(258 days)
Not Found
No
The device description and performance studies detail a standard immunoassay and LC/MS/MS method, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic device for the qualitative detection of fentanyl in hair, which is used for screening purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Psychemedics Microplate EIA For Fentanyl in Hair is an in vitro diagnostic device for the qualitative detection of fentanyl in hair."
No
The device description clearly outlines physical components including microplate wells, antibodies, enzymes, substrates, and wash buffer, which are all tangible materials used in a laboratory setting. The process also involves a pre-analytical hair treatment procedure and reading absorbance with a microplate reader, indicating a hardware component is necessary for operation.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is "an in vitro diagnostic device for the qualitative detection of fentanyl in hair." This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body to detect diseases, conditions, or infections.
- Sample Type: The device analyzes human hair, which is a sample taken from the human body.
- Purpose: The purpose is to detect the presence of fentanyl, which is relevant for workplace drug testing and potentially for identifying drug use.
- Device Description: The description details the components and process of an immunoassay performed in a laboratory setting, which is a common type of in vitro diagnostic test.
The information provided strongly indicates that this device is intended to be used outside of the body to analyze a human sample for diagnostic or screening purposes, fitting the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Psychemedics Microplate EIA For Fentanyl in Hair is an in vitro diagnostic device for the qualitative detection of fentanyl in hair. The assay is intended for use in workplace settings for the qualitative analysis of human head and body hair. The assay uses a cutoff calibrator of 0.2 ng fentanyl/10 mg hair.
Psychemedics plans to perform this test at one site. Psychemedics has not performed an evaluation of reproducibility at different laboratories.
The Psychemedics Microplate EIA For Fentanyl in Hair provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) using deuterated internal standards in multiple reaction monitoring (MRM) mode is the confirmatory method used by Psychemedics Corporation. This confirmatory method uses a cutoff of 0.2 ng of fentanyl/10 mg hair.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The Psychemedics Microplate EIA For Fentanyl in Hair consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Fentanyl. The screening portion of the test system consists of (1) microplate wells coated with fentanyl conjugated to bovine serum albumin (BSA), monoclonal rabbit anti-fentanyl, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
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
Workplace settings
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Studies:
Performed by spiking negative hair with previously LC/MS/MS-validated calibrator and control spiking solutions to achieve concentrations of negative, the cutoff of 0.2 ng/10 mg hair, and +/-75%, +/-50%, and +/- 25% of the cutoff.
- Intra-Assay: At different levels (negative, -75%, -50%, -25%, +25%, +50%, +75%, +100% of cutoff), the numbers of negative (NEG) and positive (POS) results were recorded (e.g., for B₀ (-100%), 10 NEG, 0 POS; for plus 100%, 0 NEG, 10 POS).
- Inter-Assay: Similar levels, but with 50 replicates instead of 10.
Comparison Testing:
- 197 samples (head and body hair) confirmed by LC/MS/MS were tested in parallel with the Psychemedics Fentanyl EIA.
- Relative to LC/MS/MS results, no false negative EIA results occurred.
- Ten positive EIA results did not confirm at or above the cutoff of 0.2 ng fentanyl/10 mg hair by LC/MS/MS. These false positives were attributed to washing effects before confirmation or cross-reactivity with other fentanyl compounds.
Cosmetic Treatments:
- Twenty fentanyl-negative head hair samples were treated with bleach, permanent wave, dye, relaxer, and shampoo. No significant differences in EIA results were observed; all samples remained negative.
- Twelve fentanyl-positive head hair samples were treated with permanent wave, dye, relaxer, or shampoo. The ratio of fentanyl in treated samples to untreated samples was 106.3% for Dye (with bleach), 106.5% for Relaxer, 98.4% for Shampoo, and 101% for Perm.
Summary of Cross-reactivity and Interference Studies:
- Cross-reactivity of related compounds was tested (e.g., Butyryl fentanyl: 200% cross-reactivity, equivalent to 0.10 ng Fentanyl/10 mg hair; Fentanyl: 100% cross-reactivity, equivalent to 0.20 ng Fentanyl/10 mg hair).
- Many compounds showed no cross-reactivity in the Fentanyl EIA assay.
- Many compounds showed no interference in the Fentanyl EIA assay.
Calibrator:
- Calibrators and control materials confirmed by LC/MS/MS.
Sample Stability During Shipping and Storage:
- Five samples showed no significant differences between results before and after shipping and one month of storage.
Recovery:
- Hair sample preparation by nonproteolytic digestion (US Patent 8,084,215) at 37°C.
