Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies detail a standard ELISA immunoassay process for detecting cocaine in hair. There is no mention of algorithms, machine learning models, or AI-driven analysis of the results. The interpretation is based on a simple comparison of absorbance values to a cutoff calibrator.

Therapeutic

No
The device is an in vitro diagnostic device used to detect cocaine in hair samples, not to treat a condition or disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a laboratory-based in vitro diagnostic test system that involves physical manipulation of hair samples, chemical extraction, and an ELISA assay using a microtiter plate and plate reader. This involves significant hardware components and laboratory procedures, not just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is an in vitro diagnostic device intended exclusively for in-house professional use..."
Nature of the Test: The device performs a test on a biological specimen (hair) to detect the presence of a substance (cocaine and its metabolites) for diagnostic purposes (determining if cocaine is present). This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
ELISA Method: The use of an Enzyme Linked Immunosorbent Assay (ELISA) is a common technique used in IVD devices for detecting specific substances in biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Quest Diagnostics HairCheck-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.

The Hair Check-DT (Cocaine) test system was evaluated in two distinct study populations; individuals known to be chronic drug abusers, and individuals proclaiming to be drug-free.

The Quest Diagnostics Hair Check-DT (Cocaine) test system provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatography mass spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Product codes (comma separated list FDA assigned to the subject device)

DIO

Device Description

The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.
The ELISA Cocaine Kit is based on the competition for a limited number of antibody sites by unlabeled cocaine/cocaine metabolites and enzyme-labeled drug. The two will bind to the antibody in proportion to their concentration in solution.
Once accessioned in the lab, the aluminum foil is opened and the specimen is cut at approximately 3.9 cm from the root end. This specimen is cut into smaller lengths and mixed to ensure homogeneity. Ten milligrams of the specimen is weighed out and placed into a properly labeled test tube. The specimen is then washed with methanol, decanted, and then placed in hot methanol containing 0.5% (v/v) trifluoroacetic acid for one hour forty-five minutes. The extracted methanol solution is then transferred to a new tube and evaporated under nitrogen. The tubes are reconstituted with phosphate buffer and assayed using the Cocaine ELISA Kit. This kit is a solid-phase microtiter plate immunoassay in which the microwells are coated with a high affinity capture antibody to cocaine. A hair sample extract is added to the well, followed by the horseradish peroxidase (HRP) enzyme conjugate. During this initial phase, the enzyme conjugate competes with the analyte in the sample for binding sites on the antibody-coated microwells. A wash solution (Tween-20 in phosphate buffered saline solution) is then applied to remove any unbound materials such as excess conjugate and residual sample. Enzyme substrate solution containing 3, 3', 5, 5'-tetramethylbenzidine (TMB) is then added for the final color development process. The reaction is stopped with 1N sulfuric acid and the absorbance is read at 450 nm, with a reference wavelength of 620 nm, using a plate reader. Color intensity is inversely proportional to the amount of analyte present in the sample. Therefore, samples that contain drug or analyte will inhibit binding of the enzyme conjugate to the antibody, resulting in little substrate binding and less color development than in the negative calibrator. For the screening assay an absorbance less than or equal to the absorbance of the 300 pg cocaine/mg hair cutoff calibrator is indicative of the presence of cocaine/cocaine metabolites.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

head hair samples

Indicated Patient Age Range

Not Found

Intended User / Care Setting

in-house professional use

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/Cutoff Characterization
Precision/Reproducibility aliquots were tested in quintuplicate (i.e. 5-replicates) on each of ten (10) different days using the Quest Diagnostics Cocaine specific ELISA kit (Lot # EVAL1). The same nine (9) samples/levels were analyzed in replicates of five (5) over the course of ten (10) days, alternating the order of the levels on the microplates each day. Calibrator and control materials were analyzed in wells located prior to and after the specimens on the microplates each day of testing. The overall (between-run) precision (CV %) was less than 10% for all spiked (25%, 50%, 100%, 125%, 150%, 175%, and 200%) levels of analyte. The mean Ratio minus 2 SD of the 50% samples was greater than the mean Ratio plus 2 SD of the 100% sample on each day of analysis. The mean Ratio minus 2 SD of the 100% sample was greater than the mean Ratio plus 2 SD of the 150% sample on each day of analysis. There is no crossover ±50% of the cutoff. Sample size: 50 for each level (0%, 25%, 50%, 75%, 100%, 125%, 150%, 175%, 200%).

Cross-Reactivity
Eleven (11) compounds, structurally related to cocaine and known cocaine metabolites, were tested for cross-reactivity. The cross-reactant solutions were prepared by adding the compounds to negative hair matrix. The concentrations listed produced a result approximately equal to the cutoff calibrator. Cross-reactivity for tested compounds ranged from

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

QUEST DIAGNOSTICS INCORPORATED November 18, 2016 LISA CHRISTO QUALITY ASSURANCE AND REGULATORY AFFAIRS MANAGER 10101 RENNER BLVD. LENEXA KS 66219-9275

Re: K152232

Trade/Device Name: Ouest Diagnostics HairCheck-DT (Cocaine) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO Dated: November 14, 2016 Received: November 15, 2016

Dear Ms. Christo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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 does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Katherine Serrano -S

For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K152232

Device Name

Quest Diagnostics HairCheck-DT (Cocaine)

Indications for Use (Describe)

Intended Use

The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.

The Hair Check-DT (Cocaine) test system was evaluated in two distinct study populations; individuals known to be chronic drug abusers, and individuals proclaiming to be drug-free.

The Quest Diagnostics Hair Check-DT (Cocaine) test system provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatography mass spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the Quest Diagnostics logo. The logo consists of a stylized "Q" symbol on the left and the words "Quest Diagnostics" on the right. The word "Quest" is in a larger, bolder font than the word "Diagnostics".

