Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on traditional immunoassay (ELISA) and chemical analysis (GC/MS) methods, with no mention of AI or ML.

Therapeutic

No.
This device is an in vitro diagnostic test used to detect the presence of PCP in human hair for screening purposes; it is not designed to treat a medical condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" states that the device is an "in vitro diagnostic test" and is used for "the determination of the presence of PCP in human hair... for the purpose of identifying the use of PCP." This directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic test that utilizes an enzyme-linked immunosorbent assay (ELISA) and a pre-analytical hair treatment procedure, which are physical components and processes, not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The very first sentence explicitly states: "The Omega Laboratories Hair Drug Screening Assay Phencyclidine is an in vitro diagnostic test..." This is the most direct indicator.
Device Description: The description details a laboratory procedure involving the analysis of a biological sample (human hair) using an enzyme immunoassay (ELISA) to detect a substance (PCP). This aligns with the definition of an in vitro diagnostic test, which is performed outside the body on biological specimens.
Intended User/Care Setting: The test is intended for "single laboratory use only by trained laboratory personnel," which is typical for IVD tests performed in a clinical or forensic laboratory setting.

The information provided clearly indicates that this device is designed to be used in a laboratory setting to analyze a biological sample for diagnostic purposes (identifying the use of PCP).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Omega Laboratories Hair Drug Screening Assay Phencyclidine is an in vitro diagnostic test that is intended to be used for the determination of the presence of PCP in human hair from the head and body. The Omega Laboratories Hair Drug Screening Assay utilizes an enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose of identifying the use of PCP. 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)

LCM

Device Description

The Assay is an enzyme immunoassay for the qualitative detection of phencyclidine in head and body hair (hair). Phencyclidine (PCP), the hallucinogen commonly referred to as Angel Dust, can be detected in hair.

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

After the extraction treatment, the test sample is added to a well of the coated 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 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. A background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug present in the sample. For the screening of PCP in hair, an enzyme linked immunosorbent assay (ELISA) procedure has been established.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human hair from the head and body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

single laboratory use only by trained laboratory personnel

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 Study:

Intra-assay Precision using individual samples: Five hair specimens positive for PCP were analyzed. Each divided into 6 aliquots (approx. 20 mg). Three aliquots treated and analyzed in one run.
- PCP concentrations: 399, 560, 1435, 4528, 7096 pg/mg. All replicates were positive.
Intra-assay precision studies: 11 replicates of negative hair samples spiked to: zero, -75%, -50%, -25% below cutoff, and +25%, +75%, +100% above cutoff.
- Cutoff: 300 pg/mg. All samples below cutoff (0-225 pg/mg) were negative. All samples above cutoff (375-600 pg/mg) were positive.
Inter-assay precision studies: Negative hair samples spiked to: zero, -75%, -50%, -25% below cutoff, and +25%, +50%, +75%, +100% above cutoff. 11 replicates analyzed over 20 non-consecutive days.
- N = 220 for each concentration. All samples below cutoff (0-225 pg/mg) were negative. All samples above cutoff (375-600 pg/mg) were positive.

Agreement Study:

Original study (K101059) compared ELISA results against quantitative GC/MS on 352 donor hair samples. (See K101059 (OLSR10)).
Second study (for body hair): 41 specimens added to existing Agreement (OLSR10 Rev 2) for a total of 393 specimens (Negative n=177 and Positive n=216).
Results summarized in a table showing ELISA Test Result vs. GC/MS results at different pg/mg ranges.
- ELISA Positive samples: 0 GC/MS Negative (450).
- ELISA Negative samples: 150 GC/MS Negative (450).
Discordant results: 20 head and body hair samples (table showing ELISA POS/NEG vs. GC/MS total PCP equivalents).

Cosmetic Treatment Study:

Documented effects of various cosmetic treatments (shampoo, perm, dye, bleach, relaxer) on ELISA PCP Screening Protocol using head hair.
Negative Samples (n=86): Mean Absorbance change was small for all treatments.
Positive Samples (n=89):
- Mean Absorbance change was generally small.
- 6 of 89 samples reported a change from positive to negative due to treatment:
  - Permanent treatments: 3 of 18 became negative.
  - Dye: 2 of 18 became negative.
  - Relaxer: 1 of 18 became negative.
  - Other treatment types: no change.

