(300 days)
Not Found
No
The description details a standard enzyme immunoassay (EIA) process for detecting phencyclidine in hair. There is no mention of AI, ML, or any computational analysis beyond reading absorbance values from a microplate reader. The performance studies focus on traditional analytical validation methods.
No
Explanation: This device is an in vitro diagnostic device used for the preliminary qualitative detection of phencyclidine in hair samples, which is for diagnostic purposes, not for treating a condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This is an in vitro diagnostic device..."
No
The device description clearly outlines physical components like microplate wells, antibodies, enzymes, and chemical reagents, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: 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 a preliminary qualitative detection of phencyclidine in human hair samples using an enzyme immunoassay (EIA). This is a laboratory-based test performed on a biological sample (hair) to provide information about a person's health status (drug use).
- Device Description: The description details the components of the test system, including reagents and a microplate reader, which are typical for in vitro diagnostic assays.
- Performance Studies: The document describes various performance studies (precision, agreement, cosmetic treatment, contamination, cross-reactivity, interference, stability, recovery) which are standard for evaluating the performance of IVD devices.
The fact that it is intended for exclusive use by Psychemedics and not for sale to the general public does not negate its classification as an IVD. It is still a device used in vitro to diagnose or provide information about a person's health.
N/A
Intended Use / Indications for Use
The Psychemedics Microplate ELA for Phencyclidine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of phencyclidine in human head and body hair samples using a phencyclidine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics EIA Phencyclidine 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-abuse test result.
Product codes
LCM
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 Phencyclidine. 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 phencyclidine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-phencyclidine, goat anti-rabbit 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
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 nonprofessionals.
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 precision studies were performed at various levels (B₀ (-100%), -75%, -50%, -25%, +25%, +50%, +75%, +100%).
- Intra-Assay: All 15 samples at negative levels were negative, and all 15 samples at positive levels were positive.
- Inter-Assay: All 75 samples at negative levels were negative, and all 75 samples at positive levels were positive.
Agreement Testing:
- Total samples: 140 negative samples, 24 samples below cutoff, 15 samples between cutoff and +100% of cutoff, and 46 samples >100% of cutoff were confirmed by GC/MS. Additionally, 224 negative samples were compared to the predicate device. 15% of total samples were body hair.
- EIA Positive: 0 samples +100% of cutoff.
- EIA Negative: 140 samples +100% of cutoff.
- Agreement with Predicate: 364 samples were negative by predicate and EIA negative. The table for positive predicate comparison is incomplete with "C" and "-4440-4".
Cosmetic Treatment Study:
- PCP-negative hair samples (20 each treated with bleach, permanent wave, dye, relaxer, shampoo): No significant differences observed, all remained negative after treatment.
- PCP-positive hair samples (12 each treated with bleach, permanent wave, dye, relaxer, shampoo): Mean B/B₀ x 100 values were consistent before and after treatment. No samples positive for PCP became negative after cosmetic treatment.
Contamination Study:
- Hair soaked in 1000 ng phencyclidine/mL water: Before washing, 138.5 to 265.4 ng/10 mg hair. After washing, 3.3 to 16.4 ng/10 mg hair. All samples were determined to be contaminated rather than positive after applying the wash criterion.
- Hair soaked in 1000 ng phencyclidine/mL saline: Before washing, 38.1 to 88.9 ng/10 mg hair. After washing, 0.7 to 3.0 ng/10 mg hair. One sample at the cutoff was determined to be contaminated rather than positive after applying the wash criterion.
Cross-reactivity and Interference Studies:
- Cross-reactivity: 1-(1-Phenylcyclohexyl) morpholine (PCM) at 60 (5.0%) and Metaphit at 10 (30%) showed cross-reactivity.
- No cross-reactivity for 64 other compounds.
- No interference for 128 compounds tested at +/-50% of the cutoff.
Stability of Calibrator and Control Solutions:
- Stability of PCP in methanol in the presence of other drugs of abuse was shown to exceed 1 year.
Recovery Study:
- Recovery of PCP from hair of PCP users was shown to be substantially equivalent to the method of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not explicitly stated as Sensitivity, Specificity, PPV, NPV. Precision studies showed 100% agreement for negative and positive samples at various concentration levels.
Predicate Device(s)
Psychemedics Phencyclidine Assay, K011275
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510K SUMMARY
MAY - 1 2012
510K: K111928 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: April 25, 2012 Device Trade Name: Psychemedics Microplate EIA for Phencyclidine in Hair Predicate Device: Psychemedics Phencyclidine Assay, K011275 Product Code: LCM Device Classification/Name: Enzyme Immunoassay, Phencyclidine, Unclassified Intended Use: The Psychemedics Microplate ELA for Phencyclidine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of phencyclidine in human head and body hair samples using a phencyclidine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics EIA Phencyclidine 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-abuse test result. The test consists of two parts; a pre-analytical hair treatment procedure Assay Description: (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Phencyclidine. 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 phencyclidine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-phencyclidine, goat anti-rabbit 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 Sample Collection: is placed in a V-shaped aluminum foil sample holder with the root end of
Sample Collection:
1
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 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 for PCP EIA, Microplate washer and reader, GC/MS for confirmation.