1.0 510(k) Summary

| Applicant | Quest Diagnostics Incorporated
10101 Renner Blvd.
Lenexa, KS 66219-9275
USA |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 11/17/2016 |
| Primary Contact | Lisa Christo
Tel 913-577-1784
Lisa.x.Christo@questdiagnostics.com |
| Alternate Contact | R. H. Barry Sample, Ph.D.
Tel 770-800-9870
Barry.x.Sample@questdiagnostics.com |
| Proprietary Name | Quest Diagnostics HairCheck-DT (Cocaine) |
| Generic Name | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| US Product Code | DIO – Enzyme Immunoassay, Cocaine and Cocaine Metabolites |
| US Regulation Number | 862.3250 |
| Classification | United States Class II |
| CLIA Complexity | High |
| Analyte | Cocaine |
| Special Instrument Requirements | The device is for use with an automated microplate reader capable of measuring at 450 and 620 nm. |
| Specimen Collection | Head Hair |
| Predicate Device | Quest Diagnostics HairCheck-DT (Cocaine) (K023626) |
| Reference Method | Presumptive positives are confirmed with Quantitative GC-MS |
| Device Description | The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked
Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through
the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair.
This test system has not been evaluated for use with hair specimens from locations other than the
head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not
intended for sale to anyone.
The ELISA Cocaine Kit is based on the competition for a limited number of antibody sites by
unlabeled cocaine/cocaine metabolites and enzyme-labeled drug. The two will bind to the antibody in
proportion to their concentration in solution.
Once accessioned in the lab, the aluminum foil is opened and the specimen is cut at approxima
3.9 cm from the root end. This specimen is cut into smaller lengths and mixed to ens
homogeneity. Ten milligrams of the specimen is weighed out and placed into a properly labeled test
tube. The specimen is then washed with methanol, decanted, and then placed in hot methanol |
| | containing 0.5% (v/v) trifluoroacetic acid for one hour forty-five minutes. The extracted methanol
solution is then transferred to a new tube and evaporated under nitrogen. The tubes are
reconstituted with phosphate buffer and assayed using the Cocaine ELISA Kit. This kit is a solid-
phase microtiter plate immunoassay in which the microwells are coated with a high affinity capture
antibody to cocaine. A hair sample extract is added to the well, followed by the horseradish
peroxidase (HRP) enzyme conjugate. During this initial phase, the enzyme conjugate competes with
the analyte in the sample for binding sites on the antibody-coated microwells. A wash solution
(Tween-20 in phosphate buffered saline solution) is then applied to remove any unbound materials
such as excess conjugate and residual sample. Enzyme substrate solution containing 3, 3', 5, 5'-
tetramethylbenzidine (TMB) is then added for the final color development process. The reaction is
stopped with 1N sulfuric acid and the absorbance is read at 450 nm, with a reference wavelength of
620 nm, using a plate reader. Color intensity is inversely proportional to the amount of analyte
present in the sample. Therefore, samples that contain drug or analyte will inhibit binding of the
enzyme conjugate to the antibody, resulting in little substrate binding and less color development
than in the negative calibrator. For the screening assay an absorbance less than or equal to the
absorbance of the 300 pg cocaine/mg hair cutoff calibrator is indicative of the presence of
cocaine/cocaine metabolites. |
| Device
Background | Cocaine is one of the most potent of the naturally occurring central nervous system stimulants. The
compound is found in the leaves of Erythroxylon coca, a South American shrub, in amounts of up to
2% by weight. It was first isolated in pure form in 1855, and has been widely utilized in medicine
as a local anesthetic and increasingly by drug abusers for its stimulant properties. For anesthetic
uses, cocaine is administered topically as the hydrochloride in 1-4% solutions for ophthalmologic
procedures and in 10-20% solutions for the membranes of the nose and throat. When self-
administered, it is commonly taken as the hydrochloride by nasal insufflation or intravenous
injection or as the free base by smoking in doses of 10-120 mg.1 |
| | Cocaine is the primary analyte found in hair after cocaine ingestion, in spite of its very short half-life
in plasma. The major blood and urine metabolite, benzoylecgonine, whose concentration in plasma
far exceeds cocaine's, is present in hair at relatively lower concentrations. Additionally, the cocaine
metabolite cocaethylene (ethylbenzoylecgonine) may be found in hair. |
| Intended Use | The Quest Diagnostics HairCheck-DT (Cocaine) test system utilizes an Enzyme Linked
Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through
the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair.
This test system has not been evaluated for use with hair specimens from locations other than the
head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not
intended for sale to anyone.
The HairCheck-DT (Cocaine) test system was evaluated in two distinct study populations; individuals
known to be chronic drug abusers, and individuals proclaiming to be drug-free.
The Quest Diagnostics HairCheck-DT (Cocaine) test system provides only a preliminary analytical test
result. To confirm a presumptive screen positive result, a more specific alternate chemical method,
such as gas chromatography-mass spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass
Spectrometry (LC-MS/MS), must be used. Clinical consideration and professional judgment should be
applied to any drug of abuse test result, particularly when preliminary positive results are obtained. |
| Indications | See Intended Use Statement |
| Studies | Precision/Reproducibility Cross reactivity (Structurally related compounds) Interferences (Unrelated compounds) Method Comparison Within-Run Specimen Extraction Reproducibility Cosmetic Hair Treatment Specimen Shipping Stability Study Accelerated Reagent Stability Shelf Life (Real Time) Stability |

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Image /page/4/Picture/0 description: The image shows the logo for Quest Diagnostics. The logo consists of a circular symbol with an arrow pointing downwards and to the left. To the right of the symbol is the text "Quest Diagnostics" in a sans-serif font. The word "Quest" is larger and bolder than the word "Diagnostics".

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Image /page/5/Picture/0 description: The image shows the logo for Quest Diagnostics. The logo consists of a stylized "Q" symbol on the left, with the words "Quest" and "Diagnostics" to the right of the symbol. The "Q" symbol is a circular shape with an arrow pointing inward, and the text is in a sans-serif font.

2.0 Classification and Regulatory Status

U.S. Classification 2.1

Class II

3.0 Intended Use and Indications

3.1 Intended Use - Quest Diagnostics HairCheck-DT (Cocaine)

The Quest Diagnostics HairCheck-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.

The HairCheck-DT (Cocaine) test system was evaluated in two distinct study populations; individuals known to be chronic drug abusers, and individuals proclaiming to be drug-free.

The Quest Diagnostics HairCheck-DT (Cocaine) test system provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatography-mass spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

3.2 Indications

See Intended Use Above

3.3 Reactivity and Corresponding Follow-up

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Image /page/6/Picture/0 description: The image shows the Quest Diagnostics logo. The logo consists of a stylized letter Q on the left and the words "Quest Diagnostics" on the right. The letter Q is a circular shape with a break in the upper right quadrant, and an arrow pointing inward. The word "Quest" is above the word "Diagnostics".

Reactivity and Corresponding Follow-up
Result	Follow-up
Cocaine Detected/Not
detected	The Quest Diagnostics HairCheck-DT (Cocaine) ELISA provides only a
preliminary result. To obtain confirmed analytical results a more
specific alternate method, such as gas chromatography/-mass
spectrometry (GC/-MS) or Liquid Chromatography-Tandem Mass
Spectrometry (LC/-MS/MS), must be used. Clinical consideration and
professional judgment must be applied to any drug of abuse test
result, particularly in evaluating a preliminary positive result.
A positive test result does not always mean a person took illegal drugs
and a negative test result does not always mean a person did not take
illegal drugs. There are a number of factors that influence the
reliability of drug tests.
Invalid Result	Repeat testing with a newly prepared sample.

Major Risks and Benefits vs. Result 3.4

There are no major risks. The Quest Diagnostics Hair Check-DT (Cocaine) test system is a screening test for the presence of Cocaine and all presumptively positive specimens should be tested with a more specific alternate chemical method, such as gas chromatography-mass spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), to obtain a confirmed result.

Comment [MJ2]: Font size

Device Description 3.5

The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone.

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 ELISA screening assay consists of micro strip plates coated with mouse anti-Cocaine monoclonal antibody, enzyme concentrate conjugate (horseradish peroxidase conjugated to cocaine), enzyme diluent, substrate containing tetramethylbenzidine (TMB), concentrated wash solution, acid stop solution containing 1 N H2SO4.

Pre-Analytical:

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A sample of hair (approximately 120 strands) should be cut as close as possible to the scalp, preferably from the back of the crown (vertex). This kit has not been evaluated for other types of hair. The amount of hair collected in this manner is such that a 3.9 cm long sample should weigh approximately 100 – 120 mg. The hair is placed in the V-shaped aluminum foil, ensuring that the root ends are aligned with the pointed end of the foil. The aluminum foil is pinched tightly around the length of hair (DO NOT BEND IN HALF). The foil is placed in a sample acquisition card, root end left towards the arrow. The card is then sealed lengthwise with the box seal. The card is placed in the Toxicology Specimen Baqqie and sealed. Keep hair specimens at ambient temperature until they are shipped, without refrigeration, to the laboratory. No special handling is needed.

Unknown specimens are prepared by weighing out ten (10) milligrams of the hair that has been cut into a fine mince (0.2-0.5 cm) and placing it into a properly labeled test tube. Wash specimens: add 2 mL of methanol to each specimen and let stand for 5 minutes at room temperature. Swirl and discard the methanol with a disposable pipette. Take care not to aspirate any hair into the pipette. Extract specimens: Add 3 mL of acidified methanol (0.5% (v/v) Trifluoroacetic acid (TFA) in methanol) and place in heated water bath (62°C) for 1 hour 45 minutes. Remove the samples from the water bath and transfer them to a heated sonicator set at 55°C. Sonicate the samples for 15 minutes. Dry the specimens: Transfer the methanol solution to a new tube and evaporate until dry under nitrogen. Reconstitute dried specimens with 0.025 mL of acetonitrile and 0.3 mL of phosphate buffer and vortex.

Test Principle:

The ELISA Cocaine Kit is based on the competition for a limited number of antibody sites by unlabeled cocaine/cocaine metabolites and enzyme-labeled drug. The two will bind to the antibody in proportion to their concentration in solution.

