(414 days)
No
The device description details a homogeneous enzyme immunoassay (HEIA) based on chemical reactions and spectrophotometric measurement. There is no mention of AI, ML, or any computational algorithms used for analysis or interpretation beyond standard data processing of absorbance changes. The performance studies focus on chemical comparisons and agreement with a reference method (LC/MS/MS), not on the performance of an AI/ML model.
No.
The device is for the preliminary qualitative detection of cocaine in hair for identifying cocaine use, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is for the "preliminary qualitative detection of cocaine in human head and body hair for the purpose of identifying cocaine use," which is a diagnostic purpose.
No
The device description clearly outlines a homogeneous enzyme immunoassay (HEIA) test consisting of a pre-analytical hair treatment procedure and a screening assay involving reagents (R1 and R2). This indicates a physical, chemical-based test system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the "preliminary qualitative detection of cocaine in human head and body hair... for the purpose of identifying cocaine use." This clearly indicates it's used to test a biological sample (hair) to gain information about a person's health status (cocaine use).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses reagents to measure the presence of cocaine in a processed hair sample. This is a laboratory-based test performed on a sample taken from the body.
- Anatomical Site: The sample is taken from "Human head and body hair," which is a biological specimen.
- Intended User / Care Setting: It's for "In-house professional use," indicating it's used in a laboratory or clinical setting by trained professionals.
- Performance Studies: The document describes performance studies comparing the device's results to a confirmatory method (LC/MS/MS), which is typical for IVD validation.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K111925) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used to demonstrate substantial equivalence to previously cleared IVDs.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease or for the determination of the state of health. This device fits that description by testing a human sample (hair) to identify cocaine use, which can be relevant to a person's health status and potentially impact diagnosis or treatment decisions.
N/A
Intended Use / Indications for Use
The Psychemedics homogeneous enzyme immunoassay for cocaine in hair is an enzyme immunoassay for the preliminary qualitative detection of cocaine in human head and body hair using a cocaine calibrator of 5 ng/10 mg hair for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use and not for sale to anyone.
The Psychemedics HEIA Cocaine Assay provides only a preliminary analytical test result. To confirm positive results, a more specific alternate chemical method (e.g. LC/MS/MS) must be used. Clinical consideration and professional judgement should be applied to the interpretation of any drug-of-abuse test result.
Product codes
JXO
Device Description
The homogeneous enzyme immunoassay (HEIA) test consists of two parts; a pre-analytical hair treatment procedure (to extract cocaine from the solid hair matrix to a measurable liquid matrix) and the screening assay, the Psychemedics Cocaine 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 Cocaine HEIA consists of reagents R1 (anti-cocaine monoclonal antibody with substrate) and R2 (cocaine 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 cocaine in hair samples stored at room temperature has been shown for approximately 6 months. Cocaine in samples shipped coast-to-coast twice was stable.
Materials Required: Hair sample collection kit, HEIA for Cocaine, automated clinical chemistry analyzer, LC/MS/MS for confirmation.
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-house professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Study 1: Samples positive or negative for cocaine were identified using the Psychemedics cocaine microplate assay (K111925), and then tested with the test device, the Psychemedics HEIA for cocaine in hair. The test device (assay) has been validated using 215 individual hair samples collected anonymously from a workplace setting. One hundred and twenty-three negative samples and 92 positive samples were identified by the immunoassays.
The stored hair samples were then tested using Psychemedics' LC/MS/MS confirmatory assay, to compare the Psychemedics HEIA results with the washed LC/MS/MS results. The studies comparing the HEIA with washed LC/MS/MS documented the source of hair (head or body) and other demographics as available.
Study 2: An additional set of samples were identified using the Psychemedics cocaine microplate assay and the test device. These samples were tested using Psychemedics' LC/MS/MS confirmatory assay both with and without prior washing of the samples, to compare the Psychemedics HEIA results with unwashed LC/MS/MS results and washed LC/MS/MS results. The studies comparing the HEIA with unwashed and washed 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)
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 5 ng cocaine/10 mg hair, and +/- 75%, +/-50% and +/-25% of the cutoff calibrator.
Cross Reactivity Summary: The cross reactivity of the following metabolites and cocaine structural analogs was evaluated by determining the minimum concentration that would result approximately equivalent to the 5.0 ng cocaine/10 mg hair cutoff.
Compounds with cross reactivity: Benzoylecgonine, Norcocaine, Cocaethylene, Ecgonine, Ecgonine Methyl Ester, Anhydroecgonine Methyl Ester.