Cross-reactivities and Interference studies:

Evaluated specificity and possible effect of interfering compounds using head hair.
Confirmed that metaphit, 4-hydroxyphencyclidine, and phencyclidine morpholine may contribute to a PCP positive ELISA result due to structural similarity.
Cross-reactivity percentages: Phencyclidine (100%), Metaphit (60.0%), 4-Hydroxy-Phencyclidine (5.0%), Phencyclidine Morpholine (20.0%). Doxylamine (Did not produce a result).
None of the other 270 compounds demonstrated interference.

Environmental Contamination:

Preliminary positive results by screening method could be due to environmental contamination. Recommends confirmation testing by reference method (e.g., GC/MS) to distinguish true positives from external exposure.

Calibrator and Control:

In-house calibrator and control solutions for Omega's labs only.
Stability study demonstrated PCP in methanol stability for one year when refrigerated in amber bottle.

Recovery Study:

Evaluated effectiveness of extraction method.
Five head hair samples previously confirmed positive for PCP. Aliquoted in duplicate: one through acidic-methanol extraction, one through 100% recovery extraction.

Shipping Study:

Determined effect of extreme temperatures/humidity during sample shipments.
137 head hair samples (30 positive, 100 negative, 7 near cutoff).
Four shipping boxes (25 negative, 7+ positive, 2+ near cutoff) subjected to diverse temperatures/humidity and shipped to different US locations.
Average mean % of change in result prior to shipping and after shipping was 0% for all locations combined.
Hair sample is solid matrix, less susceptible to temperature constraints than urine.
All negative samples remained negative after shipping.
Two pre-shipping samples that screened negative, screened positive after shipping.
Two pre-shipping positive screen samples, screened negative after shipping.

Stability Study:

Determined effect of extended storage on PCP level in hair samples.
N = 137 head hair samples.
Range in concentration before storage: 110 - 4999 pg/mg hair.
Range in concentration after storage: 115 - 5102 pg/mg hair.
Mean Change: -8%. Max decrease: -32%, Min decrease: -2%. Max increase: 9%, Min increase: 2%.
8 samples increased in concentration, 12 decreased.
Conclusion: Based on 8% mean percent change over 2.5 years, donor sample PCP drug stability is maintained. Shelf life for hair samples set at 1 year.

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

Not Found (Performance metrics are described in terms of agreement, discordant results, and precision rather than sensitivity, specificity, PPV, or NPV explicitly, although these could be calculated from the agreement table)

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 Phencyclidine (K101059)

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

N/A

Summary

0

K131181

Premarket Notification - 510(k) Omega Laboratories Hair Drug Screening Assay Phencyclidine 510(k) Summary Page 1 of 12

510(k) Summary

JUN 2 5 2013

June 25, 2013

Trade Name: Omega Laboratories Hair Drug Screening Assay Phencyclidine Common Name: Hair Drug Screening Assay Phencyclidine

Applicant:

William R. Corl Chief Executive Officer 400 North Cleveland Mogadore, OH 44260 Tel: 330-628-5748 Fax: 330-628-5803

Classification or descriptor	Name or designation
Trade Name	Omega Laboratories Hair Drug Screening Assay
Phencyclidine
Common Name	Hair Drug Screening Assay for Phencyclidine (PCP)
Classification Name	Enzyme immunoassay, phencyclidine
Classification Panel	91 (Toxicology)
Product Code	LCM
Regulation Number	Unclassified, Enzyme Immunoassay, PCP

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq. Managing Director

400 North Cleveland Mogadore, OH 44260 Tel: 248-573-5040 Cell: 734-330-5990 email: rbard@reglaw.net

1

1.0 ASSAY SUMMARY

The Assay is an enzyme immunoassay for the qualitative detection of phencyclidine in head and body hair (hair). Phencyclidine (PCP), the hallucinogen commonly referred to as Angel Dust, can be detected in hair.

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

After the extraction treatment, the test sample is added to a well of the coated 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 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. A background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug present in the sample. For the screening of PCP in hair, an enzyme linked immunosorbent assay (ELISA) procedure has been established.

2.0 PREDICATE DEVICES

Omega Laboratories Hair Drug Screening Assay Phencyclidine (K101059)

3.0 INTENDED USE AND INDICATIONS FOR USE

The Omega Laboratories Hair Drug Screening Assay Phencyclidine is an in vitro diagnostic test that is intended to be used for the determination of the presence of PCP in human hair from the head and body. The Omega Laboratories Hair Drug Screening Assay utilizes an enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose of identifying the use of PCP. 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.

