(61 days)
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.
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.
Acceptance Criteria and Device Performance for Omega Laboratories Hair Drug Screening Assay Phencyclidine (K131181)
The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is an in vitro diagnostic test for the qualitative detection of PCP in human head and body hair at or above 300 pg/mg.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria (e.g., target true positive rate, true negative rate, or specific ranges for precision values) against which the study results are directly measured. However, the studies demonstrate the precision, agreement with a reference method, and robustness of the assay. The performance is reported in terms of observed precision and agreement rates.
| Performance Metric | Acceptance Criteria (Implicit/Demonstrated) | Reported Device Performance |
|---|---|---|
| Intra-assay Precision (Individual Samples) | Consistent detection of PCP in positive samples. | 100% positive agreement for 3 replicates of 5 different positive PCP samples (399-7096 pg/mg). |
| Intra-assay Precision (Spiked Samples at Cutoff) | Consistent detection across negative, below cutoff, and above cutoff concentrations. | Negative samples (0, 75, 150, 225 pg/mg): 100% negative results (11/11 replicates each).Positive samples (375, 450, 525, 600 pg/mg): 100% positive results (11/11 replicates each). |
| Inter-assay Precision (Spiked Samples at Cutoff) | Consistent detection across negative, below cutoff, and above cutoff concentrations over multiple runs. | Negative samples (0, 75, 150, 225 pg/mg): 100% negative results (220/220 replicates each).Positive samples (375, 450, 525, 600 pg/mg): 100% positive results (220/220 replicates each). |
| Agreement with GC/MS (Combined Head & Body Hair) | High agreement with GC/MS as the confirmatory method, especially around the cutoff. | Total samples (n=393):- ELISA Positive / GC/MS Positive (>300 pg/mg): 38 + 162 = 200 samples- ELISA Negative / GC/MS Negative (<300 pg/mg): 150 + 15 + 8 = 173 samples- Discordant Results (Positive ELISA / Negative GC/MS): 1 (150 pg/mg) + 15 (150-299 pg/mg) = 16 samples- Discordant Results (Negative ELISA / Positive GC/MS): 4 (300-450 pg/mg) = 4 samples(Note: Specific metrics like Sensitivity, Specificity, PPV, NPV are not calculated in the provided text but can be derived from the table.) |
| Cosmetic Treatment Effects (Negative Samples) | Cosmetic treatments should not induce false positives in negative samples. | All treated negative samples remained negative (n=86 samples across 10 treatments). |
| Cosmetic Treatment Effects (Positive Samples) | Minimal impact on test results for positive samples. | 6 out of 89 positive samples changed from positive to negative after treatment (Perm #1: 3/18, Dye 1: 2/18, Relaxer #1: 1/18). All other treatments showed no change from positive to negative. |
| Cross-reactivity | Limited or no cross-reactivity with non-PCP compounds, except for specified structurally similar compounds. | - 100% cross-reactivity with Phencyclidine (control).- Other structurally similar compounds showed cross-reactivity: Metaphit (60.0%), Phencyclidine Morpholine (20.0%), 4-Hydroxy-Phencyclidine (5.0%).- None of the other 270 tested compounds demonstrated interference. |
| Environmental Contamination | Positive results due to environmental contamination should be distinguishable via confirmation testing. | Acknowledged that preliminary positive results could be due to environmental contamination, recommending confirmation testing. |
| Calibrator and Control Stability | Stable for at least one year. | Stability of PCP in methanol demonstrated for one year when stored refrigerated in an amber bottle, supporting the 1-year expiration date. |
| Extraction Recovery | Effective extraction of PCP from hair. | Performance evaluated using 5 previously confirmed positive head hair samples, processed with acidic-methanol extraction. (Specific recovery rates are not explicitly reported, but the study implies effectiveness). |
| Shipping Stability | Hair samples should tolerate shipping conditions without affecting test results. | Average mean % of change in result prior to shipping and after shipping was 0% for all locations combined. All negative samples remained negative. Small number of positive/near-positive samples changed status (2 negative became positive, 2 positive became negative). |
| Long-term Storage Stability | PCP levels in hair samples should remain stable over extended storage. | Mean change of -8% over 2.5 years of storage in 137 head hair samples. Range of change: -32% to +9%. Considered stable for the set shelf life of 1 year. |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Agreement Study (Primary Test Set): A total of 393 donor hair samples.
