(60 days)
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.
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.
Acceptance Criteria and Device Performance for Psychemedics Microplate EIA for Oxycodone in Hair
The Psychemedics Microplate EIA for Oxycodone in Hair is an enzyme immunoassay for the preliminary qualitative detection of oxycodone in human head and body hair. The device's performance was evaluated through precision studies and agreement testing against LC/MS/MS confirmation.
1. Table of Acceptance Criteria and Reported Device Performance
The direct acceptance criteria for the device are not explicitly stated as numerical targets in the provided document. However, the performance is reported in terms of precision (intra-assay and inter-assay agreement at various concentrations relative to the cutoff) and agreement with the confirmatory method (LC/MS/MS). The implied acceptance criteria are high agreement percentages for both positive and negative samples around the cutoff.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Intra-Assay) | High agreement for negative and positive samples at various levels relative to the 2 ng/10 mg hair cutoff. | - Negative (B0, -75%, -50%, -25%): 15/15 reported as NEG- Positive (plus 25%, plus 50%, plus 75%, plus 100%): 15/15 reported as POS |
| Precision (Inter-Assay) | High agreement for negative and positive samples at various levels relative to the 2 ng/10 mg hair cutoff. | - Negative (B0, -75%, -50%, -25%): 75/75 reported as NEG- Positive (plus 25%, plus 50%, plus 75%, plus 100%): 75/75 reported as POS |
| Agreement with LC/MS/MS | High concordance between EIA results and LC/MS/MS confirmation, especially for samples around the cutoff. | - 47 Negative HC/MS/MS samples (< -10% of Cutoff): All 47 were EIA Negative.- 4 LC/MS/MS samples (≥10% and < -50% of Cutoff): All 4 were EIA Negative.- 6 LC/MS/MS samples (≥ -50% and < Cutoff): All 6 were EIA Negative.- 87 LC/MS/MS samples (≥ +100% of cutoff): All 87 were EIA Positive.- 2 LC/MS/MS samples (≥ +50% and < +100% of cutoff): All 2 were EIA Positive. |
| Discordant Results | Discrepant results, if any, should be explainable and primarily occur as EIA positive/confirmatory negative. | All 7 discordant results from the agreement study were EIA Positive but LC/MS/MS Negative (ranging from 1.16 to 1.96 ng oxycodone-equivalents/10 mg hair, below the 2 ng/10 mg hair cutoff). This is explained by the washing procedure used for confirmatory testing but not for screening. |
| Cross-reactivity | Limited cross-reactivity with non-target compounds. | Significant cross-reactivity (100%) with Oxymorphone and (7.7%) with Hydrocodone. 138 other compounds showed no cross-reactivity. |
| Interference | No significant interference from common substances (e.g., cosmetic treatments). | - Cosmetic Treatments (Negative Hair): No significant differences in EIA results; all remained negative after treatment (bleach, permanent wave, dye, relaxer, shampoo).- Cosmetic Treatments (Positive Hair): None of the positive samples became negative by EIA or LC/MS/MS after treatment (bleach, permanent wave, dye, relaxer, shampoo).- Other Interferents: 116 compounds tested showed no interference at +/-50% of the cutoff. |
| Environmental Contamination | Effective removal of external contamination by the wash procedure. | - Soaking in 500 ng oxycodone/mL water: All samples negative after washing (amount remaining 0.05 to 0.94 ng/10 mg hair, below cutoff).- Soaking in 500 ng oxycodone/mL saline: All samples negative after washing (amount remaining 0.11 to 0.42 ng/10 mg hair, below cutoff). |
| Recovery | High recovery rate of oxycodone from hair. | Averaged 89% recovery from hair in a 2-hour incubation. |
| Stability | Demonstrated stability of calibrators and controls. | 6 months stability shown for calibrator and control solutions (ongoing studies for 1-year stability). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size for Agreement Testing: 161 samples.
- Data Provenance: The document does not explicitly state the country of origin. However, given the submission is to the U.S. FDA, it is likely the data was collected in the U.S. The study involved subjects aged 19-67 years, 92 males and 69 females, various hair colors (82 black, 74 brown, 5 grey), and diverse ethnicities (79 Caucasian, 24 African-American, 34 Hispanic, 24 Asian). It included 134 head hair samples and 27 body hair samples. The study appears to be prospective in nature, as samples were tested in parallel by the EIA and LC/MS/MS, and specific demographic and sample characteristics were recorded for this study. The precision studies involved spiking negative hair samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the traditional sense for an analytical device.
