(86 days)
The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC (THCA) is an in vitro diagnostic that is intended to be used for the determination of the presence of cannabinoids in human head and body hair samples. The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC utilizes the International Diagnostic Systems Corp. enzyme linked immunosorbant assay (ELISA) for THC Metabolite Testing Kit, for the qualitative detection of THCA at or above 1 pg/mg of hair for the purpose of identifying the use of cannabinoids.
The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC provides only preliminary analytical test results and must be used in combination with a more specific alternate chemical method in order to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is used as the confirmation method, along with deuterated internal standards.
Omega plans to perform this test at one site. Omega has not performed an evaluation of reproducibility at different laboratories.
The test consists of two parts; a pre-analytical proprietary and patent pending hair treatment procedure (to remove THCA from the solid hair matrix to a measurable liquid matrix), and the screening assay. The screening assay is an Enzyme-Linked ImmunoSorbent Assay (ELISA).
Sample is added to a well of the micro strip plate and enzyme conjugate is added, followed by incubation. During this phase, the enzyme-labeled drug conjugate competes with drug in the sample for a limited number of binding sites on the rabbit antibody-coated micro wells. The two bind in proportion to their concentrations. A wash solution is applied to remove any unbound materials. Enzyme substrate solution containing a chromagen is added. The reaction is stopped with an acid and the absorbance is read using a plate reader at 450 nm. A background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug present in the sample.
The Omega Laboratories Hair Drug Screening Assay for THCA (subject device) is an in vitro diagnostic test for the qualitative detection of THCA in human head and body hair samples at or above 1 pg/mg. The device's performance was evaluated through precision and cross-reactivity studies.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" against which the device's performance is measured in a pass/fail manner. Instead, the studies demonstrate the device's precision and cross-reactivity, which are implicitly accepted as sufficient for a screening assay that requires confirmation by a more specific method.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intra-assay Precision (Qualitative) | All samples at or above cutoff (1.25, 1.50, 1.75, 2.00 pg/mg) should be positive. All samples below cutoff (0, 0.25, 0.50, 0.75 pg/mg) should be negative. | For concentrations 0, 0.25, 0.50, 0.75 pg/mg, all 10 replicates were negative. For concentrations 1.25, 1.50, 1.75, 2.00 pg/mg, all 10 replicates were positive. |
| Inter-assay Precision (Qualitative) | All samples at or above cutoff (1.25, 1.50, 1.75, 2.00 pg/mg) should be positive. All samples below cutoff (0, 0.25, 0.50, 0.75 pg/mg) should be negative. | For concentrations 0, 0.25, 0.50, 0.75 pg/mg, all 200 replicates were negative. For concentrations 1.25, 1.50, 1.75, 2.00 pg/mg, all 200 replicates were positive. |
| Cross-reactivity | Acknowledge that structurally similar compounds may contribute to a presumptive positive, but emphasize that these will not confirm via GC/MS/MS. Demonstrate minimal or negligible cross-reactivity with unrelated compounds. | Structurally similar compounds (e.g., (-)-11-nor-9-Carboxy-delta9-THC, (+/-)-11-nor-9-Carboxy-delta9-THC, (-)-11-nor-9-Carboxy-delta8-THC, (-)-delta8-THC, (-)-delta9-THC, (+/-) 11-Hydroxy-delta9-THC, Cannabinol, Cannabidiol) showed varying degrees of cross-reactivity. Nabilone and JWH-018 showed negligible cross-reactivity. The report indicates that GC/MS/MS confirmation resolves these presumptive positives. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Intra-assay Precision: 10 replicates for each of 8 different THCA concentrations (80 samples total).
- Inter-assay Precision: 200 replicates for each of 8 different THCA concentrations (1600 samples total).
- Cross-reactivity: The number of replicates for each compound is listed as 'n=3' for the cutoff control equivalence.
- Stability Studies: Two storage time points (1 year and 2.5 years) were used for stability studies, but the number of unique samples tested is not explicitly stated.
