(60 days)
RapidOne-OXY Test, K014101
Not Found
No
The description details a standard enzyme immunoassay (EIA) process for detecting oxycodone in hair. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as an "in vitro diagnostic device" for the preliminary qualitative detection of oxycodone in hair, not for treatment or diagnosis of a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This is an in vitro diagnostic device intended exclusively for Psychemedics use only."
No
The device description clearly outlines physical components like microplate wells, antibodies, enzymes, substrates, and wash buffer, which are integral to the test's function. It also describes a pre-analytical hair treatment procedure. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: 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."
- Nature of the Test: The device performs an "enzyme immunoassay (EIA) for the preliminary qualitative detection of the opiate oxycodone in human head and body hair." This is a laboratory test performed on a biological sample (hair) to provide information about a person's health status (presence of oxycodone).
- Device Description: The description details the components and process of a laboratory assay, including microplate wells, antibodies, enzymes, substrates, and a microplate reader. This is consistent with the description of an in vitro diagnostic test.
- Performance Studies: The document describes performance studies such as precision, agreement testing with a confirmatory method (LC/MS/MS), cross-reactivity, interference, and stability. These are standard types of studies conducted for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K014101; RapidOne-OXY Test) indicates that this device is being compared to a previously cleared IVD device, which is a common part of the regulatory process for IVDs.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Psychemedics Microplate EIA for Oxycodone is an enzyme immunoassay (EIA) for the preliminary qualitative detection of the opiate oxycodone in human head and body hair using an oxycodone calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying oxycodone 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 oxycodone 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.
Psychemedics plans to perform this test at one site. Psychemedics has not performed an evaluation of reproducibility at different sites.
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 Oxycodone. 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 oxycodone conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-oxycodone, goat anti-rabbit secondary · antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (which stops 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
subjects ranging in age from 19 to 67 years
Intended User / Care Setting
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
One hundred sixty one samples were confirmed by LC/MS/MS in parallel with testing by the Psychemedics Oxycodone EIA.
The studies comparing the EIA with LC/MS/MS comprised the following: subjects ranging in age from 19 to 67 years; 92 males and 69 females; 82 black hair samples, 74 brown (from light brown to dark brown), and 5 grey or "salt & pepper;" 79 Caucasian subjects, 24 African-American, 34 Hispanic, and 24 Asian; 134 head hair samples, 27 body hair.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Studies:
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 2 ng/10 mg hair, and +/-75%, +/-50%, and +/- 25% of the cutoff.
Summary - Intra-Assay (15 samples per level): NEG at B0, -75%, -50%, -25% (15 each); POS at plus 25%, 50%, 75%, 100% (15 each).
Summary - Inter-Assay (75 samples per level): NEG at B0, -75%, -50%, -25% (75 each); POS at plus 25%, 50%, 75%, 100% (75 each).
Agreement Testing:
One hundred sixty one samples were confirmed by LC/MS/MS in parallel with testing by the Psychemedics Oxycodone EIA.
LC/MS/MS Oxycodone Equivalents vs. EIA Results:
- Negative (=10% and = -50% and = Cutoff, and = +50% and = +100% of cutoff: EIA Positive: 87, EIA Negative: 0
Discordant Results of Comparison Testing:
7 samples were EIA Positive but LC/MS/MS negative (below cutoff of 2 ng/10 mg hair, ranging from 1.16 to 1.96 ng/10 mg hair). This is expected as screening assay samples are not washed, whereas confirmation samples are extensively washed.
Cosmetic Treatments:
- 20 opiate-negative hair samples were treated with bleach, permanent wave, dye, relaxer, and shampoo (2 brands each). All samples remained negative by EIA after treatment. Confirmed by LC/MS/MS prior to treatments.
- 12-16 oxycodone-positive hair samples were treated with bleach, permanent wave, dye, relaxer, and shampoo (2 brands each). None of the samples became negative by either EIA or LC/MS/MS after treatment.
Environmental Contamination:
- Hair soaked in 500 ng oxycodone/mL of water: Before washing, 0.8 to 20.9 ng/10 mg hair. After washing (by specified procedure), all samples negative (0.05 to 0.94 ng/10 mg hair remaining).
- Hair soaked in 500 ng oxycodone/mL of saline: Before washing, 0.7 to 2.5 ng/10 mg hair. After washing, all samples negative (0.11 to 0.42 ng/10 mg hair remaining).
Stability of Calibrator and Control Solutions:
Stability of oxycodone calibrator and control solutions was shown to be 6 months, with ongoing studies for 1-year stability.
Recovery:
Recovery of oxycodone from hair in a 2-hour incubation averaged 89%.
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.