4.0 ASSAY DESCRIPTIONS

4.1 The Omega Laboratories Hair Drug Screening Assay Phencyclidine is a test system that utilizes an ELISA PCP reagents and a micro-plate reader for the qualitative detection of Phencyclidine in head or body hair samples at or above 300 pg/mg. It is an assay intended exclusively for single laboratory use by trained laboratory personnel only and is not intended for sale to anyone. This is a qualitative assay and the performance at low concentrations was evaluated in the precision studies.

2

Premarket Notification - 510(k) Omega Laboratories Hair Drug Screening Assay Phencyclidine 510(k) Summary Page 3 of 12

4.2 The Omega Laboratories Hair Drug Screening Assay Phencyclidine screening test provides only a preliminary analytical test result. To confirm a screen positive result, a more specific alternate chemical method must be used.
4.3 Assay
- 4.3.1 The test consists of two parts; a pre-analytical proprietary and patent pending hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix), and the screening assay.
4.4 Specifications
- 4.4.1 Donor Sample Collection
  - 4.4.1.1 Donor samples are collected using the Omega Collection Kit. Hair samples stored in the Kit have a one year shelf life.
- ELISA PCP (microplate format) 4.4.2
  - 4.4.2.1 The PCP assay utilizes an enzyme-linked immunosorbent assay technology (ELISA). ELISA utilizes highly sensitive and specific (polyclonal goat) antibodies onto a solid-phase surface such as a microwell plate. The sample to be tested competes with an enzyme solution for the binding sites of the antibody. If the enzyme binds to the antibody, a color change occurs after the addition of substrate. The darker the color, the lower the amount of analyte in the sample.

4.5 Materials

4.5.1 Sample Collection Kit
4.5.2 ELISA PCP microplate, reagents, controls
4.5.3 Micro Plate Reader

3

5.0 COMPARISON OF OMEGA LABORATORIES PCP ASSAY AND ITS PREDICATES

Table 2: Comparison of Omega Laboratories PCP Assay vs Omega Laboratories Hair Drug Screening Assay

Phencyclidine (PCP)

| Comparison
Element | Omega Laboratories Hair Drug
Screening Assay Phencyclidine
(K131181) | Omega Laboratories Hair Drug
Screening Assay Phencyclidine
K101059 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Laboratory | Omega Laboratories, Inc. | Omega Laboratories, Inc. |
| Indication for/
Intended Use | The Omega Laboratories Hair Drug
Screening Assay Phencyclidine is an in
vitro diagnostic test that is intended to
be used for the determination of the
presence of PCP in human hair from the
head and body. The Omega
Laboratories Hair Drug Screening Assay
(PCP) utilizes an enzyme linked
immunosorbent assay (ELISA) for PCP,
for the qualitative detection of PCP at or
above 300 pg/mg of hair for the purpose
of identifying the use of PCP. 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 |
| Product Code | LCM | Same |
| Measurand | Phencyclidine (PCP) | Same |
| Method of
Measurement | Microplate reader. Read at 450 nm | Same |
| Matrix | Head and body hair | Head hair |
| Cutoff
concentration | 300 pg PCP/mg hair | Same |
| Type of Test | ELISA (polyclonal goat antibodies) | Same |
| Comparison
Element | Omega Laboratories Hair Drug
Screening Assay Phencyclidine
(K131181) | Omega Laboratories Hair Drug
Screening Assay Phencyclidine
K101059 |
| Extraction
Method | Acid-methanol to facilitate extraction of
PCP from hair. | Same |

4

Premarket Notification - 510(k) Omega Laboratories Hair Drug Screening Assay Photing Productions Collinion
Omega Laboratories Hair Drug Screening Assay Phonomary

Table 2: Comparison of Omega Laboratories PCP Assay vs Omega Laboratories Hair Drug Screening Assay

5

SUMMARY OF PERFORMANCE TESTING 6.0

6.1 Precision Study
- 6.1.1 The Precision Study was performed to evaluate the intra and inter-assay precision/reproducibility of the Protocol using head hair samples.

