(38 days)
Cozart EIA Amphetamine Oral Fluid Microplate Kit, K033743
Not Found
No
The device description and performance studies focus on standard immunoassay techniques and chemical analysis (LC/MS/MS). There is no mention of AI or ML in the text.
No
The device is an in vitro diagnostic device used for the preliminary qualitative detection of amphetamine in hair samples, not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This is an in vitro diagnostic device intended exclusively for Psychemedics use only."
No
The device description clearly outlines a test kit with physical components (microplate wells, antibodies, enzymes, substrates, buffers) and a pre-analytical hair treatment procedure, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This is an in vitro diagnostic device intended exclusively for Psychemedics use only."
- Purpose: The device is intended for the "preliminary qualitative detection of amphetamine in human head and body hair... for the purpose of identifying amphetamine use." This is a diagnostic purpose, aiming to identify the presence of a substance in a biological sample to inform about a physiological state (drug use).
- Sample Type: The device analyzes "human head and body hair," which is a biological specimen.
- Method: It uses an "enzyme immunoassay (EIA)," which is a common in vitro diagnostic technique.
- Testing Location: While intended for exclusive use by Psychemedics at one site, the testing is performed in vitro (outside the body) on a biological sample.
The fact that it's intended for exclusive use by Psychemedics and requires confirmatory testing does not negate its classification as an IVD. It's a preliminary diagnostic tool used in a laboratory setting.
N/A
Intended Use / Indications for Use
The Psychemedics Microplate EIA for Amphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying amphetamine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only. Psychemedics has not performed an evaluation of reproducibility at different laboratories.
The Psychemedics Microplate EIA amphetamine assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Psychemedics plans to perform this test at one site. Psychemedics has not performed an evaluation of reproducibility at different sites.
Product codes (comma separated list FDA assigned to the subject device)
DKZ
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 Amphetamine. The screening portion of the test system consists of ( 1 ) microplate wells coated with multiple antigens including methamphetamine conjugated to bovine serum albumin (BSA), monoclonal mouse anti-amphetamine, rabbit anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
Sample Collection & Stability: 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 foif. 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. Stability of amphetamine in hair samples stored at room temperature has been shown for at least one year. Amphetamine in samples shipped coast-to-coast twice was stable.
Materials required: Hair sample collection kit, Microplate ElA for Amphetamine, Microplate washer and reader, LC/MS/MS for confirmation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Human head and body hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended exclusively for Psychemedics 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Studies: Performed by spiking negative hair with previously LC/MS/MS-validated calibrator and control spiking solutions to achieve concentrations of negative, the cutoff of 2 ng/10 mg hair, and +/-75%, +/-50%, and +/- 25% of the cutoff.
Comparison Testing: One hundred eighty samples comprising both head and body hair were confirmed by LC/MS/MS in parallel with testing by the Psychemedics Amphetamine EIA. The studies documented age, gender, ethnicity, hair color, and source of hair (body or head hair).
Cosmetic Treatments: Twenty amphetamine-negative head hair samples were treated with bleach, permanent wave, dye, relaxer, and shampoo (10 samples per brand for two brands). Twelve amphetamine-positive head hair samples were treated similarly (6 samples per brand for two brands).
Cross-reactivity and Interference Studies: Chloramphetamine, MDA, PMA and Phentermine showed significant cross-reactivity. One-hundred-forty other compounds showed no cross-reactivity. One-hundred-nineteen compounds tested for interference at +/-50% of the cutoff showed no interference.
Environmental Contamination:
Aqueous Washing of Samples Soaked in Water and Saline Solutions of Amphetamine: Tested hair samples soaked in 500 ng amphetamine/mL of water and saline, then washed with Psychemedics' standard wash procedure (aqueous buffer).
Alternative Wash Procedure (90% Ethanol): Tested 10 head hair samples soaked in amphetamine/water solution and 13 head hair samples soaked in amphetamine/saline solution, followed by the alternative ethanol wash.
Storage and Shipping Stability: Twenty-one amphetamine-positive head hair samples tested after 1 year of storage under ambient conditions. Twenty-one amphetamine-positive head hair samples tested before and after two coast-to-coast shippings.
Stability of Calibrator and Control Solutions: Amphetamine calibrator and control solutions showed 9 months stability.
Recovery: Recovery of amphetamine from hair in a 2-hour incubation ranged from 100 to 110%. Determined by LC/MS/MS measurements of extended sequential hair extractions.
