Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic immunoassay (ELISA) for detecting cocaine in hair, followed by GC/MS confirmation. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies. The performance studies focus on traditional analytical validation metrics like precision, agreement with a reference method, cross-reactivity, and stability.

Therapeutic

No.
This device is an in vitro diagnostic test for detecting cocaine and its metabolites in hair, not for treating a disease or condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is an in vitro diagnostic test." This directly identifies the device as diagnostic.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic test that involves the physical analysis of hair samples using an ELISA protocol, which is a laboratory-based assay requiring physical reagents and equipment. It is not solely software.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is an in vitro diagnostic test..."

This statement directly identifies the device as an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is an in vitro diagnostic test that is intended for the qualitative detection of Cocaine at or above 500 pg/mg in human head and body hair. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.
This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

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

DIO

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human head and body hair.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

single laboratory 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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

PRECISION:
Intra-assay precision studies: 11 replicates of negative head hair samples spiked to 8 concentrations of cocaine (zero drug, -75%, -50%, -25% below the cutoff, and +25%, +50%, +75% and +100% above the cutoff). All samples were treated and analyzed in the same manner as donor hair samples and measured in one run. Head hair was used. Result: All samples tested negative below cutoff and positive at or above cutoff.
Inter-assay precision studies: Negative head hair samples spiked to 8 concentrations of cocaine (zero drug, -75%, -50%, -25% below the cutoff, and +25%, +75% and +100% above the cutoff). Eleven replicates prepared and analyzed over 20 non-consecutive runs. Precision was acceptable if %CV was less than 15%.
Result: All 220 replicates for each concentration were either negative below cutoff or positive at or above cutoff.

AGREEMENT:
The method comparison was performed by testing 424 hair samples in three studies with the candidate assay and comparing to the reference method, GC/MS. Each specimen was divided into two aliquots and one was used for screening and the other for GC/MS confirmation. Testing was performed on body and head hair samples from different ages, gender, ethnicities and hair color.

Results:
ELISA Test Result: Positive | GC/MS Negative (750 pg/mg): 210
ELISA Test Result: Negative | GC/MS Negative (750 pg/mg): 0

CROSSREACTIVITY:
The Crossreactivity Study demonstrated that the presence of the structurally similar compounds Anhydroecgonine methyl ester, Benzoylecgonine isopropyl ester, Meta-Hydroxybenzoylecgonine, Cocaine, Cocaethylene, Ecgonine, Ecgonine methyl ester, Norbenzoylecgonine, Norcocaine, and Norcocaethylene may contribute to a Cocaine positive ELISA result when utilizing this protocol. Since a GC/MS confirmation is performed on all presumptive positive screening results, these compounds will not confirm as a positive result report. None of the other compounds studied demonstrated any interference with the protocol. Head hair was used in this study.

Effect of Interfering Compounds:
A variety of structurally related and unrelated compounds were tested for interference at 10000ng/ml (400000pd/mg) in the Omeda Laboratories, Inc. ELISA Cocaine Screening Protocol. Negative hair extracts were spiked with Cocaine at -50% (250pg/mg), +125% (625pd/mg) and +150% (750pg/mg) of the Cocaine Cutoff Concentration (500pg/mg). These were then additionally spiked with 10000ng/ml (40000pg/mg) of the structurally related compounds unless otherwise noted. The absorbances were compared to the 500 pg/mg Cocaine cutoff control (CO). Only those compounds that were structurally cross reactive interfered in the assay. These structurally related compounds produced a positive response due to significant cross-reactivity. Compounds tested that were not structurally cross-reactive did not interfere with the assay at any of the tested concentrations. No tested samples produced a negative result when expected to be positive. The analysis was performed in triplicate. Head hair was used for this study.

CALIBRATOR AND CONTROL:
The Omega Laboratories, Inc. ELISA Cocaine Screening Protocol utilizes in-house prepared calibrator and control solutions. This study successfully demonstrated the validation and stability of these solutions and the traceability to NIST standards. Head hair was used in this study.

STABILITY:
The Stability Study demonstrated that the mean variance on the concentration of combined cocaine+ cocaine metabolites in 50 head hair samples when stored for an extended period of approximately 2 years was -23%. Additionally, the largest decrease and increase for combined cocaine metabolites was -46% and 17%, respectively. The general trend of decreasing cocaine and increasing benzovlecgonine may be consistent with non-enzymatic hydrolysis of cocaine to benzoylecgonine. Head hair was used in this study.

SHIPPING:
A total of 200 hair samples were use in the study; 100 positive samples and 100 negative samples. Head hair was used in this study. The Shipping Study demonstrated that there was no adverse effect on head hair samples that would affect the screening assay when samples are exposed to extreme temperatures and variations in humidity that might occur during sample transport. The average percent change in Positive Cocaine sample GC/MS results prior to shipping and after shipping was +5% for all locations combined. Additionally, there were no discordant results pre- and post-shipping (as confirmed by GC/MS).

