(300 days)
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.
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.
The provided document describes the Psychemedics Microplate EIA for Methamphetamine in Hair, an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human hair samples. The study aims to demonstrate substantial equivalence to a predicate device (Psychemedics Methamphetamine and MDMA Assay, K011185) and alignment with LC/MS/MS results.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a formal table format. However, it presents performance data that implies the criteria for the device to be considered substantially equivalent and perform adequately. Based on the provided "Agreement Testing" section, we can infer the following:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Agreement with Predicate | Low discordance with the predicate device. A high percentage of agreement for both negative and positive results compared to the predicate. | * Discordance between EIA and RIA (predicate) was < 0.2%. * Compared to Predicate (536 samples): * EIA Positive vs. Predicate Positive: 103 * EIA Negative vs. Predicate Negative: 428 * EIA Negative vs. Predicate Positive: 5 (These are "false negatives" by EIA compared to predicate) * EIA Positive vs. Predicate Negative: 0 (These are "false positives" by EIA compared to predicate) |
| Accuracy (vs. LC/MS/MS) | High agreement with LC/MS/MS confirmation, especially for positive and negative samples, and correct classification of samples around the cutoff. Negative EIA results should be confirmed as truly negative by LC/MS/MS. | * Compared to LC/MS/MS (213 samples): * EIA Positive, LC/MS/MS ≥ Cutoff: 78 (True Positives, clearly above cutoff) * EIA Positive, LC/MS/MS < Cutoff (but ≥ -50% of Cutoff): 9 (May be true positives close to cutoff, or minor discordance) * EIA Positive, LC/MS/MS ≥ Cutoff, and < +50% of Cutoff: 8 (True Positives close to cutoff) * EIA Positive, LC/MS/MS ≥ +50% of Cutoff & < +100% of Cutoff: 8 (True Positives, above cutoff) * EIA Negative, LC/MS/MS 0: 105 (True Negatives) * EIA Negative, LC/MS/MS ≥ -50% of Cutoff & < Cutoff: 3 (False Negatives by EIA, close to cutoff) * EIA Negative, LC/MS/MS ≥ Cutoff, and < +50% of Cutoff: 0 (No false negatives by EIA in this range) * EIA Negative, LC/MS/MS ≥ +50% of Cutoff & < +100% of Cutoff: 2 (False Negatives by EIA) * Crucially, the document states: "The samples [where EIA was negative but predicate was positive] were negative by LC/MS/MS, demonstrating that the EIA negative results, although discordant with the predicate, are correct." This implies the device passed this specific criterion where it disagreed with the predicate. |
| Precision | Consistent and accurate classification of samples across different concentrations relative to the cutoff (negative, on-cutoff, positive). | * Intra-Assay (e.g., repeatability): * At negative concentrations (B₀ -100% to -25%): 15/15 classified as negative. * At positive concentrations (plus 25% to plus 100%): 15/15 classified as positive. * Inter-Assay (e.g., reproducibility): * At negative concentrations (B₀ -100% to -25%): 75/75 classified as negative. * At positive concentrations (plus 25% to plus 100%): 75/75 classified as positive. |
| Cosmetic Treatment Impact | Cosmetic treatments should not significantly alter the test result for negative samples (they should remain negative) or change positive samples to negative. | * Negative Samples: 20 samples each treated with bleach, permanent wave, dye, relaxer, and shampoo. "No significant differences were observed for the negative hair samples before and after the treatments; all samples remained negative after the treatments." * Positive Samples: 12 samples each treated with bleach, permanent wave, dye, relaxer, and shampoo. "No positive samples became negative after cosmetic treatment." (Means and ranges of B/B₀ x 100 values were provided, showing consistent positive results). |
| Environmental Contamination | The wash procedure should effectively remove external contamination such that contaminated samples, after washing, are below the cutoff or correctly identified as contaminated. | * Soaked in 1000 ng/mL Methamphetamine (water): Pre-wash ranged 38.6-98.7 ng/10 mg. Post-wash ranged 1.1-3.0 ng/10 mg. "no samples at or above the cutoff even before application of the wash criterion." * Soaked in 1000 ng/mL Methamphetamine (saline): Pre-wash ranged 8.5-29.3 ng/10 mg. Post-wash ranged 0.2-1.0 ng/10 mg. "all samples negative (i.e, below the cutoff) even without application of the wash criterion." * The "Wash Criterion" calculation and application method for confirmation is described to differentiate ingestion from contamination. |
| Cross-Reactivity | Limited cross-reactivity with structurally similar compounds. Cross-reactivity with critical compounds should be known and within acceptable limits. | * 5 compounds showed cross-reactivity (MDMA (100%), MDEA (50%), L-methamphetamine (17%), PMA (6.2%), PMMA (83.3%)). * 67 other compounds showed no cross-reactivity. |
| Interference | No significant interference from common substances within specified concentration ranges. | * 128 compounds tested for interference at +/-50% of the cutoff showed no interference. |
| Recovery | Recovery of methamphetamine from hair of users should be comparable to the predicate device. | * "Recovery of methamphetamine from hair of methamphetamine users was shown to be substantially equivalent to that of the predicate device." |
| Stability | Calibrator and control solutions should remain stable for a defined period. | * "Stability of methamphetamine in methanol in the presence of other drugs of abuse was shown to exceed 1 year." |
2. Sample Size Used for the Test Set and Data Provenance
- Agreement Testing (vs. Predicate): 536 hair samples.
