OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES

K131128 · Omega Laboratories, Inc. · DIO · Nov 13, 2013 · Clinical Toxicology

Device Facts

• Record ID: K131128
• Device Name: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
• Applicant: Omega Laboratories, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Nov 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

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.

Device Story

The Omega Laboratories Hair Drug Screening Assay is an in vitro diagnostic test for detecting cocaine and its metabolites in human hair. The device utilizes an ELISA (Enzyme-Linked Immunosorbent Assay) principle to analyze hair samples. Hair specimens are processed using a proprietary acid-methanol extraction method involving pulverization rather than simple cutting, which improves extraction efficiency. The assay is performed in a laboratory setting by trained personnel. The input is a prepared hair extract; the output is a qualitative result measured via a microplate reader at 450 nm. Presumptive positive results are identified based on a 500 pg/mg cutoff and must be confirmed using GC/MS. The assay assists healthcare providers or authorized entities in identifying potential drug use, providing a screening tool that requires professional judgment for interpretation. The device benefits patients by facilitating drug screening programs while ensuring that positive results are verified through more specific chemical methods.

Clinical Evidence

Bench testing only. Method comparison study conducted on 424 specimens (head and body hair) comparing ELISA screening results against GC/MS confirmation. Results showed high agreement with GC/MS. No clinical studies performed.

Technological Characteristics

ELISA-based immunoassay. Uses acid-methanol extraction with proprietary hair pulverization. Measurement via microplate reader at 450 nm. Cutoff: 500 pg/mg. Matrix: human head and body hair. Traceable to NIST standards. Software/algorithm: standard ELISA absorbance thresholding.

Indications for Use

Indicated for the qualitative detection of cocaine and its metabolites at or above 500 pg/mg in human head and body hair specimens. Intended for professional laboratory use to screen for drug abuse; presumptive positive results require confirmation via GC/MS.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (k112808)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k131128

B. Purpose for Submission:
Addition of body hair claim

C. Measurand:
Cocaine and cocaine metabolites in hair

D. Type of Test:
Qualitative ELISA Immunoassay

E. Applicant:
Omega Laboratories, Inc.

F. Proprietary and Established Names:
Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

G. Regulatory Information:
1. Regulation section:
21 CFR §862.3250, Cocaine and Cocaine Metabolite Test System
2. Classification:
Class II
3. Product code:
DIO – Enzyme Immunoassay, Cocaine and Cocaine Metabolites
4. Panel:
Toxicology (91)

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H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) 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.

3. Special conditions for use statement(s):

The assay provides only a preliminary analytical test result. A more specific alternative chemical method (e.g. LC/MS/MS) must be used to obtain a confirmed analytical result. Other chemical confirmation methods are available. Clinical consideration and professional judgment must be applied to the interpretation of any drug-of-abuse test result.

4. Special instrument requirements:

Confirmation testing is performed using an Agilent 6890 Series Gas Chromatograph/Agilent 5973 Mass Spectrometer (GC/MS) operation in the selected ion monitoring mode using a deuterated internal standard. MSD Chemstation™ software is used for data collection and analysis.

I. Device Description:

Donor head and body hair samples are collected using the Omega Collection Kit. The Donor Sample is shipped to the Company facility where testing is conducted by trained scientists under the direction of the Laboratory Director. This submission accepts Donor Samples from trained external sources and does not conduct any Point of Care Testing or on-site testing (pre-employment, insurance, court ordered, employment random screening etc.).

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The assay consists of two parts; a pre-analytical hair treatment procedure (to extract cocaine from the solid hair matrix to a measurable liquid matrix), and the screening assay. The screening assay is an Enzyme-Linked ImmunoSorbent Assay (ELISA).