COSMETIC TREATMENT:
Sixty six hair specimens previously determined to be negative for cocaine were obtained and the ethnic origin, hair color and curvature were documented. One hundred and ten hair specimens potentially positive for cocaine were obtained and the ethnic origin, hair color and curvature were documented. Each specimen was divided into 2 aliquots. One aliquot was analyzed by the ELISA protocol and by the GC/MS confirmation method. Of the 176 treated specimens, four initially POSITIVE ELISA assays (one bleach and three permanent) reported NEG ELISA results after treatment.

ENVIRONMENTAL CONTAMINATION:
Preliminary positive hair sample results by the screening method could be due to environmental contamination. All positive samples should be sent for confirmation testing on a reference method to distinguish between true positives and those samples that were positive due to external exposure. Head hair was used for this study.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found (Specific performance metrics like sensitivity, specificity for the agreement study are not explicitly provided, only raw counts).

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.

Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (K112808)

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

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

0

Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 1 of 22

i

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

510(k) Number:	K131128
Date of Summary:	Nov. 8, 2013
Applicant:	William R. Corl
Chief Executive Officer
Omega Laboratories, Inc.
400 North Cleveland
Mogadore, OH 44260
Tel: 330-628-5748
Fax: 330-628-5803

NOV 1 3 2013

Correspondent:
Name:	ROBERT J BARD, JD, CQE, RAC
Address:	Omega Laboratories
400 North Cleveland, Mogadore, OH 44260
Phone Number:	248-573-5040
E-mail	rbard@reglaw.net
Product Name:
Trade Name:	Omega Laboratories Hair Drug Screening Assay for Cocaine and
Cocaine Metabolites
Common Name:	Hair Drug Screening Assay Cocaine and Cocaine Metabolites
Regulation Number:	CFR 862.3250 (ProCode DIO)
Classification Name:	Cocaine and cocaine metabolite test system
Classification Panel:	91 (Toxicology)
Predicate Device:	Omega Laboratories Hair Drug Screening Assay for Cocaine and
Cocaine Metabolites (K112808);
Indication for Use:	The Omega Laboratories Hair Drug Screening Assay for Cocaine and
Cocaine Metabolites (Cocaine) is an in vitro diagnostic test that is
intended for the qualitative detection of Cocaine at or above 500 pg/mg
in human head and body hair. To confirm a screen positive result, a
more specific alternate chemical method, such as Gas
Chromatography/Mass Spectrometry (GC/MS) operating in the selected
ion monitoring (SIM) mode is the preferred method with deuterated
internal standards. Professional judgment should be applied to any
drug of abuse test result, particularly when presumptive positive results
are obtained.
This test is intended exclusively for single laboratory use only and is not
intended for sale to anyone.

1

Page 2 of 22

| Comparison: | When used to qualitatively detect Cocaine and Cocaine Metabolites in
head hair specimens collected with the Omega Specimen Collection
Device, the Omega assays yield results in substantial agreement with
the predicate device (see Table 1 below). |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Performance
Data: | All performance studies demonstrated that the Omega assay is in
substantial agreement with the predicate products.
Results obtained from donor specimens showed that the qualitative
results from the new assays are substantially equivalent to those
obtained from the predicate devices. |

| Comparison
Element -
Similarities | Hair Drug Screening Assay for Cocaine.
(Subject devices) | Hair Drug Screening Assay (Cocaine).
(Predicate device) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Laboratory | Omega Laboratories, Inc. | Same. |
| Indication for/
Intended Use | The Omega Laboratories Hair Drug
Screening Assay for Cocaine and Cocaine
Metabolites (Cocaine) is an in vitro
diagnostic test that is intended for the
qualitative detection of Cocaine at or
above 500 pg/mg in human head and body
hair. To confirm a screen positive result, a
more specific alternate chemical method,
such as Gas Chromatography/Mass
Spectrometry (GC/MS) operating in the
selected ion monitoring (SIM) mode is the
preferred method with deuterated internal
standards. Professional judgment should
be applied to any drug of abuse test result,
particularly when presumptive positive
results are obtained.
This test is intended exclusively for single
laboratory use only and is not intended for
sale to anyone. | Same. |
| Method of
Measurement | Microplate reader. Read at 450 nm | Same. |
| Matrix | Head and body hair | Head hair |
| Cutoff
concentration | 500 pg Cocaine /mg hair | Same. |
| Assay Principal | ELISA | Same. |

Table 1: Comparison of Omega Laboratories Cocaine Assay vs Omega Laboratories Cocaine Assay

2

| Comparison
Element -
Similarities | Hair Drug Screening Assay for Cocaine.
(Subject devices) | Hair Drug Screening Assay (Cocaine).
(Predicate device) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Extraction
Method | Utilized acid-methanol vs methanol alone
to facilitate extraction of Cocaine from hair.
Proprietary and patent pending method of
pulverizing hair vs cutting the hair into
small segments prior to acid-methanol
extraction. This improved extraction times
without loss of efficiency | Same. |

Table 1: Comparison of Omega Laboratories Cocaine Assay vs Omega Laboratories Cocaine Assay
---------------------------------------------------------------------------------------------

Performance Studies

PRECISION : Intra-assay precision studies were performed using 11 replicates of negative head hair samples spiked to the following concentrations of cocaine: zero drug, -75%, -50%, -25% below the cutoff, and +25%, +50%, +75% and+100% above the cutoff. All samples were treated and analyzed in the same manner as donor hair samples and measured in one run. Head hair was used in this study.

