OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE

K140671 · Omega Laboratories, Inc. · DJG · Jan 8, 2015 · Clinical Toxicology

Device Facts

• Record ID: K140671
• Device Name: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
• Applicant: Omega Laboratories, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jan 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test that is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in human head and body hair. To confirm a screen positive result. a more specific alternate chemical method, such as Gas ChromatographyMass 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 opiates, oxycodone, and hydrocodone in human head and body hair. The device uses an ELISA-based screening protocol. Hair samples are pulverized using a proprietary method and extracted using an acid-methanol process. The assay is performed in a single laboratory setting by trained personnel. The device produces qualitative results (positive/negative) based on a 300 pg/mg cutoff. Presumptive positive results require confirmation via GC/MS. The assay aids healthcare providers or authorized entities in identifying drug use; professional judgment is required for interpretation. The device includes stability and shipping validation to ensure sample integrity.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical method comparison studies. Combined head hair (N=176/480) and body hair (N=50) samples were tested using ELISA and confirmed via GC/MS. Results showed high agreement between screening and confirmation methods. Discordant results were analyzed and attributed to cross-reactivity or concentrations near the 300 pg/mg cutoff.

Technological Characteristics

Qualitative ELISA immunoassay. Components: micro strip plates coated with anti-morphine mouse monoclonal or anti-oxycodone rabbit polyclonal antibodies, horseradish peroxidase-conjugated enzyme, tetramethylbenzidine substrate. Requires automated microplate reader (450 nm). Extraction via acid-methanol. Single laboratory use.

Indications for Use

Indicated for the qualitative detection of opiates, oxycodone, and hydrocodone at or above 300 pg/mg in human head and body hair. Intended for single laboratory use only; requires confirmation of presumptive positive results via GC/MS.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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 Opiates, Oxycodone and Hydrocodone (k103161)

Submission Summary (Full Text)

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

A. 510(k) Number:
k140671

B. Purpose for Submission:
Addition of body hair claim

C. Measurand:
Opiates, Oxycodone and Hydrocodone in hair

D. Type of Test:
Qualitative ELISA Immunoassay

E. Applicant:
Omega Laboratories, Inc.

F. Proprietary and Established Names:
Omega Laboratories, Inc. Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone

G. Regulatory Information:
1. Regulation section:
21 CFR §862.3650, Opiate Test System
2. Classification:
Class II
3. Product code:
DJG
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 (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test that is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 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):

For Over-the-Counter Use

4. Special instrument requirements:

The screening assay is for use with an automated microplate reader capable of measuring at 450 nm.

For confirmation testing, the sponsor uses an Agilent GC/MS in selected ion monitoring (SIM) mode using deuterated internal standards.

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.

The assay consists of the following:

- Hair sample collection kit
- Micro strip plates coated with either anti-morphine mouse monoclonal or antioxycodone rabbit polyclonal antibody, enzyme conjugate (horseradish peroxidase conjugated to morphine or oxycodone), substrate (containing tetramethylbenzidine), an enzyme diluent, and wash solution

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- In-house prepared calibrators and controls are used. These are prepared solutions of morphine and oxycodone added to negative hair matrix tubes.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone

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

k103161

3. Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Laboratory | Omega Laboratories | Same |
| Indication for/Intended Use | Same except for both head and body hair | Intended to be used for the Qualitative determination of the presence of opiates, oxycodone and hydrocodon 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 | 300 pg Opiates/mg hair
300 pg Oxycodone/mg hair
300 pg Hydrocodone/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 |

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

None referenced.

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L. Test Principle:

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 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 antibody-coated micro wells. The two bind in proportion to their concentrations. A wash solution is applied to remove unbound materials. Enzyme substrate solution containing a chromagen is added. The reaction is stopped with a stop solution and absorbance is read using a plate reader at 450 nm. A background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug presented in the sample.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

See k103161 for precision/reproducibility information.

b. Linearity/assay reportable range:

Not applicable.