The Hair Drug Screening Assay for Cocaine uses the International Diagnostic Systems Corp (IDS) One-Step ELISA Cocaine micro-plate/reagents and a micro-plate reader for the qualitative detection of Cocaine in hair samples. The test system consists of micro strip plates coated with rabbit anti-BE polyclonal antibody, enzyme conjugate (horseradish peroxidase conjugated to cocaine), substrate (containing tetramethylbenzidine), and wash solution. Cut off concentration is 500 pg/mg hair.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

2. Predicate 510(k) number(s):

k112808

3. Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Laboratory | Omega Laboratories | Same |
| Indication for/Intended Use | Same except for head and body hair | Intended to be used for the qualitative determination of the presence of Cocaine in human hair from the head. |
| Method of Measurement | Same | Microplate Reader read at 450 nm |
| Matrix | Head and body hair | Head hair |
| Cut-off Concentration | Same | 500 pg Cocaine /mg hair |
| Assay Principal | Same | ELISA |
| Extraction Method | Same | Acid-methanol to facilitate extraction of Cocaine from hair. Hair is pulverized into small segments prior to acid-methanol extraction, which improves extraction times without loss of efficiency |

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K. Standard/Guidance Document Referenced (if applicable):

None referenced

L. Test Principle:

The test consists of two parts; a pre-analytical hair treatment procedure (to remove Cocaine from the solid hair matrix to a measurable liquid matrix), and the screening assay. The screening assay is an Enzyme-Linked ImmunoSorbent Assay (ELISA). Sample is added to a well of the micro strip plate and enzyme conjugate is added, followed by incubation. During this phase the enzyme-labeled drug conjugate competes with drug in the sample for a limited number of binding sites on the rabbit antibody-coated micro wells. The two bind in proportion to their concentrations. A wash solution is applied to remove any unbound materials.

Enzyme substrate solution containing a chromagen is added. The reaction is stopped with an acid and the absorbance is read using a plate reader at 450 nm and a background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug present in the sample.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

See k112808

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

See k112808 for control stability, hair storage, and shipping study information.

d. Detection limit:

See k112808

e. Analytical specificity:

Cross-reactivity of structurally similar (test) compounds was assessed by performing serial dilutions of each test compound in negative head hair matrix. The concentration of the test compound that gave a similar absorbance to the 500 pg/mg cocaine cut-off

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control was determined and percent cross reactivity was calculated. The results are shown below:

Cross reactivity of Cocaine ELISA with Structurally Similar Compounds

| Compound | Approximate Concentration of Compound (pg/mg) Equivalent to 500 pg/mg Cocaine Cutoff Control (n=3) | Percent Cross-Reactivity (%) |
| --- | --- | --- |
| Benzoylecgonine isopropyl ester | 300 | 166.7 |
| Cocaethylene | 375 | 133.3 |
| Cocaine | 500 | 100 |
| Benzoylecgonine | 600 | 83.3 |
| Meta-Hydroxybenzoylecgonine | 700 | 71.4 |
| Ecgonine | 80000 | 0.6 |
| Norbenzoylecgonine | 150000 | 0.3 |
| Norcocaine | 250000 | 0.2 |
| Norcocaethylene | 250000 | 0.2 |
| Ecgonine methyl ester | 105000 | 0.48 |
| Anhydroecgonine methyl ester | 250000 | 0.2 |
| Anhydroecgonine | No cross-reactivity achieved at highest spike concentration tested (4,000,000 pg/mg). | |
| Atropine | No cross-reactivity achieved at highest spike concentration tested (4,000,000 pg/mg). | |

Specificity was tested for several related and unrelated (test) compounds at 10,000 ng/mL (400,000 pg/mg). Negative head hair extracts were spiked with cocaine at -50% (250 pg/mg), +125% (625 pg/mg), and +150% (750 pg/mg) of the cocaine cut-off concentration (500 pg/mg). The samples were additionally spiked with the test compounds and compared to the control containing the 500 pg/mL cocaine cut-off concentration. All compounds were found to interfere at the +125% (625 pg/mg), and +150% (750 pg/mg) cut-off concentrations. The following compounds were found to interfere in the assay at the -50% (250 pg/mg) cut-off concentration (if combined equivalent cocaine concentration > 500 pg/mg)*:

- Anhydroecgonine methyl ester
- Benzoylecgonine
- Benzoylecgonine isopropyl ester
- Cocaethylene
- Cocaine
- Ecgonine
- Ecgonine methyl ester
- m-Hydroxybenzoylecgonine
- Norbenzoylecgonine
- Norcocaethylene

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Norcocaine

Note: * (% Cross-Reactivity/100) X (400,000 pg/mg tested concentration) = X pg/mg cocaine equivalents. X pg/mg cocaine equivalents + 250 mg/pg cocaine (-50% cocaine cut-off)= combined equivalent cocaine concentration.

