(88 days)
Not Found
No
The summary describes a laboratory developed test utilizing ELISA and GC/MS, which are standard analytical chemistry techniques, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
This device is a diagnostic tool used to detect the presence of PCP in hair samples, not to treat a medical condition.
Yes
This device is a laboratory developed test that determines the presence of PCP in human hair from the head, which is a diagnostic purpose.
No
The device description explicitly states it is a "test system that utilizes the International Diagnostic Systems Corp (IDS) One-Step ELISA PCP reagents and a micro-plate reader" and includes a "pre-analytical proprietary and patent pending hair treatment procedure." These are physical components and procedures, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "determination of the presence of PCP in human hair from the head" for the purpose of "identifying the use of PCP." This is a diagnostic purpose performed in vitro (outside the body) on a biological sample (hair).
- Device Description: It describes a "test system" that utilizes reagents and a micro-plate reader for the "qualitative detection of Phencyclidine in hair samples." This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnostic purposes.
- Sample Type: It uses "human hair from the head," which is a biological specimen.
- Testing Method: It utilizes an "enzyme linked immunosorbent assay (ELISA)," which is a common in vitro diagnostic technique.
- Performance Studies: The document includes performance studies like precision, agreement (comparison to GC/MS), cross-reactivity, and stability, which are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The mention of predicate devices (K042726 Quest Diagnostics HairCheck-DT (PCP) and K011275 Psychemedics Corporation RIA Phencyclidine (PCP) Assay) which are also hair drug screening assays, further supports its classification as an IVD.
While it is a "laboratory developed test" intended for "in-house laboratory use only" and "not intended for sale to anyone," these characteristics describe the distribution and use model of the IVD, not whether it is an IVD. The core function of the device is to perform a diagnostic test on a biological sample in vitro.
N/A
Intended Use / Indications for Use
The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is a laboratory developed test that is intended to be used for the determination of the presence of PCP in human hair from the head. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes the International Diagnostic Systems Corp (IDS) One-Step 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 laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers, this laboratory developed test as a service to its clients.
Product codes (comma separated list FDA assigned to the subject device)
LCM
Device Description
The Omega Laboratories Hair Drug Screening Assay (PCP) is a test system that utilizes the International Diagnostic Systems Corp (IDS) One-Step ELISA PCP reagents and a micro-plate reader for the qualitative detection of Phencyclidine in hair samples at or above 300 pg/mg. It is an assay intended exclusively for in-house use by trained laboratory personnel only and is not intended for sale to anyone.
The Omega Laboratories Hair Drug Screening Assay (PCP) screening test provides only a preliminary analytical test result. To confirm a screen positive result, a more specific alternate chemical method must be used.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human hair from the head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service to its clients.
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: The Screening Protocol was studied to evaluate its precision/reproducibility. The Precision Study was performed to evaluate the intra and inter-assay precision/reproducibility of the Protocol. Evaluation of the precision of the Omega Laboratories, Inc. ELISA PCP Screening Protocol demonstrated that the intra and inter-assay precision using spiked samples was acceptable (%CV of 10% or less). Evaluation of the precision of the Omega Laboratories, Inc. ELISA PCP Screening Protocol using this study design demonstrated that the intra-assay precision using individual donor sample replicates was acceptable (%CV of 15% or less).
Agreement Study: The Agreement Study 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 (Negative n=176 and Positive n=176). Evaluation of the agreement of the Omega Laboratories, Inc. ELISA PCP Screening Protocol vs quantitative GC/MS results demonstrated the false detection rate of samples containing PCP at levels higher than 50% above cutoff concentration is 0% and the false detection rate of PCP at levels less than 50% of the cutoff concentration is 0.6%.
Cosmetic Treatment Study: The Cosmetic Treatment study documented the absence of effects of various cosmetic treatments on the Omega Laboratories, Inc. ELISA PCP Screening Protocol. Permanent treatments had the greatest effect on positive samples followed by bleaching resulting in an average decrease in PCP concentration of 36% and 28%, respectively. The mean effect of relaxer or shampoo treatments was negligible i.e. the mean change was within the standard uncertainty range of the GC/MS confirmation assay.
