(300 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the Psychemedics Microplate EIA for Phencyclidine in Hair, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Agreement with GC/MS | High agreement (e.g., sensitivity, specificity, accuracy) for preliminary qualitative detection of phencyclidine at the 3 ng/10 mg hair cutoff. | Concordance with GC/MS:- EIA Positive, GC/MS ≤ -10% of Cutoff: 0- EIA Positive, GC/MS Between -10% and -50% of Cutoff: 0- EIA Positive, GC/MS Between -50% and Cutoff: 2- EIA Positive, GC/MS Between Cutoff and +50%: 8- EIA Positive, GC/MS Between +50% and +100%: 7- EIA Positive, GC/MS > +100% of Cutoff: 46- EIA Negative, GC/MS ≤ -10% of Cutoff: 140- EIA Negative, GC/MS Between -10% and -50% of Cutoff: 1- EIA Negative, GC/MS Between -50% and Cutoff: 13- EIA Negative, GC/MS Between Cutoff and +50%: 0- EIA Negative, GC/MS Between +50% and +100%: 0- EIA Negative, GC/MS > +100% of Cutoff: 0 |
| Agreement with Predicate Device | High agreement in classifying samples as positive or negative compared to the predicate device (Psychemedics Phencyclidine Assay, K011275). | Agreement with Predicate:- EIA Positive, Predicate Negative: (Data missing in table)- EIA Positive, Predicate Positive: (Data missing in table, likely refers to 'C' in table)- EIA Negative, Predicate Negative: 364- EIA Negative, Predicate Positive: (Data missing in table) |
| Precision | Consistent results (intra-assay and inter-assay) across different concentrations relative to the cutoff (negative control, various percentages above/below cutoff). | Intra-Assay:- B₀ (-100%): 15 NEG, 0 POS- -75%: 15 NEG, 0 POS- -50%: 15 NEG, 0 POS- -25%: 15 NEG, 0 POS- +25%: 0 NEG, 15 POS- +50%: 0 NEG, 15 POS- +75%: 0 NEG, 15 POS- +100%: 0 NEG, 15 POSInter-Assay:- B₀ (-100%): 75 NEG, 0 POS- -75%: 75 NEG, 0 POS- -50%: 75 NEG, 0 POS- -25%: 75 NEG, 0 POS- +25%: 0 NEG, 75 POS- +50%: 0 NEG, 75 POS- +75%: 0 NEG, 75 POS- +100%: 0 NEG, 75 POS |
| Cosmetic Treatment Effects | Cosmetic treatments (bleach, permanent wave, dye, relaxer, shampoo) should not convert PCP-negative samples to positive, nor convert PCP-positive samples to negative. | Negative Samples: All 20 samples per treatment (bleach, perm, dye, relaxer, shampoo) remained negative after treatment (total 100 samples).Positive Samples: No samples positive for PCP became negative after cosmetic treatment (12 samples per treatment type, total 60 samples). Average B/B₀ x 100 values before and after treatment showed minimal change. |
| Contamination Effects | The device should accurately identify contamination and distinguish it from actual drug use (ingestion). | PCP in Water Contamination:- 8 samples soaked in 1000 ng phencyclidine/mL water.- Post-wash, remaining PCP ranged from 3.3 to 16.4 ng/10 mg hair.- After applying the wash criterion, all were determined contaminated, not positive for ingestion.PCP in Saline Contamination:- 8 samples soaked in 1000 ng phencyclidine/mL saline.- Post-wash, remaining PCP ranged from 0.7 to 3.0 ng/10 mg hair.- Seven samples were negative without wash criterion.- One sample at cutoff was determined contaminated after applying wash criterion. |
| Cross-reactivity | Minimal cross-reactivity with structurally similar compounds, and no cross-reactivity with a wide range of other substances. | Cross-reactivity observed:- 1-(1-Phenylcyclohexyl)morpholine (PCM): 5.0% (at 60 ng/10 mg hair)- Metaphit: 30% (at 10 ng/10 mg hair)No cross-reactivity: 64 other compounds.No interference with 128 compounds at +/- 50% of cutoff. |
| Recovery | Recovery of PCP from hair of PCP users should be substantially equivalent to the predicate device. | Reported as "substantially equivalent to the method of the predicate device." |
| Calibrator/Control Stability | Calibrator and control solutions should remain stable for a specified period. | Stability of PCP in methanol in the presence of other drugs of abuse shown to exceed 1 year. |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Agreement Testing (compared to GC/MS):
- Total samples: 229 samples (140 negative, 24 below cutoff, 15 between cutoff and +100% of cutoff, 46 >100% of cutoff).
- Body hair samples: 15% of the total samples.
- Agreement Testing (compared to Predicate Device):
- Total samples: An additional 224 negative samples were compared to the predicate. (There appear to be missing values/errors in the provided table for positive comparisons).
- Precision Studies:
- Intra-Assay: 15 replicates per concentration level (total 8 levels tested).
- Inter-Assay: 75 replicates per concentration level (total 8 levels tested).
- Cosmetic Treatment Studies:
- Negative samples: 100 samples (20 per treatment type: bleach, permanent wave, dye, relaxer, shampoo; 10 samples per brand for each treatment).