Once accessioned in the lab the aluminum foil is opened and the specimen is cut at approximately 3.9 cm from the root end. This specimen is cut into smaller lengths and mixed to ensure homogeneity. Ten (10) milligrams of the specimen is weighed out and placed into a properly labeled test tube. The specimen is then washed with methanol, decanted, and then placed in hot methanol for two hours. The methanol is then transferred to a new tube and evaporated under nitrogen. The tubes are reconstituted with phosphate buffer and assayed using the ELISA Cocaine Kit. This kit is a solid-phase microtiter plate immunoassay in which the microwells are coated with a high affinity capture antibody to cocaine. A hair sample extract is added to the well, followed by the horseradish peroxidase (HRP) enzyme conjugate. During this initial phase, the enzyme conjugate competes with the analyte in the sample for binding sites on the antibody-coated microwells. A wash solution (Tween-20 in phosphate buffered saline solution) is then applied to remove any unbound materials such as excess conjugate and residual sample. Enzyme substrate solution containing 3,3', 5,5'tetramethylbenzidine (TMB) is then added for the final color development process. The reaction is stopped with 1N sulfuric acid and the absorbance is read at 450 nm with a reference wavelength of

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Image /page/8/Picture/0 description: The image shows the logo for Quest Diagnostics. The logo consists of a stylized letter "Q" on the left and the words "Quest Diagnostics" on the right. The "Q" is a circular shape with an arrow pointing inward, and the words "Quest Diagnostics" are in a sans-serif font.

620 nm using a plate reader. Color intensity is inversely proportional to the amount of analyte present in the sample. Therefore, samples that contain drug or analyte will inhibit binding of the enzyme conjugate to the antibody, resulting in little substrate binding and less color development than in the negative calibrator. For the screening assay an absorbance less than or equal to the absorbance of the 300 pg cocaine/mg hair cut-off calibrator is indicative of the presence of cocaine/cocaine metabolites.

3.6 Kit Components

Each kit Quest Diagnostics HairCheck-DT (Cocaine) contains enough reagents to make 4,800 determinations

Reagents

50 x 96 well micro strip plates (12 x 8), coated with mouse anti-Cocaine monoclonal antibody.

2 x 4 mL of enzyme concentrate conjugate (horseradish peroxidase conjugated to cocaine) in a proprietary buffer containing stabilizing agents and thimerosal.

2 x 400 mL of enzyme diluent as a proprietary buffer containing stabilizing agents and thimerosal.

1 x 500 mL of substrate containing tetramethylbenzidine (TMB) and hydrogen peroxide in a citrate buffer containing stabilizers.

1 x 1000 mL of concentrated wash solution with surfactants and thimerosal as a preservative; Dilute 1:10 with deionized water prior to use.

1 x 500 mL of acid stop solution containing 1 N H2SO4.

Calibrators and Controls for Screening Assay:

100mL of 1X HairCheck-DT (Cocaine) Negative Containing 0 pg cocaine/mg hair (No need to dilute, provided at working concentration)

5mL of 40X HairCheck-DT (Cocaine) Low Control containing 6,000 pg cocaine/mg hair (Dilute 1:40 with Negative Control to reach 1X Low Control working concentration of 150 pg cocaine/mg hair)

5mL of 40X HairCheck-DT (Cocaine) Cutoff Calibrator containing 12,000 pg cocaine/mg hair (Dilute 1:40 with Neqative Control to reach 1X calibrator working concentration of 300 pg cocaine/mg hair/

5mL of 40X HairCheck-DT (Cocaine) High Control containing 18,000 pg cocaine/mg hair (Dilute 1:40 with Negative Control to reach 1X High Control working concentration of 450 pg cocaine/mg hair

40X Calibrator and Control solutions are prepared from Cerilliant C-008, 1.0 mg/mL Cocaine in Acetonitrile Certified Reference Material. Calibrator and Control solutions are prepared by diluting commercial reference materials with water and methanol to achieve the target drug concentration; they are prepared in a similar manner however the Calibrator is made from different reference stock material than the Controls and are prepared at different concentrations. The shelf life of these solutions is 1 year at -20° C.

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Image /page/9/Picture/0 description: The image contains the Quest Diagnostics logo. The logo consists of a stylized "Q" symbol on the left, followed by the text "Quest" on the top line and "Diagnostics" on the bottom line. The "Q" symbol is a circular shape with an arrow pointing inward.

Predicate Device Information

3.7 Comparison to Predicate

Similarities

Similarities	Subject Device	Predicate
	Quest Diagnostics HairCheck-DT (Cocaine)
(K152232)	Quest Diagnostics HairCheck-DT (Cocaine)
(K023626) September 29, 2003
Intended Use	Same	Same
Sample Type	Head Hair	Head Hair
Collection Device	Same	Same
Low Control	150 pg cocaine/mg hair	150 pg cocaine/mg hair
Cutoff	300 pg cocaine/mg hair	300 pg cocaine/mg hair
Operating Principle	Qualitative Immunoassay	Qualitative Immunoassay
Competitive
Enzyme-conjugate	HRP - Cocaine	HRP - Cocaine
CLIA Complexity	High	High
Substrate	TMB	TMB

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Quest Diagnostics HAIRCHECK-DT (Cocaine) 510(k) Summary Page 8 of 27

Differences

Difference	Subject Device	Predicate
	Quest Diagnostics HairCheck-DT
(Cocaine) (K152232)	Previously Cleared 510K Device (K023626)
September 29, 2003)
Antibody	Mouse anti-Cocaine monoclonal antibody	Rabbit anti-Cocaine polyclonal antibody
Extraction Method	Acidified Methanol (0.5% Trifluoroacetic
acid) (TFA)	Methanol
High Control	High Control modified to 450 pg/mg
equivalent concentration in Hair or +50% of
cutoff concentration.	High Control - 600 pg/mg equivalent
concentration in Hair or +100% of cutoff
concentration.
Sample Size	Sample Preparation modified to 10 mg of
Hair used for extraction then reconstituted
with 0.3 mL phosphate buffer	Sample Preparation 20 mg of Hair used for
extraction then reconstituted with 0.6 mL
phosphate buffer
Measurement
Wavelength	Assay absorbance measured at 450 nm with
a reference wavelength of 620 nm.	Assay absorbance was measured at 450 nm with a
reference wavelength of 630 nm.
Kit
Configuration	Kit Configuration modified to = 50
microplate kit	Kit Configuration = 5 microplate kit

4.0 Studies

Precision Studies/Cutoff Characterization 4.1

Precision

Precision/Reproducibility aliquots were tested in quintuplicate (i.e. 5-replicates) on each of ten (10) different days using the Quest Diagnostics Cocaine specific ELISA kit (Lot # EVAL1). The same nine (9) samples/levels were analyzed in replicates of five (5) over the course of ten (10) days, alternating the order of the levels on the microplates each day. Calibrator and control materials were analyzed in wells located prior to and after the specimens on the microplates each day of testing.

Within-Run Precision

A summary of data for the 10 days of testing for between-run and within-run precision (reproducibility) is shown in the tables below.

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Quest Diagnostics HAIRCHECK-DT (Cocaine) 510(k) Summary Page 9 of 27

Table 1: Precision Performance at the Cutoff and Overall (Between-Run) Precision
	0%	25%	50%	75%	100%	125%	150%	175%	200%
Target ng/mL	0.0	2.5	5.0	7.5	10.0	12.5	15.0	17.5	20.0
Target pg/mg	0.0	75.0	150.0	225.0	300.0	375.0	450.0	525.0	600.0
Level	1	2	3	4	5	6	7	8	9
Count	50	50	50	50	50	50	50	50	50
Grand Mean	2.1528	1.6717	1.3752	1.1560	1.0008	0.9025	0.7948	0.7224	0.6484
Within run SD	0.0730	0.0526	0.0359	0.0339	0.0380	0.0300	0.0285	0.0293	0.0270
Within run CV	3.39%	3.15%	2.61%	2.94%	3.80%	3.32%	3.59%	4.05%	4.16%
Overall SD	0.1886	0.1321	0.0965	0.0667	0.0805	0.0673	0.0540	0.0503	0.0464
Overall CV	8.76%	7.90%	7.02%	5.77%	8.04%	7.46%	6.79%	6.96%	7.16%
Within-Device SD	0.1844	0.1287	0.0949	0.0751	0.0759	0.0643	0.0495	0.0447	0.0412
	8.57%	7.70%	6.90%	6.50%	7.59%	7.13%	6.23%	6.18%	6.36%

The overall (between-run) precision (CV %) was less than 10% for all spiked (25%, 50%, 100%, 125%, 150%, 175%, and 200%) levels of analyte.