- 16% (approximately 86 samples) were body hair samples; the remainder were head hair.
- Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, it's implied to be real-world human hair samples.
- Agreement Testing (vs. LC/MS/MS): 213 of the 536 samples.
- Precision Studies:
- Intra-Assay: 15 replicates per level (negative: 4 levels, positive: 4 levels). Total 120 tests.
- Inter-Assay: 75 replicates per level (negative: 4 levels, positive: 4 levels). Total 600 tests.
- Cosmetic Treatment Study:
- 20 methamphetamine-negative samples per cosmetic treatment type (5 types = 100 samples).
- 12 methamphetamine-positive samples per cosmetic treatment type (5 types = 60 samples).
- Contamination Study: The number of hair samples used for the contamination study is not explicitly stated, but it describes soaking hair in methamphetamine solutions and then washing them.
- Cross-reactivity and Interference Studies:
- Cross-reactivity: 5 compounds that cross-reacted, plus 67 other compounds showing no cross-reactivity (total 72 compounds).
- Interference: 128 compounds tested.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated in the provided text for any of the studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
-
The ground truth in this submission is established through:
- Predicate Device (RIA): The Psychemedics Methamphetamine and MDMA Assay, K011185. This is another diagnostic test, itself validated.
- LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry): This is described as a "more specific alternate chemical method" and is used for confirmation. This technique is typically considered the gold standard for drug quantification.
- Clinical consideration and professional judgment: The document notes that these "must be applied to the interpretation of any drug-of-abuse test result."
-
No "experts" in the traditional sense of human readers/interpreters (e.g., radiologists) were used to establish ground truth. The ground truth is based on the analytical results of the predicate device and, more definitively, the LC/MS/MS method. The qualifications of individuals performing these LC/MS/MS confirmations are not detailed, but it's a standard laboratory practice requiring trained analytical chemists.
4. Adjudication Method for the Test Set
Since the ground truth is established by objective analytical methods (predicate device, and primarily LC/MS/MS), there is no adjudication method by multiple human experts (e.g., 2+1, 3+1). The LC/MS/MS results serve as the definitive ground truth for the subsets of samples that underwent that testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There was no MRMC comparative effectiveness study performed. This device is an immunoassay, and its output is an analytical result (positive/negative based on a cutoff, or quantitative for confirmation) rather than an image or complex data requiring interpretation by multiple human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.
6. Standalone (Algorithm Only) Performance
Yes, the studies reported are for the standalone performance of the Psychemedics Microplate EIA for Methamphetamine in Hair. The performance metrics (precision, agreement with predicate/LC/MS/MS, cosmetic treatment, contamination, cross-reactivity, interference, recovery, stability) all describe the direct output of the assay itself, without human-in-the-loop assistance in the interpretation of the primary result (detection of methamphetamine).
7. Type of Ground Truth Used
The primary ground truth used is LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry), which is a gold-standard analytical confirmation method for drug testing. The predicate device (RIA) also served as a comparative ground truth to demonstrate substantial equivalence, but LC/MS/MS was utilized to confirm the accuracy of discordant results.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for a training set. This is an immunoassay, which typically involves pre-developed reagents and protocols rather than a machine learning algorithm requiring a "training set" for model development. The precision and agreement studies are performance validation tests, not training data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of a machine learning algorithm, this question is not applicable based on the provided text. The device is a chemical assay, not an AI/ML diagnostic.
{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 forMethamphetamine is an enzymeimmunoassay (EIA) for the preliminaryqualitative detection ofmethamphetamine in human head andbody hair samples using amethamphetamine calibrator at 5 ng /10mg hair cutoff for the purpose ofidentifying methamphetamine use. Thisproduct is intended exclusively for in-house professional use only and not forsale to anyone. The test is not intendedfor over the counter sale to non-professionals.The Psychemedics Microplate EIA forMethamphetamine in Hair providesonly a preliminary analytical test result.To confirm a presumptive screenpositive result, a more specific alternatechemical method such as LC/MS/MS(liquid chromatography/massspectrometry/mass spectrometry) mustbe used. Clinical consideration andprofessional judgment must be appliedto the interpretation of any drug-of-abuse test result. | The Psychemedics Methamphetamineand MDMA assay is aradioimmunoassay (RIA) for thepreliminary detection of d-methamphetamine, d,l-MDMA andmetabolites in human hair samplesusing a 5 ng/10 mg hair cutoff for thepurpose of identifyingmethamphetamine or MDMA(ecstasy) use. For a quantitativeanalytical results or to confirmpositive results via the presence of themethamphetamine, MDMA andmetbaolites, a more specific alternatechemical method must be used inorder to obtain a confirmed analyticalresult. |
| 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 |
| ConfirmationMethod | 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 < 0.2%. Sixteen percent of the total samples in the studies were body hair samples.
