| body hair using an amphetamine | ||
| calibrator of 3 ng/10 mg hair for the | ||
| purpose of identifying amphetamine | ||
| use. This is an in vitro diagnostic | ||
| device intended exclusively for | ||
| Psychemedics use only and is not | ||
| for sale to anyone. | ||
| The enzyme immunoassay system | ||
| provides only a preliminary | ||
| analytical test result. To confirm a | ||
| presumptive screen positive result, | ||
| a more specific alternate chemical | ||
| method such as LC/MS/MS (liquid | ||
| chromatography/mass | ||
| spectrometry/mass spectrometry) | ||
| must be used. Clinical | ||
| consideration and professional | ||
| judgement must be applied to the | ||
| interpretation of any drug-of-abuse | ||
| test result. | The Psychemedics Microplate EIA | |
| for Amphetamine is an enzyme | ||
| immunoassay (EIA) for the | ||
| preliminary qualitative detection of | ||
| amphetamine in human head and | ||
| body hair samples using an | ||
| amphetamine calibrator at 3 ng/10 | ||
| mg hair cutoff for the purpose of | ||
| identifying amphetamine use. This | ||
| is an in vitro diagnostic device | ||
| intended exclusively for | ||
| Psychemedics use only. | ||
| Psychemedics has not performed | ||
| an evaluation of reproducibility at | ||
| different laboratories. | ||
| The Psychemedics Microplate EIA | ||
| amphetamine assay provides only a | ||
| preliminary analytical test result. A | ||
| more specific alternative chemical | ||
| method must be used in order to | ||
| obtain a confirmed analytical | ||
| result. Gas or Liquid | ||
| Chromatography/Double Mass | ||
| Spectrometry (GC/MS or | ||
| LC/MS/MS) is the preferred | ||
| confirmatory method. Clinical | ||
| consideration and professional | ||
| judgement should be exercised | ||
| with any drug of abuse test result, | ||
| particularly when the result is positive. | ||
| Product Code | DKZ | DKZ |
| Measurand | Amphetamine | Amphetamine |
| Test System | Psychemedics Homogeneous | |
| Enzyme Immunoassay for | ||
| Amphetamines in Hair | Psychemedics Microplate EIA for | |
| Amphetamine in Hair | ||
| Sample Matrix | Human Hair | Human Hair |
| Method of Measurement | Automated Clinical Chemistry | |
| Analyzer at 340 nm | Microplate Reader at 450 nm | |
| Type of Test | Enzyme Immunoassay | Enzyme Immunoassay |
| Extraction Method | Acidic aqueous buffer | Patented Digestion Method |
| Confirmation Method | LC/MS/MS | LC/MS/MS |
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Performance Testing Summary: Precision studies were performed by spiking negative hair with previously LC/MS/MS validated calibrator and control solutions to achieve concentrations of negative, the cutoff calibrator of 3 ng methamphetamine/10 mg hair, 5 ng methamphetamine/10 mg hair, or 3 ng amphetamine/10 mg hair, and +/- 75%, +/-50% and +/-25% of the cutoff calibrator.
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| Methamphetamine Intra-Assay and Inter-Assay Precision Summary, 3 ng | ||
|---|---|---|
| Methamphetamine/10 mg Hair Calibrator | ||
| 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 |
| Methamphetamine Intra-Assay and Inter-Assay Precision Summary, 5 ng | |||||
|---|---|---|---|---|---|
| Methamphetamine/10 mg Hair Calibrator | |||||
| 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 |
| Amphetamine Intra-Assay and Inter-Assay Precision Summary | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Summary Intra-Assay Precision | Summary Inter-Assay Precision | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Level NEG POS -100% 8 0 -75% 8 0 -50% 8 0 -25% 8 0 +25% 0 8 +50 0 8 +75% 0 8 +100% 0 8 | Level NEG POS -100% 80 0 -75% 80 0 -50% 80 0 -25% 80 0 +25% 0 80 +50 0 80 +75% 0 80 +100% 0 80 |
Cross Reactivity Summary:
The cross reactivity of the following metabolites and amphetamines structural analogs was evaluated by determining the minimum concentration that would result approximately equivalent to the 3.0 ng methamphetamine/10 mg hair and 5.0 ng methamphetamine/10 mg cutoffs.
