(300 days)
Not Found
No
The description details a standard enzyme immunoassay (EIA) process for detecting opiates in hair. There is no mention of AI, ML, or any computational methods beyond reading absorbance values with a microplate reader.
No
The device is an in vitro diagnostic (IVD) device used for the preliminary qualitative detection of opiates in hair samples, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone."
No
The device description clearly outlines a physical test kit with reagents, microplate wells, and a pre-analytical hair treatment procedure. It also mentions reading absorbance with a microplate reader, which is a hardware component. This is an in vitro diagnostic device, 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 is "an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair... for the purpose of identifying opiate use." This describes a test performed on a biological sample (hair) to provide information about a person's health status (opiate use).
- IVD Statement: The intended use also explicitly states, "This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone." This is a direct declaration that the device is an IVD.
- In Vitro: The test is performed "in vitro," meaning outside of the living body, on a sample of hair.
- Diagnostic: While it provides a "preliminary analytical test result," the purpose is to aid in the "identifying opiate use," which is a diagnostic purpose. The need for confirmatory testing is common for preliminary diagnostic tests.
- Sample Type: It uses a human biological sample (hair).
Therefore, based on the intended use, the explicit statement, and the nature of the test, this device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Psychemedics Microplate EIA for Opiates is an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Microplate EIA opiate assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/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
DJG
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 Opiates. 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 morphine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-morphine, rabbit anti-goat 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
This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Studies:
Intra-Assay and Inter-Assay studies were performed at various levels (B₀ (-100%), -75%, -50%, -25%, plus 25%, plus 50%, plus 75%, plus 100%) for both negative and positive results. For Intra-Assay, there were 15 replicates for each level. For Inter-Assay, there were 75 replicates for each level. All results were either 0 or 15/75, indicating precise detection at different concentration levels.
Agreement Testing:
The agreement studies included 383 head hair samples and 90 body hair samples, totaling 473 hair samples. These samples were assayed by both the predicate device and the Psychemedics Opiates EIA. The discordance between EIA and RIA was
§ 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).
0
K111926
MAY - 1 2012
510 K SUMMARY
Psychemedics Microplate EIA for Opiates in Hair
Psychemedics Opiates Assay, K000851
Submitted By:
Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 TEL: 310 216 7776 FAX: 310 216 6662
Submission Contact:
Virginia Hill April 25, 2012
DIG
Date Prepared:
Device Trade Name:
Predicate Device:
Product Code:
Device Classification/Name:
Intended Use:
Assay Description:
Sample Collection:
21 CFR 862.3650, Enzyme Immunoassay, Opiates; Classification II; The Psychemedics Microplate EIA for Opiates is an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Microplate EIA opiate assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liguid Chromatography/Mass Spectrometry (GC/MS or LC/MS or LC/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 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 Opiates. 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 morphine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-morphine, rabbit anti-goat 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
1
foil is crimped around the sample, securing the hair specimen firmly into place within the foil. The hair samples 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 Opiates, Microplate washer and reader, LC/MS/MS for confirmation.