- Positive samples: 60 samples (12 per treatment type: bleach, permanent wave, dye, relaxer, shampoo; 6 samples per brand for each treatment).
- Contamination Study: 16 hair samples (8 soaked in water-PCP, 8 soaked in saline-PCP).
- Cross-reactivity and Interference Studies: 66 compounds for cross-reactivity (2 showed cross-reactivity, 64 did not), and 128 compounds for interference.
- Data Provenance: Not explicitly stated, but the submission is from a US company (Psychemedics Corporation, Culver City, CA). The context of a 510(k) submission generally implies prospective collection for performance evaluation or retrospective analysis of samples typical for the intended use.
- Retrospective/Prospective: Not explicitly stated. The nature of the studies (e.g., controlled spiking for precision, controlled cosmetic treatments, contamination studies) suggests a mix of controlled experimental prospective studies and likely retrospective collection of clinical samples for agreement testing.
- Agreement Testing (compared to GC/MS):
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the test set (primarily for agreement studies) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical chemical method, not human expert consensus. GC/MS is considered the gold standard for confirming drug presence and concentration in forensic and clinical toxicology. Therefore, no human experts were used to establish this analytical ground truth.
-
Adjudication method for the test set:
- Not applicable/mentioned for the analytical ground truth (GC/MS). For the comparison between the new device and the predicate, there's no mention of an adjudication process; it's a direct comparison of results.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is an in vitro diagnostic (IVD) device, specifically an immunoassay for drug detection. It does not involve human readers interpreting results in the way an imaging AI typically would. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance studies described (Agreement with GC/MS, Precision, Cosmetic Treatment Effects, Contamination Effects, Cross-reactivity) represent the standalone performance of the Psychemedics Microplate EIA for Phencyclidine. The device provides a preliminary analytical test result. While a human is involved in running the assay and interpreting the preliminary qualitative result, the performance data presented are inherent to the assay's chemical and enzymatic reactions (the "algorithm" in a broad sense for IVDs). However, it's crucial to note the stated intended use that positive results must be confirmed by GC/MS, implying a human-in-the-loop for definitive diagnosis, but the reported performance metrics are for the assay itself.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Ground Truth: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the ground truth for confirming the presence and concentration of phencyclidine in hair samples. This is a highly accurate chemical method, considered the definitive standard for such measurements.
-
The sample size for the training set:
- The document describes device performance studies for a submitted medical device (Psychemedics Microplate EIA). These types of submissions typically focus on validation studies (test sets) rather than detailing the full development and "training" of the assay, especially since it's a traditional immunoassay, not a machine learning algorithm in the modern sense. Therefore, no specific "training set" sample size is mentioned or applicable in the context of this traditional immunoassay device. The assay design and formulation would have been optimized during development, but this wouldn't be referred to as a "training set" in the way it is for AI.
-
How the ground truth for the training set was established:
- As stated above, the concept of a "training set" and associated "ground truth" doesn't directly apply here as it would for an AI/ML-based device. The assay components and their interactions (e.g., antibodies, substrates, reagents) are designed based on known biochemical principles and then validated through performance testing against established analytical methods like GC/MS and predicate devices.
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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:
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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 forPhencyclidine is an enzyme immunoassay(EIA) for the preliminary qualitativedetection of phencyclidine in human headand body hair samples using a phencyclidinecalibrator at 3 ng /10 mg hair cutoff for thepurpose of identifying phencyclidine use.This is an in vitro diagnostic device intendedexclusively for Psychemedics use only and isnot intended for sale to anyone. The test isnot intended for over the counter sale tononprofessionals.The Psychemedics EIA Phencyclidine Assayprovides only a preliminary analytical testresult. To obtain a quantitative analyticalresult or to confirm positive results, a morespecific alternate chemical method (e.g.GC/MS) must be used. Clinicalconsideration and professional judgmentshould be applied to the interpretation of anydrug-of-abuse test result. | The Psychemedics PCP assay is aradioimmunoassay (RIA) for thepreliminary detection of phencyclidine(PCP) in hair using a 3 ng/10 mg haircutoff for the purposes of identifyingPCP use. For a quantitative analyticalresults or to confirm positive results viathe presence of PCP, a more specificalternate chemical method must be usedin order to obtain a confirmed analyticalresults |
| 510k | K111928 | K011275 |
| Measurand | Phencyclidine | Phencyclidine |
| Matrix | Human head or body hair | Human head or body hair |
| Cutoffconcentration | 3 ng phencyclidine/10 mg hair | 3 ng phencyclidine /10 mg hair |
| Type of Test | Enzyme Immunoassay | Radioimmunoassay |
| Method ofmeasurement | Microplate reader | Gamma counter |
| ExtractionMethod | Nonproteolytic Digestion | Proteolytic Digestion |
| Confirmation | GC/MS | GC/MS |
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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 % ofCutoff | Between -10% and -50% ofCutoff | Between-50% andCutoff | BetweenCutoff,And +50% | Between+50% and+100% | > +100% ofcutoff |
|---|---|---|---|---|---|---|
| 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 OFEIA 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
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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.
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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 toProduce a positive test at the cutoff of 3ng 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.
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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.
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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
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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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