8
| Cross Reactivities, Methamphetamine 3 ng/10 mg Calibrator, Structurally Related | ||
|---|---|---|
| Compounds and Metabolites | ||
| Compound | % Cross | |
| Reactivity | Concentration Equivalent to 3.0 ng | |
| Methamphetamine/10 mg Hair | ||
| MDMA | 81 | 3.7 |
| Para-Methoxy Methamphetamine | 50 | 6.0 |
| 1R, 2S Ephedrine | 20 | 15 |
| MDEA | 12 | 25 |
| R-Methamphetamine | 2 | 150 |
| D-Amphetamine | 300 | |
| L-Amphetamine | 300 | |
| MDA | 300 | |
| Para-methoxy Amphetamine | 300 |
| Cross Reactivities, Methamphetamine 5 ng/10 mg Calibrator, Structurally Related
| Compounds and Metabolites | ||
|---|---|---|
| Compound | % Cross | |
| Reactivity | Concentration Equivalent to 5.0 ng | |
| Methamphetamine/10 mg Hair | ||
| MDMA | 83 | 6 |
| Para-Methoxy Methamphetamine | 50 | 10 |
| 1R, 2S Ephedrine | 20 | 25 |
| MDEA | 10 | 50 |
| R-(-)-Methamphetamine | 2 | 175 |
| D-Amphetamine | 500 | |
| L-Amphetamine | 500 | |
| MDA | 500 | |
| Para-methoxy Amphetamine | 500 |
The following compounds were shown to have no cross reactivity in the methamphetamine assay using the 3 ng or 5 ng methamphetamine/10 mg hair calibrator.
Lisinopril Dihydrate, Atropine, Bupropion, Cotinine, Cannabinol, Chlorpheniramine Maleate, O-Desmethylvenlafaxine, Desipiramine, Doxylamine Succinate, 1S, 2R-Ephedrine, Amitriptyline, Dextromethorphan, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, Phenylephrine, Triamterene, Naproxen, Nicotine, Nortriptyline, Propoxyphene, R,R-Pseudoepedrine, Thioridazine, Cis-Tramadol, Venlafaxine HCl, 8-(-)11-nor-9carboxy-delta 9 THC, 11-nor-9-carboxy-delta 9 THC, Amoxicillin, Propanolol, Promethazine, Phenmetrazine, Phendimetrazine, Benzocaine, Dimenhydrinate, Metanephrin, Carbamazepine, Diazepine, Nordiazepam, Oxazepam, Acetominophen, Caffeine, Dyphylline, Methaqualone, Theophylline, Amphetamine, Cetrizine DiHCl, Imipramine, Phencyclidine, Phenylpropanolamine, Amitryptiline, Bupivacaine HCl, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, Pheynylephrine, Triamterene, Ethosuximide, Alpha-methyl-alpha-propyl succinimide, Metharbital, Barbital, Mehsuximde, Phensuximide, N-Normethsuximide, Mephyton, Ethotoin, Mephobarbital, PEMA, Phenobarbital, Methyl PEMA, 10, 11
9
Dihydrocarbamazepine, Primidone, 5,5-Diphenylhydantoin, 4-Methylprimidone, Butabarbital, Amobarbital, Secobarbital, Hexobarbital, Azithromyocin 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, Lamotrigeine, L-Thyroxine, Methylphenidate HCl, Omeprazole, Levetiracetam, Sertaline HCl, Topiramate, Zolpidem Tartrate, Zonisamide, Amlopidine Besylate Atorvastatin Calcium Salt
The cross reactivity of the following metabolites and amphetamines structural analogs was evaluated by determining the minimum concentration that would result approximately equivalent to the 3.0 ng amphetamine/10 mg hair cutoff.
| Cross Reactivities of Structurally Related Compounds and Metabolites | ||
|---|---|---|
| Compound | % Cross | |
| Reactivity | Concentration Equivalent to 3.0 ng | |
| Amphetamine/10 mg Hair | ||
| MDA | 100 | 3.0 |
| Phentermine | 25 | 12 |
| D-Methamphetamine | 300 | |
| MDMA | 300 | |
| Phenmetrazine | 300 | |
| 1R, 2S Ephedrine | 300 |
The following compounds were shown to have no cross reactivity in the Amphetamine assay.