Intra-assay Precision using individual samples was performed to characterize precision when replicate measurements of single hair samples were analyzed. Five hair specimens previously found to be positive for PCP were analyzed. Each hair specimen was divided into 6 aliquots of approximately 20 mg each. Three aliquots were treated and analyzed in the same manner as donor hair samples and measured in one run.

| Drug | Concentration of
Sample (pg/mg) | Number of
Replicates | Results #
Negative | Results #
Positive |
|------|------------------------------------|-------------------------|-----------------------|-----------------------|
| PCP | 399 | 3 | 0 | 3 |
| PCP | 560 | 3 | 0 | 3 |
| PCP | 1435 | 3 | 0 | 3 |
| PCP | 4528 | 3 | 0 | 3 |
| PCP | 7096 | 3 | 0 | 3 |

Table 3: Intra-Assay Precision of Individual Replicates Studies

Intra-assay precision studies were performed using 11 replicates of negative hair samples spiked to the following concentrations of PCP: 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 and measured in one run.

Table 4: Intra-Assay PCP Precision Studies (CO=300 pg/mg)
-----------------------------------------------------------	--

| Drug | Concentration of
Sample (pg/mg) | Number of
Replicates | Results #
Negative | Results #
Positive |
|------|------------------------------------|-------------------------|-----------------------|-----------------------|
| PCP | 0 | 11 | 11 | 0 |
| PCP | 75 | 11 | 11 | 0 |
| PCP | 150 | 11 | 11 | 0 |
| PCP | 225 | 11 | 11 | 0 |
| PCP | 375 | 11 | 0 | 11 |
| PCP | 450 | 11 | 0 | 11 |
| PCP | 525 | 11 | 0 | 11 |
| PCP | 600 | 11 | 0 | 11 |

n = 11 for each concentration

6

Inter-assay precision studies were performed using negative hair samples spiked to the following concentrations of PCP: 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. Eleven replicates of these were prepared and analyzed over 20 non-consecutive days.

| Drug | Concentration of
Sample (pg/mg) | Number of
Replicates | Results #
Negative | Results #
Positive |
|------|------------------------------------|-------------------------|-----------------------|-----------------------|
| PCP | 0 | 220 | 220 | 0 |
| PCP | 75 | 220 | 220 | 0 |
| PCP | 150 | 220 | 220 | 0 |
| PCP | 225 | 220 | 220 | 0 |
| PCP | 375 | 220 | 0 | 220 |
| PCP | 450 | 220 | 0 | 220 |
| PCP | 525 | 220 | 0 | 220 |
| PCP | 600 | 220 | 0 | 220 |

Table 5: Inter-Assay PCP Precision Studies (CO=300pg/mg)

N = 220 for each concentration

6.2 Agreement Study

6.2.1 The original Agreement Study (K101059) was performed by comparing ELISA results against quantitative GC/MS confirmatory results on the same hair specimens. A total of 352 donor hair samples were tested in this study. See K101059 (OLSR10).
6.2.2 A second study was conducted to support the use of the PCP assay with body hair in addition to the already cleared head hair. A total of 41 specimens were added to the existing Agreement (OLSR10 Rev 2) for a total of 393 specimens (Negative n=177 and Positive n=216)

| ELISA
Test
Result | GC/MS
Negative
(450
pg/mg) |
|-------------------------|-----------------------------------|-----------------------------------|-------------------------------------------|----------------------------------------|-----------------------------------|
| Positive | 0 | 1 | 15 | 38 | 162 |
| Negative | 150 | 15 | 8 | 4 | 0 |

Table 6: Summary of Agreement Study Results Head and Body Hair (n=393)

7

Premarket Notification - 510(k) Omega Laboratories Hair Drug Screening Assay Phencyclidine
Page 8 of 12

| Screening
Cutoff (pg/mg) | ELISA PCP Test
Result (POS/NEG) | GC/MS Cutoff
(pg/mg) | GC/MS Drug
Result (Total
PCP Equivalents
pg/mg) | Associated
Crossreacting
Compound |
|-----------------------------|---- | 300 | POS structurally similar |
| 300 | POS hydroxyphencyclidine, |
| 300 | POS morpholine may |
| 300 | POS positive ELISA |
| 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | POS | 300 | NEG | 300 | NEG | 300 | NEG | 300 | NEG --------------------------------|-------------------------|----------------------------------------------------------|-------------------------------------------------|
| 300 | 122 | The presence of the
| 300 | 166 | compounds metaphit, 4-
| 300 | 184 | and phencyclidine
| 300 | 264 | contribute to a PCP
| 300 | 267 | |
| 300 | 272 | |
| 300 | 280 | |
| 300 | 284 | |
| 300 | 286 | |
| 300 | 287 | |
| 300 | 287 | |
| 300 | 288 | |
| 300 | 290 | |
| 300 | 291 | |
| 300 | 293 | |
| 300 | 298 | |
| 300 | 301 | NA |
| 300 | 301 | |
| 300 | 305 | |
| 300 | 313 | |

Table 7: GC/MS Summary of Discordant Results [n = 20 head and body hair samples]

6.3 Cosmetic Treatment Study

6.3.1 The Cosmetic Treatment study documented the effects of various cosmetic treatments on the Omega Laboratories, Inc. ELISA PCP Screening Protocol using head hair.