- Recovery of fentanyl was at least 80% complete at 2 hours.
Environmental Contamination:
- Adressed by an extensive washing procedure prior to confirmation.
- After washing, 9 samples contaminated with 2 ng fentanyl/mL of saline resulted in 0.0527 ng of fentanyl /10 mg hair or below LOQ, which is below the 0.20 ng/10 mg hair cutoff.
Summary of Performance Testing of the LCMSMS for Fentanyl and Norfentanyl in Hair:
- Recovery from Hair: From 5 authentic samples, recovery was greater than 96%.
- Recovery of Analytes and Internal Standard with SPE: Recoveries of analytes and I.S. were greater than 50%, with precisions less than 5% CV. Averages of 5 samples were 98 - 102% of target concentrations.
- Precision:
- Intra-Assay Precision Around the Cutoff: 5 analyses at 0.1, 0.15, 0.2, 0.25, 0.3 ng/10 mg hair. Also 5 analyses, for 5 days, at 0.1, 0.2, 0.3 ng/10 mg hair.
- Intra-Assay Precision over the Range of the Assay: 5 samples each of 0.01, 0.02, 0.04, 0.06, 0.08, 0.1, 0.15, 0.2, 0.25, 1.5, 4.5, 6.0, 7.5 ng/10 mg hair.
- Results: All sets of replicates had 0.995.
- Validity of Dilution: Demonstrated by analyzing 3 dilutions of a 3 ng/100 uL solution.
- Carryover: No signal detected in negative samples following 7.5 ng/10 mg hair samples, indicating no carryover up to this concentration.
- Specificity (LCMSMS):
- Matrix Effects: No ionization suppression or enhancement greater than +/- 15%.
- Interference from Internal Standard or nondeuterated analytes: No D5 contaminant in Dg analytes, and no Do contaminant in D5 analytes.
- Interference from other compounds: No interference detected from 37 individual compounds and 38 compounds in 5 mixes.
- Accuracy:
- Results from 5 proficiency testing samples were near target concentrations and survey ranges.
- LLOQ Precision: LLOQ at 0.01 ng/10 mg hair. S:N ratios for 5 samples spiked at 0.01 ng/10 mg hair were 382-717 for fentanyl and 47-78 for norfentanyl, both much greater than 19:1 to 20:1.
- Specificity data supports accuracy. Absence of carryover ensures accuracy.
- Agreement among triplicate analyses of 4 authentic positive hair samples showed less than 15% CV.
- Reproducibility among multiple hair types spiked at LLOQ/LOD, Cutoff, mid-range showed >90% target concentration and
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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SUMMARY (K182103)
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: K182103
| Submitted By: | Psychemedics Corporation
5832 Uplander Way
Culver City, CA 90230
TEL: 310 216 7776
FAX: 310 216 6662 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Virginia Hill |
| Date Prepared: | August 2, 2018 |
| Device Trade Name: | Psychemedics Microplate EIA for Fentanyl in Hair |
| Predicate Device: | Psychemedics Microplate EIA for Opiates in Hair |
| Product Code: | DJG |
| Device Classification/Name: | 21 CFR 862.3650, Opiate Test System;
Classification II; |
| Intended Use: | The Psychemedics Microplate EIA For Fentanyl in Hair is an in vitro
diagnostic device for the qualitative detection of fentanyl in hair. The
assay is intended for use in workplace settings for the qualitative
analysis of human head and body hair. The assay uses a cutoff
calibrator of 0.2 ng fentanyl/10 mg hair.
Psychemedics plans to perform this test at one site. Psychemedics has
not performed an evaluation of reproducibility at different laboratories.
The Psychemedics Microplate EIA For Fentanyl in Hair provides only
a preliminary analytical test result. A more specific alternate chemical
method must be used to obtain a confirmed analytical result. Liquid
Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS)
using deuterated internal standards in multiple reaction monitoring
(MRM) mode is the confirmatory method used by Psychemedics
Corporation. This confirmatory method uses a cutoff of 0.2 ng of
fentanyl/10 mg hair. |
| Limitations: | The assay is designed only for human body and head hair.
The results of the Psychemedics Microplate EIA For Fentanyl in Hair
should be used solely for workplace decisions—to make hiring and
employment decisions. The results of the test should not be used to make
decisions to initiate, change, or stop medical or mental health therapy |
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Positive screening results only indicate the presumptive presence of fentanyl and require additional analysis by mass spectrometry to obtain a confirmed result. Certain medication or dietary supplements that contain fentanyl and/or compounds that may be metabolized to produce fentanyl may cause a positive result. Studies to determine the correlation of the typical doses for those drugs and dietary supplements to concentrations of fentanyl in hair have not been performed. The clinical performance of this assay has not been characterized with regard to the amount and frequency of fentanyl ingestion needed to test positive. Negative results should be interpreted with caution.