- Qualifications of Experts: The ground truth for the device's performance was established using LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry), which is described as the "preferred confirmatory method" for drug testing. This is an objective, instrumental analytical technique, not reliant on human expert interpretation of images or clinical findings. The validation of the LC/MS/MS method itself would have been performed by qualified analytical chemists or toxicologists in a laboratory setting.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The comparison was made between the preliminary results of the EIA and the objective, quantitative results of LC/MS/MS. There was no human adjudication process described between different readers or interpretations for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This device is an analytical laboratory assay, not an imaging device or one requiring human interpretation for its primary output. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.
6. If a Standalone Study Was Done
- Yes, a standalone performance study was done for the Psychemedics Microplate EIA for Oxycodone. The "Agreement Testing" section directly details the performance of the EIA device alone (without human interpretation beyond reading the microplate reader output) against the LC/MS/MS ground truth. The agreement data clearly shows the algorithm's performance in categorizing samples as positive or negative based on the prescribed cutoff.
7. The Type of Ground Truth Used
- The primary ground truth used was LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) confirmation. This is an objective, quantitative analytical method considered the gold standard for confirming the presence and concentration of drugs in biological samples.
8. The Sample Size for the Training Set
- The document does not provide information on a specific training set size. The device is an immunoassay kit, and such kits are typically developed and optimized through iterative chemical and biological experimentation, rather than being "trained" in the machine learning sense on a large dataset. The studies described (precision, agreement, cross-reactivity, interference) are validation studies for the finalized assay.
9. How the Ground Truth for the Training Set Was Established
- Since there is no explicit mention of a training set in the context of machine learning, this question is not directly applicable. For the development and optimization of the immunoassay, the "ground truth" for calibrator and control solutions would be established by preparing them from certified standards and validating their concentrations using reference analytical methods, likely including LC/MS/MS.
{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 WayCulver City, CA 90230TEL: 310 216 7776FAX: 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 enzymeimmunoassay (EIA) for the preliminary qualitative detection ofthe opiate oxycodone in human head and body hair using anoxycodone calibrator at 2 ng /10 mg hair cutoff for the purposeof identifying oxycodone use. This is an in vitro diagnosticdevice intended exclusively for Psychemedics use only and isnot intended for sale to anyone. | |
| The Psychemedics Microplate EIA oxycodone assay providesonly a preliminary analytical test result. A more specificalternative chemical method must be used in order to obtain aconfirmed analytical result. Gas or LiquidChromatography/Mass Spectrometry (GC/MS or LC/MS orLC/MS/MS) is the preferred confirmatory method. Clinicalconsideration and professional judgment should be exercisedwith any drug of abuse test result, particularly when thepreliminary result is positive. | ||
| Assay Description: | The test consists of two parts; a pre-analytical hair treatmentprocedure (to convert the solid matrix of hair to a measurableliquid matrix) and the screening assay, the PsychemedicsMicroplate EIA for Oxycodone. The drug is recovered from thehair using a patented method (U.S. Patent #8,084,215).Thescreening portion of the test system consists of (1) microplate | |
| Item | Proposed Device | RapidOne-OXY TestK014101 |
| Indications/Intended use | The Psychemedics MicroplateEIA for Oxycodone is anenzyme immunoassay (EIA)for the preliminary qualitativedetection of the opiateoxycodone in human head andbody hair using an oxycodonecalibrator at 2 ng /10 mg haircutoff for the purpose ofidentifying oxycodone use.The Psychemedics MicroplateEIA oxycodone assay providesonly a preliminary analyticaltest result. A more specificalternative chemical methodmust be used in order to obtaina confirmed analytical result.Gas or LiquidChromatography/MassSpectrometry (GC/MS orLC/MS or LC/MS/MS) is thepreferred confirmatorymethod. | RapidOne OXY Test is a one-step, lateral flow immune-assay for the detection ofoxycodone in urine. It isintended for qualitativedetection of oxycodone inhuman urine at 100 ng/mL.RapidOne OXY Test isintended for professional use.It is not intended for over-the-counter sales to non-professionals. It provides onlypreliminary analytical testresults. A more specificalternate chemical methodmust be used in order to obtaina confirmed result. GC/MS isthe preferred confirmatorymethod. |
| 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-OxycodoneEquivalents: | Negative(<-10% ofCutoff) | ≥10%and<-50%of Cutoff | ≥ -50%and< Cutoff | ≥ Cutoff,and <+50% ofcutoff | ≥ +50%and< +100%of cutoff | ≥ +100%of cutoff |
|---|---|---|---|---|---|---|
| EIA Positive | 0 | 0 | 7 | 8 | 2 | 87 |
| EIA Negative | 47 | 4 | 6 | 0 | 0 | 0 |
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.
