(300 days)
Not Found
No
The description details a standard enzyme immunoassay (EIA) and LC/MS/MS confirmation process, which are traditional laboratory techniques. There is no mention of AI or ML in the device description, performance studies, or key metrics.
No.
This device is an immunoassay intended for the preliminary qualitative detection of methamphetamine in hair samples to identify methamphetamine use, not to treat a condition or disease.
Yes
The device is intended for the "preliminary qualitative detection of methamphetamine in human head and body hair samples... for the purpose of identifying methamphetamine use," which describes a diagnostic function.
No
The device description clearly outlines physical components like microplate wells, antibodies, enzymes, substrates, and wash buffer, which are all hardware components of an immunoassay kit. While a microplate reader is mentioned for reading absorbance, the core of the device is a chemical assay, not software.
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 methamphetamine in human head and body hair samples... for the purpose of identifying methamphetamine use." This is a diagnostic purpose, aiming to identify the presence of a substance in a biological sample to infer a condition (drug use).
- Sample Type: It uses "human head and body hair samples," which are biological specimens.
- Method: It employs an "enzyme immunoassay (EIA)," which is a common in vitro diagnostic technique.
- Device Description: The description details the components and process of an assay performed on a biological sample outside of the body.
- Performance Studies: The document includes performance studies like precision, agreement testing, and cross-reactivity, which are standard for evaluating the performance of IVD devices.
The fact that it's for "in-house professional use only" and provides a "preliminary analytical test result" that requires confirmation by another method (LC/MS/MS) does not negate its classification as an IVD. Many IVDs are intended for professional use and serve as screening tests requiring confirmation.
N/A
Intended Use / Indications for Use
The Psychemedics Microplate EIA for Methamphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying methamphetamine use. This product is intended exclusively for inhouse professional use only and is not for sale to anyone.
The Psychemedics Microplate EIA for Methamphetamine 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 must be applied to the interpretation of any drug-of-abuse test result.
Product codes
DKZ, LAF
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 Methamphetamine. 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 methamphetamine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-methamphetamine, 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
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)
Precision Studies:
Intra-Assay and Inter-Assay
- Intra-Assay: 15 samples per level (B₀ (-100%), -75%, -50%, -25%, plus 25%, plus 50%, plus 75%, plus 100%). Results categorized as Negative or Positive.
- Inter-Assay: 75 samples per level (B₀ (-100%), -75%, -50%, -25%, plus 25%, plus 50%, plus 75%, plus 100%). Results categorized as Negative or Positive.
Agreement Testing:
- 536 hair samples were assayed by the predicate device and by the Psychemedics Methamphetamine EIA. The discordance between EIA and RIA was
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
MAY - 1 202
510K SUMMARY
510K Number: Submitted By:
K111927 Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 TEL: 310 216 7776 FAX: 310 216 6662
Submission Contact:
Virginia Hill
April 25, 2012
DKZ
Device Trade Name:
Predicate Device:
Date Prepared:
Product Code:
Device Classification/Name:
Intended Use:
Assay Description:
21 CFR 862,3100, Enzyme Immunoassay, Methamphetamine and Methamphetamine Metabolites; Classification II;
Psychemedics Microplate EIA for Methamphetamine in Hair
Psychemedics Methamphetamine and MDMA Assay, K011185
The Psychemedics Microplate EIA for Methamphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng/10 mg hair cutoff for the purpose of identifying methamphetamine use. This product is intended exclusively for in-house professional use only and is not for sale to anyone.
The Psychemedics Microplate EIA for Methamphetamine in Hair provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical chromatography/mass LC/MS/MS (liquid method such as spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgment must be applied to the interpretation of any drug-of-abuse 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 Methamphetamine. 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 methamphetamine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-methamphetamine, rabbit anti-goat secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCI to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
1
Sample Collection:
A sample of hair should be cut as close as possible to the skin. The hair is placed in a V-shaped aluminum foil sample holder with the root end of the hair protruding beyond the slanted edge of the foil. The aluminum foil is crimped around the sample, securing the hair specimen firmly into place within the foil. The hair sample crimped within the foil is placed in a sample acquisition card envelope and the envelope is sealed with a tamper-evident seal. Hair specimens are kept at ambient temperature in a secure location until they are shipped without refrigeration to the laboratory.