Evaluation of separation around the cutoff:

The Ratio was calculated (sample OD/cutoff OD) for each of the test samples. The mean Ratio and standard deviation (SD) of all pools were calculated for each day of analysis. The mean Ratio minus 2 SD of the 50% samples was greater than the mean Ratio plus 2 SD of the 100% sample on each day of analysis (Table 3, highlighted in blue). The mean Ratio minus 2 SD of the 100% sample was greater than the mean Ratio plus 2 SD of the 150% sample on each day of analysis (Table 3, highlighted in green).

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Table 3	0%	25%	50%	75%	100%	125%	150%	175%	200%
Target ng/mL	0.00	2.50	5.00	7.50	10.00	12.50	15.00	17.50	20.00
Target pg/mg	0	75	150	225	300	375	450	525	600
Day 1	Ratio Mean	1.8483	1.5442	1.2123	1.0572	0.8857	0.8079	0.7210	0.6863	0.6073
	CV%	1.2153	1.9844	1.3843	2.5001	3.8027	1.0648	2.4284	4.8712	2.3754
	SD	0.0225	0.0306	0.0168	0.0264	0.0337	0.0086	0.0175	0.0334	0.0144
	Mean - 2SD	1.8034	1.4829	1.1787	1.0044	0.8184	0.7907	0.6860	0.6195	0.5785
	Mean + 2SD	1.8932	1.6054	1.2458	1.1101	0.9531	0.8251	0.7560	0.7532	0.6362
Day 2	Ratio Mean	2.0159	1.5713	1.3047	1.0966	0.9479	0.8563	0.7467	0.6914	0.5956
	CV%	3.4755	4.0995	1.6774	2.9173	4.1082	6.5546	2.6096	3.9606	6.2692
	SD	0.0701	0.0644	0.0219	0.0320	0.0389	0.0561	0.0195	0.0274	0.0373
	Mean - 2SD	1.8758	1.4425	1.2609	1.0326	0.8700	0.7441	0.7077	0.6366	0.5209
	Mean + 2SD	2.1560	1.7002	1.3485	1.1606	1.0258	0.9686	0.7856	0.7461	0.6703
Day 3	Ratio Mean	2.1234	1.6385	1.4056	1.1825	1.0004	0.9342	0.8144	0.7813	0.6627
	CV%	4.7981	3.2186	1.9418	3.5366	5.9573	2.9866	2.2994	3.8651	5.1202
	SD	0.1019	0.0527	0.0273	0.0418	0.0596	0.0279	0.0187	0.0302	0.0339
	Mean - 2SD	1.9196	1.5331	1.3510	1.0989	0.8812	0.8784	0.7769	0.7209	0.5948
	Mean + 2SD	2.3271	1.7440	1.4602	1.2662	1.1195	0.9900	0.8518	0.8417	0.7306
Day 4	Ratio Mean	2.3294	1.9086	1.4802	1.2161	1.0487	0.9724	0.8993	0.7225	0.7066
	CV%	2.4899	1.9087	2.1544	1.8256	4.1469	1.5554	1.8522	2.3310	1.2972
	SD	0.0580	0.0364	0.0319	0.0222	0.0435	0.0151	0.0167	0.0168	0.0092
	Mean - 2SD	2.2134	1.8357	1.4164	1.1717	0.9617	0.9421	0.8660	0.6888	0.6883
	Mean + 2SD	2.4454	1.9814	1.5439	1.2605	1.1357	1.0026	0.9327	0.7562	0.7249
Day 5	Ratio Mean	2.2568	1.8108	1.5129	1.2434	1.1016	0.9556	0.8357	0.7673	0.6618
	CV%	4.3389	4.4107	1.8535	1.8499	5.1149	6.0551	5.8537	4.2541	4.4263
	SD	0.0979	0.0799	0.0280	0.0230	0.0563	0.0579	0.0489	0.0326	0.0293
	Mean - 2SD	2.0609	1.6511	1.4568	1.1974	0.9889	0.8399	0.7378	0.7021	0.6032
	Mean + 2SD	2.4526	1.9705	1.5690	1.2894	1.2143	1.0714	0.9335	0.8326	0.7204
Day 6	Ratio Mean	1.9474	1.5777	1.2931	1.1126	0.9226	0.8831	0.7733	0.6602	0.6027
	CV%	3.0262	3.8811	2.3540	4.2944	3.9541	1.6289	3.1115	4.5580	4.7650
	SD	0.0589	0.0612	0.0304	0.0478	0.0365	0.0144	0.0241	0.0301	0.0287
	Mean - 2SD	0.1179	1.4552	1.2322	1.0170	0.8496	0.8543	0.7252	0.6000	0.5452
	Mean + 2SD	2.0653	1.7002	1.3540	1.2082	0.9956	0.9119	0.8214	0.7204	0.6601
Day 7	Ratio Mean	2.1805	1.5773	1.3210	1.1383	0.9425	0.8195	0.7766	0.6943	0.6220
	CV%	1.5486	2.1530	2.2088	1.8923	1.8945	2.6357	3.1600	5.0606	2.9375
	SD	0.0338	0.0340	0.0292	0.0215	0.0179	0.0216	0.0245	0.0351	0.0183
	Mean - 2SD	2.1130	1.5094	1.2627	1.0952	0.9068	0.7763	0.7275	0.6240	0.5854
	Mean + 2SD	2.2480	1.6452	1.3794	1.1814	0.9783	0.8627	0.8256	0.7645	0.6585
Day 8	Ratio Mean	2.1334	1.6134	1.3586	1.1137	0.9908	0.8804	0.7759	0.6909	0.6381
	CV%	5.3536	4.1662	3.6210	3.7870	2.5106	1.1416	5.2141	3.9432	6.0450
	SD	0.1142	0.0672	0.0492	0.0422	0.0249	0.0101	0.0405	0.0272	0.0386
	Mean - 2SD	1.9050	1.4789	1.2602	1.0293	0.9410	0.8603	0.6950	0.6364	0.5610
	Mean + 2SD	2.3618	1.7478	1.4570	1.1980	1.0406	0.9005	0.8568	0.7454	0.7153
Day 9	Ratio Mean	2.2169	1.8277	1.4654	1.1740	1.0888	0.9158	0.8056	0.7430	0.6868
	CV%	2.8457	1.7283	2.8598	3.0449	1.8643	2.0844	2.6747	3.3639	2.5813
	SD	0.0631	0.0316	0.0419	0.0357	0.0203	0.0191	0.0215	0.0250	0.0177
	Mean - 2SD	2.0907	1.7645	1.5911	1.1025	1.0482	0.8776	0.7626	0.6930	0.6513
	Mean + 2SD	2.3431	1.8909	1.5492	1.2455	1.1294	0.9540	0.8487	0.7930	0.7223
Day 10	Ratio Mean	2.4759	1.6472	1.3979	1.2257	1.0786	1.0000	0.7991	0.7866	0.7000
	CV%	2.1856	2.4765	4.3044	2.8590	2.0787	1.6642	4.2157	3.8889	3.5696
	SD	0.0541	0.0408	0.0602	0.0350	0.0224	0.0166	0.0337	0.0306	0.0250
	Mean - 2SD	2.3676	1.5656	1.2776	1.1557	1.0337	0.9667	0.7317	0.7254	0.6500

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Quest Diagnostics HAIRCHECK-DT (Cocaine) 510(k) Summary Page 11 of 27

% Relative to Cutoff	0%	25%	50%	75%	100%	125%	150%	175%	200%
Target pg/mg	0	75	150	225	300	375	450	525	600
Negative Count	50	50	50	50	25	3	0	0	0
Positive Count	0	0	0	0	25	47	50	50	50
% Negative	100%	100%	100%	100%	50%	6%	0%	0%	0%
% Positive	0%	0%	0%	0%	50%	94%	100%	100%	100%

Table 4: % Positive and Negative

Table 4 also demonstrates separation around the cutoff. There is no crossover ±50% of the cutoff.

