(300 days)
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No
The document describes a standard enzyme immunoassay (EIA) and subsequent confirmatory testing methods (GC/MS/MS). There is no mention of AI, ML, or any computational methods that would suggest their use in the device's operation or analysis.
No.
This device is an in vitro diagnostic device used for preliminary detection of cannabinoids in hair, not for treating any medical condition.
Yes
This device is an "in vitro diagnostic device intended exclusively for Psychemedics use only" for the "preliminary qualitative detection of cannabinoids in human head and body hair samples." It provides an analytical test result which is then subject to confirmation by a more specific method, indicating its role in the diagnostic process.
No
The device description clearly outlines physical components like a microplate, antibodies, substrate, and buffer, 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/Indications for Use: The document explicitly states, "This is an in vitro diagnostic device intended exclusively for Psychemedics use only..." This is a clear declaration of its intended use as an IVD.
- Nature of the Test: The device performs an enzyme immunoassay (EIA) on human hair samples to detect the presence of cannabinoids. This is a laboratory test performed in vitro (outside the body) on a biological specimen to provide information about a person's health status (in this case, potential drug use).
- Purpose: The purpose is to identify marijuana use, which is a diagnostic purpose.
- Device Description: The description details the components of the assay (microplate, antibodies, substrate, etc.), which are typical components of an in vitro diagnostic test kit.
The fact that it's intended for "Psychemedics use only" and "not intended for sale to anyone" doesn't change its classification as an IVD. It simply indicates a restricted distribution and intended user group.
N/A
Intended Use / Indications for Use
The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoids in human head and body hair samples using a 11-nor-9-Carboxy- Δ9-THC calibrator at 10 pg/10 mg hair cutoff for the purpose of identifying marijuana use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Chemiluminscent Microplate EIA for Cannabinoids 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 Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Product codes (comma separated list FDA assigned to the subject device)
LDJ
Device Description
The EIA screening test consists of two parts; a pre-analytical hair treatment procedure to recover the cannabinoids from the hair and the screening assay, the Psychemedics Chemiluminescent EIA for Cannabinoids in Hair. The device comprises a white microplate coated with the antigen (11-nor-9-carboxy-delta-8-tetrahydrocannabinol) conjugated to BSA, polyclonal rabbit anticannabinoid antibody, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), a chemiluminescent substrate, and platewashing buffer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human head and body hair samples
Indicated Patient Age Range
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Intended User / Care Setting
exclusively for Psychemedics use only and is not intended for sale to anyone.
The test is not intended for over the counter sale to non-professionals.
Description of the training set, sample size, data source, and annotation protocol
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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)
Summary of Precision Studies
Intra-Assay precision data is provided for NEG and POS levels: NEG had 15 counts for B₀ (-100%), -75%, -50%, -25% levels, while POS had 15 counts for plus 25%, plus 50%, plus 75%, plus 100% levels.
Inter-Assay precision data is provided for NEG and POS levels: NEG had 75 counts for B₀ (-100%), -75%, -50%, -25% levels, while POS had 75 counts for plus 25%, plus 50%, plus 75%, plus 100% levels.
Agreement Testing
Six-hundred-ten hair samples were assayed by the predicate device and by the Psychemedics Methamphetamine EIA. The number of body hair samples in the study was 18.9% of the total hair samples. The discordance between EIA and RIA was
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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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510K SUMMARY
510K Number: Submitted By:
K111929 Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 TEL: 310 216 7776 FAX: 310 216 6662
Submission Contact:
Virginia Hill
Date Prepared:
April 25, 2012
LDJ
Device Trade Name:
Psychemedics Chemiluminescent Microplate EIA for Cannabinoids in Hair
Psychemedics Marijuana Screening and Confirmatory Test System
21 CFR 862.3870, Enzyme Immunoassay, Cannabinoids;
Predicate Device:
Product Code:
Device Classification/Name:
Intended Use:
Assay Description:
Classification II; The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoids in human head and body hair samples using a 11nor-9-Carboxy- Δ -THC calibrator at 10 pg/10 mg hair cutoff for the purpose of identifying marijuana use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Chemiluminscent Microplate EIA for Cannabinoids 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 Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
The EIA screening test consists of two parts; a pre-analytical hair treatment procedure to recover the cannabinoids from the hair and the screening assay, the Psychemedics Chemiluminescent EIA for Cannabinoids in Hair. The device comprises a white microplate coated with the antigen (11-nor-9-carboxy-delta-8-tetrahydrocannabinol) conjugated to BSA, polyclonal rabbit anticannabinoid antibody, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), a chemiluminescent substrate, and platewashing buffer.