## Cosmetic treatment and environmental contamination

See k112808 for cosmetic treatment and environmental contamination study information

f. Assay cut-off:

See k112808

## 2. Comparison studies:

a. Method comparison with predicate device:

In the first of three agreement studies, 345 head hair specimens (including 100 negative specimens) were analyzed utilizing the ELISA technique described above. An additional 30 head hair negative specimens were analyzed in a second study and 49 body hair specimens were analyzed in the third study. Each specimen was divided into 2 aliquots for screening and GC/MS confirmation to verify the quantitative value of cocaine compared to the 500 pg/mg cut-off. The combined results (n=424) are shown below:

| ELISA Test Result | GC/MS Negative (<50 pg/mg) | GC/MS Negative (<250 pg/mg) | GC/MS Negative (250-499 pg/mg) | GC/MS Positive (500-750 pg/mg) | GC/MS Positive (>750 pg/mg) |
| --- | --- | --- | --- | --- | --- |
| Positive (Candidate Device) | 0 | 0 | 31 | 24 | 210 |
| Negative (Candidate Device) | 122 | 3 | 34 | 0 | 0 |
| Screening Cutoff (pg/mg) | ELISA Test Result (POS/NEG) | Drug | | | GC/MS Drug Result |
| --- | --- | --- | --- | --- | --- |
| | | Cocaine | Benzoylecogonine | Cocaethylene | |
| 500 | Positive | 189 | 83 | 0 | 272 |
| 500 | Positive | 227 | 44 | 0 | 271 |
| 500 | Positive | 273 | 0 | 0 | 273 |
| 500 | Positive | 219 | 87 | 0 | 306 |
| 500 | Positive | 251 | 50 | 0 | 301 |
| 500 | Positive | 260 | 50 | 0 | 310 |
| 500 | Positive | 230 | 87 | 0 | 317 |
| 500 | Positive | 278 | 48 | 0 | 326 |

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| 500 | Positive | 272 | 65 | 0 | 337 |
| --- | --- | --- | --- | --- | --- |
| 500 | Positive | 334 | 0 | 0 | 334 |
| 500 | Positive | 238 | 116 | 0 | 354 |
| 500 | Positive | 342 | 0 | 0 | 342 |
| 500 | Positive | 313 | 43 | 0 | 356 |
| 500 | Positive | 335 | 28 | 0 | 363 |
| 500 | Positive | 284 | 106 | 0 | 390 |
| 500 | Positive | 294 | 103 | 0 | 397 |
| 500 | Positive | 354 | 47 | 0 | 401 |
| 500 | Positive | 333 | 79 | 0 | 412 |
| 500 | Positive | 364 | 54 | 0 | 418 |
| 500 | Positive | 328 | 98 | 0 | 426 |
| 500 | Positive | 265 | 118 | 65 | 448 |
| 500 | Positive | 424 | 37 | 0 | 461 |
| 500 | Positive | 393 | 77 | 0 | 470 |
| 500 | Positive | 390 | 85 | 0 | 475 |
| 500 | Positive | 433 | 42 | 0 | 475 |
| 500 | Positive | 469 | 0 | 0 | 469 |
| 500 | Positive | 444 | 32 | 0 | 476 |
| 500 | Positive | 336 | 32 | 94 | 462 |
| 500 | Positive | 491 | 0 | 0 | 491 |
| 500 | Positive | 453 | 46 | 0 | 499 |
| 500 | Positive | 497 | 0 | 0 | 497 |

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

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4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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