| Comparison of Psychemedics Microplate ElA for PCP with Psychemedics RIA Assay for PCP | ||||||
|---|---|---|---|---|---|---|
| -- | --------------------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
| Item | Device | Predicate |
|---|---|---|
| Indications for Use | The Psychemedics Microplate EIA for | |
| Phencyclidine is an enzyme immunoassay | ||
| (EIA) for the preliminary qualitative | ||
| detection of phencyclidine in human head | ||
| and body hair samples using a phencyclidine | ||
| calibrator at 3 ng /10 mg hair cutoff for the | ||
| purpose of identifying phencyclidine 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 | ||
| nonprofessionals. |
The Psychemedics EIA Phencyclidine 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-abuse test result. | The Psychemedics PCP assay is a
radioimmunoassay (RIA) for the
preliminary detection of phencyclidine
(PCP) in hair using a 3 ng/10 mg hair
cutoff for the purposes of identifying
PCP use. For a quantitative analytical
results or to confirm positive results via
the presence of PCP, a more specific
alternate chemical method must be used
in order to obtain a confirmed analytical
results |
| 510k | K111928 | K011275 |
| Measurand | Phencyclidine | Phencyclidine |
| Matrix | Human head or body hair | Human head or body hair |
| Cutoff
concentration | 3 ng phencyclidine/10 mg hair | 3 ng phencyclidine /10 mg hair |
| Type of Test | Enzyme Immunoassay | Radioimmunoassay |
| Method of
measurement | Microplate reader | Gamma counter |
| Extraction
Method | Nonproteolytic Digestion | Proteolytic Digestion |
| Confirmation | GC/MS | GC/MS |
2
Summary of Performance Testing:
| Precision Studies | |
|---|---|
| Intra-Assay | 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-forty negative samples, twenty-four samples below the cutoff, 15 samples between the cutoff and+100% of the cutoff , and 46 samples >100% of the cutoff, were confirmed by GC/MS, and an additional 224 negative samples were compared to the predicate. Of the total samples, 15% were body hair samples.
| LC/MS/MS: | ≤ -10 % of
Cutoff | Between -
10% and -
50% of
Cutoff | Between
-50% and
Cutoff | Between
Cutoff,
And +50% | Between
+50% and
+100% | > +100% of
cutoff |
|--------------|----------------------|--------------------------------------------|-------------------------------|--------------------------------|------------------------------|----------------------|
| EIA Positive | 0 | 0 | 2 | 8 | 7 | 46 |
| EIA Negative | 140 | 1 | 13 | 0 | 0 | 0 |
| Negative by Predicate | Positive by Predicate | |
|---|---|---|
| EIA Positive | C | |
| A CARRENA A COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION OF | ||
| EIA Negative | 364 | -4440-4 |
Cosmetic Treatment Study
Twenty PCP-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 were observed for the negative hair samples before and after the treatments; all samples remained negative after the treatments.
Twelve PCP-positive hair samples were treated with bleach, 12 with permanent wave, 12 with dye, 12 with relaxer, and 12 with shampoo, and the results compared to the same samples without the treatments. In each case of the 12 samples treated with a type of cosmetic treatment, 6 samples were treated with one brand of a particular product and 6 other samples with a second brand. The average of the EIA B/Bo x 100 values obtained for the samples in each set before treatment is shown, with the range following in
3
parenthesis. In the second row of the average of the EIA B/Bo x 100 values obtained for the samples in cach set after treatment is shown, with the range following in parenthesis. No samples positive for PCP became negative after cosmetic treatment.
| Treatment | Bleach | Dye | Perm | Relaxer | Shampoo |
|---|---|---|---|---|---|
| Status | Mean (Range) of B/B₀ x 100 Values of 12 PCP-Positive Samples in PCP EIA | ||||
| Before | 35.3 (22.0 - 48.4) | 35.3 (17.0 - 53.8) | 40.0 (23.2 - 63.7) | 34.3 (23.2 - 53.8) | 33.4 (17.0 - 56.3) |
| After | 34.0 (19.4-50.8) | 35.8 (17.0 -53.1) | 40.2 (22.8 - 63.7) | 35.6 (25.0 - 49.5) | 34.3 (17.7 - 54.7) |
Contamination Study
Contamination of 8 hair samples by soaking in 1000 ng phencyclidine /mL of water resulted in a range of phencyclidine on the hair of 138.5 to 265.4 ng of phencyclidine /10 mg hair before washing. After washing by the procedure described in (2) above, the amount of phencyclidine remaining on the hair samples ranged from 3.3 to 16.4 ng/10 mg hair, with all samples appearing to be positive before application of the wash criterion. After application of the wash criterion (see below), all of these samples containing phencyclidine above the cutoff were determined to be contaminated rather than positive.