- Cosmetic Treatment Study: The mean effect was calculated from 8 positive samples with available data for quantitative values before and after all treatments.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The precision studies used "negative hair samples spiked" to various concentrations, indicating laboratory-controlled conditions rather than direct donor specimens for these specific tests. However, it mentions "Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices," implying some testing with actual donor samples, though details are scarce.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish ground truth for the test set in the context of clinical interpretation or diagnostic decision-making. The ground truth for the precision studies was established by spiking known concentrations of THCA into negative hair samples. For presumptive positive screening results, the document clearly states that Gas Chromatograph-Mass Spectrometry (GC/MS/MS) is used as the confirmation method to obtain a confirmed result, implying this highly precise analytical method serves as the ultimate ground truth for chemical identification and quantification.
4. Adjudication Method for the Test Set:
Not applicable in the conventional sense for clinical studies involving multiple readers. The evaluation of the device relied on analytical performance characteristics (precision, cross-reactivity) where the "ground truth" was determined by the known concentrations of spiked samples or by a reference analytical method (GC/MS/MS) for confirmation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes an in vitro diagnostic device and its analytical performance, not a system involving human readers interpreting results in a clinical setting that would benefit from an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the performance studies described (Precision, Cross-reactivity, Calibrator and Control, Stability, Cosmetic Treatment) are all "standalone" in nature, evaluating the analytical performance of the Omega Laboratories Hair Drug Screening Assay for THCA as an algorithm/assay without human intervention in the detection and initial qualitative determination steps. The human element is involved in the overall workflow (e.g., sample preparation, running the ELISA, interpreting the absorbance readings against a cutoff, and performing GC/MS/MS confirmation), but the reported performance metrics focus on the assay's biochemical and analytical accuracy.
7. The Type of Ground Truth Used:
- Precision Studies: Known, spiked concentrations of THCA in negative hair samples served as the ground truth.
- Cross-reactivity Studies: Known concentrations of various compounds and their measured cross-reactivity against the target analyte.
- Confirmation of Presumptive Positives: Gas Chromatograph-Mass Spectrometry (GC/MS/MS) is explicitly stated as the confirmation method, which serves as the definitive ground truth for chemical identification and quantification of THCA.
8. The Sample Size for the Training Set:
The document does not specify a separate "training set" as it is describing an ELISA assay, not a machine learning algorithm that typically requires a distinct training phase. The analytical methods (ELISA protocol, cutoff determination) are established through development and validation, rather than typical machine learning training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for this type of in vitro diagnostic device. The "ground truth" for establishing the assay's parameters (e.g., cutoff, reagent concentrations) would have been determined through internal development and validation processes, likely using characterized samples with known THCA concentrations and optimizing the assay for sensitivity and specificity around the 1 pg/mg cutoff. However, the document does not detail this developmental phase; it focuses on the validation of the final device.
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Omega Laboratories. Inc. 510(k) Summary Omega Hair Drug Screening Assay for THCA
510(k) Summary
DEC 5 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
510(k) Number: K122759
Date of Summary: December 4, 2012
Applicant:
William R. Corl Vice President of Operations
Omega Laboratories. Inc. 400 North Cleveland Mogadore, OH 44260 Tel: 330-628-5748 Fax: 330-628-5803
Correspondent: Name:
Robert J Bard, JD
Address:
Phone Number: E-mail
Omega Laboratories 400 North Cleveland, Mogadore, OH 44260 248-573-5040 rbard@reglaw.net
Hair Drug Screening Assay for THCA
Product Name:
Omega Laboratories Hair Drug Screening Assay Carboxy-THC (THCA)
Common Name:
Trade Name:
Regulation Number: 21 CFR 862.3870 (ProCode LDJ)
Classification Name: Enzyme immunoassay, Cannabinoids
Classification Panel: 91 (Toxicology)
Psychemedics Microplate EIA for Cannabinoids in Hair K111929 Predicate Device:
Product Description:
The test consists of two parts; a pre-analytical proprietary and patent pending hair treatment procedure (to remove THCA from the solid hair matrix to a measurable liquid matrix), and the screening assay. The screening assay is an Enzyme-Linked ImmunoSorbent Assay (ELISA).