8

Premarket Notification - 510(k) Omega Laboratories Hair Drug Screening Assay Phencyclidine 510(k) Summary Page 9 of 12

Table 8: Hair Treatment Assignment

Table 9: Effects of Hair Treatments on Negative Samples (ELISA Assay) n=86

| Treatment | Shampoo
#1 | Shampoo
#2 | Perm
#1 | Perm
#2 | Dye 1 | Dye 2 | Bleach
#1 | Bleach
#2 | Relaxer
#1 | Relaxer
#2 |
|-----------------------------|---------------|---------------|------------|------------|-------|--------|--------------|--------------|---------------|---------------|
| Mean Abs.
Untreated Hair | 1.858 | 1.728 | 1.810 | 1.605 | 1.828 | 1.727 | 1.810 | 1.719 | 1.699 | 1.742 |
| Mean Abs.
Treated Hair | 1.841 | 1.743 | 1.767 | 1.613 | 1.855 | 1.718 | 1.830 | 1.800 | 1.693 | 1.738 |
| Mean Change | -0.017 | 0.015 | -0.043 | 0.008 | 0.026 | -0.009 | 0.020 | 0.081 | -0.006 | -0.004 |

Table 10: Effects of Hair Treatments on Positive Samples (ELISA Assay) n=89

| Treatment | Shampoo
#1 | Shampoo
#2 | Perm
#1 | Perm
#2 | Dye 1 | Dye 2 | Bleach
#1 | Bleach
#2 | Relaxer
#1 | Relaxer
#2 |
|-----------------------------|---------------|---------------|------------|------------|-------|-------|--------------|--------------|---------------|---------------|
| Mean Abs.
Untreated Hair | 0.452 | 0.417 | 0.250 | 0.465 | 0.468 | 0.442 | 0.359 | 0.331 | 0.417 | 0.505 |
| Mean Abs.
Treated Hair | 0.473 | 0.445 | 0.279 | 0.526 | 0.485 | 0.456 | 0.354 | 0.326 | 0.441 | 0.547 |
| Mean Change | 0.023 | 0.029 | 0.029 | 0.061 | 0.016 | 0.015 | -0.005 | -0.005 | 0.024 | 0.042 |
| Change POS
to NEG | 0/17 | | 3/18 | | 2/18 | | 0/18 | | 1/18 | |

6.3.2 Permanent treatments saw the greatest effect on positive samples (3 of 18 became negative after treatment); followed by Dye (2 of 18 becoming negative after treatment) and then Relaxer (1 of 18). All other treatment types saw no change in

9

Premarket Notification - 510(k) Omega Laboratories Hair Drug Screening Assay Phencyclidine 510(k) Summary Page 10 of 12

assay results (6 of 89 samples reported a change from positive to negative as a result of the treatment.

6.4 Cross reativities
Cross Reactivity and Interference studies were conducted to evaluate the specificity of the Omega Laboratories, Inc. ELISA PCP Screening Protocol and the possible effect of interfering compounds using head hair.
6.4.1 The study demonstrated that the presence of the structurally similar compounds metaphit, 4-hydroxyphencyclidine, and phencyclidine morpholine may contribute to a PCP positive ELISA result when utilizing this protocol. None of the other (270) compounds demonstrated interference with the ELISA PCP protocol.

| Compound | Approximate Concentration
of Compound (pg/mg)
Equivalent to 300pg/mg
Phencyclidine Cutoff
Control
(n=3) | Percent Crossreactivity
(%) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Phencyclidine | 300 | 100 |
| Metaphit | 500 | 60.0 |
| 4-Hydroxy-Phencyclidine | 6000 | 5.0 |
| Doxylamine | 40000 | Did not produce a result |
| Phencyclidine Morpholine | 1500 | 20.0 |

Table 11. Crossreactivity of Phencyclidine ELISA with Structurally Similar Compounds