Materials required:
Hair sample collection kit, Microplate EIA for Methamphetamine, Microplate washer and reader, LC/MS/MS for confirmation.
| Comparison of Psychemedics Microplate ElA for Methamphetamine with Psychemedics RiA | |
|---|---|
| Assay for Methamphetamine/MDMA |
| Item | Device | Predicate |
|---|---|---|
| Indications for Use | The Psychemedics Microplate EIA for | |
| Methamphetamine is an enzyme | ||
| immunoassay (EIA) for the preliminary | ||
| qualitative detection of | ||
| methamphetamine in human head and | ||
| body hair samples using a | ||
| methamphetamine calibrator at 5 ng /10 | ||
| mg hair cutoff for the purpose of | ||
| identifying methamphetamine 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 Microplate EIA for
Methamphetamine 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 must be applied
to the interpretation of any drug-of-
abuse test result. | The Psychemedics Methamphetamine
and MDMA assay is a
radioimmunoassay (RIA) for the
preliminary detection of d-
methamphetamine, d,l-MDMA and
metabolites in human hair samples
using a 5 ng/10 mg hair cutoff for the
purpose of identifying
methamphetamine or MDMA
(ecstasy) use. For a quantitative
analytical results or to confirm
positive results via the presence of the
methamphetamine, MDMA and
metbaolites, a more specific alternate
chemical method must be used in
order to obtain a confirmed analytical
result. |
| 510k | K111927 | K011185 |
| Measurand | Methamphetamine | Methamphetamine |
| Matrix | Human head or body hair | Human head or body hair |
| Cutoff concentration | 5 ng methamphetamine/10 mg hair | 5 ng methamphetamine/10 mg hair |
| Type of Test | Enzyme Immunoassay | Radioimmunoassay |
| Method of | Microplate reader | Microplate reader |
2
| Measurement | ||
|---|---|---|
| Extraction Method | Nonproteolytic Digestion | Proteolytic Digestion |
| Confirmation | ||
| Method | LC/MS/MS | LC/MS/MS |
Summary of Performance Testing
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
Five-hundred-thirty-six hair samples were assayed by the predicate device and by the Psychemedics Methamphetamine EIA. The discordance between EIA and RIA was the parent drug cutoff, the sample is interpreted as positive due to ingestion. The parent-drug cutoff value for methamphetamine, MDMA or MDEA is 5 ng/10 mg hair.
Cross-reactivity and Interference Studies
Five compounds, shown in the table below, showed cross-reactivity in the Methamphetamine EIA assay. Sixty-seven other compounds showed no cross-reactivity in the assay. One-hundred-twenty-eight 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 5 ng
methamphetamine/10 mg hair | Percent Cross-
reactivity* |
|-------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------|
| MDMA | 5 | 100 |
| MDEA | 10 | 50 |
| L-methamphetamine | 29 | 17 |
| PMA | 80 | 6.2 |
| PMMA | 6 | 83.3 |
ivity of related Compounds in Oniates FLA
Stability of Calibrator and Control Solutions
The methamphetamine calibrator and control solutions are prepared in-house by the laboratory from certified standards. Stability of methamphetamine in methanol in the presence of other drugs of abuse was shown to exceed 1 year.
Recovery Study
Recovery of methamphetamine from hair of methamphetamine users was shown to be substantially equivalent to that of the predicate device.
Conclusion:
The Psychemedics Microplate EIA for Methamphetamine in Hair is substantially equivalent to the predicate device K011185, 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
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
Re: K111927 Psychemedics Microplate EIA for Methamphetamine in Hair Trade/Device Name: Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: LAF 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 reviewed your Section 9 ro(x) promained institution in the indications for the indications for relerenced above and have decemblicate devices marketed in interstate commerce use stated in the encrosure) to rogally that of the Medical Device Amendments, or to devices that prob to May 26, 1770, the chaetholte and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, ACL (ACI) market the device, subject to the general controls provisions of the Act. The general interetore, market me device, subject to the general for annual registration, listing of devices, good comfors provisions of the Net merded requiritions 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 (Sec above) into existing major regulations affecting your device can be filly be subject to such additional controlls. Extrements (CFR), Parts 800 to 895. 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 and of the ex Please be advised that FDA S Issualled of a substaintial oppur device with other requirement of the Act or that FDA hiade a decermination mat your as four as they other Federal agencies. You must comply
any Federal statutes and regulations administered by other Federal lightne (1 with all the Act's requirements, including, but not limited to: registration and listing (2) CFR Pat with all the Act STEquirenchs, melaamig, ouver manufacturing practice requirements as set
807); labeling (21 CFR Parts 801 and 809); and good forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin harketing your as have equivalence of your device to a legally premarket hourication. The PDA midning of Sabbanian equice and thus, permits 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/Resourcesfor You/Industry/default.htm
Sincerely vours.
$\mathcal{N}$
Couriney 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 : K111927
Device Name: Psychemedics Microplate EIA for Methamphetamine in Hair
Indications For Use:
The Psychemedics Microplate EIA for Methamphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying methamphetamine use. This product is intended exclusively for inhouse professional use only and is not for sale to anyone.
The Psychemedics Microplate EIA for Methamphetamine 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 must 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)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 111927