Key Results: Precision studies showed consistent results. Comparison testing data provided for positive and negative EIA results against different LC/MS/MS concentration ranges. Cosmetic treatments did not significantly change EIA results for negative or positive samples. Specific compounds showed cross-reactivity. Contamination studies showed the wash procedures were effective in reducing externally applied amphetamine levels. Storage and shipping did not significantly impact results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Raw data for comparison testing is provided, but no calculated sensitivity, specificity, PPV, NPV values).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cozart EIA Amphetamine Oral Fluid Microplate Kit, K033743
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
510 K SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K130811
Submitted By:
Psychemedics Corporation
5832 Uplander Way Culver City, CA 90230 TEL: 310 216 7776 FAX: 310 216 6662
Submission Contact:
Virginia Hill March 22, 2013
DKZ
Date Prepared:
Device Trade Name:
Predicate Device:
Product Code:
Device Classification/Name:
Intended Use:
Assay Description:
21 CFR 862.3100, Enzyme Immunoassay, Amphetamine; Classification II;
Psychemedics Microplate EIA for Amphetamine in Hair
Cozart EIA Amphetamine Oral Fluid Microplate Kit, K033743
The Psychemedics Microplate ELA for Amphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying amphetamine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only. Psychemedics has not performed an evaluation of reproducibility at different laboratories.
The Psychemedics Microplate EIA amphetamine assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Double Mass Spectrometry (GC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Amphetamine. The screening portion of the test system consists of ( 1 ) microplate wells coated with multiple antigens including methamphetamine conjugated to bovine serum albumin (BSA), monoclonal mouse anti-amphetamine, rabbit anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to
1
acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
Sample Collection & Stability: 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 foif. 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. Stability of amphetamine in hair samples stored at room temperature has been shown for at least one year. Amphetamine in samples shipped coast-to-coast twice was stable.
Materials required:
Hair sample collection kit, Microplate ElA for Amphetamine, Microplate washer and reader, LC/MS/MS for confirmation.
| Item | Proposed Device | Cozart EIA Amphetamines
Oral Fluid Microplate Kit |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications/
Intended use | The Psychemedics Microplate EIA
for Amphetamine is an enzyme
immunoassay (EIA) for the
preliminary qualitative detection of
amphetamine in human head and
body hair using an amphetamine
calibrator at 3 ng /10 mg hair cutoff
for the purpose of identifying
amphetamine use.
The Psychemedics Microplate EIA
amphetamine assay provides only a
preliminary analytical test result. A
more specific alternative chemical
method must be used in order to
obtain a confirmed analytical result.
Gas or Liquid
Chromatography/Mass
Spectrometry/Mass Spectrometry
(GC/MS or LC/MS/MS) is the
preferred confirmatory method. | Cozart EIA Amphetamines Oral
Fluid Microplate Kit is a
qualitative test for amphetamine
in oral fluid. It is intended for
qualitative detection of
amphetamine in human oral fluid
at 100 ng/mL. The test is
intended for professional use. It
is not intended for over-the-
counter sales to non-
professionals. It provides only
preliminary analytical test
results. A more specific alternate
chemical method must be used in
order to obtain a confirmed
result. GC/MS is the preferred
confirmatory method. |
| Product Code | DKZ | DKZ |
| Measurand | Amphetamine in Hair | Amphetamine in Oral Fluid |
| Test System | Psychemedics EIA for
Amphetamine in Hair | Cozart EIA Amphetamines Oral
Fluid Microplate Kit |
| Sample Matrix | Human Hair | Human Oral Fluid |
| Method of Measurement | Microplate reader, read at 450 nm | Microplate reader, read at 450 nm |
| Cutoff | 3 ng amphetamine/10 mg hair
(300 pg amphetamine /mg hair) | 100 ng amphetamine/mL oral fluid |
Comparison with Predicate:
2
| Type of Test | Enzyme Immunoassay | Enzyme Immunoassay |
|---|---|---|
| Extraction Method | Patented Digestion method | Not applicable |
| Confirmation Method | LC/MS/MS | GC/MS |
Summary of Performance Testing
·
The precision studies were performed by spiking negative hair with previously LC/MS/MS-validated calibrator and control spiking solutions to achieve concentrations of negative, the cutoff of 2 ng/10 mg hair, and +/-75%, +/-50%, and +/- 25% of the cutoff. Precision Studies
| Summary -Intra-Assay | Summary-Inter-Assay | ||||
|---|---|---|---|---|---|
| LEVEL | NEG | POS | LEVEL | NEG | POS |
| B 0 (-100%) | 15 | 0 | B 0 (-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 |
ComparisonTesting
One hundred eighty samples comprising both head and body hair were confirmed by LC/MS/MS in parallel with testing by the Psychemedics Amphetamine EIA, with the results shown in the following table.
The studies comparing the EIA with LC/MS/MS documented the age, gender and ethnicity of subjects, hair color, and source of hair (body or head hair).
| Amphetamine
EIA Test Result | Negative
by GC/MS | Less than half
the cutoff
concentration by
GC/MS | Near Cutoff Negative
(Between 50% below
the cutoff and the
cutoff) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff) | High Positive
(Greater than
50% above the
cutoff) |
|--------------------------------|----------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------|
| Positive | 14 | 2 | 17 | 22 | 59 |
| Negative | 38 | 17 | 11 | 0 | 0 |
3
Discordant Results of Comparison Testing
.