{3}------------------------------------------------
Discordant Results of Comparison Testing
| Sample # | Cutoff Value(ng/10 mg hair) | Candidate Device(+/-) | LC/MS/MS(ng oxycodone-equivalents/10 mg hair) |
|---|---|---|---|
| 3 | 2 | POS | 1.16 |
| 5 | 2 | POS | 1.28 |
| 10 | 2 | POS | 1.46 |
| 12 | 2 | POS | 1.78 |
| 13 | 2 | POS | 1.95 |
| 14 | 2 | POS | 1.95 |
| 15 | 2 | POS | 1.96 |
All of the discrepant results were positive in the immunoassay but fell below the cutoff by LC/MS/MS analysis. This is expected, as the samples are not washed for the screening assay, whereas once determined to be presumptive in the screening assay, second aliquots of the samples are weighed and washed extensively by our published wash procedures prior to digestion and extraction for LC/MS/MS
Cosmetic Treatments
Twenty opiate-negative hair samples were treated with bleach, 20 with permanent wave, 20 with dye, 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. Samples were confirmed by LC/MS/MS prior to the treatments.
Twelve to sixteen oxycodone-positive hair samples were treated with bleach, permanent wave, dye, relaxer, and 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 - 8 samples were treated with one brand of a particular product and 6 - 8 samples with a second brand. None of the samples became negative, by either EIA or LC/MS/MS, after treatment with any of the cosmetic products.
The Wash Procedure and Confirmation by LC/MS/MS
Wash procedure
- Add 2 mL of dry isopropanol and shake in waterbath for 15 minutes at 37°C .............................................................................................................................................................................. with shaking @ 100 -120 oscillations/minute. Remove isopropanol.
- ii. Add 2 mL of Wash Buffer (0.01 M phosphate buffer, pH 6.0, containing 0.1% BSA) and shake in waterbath for 30 minutes at 37℃ with shaking @ 100 -120 oscillations/minute. Remove Buffer.
- iii. Repeat Step ii. two more times.
- iv. Add 2 mL of Wash Buffer, and shake in waterbath for 60minutes at 37°C with shaking @ 100 -120 oscillations/minute. Remove Buffer.
{4}------------------------------------------------
- v. Repeat Step iv. one more time. Hair sample is now ready for digestin and extraction for LC/MS/MS confirmation.
Confirmation
After washing the hair is digested with dithiothreitol and proteinase K for 6 hours. The digestion supernatant is extracted and confirmed by LC/MS/MS for opiates, including oxycodone.
Summary of Cross-reactivity and Interference Studies
Two compounds, oxymorphone and hydrocodone, showed significant cross-reactivity in the Opiate EIA assay. One-hundred-thirty-eight other compounds showed no cross-reactivity in the assay. One-hundred-sixteen compounds tested for interference at +/-50% of the cutoff showed no interference in the assay.
| Sample/Test Compound | % Cross-reactivity | Expected Concentration at2ng Oxycodone/10 mg hairCutoff |
|---|---|---|
| Oxymorphone | 100 | 2 |
| Hydrocodone | 7.7 | 26 |
| Hydromorphone | 0.2 | 1000 |
| Codeine | < 0.2 | >1000 |
| Acetylcodeine | < 0.2 | >1000 |
| 6-AcetyImorphine | < 0.2 | >1000 |
| Morphine | < 0.2 | >1000 |
| Propoxyphene | < 0.2 | >1000 |
| Methadone | < 0.2 | >1000 |
| Dihydrocodeine | < 0.2 | >1000 |
| Ethylmorphine | < 0.2 | >1000 |
| Dihydromorphine | < 0.2 | >1000 |
| Naloxone | < 0.2 | >1000 |
| Naltrexone | < 0.2 | >1000 |
| Nalorphine | < 0.2 | >1000 |
| Propoxyphene | < 0.2 | >1000 |
| Morphine Glucuronide | < 0.2 | >1000 |
| Meperidine | < 0.2 | >1000 |
| Dihydrocodeine | < 0.2 | >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)
§ 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).