1
Sample Collection:
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.
Materials required:
Hair sample collection kit, Chemiluminescent Microplate EIA for Cannabinoids, Microplate washer and reader, GC/MS/MS for confirmation.
| Item | Device | Predicate |
|---|---|---|
| Indications for Use | The Psychemedics Microplate EIA for | |
| Cannabinoids in Hair is an enzyme | ||
| immunoassay (EIA) for the | ||
| preliminary qualitative detection of | ||
| cannabinoids in human head and | ||
| body hair samples using a 11-nor-9- | ||
| Carboxy- Δ9-THC calibrator at 10 | ||
| pg/10 mg hair cutoff for the purpose | ||
| of identifying marijuana use. This is | ||
| an in vitro diagnostic device intended | ||
| exclusively for Psychemedics use only | ||
| and is not intended for sale to anyone. | ||
| The test is not intended for over the | ||
| counter sale to non-professionals. |
The Psychemedics Chemiluminscent
Microplate EIA for Cannabinoids 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 Chromatography/Mass
Spectrometry/Mass Spectrometry
(GC/MS/MS) is the preferred
confirmatory method. Clinical
consideration and professional
judgment should be exercised with any
drug of abuse test result, particularly
when the preliminary result is positive. | The Psychemedics Marijuana
Screening and Confirmatory Test
System is a bipartite device
employing radioimmunoassay (RIA)
for qualitative screening and mass
spectrometry for confirmation and the
final quantitative reporting of
carboxy-THC in human hair samples
at concentrations at or above 1 pg
carboxy-THC/10 mg hair for the
purpose of determining marijuana use.
This product is intended exclusively
for in-house professional use only.
The test is not intended for over the
counter sale to nonprofessionals.
Clinical consideration and
professional judgment should be
applied to any drug of abuse test
result. |
| 510k | K111929 | K011426 |
| Measurand | Carboxy-THC /Cannabinoids | Carboxy-THC /Cannabinoids |
| Matrix | Human head or body hair | Human head or body hair |
| Cutoff | 10 pg carboxy-THC/10 mg hair | 1 pg carboxy-THC/10 mg hair |
Comparison of Psychemedics Chemiluminescent Microplate EIA for Cannabinoids with Psychemedics Marijuana Screening and Confirmatory Test System
2
| Type of Test | Enzyme Immunoassay | Radioimmunoassay |
|---|---|---|
| Method of | ||
| Measurement | Microplate reader | Gamma Counter |
| Extraction Method | Acidic Extraction | Proteolytic Digestion |
| Confirmation | GC/MS/MS | GC/MS/MS |
Summary of Performance Testing
Summary of Precision Studies
| Summary -Intra-Assay | Summary-Inter-Assay | ||||
|---|---|---|---|---|---|
| LEVEL | NEG | POS | LEVEL | NEG | POS |
| B₀ (-100%) | 15 | 0 | B₀ (-100%) | 75 | 0 |
| -75% | 15 | 0 | -75% | 75 | 0 |
| -50% | 15 | 0 | -50% | 75 | 0 |
| -25% | 15 | 0 | -25% | 75 | 0 |
| plus 25% | 0 | 15 | plus 25% | 0 | 75 |
| plus 50% | 0 | 15 | plus 50% | 0 | 75 |
| plus 75% | 0 | 15 | plus 75% | 0 | 75 |
| plus 100% | 0 | 15 | plus 100% | 0 | 75 |
Agreement Testing
Six-hundred-ten hair samples were assayed by the predicate device and by the Psychemedics Methamphetamine EIA. The number of body hair samples in the study was 18.9% of the total hair samples. The discordance between EIA and RIA was