Compounds shown to have no cross reactivity: 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, Methamphetamine, 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-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.
Interference: The following compounds were shown to have no interference in the cocaine assay. Atropine, Bupropion, Cotinine, Cannabinol, Chlorpheniramine maleate, O- Desmethylvenlafaxine, Desipiramine, Doxylamine Succinate, 1S, 2R Ephedrine, Anhydroecgonine methyl ester, Naproxen, Nicotine, Nortriptyline, Propoxyphen, R,mR-Pseudoephedrine, Thioridazine, Cis-Tramadol, Venlafaxine HCl, 8-(-)-11-nor-9-carboxy-delta-9 THC, 11-nor-9-carboxy-delta 9 THC,Amoxicillin, Propanolol, Promethazine, Phenmetrazine, Phendimetrazine, Benzocaine, Ecgonine, Metanephrin, Glutethimide, Meprobamate, Methyprylon, Carbamazepine, Diazepam, Nordiazepam, Oxazapam, Acetominophen, Caffeine, Dyphylline, Methaqualone, Theophylline, Amitryptiline, Dextromethorphan, Lidocaine, Methocarbamol, Nordoxepin, Pentazocine, Phenylephrine, Triamterene, Ethosuximde, a-Methyl-a-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, Acetominophen, Caffeine, Chlorpheniramine, Ibuprogen, Naproxen, R,R-(-)-Pseudoepedrine, Epinephrine (±), Metanephrine (±), Normetanephrine (±), Alprazolam, Cimetidine, Citalopram HBr, Clonazepam, Clopidogrel Bisulfate, Fluconazole, Hydorchlorothiazide, Lamotrigine, L-Thyroxine, Methylphenidate HCl, Omeprazole, Amlopidine Besylate, Atorvastatin Calcium Salt, Azithromycin Dihydrate, Bupivacaine HCl Monohydrate, Cetirizine Di-HCl, Dimenhydrinate, Lisinopril Dihydrate, Propanolol, Benzocaine, Metanephrin.
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 Stability During Storage: Five cocaine 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 cocaine in the method was shown on average to be at least 81% complete after 2 hours.
Cosmetic Treatments: Ten cocaine-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 10 samples treated with a type of cosmetic treatment, all samples remained negative after the treatments.
Seven cocaine-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:
Study 1: Samples positive or negative for cocaine were identified using the Psychemedics cocaine microplate assay (K111925), and then tested with the test device, the Psychemedics HEIA for cocaine in hair. The test device (assay) has been validated using 215 individual hair samples collected anonymously from a workplace setting. One hundred and twenty-three negative samples and 92 positive samples were identified by the immunoassays.
The stored hair samples were then tested using Psychemedics' LC/MS/MS confirmatory assay, to compare the Psychemedics HEIA results with the washed LC/MS/MS results. The studies comparing the HEIA with washed LC/MS/MS documented the source of hair (head or body) and other demographics as available.
The comparison of the Psychemedics Cocaine HEIA with washed LC/MS/MS showed 0 positive HEIA/negative LC/MS/MS results for LC/MS/MS values 7.50 ng/10 mg hair. For negative HEIA, there were 119 for 7.50 ng/10 mg hair.
Discordant Results: Positive HEIA/Negative LC/MS/MS: 3 samples were positive by HEIA and negative by LC/MS/MS after washing, with LC/MS/MS results of 3.49, 3.75, and 4.27 ng Cocaine/10 mg hair. This is attributed to washing prior to LC/MS/MS confirmation removing external contamination or sweat-derived drug.
Study 2: An additional set of samples were identified using the Psychemedics cocaine microplate assay and the test device. These samples were tested using Psychemedics' LC/MS/MS confirmatory assay both with and without prior washing of the samples, to compare the Psychemedics HEIA results with unwashed LC/MS/MS results and washed LC/MS/MS results. The studies comparing the HEIA with unwashed and washed LC/MS/MS documented the source of hair (head or body) and other demographics as available.
Comparison of Cocaine HEIA Screening Results with Unwashed Cocaine LC/MS/MS: Positive HEIA: 0 ( 7.50). Negative HEIA: 44 ( 7.50).
Comparison of Cocaine HEIA Screening Results with Washed Cocaine LC/MS/MS: Positive HEIA: 0 ( 7.50). Negative HEIA: 48 ( 7.50).