4.2 Cross-Reactivity

Structurally Related Compounds

Cocaine, structurally-related compounds, pharmacologically-related compounds, and metabolites were tested for cross-reactivity in the assay. Eleven (11) compounds, structurally related to cocaine and known cocaine metabolites, were selected for the study (see table below for the list). The cross-reactant solutions were prepared by adding the compounds to negative hair matrix. The concentrations listed below produced a result approximately equal to the cutoff calibrator.

Serial dilutions of each compound were prepared and analyzed. If the OD response of the spiked sample was positive then the spiked sample was diluted further with finer dilutions until a positive result was obtained with an OD within 5% of the cutoff value (sample OD/Cutoff OD). Cross reactivity was calculated as: (Cutoff Concentration/Lowest Cross Reactant Concentration with a Positive Result) x 100.

| Compound | Cross
Reactivity (%) | Tested Concentration in
Negative Hair Matrix
(ng/mL) | Concentration of compound
(pg/mg hair) needed to
produce results equivalent to
300 pg/mg of Cocaine |
|---------------------------------|-------------------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Anhydroecgonine | 300,000 |
| Anhydroecgonine methyl ester | 300,000 |
| Atropine | 300,000 |
| Benzoylecgonine | 143% | 7 | 210 |
| Cocatheylene | 125% | 8 | 240 |
| Ecgonine | 300,000 |
| Ecgonine methyl ester | 300,000 |
| Meta-hydroxybenzoylecgonine | 200% | 5 | 150 |
| Norcocaine | 1% | 1,000 | 30,000 |
| Tropacocaine | 8% | 125 | 3,750 |
| Cocaine | 100% | 10 | 300 |
| Cocaine N-oxide HCI | 11% | 90 | 2,700 |
| Scopolamine hydrobromide | 300,000 |
| Norbenzoylecgonine | 1% | 900 | 27,000 |
| m-hydroxycocaine | 67% | 15 | 105 |
| Benzoylecgonine Isopropyl Ester | 182% | 5.5 | 165 |

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Conclusions

Cross-reactivity for tested compounds ranged from 450 pg/mg |
| Negative | 44 | 2 | 0 | 0 |
| Positive | 1 | 3 | 5 | 45 |

Overall Accuracy
% Agreement among positive	100% (50/50)
% Agreement among negative	92% (46/50)

Definitions:

Ratio = specimen OD/mean OD of cutoff calibrator Negative by ELISA: Ratio >1.0 Negative by GC-MS: 450 pg/mg

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Discrepant Results

| Unique
Identifier | GC-MS pg/mg | | | | Cocaine
Eq. Total | ELISA
Ratio
OD | Device
Result | Reference
Number |
|----------------------|-------------|-----|----|-----|----------------------|----------------------|------------------|---------------------|
| | BE | COC | CE | NOR | | | P/N | |
| MCC 06 | 0 | 0 | 0 | 0 | 0 | 0.038 | POS | 1 |
| MCC 47 | 0 | 155 | 0 | 0 | 155 | 0.807 | POS | 2 |
| MCC 49 | 0 | 190 | 0 | 0 | 190 | 0.704 | POS | 3 |
| MCC 50 | 80 | 272 | 0 | 0 | 386 | 0.560 | POS | 4 |

BE-Benzoylecgonine

COC-Cocaine

CE-Cocaethylene

NC-Norcocaine

(1) This specimen confirmed negative by GC-MS for cocaine and metabolites, yet screened strongly positive by the HairCheck-DT ELISA device. The hair specimen was dyed pink, likely using Manic Panic Semi-Permanent Cotton Candy Pink Hair Color, or similar hair care product. A deep pink color was encountered during the extraction and re-suspension process and the specimen was also robustly pink when pipetted onto the ELISA plates. Exposing the specimen to a black light resulted in intense pink fluorescence emission. The cited hair care product contains three cationic dyes, Basic Violet 16, Safranin O and Methylene Blue. All three dyes are fluorescent, emitting in the vicinity of 583-595 nm, the red region of the visible light spectrum. Further investigation into the effect of semi-permanent dyes on the assay has provided evidence that the binding of cocaine-HRP-conjugate to the antibody is disrupted by the presence of high concentrations of these dyes (relative to the concentration of cocaine) in sample extracts. This effect however, is not specific to the cocaine antibody since the offending hair specimen also produced false positive results in the HairCheck-DT (Opiates) ELISA and the HairCheck-DT (Methamphetamine) ELISA. Semi-permanent hair care products contain various cationic dyes that are readily extracted along with the cocaine during the pre-analytical sample preparation. The high concentration of extracted dyes, leads to positive interference through interaction with one or more steps of the fundamental immunoassay procedure.

(2) This specimen confirmed negative by GC-MS with a quantitative value of 155 pg cocaine/mg hair.

(3) This specimen confirmed negative by GC-MS with a quantitative value of 190 pg cocaine/mg hair.

(4) This specimen confirmed negative by GC-MS with a quantitative value of 272 pg cocaine/mg hair, but also contained 80 pg/mg of benzoylecgonine.

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4.5 Within-Run Specimen Extraction Reproducibility

This study assessed the within-run reproducibility of hair specimen extraction by the ELISA and GC-MS method by evaluating three (3) replicates of five (5) cocaine positive specimens on the HairCheck-DT (Cocaine) ELISA as well as the GC-MS confirmatory method.

| Unique ID
Number | [Cocaine]
(pg/mg) | Replicate
Number | Mean OD | Coeff. of
Var.
(CV%) | ELISA
Pos/Neg |
|---------------------|----------------------|---------------------|---------|----------------------------|------------------|
| 1 | 560 | 3 | 0.811 | 0.6 % | 3/0 |
| 2 | 18078 | 3 | 0.025 | 2.3 % | 3/0 |
| 3 | 2926 | 3 | 0.116 | 7.8 % | 3/0 |
| 4 | 7698 | 3 | 0.059 | 3.5 % | 3/0 |
| 5 | 2320 | 3 | 0.231 | 5.2 % | 3/0 |

Reproducibility Results

Conclusions

These results demonstrate the reproducibility of the specimen extraction and result for both the HairCheck-DT (Cocaine) ELISA as well as the GC-MS confirmatory method. Each replicate of each individual sample was positive for cocaine (100% agreement) by the HairCheck-DT (Cocaine) ELISA immunoassay and positive for cocaine by the GC-MS confirmation method. The within-run coefficient of variation for the GC-MS assay for cocaine was 6.7%. The within-run coefficients of variation for each of the five hair specimens by ELISA immunoassay (OD) was less than 10%, with an overall mean coefficient of variation of 3.9%.

Specimen Shipping Stability 4.6

In order to demonstrate the stability of cocaine in hair specimens during the shipping process, 56 hair samples- twenty eight (28) confirmed positive cocaine hair specimens, of which three specimens (3) have pre-shipping quantitative GC-MS results in the near cutoff positive concentration range (300 to 449 pg/mg Cocaine) and twenty eight (28) confirmed negative cocaine hair specimens, of which three (3) have pre-shipping quantitative GC-MS results in the near cutoff negative concentration range (150 to 299 pg/mg Cocaine) were shipped to eight different geographical locations and the temperatures tracked during shipping. By enclosing an electronic temperature sensor within each shipment of hair samples, we were able to retrieve a range of temperatures collected every 20 minutes during the shipping process. In order to mimic potential shipping extreme temperatures, the hair was first cold shocked at -15°C for 15 hours and then heat shocked at +47°C for 6 hours prior to shipping.

After the boxes were returned to facility, ELISA screening and GC-MS confirmation were performed on each sample and compared to the non-shipped results for the same samples. The cocaine negative samples that were shipped maintained their neqative status both for ELISA screening and GC-MS with respect to cocaine levels. One of the borderline negative samples originally screened positive prior to

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shipping and all three of the borderline negative samples screened positive after shipping due to variability near the cutoff of the ELISA screening method. The cocaine positive samples that were shipped maintained their positive status for both the ELISA screening and the GC-MS confirmation with respect to cocaine levels.