Positive |
|---------|---------------------------------------|-------------------------|-----------------------|--------------------------|
| Cocaine | 0 (Negative) | 11 | 11 | 0 |
| Cocaine | 125 (-75%) | 11 | 11 | 0 |
| Cocaine | 250 (-50%) | 11 | 11 | 0 |
| Cocaine | 375 (-25%) | 11 | 11 | 0 |
| Cocaine | 625 (+25%) | 11 | 0 | 11 |
| Cocaine | 750 (+50%) | 11 | 0 | 11 |
| Cocaine | 875 (+75%) | 11 | 0 | 11 |
| Cocaine | 1000 (+100%) | 11 | 0 | 11 |

Table 2: Intra-Assay Cocaine Precision Studies (11 replicates/8 concentrations n= 88)

Inter-assay precision studies were performed using negative head hair samples spiked to the following concentrations of cocaine: zero drug, -75%, -50%, -25% below the cutoff, and +25%, +75% and+100% above the cutoff. All samples were treated and analyzed in the same manner as donor hair samples. Eleven replicates of these were prepared and analyzed over 20 non-consecutive. The precision of the assay was deemed to be acceptable if the %CV was less than 15%.

3

| Drug | Concentration of
Sample (pg/mg) | Number of
Replicates | Results #
Negative | Results #
Positive |
|---------|------------------------------------|-------------------------|-----------------------|-----------------------|
| Cocaine | 0 (Negative) | 220 | 220 | 0 |
| Cocaine | 125 (-75%) | 220 | 220 | 0 |
| Cocaine | 250 (-50%) | 220 | 220 | 0 |
| Cocaine | 375 (-25%) | 220 | 220 | 0 |
| Cocaine | 625 (+25%) | 220 | 0 | 220 |
| Cocaine | 750 (+50%) | 220 | 0 | 220 |
| Cocaine | 875 (+75%) | 220 | 0 | 220 |
| Cocaine | 1000 (+100%) | 220 | 0 | 220 |

Table 3: Inter-Assay Cocaine Precision Studies (CO=500 pg/mg) (11 replicates/8 concentrations over 20 n= 1760)

AGREEMENT: The method comparison was performed by testing 424 hair samples in three studies with the candidate assay and comparing to the reference method, GC/MS. Each specimen was divided into two aliquots and one was used for screening and the other for GC/MS confirmation. Testing was performed on body and head hair samples from different ages, gender, ethnicities and hair color. The results were:

Table 4a: Cocaine Agreement Studies (n=424)

| ELISA Test
Result | GC/MS Negative
(750 pg/mg) |
|----------------------|-------------------------------|--------------------------------|------------------------------------|------------------------------------|--------------------------------|
| Positive | 0 | 0 | 31 | 24 | 210 |
| Negative | 122 | 3 | 34 | 0 | 0 |

Table 4b: GC/MS Summary of Discordant Results

'

| Screening
Cutoff
(pg/mg) | ELISA Test Result
(POS/NEG) | Drug | | (pg/mg) |
|--------------------------------|---- | | | 500 | POS | 500 | POS | Screening
Cutoff
(pg/mg) | ELISA Test Result
(POS/NEG) | Drug | | (pg/mg) |
| | | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | Screening
Cutoff
(pg/mg) | ELISA Test Result
(POS/NEG) | Drug | | (pg/mg) |
| | | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | 500 | POS | GC/MS Drug Result
----------------------------|---------|------------------|--------------|------------------------------|
| Cocaine | Benzoylecogonine | Cocaethylene | |
| 189 | 83 | 0 | 272 |
| 227 | 44 | 0 | 271 |
| GC/MS Drug Result
| Cocaine | Benzoylecogonine | Cocaethylene | |
| 273 | 0 | 0 | 273 |
| 219 | 87 | 0 | 306 |
| 251 | 50 | 0 | 301 |
| 260 | 50 | 0 | 310 |
| 230 | 87 | 0 | 317 |
| 278 | 48 | 0 | 326 |
| 272 | 65 | 0 | 337 |
| 334 | 0 | 0 | 334 |
| 238 | 116 | 0 | 354 |
| 342 | 0 | 0 | 342 |
| 313 | 43 | 0 | 356 |
| 335 | 28 | 0 | 363 |
| 284 | 106 | 0 | 390 |
| 294 | 103 | 0 | 397 |
| 354 | 47 | 0 | 401 |
| 333 | 79 | 0 | 412 |
| 364 | 54 | 0 | 418 |
| 328 | 98 | 0 | 426 |
| 265 | 118 | 65 | 448 |
| 424 | 37 | 0 | 461 |
| 393 | 77 | 0 | 470 |
| 390 | 85 | 0 | 475 |
| GC/MS Drug Result
| Cocaine | Benzoylecogonine | Cocaethylene | |
| 433 | 42 | 0 | 475 |
| 469 | 0 | 0 | 469 |
| 444 | 32 | 0 | 476 |
| 336 | 32 | 94 | 462 |
| 491 | 0 | 0 | 491 |
| 453 | 46 | 0 | 499 |
| 497 | 0 | 0 | 497 |