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective/Prospective: Not specified. The original study (K101059) included 352 samples, and a second study added 41 more, suggesting they were previously collected donor samples.
-
Precision Studies:
- Intra-assay (Individual): 5 hair specimens, each divided into 6 aliquots (3 aliquots analyzed), yielding a total of 15 test measurements.
- Intra-assay (Spiked): 11 replicates for 8 concentrations, totaling 88 test measurements.
- Inter-assay (Spiked): 11 replicates for 8 concentrations, analyzed over 20 non-consecutive days, totaling 220 test measurements for each concentration (1760 total measurements).
-
Cosmetic Treatment Study:
- Negative Samples: n=86 samples.
- Positive Samples: n=89 samples.
-
Cross-reactivity: Tested against 273 compounds (Phencyclidine, 4 structurally similar compounds, and 269 other compounds mentioned as "None of the other (270) compounds").
-
Shipping Study: n=137 head hair samples (30 positive, 100 negative, 7 near cutoff).
-
Stability Study (Long-term Storage): n=137 head hair samples.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the ELISA assay itself, as the gold standard for confirmation is typically a different analytical method.
For the Agreement Study, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) operating in selected ion monitoring (SIM) mode with deuterated internal standards. This is an objective, analytical method, not typically relying on expert interpretation in the same way as, for example, medical imaging. Therefore, "experts" in the sense of trained clinicians making diagnoses are not applicable here. The GC/MS analysis itself requires trained laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable in the traditional sense for this type of analytical device. The "ground truth" for the test set in the Agreement Study was determined by GC/MS results. The ELISA results were then compared directly against these quantitative GC/MS measurements. There was no human consensus or adjudication process described for reconciling discrepancies between the ELISA and GC/MS results; discrepancies were simply reported (Table 7).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices that involve human interpretation (e.g., radiological images) where the performance of human readers with and without AI assistance is compared. The Omega Laboratories Hair Drug Screening Assay Phencyclidine is an automated in vitro diagnostic assay, not one that involves human "readers" interpreting results in a subjective manner that would be assisted by AI.
6. Standalone Performance
Yes, a standalone performance study was performed (algorithm only without human-in-the-loop performance). The entire performance summary (sections 6.1 through 6.9) describes the analytical performance of the ELISA assay as a standalone system.
- Precision studies (Intra-assay and Inter-assay): Demonstrate the reproducibility of the device's output.
- Agreement Study: Compares the device's output directly against a gold standard analytical method (GC/MS) without human intervention in the device's determination.
- Cosmetic Treatment, Cross-reactivity, Shipping, and Stability Studies: Evaluate the robustness and analytical validity of the device's performance under various conditions.
7. Type of Ground Truth Used
The ground truth used for the primary performance assessment (Agreement Study) was quantitative Gas Chromatography/Mass Spectrometry (GC/MS) results with deuterated internal standards. This is an objective, analytical "confirmatory method" that scientifically determines the presence and concentration of PCP in the hair samples.
8. Sample Size for the Training Set
The document does not provide information on a specific training set size. As this is a 510(k) submission for an enzyme immunoassay, the development process typically involves assay optimization and validation. It's common for such devices not to have a distinct "training set" in the machine learning sense, but rather a development and optimization phase where parameters are set using various samples, followed by independent validation (the "test set" described in the performance summary).
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" is not explicitly mentioned or characterized in terms of ground truth establishment, this information is not provided in the document. The overall assay development and optimization (which can be considered analogous to a training phase) would have relied on established analytical chemistry principles and potentially internal reference methods to ensure the assay's ability to detect PCP and quantify its presence relative to the cutoff.
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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 AssayPhencyclidine |
| 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
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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.
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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.