Lisinopril Dihydrate, Atropine, Bupropion, Cotinine, Cannabinol, Chlorpheniramine Maleate, O-Desmethylvenlafaxine, Desipiramine, Doxylamine Succinate, 1S, 2R-Ephedrine, Amitriptyline, Dextromethorphan, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, Phenylephrine, Triamterene, Naproxen, Nicotine, Nortriptyline, Propoxyphene, R,R-Pseudoepedrine, Thioridazine, Cis-Tramadol, Venlafaxine HCl. 8-(-)11-nor-9carboxy-delta 9 THC, 11-nor-9-carboxy-delta 9 THC, Amoxicillin, Propanolol, Promethazine, Phenmetrazine, Phendimetrazine, Benzocaine, Dimenhydrinate, Metanephrin, Carbamazepine, Diazepine, Nordiazepam, Oxazepam, Acetominophen, Caffeine, Dyphylline, Methaqualone, Theophylline, Cetrizine DiHCl, Imipramine, Methamphetamine, Phencyclidine, Phenylpropanolamine, Amitryptiline, Bupivacaine HCl, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, Pheynylephrine, Triamterene, Ethosuximide, Alpha-methyl-alphapropyl succinimide, Metharbital, Barbital, Mehsuximde, Phensuximide, N-Normethsuximide, Mephyton, Ethotoin, Mephobarbital, PEMA, Phenobarbital, Methyl PEMA, 10, 11-Dihydrocarbamazepine, Primidone, 5,5-Diphenylhydantoin, 4-Methylprimidone, Butabarbital, Amobarbital, Secobarbital, Hexobarbital, Azithromyocin Dihydrate, Glutethimide, Methaqualone, Diazepam, Chlorpromazine, Flurazepam, AM-2201, JWH-019,
10
| | 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, Lamotrigeine, L-Thyroxine, Methylphenidate HCl,
Omeprazole, Levetiracetam, Sertaline HCl, Topiramate, Zolpidem Tartrate,
Zonisamide, Amlopidine Besylate Atorvastatin Calcium Salt |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interference: | The following compounds were shown to have no interference in the
methamphetamine and amphetamine assays. |
| | Anhydroecgonine Methyl Ester, Atropine, Bupropion, Cotinine, Cannabinol,
Chlorpheniramine maleate, O-Desmethylvenlafaxine, Desipiramine,
Doxylamine Succinate, 1S, 2R-Ephedrine, Naproxen, Nicotine, Nortriptyline,
Propoxyphene, R,R-Pseudoephedrine, Thioridazine, Cis-Tramadol, Venlafaxine
HCl, 8-(-)-11-nor-9-caroxy-delta-9 THC, 11-nor-9-carboxy-delta-9 THC,
Amoxicillin, Propanolol, Promethazine, Phenmetrazine, Phendimetrazine,
Benzocaine, Ecgonine, Metanephrin, Glutethimide, Meprobamate, Methyprylon,
Carbamazepine, Diazepam, Nordiazepam, Oxazepam, Acetaminophen,
Caffeine, Dyphylline, Methaqualone, Theophylline, Amitryptiline,
Dextromethorphan, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine,
Phenylephrine, Triamterene, Ethosuximide, a-Methyl-a-propylsuccinimide,
Metharbital, Barbital, Methsuximide, Phensuximide, N-Normethylsuximide,
Mephenytoin, Ethytion, 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 (±), Norepinephrine (±), normetanephrine (±),
Alprazolam, Cimetidine, Citalopram HBr, Clonazepam, Clopidogrel Bisulfate,
Fluconazole, Hydrochlorothiazide, Lamotrigine, L-Thyroxine, Methylphenidate
HCl, Omeprazole, Amlopidine Besylate, Atorvastatin Calcium Salt,
Azithromycin Dihydrate, Bupivacaine HCl, Cetirizine Di-HCl, Dimenhydrinate,
Lisinopril Dihydrate, Butabarbital, Amobarbital, Secobarbital, Hexobarbital,
Medazepam, Lorazepam, Temazepam, Bromazepam, Carbamazepine,
Levetiracetam, Metformin HCl, Phenobarbital, Phenytoin, R-(-)-Phenylephrine
HCl, Sertraline HCl, Topiramate, Zolpidem Tartrate, Zonisamide, 11-nor-9-
caroxy-delta-8 THC, Streptomycin Solution, Procaine, Erythromycin, Penicillin
G, Mepivacaine, Vanilmandelic Acid (±), 5-Hydroxyindole-3-Acetic Acid,
Homovanilic Acid |
| 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 |
| Sample Shipping Stability
During Storage: | 9 methamphetamine positive samples remained positive after approximately 8
months in storage and after shipping twice coast-to-coast. 9 amphetamine
positive samples remained positive after approximately 6 months in storage and
after shipping twice coast-to-coast. |
| Recovery: | The hair sample preparation for the screening HEIA is a phosphate buffer
extraction procedure. Recovery of methamphetamine in the method was shown
on average to be approximately 100% complete after extraction for 3 hours.