Cross Reactivities: Cross Reactivity and Interference were studied to evaluate the specificity of the Omega Laboratories. Inc. ELISA PCP Screening Protocol and the possible effect of interfering compounds. 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. Since a GC/MS confirmation is performed on all presumptive positive screening results, these interfering compounds will not confirm as a positive PCP result report.
Environmental Contamination: Two studies were conducted. The first study involved exposing drug-free hair to PCP, washing the hair with methanol three times, performing confirmation testing on the samples and the washes, and observing the final test result. The second study involved performing confirmation testing on known positive samples and observing whether the methanol washes change the final result. The studies examined the following potential exposure modes: Dry Contact, Dry Contact plus Liquid, Dry Contact ply Saline (NaCl) Solution and Smoke. Based on the study results, the proposed testing procedures are able to distinguish between true analytically positive samples and those that have been externally exposed to PCP.
Calibrator and Control: The in-house calibrator and control solutions are prepared solely for use within Omega and only at its laboratories in Mogadore, OH. 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.
Recovery Study: The Extraction Recovery Study evaluated the effectiveness of the extraction method utilized by the Omega Laboratories, Inc. ELISA PCP Screening Protocol. The GC/MS results of the acidic-methanol extraction were compared to the results of the 100% recovery base hydrolysis extraction to determine the relative recovery of PCP using the acidic-methanol incubation. The mean recovery for the acidic-methanol extraction was 102%.
Shipping Study: 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. 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.
Stability Study: 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. Based on the 8 % mean percent change over the 2.5 year storage, donor sample PCP drug stability is maintained at value well within the Acceptance Criteria of less 15% and is consider acceptable for use in the Protocol. Shelf life for the hair samples has been set at 1 year after collection.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
N/A
0
JUL 1 2 2010
Premarket Notification - 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
SUMMARY OF SAFETY AND EFFECTIVENESS
April 12, 2010
Trade Name: Hair Drug Screening Assay (PCP)
Common Name: Hair Drug Screening Assay (PCP)
Applicant:
William R. Corl Vice President of Operations
400 North Cleveland Mogadore, OH 44260 Tel: 330-628-5748 Fax: 330-628-5803
Classification Name:
Classification Panel: Clinical Chemistry
All questions and/or comments concerning this document should be made to:
Robert J. Bard, Esq. Managing Director
HealthCare Technologies Consultants PO Box 506 South Lyon. MI 48178 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 hair.
Phencyclidine (PCP), the hallucinogen commonly referred to as Angel Dust, can be detected in hair. Human head hair grows at approximately ½ inch per month, and has been measured using various biomarkers (1,2). Hair, due to its growth rate and stability, offers a much longer history of drug usage than any other matrix. Hair has been increasingly chosen as a workplace test specimen, since, in contrast to urine, the collection is observed, and the possibility of adulteration or substitution of the specimens is reduced. PCP itself is incorporated into the growing hair shaft. For the screening of PCP in hair, an enzyme linked immunosorbent assay (ELISA) procedure has been established; and for confirmatory analysis, gas chromatography with mass spectrometric detection is the preferred laboratory procedure.
Classification or descriptor | Name or designation |
---|---|
Trade Name | Hair Drug Screening Assay for Phencyclidine (PCP) |
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 |
1.1 Classification Information
PREDICATE DEVICES 2.0
- 2.1 Quest Diagnostics HairCheck-DT (PCP)
- 510(k) Number: K042726 2.1.1
- Psychemedics Corporation RIA Phencyclidine (PCP) Assay 2.2
- 510(k) Number: K011275 2.2.1
INTENDED USE AND INDICATIONS FOR USE 3.0
- The Omega Laboratories Hair Drug Screening Assay Phencyclidine 3.1 (PCP) is a laboratory developed test that is intended to be used for the determination of the presence of PCP in human hair from the head. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes the International Diagnostic Systems Corp (IDS) One-Step 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
2
iudament should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained. This laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service to its clients. The Omega Laboratories Hair Drug Screening Assay (PCP) screening test provides only a preliminary qualitative test result. 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 laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service to its clients.