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

See k103161 for calibrator and control materials information, hair sample stability, and shipping study information.

d. Detection limit:

Not applicable.

e. Analytical specificity:

See k103161 for cross reactivity, interference (structurally related and unrelated compounds), hair treatment, and environmental contamination studies.

In addition to studies conducted in k103161, the sponsor performed additional cross reactivity testing on several structurally similar compounds including Buprenorphine, Noroxymorphone, 3-Methoxynaltrexone, Morphine-6-betaglucuronide, Nalmefene, Nalorphine, Naloxone-3-beta-D-glucuronide, Naltrexone, Naltriben. These compounds appeared to contribute to an Opiate or Oxycodone positive ELISA result

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at -50% cutoff, but did not show cross reactivity when tested at concentrations up to 400,000pg/mg.

To investigate this discrepancy, cross reactivity was tested at up to 10 fold higher concentrations. Expected results were obtained. The results are summarized in the tables below. The tables below are also included in the device labeling.

Cross reactivity of Opiates ELISA with Structurally Similar Compounds

| Compound | Concentration of Compound (pg/mg) Equivalent to 300 pg/mg Opiates Cutoff Control | Percent Cross-Reactivity (%) |
| --- | --- | --- |
| Morphine-6-β-D-glucuronide | 800 | 37.5 |
| Nalorphine | 8500 | 3.5 |
| Buprenorphine | 600000 | 0.050 |
| 3-Methoxynaltrexone | 900000 | 0.033 |
| Naltrexone | 3000000 | 0.010 |
| Noroxymorphone | 4000000 | 0.008 |
| Nalmefene | * | 0.00 |
| Naloxone-3-β-D-glucuronide | * | 0.00 |
| Naltriben | * | 0.00 |

* Unable to generate an assay absorbance equivalent to 300pg/mg Opiates cutoff. Highest concentration tested was 4,000,000pg/mg.

Cross Reactivity of Omega Laboratories, Inc. Oxycodone ELISA with Structurally Similar Compounds

| Compound | Concentration of Compound (pg/mg) Equivalent to 300 pg/mg Oxycodone Cutoff Control | Percent Cross-Reactivity (%) |
| --- | --- | --- |
| Morphine-6-β-D-glucuronide | 31000 | 0.97 |
| Nalorphine | 300000 | 0.10 |
| Buprenorphine | * | 0.00 |
| 3-Methoxynaltrexone | 380000 | 0.08 |
| Naltrexone | 50000 | 0.60 |
| Noroxymorphone | 58000 | 0.52 |
| Nalmefene | 300000 | 0.10 |
| Naloxone-3-β-D-glucuronide | 680000 | 0.04 |
| Naltriben | 300000 | 0.10 |

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* Unable to generate an assay absorbance equivalent to 300pg/mg Oxycodone cutoff. Highest concentration tested was 4,000,000pg/mg

f. Assay cut-off:

See k103161.

2. Comparison studies:

a. Method comparison with predicate device:

Method comparison studies on head hair samples were performed and reported in the predicate submission (k103161). Additional method comparison studies were performed for this current submission with 50 body hair samples. Each tested sample was divided into two aliquots and one was used for screening on the candidate device (ELISA assay) and the other for GC/MS confirmation. Testing was performed on hair samples from different ages, gender, ethnicities and hair color. The combined head hair (performed in k103161) and body hair (this submission) results are shown below:

Opiates Equivalents Summary of Agreement Study Results, Head Hair (N=176) and Body Hair (N=50)

| ELISA Test Result | Negativ e by GC/MS | Less than half the cutoff concentration by GC/MS | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (Greater that 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 2 | 24 | 116 |
| Negative | 70 | 4 | 9 | 1 | 0 |

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GC/MS Summary of Opiates Equivalents Discordant Results (N=3)

| Sample No. | Screening Cutoff (pg/mg) | ELISA Test Result (POS/NEG) | GC/MS Cutoff (pg/mg) | GC/MS Drug Result (pg/mg) |
| --- | --- | --- | --- | --- |
| 16 | 300 | POS | 300 | HDC 268 |
| 150 | 300 | POS | 300 | HDC 299 |
| 29 | 300 | NEG | 300 | HDC 354 |