Summary of results for positive specimens

	Pre-Shipping		Post-Shipping
	GC-MS	ELISA	GC-MS	ELISA
Positive	28	28	28	28
Negative	0	0	0	0

Summary of results for negative specimens

	Pre-Shipping		Post-Shipping
	GC-MS	ELISA	GC-MS	ELISA
Positive	0	1*	0	3**
Negative	28	27	28	25

One of the three Near Cutoff Negative specimens (as determined by GC-MS pre-shipping) screened positive by ELISA prior to shipping.

** Three of three Near Cutoff Negative specimens (as determined by GC-MS pre-shipping) screened positive by ELISA post-shipping.

Conclusions

This study agrees with published literature that hair specimens containing cocaine are stable to various shipping regimes. No changes in positive or negative status were produced upon shipment of the hair other than borderline specimens which could be expected due to variability near the cutoff of the ELISA screening assay. The hair samples were exposed to a range of temperatures that exceeded what would normally be encountered in a standard shipping process, with no changes in reportable status.

Cosmetic Hair Treatment Studies 4.7

This study is designed to assess the contribution of various common cosmetic hair treatments; shampooing, dyeing, bleaching, perming, and relaxing, on the detection of cocaine using the HairCheck DT Cocaine ELISA. This data is used by end-users (customers) to assess the degree to which various cosmetic hair treatments may interfere with Cocaine detection in their donor population.

This study involves the testing of a panel of sixty (60) confirmed positive cocaine hair samples and sixty (60) screened negative cocaine hair samples that are treated with one of five (5) cosmetic hair treatments or left untreated. Cocaine positive hair is defined as a hair sample confirmed by GC-MS as

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having greater than 300 pg/mg cocaine. Absorbance readings after treatment were compared to absorbance readings prior to treatment, with the resulting change and direction of change noted. The resulting changes in ELISA test results (if any) are also noted, and are included in the table(s) below. (Absorbance values are normalized to the absorbance value of the cutoff calibrator absorbance value.)

ELISA Results for Cocaine Positive Hair

	Pre-Treatment		Post-Treatment		Pre to Post
	Number of
Samples Positive
by GC-MS	Number of
Samples Positive
by ELISA	Number of
Samples Positive by
GC-MS	Number of
Samples Positive by
ELISA	Range of
% change in OD
Shampoo	12	12	12	12	(-48%, +56%)
Brown Dye	12	12	12	12	(-59%, +174%)
Bleach	12	12	12	12	(-31%, +278%)
Perm	12	12	12	12	(-60%, +61%)
Relaxer	12	12	12	12	(+12%, +197%)

Cocaine positive hair remained positive by ELISA post-treatment, though substantial loss of cocaine was observed by GC-MS with bleach and relaxer.

Positive Specimens Individual Results

		Pre-Cosmetic Treatment				Post-Cosmetic Treatment
Treatment	Unique
ID	Cocaine
GC-MS
pg/mg	ELISA
Raw OD	Cal.
OD	ELISA
P/N	ELISA
Raw OD	Cal.
OD	ELISA
P/N	%Change
(ELISA
Raw OD)
Shampoo	P1	809	0.772	1.732	POS	0.976	1.732	POS	26%
	P2	1391	0.505	1.732	POS	0.504	1.732	POS	0%
	P3	4209	0.164	1.732	POS	0.165	1.732	POS	1%
	P4	5927	0.089	1.732	POS	0.115	1.732	POS	29%
	P5	804	0.664	1.732	POS	0.849	1.732	POS	28%
	P6	929	0.475	1.732	POS	0.739	1.732	POS	56%
	P7	793	0.817	1.732	POS	0.698	1.732	POS	-15%
	P8	984	0.275	1.732	POS	0.316	1.732	POS	15%
	P9	1336	0.417	1.732	POS	0.222	1.732	POS	-47%
	P10	1471	0.617	1.732	POS	0.322	1.732	POS	-48%
	P11	2064	0.229	1.732	POS	0.143	1.732	POS	-38%
	P12	812	0.437	1.732	POS	0.3	1.732	POS	-31%
	P13	951	0.722	1.732	POS	0.623	1.732	POS	-14%
	P14	968	0.739	1.732	POS	0.544	1.732	POS	-26%
	P15	1553	0.429	1.732	POS	0.368	1.732	POS	-14%
Brown Dye	P16	1596	0.366	1.732	POS	0.414	1.732	POS	13%
	P17	3536	0.199	1.732	POS	0.082	1.732	POS	-59%
	P18	1306	0.166	1.732	POS	0.455	1.732	POS	174%
	P19	1480	0.57	1.732	POS	0.389	1.732	POS	-32%

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	P20	1852	0.322	1.732	POS	0.259	1.732	POS	-20%
	P21	919	0.499	1.732	POS	0.467	1.732	POS	-6%
	P22	968	0.125	1.732	POS	0.262	1.732	POS	110%
	P23	4375	0.159	1.732	POS	0.166	1.732	POS	4%
	P24	6948	0.047	1.732	POS	0.043	1.732	POS	-9%
	P25	810	0.516	1.732	POS	0.899	1.732	POS	74%
	P26	1315	0.264	1.732	POS	0.379	1.732	POS	44%
	P27	3605	0.118	1.732	POS	0.16	1.732	POS	36%
	P28	5158	0.043	1.732	POS	0.06	1.732	POS	40%
	P29	5796	0.063	1.732	POS	0.096	1.732	POS	52%
Bleach
Blonde	P30	6812	0.073	1.732	POS	0.067	1.732	POS	-8%
	P31	22770	0.034	1.732	POS	0.028	1.732	POS	-18%
	P32	39769	0.016	1.732	POS	0.016	1.732	POS	0%
	P33	750	0.389	1.732	POS	0.627	1.732	POS	61%
	P34	6920	0.049	1.732	POS	0.185	1.732	POS	278%
	P35	1440	0.315	1.732	POS	0.511	1.732	POS	62%
	P36	1607	0.345	1.732	POS	0.239	1.732	POS	-31%

			Pre-Cosmetic Treatment				Post-Cosmetic Treatment
Treatment	Unique
ID	Cocaine
GC-MS
pg/mg	ELISA
Raw OD	Cal.
OD	ELISA
P/N	ELISA
Raw OD	Cal. OD	ELISA
P/N	%Change
(ELISA
Raw OD)
Perm	P37	1662	0.181	1.480	POS	0.23	1.480	POS	27%
	P38	1779	0.249	1.480	POS	0.365	1.480	POS	47%
	P39	2298	0.112	1.480	POS	0.123	1.480	POS	10%
	P40	3497	0.1	1.480	POS	0.088	1.480	POS	-12%
	P41	4142	0.054	1.480	POS	0.087	1.480	POS	61%
	P42	4522	0.11	1.480	POS	0.107	1.480	POS	-3%
	P43	5461	0.098	1.480	POS	0.104	1.480	POS	6%
	P44	5698	0.093	1.480	POS	0.112	1.480	POS	20%
	P45	5993	0.034	1.480	POS	0.039	1.480	POS	15%
	P46	6376	0.072	1.480	POS	0.081	1.480	POS	13%
	P47	6786	0.082	1.480	POS	0.102	1.480	POS	24%
	P48	8315	0.219	1.480	POS	0.087	1.480	POS	-60%
Relaxer	P49	9203	0.049	1.480	POS	0.067	1.480	POS	37%
	P50	20000	0.021	1.480	POS	0.026	1.480	POS	24%
	P51	856	0.619	1.480	POS	0.833	1.480	POS	35%
	P52	1455	0.189	1.480	POS	0.509	1.480	POS	169%

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P53	1555	0.354	1.480	POS	0.409	1.480	POS	16%
P54	1597	0.065	1.480	POS	0.107	1.480	POS	65%
P55	2039	0.245	1.480	POS	0.294	1.480	POS	20%
P56	3462	0.109	1.480	POS	0.122	1.480	POS	12%
P57	4491	0.129	1.480	POS	0.187	1.480	POS	45%
P58	8147	0.024	1.480	POS	0.043	1.480	POS	79%
P59	11024	0.03	1.480	POS	0.089	1.480	POS	197%
P60	20000	0.015	1.480	POS	0.031	1.480	POS	107%

ELISA Results for Cocaine Negative Hair

	Pre-Treatment		Post-Treatment		Pre to Post
	Number of
Samples Negative
by GC-MS	Number of
Samples Negative
by ELISA	Number of Samples
Negative by GC-MS	Number of Samples
Negative by ELISA	Range of
% change in OD
Shampoo	12	12	12	12	(-8%, +10%)
Brown Dye	12	12	12	12	(-16%, +4%)
Bleach	12	12	12	12	(-9%, +5%)
Perm	12	12	12	12	(-7%, +6%)
Relaxer	12	12	12	12	(-16%, +4%)

Cocaine negative hair remained negative by ELISA post-treatment.

