(300 days)
Not Found
No
The device description and performance studies detail a standard enzyme immunoassay (EIA) process involving chemical reactions, antibody binding, and absorbance reading. There is no mention of AI, ML, or any computational analysis beyond basic data processing of absorbance values.
No
The device is an in vitro diagnostic (IVD) test for the detection of cocaine in hair samples, which provides analytical results but does not directly treat or diagnose a disease or condition.
Yes
The device is an enzyme immunoassay (EIA) intended for the preliminary qualitative detection of cocaine in human hair samples to identify cocaine use. Such detection tests for substances in the body are considered diagnostic.
No
The device description clearly outlines physical components like microplate wells, antibodies, enzymes, substrates, and wash buffer, which are integral to the assay and require a microplate reader for absorbance readings. This indicates it is a hardware-based diagnostic test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "preliminary qualitative detection of cocaine in human head and body hair samples... for the purpose of identifying cocaine use." This is a diagnostic purpose, analyzing a human sample to gain information about a person's health or condition (in this case, drug use).
- Sample Type: It uses "human head and body hair samples," which are biological specimens taken from the human body.
- Method: It employs an "enzyme immunoassay (EIA)," which is a common in vitro diagnostic technique.
- Device Description: The description details the components and process for analyzing the hair sample in a laboratory setting.
The definition of an In Vitro Diagnostic (IVD) device generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While drug use detection isn't always strictly considered a "disease," it falls under the broader scope of determining a state of health or condition through the analysis of in vitro samples.
The fact that it's for "in-house professional use only" and not for sale to the general public is a characteristic of some IVDs, particularly those used in clinical or forensic laboratories.
N/A
Intended Use / Indications for Use
The Psychemedics Microplate EIA for Cocaine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine and metabolites in human head and body hair 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 only and is not for sale to anyone.
The Psychemedics Microplate EIA for Cocaine in Hair 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 judgment should be applied to the interpretation of any drug-of-abuse test result.
Product codes (comma separated list FDA assigned to the subject device)
JXO
Device Description
The test 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 Cocaine. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215). The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including benzoylecgonine conjugated to bovine serum albumin (BSA) (patent pending), monoclonal mouse anti-cocaine, goat anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify the final 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
In-house professional use only
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)
Summary -Intra-Assay
Level, NEG, POS
B₀ (-100%), 15, 0
-75%, 15, 0
-50%, 15, 0
-25%, 15, 0
plus 25%, 0, 15
plus 50%, 0, 15
plus 75%, 0, 15
plus 100%, 0, 15
Summary-Inter-Assay
Level, NEG, POS
B₀ (-100%), 75, 0
-75%, 75, 0
-50%, 75, 0
-25%, 75, 0
plus 25%, 0, 75
plus 50%, 0, 75
plus 75%, 0, 75
plus 100%, 0, 75
Agreement Testing
Study Type: Agreement Testing. Sample Size: Four hundred-twenty-five hair samples. Data Source: Assayed by the predicate device and by the Psychemedics Cocaine EIA. Key Results: Four samples near the cutoff and positive with the predicate device were negative with the EIA device and by LC/MS/MS. The discordance between EIA and RIA was Cutoff | ≥ Cutoff, And
§ 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
510K SUMMARY
510K Number: Submitted By: K111925 Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 TEL: 310 216 7776 FAX: 310 216 6662
Submission Contact:
Date Prepared:
Device Trade Name:
Predicate Device:
Product Code:
Device Classification/Name:
Intended Use:
Assay Description:
Sample Collection: ·
Psychemedics Corporation
5832 Uplander Way
Culver City, CA 90230
TEL: 310 216 7776
FAX: 310 216 6662
Virginia Hill
April 25, 2012
Psychemedics Microplate EIA for Cocaine in Hair
Psychemedics Cocaine Assay, K010868
.الا الام
21 CFR 862.3250, Enzyme Immunoassay, Cocaine; Classification II;
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 only and not for sale to anyone.
The Psychemedics EIA Cocaine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GC/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abusc test result.
The test 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 Cocaine. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215). The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including benzoylecgonine conjugated to bovine serum albumin (BSA) (patent pending), monoclonal mouse anti-cocaine, goat anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader. .
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
1
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, Microplate EIA for Cocaine, Microplate washer and reader, LC/MS/MS for confirmation.