ASSAY DESCRIPTIONS 4.0
- 4.1 The Omega Laboratories Hair Drug Screening Assay (PCP) is a test system that utilizes the International Diagnostic Systems Corp (IDS) One-Step ELISA PCP reagents and a micro-plate reader for the qualitative detection of Phencyclidine in hair samples at or above 300 pg/mg. It is an assay intended exclusively for in-house use by trained laboratory personnel only and is not intended for sale to anyone.
- 4.2 The Omega Laboratories Hair Drug Screening Assay (PCP) 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 or a similar system that are equivalent to the Omega Collection Kit specifications. Hair samples stored in the Kit have a one vear shelf life.
- 4.4.2 IDS One-Step ELISA PCP (microplate format)
4.4.2.1 The IDS PCP utilizes an enzyme-linked immunosorbent assav technology (ELISA). ELISA utilizes highly sensitive and specific 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
3
Premarket Notification - 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
color change occurs after the addition of substrate. The darker the color, the lower the amount of analyte in the sample.
Materials 4.5
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ
- Sample Collection Kit 4.5.1
- IDS One-Step ELISA PCP Kit 4.5.2
- Micro Plate Read 4.5.3
GC/MS for Confirmation Testing 4.5.4
4
COMPARISON OF BASESENS SYSTEM AND ITS PREDICATES
.0
Comparison of Omega Laboratories PCP Assay vs Quest Diagnostic Hair Check-DT (PCP) Assay 5.1
| | Hair Drug Screening Assay for
Phencyclidine (PCP). (Subject devices) | Hair Drug Screening Assay for
Phencyclidine (PCP). (Predicate device
**K042726) | Psychemedics RIA Phencyclidine
Assay (Predicate device. K011275). |
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Omega Laboratories, Inc. | Quest Diagnostics, Inc. | Psychemedics Corp |
| | The Omega Laboratories Hair Drug
Screening Assay Phencyclidine (PCP) is a
laboratory developed test that is intended to
be used for the determination of the
presence of PCP in human hair. The
Omega Laboratories Hair Drug Screening
Assay (PCP) utilizes the International
Diagnostic Systems Corp (IDS) One-Step
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 laboratory developed test is intended
exclusively for in-house laboratory use only
and is not intended for sale to anyone.
Omega offers this laboratory developed test
as a service to its clients. | The Quest Diagnostics Hair Check-DT
(PCP) is a test system that utilizes the
IDS One-Step ELISA PCP Kit for the
qualitative detection of Phencyclidine at
or above 300 pg/mg in head hair
samples. This test system has not been
evaluated for use in specific user
populations or with hair specimens other
than the head. It is an in vitro diagnostic
device intended exclusively for in-house
professional use only and is not intended
for sale to anyone.