| Negative by Predicate | Positive by Predicate | |
|---|---|---|
| EIA Positive | 0 | 103 |
| EIA Negative | 428 | 5 |
Two-hundred thirteen of the samples were confirmed by LC/MS/MS, with the results shown in the following table.
| LC/MS/MS: | 0 | ≥ -50% ofCutoff &< Cutoff | ≥ Cutoff,And < +50%of Cutoff | ≥ +50% ofCutoff &< +100% ofCutoff | ≥ +100% ofcutoff |
|---|---|---|---|---|---|
| EIA Positive | 0 | 9 | 8 | 8 | 78 |
| EIA Negative | 105 | 3 | 0 | 2 | 0 |
Samples vary in the amount of contamination on the surface; in fact, contamination is, by its very nature, random in the way in which it may present on the hair sample. Therefore, it is not surprising that a sample might be positive in one screening assay and not in the next, even if the assays are the same technology. The samples were negative by LC/MS/MS, demonstrating that the EIA negative results, although discordant with the predicate, are correct.
Cosmetic Treatment Study
{3}------------------------------------------------
Twenty methamphetamine-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 methamphetamine-positive hair samples were treated with bleach, 12 with permanent wave, 12 with dve. 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 means and ranges of the EIA results of the 12 samples before and after the cosmetic treatments are shown in the table below. No positive samples became negative after cosmetic treatment.
| Treatment | Bleach | Dye | Perm | Relaxer | Shampoo |
|---|---|---|---|---|---|
| Status | Mean (Range) of B/B₀ x 100 Values of 12 Methamphetamine-Positive Samples in Methamphetamine EIA | Mean (Range) of B/B₀ x 100 Values of 12 Methamphetamine-Positive Samples in Methamphetamine EIA | Mean (Range) of B/B₀ x 100 Values of 12 Methamphetamine-Positive Samples in Methamphetamine EIA | Mean (Range) of B/B₀ x 100 Values of 12 Methamphetamine-Positive Samples in Methamphetamine EIA | Mean (Range) of B/B₀ x 100 Values of 12 Methamphetamine-Positive Samples in Methamphetamine EIA |
| Before | 21.1 (6.6 - 55.5) | 22.1 (6.6 - 45.0) | 22.1 (6.6 - 55.5) | 21.3 (10.3 - 55.5) | 24.9 (6.6 - 55.5) |
| After | 25.0 (6.1 - 56.2) | 25.7 (7.4 - 50.9) | 36.3 (13.4 - 57.8) | 32.4 (10.2 - 67.4) | 26.3 (7.6 - 52.9) |
Contamination Study
Potential environmental contamination of samples that are identified is presumptive positive in the screening assay is addressed by an extensive washing procedure prior to confirmation and application of a wash criterion following confirmation, as described below.
Contamination of hair by soaking in 1000 ng methamphetamine /mL of water resulted in a range of methamphetamine on the hair of 38.6 to 98.7 ng of methamphetamine /10 mg hair before washing. After washing by the procedure described below, the amount of methamphetamine remaining on the hair samples ranged from 1.1 to 3.0 ng/10 mg hair, with no samples at or above the cutoff even before application of the wash criterion.
Contamination of hair by soaking in 1000 ng methamphetamine /mL of saline resulted in a range of methamphetamine on the hair of 8.5 to 29.3 ng of methamphetamine /10 mg hair before washing. After washing by the procedure described below, the amount of methamphetamine remaining on the hair samples ranged from 0.2 to 1.0 ng/10 mg hair, with all samples negative (i.e, below the cutoff) even without application of the wash criterion.
The Wash Procedure
- Wash by Psychemedics' standard wash procedure: a.
- Add 2 mL of dry isopropanol and shake in waterbath for 15 minutes at 37°C with I. shaking @ 100 -120 oscillations/minute. Remove isopropanol.
- 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. 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.
- Repeat Step iv. one more time v.
- vi. Save wash from Step v.
- Analyze the last wash for methamphetamine. b.
{4}------------------------------------------------
Confirmation and Interpretation
- a. Perform confirmation procedures for methamphetamine, MDMA, MDEA, amphelamine.
- b. Calculate wash criterion:
- Multiply the last wash value by 3.5. i.
- Subtract the value of the drug in the last wash from the value of the drug in ii. the digested hair.
- If the result is less than the cutoff for the drug in the hair, the sample is interpreted as iii. contaminated. If the result is > 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 Producea positive test at the cutoff of 5 ngmethamphetamine/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
§ 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).