4

Table 4b: GC/MS Summary of Discordant Results

5

Table 4b: GC/MS Summary of Discordant Results

CROSSREACTIVITY: The Crossreactivity Study demonstrated that the presence of the structurally similar compounds Anhydroecgonine methyl ester, Benzoylecgonine isopropyl ester, Meta-Hydroxybenzoylecgonine, Cocaine, Cocaethylene, Ecgonine, Ecgonine methyl ester, Norbenzoylecgonine, Norcocaine, and Norcocaethylene may contribute to a Cocaine positive ELISA result when utilizing this protocol. Since a GC/MS confirmation is performed on all presumptive positive screening results, these compounds will not confirm as a positive result report. None of the other compounds studied demonstrated any interference with the protocol. Head hair was used in this study.

Table 5a: Cross reactivity of Omega Laboratories, Inc. Cocaine ELISA with Structurally Similar Compounds

| Compound | Approximate Concentration
of Compound (pg/mg)
Equivalent to 500pg/mg
Cocaine Cutoff Control | Percent Crossreactivity (%) |
|------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------|
| | (n=3) | |
| Benzoylecgonine isopropyl
ester | 300 | 166.7 |
| Cocaethylene | 375 | 133.3 |
| Cocaine | 500 | 100.0 |
| Benzoylecgonine | 600 | 83.3 |
| Meta-Hydroxybenzoylecgonine | 700 | 71.4 |
| Ecgonine | 80000 | 0.6 |
| Norbenzoylecgonine | 150000 | 0.3 |

6

Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 7 of 22

| Compound | Approximate Concentration
of Compound (pg/mg)
Equivalent to 500pg/mg
Cocaine Cutoff Control | Percent Crossreactivity (%) |
|------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------|
| | (n=3) | |
| Norcocaine | 250000 | 0.2 |
| Norcocaethylene | 250000 | 0.2 |
| Ecgonine methyl ester | 105000 | 0.48 |
| Anhydroecgonine methyl ester | 250000 | 0.2 |
| Anhydroecgonine | Not achieved at highest spike concentration.
4000000 pg/mg | |
| Atropine | Not achieved at highest spike concentration.
4000000 pg/mg | |

Table 5a: Cross reactivity of Omega Laboratories, Inc. Cocaine ELISA with Structurally Similar Compounds

Although the percent cross-reactivity for Ecognine. Norcocaine. Norcocaine, Norcocaine, Norcocaethylene, Econine methyl ester and Anhydroecgonine methyl ester could be considered "low", they have been validated and are sufficiently high enough to produce a "positive" result at these testing concentrations. With the levels of cross-reactivity presented in the table above, these compounds demonstrate positive interference at -50%, +125% and +150% of the cut-off. To demonstrate that these drugs are sufficiently cross-reactive, the table below mathematically re-expresses the percent cross-reactivities as cocaine equivalent concentrations at -50% of the cut-off (250 pg/mg), using Anhydroecgonine methyl ester as an example. This was accomplished by multiplying the (Observed Cross-reactivity) by the (Tested Concentration pg/mg) and adding the 250 pg/mg cocaine present in the sample at -50% of the cut-off.

Example: Anhydroecgonine methyl ester spiked at 400,000 pg/mg into -50% of the cut-off cocaine control sample.

For this calculation we used 0.2% for the Anhydroecqonine methyl ester percent cross-reactivity.

(0.2/100) X (400,000 pg/mg tested concentration) = 800 pg/mg cocaine equivalents.

800 pg/mg cocaine equivalents + 250 pg/mg Cocaine present at -50% of the cutoff = 1050 pg/mg combined equivalent cocaine concentration.

This observed concentration is greater than the 500 pg/mg cocaine cutoff control. Similar calculations can be made for +125% and 150% of the cut-off.

7

Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 8 of 22

Effect of Interfering Compounds: A variety of structurally related and unrelated compounds were tested for interference at 10000ng/ml (400000pd/mg) in the Omeda Laboratories, Inc. ELISA Cocaine Screening Protocol. Negative hair extracts were spiked with Cocaine at -50% (250pg/mg), +125% (625pd/mg) and +150% (750pg/mg) of the Cocaine Cutoff Concentration (500pg/mg). These were then additionally spiked with 10000ng/ml (40000pg/mg) of the structurally related compounds unless otherwise noted. The absorbances were compared to the 500 pg/mg Cocaine cutoff control (CO). Only those compounds that were structurally cross reactive interfered in the assay. These structurally related compounds produced a positive response due to significant cross-reactivity. Compounds tested that were not structurally cross-reactive did not interfere with the assay at any of the tested concentrations. No tested samples produced a negative result when expected to be positive. The analysis was performed in triplicate. Head hair was used for this study.

| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------|
| (-) 11-nor-9-carboxy-delta8-
Tetrahydrocannabinol | NEG | POS | POS |
| (-) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | NEG | POS | POS |
| R (-) Amphetamine | NEG | POS | POS |
| (-) Cotinine | NEG | POS | POS |
| (-) Cotinine -N-oxide | NEG | POS | POS |
| (-) Isoproterenol | NEG | POS | POS |
| (-) Methamphetamine | NEG | POS | POS |
| (-) Nicotine | NEG | POS | POS |
| (-) Phenylephrine | NEG | POS | POS |
| (-)-Alpha-methadol | NEG | POS | POS |
| (+) Amphetamine | NEG | POS | POS |
| (+) Isoproterenol | NEG | POS | POS |
| (+) Methamphetamine | NEG | POS | POS |
| (+) Pseudoephedrine | NEG | POS | POS |
| (+/-) 11-nor-9-carboxy-delta9-
Tetrahydrocannabinol | NEG | POS | POS |
| (+/-) 2,5-Dimethoxy- 4- | NEG | POS | POS |
| Inc. Cocaine ELISA Assay | | | |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| bromoamphetamine | | | |
| (+/-) Alphaprodine | NEG | POS | POS |
| (+/-) Ketamine | NEG | POS | POS |
| (+/-) MBDB | NEG | POS | POS |
| (+/-) MDA | NEG | POS | POS |
| (+/-) MDEA | NEG | POS | POS |
| (+/-) MDMA | NEG | POS | POS |
| (+/-) Metanephrine | NEG | POS | POS |
| (+/-) Metoprolol | NEG | POS | POS |
| (+/-) Norcotinine | NEG | POS | POS |
| (+/-) Propanolol | NEG | POS | POS |
| (+/-) Trans-3'-Hydroxycotinine | NEG | POS | POS |
| 11-Hydroxy-delta9-
Tetrahydrocannabinol | NEG | POS | POS |
| 19-Nortestosterone
(Nandrolone) | NEG | POS | POS |
| 1R,2S (-) Ephedrine | NEG | POS | POS |
| 1S,2R (+) Ephedrine | NEG | POS | POS |
| 2-Oxo-3-hydroxy-LSD | NEG | POS | POS |
| 3-methoxynaltrexone | NEG | POS | POS |
| 3-Trans-Hydroxy-norcotinine | NEG | POS | POS |
| 4-Acetoamidophenol | NEG | POS | POS |
| 4-Hydroxy-Phencyclidine | NEG | POS | POS |
| 5,5-Diphenylhydantoin | NEG | POS | POS |
| Inc. Cocaine ELISA Assay | | | |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| 6-Acetyl-codeine | NEG | POS | POS |
| 6-Monoacetylmorphine | NEG | POS | POS |
| 7-Aminoclonazepam | NEG | POS | POS |
| 7-Aminonitrazepam | NEG | POS | POS |
| Acebutolol | NEG | POS | POS |
| Acetophenetidin | NEG | POS | POS |
| Acetopromazine | NEG | POS | POS |
| Acetylsalicyclic acid | NEG | POS | POS |
| Alfentanil | NEG | POS | POS |
| Alpha-Ergocryptine | NEG | POS | POS |
| Alprazolam | NEG | POS | POS |
| 7-Aminoflunitrazepam | NEG | POS | POS |
| Aminorex | NEG | POS | POS |
| Amitriptyline | NEG | POS | POS |
| Amobarbital | NEG | POS | POS |
| Amoxicillin | NEG | POS | POS |
| Anhydroecgonine | NEG | POS | POS |
| Anhydroecgonine methyl ester | POS | POS | POS |
| Anileridine | NEG | POS | POS |
| Apomorphine | NEG | POS | POS |
| Atenolol | NEG | POS | POS |
| Atropine | NEG | POS | POS |
| Azaperone | NEG | POS | POS |
| | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | | |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Benzoylecgonine | POS | POS | POS |
| Benzoylecgonine isopropyl
ester | POS | POS | POS |
| Betamethasone | NEG | POS | POS |
| Boldenone | NEG | POS | POS |
| Bumetanide | NEG | POS | POS |
| Bupivicaine | NEG | POS | POS |
| Buprenorphine | NEG | POS | POS |
| Buspirone | NEG | POS | POS |
| Butabarbital | NEG | POS | POS |
| Butalbital | NEG | POS | POS |
| Caffeine | NEG | POS | POS |
| Cannabidiol | NEG | POS | POS |
| Cannabinol | NEG | POS | POS |
| Carbamazepine | NEG | POS | POS |
| Carisoprodol | NEG | POS | POS |
| Chlordiazepoxide | NEG | POS | POS |
| Chlorpromazine | NEG | POS | POS |
| Cimeterol | NEG | POS | POS |
| Clenbuterol | NEG | POS | POS |
| Clomipramine | NEG | POS | POS |
| Clonazepam | NEG | POS | POS |
| Clonidine | NEG | POS | POS |