Discordant Results: Positive HEIA/Negative LC/MS/MS: Two samples were positive by HEIA and Negative by unwashed and washed LC/MS/MS. Both samples confirmed within 15% of the LC/MS/MS cutoff when unwashed. After washing, both samples decreased in cocaine concentration. Sample 1 (HEIA POS, unwashed LC/MS/MS 4.43 ng/10 mg, washed LC/MS/MS 3.75 ng/10 mg), Sample 2 (HEIA POS, unwashed LC/MS/MS 4.96 ng/10 mg, washed LC/MS/MS 4.27 ng/10 mg).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 Cocaine in Hair, K111925
Reference Device(s)
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
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 25, 2021
Psychemedics Corporation Neil Stowe Principal Scientist 5832 Uplander Way Culver City, California 90230
Re: K201228
Trade/Device Name: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and Cocaine Metabolite Test System Regulatory Class: Class II Product Code: JXO Dated: October 26, 2020 Received: October 27, 2020
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 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
1
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
2
Indications for Use
510(k) Number (if known) K201228
Device Name
Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
Indications for Use (Describe)
The Psychemedics homogeneous enzyme immunoassay for cocaine in hair is an enzyme immunoassay for the preliminary qualitative detection of cocaine in human head and body hair using a cocaine calibrator of 5 ng/10 mg hair for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use and not for sale to anyone.
The Psychemedics EIA Cocaine Assay provides only a preliminary analytical test results, a more specific alternate chemical method (e.g. LC/MS/MS) must be used. Clinical consideration and professional judgement should be applied to the interpretation of any drug-of-abuse test result.
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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3
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: | K201228 | ||
|---|---|---|---|
| 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: | 10-26-2020 | ||
| Device Trade Name: | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair | ||
| Predicate Device: | Psychemedics Microplate EIA for Cocaine in Hair, K111925 | ||
| Product Code: | JXO | ||
| Device/Classification Name: | 21 CFR 862.3250 Cocaine and Cocaine Metabolite Test System, Classification II | ||
| Intended Use: | The Psychemedics homogeneous enzyme immunoassay for cocaine in hair is an enzyme immunoassay for the preliminary qualitative detection of cocaine in human head and body hair using a cocaine calibrator of 5 ng/10 mg hair for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use and is not for sale to anyone. |
The Psychemedics HEIA Cocaine Assay provides only a preliminary analytical test result. To confirm positive results, a more specific alternate chemical method (e.g. LC/MS/MS) must be used. Clinical consideration and professional judgement should be applied to the interpretation of any drug-of-abuse test result. | | |
| Device Description: | The homogeneous enzyme immunoassay (HEIA) test consists of two parts; a pre-analytical hair treatment procedure (to extract cocaine from the solid hair matrix to a measurable liquid matrix) and the screening assay, the Psychemedics Cocaine 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. | | |
4
| The Psychemedics Cocaine HEIA consists of reagents R1 (anti-cocaine
monoclonal antibody with substrate) and R2 (cocaine 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 cocaine in hair samples |
| stored at room temperature has been shown for approximately 6 months. |
| Cocaine in samples shipped coast-to-coast twice was stable. |
| Materials Required: Hair sample collection kit, HEIA for Cocaine, automated clinical chemistry |
| analyzer, LC/MS/MS for confirmation. |
5
Comparison with Predicate:
| Item | Proposed Device | Psychemedics Cocaine Assay,
K111925 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications/Intended Use | The Psychemedics homogeneous
enzyme immunoassay for cocaine
in hair is an enzyme immunoassay
for the preliminary qualitative
detection of cocaine in human head
and body hair using a cocaine
calibrator of 5 ng/10 mg hair for the
purpose of identifying cocaine use.
This product is intended
exclusively for in-house
professional use and not for sale to
anyone.
The Psychemedics EIA Cocaine
Assay provides only a preliminary
analytical test result. To confirm
positive results, a more specific
alternate chemical method (e.g.
LC/MS/MS) must be used. Clinical
consideration and professional
judgement should be applied to the
interpretation of any drug-of-abuse
test result. | The Psychemedics Microplate EIA
for Cocaine is an enzyme
immunoassay (EIA) for the
preliminary qualitative detection of
cocaine in human head and body
hair samples using a cocaine
calibrator at 5 ng/10 mg hair cutoff
for the purpose of identifying
cocaine 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 Cocaine
Assay provides only a preliminary
analytical test result. To confirm
positive results, a more specific
alternate chemical method (e.g.