Sample is added to a well of the micro strip plate and enzyme conjugate is added, followed by incubation. During this phase, the enzyme-labeled drug conjugate competes with drug in the sample for a limited number of binding sites on the rabbit antibody-coated micro wells. The two bind in proportion to their concentrations. A wash solution is applied to remove any unbound materials. Enzyme substrate solution containing a chromagen is added. The reaction is stopped with an acid and the absorbance is read using a plate reader at 450 nm. A background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug present in the
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sample.
Indication for Use: The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC (THCA) is an in vitro diagnostic test that is intended to be used for the determination of the presence of cannabinoids in human head and body hair samples. The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC utilizes the International Diagnostics Systems Corp. enzyme linked immunosorbent assay (ELISA) for THC Metabolite Testing Kit, for the qualitative detection of THCA at or above 1 pg/mg of hair for the purpose of identifying the use of cannabinoids. The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC provides only preliminary analytical test results and must be used in combination with a more specific alternate chemical method in order to obtain a confirmed result. Gas Chromatograph- Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is used as the confirmation method, along with deuterated internal standards. Omega plans to perform this test at one site. Omega has not performed an evaluation of reproducibility at different laboratories. See Appendix A Comparison: Performance Data: Performance characteristic studies were conducted for All performance studies demonstrated that the Omega assay is in substantial agreement with the predicate products. Results obtained from donor specimens showed that the qualitative results from the new assays are substantially equivalent to those obtained from the predicate devices.
LIMITATIONS: Performance of this assay in specific user populations has not been characterized. The donor population in the historical data was not fully characterized. Interpretation of results must take into account that drug concentrations detected in hair from a single individual can vary extensively depending on the site of collection. Positive screening results only indicate the presence of THCA, and require a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS/MS) to confirm the result. A negative screening result does not necessarily rule out the possibility of THC use, i.e., time of collection, frequency of use, mode of ingestion, dosage used, hair types and other factors may influence results. It will not be possible to document all possible effects due to treatments such as bleaching, straightening and dying. There is a possibility that other substances and/or factors not evaluated in the interference studies may interfere with the test and cause false results that cannot be confirmed by mass spectrometry, e.g. technical or procedural errors.
PRECISION : Intra-assay precision studies were performed using 10 replicates of negative hair samples spiked to the following concentrations of THCA: zero drug, -75%, -25%, -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 and measured in one run.
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| Drug | Concentrationof Sample(pg/mg) | Number ofReplicates | Results #Negative | Results #Positive |
|---|---|---|---|---|
| THCA | 0 | 10 | 10 | 0 |
| THCA | 0.25 | 10 | 10 | 0 |
| THCA | 0.50 | 10 | 10 | 0 |
| THCA | 0.75 | 10 | 10 | 0 |
| THCA | 1.25 | 10 | 0 | 10 |
| THCA | 1.50 | 10 | 0 | 10 |
| THCA | 1.75 | 10 | 0 | 10 |
| THCA | 2.00 | 10 | 0 | 10 |
THCA Intra-Assay Precision Studies
Inter-assay precision studies were performed using negative hair samples spiked to the following concentrations of THCA: 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. Ten replicates of these were prepared and analyzed over 20 non-consecutive.