Negative Specimen Individual Results

			Pre-Cosmetic Treatment	Post-Cosmetic Treatment
Treatment	Unique
ID	Cocaine
GC-MS
pg/mg	ELISA
Raw OD	Cal.
OD	ELISA
P/N	ELISA
Raw OD	Cal.
OD	ELISA
P/N	%Change
(ELISA
Raw OD)
	N1	0	2.65	1.562	NEG	2.698	1.562	NEG	2%
	N2	0	2.785	1.562	NEG	2.559	1.562	NEG	-8%
	N3	0	2.828	1.562	NEG	2.928	1.562	NEG	4%
	N4	0	2.767	1.562	NEG	2.85	1.562	NEG	3%
	N5	0	2.795	1.562	NEG	2.767	1.562	NEG	-1%
	N6	0	2.553	1.562	NEG	2.802	1.562	NEG	10%
Shampoo	N7	0	2.5	1.562	NEG	2.64	1.562	NEG	6%
	N8	0	2.837	1.562	NEG	2.763	1.562	NEG	-3%
	N9	0	2.562	1.562	NEG	2.406	1.562	NEG	-6%
	N10	0	2.572	1.562	NEG	2.663	1.562	NEG	4%
	N11	0	2.648	1.562	NEG	2.705	1.562	NEG	2%
	N12	0	2.679	1.562	NEG	2.647	1.562	NEG	-1%
	N13	0	2.703	1.562	NEG	2.471	1.562	NEG	-9%
Brown Dye	N14	0	2.756	1.562	NEG	2.583	1.562	NEG	-6%
	N15	0	2.41	1.562	NEG	2.5	1.562	NEG	4%
	N16	0	2.618	1.562	NEG	2.326	1.562	NEG	-11%
	N17	0	2.678	1.562	NEG	2.57	1.562	NEG	-4%
	N18	0	2.559	1.562	NEG	2.375	1.562	NEG	-7%
	N19	0	2.81	1.562	NEG	2.455	1.562	NEG	-13%
	N20	0	2.94	1.562	NEG	2.468	1.562	NEG	-16%
	N21	0	2.731	1.562	NEG	2.605	1.562	NEG	-5%
	N22	0	2.765	1.562	NEG	2.427	1.562	NEG	-12%
	N23	0	2.772	1.562	NEG	2.515	1.562	NEG	-9%
	N24	0	2.528	1.562	NEG	2.526	1.562	NEG	0%
	Pre-Cosmetic Treatment					Post-Cosmetic Treatment
Treatment	Unique
ID	Cocaine
GC-MS
pg/mg	ELISA
Raw OD	Cal.
OD	ELISA
P/N	ELISA
Raw OD	Cal.
OD	ELISA
P/N	%Change
(ELISA
Raw OD)
	N25	0	2.72	1.562	NEG	2.484	1.562	NEG	-9%
	N26	0	2.487	1.562	NEG	2.611	1.562	NEG	5%
	N27	0	2.568	1.562	NEG	2.512	1.562	NEG	-2%
	N28	0	2.754	1.562	NEG	2.711	1.562	NEG	-2%
	N29	0	2.853	1.562	NEG	2.875	1.562	NEG	1%
Bleach
Blonde	N30	0	2.744	1.562	NEG	2.862	1.562	NEG	4%
	N31	0	2.712	1.562	NEG	2.644	1.562	NEG	-3%
	N32	0	2.911	1.562	NEG	2.785	1.562	NEG	-4%
	N33	0	2.472	1.562	NEG	2.579	1.562	NEG	4%
	N34	0	2.737	1.562	NEG	2.718	1.562	NEG	-1%
	N35	0	2.674	1.562	NEG	2.654	1.562	NEG	-1%
	N36	0	2.709	1.562	NEG	2.775	1.562	NEG	2%
	N37	0	2.469	1.348	NEG	2.327	1.348	NEG	-6%
	N38	0	2.486	1.348	NEG	2.4	1.348	NEG	-3%
	N39	0	2.445	1.348	NEG	2.504	1.348	NEG	2%
	N40	0	2.439	1.348	NEG	2.56	1.348	NEG	5%
	N41	0	2.436	1.348	NEG	2.271	1.348	NEG	-7%
Perm	N42	0	2.574	1.348	NEG	2.519	1.348	NEG	-2%
	N43	0	2.578	1.348	NEG	2.573	1.348	NEG	0%
	N44	0	2.672	1.348	NEG	2.52	1.348	NEG	-6%
	N45	0	2.574	1.348	NEG	2.496	1.348	NEG	-3%
	N46	0	2.452	1.348	NEG	2.303	1.348	NEG	-6%
	N47	0	2.578	1.348	NEG	2.531	1.348	NEG	-2%
	N48	0	2.446	1.348	NEG	2.589	1.348	NEG	6%
	N49	0	2.481	1.348	NEG	2.393	1.348	NEG	-4%
Relaxer	N50	0	2.338	1.348	NEG	2.251	1.348	NEG	-4%
	N51	0	2.543	1.348	NEG	2.3	1.348	NEG	-10%
	N52	0	2.381	1.348	NEG	2.355	1.348	NEG	-1%
N53	0	2.576	1.348	NEG	2.161	1.348	NEG	-16%
N54	0	2.583	1.348	NEG	2.281	1.348	NEG	-12%
N55	0	2.528	1.348	NEG	2.323	1.348	NEG	-8%
N56	0	2.294	1.348	NEG	2.139	1.348	NEG	-7%
N57	0	2.223	1.348	NEG	2.317	1.348	NEG	4%
N58	0	2.365	1.348	NEG	2.248	1.348	NEG	-5%
N59	0	2.475	1.348	NEG	2.228	1.348	NEG	-10%
N60	0	2.359	1.348	NEG	2.396	1.348	NEG	2%

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25

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Quest Diagnostics HAIRCHECK-DT (Cocaine) 510(k) Summary Page 23 of 27

Conclusions

The results of this study agree with the extensive published literature15-24 that the use of various cosmetic hair treatments can potentially reduce the amount of drug and drug metabolites detected in hair specimens. In this study, certain cosmetic treatments did lead to a substantial change in raw optical density values obtained in the ELISA, i.e. - relaxing and bleaching, due to loss of cocaine during the treatment. It is possible that a cosmetic hair treatment could cause a negative hair sample to read positive hair sample to read negative. Bleaching and relaxing had the most significant effect, decreasing the extent of positivity of positive specimens. None of the treatments tested significantly impacted the negative specimens.

Variance in how much drug and/or drug metabolites are incorporated into hair as a result of drug use is dependent upon the characteristics of the donor and hair specimen (e.g. age, texture, shape (thickness), density, melanin content, and segment of hair tested). Analogously, cosmetic treatments may also have a varying degree of effect on the drug concentration measured in hair specimens for the same reasons i.e., the effect of the treatment is impacted by the individual characteristics of each hair specimen (e.g. degree of penetration into the hair, effect on hair structure/matrix). The variability in the effect of cosmetic treatments can be seen in the Percent Change (ELISA OD) column of the tables above with bleaching, dyeing, and relaxing exhibiting the most variable effect on the optical density (i.e. the detected cocaine concentration or how positive the specimen was after treatment). The effect of each cosmetic treatment on negative specimens demonstrated minimal variability between specimens. Additionally, despite the hair specimens being minced and mixed in this study prior to assignment into the Treatment groups, differences in drug concentration between the hair segments, due to inconsistent drug use, cannot be discounted as a contributor to the variability observed between specimens.