LC/MS/MS) must be used. Clinical
consideration and professional
judgement should be applied to the
interpretation of any drug-of-abuse
test result. |
| Product Code | JXO | JXO |
| Measurand | Cocaine | Cocaine |
| Test System | Psychemedics Homogeneous
Enzyme Immunoassay for Cocaine
in Hair | Psychemedics Microplate EIA for
Cocaine 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 |
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 5 ng cocaine/10 mg hair, and +/- 75%, +/-50% and +/-25% of the cutoff calibrator.
6
| 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 cocaine structural analogs was evaluated by determining the minimum concentration that would result approximately equivalent to the 5.0 ng cocaine/10 mg hair cutoff.
| Cross Reactivities of Structurally Related Compounds and Metabolites | ||
|---|---|---|
| Compound | % Cross | |
| Reactivity | Concentration Equivalent to | |
| 5.0 ng Cocaine/10 mg Hair | ||
| Benzoylecgonine | 2.0 | 250 |
| Norcocaine | 20 | 25 |
| Cocaethylene | 55.5 | 9 |
| Ecgonine | 500 | |
| Ecgonine Methyl Ester | 500 | |
| Anhydroecgonine Methyl Ester | 500 |
The following compounds were shown to have no cross reactivity in the Cocaine 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, Amphetamine, Cetrizine DiHCl, Imipramine, Methamphetamine, 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-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,
7
| | 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 cocaine
assay. |
| | Atropine, Bupropion, Cotinine, Cannabinol, Chlorpheniramine maleate, O-
Desmethylvenlafaxine, Desipiramine, Doxylamine Succinate, 1S, 2R Ephedrine,
Anhydroecgonine methyl ester, Naproxen, Nicotine, Nortriptyline,
Propoxyphen, R,mR-Pseudoephedrine, Thioridazine, Cis-Tramadol,
Venlafaxine HCl, 8-(-)-11-nor-9-carboxy-delta-9 THC, 11-nor-9-carboxy-delta
9 THC,Amoxicillin, Propanolol, Promethazine, Phenmetrazine,
Phendimetrazine, Benzocaine, Ecgonine, Metanephrin, Glutethimide,
Meprobamate, Methyprylon, Carbamazepine, Diazepam, Nordiazepam,
Oxazapam, Acetominophen, Caffeine, Dyphylline, Methaqualone,
Theophylline, Amitryptiline, Dextromethorphan, Lidocaine, Methocarbamol,
Nordoxepin, Pentazocine, Phenylephrine, Triamterene, Ethosuximde, a-Methyl-
a-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, Acetominophen, Caffeine, Chlorpheniramine, Ibuprogen, Naproxen,
R,R-(-)-Pseudoepedrine, Epinephrine (±), Metanephrine (±), Normetanephrine
(±), Alprazolam, Cimetidine, Citalopram HBr, Clonazepam, Clopidogrel
Bisulfate, Fluconazole, Hydorchlorothiazide, Lamotrigine, L-Thyroxine,
Methylphenidate HCl, Omeprazole, Amlopidine Besylate, Atorvastatin Calcium
Salt, Azithromycin Dihydrate, Bupivacaine HCl Monohydrate, Cetirizine Di-
HCl, Dimenhydrinate, Lisinopril Dihydrate, Propanolol, Benzocaine,
Metanephrin |
| 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 Stability
During Storage: | Five cocaine 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 cocaine in the method was shown on average
to be at least 81% complete after 2 hours. |
| Cosmetic Treatments: | Ten cocaine-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 10 samples treated with a type of cosmetic treatment, all
samples remained negative after the treatments.
Seven cocaine-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: | Study 1:
Samples positive or negative for cocaine were identified using the Psychemedics
cocaine microplate assay (K111925), and then tested with the test device, the
Psychemedics HEIA for cocaine in hair. The test device (assay) has been
validated using 215 individual hair samples collected anonymously from a
workplace setting. One hundred and twenty-three negative samples and 92
positive samples were identified by the immunoassays.
The stored hair samples were then tested using Psychemedics' LC/MS/MS
confirmatory assay, to compare the Psychemedics HEIA results with the washed
LC/MS/MS results. The studies comparing the HEIA with washed LC/MS/MS
documented the source of hair (head or body) and other demographics as
available. The comparison of the Psychemedics Cocaine HEIA with washed
LC/MS/MS is shown in the following tables. |
8
| Table 1. Comparison of Cocaine HEIA Screening Results with LC/MS/MS of Washed Samples | ||||
|---|---|---|---|---|
| HEIA Result | LC/MS/MS Result, ng Cocaine/10 mg hair (% of cutoff calibrator) | |||
| 7.50 (> 50% above cutoff) | ||||
| Positive | 0 | 3 | 14 | 75 |
| Negative | 119 | 4 | 0 | 0 |
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.