Recovery of amphetamine in the method was shown on average to be
approximately 100% complete after extraction for 3 hours. |
| Cosmetic Treatments: | 5 methamphetamine-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 5 samples treated with a type of cosmetic
treatment, all samples remained negative after the treatments.
4 methamphetamine-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 after the treatments.
5 amphetamine-negative head hair samples were treated with dye, shampoo and
relaxer and the results compared to the same samples without treatments. 4
amphetamine-negative head hair samples were treated with perm and the results
compared to the same samples without treatments. In each case of the samples
treated with a type of cosmetic treatment, all samples remained negative after
the treatments.
4 amphetamine-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 after the treatments. |
| Comparison Studies: | Methamphetamine, 3 ng methamphetamine/10 mg hair calibrator
Samples positive or negative for methamphetamine were identified using the
Psychemedics methamphetamine microplate assay (K111927), and then tested
with the test device, the Psychemedics HEIA for methamphetamine in hair. The
test device (assay) has been validated at the 3 ng methamphetamine/10 mg hair
cutoff using 114 individual hair samples collected anonymously from a
workplace setting. 58 negative samples and 56 positive samples were identified
by the test device.
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 Methamphetamine HEIA at the
3 ng/10 mg hair calibrator with LC/MS/MS is shown in the following table. |
11
12
| Methamphetamine 3 ng/10 mg hair Calibrator Comparison Study | ||||
|---|---|---|---|---|
| HEIA Result | Washed LC/MS/MS Result, ng Methamphetamine/10 mg hair (% of cutoff calibrator) | |||
| 4.50 (> 50% above cutoff) | ||||
| Positive | 0 | 2 | 19 | 35 |
| Negative | 53 | 5 | 0 | 0 |
Methamphetamine Discordant Results at the 3 ng methamphetamine/10 mg hair calibrator: Positive HEIA/Negative LC/MS/MS
Washing of hair before confirmation: exclusion of potential environmental contamination and/or sweat-derived drug from hair analysis results can result in APPARENT discordant results. Ingested drugs are present in perspiration, which settles on the hair and requires removal if the hair analysis result is to reflect amount of drug ingested rather than exposure to the sweat-derived drug. Drug could also be present as a result of environmental contamination (e.g., powder, smoke). Hair is not washed prior to screening, as it would not be reasonable to wash hundreds of negative hair samples; i.e., samples that are negative without washing. Thus, it is expected that the washing performed before LC/MS/MS confirmation of presumptive positives removes external drug and the confirmation results may then be lower than the screening may have predicted without the consideration of sweat-derived drug and/or drug from environmental contamination.
| Methamphetamine, 3 ng/10 mg Hair Calibrator Discordant Results | ||||
|---|---|---|---|---|
| Sample | HEIA Result | Unwashed | ||
| LC/MS/MS | ||||
| Result (ng | ||||
| Meth/10 | ||||
| mg hair) | Washed | |||
| LC/MS/MS | ||||
| Result (ng | ||||
| Meth/10 | ||||
| mg hair) | Comment | |||
| 1 | POS | 4.70 | 2.43 | Samples are screened by HEIA without hair washing. |
| LC/MS/MS is performed only after washing once with | ||||
| 2 | POS | 4.80 | 2.46 | isopropanol, 3 times 30 minutes with 90% Ethanol, |
| then 2 times 60 minutes with 90% Ethanol. Thus, it is | ||||
| expected that some samples will be negative by | ||||
| LC/MS/MS after washing. |
Methamphetamine, 5 ng methamphetamine/10 mg hair calibrator
Samples positive or negative for methamphetamine were identified using the Psychemedics methamphetamine microplate assay (K111927), and then tested with the test device, the Psychemedics HEIA for methamphetamine in hair. The test device (assay) has been validated at the 5 ng methamphetamine/10 mg hair cutoff using 94 individual hair samples collected anonymously from a workplace setting. 49 negative samples and 45 positive samples were identified by the test device.