6.5 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 that were positive due to external exposure.
6.6 Calibrator and Control
- 6.6.1 The in-house calibrator and control solutions are prepared solely for use within Omega and only at its laboratories in Mogadore, OH.
- 6.6.2 The study demonstrated the stability of PCP in methanol for a period of one year when stored refrigerated in an amber bottle is also attached. This validates the one 1 year expiration date for the PCP Calibrator Stock Solution

10

Recovery Study 6.7

6.7.1 The Extraction Recovery Study evaluated the effectiveness of the extraction method utilized by the Omega Laboratories, Inc. ELISA PCP Screening Protocol.
6.7.2 Five head hair samples that previously confirmed positive for PCP were used for these studies. Samples were aliquoted in duplicate: one aliquot was taken through the acidic-methanol extraction and the other was taken through the 100% recovery extraction.
6.8 Shipping Study
- 6.8.1 The Shipping Study was conducted to determine whether there is any adverse effect on donor hair samples when exposed to extreme temperatures and variations in humidity that might occur during sample shipments.
- 6.8.2 137 head hair samples were used in the shipping study: 30 previously confirmed Positive samples. 100 previously screened negative samples and 7 samples that were just under the cutoff. Each box contained a variety of hair color and curvature. Four separate shipping boxes each containing 25 previously screened Negative samples, at least 7 previously confirmed Positive samples and at least 2 samples close to cutoff were stored in a freezer over night then heated for a period of at least four hours. The minimum and maximum temperature and humidity ranges are in Table S1 below. Each box was then shipped to a different location in the United States of America. (Portland, Maine, Anchorage, Alaska, Naples, Florida and Tempe, Arizona). The shipments were held at their respective locations for a period of at least two days then returned to Omega.
- 6.8.3 The average mean % of change in result prior to shipping and after shipping was 0% for all locations combined. The study demonstrated that because a hair sample is a solid matrix, it is not susceptible to the same temperature constraints as a urine sample. All negative sample remained negative after shipping. Of the Positive and near Positive samples, two pre-shipping samples that screened negative, screened positive after shipping. Of the pre-shipping positive screen, two samples screened negative after shipping.
6.9 Stability Study
- 6.9.1 The Stability Study was conducted to determine whether there are any adverse effects on the level of PCP contained in a hair sample when it is placed in storage for an extended period of time.

11

Premarket Notification - 510(k) Omega Laboratories Hair Drug Screening Assay Phencyclidine 510(k) Summary Page 12 of 12

Table 12: Stability values (n = 137 head hair samples)
--------------------------------------------------------

Measured value	Value or range
Range in concentration pg/mg hair (Before)	110 - 4999
Range in concentration pg/mg hair (After)	115 - 5102
Mean Change	-8%
% Max and Min Decrease	-32% and -2%
% Max and Min Increase	9% and 2%
Number that increased in concentration	8
Number that decreased in concentration	12

Based on the 8 % mean percent change over the 2.5 year storage, donor sample PCP drug stability is maintained. Shelf life for the hair samples has been set at 1 year after collection.

7.0 Conclusion:

The Omega Laboratories Hair Drug Screening Assay Phencyclidine using both head and body hair does not raise any new safety and efficacy concerns when compared to the cleared Omega Assay for Phencyclidine (PCP) using head hair only.

Based on the design and performance test results, the Omega assay is substantially equivalent to the predicate Phencyclidine (PCP).

12

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping waves or ribbons.

Public Health Service

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

June 25, 2013

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

Re: K131181

Trade/Device Name: Omega Laboratories Hair Drug Screening Assay Phencyclidine Regulation Number: 21 CFR 862.3100 Regulatory Class: Unclassified Product Code: LCM Dated: February 23, 2013 Received: April 25, 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 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.

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Page 2-Mr. Bard

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. 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/Resourcesfor You/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

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Indication for Use

510(k) Number: K131181

Device Name: Omega Laboratories Hair Drug Screening Assay Phencyclidine

· Indications for Use:

The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is an in vitro diagnostic test that is intended to be used for the determination of the presence of PCP in human hair from the head and body. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes an enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose of identifying the use of PCP. 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 anvone.

Prescription Use (21 CFR Part 801 Subpart D) Over the Counter Use X (21 CFR Part 801 Subpart C)

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

And/Or

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

Denise Johnson-lyles -5 2013.06.25 10:55:51 -04'00'

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

510(k) K131181