- September 19. 1. 1.
.
.
.
| Discordant Results of Comparison Testing | ||
|---|---|---|
| Screening Cutoff | ||
| ( ng/10 mg hair) | Amphetamine EIA | |
| Result (POS/NEG) | LC/MS/MS Drug Result (ng/ 10 mg hair) | |
| 3 | POS | 0 amphetamine, 16 phentermine |
| 3 | POS | 0 amphetamine, 16 phentermine |
| 3 | POS | 0 amphetamine, 17 phentermine |
| 3 | POS | 0 amphetamine, 18 phentermine |
| 3 | POS | 0 amphetamine, 19 phentermine |
| 3 | POS | 0 amphetamine, 23 phentermine |
| 3 | POS | 0 amphetamine, 23 phentermine |
| 3 | POS | 0 amphetamine, 23 phentermine |
| 3 | POS | 0 amphetamine, 40 phentermine |
| 3 | POS | 0 amphetamine, 44 phentermine |
| 3 | POS | 0 amphetamine, 49 phentermine |
| 3 | POS | 0 amphetamine, 55 phentermine |
| 3 | POS | 0 amphetamine, 65 phentermine |
| 3 | POS | 0 amphetamine, 86 phentermine |
| 3 | POS | 1.2 amphetamine, 9.6 methamphetamine |
| 3 | POS | 1.3 amphetamine, 21.8 methamphetamine |
| 3 | POS | 1.4 amphetamine, 21 methamphetamine |
| 3 | POS | 2.0 amphetamine, 20.6 methamphetamine |
| 3 | POS | 2.1 amphetamine, 39.8 methamphetamine |
| 3 | POS | 2.6 amphetamine, 31.7 methamphetamine |
| 3 | POS | 2.8 amphetamine, 24.1 methamphetamine |
| 3 | POS | 1.6 amphetamine, 27.8 methamphetamine |
| 3 | POS | 1.6 amphetamine, 31 methamphetamine |
| 3 | POS | 1.7 amphetamine, 15.6 methamphetamine |
| 3 | POS | 2.0 amphetamine, 31 methamphetamine |
| 3 | POS | 2.1 amphetamine, 25 methamphetamine |
| 3 | POS | 2.2 amphetamine, 26.8 methamphetamine |
| 3 | POS | 2.6 amphetamine, 10.8 methamphetamine |
| 3 | POS | 2.5 amphetamine, 14.2 methamphetamine |
| 3 | POS | 2.5 amphetamine, 49.8 methamphetamine |
| 3 | POS | 2.7 amphetamine, 41.9 methamphetamine |
| 3 | POS | 2.8 amphetamine, 32.6 methamphetamine |
| 3 | POS | 1.7 amphetamine, 17.5 methamphetamine |
the state of the state of the states
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1:00 PM IST STATE
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Cosmetic Treatments
Twenty amphetamine-negative head hair samples were treated with bleach, 20 with permanent wave, 20 with dye, 20 with relaxer, and 20 with shampoo, and the results compared to the same samples without the treatments. In each case of the 20 samples treated with a type of cosmetic treatment, 10 samples were treated with one brand of a particular product and 10 other samples with a second brand. No significant differences in EIA results were observed for the negative hair samples before and after the treatments; all samples remained negative after the treatments.
Twelve amphetamine-positive head hair samples were treated with bleach, permanent wave, dye, relaxer, and shampoo, and the results compared to the same samples without the treatments. In each case of samples treated with a type of cosmetic treatment, 6 samples were treated with one brand of a particular product and 6 other samples with a second brand. None of the samples became negative, by either EIA or LC/MS/MS, after treatment with any of the cosmetic products.
Summary of Cross-reactivity and Interference Studies
Chloramphetamine, MDA, PMA and Phentermine showed significant cross-reactivity in the amphetamine One-hundred-forty other compounds showed no cross-reactivity in the assay. One-hundred-EIA. nineteen compounds tested for interference at +/-50% of the cutoff showed no interference in the assay.