RapidOne-OXY Test, K014101
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 862.3650 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
FEB 0 8 2013
.1
510 K SUMMARY
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: | K123799 | |
|---|---|---|
| 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: | December 7, 2012 | |
| Device Trade Name: | Psychemedics Microplate EIA for Oxycodone in Hair | |
| Predicate Device: | RapidOne-OXY Test, K014101 | |
| Product Code: | DJG | |
| Device Classification/Name: | 21 CFR 862.3650, Enzyme Immunoassay, Opiates; | |
| Classification II; | ||
| Intended Use: | The Psychemedics Microplate EIA for Oxycodone is an enzyme | |
| immunoassay (EIA) for the preliminary qualitative detection of | ||
| the opiate oxycodone in human head and body hair using an | ||
| oxycodone calibrator at 2 ng /10 mg hair cutoff for the purpose | ||
| of identifying oxycodone 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 oxycodone 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. | ||
| Assay 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 Oxycodone. 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 | ||
| Item | Proposed Device | RapidOne-OXY Test |
| K014101 | ||
| Indications/ | ||
| Intended use | The Psychemedics Microplate | |
| EIA for Oxycodone is an | ||
| enzyme immunoassay (EIA) | ||
| for the preliminary qualitative | ||
| detection of the opiate | ||
| oxycodone in human head and | ||
| body hair using an oxycodone | ||
| calibrator at 2 ng /10 mg hair | ||
| cutoff for the purpose of | ||
| identifying oxycodone use. | ||
| The Psychemedics Microplate | ||
| EIA oxycodone 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. | RapidOne OXY Test is a one- | |
| step, lateral flow immune- | ||
| assay for the detection of | ||
| oxycodone in urine. It is | ||
| intended for qualitative | ||
| detection of oxycodone in | ||
| human urine at 100 ng/mL. | ||
| RapidOne OXY Test is | ||
| intended for professional use. | ||
| It is not intended for over-the- | ||
| counter sales to non- | ||
| professionals. It provides only | ||
| preliminary analytical test | ||
| results. A more specific | ||
| alternate chemical method | ||
| must be used in order to obtain | ||
| a confirmed result. GC/MS is | ||
| the preferred confirmatory | ||
| method. | ||
| Product Code | DJG | DJG |
1
wells coated with multiple drugs including oxycodone conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-oxycodone, goat anti-rabbit secondary · antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (which stops the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
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, Microplate EIA for Opiates, Microplate washer and reader, LC/MS/MS for confirmation.
Comparison with Predicate:
2
| Measurand | Oxycodone in Hair | Oxycodone in Urine |
|---|---|---|
| Test System | Psychemedics EIA for Oxycodone in Hair | American Bio Medica Corp. |
| "RapidOne-OXY" Test | ||
| Sample Matrix | Hair | Urine |
| Method of Measurement | Microplate reader, read at 450 nm | Lateral Flow immunoassay, visually read endpoint |
| Cutoff | 2 ng oxycodone/10 mg hair | |
| (200 pg oxycodone/mg hair) | 100 ng oxycodone/mL urine | |
| Type of Test | Enzyme Immunoassay | Immunoassay |
| Extraction Method | Patented Digestion method | Not applicable |
| Confirmation Method | LC/MS/MS | GC/MS |
Summary of Performance Testing
The precision studies were performed by spiking negative hair with previously LC/MS/MSvalidated calibrator and control spiking solutions to achieve concentrations of negative, the cutoff of 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%) | 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
One hundred sixty one samples were confirmed by LC/MS/MS in parallel with testing by the Psychemedics Oxycodone EIA, with the results shown in the following table.
| LC/MS/MS-
Oxycodone
Equivalents: | Negative
(1000 |
| Acetylcodeine | 1000 |
| 6-AcetyImorphine | 1000 |
| Morphine | 1000 |
| Propoxyphene | 1000 |
| Methadone | 1000 |
| Dihydrocodeine | 1000 |
| Ethylmorphine | 1000 |
| Dihydromorphine | 1000 |
| Naloxone | 1000 |
| Naltrexone | 1000 |
| Nalorphine | 1000 |
| Propoxyphene | 1000 |
| Morphine Glucuronide | 1000 |
| Meperidine | 1000 |
| Dihydrocodeine | 1000 |
Cross-reactivity of related Compounds in Oxycodone EIA
Environmental Contamination
Contamination of hair by soaking in 500 ng oxycodone /mL of water resulted in a range of oxycodone on the hair of 0.8 to 20.9 ng of oxycodone /10 mg hair before washing. After washing by the procedure described above, all samples were negative, with the amount of oxycodone remaining on the hair samples ranging from 0.05 to 0.94 ng/10 mg hair.
Contamination of hair by soaking in 500 ng oxycodone /mL of saline resulted in a range of oxycodone on the hair of 0.7 to 2.5 ng of oxycodone /10 mg hair before washing. After washing by the procedure described above, all samples were negative, with the
5
amount of oxycodone remaining on the hair samples ranging from 0.11 to 0.42 ng/10 mg hair.
Stability of Calibrator and Control Solutions
The oxycodone calibrator and control solutions are prepared in-house by the laboratory from certified standards. Stability of the oxycodone calibrator and control solutions was shown to be 6 months, with ongoing studies to demonstrate 1-year stability.
Recovery
Recovery of oxycodone from hair in a 2-hour incubation averaged 89%.
Conclusion:
Comparison of results of the Psychemedics Microplate EIA for Oxycodone in Hair with LC/MS/MS confirmation showed the results to be substantially equivalent. The Psychemedics Microplate EIA for Oxycodone in Hair is substantially equivalent to the predicate, based on acceptable performance studies, including precision, specificity, interference (including cosmetic effects), and removal of external contamination.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2013
Psychemedics Corporation c/o Ms. Virginia Hill 5832 Uplander Way Culver City, CA 90230
Re: K123799
Trade/Device Name: Psychemedics Microplate EIA for Oxycodone in Hair Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG Dated: January 11, 2013 Received: January 17, 2013
Dear Ms. Hill:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
7
Page 2-Ms. Hill
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson for
Courtney H. Lias, Ph.D. Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K123799
Device Name: Psychemedics Microplate EIA for Oxycodone in Hair
Indications for Use:
The Psychemedics Microplate ElA for Oxycodone is an enzyme immunoassay (EIA) for the preliminary qualitative detection of oxycodone in human head and body hair using a oxycodone calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying oxycodone 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 oxycodone 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.
Psychemedics plans to perform this test at one site. Psychemedics has not performed an evaluation of reproducibility at different sites.
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 Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -5 2013.02.05 14:46:03 -05'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)