Comparison of Psychemedics Microplate ElA for Opiates with Psychemedics RIA Assay for Opiates
| Item | Device | Predicate |
|---|---|---|
| Indications for Use | The Psychemedics Microplate EIA for | |
| Opiates is an enzyme immunoassay (EIA) | ||
| for the preliminary qualitative detection of | ||
| opiates in human head and body hair using a | ||
| morphine calibrator at 2 ng /10 mg hair | ||
| cutoff for the purpose of identifying opiate | ||
| 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 Microplate EIA opiate
assay provides only a preliminary analytical
test result. A more specific alternative
chemical method must be used in order to
obtain a confirmed analytical result. Gas or
Liquid Chromatography/Mass Spectrometry
(GC/MS or LC/MS or LC/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 Opiate assay is a
radioimmunoassay (RIA) for the
preliminary detection of morphine in
hair using a 2 ng/10 mg hair cutoff
for the purposes of identifying opiate
use. For a quantitative analytical
results or to confirm positive results
via the presence of the heroin
metabolite, 6-monoacetylmorphine
(6-MAM), a more specific alternate
chemical method must be used in
order to obtain a confirmed analytical
results |
| 510k | K111926 | K000851 |
| Measurand | Opiates | Opiates |
| Matrix | Human head or body hair | Human head or body hair |
| Cutoff
concentration | 2 ng morphine10 mg hair | 2 ng morphine /10 mg hair |
| Type of Test | Enzyme Immunoassay | Radioimmunoassay |
| Method of
measurement | Microplate reader | Gamma counter |
| Extraction
Method | Nonproteolytic Digestion | Proteolytic Digestion |
| Confirmation | LC/MS/MS | LC/MS/MS |
2
Summary of Performance Testing
| 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 |
Precision Studies
Agreement Testing
The agreement studies included 383 head hair samples and 90 body hair samples. Four hundred-seventythree hair samples were assayed by the predicate device and by the Psychemedics Opiates EIA. The discordance between EIA and RIA was the parent drug cutoff, in combination with other metabolite criteria, the sample is interpreted as positive due to ingestion. The confirmation cutoff values for the opiates is 2 ng/10 mg hair.
Summary of Cross-reactivity and Interference Studies
Six compounds, shown in the table below, showed cross-reactivity in the Opiate EIA assay. Sixty-five other compounds showed no cross-reactivity in the assay. One-hundred-fifty-six compounds tested for interference at +/-50% of the cutoff showed no interference in the assay.
| Compound | Amount of Compound required to Produce
a positive test at the cutoff of 2 ng
morphine/10 mg hair | Percent Cross-reactivity* |
|----------------------|--------------------------------------------------------------------------------------------------------|---------------------------|
| Codeine | 1.8 | 111 |
| Hydromorphone | 38 | 5.2 |
| Hydrocodone | 4.8 | 41.7 |
| Acetylcodeine | 3.5 | 57.1 |
| 6-Acetylmorphine | 4.6 | 43.5 |
| Morphine Glucuronide | 13.3 | 15 |
of related Compo
Stability of Calibrator and Control Solutions
The morphine calibrator and control solutions are prepared in-house by the laboratory from certified standards. Stability of morphine in methanol in the presence of other drugs of abuse was shown to exceed 1 year.
Recovery
Recovery of opiates from hair of opiate users was shown to be substantially equivalent to that of the predicate device.
Conclusion:
The Psychemedics Microplate EIA for Opiates in Hair is substantially equivalent to the predicate device K000851, 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 Department of Health & Human Services (HHS). The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
PSYCHEMEDICS CORP. c/o Virginia Hill 5832 Uplander Way Culver City, CA 90230
MAY - 1 2012
Re: K111926
KT11220
Trade Name: PSYCHEMEDICS MICROPLATE EIA FOR OPIATES IN HAIR Regulation Number: 21 CFR §862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Codes: DJG 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 nave roviewed your eee atermined 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 mensiale conments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to do resos that the Act (Act) that do not require approval of a premarket the rederal 1 000, Drug, und Commons , therefore, market the device, subject to the general approval upprisation () ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . controls provisions of the Fist - tion, listing of devices, good 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 II your device is classified (see as a roll additional controls. Existing major regulations affecting (I MA), it may of subject to tack active of Federal Regulations (CFR), Parts 800 to 895. your device can oc round in Title B2, Oncouncements 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 mean that IDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal spacies. of the Act of ally rederal statutes and rogulations, but not limited to: registration 1 ou must comply with an the Hot Hot eight store (21 CFR Parts 801 and 809); medical device and listing (21 CFR Part 607), laceming (21 CFR 803); and good reporting (reporting of medical device related daverse evening (
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
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 vours,
signature
Counney 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: K111926
Device Name: Psychemedics Microplate EIA for Opiates in Hair
Indications For Use:
The Psychemedics Microplate EIA for Opiates is an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Microplate EIA opiate assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/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.
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)
CARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1111926
Page 1 of 1