| Compound | Percent
Cross-
reactivity* | Expected Concentration
Equivalent to 3 ng
Amphetamine/10 mg hair |
|---------------------|----------------------------------|------------------------------------------------------------------------|
| MDA | 120 | 2.5 |
| d-amphetamine | 100 | 3.0 |
| PMA | 100 | 3.0 |
| Chloramphetamine | 79 | 3.8 |
| Phentermine | 17.6 | 17 |
| l-amphetamine | 1.1 | 270 |
| MDMA | 0.5 | 600 |
| PMMA | 0.5 | 600 |
| Phenylpropanolamine | 1000 |
| Pseudoephedrine | 1000 |
| IR, 2S Ephedrine | 1000 |
| S,S Pseudoephedrine | 1000 |
| Phenylethylamine | 1000 |
| MDEA | 1000 |
| L-methamphetamine | 1000 |
| Ranitidine | 1000 |
| Fenfluramine | 1000 |
| Mephentermine | 1000 |
| Phenmetrazine | 1000 |
| Phendimetrazine | 1000 |
| Metanephrin | 1000 |
Cross-reactivity of related Compounds in Amphetamine EIA
5
Environmental Contamination
Aqueous Washing of Samples Soaked in Water and Saline Solutions of Amphetamine
Contamination of head hair samples by soaking in 500 ng amphetamine /mL of water resulted in a range of amphetamine on the hair of 7.9 - 225.8 ng of amphetamine /10 mg hair before washing. After washing by the procedure described below, the amount of oxycodone remaining on the hair samples from 0.6 to 76.3/10 mg hair, with 8 of the 11 samples appearing to be positive before application of the wash criterion. After application of the wash criterion, all of these samples containing amphetamine above the cutoff were determined to be contaminated (not positive).
Contamination of head hair samples by soaking in 500 ng amphetamine/mL of saline resulted in a range of amphetamine on the hair of 2.3 - 42.8 ng of amphetamine /10 mg hair before washing. by Psychemedics hair washing procedure (below), the amount of amphetamine remaining on the hair samples ranged from 0.5 to 9.5 ng/10 mg hair, with 10 of 11 samples below the cutoff even without application of the wash criterion. The one sample that was above the cutoff was determined to be negative by the wash criterion.
The Aqueous Buffer Wash Procedure
- a. Wash by Psychemedics' standard wash procedure:
- Add 2 mL of dry isopropanol and shake in waterbath for 15 minutes at 37℃ with shaking @ i. 100 -120 oscillations/minute. Remove isopropanol.
- ii. Add 2 mL of Wash Buffer (0.01 M phosphate buffer, pH 6.0, containing 0.1% BSA) and shake in waterbath for 30 minutes at 37℃ with shaking @ 100 -120 oscillations/minute. Remove Buffer.
- iii. Repeat Step ii. two more times.
- iv. Add 2 mL of Wash Buffer, and shake in waterbath for 60 minutes at 37℃ with shaking @ 100 -120 oscillations/minute. Remove Buffer.
- Repeat Step iv. one more time. Remove Buffer and save for analysis. Hair samples are now V. ready for digestion and extraction for LC/MS/MS analysis
4. Contamination Results for Amphetamine
Abbreviations used in the tables below: Hair Color: BLK, black; BRN, brown; LT, light; DK, dark; BLND, Blond. Ethnicity: As, Asian; Af-Am, African; H, Hispanic; Ca, Caucasian; Curvature: S, straight; C, curly. Contamination of Hair in 500 ng Amphetamine/mL Water-Aqueous Buffer Wash
| Sample
| Color | Curvature,
Ethnicity | Total
Drug
on
Hair* | Drug in Hair
after
Washing** | Drug in
Last
Wash | Apply Wash
Criterion*** | POS/
NEG | P, porous; VP,
very porous; N,
normal |
|-------------|---------|-------------------------|------------------------------|------------------------------------|-------------------------|----------------------------|-------------|---------------------------------------------|
| | | | ng amphetamine/10 mg hair | | | | | |
| 1 | MED BRN | S, Ca | 35.1 | 5.98 | 39.07 | -130.77 | NEG | VP |
| 2 | DK BRN | S, H | 225.8 | 76.36 | 253.38 | -810.47 | NEG | VP |
| 3 | BLK | S, As | 7.97 | 2.68 | 8.80 | NA | NEG | N |
| 4 | DK BRN | S, H | 19.35 | 3.64 | 18.75 | -61.99 | NEG | N |
| 5 | MED BRN | S, Ca | 13.03 | 3.52 | 14.34 | -46.67 | NEG | N |
| 6 | MED BRN | S, Ca | 26.66 | 3.11 | 21.10 | -70.74 | NEG | P |
| 7 | LT BRN | S, Ca | 23.58 | 5.36 | 21.49 | -69.86 | NEG | N |
| 8 | LT BRN | S, Ca | 30.82 | 5.65 | 37.30 | -124.90 | NEG | P |
| 9 | BLK | C, Af Am | 3.40 | 0.67 | 4.06 | NA | NEG | N |
| 10 | BLND | S, Ca | 2.71 | 0.75 | 1.96 | NA | NEG | N |
| 11 | BLND | S, Ca | 72.6 | 5.93 | 49.41 | -167.01 | NEG | P |
6
*Total Amphetamine found by LC/MS/MS with unwashed hair samples.
** Wash Criterion: Hair - (3.5 x Last Wash); if Wash Criterion result is