The stored hair samples were then tested using Psychemedics' LC/MS/MS confirmatory assay, to compare the Psychemedics HEIA results with the
13
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 Methamphetamine HEIA at the 5 ng/10 mg hair calibrator with LC/MS/MS is shown in the following table.
| Methamphetamine 5 ng/10 mg hair Calibrator Comparison Study | ||||
|---|---|---|---|---|
| HEIA Result | Washed LC/MS/MS Result, ng Methamphetamine /10 mg hair (% of cutoff calibrator) | |||
| 7.50 (> 50% above cutoff) | ||||
| Positive | 0 | 2 | 6 | 37 |
| Negative | 45 | 4 | 0 | 0 |
Methamphetamine Discordant Results at the 5 ng methamphetamine/10 mg hair calibrator: Positive HEIA/Negative LC/MS/MS
Washing of hair before confirmation: exclusion of potential environmental contamination and/or sweat-derived drug from hair analysis results can result in APPARENT discordant results. Ingested drugs are present in perspiration, which settles on the hair and requires removal if the hair analysis result is to reflect amount of drug ingested rather than exposure to the sweat-derived drug. Drug could also be present as a result of environmental contamination (e.g., powder, smoke). Hair is not washed prior to screening, as it would not be reasonable to wash hundreds of negative hair samples; i.e., samples that are negative without washing. Thus, it is expected that the washing performed before LC/MS/MS confirmation of presumptive positives removes external drug and the confirmation results may then be lower than the screening may have predicted without the consideration of sweat-derived drug and/or drug from environmental contamination.
| Methamphetamine, 5 ng/10 mg Hair Calibrator Discordant Results | ||||
|---|---|---|---|---|
| Sample | HEIA Result | Unwashed | ||
| LC/MS/MS | ||||
| Result (ng | ||||
| Meth/10 | ||||
| mg hair) | Washed | |||
| LC/MS/MS | ||||
| Result (ng | ||||
| Meth/10 | ||||
| mg hair) | Comment | |||
| 1 | POS | 6.18 | 4.28 | Samples are screened by HEIA without hair washing. |
| LC/MS/MS is performed only after washing once with | ||||
| 2 | POS | 5.57 | 4.56 | isopropanol, 3 times 30 minutes with 90% Ethanol, |
| then 2 times 60 minutes with 90% Ethanol. Thus, it is | ||||
| expected that some samples will be negative by | ||||
| LC/MS/MS after washing. |
Amphetamine, 3 ng Amphetamine/10 mg hair calibrator
Samples positive or negative for amphetamine were identified using the Psychemedics methamphetamine microplate assay (K130811), and then tested with the test device, the Psychemedics HEIA for amphetamine in hair. The test device (assay) has been validated using 96 individual hair samples collected
14
anonymously from a workplace setting. 48 negative samples and 48 positive samples were identified by the test device.
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 Amphetamine HEIA with LC/MS/MS is shown in the following table.
| Amphetamine 3 ng/10 mg hair Calibrator Comparison Study | ||||
|---|---|---|---|---|
| HEIA Result | Washed LC/MS/MS Result, ng Amphetamine/10 mg hair (% of cutoff calibrator) | |||
| 4.50 (> 50% above cutoff) | ||||
| Positive | 0 | 2 | 15 | 31 |
| Negative | 42 | 6 | 0 | 0 |
Amphetamine Discordant Results: Positive HEIA/Negative LC/MS/MS
Washing of hair before confirmation: exclusion of potential environmental contamination and/or sweat-derived drug from hair analysis results can result in APPARENT discordant results. Ingested drugs are present in perspiration, which settles on the hair and requires removal if the hair analysis result is to reflect amount of drug ingested rather than exposure to the sweat-derived drug. Drug could also be present as a result of environmental contamination (e.g., powder, smoke). Hair is not washed prior to screening, as it would not be reasonable to wash hundreds of negative hair samples; i.e., samples that are negative without washing. Thus, it is expected that the washing performed before LC/MS/MS confirmation of presumptive positives removes external drug and the confirmation results may then be lower than the screening may have predicted without the consideration of sweat-derived drug and/or drug from environmental contamination.
| Amphetamine, 3 ng/10 mg Hair Calibrator Discordant Results | ||||
|---|---|---|---|---|
| Sample | HEIA Result | Unwashed | ||
| LC/MS/MS | ||||
| Result (ng | ||||
| Amphetamine/10 | ||||
| mg hair) | Washed | |||
| LC/MS/MS | ||||
| Result (ng | ||||
| Amphetamine/10 | ||||
| mg hair) | Comment | |||
| 1 | POS | 3.18 | 2.51 | Samples are screened by HEIA without hair washing. LC/MS/MS is performed only after washing once with isopropanol, 3 times 30 minutes with 90% Ethanol, then 2 times 60 minutes with 90% Ethanol. Thus, it is expected that some samples will be negative by LC/MS/MS after washing. |
| 2 | POS | 5.82 | 2.73 |
15
Conclusion:
The Psychemedics HEIA for amphetamines in hair is substantially equivalent based on acceptable performance studies, including precision, specificity and interference (including cosmetic effects).