The Quest Diagnostics Hair Check-DT
(PCP) screening test provides only a
preliminary analytical test result. A more
spécific alternate chemical method must
be used in order to obtain a confirmed
result. Gas Chromatograph - Mass
Spectrometry operating in the selected
ion monitoring (SIM) mode is the
preferred method with deuterated internal
standards. Other chemical confirmation
methods are available. Clinical
consideration and professional judgment
should be applied to any drug of abuse
test result, particularly when preliminary
positive results are obtained. (From FDA
Published Statement of Indications for
Use) | The Psychemedics PCP Assay is a
radioimmunoassay (RIA) for the
preliminary qualitative and semi-
quantitative detection of phencyclidine
(PCP) in hair using a 3 ng/110 mg hair
cutoff for the purpose of identifying
PCP use. For a quantitative analytical
result or to confirm positive results via
the presence of PCP. a more specific
alternate chemical method must be
used in order to obtain a confirmed
analytical result. (From FDA
Published Statement of Indications for
Use) |
Page 1 of 11
5
Product Code | Summary of Safety and Effectivene | |||
---|---|---|---|---|
LCM | LCM | LCL | ||
Measurand | Phencyclidine (PCP) in hair | Phencyclidine (PCP) in hair | Phencyclidine (PCP) in hair | |
Test system | International Diagnostics Systems Corp | |||
Forensic Human Drugs of Abuse | ||||
One-Step ELISA for Hair Testing Kit – IDS | ||||
part# PCP-480-OM. | International Diagnostics Systems Corp | |||
Forensic Human Drugs of Abuse | ||||
One-Step ELISA for Hair Testing Kit – | ||||
IDS part# PCP-480-OM. | Polyclonal primary antibody; | |||
isotopically labeled PCP; double | ||||
antibody precipitation | ||||
Method of | ||||
Measurement | Microplate reader. Read at 450 nm | Microplate reader. Read at 450 nm | ||
Matrix | Head hair | Head hair | Hair/Head hair | |
Cutoff | ||||
concentration | 300 pg PCP/mg hair | 300 pg PCP/mg hair | 3 ng PCP/10 mg hair | |
Type of Test | ELISA | ELISA | Radioimmunoassay (RIA) | |
Extraction | ||||
Method | Utilized acid-methanol vs methanol alone to | |||
facilitate extraction of PCP from hair. | ||||
Proprietary and patent pending method of | ||||
Pulverizing hair vs cutting the hair into small | ||||
segments prior to acid-methanol extraction. | ||||
This improved extraction times without loss | ||||
of efficiency | Methanol | Proprietary | ||
The hair sample preparation for the | ||||
assay is a 2-hour, pH = 9.5, | ||||
enzymatic dilation of the hair. | ||||
Confirmation | ||||
methods | GC/MS | GC/MS | GC/MS | |
Produces | ||||
radioactive | ||||
waste | No | No | Yes |
Page 2 of 11
:
6
SUMMARY OF PERFORMANCE TESTING 6.0
- 6.1 Precision Study
- 6.1.1 The Screening Protocol was studied to evaluate its precision/reproducibility. The Precision Study was performed to evaluate the intra and inter-assay precision/reproducibility of the Protocol.
| PCP Spiked
Sample | negative | 75 pg/mg
-75% | 150 pg/mg
-50% | 225 pg/mg
-25% | 375 pg/mg
+25% | 450 pg/mg
+50% | 525 pg/mg
+75% | 600 pg/mg
+100% |
|-----------------------|----------|------------------|-------------------|-------------------|-------------------|-------------------|-------------------|--------------------|
| Mean Abs. (450
nm) | 1.926 | 1.203 | 0.865 | 0.697 | 0.505 | 0.437 | 0.398 | 0.348 |
| S.D. | 0.05531 | 0.08171 | 0.03957 | 0.03382 | 0.02465 | 0.02637 | 0.02467 | 0.02157 |
| %CV | 2.9 | 3.8 | 4.6 | 4.9 | 4.9 | 6.0 | 6.2 | 6.2 |
Inter-Assay Precision using Spiked Samples (normalized data)
Intra-assay Precision of PCP using Individual Hair Specimens
Accession # | A | B | C | D | E |
---|---|---|---|---|---|
0.521 | 0.486 | 0.282 | 0.115 | 0.058 | |
0.534 | 0.492 | 0.342 | 0.113 | 0.073 | |
0.466 | 0.527 | 0.256 | 0.105 | 0.053 | |
Mean | 0.507 | 0.502 | 0.293 | 0.111 | 0.061 |
S.D. | 0.03609709 | 0.0221 | 0.0441 | 0.0053 | 0.0104 |
%CV | 7.1 | 4.4 | 15.0 | 4.8 | 17.0 |