9
| Table 2. Discordant Results Between HEIA and Washed LC/MS/MS | |||
|---|---|---|---|
| Sample | HEIA Result | LC/MS/MS Result (ng Cocaine/10 mg hair) | Comment |
| 1 | POS | 3.49 | Samples are screened by HEIA without hair washing. |
| LC/MS/MS is performed only after washing once with isopropanol, 3 times 30 minutes with 0.01 M phosphate buffer and 2 times with 0.01 M phosphate buffer for 60 minutes. Thus, it is expected that some samples will be negative by LC/MS/MS after washing. | |||
| 2 | POS | 3.75 | |
| 3 | POS | 4.27 |
Study 2:
An additional set of samples were identified using the Psychemedics cocaine microplate assay and the test device. These samples were tested using Psychemedics' LC/MS/MS confirmatory assay both with and without prior washing of the samples, to compare the Psychemedics HEIA results with unwashed LC/MS/MS results and washed LC/MS/MS results. The studies comparing the HEIA with unwashed and washed LC/MS/MS documented the source of hair (head or body) and other demographics as available. The comparison of the Psychemedics Cocaine HEIA with unwashed and washed LC/MS/MS is shown in the following tables.
| Table 3. Comparison of Cocaine HEIA Screening Results with Unwashed Cocaine LC/MS/MS | ||||
|---|---|---|---|---|
| HEIA Result | LC/MS/MS Result, ng Cocaine/10 mg hair (% of cutoff calibrator) | |||
| 7.50 (> 50% above cutoff) | ||||
| Positive | 0 | 2 | 4 | 35 |
| Negative | 44 | 7 | 0 | 0 |
| Table 4. Comparison of Cocaine HEIA Screening Results with Washed Cocaine LC/MS/MS | ||||
|---|---|---|---|---|
| HEIA Result | LC/MS/MS Result, ng Cocaine/10 mg hair (% of cutoff calibrator) | |||
| 7.50 (> 50% above cutoff) | ||||
| Positive | 0 | 2 | 8 | 31 |
| Negative | 48 | 3 | 0 | 0 |
Discordant Results: Positive HEIA/Negative LC/MS/MS
Two samples in the second study were positive by HEIA and Negative by unwashed and washed LC/MS/MS. Both samples confirmed within 15% of the LC/MS/MS cutoff when unwashed. After washing, both samples decreased in cocaine concentration.
10
| Table 5. Discordant Results Between HEIA and Unwashed LC/MS/MS | |||
|---|---|---|---|
| Sample | HEIA Result | LC/MS/MS Result (ng Cocaine/10 mg hair) | Comment |
| 1 | POS | 4.43 | Although samples 1 and 2 confirmed negative after screening positive, they confirmed within 15% of the 5 ng/10 mg cocaine LC/MS/MS cutoff. |
| 2 | POS | 4.96 |
| Sample | HEIA Result | LC/MS/MS Result (ng Cocaine/10 mg hair) | Comment |
|---|---|---|---|
| 1 | POS | 3.75 | Samples 1 and 2 confirmed negative after screening positive and washing before LC/MS/MS. Confirmation of these samples after washing found a decrease in cocaine concentration relative to the unwashed samples. |
| 2 | POS | 4.27 |
| Table 7. Comparison of Unwashed and Washed Samples | |||
|---|---|---|---|
| Sample # | Unwashed LC/MS/MS (ng Cocaine/10 mg hair) | Washed LC/MS/MS (ng Cocaine/10 mg hair) | Comment |
| 1 | 4.43 | 3.75 | |
| 2 | 4.96 | 4.27 | Both samples 1 and 2 had a decrease in cocaine concentration after washing. |
| Table 8. Unwashed and Washed Comparison Study Sample Characteristics | ||||||||
|---|---|---|---|---|---|---|---|---|
| Hair Source | Gender | Hair Color | ||||||
| Head | Body | Male | Female | Brown | Black | Salt/Pepper | ||
| # of Samples | 65 | 27 | 79 | 13 | 47 | 39 | 6 |
Conclusion:
The Psychemedics HEIA for cocaine in hair is substantially equivalent based on acceptable performance studies, including precision, specificity and interference (including cosmetic effects).