| Inc. Cocaine ELISA Assay | | | |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Clozapine | NEG | POS | POS |
| Cocaethylene | POS | POS | POS |
| Cocaine | POS | POS | POS |
| Codeine | NEG | POS | POS |
| Corticosterone | NEG | POS | POS |
| Cortisone | NEG | POS | POS |
| Cotinine-N-beta-D-
Glucuronide | NEG | POS | POS |
| Cyclobenzaprine | NEG | POS | POS |
| d,I-N-Desmethylvenlafaxine | NEG | POS | POS |
| Delta8-Tetrahydrocannabinol | NEG | POS | POS |
| Delta9-Tetrahydrocannabinol | NEG | POS | POS |
| Deoxycorticosterone | NEG | POS | POS |
| Desalkyiflurazepam | NEG | POS | POS |
| Desipramine | NEG | POS | POS |
| Desmethyldoxepin (cis/trans) | NEG | POS | POS |
| Despropionyl-fentanyl | NEG | POS | POS |
| Dexamethasone | NEG | POS | POS |
| Dextromethorphan | NEG | POS | POS |
| Diazepam | NEG | POS | POS |
| Dibucaine | NEG | POS | POS |
| Dihydrocodeine | NEG | POS | POS |
| Dihydroergotamine | NEG | POS | POS |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Dihydromorphine | NEG | POS | POS |
| Diphenhydramine | NEG | POS | POS |
| Diphenoxylate | NEG | POS | POS |
| Diprenorphine | NEG | POS | POS |
| Dothiepin (cis/trans) | NEG | POS | POS |
| Doxepin | NEG | POS | POS |
| Doxylamine | NEG | POS | POS |
| Droperidol | NEG | POS | POS |
| Ecgonine | POS | POS | POS |
| Ecgonine methyl ester | POS | POS | POS |
| EDDP | NEG | POS | POS |
| Effexor (Venlafaxine) | NEG | POS | POS |
| EMDP | NEG | POS | POS |
| Ergonovine | NEG | POS | POS |
| Erythromycin | NEG | POS | POS |
| Estazolam | NEG | POS | POS |
| Ethacrynic acid | NEG | POS | POS |
| Ethopropazine | NEG | POS | POS |
| Ethylmorphine | NEG | POS | POS |
| Fenfluramine | NEG | POS | POS |
| Fentanyl | NEG | POS | POS |
| Flumethasone | NEG | POS | POS |
| Flunitrazepam | NEG | POS | POS |
| Inc. Cocaine ELISA Assay | | | |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Fluphenazine | NEG | POS | POS |
| Flurazepam | NEG | POS | POS |
| Furosemide | NEG | POS | POS |
| Gentamicin | NEG | POS | POS |
| Gluthimide | NEG | POS | POS |
| Haloperidol | NEG | POS | POS |
| Heroin | NEG | POS | POS |
| Hexobarbital | NEG | POS | POS |
| HMMA | NEG | POS | POS |
| Hydrochlorothiazide | NEG | POS | POS |
| Hydrocodone | NEG | POS | POS |
| Hydrocortisone | NEG | POS | POS |
| Hydromorphone | NEG | POS | POS |
| (+/-) 4-Hydroxyephedrine | NEG | POS | POS |
| Hydroxymethamphetamine | NEG | POS | POS |
| Ibogaine | NEG | POS | POS |
| Ibuprofen | NEG | POS | POS |
| Imipramine | NEG | POS | POS |
| Ketoprofen | NEG | POS | POS |
| LAAM | NEG | POS | POS |
| Labetalol | NEG | POS | POS |
| LAMPA (1000ng/ml) | NEG | POS | POS |
| Levorphanol | NEG | POS | POS |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| L-Hyoscyamine | NEG | POS | POS |
| Lidocaine | NEG | POS | POS |
| Lorazepam | NEG | POS | POS |
| LSD | NEG | POS | POS |
| Lysergic acid | NEG | POS | POS |
| Lysergol | NEG | POS | POS |
| Maprotiline | NEG | POS | POS |
| Meperidine | NEG | POS | POS |
| Mephentermine | NEG | POS | POS |
| Mepivacaine | NEG | POS | POS |
| Metaphit | NEG | POS | POS |
| Metaproterenol | NEG | POS | POS |
| Metaraminol | NEG | POS | POS |
| Methadone | NEG | POS | POS |
| Methohexital | NEG | POS | POS |
| Methoxyphenamine | NEG | POS | POS |
| Methylergonovine | NEG | POS | POS |
| Methylphenidate | NEG | POS | POS |
| m-Hydroxybenzoylecgonine | POS | POS | POS |
| Mianserin | NEG | POS | POS |
| Midazolam | NEG | POS | POS |
| Monensin | NEG | POS | POS |
| Morphine | NEG | POS | POS |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Morphine-3-betaglucuronide | NEG | POS | POS |
| Morphine-6-betaglucuronide | NEG | POS | POS |