95% CI | 0.041 | 0.025 | 0.050 | 0.006 | 0.012 |
95% CI Lower | 0.466 | 0.477 | 0.243 | 0.105 | 0.050 |
95% CI Upper | 0.548 | 0.527 | 0.343 | 0.117 | 0.073 |
GC/MS Analysis of Intra-assay Precision of PCP using Individual Hair Specimens
Accession # | A (pg/mg) | B (pg/mg) | C (pg/mg) | D (pg/mg) | E (pg/mg) |
---|---|---|---|---|---|
379 | 568 | 1334 | 4749 | 7493 | |
406 | 542 | 1552 | 4134 | 6754 | |
411 | 571 | 1418 | 4702 | 7040 | |
Mean | 399 | 560 | 1435 | 4528 | 7096 |
S.D. | 17.2143 | 15.9478 | 109.952 | 342.31 | 372.632 |
%CV | 4.3 | 2.8 | 7.7 | 7.6 | 5.3 |
95% CI | 19.5 | 18.0 | 124.4 | 387.4 | 421.7 |
7
Premarket Notification - 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
95% CI Lower | 379 | 542 | 1310 | 4141 | 6674 |
---|---|---|---|---|---|
95% CI Upper | 418 | 578 | 1559 | 4916 | 7517 |
- Evaluation of the precision of the Omega Laboratories, Inc. 6.1.2 ELISA PCP Screening Protocol demonstrated that the intra and inter-assay precision using spiked samples was acceptable (%CV of 10% or less).
- Evaluation of the precision of the Omega Laboratories, Inc. 6.1.3 ELISA PCP Screening Protocol using this study design demonstrated that the intra-assay precision using individual donor sample replicates was acceptable (%CV of 15% or less).
6.2 Agreement Study
- The Agreement Study was performed by comparing ELISA 6.2.1 results against quantitative GC/MS confirmatory results on the same hair specimens. A total of 352 donor hair samples were tested in this study (Negative n=176 and Positive n=176).
| IDS ELISA
PCP Test
Result | Negative by
GC/MS (less
than 50 pg/mg) | 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 than
50% above the
cutoff
concentration) |
|---------------------------------|----------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 1 | 14 | 33 | 128 |
| Negative | 150 | 15 | 7 | 4 | 0 |
Summary of Agreement Study Results
Evaluation of the agreement of the Omega Laboratories, Inc. 6.2.2 ELISA PCP Screening Protocol vs quantitative GC/MS results demonstrated the false detection rate of samples containing PCP at levels higher than 50% above cutoff concentration is 0% and the false detection rate of PCP at levels less than 50% of the cutoff concentration is 0.6%.
- 6.3 Cosmetic Treatment Study
- The Cosmetic Treatment study documented the absence of 6.3.1 effects of various cosmetic treatments on the Omega Laboratories, Inc. ELISA PCP Screening Protocol.
Hair Treatment Assignment | |
---|---|
BLEACH 1 | Salon Care Blue Flash Professional Powder Lightener |
BLEACH 2 | Loreal Super Oreal Blanc® Professional Powder |
Bleach | |
PERM 1 | Naturelle Natural Curls Alkiline Perm |
PERM 2 | Natural Apple Self-Timing Perm |
DYE 1 | Revlon® Colorsilk™ Black |
8
Premarket Notification - 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
DYE 2 | Garnier Herbashine Soft Mahogany Dark Brown |
---|---|
RELAXER 1 | Silk Elements™ No-Lye Sensitive Scalp Relaxer |
System | |
RELAXER 2 | Ultra Precise No-Lye Conditioning Relaxer |
SHAMPOO 1 | After Burner drug removing shampoo |
SHAMPOO 2 | Ultra Cleanse drug removing shampoo |
Summary of Effects for Positive GC/MS Confirmation Data
| Treatment | Mean change in concentration
(pg/mg) |
|-----------|-----------------------------------------|
| Bleach | -28% |
| Permanent | -36% |
| Dyeing | -5% |
| Relaxer | -9% |
| Shampoo | -4% |
- 6.3.2 Permanent treatments had the greatest effect on positive samples followed by bleaching resulting in an average decrease in PCP concentration of 36% and 28%, respectively. The mean effect of relaxer or shampoo treatments was negligible i.e. the mean change was within the standard uncertainty range of the GC/MS confirmation assay
6.4 Cross reativities
Cross Reactivity and Interference was studied were conducted to evaluate the specificity of the Omega Laboratories. Inc. ELISA PCP Screening Protocol and the possible effect of interfering compounds.