4.8 Shelf Life

Shelf life was determined using (3) kits lots on real time stability.

Evaluation Lots used to support 6 month kit shelf life claim

--------------------	----------------------------------------------------------	---------------------------	--------------------------	------------------------------

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| Evaluation lot

4	05/10/2015	11/10/2015	05/27/2015	12/29/2015
Evaluation lot
5	05/09/2015	11/09/2015	05/28/2015	11/30/2015
Evaluation lot
6	05/10/2015	11/10/2015	05/29/2015	12/29/2015

Real Time Stability ELISA – this study was conducted monthly for ~7 months for Evaluation Lot 5, and out to ~8 months for Evaluation lots 4 and 6.

Cutoff calibrator and controls stability validation of cutoff calibrator / controls concentration(s) relative to target is performed every 3 months with 5 replicates via GC-MS. 3 lots of HairCheck Cocaine kits and 3 separate "batches" of cutoff calibrator and low and high controls have been evaluated to 13 months.

Open Vial - Stability was performed for all components including the cutoff calibrator and controls. The microplates were held at room temperature for 4 hours and then returned to 2-8°C and QC was performed 30 days later. For the cutoff calibrator and controls they are stored at -20°C so moved to 2-8°C for 4 hours then returned to -20°C and held for 30 days.

Conclusion

All 3 Stability Validation lots are stable up to ~7 and ~8 months beyond the Date of Manufacture. All 3 lots of calibrator and controls have been tested at the 13 month time point and passed required QC criteria +/-20% of target value. The accelerated stability equivalent for this product is 7.6 months. Real-time stability demonstrated for (3) lots - up to 7 months, establishing the shelf-life at 6 months.

27

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6.0 Standards and Guidance Documents

Design Control Guidance for Medical Device Manufacturers (March 11, 1997)

Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) (January 10, 1997)

Guidance for Industry and FDA Staff. Format for Traditional and Abbreviated 510(k)s (August 12, 2005)

Guidance for Industry and FDA Staff, eCopy Program for Medical Device Submissions (December 3, 2015)

Guidance for Industry and FDA Staff, Refuse to Accept Policy for 501(k)s (August 4, 2015)

Guidance for Industry and FDA Staff, Use of Symbols on Labeling of for In Vitro Diagnostic Devices Intended for Professional Use (November 30, 2004)

Draft Guidance for Industry and FDA Staff, Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests (December 2, 2003) (Withdrawn)

Draft Guidance for Industry And FDA Staff, Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications (November 14, 2000)

7.0 References

1. Bourland, J. A., Hayes, E. F., Kelly, R.C., Sweeney, S.A., and Hatab, M.M., Quantitation of cocaine, benzoylecgonine, cocaethylene, methylecgonine in human hair by positive ion chemical ionization (pici) gas chromatography -tandem mass spectrometry, Journal of Analytical Toxicology Vol 24, No. 7: 489-495, 2000
Sweeney, S. A., Kelly, R. C., Bourland, J. A., Johnson, T., Brown, W. C., Lee, H. and Lewis, E., Amphetamines in 2. hair by enzyme-linked immunosorbent assay, Journal of Analytical Toxicology Vol 22, No. 6: 418-424, 1998
1. Baselt, R.C., and Cravey, R.H., Disposition of Toxic Drugs and Chemicals in Man, Fifth Edition, Chemical Toxicology Institute, Foster City, CA (2000), 676-679
1. Clarke's Isolation and Identification of Drugs, 2nd ed. Moffat A.C., Jackson JV, Moss MS, Widdop B, eds. London: The Pharmaceutical Press. 1986
Analytical Aspects of Drug Testing, Deutsch DG. NEW YORK: Wiley-Interscience, 1989. 5.
Harkey, M.R., Anatomy and physiology of hair, Forensic Science International 63 (1993), 9-18 6.
1. Henderson, G.L., Mechanisms of drug incorporation into hair, Forensic Science International 63 (1993), 19-29
1. Kalasinsky, K.S., Magluilo, J. Jr., and Schaefer, T., Study of Drug Distribution in Hair by Infrared Microscopy Visualization, Journal of Analytical Toxicology Vol 18, October 1994, 337-341
Kintz, P., Tracqui, A., and Mangin. P., Opiate Concentration in Human Head, Axillary, and Pubic Hair, Journal of 9. Forensic Sciences, JFSCA. Vol. 38. No. 3. May 1993, pp. 657-662
1. Sniegoski, L.T., and Welch, M.J., Interlaboratory Studies on the Analysis of Hair for Drugs of Abuse: Results from the fourth Exercise, Journal of Analytical Toxicology Vol 20, July/August 1996, 242-247
1. Kintz, P., Ludes, B., and Mangin, P., Detection of Drugs in Human Hair Using Abbott ADx, with Confirmation by Gas Chromatography/Mass Spectrometry (GC/MS), Journal of Forensic Sciences, JFSCA. Vol. 37. No. 1. Jan 1992. pp 328-331.
1. Kintz, P., Tracqui, A., and Mangin. P., Detection of drugs in human hair for clinical and forensic applications, International Journal of Legal Medicine, (1992) 105:1-4

Page -25

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1. Martinez, F., Poet, T.S., Pillai, R., Erickson, J., Estrada, A.L. and Watson, R.R., Cocaine Metabolite (Benzoylecgonine) in Hair and Urine of Drug Users, , Journal of Analytical Toxicology Vol 17, May/June 1993, 138-142
1. Mieczkowski, T., A research note: the outcome of GC/MS/MS confirmation of hair assays on 93 cannabinoid (+) cases, Forensic Science International 79 (1995), 83-91
1. Welch, M.J., Sniegoski, L.T., Allgood, C.C., Habram, M. (1993) Hair analysis for drugs of abuse-evaluation of analytical methods, environmental issues, and development of reference materials. Journal of Analytical Toxicology, 17, 389-398.
1. Rohrich, J., Zorntlein, J., Pötsch, L., Skopp, G., Becker, J. (2000) Effect of the shampoo Ultra Clean on drug concentrations in human hair. International Journal of Legal Medicine, 113, 102–106.
1. Skopp, G., Pötsch, L., Moeller, M.R. (1997) On cosmetically treated hair-aspects and pitfalls of interpretation. Forensic Science International, 84, 43-52.
1. Takayama, N., Tanaka, S., Kizu, R., Hayakawa, K. (1999) High performance liquid chromatography study on effects of permanent wave, dye and decolorant treatments on methamphetamine in hair. Biomedical Chromatography, 13, 257-314.
1. Pötsch, L., Skopp, G. (1996) Stability of opiates in hair fibers after exposure to cosmetic treatment. Forensic Science International, 81, 95-102.
1. Baeck, S., Han, E., Chung, H., Pyo, M. (2011) Effects of repeated hair washing and a single hair dyeing on concentrations of methamphetamine in human hairs. Forensic Science International, 206, 77– 80.
1. Agius R (2014) Utility of coloured hair for the detection of drugs and alcohol. Drug Test Anal. 6 Suppl 1:110-119.
1. Martins, L.F., Yegles, M., Thieme, D., Wennig, R. (2008) Influence of bleaching on the enatiomeric disposition of amphetamine-type stimulants in hair. Forensic Science International, 176, 38–41.
1. Pritchett JS, Phinney KW (2015). Influence of chemical straightening on the stability of drugs of abuse in hair. J Anal Toxicol. 39:13-16.
1. Jurado C, Kintz P, Menéndez M, Repetto M. (1997) "Influence of the cosmetic treatment of hair on drug testing." Int J Legal Med. 110 (3):159-63

7.0 Conclusion

The modified subject device Quest Diagnostics HairCheck-DT (Cocaine) assay submission number K152232 is substantially equivalent to the predicate device Quest Diagnostics HairCheck-DT (Cocaine) assay submission number K023626

29

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