Contamination of 8 hair samples by soaking in 1000 ng phencyclidine /mL of saline resulted in a range of phencyclidine on the hair of 38.1 to 88.9 ng of phencyclidine /10 mg hair before washing. After washing by the procedure described below, the amount of phencyclidine remaining on the hair samples ranged from 0.7 to 3.0 ng/10 mg hair, with one sample at the cutoff. Seven of the 8 samples were negative (i.e., below the cutoff) even without application of the wash criterion. After application of the wash criterion, the one sample at the cutoff was determined to be contaminated rather than positive.
The Wash Procedure
- Wash by Psychemedics' standard wash procedure: a.
- i. Add 2 mL of dry isopropanol and shake in waterbath for 15 minutes at 37℃ with shaking @ 100 -120 oscillations/minute.
- ii. Add 2 mL of Wash Buffer (0.01 M phosphate buffer, pH 6.0, with 0.1% BSA) and shake in waterbath for 30 minutes at 37℃ with shaking @ 100 -120 oscillations/minute.
- 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.
- Repeat Step iv. one more time v.
- vi. Save wash from Step v.
- Analyze the last wash for phencyclidine. b.
Confirmation and Interpretation
- a. Perform confirmation procedures for PCP. c.
- b. Calculate wash criterion: d.
- Multiply the last wash value x 5. i.
- Subtract the value of the drug in the last wash from the value of the drug in the ii. digested hair.
- iii. If the result is less than the cutoff for the drug in the hair, the sample is interpreted as contaminated. If the result is > the parent drug cutoff, the sample is interpreted as positive due to ingestion. The parent-drug cutoff value for PCP is 3ng/ 10 mg hair.
4
Cross-reactivity and Interference Studies
Two compounds, shown in the table below, showed cross-reactivity in the PCP assay. Sixty-four 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.
Cross-reactivity of related Compounds in Phencyclidine EIA
| Compound | Amount of Compound required to
Produce a positive test at the cutoff of 3
ng phencyclidine/10 mg hair | Percent Cross-
reactivity* |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------|
| 1-(1-Phenylcyclohexyl)
morpholine (PCM) | 60 | 5.0 |
| Metaphit | 10 | 30 |
Stability of Calibrator and Control Solutions
The PCP calibrator and control solutions are prepared in-house by the laboratory from certified standards. Stability of PCP in methanol in the presence of other drugs of abuse was shown to exceed 1 year.
Recovery Study
Recovery of PCP from hair of PCP users was shown to be substantially equivalent to the method of the predicate device.
Conclusion:
The Psychemedics Microplate EIA for Phencyclidine in Hair is substantially equivalent to the predicate device K011275, and the results are substantially equivalent to GC/MS results.
5
Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font. The words are arranged on a single line and centered.
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 93065
MAY - 1 2012
Re: K111928
K111920
Trade/Device Name: Psychemedics Microplate EIA for Phencyclidine in Hair
Regulation Number: 21 CFR 862.3100 Regulatory Class: Unclassified Product Code: LCM 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 510(t) premarket is substantially equivalent (for the indications
referenced above and have developed is substantially equivalent (for the indic referenced above and have device is subscannials' values marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally marked predical Devices maxicos
commerce prior to May 28, 1976, the enactment date of the Medical Device American Frood, Drug, commerce prior to May 28, 1976, the enactment and of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
devices that have been require approval of a premarket approval application (PMA).
The Ac and Cosmetic Act (Act) that do not require approval or the general controls of the Act. The Act. The
You may, therefore, market the device, subject to the general controls You may, therefore, market the Act include requirements for amual registration, listing of
general controls provisions of the Act include requirements for annual misbranding general controls provisions of the Act include requirements to amind. Togeneral controlled in the first adulteration.
udice is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) into class II (Special Collios), in Title 21, 10 in Title 21, 1
additional controls. Existing major regulations affecting your device in your controls. Existing major regulations arecting your deviews of the comments.
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further Code of Federal Regulations (CFR), I arts of the Federal Register.
announcement that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial equirements of the Act
that FDA has made a determination that your device complies with other requires of the Act that FDA has made a determination that your devices will valies. You must
or any Federal statutes and regulations administered by other Federal and listin mir Federal statutes and regulations administered by only registration and listing (21)
comply with a the requirements, including, but not limited to: registration and listin of any with all the Act's requirements, including, but not minine (reporting (reporting of
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of CFR Part 807); labeling (21 CFR Parts 801 and 800); and good manufacturing practice
medical device-related adverse events) (21 CFR 803); and good manufacturing practice el A at over , a more of the susting (OS) regulation (21 CFR Pat 820). This letter
requirements as set forth in the quality systems (QS) regulation (21 CFR Prix). This lette medial of the marketing your device as described in your Section 510(k) premarket
will allow your marketing your device as described in your Section 510(k) premarket regalisms
will allow you to begin maketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to will are and the results in a classification for your device and thus, permits your device to proceed to the market.
Image /page/5/Picture/12 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
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/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 ) 796-5680 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indication for Use
510(k) Number : K111928
Device Name: Psychemedics Microplate EIA for Phencyclidine in Hair
Indications For Use:
The Psychemedics Microplate EIA for Phencyclidine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of phencyclidine in human head and body hair samples using a phencyclidine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics EIA Phencyclidine 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-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
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
. 510(k) K111192-f
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