- The study demonstrated that the presence of the structurally 6.4.1 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. Since a GC/MS confirmation is performed on all presumptive positive screening results, these interfering compounds will not confirm as a positive PCP result report.
6.5 Environmental Contamination
- 6.5.1 Two studies were conducted. The first study involved exposing drug-free hair to PCP, washing the hair with methanol three times, performing confirmation testing on the samples and the washes, and observing the final test result. The second study involved performing confirmation testing on known positive samples and observing whether the methanol washes change the final result.
9
- The studies examined the following potential exposure modes. 6.5.2 Dry Contact, Dry Contact plus Liquid, Dry Contact ply Saline (NaCI) Solution and Smoke.
- Based on the study results, the proposed testing procedures 6.5.3 are able to distinguish between true analytically positive samples and those that have been externally exposed to PCP.
- Calibrator and Control રે છે. ક
- The in-house calibrator and control solutions are prepared 6.6.1 solely for use within Omega and only at its laboratories in Mogadore, OH.
- The study demonstrated the stability of PCP in methanol for a 6.6.2 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
- 6.7 Recovery Study
- The Extraction Recovery Study evaluated the effectiveness of 6.7.1 the extraction method utilized by the Omega Laboratories, Inc. ELISA PCP Screening Protocol.
- The GC/MS results of the acidic-methanol extraction were 6.7.2 compared to the results of the 100% recovery base hydrolysis extraction to determine the relative recovery of PCP using the acidic-methanol incubation. The mean recovery for the acidicmethanol extraction was 102%.
6.8 Shipping Study
- The Shipping Study was conducted to determine whether 6.8.1 there is any adverse effect on donor hair samples when exposed to extreme temperatures and variations in humidity that might occur during sample shipments.
- The average mean % of change in result prior to shipping and 6.8.2 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.
- 6.9 Stability Study
- The Stability Study was conducted to determine whether there 6.9.1 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.
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% |
Table 16: Stability values
10
Premarket Notification – 510(k) Hair Drug Screening Assay (PCP) Summary of Safety and Effectiveness
% 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 at value well within the Acceptance Criteria of less 15% and is consider acceptable for use in the Protocol. Shelf life for the hair samples has been set at 1 year after collection.
Conclusion:
The Omega Laboratory Hair Drug Screening Assay for Phencyclidine (PCP) does not raise any new safety and efficacy concerns when compared to the cleared Quest Diagnostics HairCheck-DT (PCP).
Based on the design and performance test results, the Omega assay is substantially equivalent to the Quest Diagnostic HairCheck-DT (PCP).
11
Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Omega Laboratories, Inc. c/o Mr. Robert J Bard JD Managing Director PO Box 506 South Lyon, Michigan 48178
JUL 1 2 2010
K101059 Re:
Trade Name: Omega Laboratories Hair Drug Screening Assay for Phencyclidine Regulation Number: Unclassified Regulatory Class: Class II Product Codes: LCM Dated: April 11, 2010
Received: April 15, 2010
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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/ReportaProblem/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
K101059 510(k):
Device Name: Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP)
Indication for Use:
The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is a laboratory developed test that is intended to be used for the determination of the presence of PCP in human hair from the head. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes the International Diagnostic Systems Corp (IDS) One-Step 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 laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers, this laboratory developed test as a service to its clients.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)