Oxycodone Summary of Agreement Study Results, Head Hair (N=480) and Body Hair (N=50)

| ELISA Test Result | Negative by GC/MS | Less than half the cutoff concentration by GC/MS | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (Greater that 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 6 | 94 | 221 |
| Negative | 140 | 6 | 14 | 2 | 0 |

*Of the 530 samples compared in the Oxycodone assays, 46 ELISA head hair positive samples were negative by GC/MS confirmation for oxycodone but positive for hydrocodone and one head hair test sample was lost during centrifugation reducing the number of test samples reported in the table to 483.

GC/MS Summary of Oxycodone Discordant Results (N=8)

| Sample No. | Screening Cutoff (pg/mg) | ELISA Test Result (POS/NEG) | GC/MS Cutoff (pg/mg) | GC/MS Drug Result (pg/mg) |
| --- | --- | --- | --- | --- |
| 835334 | 300 | NEG | 300 | OXY 169 HDC 167 |
| EXOP 39 | 300 | POS | 300 | OXY 131 HDC 83 |
| 788840 | 300 | POS | 300 | OXY 185 HDC 29 |

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| Sample No. | Screening Cutoff (pg/mg) | ELISA Test Result (POS/NEG) | GC/MS Cutoff (pg/mg) | GC/MS Drug Result (pg/mg) |
| --- | --- | --- | --- | --- |
| 787180c | 300 | POS | 300 | OXY 229
HDC 68 |
| 789526 | 300 | POS | 300 | OXY 240
HDC 49 |
| 872104 | 300 | NEG | 300 | OXY 130
HDC 221 |
| 854976 | 300 | POS | 300 | OXY 255 |
| 800488 | 300 | POS | 300 | OXY 298 |

Hydrocodone Summary of Agreement Study Results, Head Hair (N=480), Body Hair (N=50)

| ELISA Test Result | Negative by GC/MS | Less than half the cutoff concentration by GC/MS | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (Greater that 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 0 | 8 | 110 | 201 |
| Negative | 142 | 8 | 25 | 6 | 0 |

*Of the 530 samples compared in the HDC assays, 27 ELISA head hair positive samples were negative by GC/MS confirmation for hydrocodone but positive for oxycodone, one head hair test sample was lost during centrifugation and 2 ELISA head hair positive samples were not able to be confirmed by GC/MS which reduced the number of test samples reported here to 500.

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GC/MS Summary of Hydrocodone Discordant Results (N=14)

| Sample No. | Screening Cutoff (pg/mg) | ELISA Test Result (POS/NEG) | GC/MS Cutoff (pg/mg) | GC/MS Drug Result (pg/mg) |
| --- | --- | --- | --- | --- |
| 787832 | 300 | NEG | 300 | HDC 403 |
| 89 | 300 | NEG | 300 | HDC 313 |
| 65 | 300 | NEG | 300 | HDC 334 |
| 835334 | 300 | NEG | 300 | HDC 167 OXY 169 |
| 872104 | 300 | NEG | 300 | HDC 221 OXY 130 |
| 835981a | 300 | NEG | 300 | HDC 347 |
| 788840 | 300 | POS | 300 | HDC 29 OXY 185 |
| 789526 | 300 | POS | 300 | HDC 49 OXY 240 |
| 787180c | 300 | POS | 300 | HDC 68 OXY 229 |
| EXOP 39 | 300 | POS | 300 | HDC 83 OXY 131 |
| 790194 | 300 | POS | 300 | HDC 204 |
| 849237 | 300 | POS | 300 | HDC 256 |
| 904316 | 300 | POS | 300 | HDC 272 |
| 780598 | 300 | POS | 300 | HDC 283 |

b. Matrix comparison:

Not applicable.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

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b. Clinical specificity:
Not applicable.

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

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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