A negative screening test result does not necessarily rule out the possibility of fentanyl use, i.e., time of collection, frequency of use, mode of ingestion, dosage used, hair types and other factors may influence results. It is not possible to document all possible effects due to treatments such as bleaching, straightening and dyeing. There is a possibility that other substances and/or factors not listed above may interfere with the test and cause false results that cannot be confirmed by mass spectrometry.
The assay is designed only for human body and head hair.
The results of the Psychemedics Microplate EIA For Fentanyl in Hair should be used solely for workplace decisions-to make hiring and employment decisions. The results of the test should not be used to make decisions to initiate, change, or stop medical or mental health therapy
Positive screening results only indicate the presumptive presence of fentanyl and require additional analysis by mass spectrometry to obtain a confirmed result. Certain medication or dietary supplements that contain fentanyl and/or compounds that may be metabolized to produce fentanyl may cause a positive result. Studies to determine the correlation of the typical doses for those drugs and dietary supplements to concentrations of fentanyl in hair have not been performed. The clinical performance of this assay has not been characterized with regard to the amount and frequency of fentanyl ingestion needed to test positive. Negative results should be interpreted with caution.
A negative screening test result does not necessarily rule out the possibility of fentanyl use, i.e., time of collection, frequency of use, mode of ingestion, dosage used, hair types and other factors may influence results. It is not possible to document all possible effects due to treatments such as bleaching, straightening and dyeing. There is a possibility that other substances and/or factors not listed above may interfere with the test and cause false results that cannot be confirmed by mass spectrometry.
Assay Description: The Psychemedics Microplate EIA For Fentanyl in Hair consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Fentanyl. The screening portion of the test system consists of (1) microplate wells coated with fentanyl conjugated to bovine serum albumin (BSA), monoclonal rabbit anti-fentanyl, goat anti-rabbit
2
secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
Sample Collection & 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 fentanyl in hair samples stored at room temperature has been shown for over one month. Fentanyl in samples shipped coast-to-coast twice was stable.
| Materials required: | Hair sample collection kit, Microplate for Fentanyl, Microplate washer and reader, LC/MS/MS for confirmation. |
|---|---|
| --------------------- | --------------------------------------------------------------------------------------------------------------- |
| Item | Proposed Device | Opiates in Hair Assay |
|---|---|---|
| Indications/ | ||
| Intended use | The Psychemedics Microplate EIA | |
| for Fentanyl in hair is an enzyme | ||
| immunoassay (EIA) for the | ||
| preliminary qualitative detection of | ||
| fentanyl in human head and body | ||
| hair using a fentanyl calibrator at | ||
| 0.2 ng /10 mg hair cutoff for | ||
| identifying fentanyl use. | ||
| The Psychemedics Microplate EIA | ||
| Fentanyl 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. Liquid Chromatography | ||
| with MS/MS is the preferred | ||
| confirmatory method. | The Psychemedics Microplate EIA | |
| for Opiates in Hair (K111926) is a | ||
| qualitative kit for detection of | ||
| opioids in hair. This 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. Liquid | ||
| Chromatography with MS/MS is the | ||
| preferred confirmatory method. | ||
| Product Code | DJG | DJG |
| Measurand | Fentanyl in Hair | Opioids |
| Test System | Psychemedics Microplate EIA for | |
| Fentanyl in Hair | Psychemedics EIA for opiates in | |
| Hair | ||
| Sample Matrix | Human Hair | Human hair |
| Method of Measurement | Microplate reader, read at 450 nm | Microplate reader, read at 450 nm |
| Cutoff | 0.2 ng fentanyl/10 mg hair | 2 ng morphine/10 mg hair |
| Type of Test | Enzyme Immunoassay | Enzyme Immunoassay |
| Extraction Method | Patented Digestion method | Patented Digestion method |
| Confirmation Method | LC/MS/MS | LC/MS/MS |
Comparison with Predicate:
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Summary of Performance Testing of the EIA
The precision studies were performed by spiking negative hair with previously LC/MS/MS-validated calibrator and control spiking solutions to achieve concentrations of negative, the cutoff of 0.2 ng/10 mg hair, and +/-75%, +/-50%, and +/- 25% of the cutoff. Precision Studies
| Summary -Intra-Assay | Summary-Inter-Assay | ||||
|---|---|---|---|---|---|
| LEVEL | NEG | POS | LEVEL | NEG | POS |
| B₀ (-100%) | 10 | 0 | B₀ (-100%) | 50 | 0 |
| -75% | 10 | 0 | -75% | 50 | 0 |
| -50% | 10 | 0 | -50% | 50 | 0 |
| -25% | 10 | 0 | -25% | 50 | 0 |
| plus 25% | 0 | 10 | plus 25% | 0 | 50 |
| plus 50% | 0 | 10 | plus 50% | 0 | 50 |
| plus 75% | 0 | 10 | plus 75% | 0 | 50 |
| plus 100% | 0 | 10 | plus 100% | 0 | 50 |
ComparisonTesting
197 samples comprising both head and body hair were confirmed by LC/MS/MS in parallel with testing by the Psychemedics Fentanyl EIA. Relative to the LC/MS/MS results, no false negative EIA results occurred. Ten positive EIA results did not confirm at or above the cutoff of 0.2 ng fentanyl/10 mg hair by LC/MS/MS; these false positives were due to effects of washing before confirmation or to crossreactivity with other fentanyl compounds.