| Nadolol | NEG | POS | POS |
| Nalmefene | NEG | POS | POS |
| Nalorphine | NEG | POS | POS |
| Naloxone-3-beta-D-
glucuronide | NEG | POS | POS |
| Naltrexone | NEG | POS | POS |
| Naltriben | NEG | POS | POS |
| Naproxen | NEG | POS | POS |
| N-Desmethylclomipramine | NEG | POS | POS |
| N-Desmethylflunitrazepam | NEG | POS | POS |
| N-Desmethyltramadol | NEG | POS | POS |
| N-Desmethyltrimipramine | NEG | POS | POS |
| Neomycin | NEG | POS | POS |
| Nitrazepam | NEG | POS | POS |
| Norbenzoylecgonine | POS | POS | POS |
| Norbuprenorphine | NEG | POS | POS |
| Norcocaethylene | POS | POS | POS |
| Norcocaine | POS | POS | POS |
| Norcodeine | NEG | POS | POS |
| Nordiazepam | NEG | POS | POS |
| Norfentanyl | NEG | POS | POS |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Nor-LAAM | NEG | POS | POS |
| Nor-LSD/Nor-ISO-LSD | NEG | POS | POS |
| Normeperidine | NEG | POS | POS |
| Normeperidinic acid | NEG | POS | POS |
| Normorphine | NEG | POS | POS |
| Noroxycodone | NEG | POS | POS |
| Noroxymorphone | NEG | POS | POS |
| Norpropoxyphene | NEG | POS | POS |
| Nortriptyline | NEG | POS | POS |
| Noscapine | NEG | POS | POS |
| O-Desmethyltramadol | NEG | POS | POS |
| Oxazepam | NEG | POS | POS |
| Oxprenolol | NEG | POS | POS |
| Oxycodone | NEG | POS | POS |
| Oxymorphone | NEG | POS | POS |
| p-Acetamidophenyl-beta-D-
glucuronide | NEG | POS | POS |
| Papaverine | NEG | POS | POS |
| Pemoline | NEG | POS | POS |
| Penicillin G | NEG | POS | POS |
| Pentazocine | NEG | POS | POS |
| Pentobarbital | NEG | POS | POS |
| Perphenazine | NEG | POS | POS |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Phendimetrazine | NEG | POS | POS |
| Phenelzine | NEG | POS | POS |
| Phenobarbital | NEG | POS | POS |
| Phenothiazine | NEG | POS | POS |
| Phentermine | NEG | POS | POS |
| Phenylbutazone | NEG | POS | POS |
| Phenylethyamine | NEG | POS | POS |
| Phenylpropanolamine | NEG | POS | POS |
| Phencyclidine | NEG | POS | POS |
| R,R (-)-Pseudoephedrine | NEG | POS | POS |
| Phencyclidine Morpholine | NEG | POS | POS |
| PMA | NEG | POS | POS |
| PMMA | NEG | POS | POS |
| Prednisolone | NEG | POS | POS |
| Prilocaine | NEG | POS | POS |
| Prochlorperazine | NEG | POS | POS |
| Progesterone | NEG | POS | POS |
| Promazine | NEG | POS | POS |
| Promethazine | NEG | POS | POS |
| Propiomazine | NEG | POS | POS |
| Propionylpromazine | NEG | POS | POS |
| Propoxyphene | NEG | POS | POS |
| Protriptyline | NEG | POS | POS |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Quinidine | NEG | POS | POS |
| R (+) Methcathinone | NEG | POS | POS |
| R (-) Epinephrine | NEG | POS | POS |
| R (+) Cathinone | NEG | POS | POS |
| Salbutamol | NEG | POS | POS |
| Secobarbital | NEG | POS | POS |
| Sertraline | NEG | POS | POS |
| Stanazaloi | NEG | POS | POS |
| Streptomycin | NEG | POS | POS |
| Sulfadimethoxine | NEG | POS | POS |
| Sulfamethazine | NEG | POS | POS |
| Sulfathiazole | NEG | POS | POS |
| Temazepam | NEG | POS | POS |
| Terbutaline | NEG | POS | POS |
| Tetracycline | NEG | POS | POS |
| Thebaine | NEG | POS | POS |
| Theophylline | NEG | POS | POS |
| Thioridazine | NEG | POS | POS |
| Tramadol | NEG | POS | POS |
| Triamcinolone | NEG | POS | POS |
| Triazolam | NEG | POS | POS |
| Trifluoperazine | NEG | POS | POS |
| Trifluopromazine | NEG | POS | POS |
| Compound | -50% CO
(250pg/mg) | +125% CO
(625pg/mg) | +150% CO
(750pg/mg) |
| Trimeprazine | NEG | POS | POS |
| Trimipramine | NEG | POS | POS |
| Tylosin | NEG | POS | POS |
| Tyramine | NEG | POS | POS |
| Yohimbic acid | NEG | POS | POS |
| Yohimbine | NEG | POS | POS |
| Zolpidem | NEG | POS | POS |
| Zopiclone | NEG | POS | POS |