- 4.4.1 Donor Sample Collection
4.5 Materials
- 4.5.1 Sample Collection Kit
- 4.5.2 ELISA PCP microplate, reagents, controls
- 4.5.3 Micro Plate Reader
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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)
| ComparisonElement | Omega Laboratories Hair DrugScreening Assay Phencyclidine(K131181) | Omega Laboratories Hair DrugScreening Assay PhencyclidineK101059 |
|---|---|---|
| Laboratory | Omega Laboratories, Inc. | Omega Laboratories, Inc. |
| Indication for/Intended Use | The Omega Laboratories Hair DrugScreening Assay Phencyclidine is an invitro diagnostic test that is intended tobe used for the determination of thepresence of PCP in human hair from thehead and body. The OmegaLaboratories Hair Drug Screening Assay(PCP) utilizes an enzyme linkedimmunosorbent assay (ELISA) for PCP,for the qualitative detection of PCP at orabove 300 pg/mg of hair for the purposeof identifying the use of PCP. To confirma screen positive result, a more specificalternate chemical method, such as GasChromatography/Mass Spectrometry(GC/MS) operating in the selected ionmonitoring (SIM) mode is the preferredmethod with deuterated internalstandards. Professional judgment shouldbe applied to any drug of abuse testresult, particularly when presumptivepositive results are obtained.This test is intended exclusively forsingle laboratory use only and is notintended for sale to anyone. | Same |
| Product Code | LCM | Same |
| Measurand | Phencyclidine (PCP) | Same |
| Method ofMeasurement | Microplate reader. Read at 450 nm | Same |
| Matrix | Head and body hair | Head hair |
| Cutoffconcentration | 300 pg PCP/mg hair | Same |
| Type of Test | ELISA (polyclonal goat antibodies) | Same |
| ComparisonElement | Omega Laboratories Hair DrugScreening Assay Phencyclidine(K131181) | Omega Laboratories Hair DrugScreening Assay PhencyclidineK101059 |
| ExtractionMethod | Acid-methanol to facilitate extraction ofPCP from hair. | Same |
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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
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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 ofSample (pg/mg) | Number ofReplicates | 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 ofSample (pg/mg) | Number ofReplicates | 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
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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 ofSample (pg/mg) | Number ofReplicates | 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)
| ELISATestResult | GC/MSNegative(< 50 pg/mg) | GC/MSNegative(<150 pg/mg) | GC/MSNegative(150 - 299pg/mg) | GC/MSPositive (300 -450 pg/mg) | GC/MSPositive (>450pg/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)
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Premarket Notification - 510(k) Omega Laboratories Hair Drug Screening Assay Phencyclidine
Page 8 of 12
| ScreeningCutoff (pg/mg) | ELISA PCP TestResult (POS/NEG) | GC/MS Cutoff(pg/mg) | GC/MS DrugResult (TotalPCP Equivalentspg/mg) | AssociatedCrossreactingCompound |
|---|---|---|---|---|
| 300 | POS | 300 | 122 | The presence of thestructurally similar |
| 300 | POS | 300 | 166 | compounds metaphit, 4-hydroxyphencyclidine, |
| 300 | POS | 300 | 184 | and phencyclidinemorpholine may |
| 300 | POS | 300 | 264 | contribute to a PCPpositive ELISA |
| 300 | POS | 300 | 267 | |
| 300 | POS | 300 | 272 | |
| 300 | POS | 300 | 280 | |
| 300 | POS | 300 | 284 | |
| 300 | POS | 300 | 286 | |
| 300 | POS | 300 | 287 | |
| 300 | POS | 300 | 287 | |
| 300 | POS | 300 | 288 | |
| 300 | POS | 300 | 290 | |
| 300 | POS | 300 | 291 | |
| 300 | POS | 300 | 293 | |
| 300 | POS | 300 | 298 | |
| 300 | NEG | 300 | 301 | NA |
| 300 | NEG | 300 | 301 | |
| 300 | NEG | 300 | 305 | |
| 300 | NEG | 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.
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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 POSto 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
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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 Concentrationof Compound (pg/mg)Equivalent to 300pg/mgPhencyclidine CutoffControl(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
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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.
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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).
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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)
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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
N/A