Conclusions:
-
- No samples that screened negative were false negatives-i.e., no sample that screened negative confirmed above 0.2 ng/10 mg hair of any fentanyl.
-
- The comparison studies demonstrate substantial equivalence between the performance of the screening device and the LCMSMS confirmation. Cutoffs are appropriately set such that positivity of the EIA predicts positivity at > 0.2 ng/10 mg hair by LCMSMS.
Cosmetic Treatments
Twenty fentanyl-negative head hair samples were treated with bleach, 20 with permanent wave, 20 with dye (which includes bleach), 20 with relaxer, and 20 with shampoo, and the results compared to the same samples without the treatments. In each case of the 20 samples treated with a type of cosmetic treatment, 10 samples were treated with one brand of a particular product and 10 other samples with a second brand. No significant differences in EIA results were observed for the negative hair samples before and after the treatments; all samples remained negative after the treatments.
Twelve fentanyl-positive head hair samples were treated with permanent wave, dye, relaxer, or shampoo, and the results compared to the same samples without the treatments. In each case of samples treated with a type of cosmetic treatment, 6 samples were treated with one brand of a particular product and 6 with a second brand.
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| TREATMENT | (Fentanyl in Treated Samples / Fentanyl
in Untreated Samples) X 100 |
|-------------------|------------------------------------------------------------------------|
| Dye (with bleach) | 106.3 |
| Relaxer | 106.5 |
| Shampoo | 98.4 |
| Perm | 101 |
Summary of Cross-reactivity and Interference Studies
Cross-reactivity of Related Compounds in Fentanyl EIA
| | Percent Cross-
reactivity* | Expected Concentration Equivalent
to 0.2 ng Fentanyl/10 mg hair |
|------------------------------|-------------------------------|--------------------------------------------------------------------|
| Compound | | |
| Fentanyl | 100 | 0.20 |
| Butyryl fentanyl | 200 | 0.10 |
| Valeryl fentanyl | 100 | 0.20 |
| Furanyl fentanyl | 100 | 0.20 |
| Acetyl fentanyl | 125 | 0.16 |
| o-Fluorofentanyl | 100 | 0.20 |
| Acryl Fentanyl | 100 | 0.20 |
| Cyclopropyl fentanyl | 100 | 0.20 |
| Isobutyryl fentanyl | 100 | 0.20 |
| Ocfentanil | 100 | 0.20 |
| 4-Fluoro-isobutyryl fentanyl | 100 | 0.20 |
| Acetyl fentanyl | 125 | 0.16 |
| (+/-)-cis-3-methylfentanyl | 9.1 | 2.2 |
| Methyl fentanyl | 2 | 10.0 |
| Despropionyl fentanyl | 0.7 | 29.0 |
| Sufentanil citrate | 0.995. The average value of 5 determinations was within 15% of the predicted Y value. The actual data points deviated less than 10% from the regression line. Linearity of the Fentanyl/Norfentanyl Assays from 0.01 to 7.5 ng/10 mg hair was demonstrated.
Validity of Dilution was demonstrated by analyzing 3 dilutions of a 3 ng/100 uL solution of fentanyl and norfentanyl, resulting in 1.25, 0.25 and 0.125 ng/10 mg hair. Agreement of 5 determinations were 90% of target concentrations and