Table 5b: Interferences of Structurally Related and Unrelated Compounds on the Omega Laboratories, Inc. Cocaine ELISA Assay

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9

10

11

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Omega Laboratories, Inc.
Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 13 of 22

13

14

15

16

17

、

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Table 5b: Interferences of Structurally Related and Unrelated Compounds on the Omega Laboratories. Inc. Cocaine ELISA Assay

CALIBRATOR AND CONTROL: The Omega Laboratories, Inc. ELISA Cocaine Screening Protocol utilizes in-house prepared calibrator and control solutions. This study successfully demonstrated the validation and stability of these solutions and the traceability to NIST standards.

While the typical urine drugs of abuse controls challenge the cutoff calibrator with concentrations of ± 25% of the cutoff calibrator in nanograms, the hair testing industry utilizes -50% and +100% in picograms. Example -25% of a nanogram is larger than -50% of a picogram. Head hair was used in this study.

STABILITY: The Stability Study demonstrated that the mean variance on the concentration of combined cocaine+ cocaine metabolites in 50 head hair samples when stored for an extended period of approximately 2 years was -23%.

Additionally, the largest decrease and increase for combined cocaine metabolites was -46% and 17%, respectively. The general trend of decreasing cocaine and increasing benzovlecgonine may be consistent with non-enzymatic hydrolysis of cocaine to benzoylecgonine. Head hair was used in this study.

Study Observation	Cocaine	Benzoylecgonine	Norcocaine	Cocaethylene
Average
Concentration
(pg/mg)	5123	1262	287	438
Mean Change in %	-23	5	5	2
Range in
Concentration	369 - 35666	36 - 9499	39 - 1963	24 - 2101

Table 6: Cocaine Stability Study Summary of Results

20

Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 21 of 22

Study Observation	Cocaine	Benzoylecgonine	Norcocaine	Cocaethylene
(pg/mg)
% Max and Min
decrease	-50% and -5%	-47% and -2%	-30% and -0.4%	-41% and 0%
% Max and Min
increase	18% and 4%	59% and 1%	47% and 2%	135% and 0%
Number that
decreased in
concentration	45	18	16	17
Number that
increased in
concentration	5	32	20	16

SHIPPING: A total of 200 hair samples were use in the study; 100 positive samples and 100 negative samples. Head hair was used in this study.

The Shipping Study demonstrated that there was no adverse effect on head hair samples that would affect the screening assay when samples are exposed to extreme temperatures and variations in humidity that might occur during sample transport. The average percent change in Positive Cocaine sample GC/MS results prior to shipping and after shipping was +5% for all locations combined.

Additionally, there were no discordant results pre- and post-shipping (as confirmed by GC/MS).

COSMETIC TREATMENT: Numerous studies have demonstrated that the use of cosmetic treatments can reduce the amount of drugs and metabolites detected in hair specimens. This effect is completely dependent upon the nature of the hair specimen and the treatment used, and is independent of the method of analysis. This study demonstrates that the Omega Laboratories, Inc. ELISA Cocaine Screening Assay is not an exception to this phenomenon.

Sixty six hair specimens previously determined to be negative for cocaine were obtained and the ethnic origin, hair color and curvature were documented. One hundred and ten hair specimens potentially positive for cocaine were obtained and the ethnic origin, hair color and curvature were documented. Each specimen was divided into 2 aliquots. One aliquot was analyzed by the ELISA protocol and by the GC/MS confirmation method.

Of the 176 treated specimens, four initially POSITIVE ELISA assays (one bleach and three permanent) reported NEG ELISA results after treatment.

ENVIRONMENTAL CONTAMINATION: Preliminary positive hair sample results by the screening method could be due to environmental contamination. All positive samples should be sent for confirmation testing on a reference method to distinguish between true positives and those samples that were positive due to external exposure. Head hair was used for this study.

CONCLUSION:

The comparison of results of the proposed assay and GC/MS for Cocaine metabolites in head and body hair samples showed the results to be substantially equivalent

The candidate Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites is substantially equivalent to the predicate Omega Laboratories Hair Drug Screening Assay for Cocaine and

21

Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 22 of 22

Cocaine Metabolites (Cocaine) predicate device based on acceptable performance studies, including precision, specificity, interference (including cosmetic effects) and removal of environmental contamination.

22

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/22/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Content Center .. WO66-G608 Silver Spring, MD 20993-0002

November 13, 2013

Omega Laboratories, Inc. C/O Robert J. Bard, JD 400 North Cleveland MOGADORE OH 44260

Re: K131128

Trade/Device Name: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO Dated: September 18, 2013 Received: October 1, 2013

Dear Mr. Bard:

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 Part 801); 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.

23

Page 2-Mr. Bard

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson -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

24

Indications for Use

510(k) Number: K131128

Device Name: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

Indications for Use:

The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is an in vitro diagnostic test that is intended for the qualitative detection of Cocaine at or above 500 pg/mg in human head and body hair. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.

This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use x (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): K131128