Comparison of Psychemedics Microplate EIA for Cocaine with Psychemedics RIA Assay for Cocaine
| Item | Device | Predicate |
|---|---|---|
| Indications for Use | 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 only 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 obtain a quantitative
analytical result or to confirm positive
results, a more specific alternate
chemical method (e.g. LC/MS/MS)
must be used. Clinical consideration
and professional judgment should be
applied to the interpretation of any
drug-of-abuse test result. | The Psychemedics Cocaine assay is a
radioimmunoassay (RIA) for the
qualitative and semi-quantitative
detection of cocaine in head hiar, leg
hair, underarm hair and chest hair
through the measurement of cocaine
and cocaine metabolites at
concentrations at or above a 5 ng/10
mg hair cutoff. For a quantitative
analytical results or to confirm
positive results via the presence of
cocaine and cocaine metabolites, a
more specific alternate chemical
method must be used in order to
obtain a confirmed analytical result. |
| 510k | K111925 | K010868 |
| Measurand | Cocaine | Cocaine |
| Matrix | Human head or body hair | Human head or body hair |
| Cutoff concentration | 5 ng cocaine/10 mg hair | 5 ng cocaine /10 mg hair |
| Type of Test | Enzyme Immunoassay | Radioimmunoassay |
| Method of
measurement | Microplate reader | Gamma counter |
| Extraction Method | NonproteolyticDigestion | Proteolytic Digestion |
| Confirmation
Method | LC/MS/MS | LC/MS/MS |
Summary of Performance Testing:
2
| 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
Four hundred-twenty-five hair samples were assayed by the predicate device and by the Psychemedics Cocaine EIA. Four samples near the cutoff and positive with the predicate device were negative with the EIA device and by LC/MS/MS. The discordance between EIA and RIA was
Cutoff | ≥ Cutoff,
And the parent drug cutoff, in combination with other metabolite criteria, the sample is interpreted as positive due to ingestion. The parent-drug cutoff value for cocaine is 5 ng/ 10 mg hair.
Cross-reactivity and Interference Studies
Seven compounds, shown in the table below, showed cross-reactivity in the Cocaine assay. Seventynine other compounds showed no cross-reactivity in the assay. One-hundred-forty-one compounds tested for interference at +/-50% of the cutoff showed no interference in the assay.
| Cross-reactivity of related Compounds in Cocaine EIA | ||
|---|---|---|
| Compound | Amount of Compound | |
| required to Produce a positive | ||
| test at the cutoff of 5 ng | ||
| cocaine/10 mg hair | Percent Cross- | |
| reactivity* | ||
| Benzoylecgonine | 80 | 6.3 |
| Norbenzoylecgonine | 200 | 2.5 |
| Norcocaine | 8.0 | 62.5 |
| Norcocaethylene | 11 | 45.5 |
| Cocaethylene | 6.5 | 76.9 |
| Benzoylecgonine Isopropyl ester | 9 | 55 |
| Tropacocaine | 13 | 38.5 |
. .
Stability of Calibrator and Control Solutions
The cocaine calibrator and control solutions are prepared in-house by the laboratory from certified standards. Stability of cocaine in methanol in the presence of other drugs of abuse was shown to exceed 1 year.
Recovery Study
Recovery of cocaine and benzoylecgonine from hair of cocaine users was shown to be substantially equivalent to that of the predicate device.
Conclusion:
The Psychemedics Microplate EIA for Cocaine in Hair is substantially equivalent to the predicate device K010868, and the results are substantially equivalent to LC/MS/MS results.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with its wings spread, positioned to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Psychemedics Corporation c/o Virginia Hill Senior Scientist 5832 Uplander Way Culver City, CA 90230
MAY - 1 2012
K111925 Re: Psychemedics Microplate EIA for Cocaine in Hair Trade/Device Name: Regulation Number: 21CFR 862.3250 Regulation Name: Enzyme Immunoassay, Cocaine and Cocaine metabolites Regulatory Class: Class II Product Code: JXO Dated: March 9, 2012 Received: March 12, 2012
Dear Ms. Hill:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) prematically equivalent (for the indications for referenced above and nave delemined the devices marketed in interstate commerce
use stated in the enclosure) to legally mark the M. Lies Amedenents, or to devices that use stated in the enclosure) to legally hiar cleare device Amendments, or to devices that prior to May 28, 1976, the enactified in the Massar Son Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal September 19 have been reclassified in acconualice with the provisions of the Act. The Act. The general Act (Act) that do not require approval ot a picmaller applo rar applo raires of the Act. The general
therefore, market the device, subject to the general somises provisions therefore, market the device, subject to the general one personal issing of devices, good
controls provisions of the Act include requirements for annoingsismation and anylera controls provisions of the Actimende requirements for annual 149
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into Enier easy in (cass in the materice and be
may be subject to such additional controls. may be subject to such additional controls. Exismig major regalatas. found in Title 21, Code of Pederal Rogalances (120))
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 Please be advised that FDA issuance of a substantial order requirements of the Act or
that FDA has made a determination that your device complies with and somply that FDA has made a determination intered by other Federal agencies. You must comply
any Federal statutes and regulations administered by consistes. You must comply any Federal statutes and regulations administered by other trepistration and listing (21 CFR Part
with all the Act's requirements, including, but not limited to: registration with all the Act's requirements, including, but not more we regulation of the more of the more of the more of the many as set
807); labeling (21 CFR Parts 801 and 809); and 807); fabeling (21 CFR RT arts 600 = 1.0 cm (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k)
1978 (contraction of the TP to City of substantial aquivalence of your device t This letter will allow you to begal marketing your device of your device to a legally
premarket notification. The FDA finding of substantial equir device and this, permits y premarket notification. The FDA finding of substantial equivations of your device to proceed to the market.
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indication for Use
510(k) Number (if known): K111925
Device Name: Psychemedics Microplate EIA for Cocaine in Hair
Indication For Use:
The Psychemedics Microplate EIA for Cocaine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine and metabolites in human head and body hair 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 only and is not for sale to anyone.
The Psychemedics Microplate EIA for Cocaine in Hair 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 judgment should be applied to the interpretation of any drug-of-abuse test result.
Prescription Use _ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111925