| Drug | Concentrationof Sample(pg/mg) | Number ofReplicates | Results #Negative | Results #Positive |
|---|---|---|---|---|
| THCA | 0 | 200 | 200 | 0 |
| THCA | 0.25 | 200 | 200 | 0 |
| THCA | 0.50 | 200 | 200 | 0 |
| THCA | 0.75 | 200 | 200 | 0 |
| THCA | 1.25 | 200 | 0 | 200 |
| THCA | 1.50 | 200 | 0 | 200 |
| THCA | 1.75 | 200 | 0 | 200 |
| THCA | 2.00 | 200 | 0 | 200 |
Table 16: THCA Inter-Assay Precision Studies (CO=1 pg/mg)
CROSSREACTIVITY The Crossreactivity Study demonstrated that the presence of the structurally similar compounds (-) 11-nor-9-Carboxy-delta9-THC, (+/-) 11-nor-9-Carboxy-delta9-THC, (-) 11-nor-9-Carboxydelta8-THC, (-)-delta8-THC, (-)-delta9-THC, (+/-) 11-Hydroxy-delta9-THC, Cannabinol, Cannabidiol, Nabilone, and JWH-018 may contribute to a THC Metabolite positive ELISA result when utilizing this protocol. Since a GC/MS/MS confirmation is performed on all presumptive positive screening results, these compounds will not confirm as a positive result report. All of the other compounds studied did not demonstrate any interference with the protocol.
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| Compound | Approximate Concentration ofCompound (pg/mg) Equivalent to1pg/mg(-) 11-nor-9-Carboxy-delta9-THCCutoff Control(n=3) | PercentCrossreactivity(%) |
|---|---|---|
| (-)11-nor-9-Carboxy-delta9-THC | 1.0 | 100.0 |
| (+/-)11-nor-9-Carboxy-delta9-THC | 1.0 | 100.0 |
| (-)11-nor-9-Carboxy-delta8-THC | 0.45 | 222.2 |
| (-)-delta8-THC | 60.0 | 1.7 |
| (-)-delta9-THC | 50.0 | 2.0 |
| (+/-) 11-Hydroxy-delta9-THC | 5.0 | 22.2 |
| Cannabinol | 70.0 | 1.4 |
| Cannabidiol | 3000 | 0.03 |
| Nabilone | >400000 | <0.01 |
| JWH-018 | >40000 | <0.01 |
Table 22. Cross reactivity of the Omega Laboratories, Inc. THC Metabolite ELISA with Structurally Similar Compounds
CALIBRATOR AND CONTROL: The Omega Laboratories, Inc. ELISA Screening Protocol utilizes inhouse prepared calibrator and control solutions. The study demonstrated the validation and stability of these solutions along with the traceability to NIST standards.
The study demonstrated the stability of THCA in methanol for a period of six months when stored refrigerated in an amber bottle. The quantitative value after a six month period as compared to a freshly prepared solution is within 10% of the target value of 2.5 pg/mg. This validates the six months expiration date for the THCA Stock Solution.
STABILITY: Stability Studies determined whether there are any adverse effects on the level of THCA contained in a hair sample when it is placed in storage for an extended period of time. Two storage time points were used (1 year and 2.5 years)
The Stability Study demonstrated that the mean variance on the concentration of THCA in hair samples when stored for a 1 year period was -30.7%.
COSMETIC TREATMENT: Numerous studies have demonstrated that the use of cosmetic treatments can reduce the amount of drugs and metabolites detected in hair specimens (see attached references). This effect is completely dependent upon the nature of the hair specimen and the treatment used, and is
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independent of the method of analysis. This study demonstrates that the Omega Laboratories, Inc. ELISA THCA Screening Protocol is not an exception to this phenomenon.
Study results found bleach and relaxer treatments had the greatest effect on positive samples resulting in an average decrease in THCA concentration of 19%. This was followed by dying and permanents resulting in an average decrease in THCA concentration of 16%, respectively. The mean effect of shampoos was 6%.
This effect was similar for negative samples. The quantitative values before and after all treatments where data was available averaged -19% (n=8).
Conclusion:
The Omega Laboratories Hair Drug Screening Assay for THCA is substantially equivalent to the predicate Psychemedics Corp Microplate EIA for Cannabinoids in Hair (K111929).
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Appendix A: Comparison of Omega Laboratories THCA Assay vs Psychemedics Microplate EIA for Cannabinoids in Hai
| ComparisonElement -Similarities | Hair Drug Screening Assay for THCA (Subjectdevices) | Psychemedics Microplate EIA for Cannabinoids in Hair(K111929)Primary Predicate |
|---|---|---|
| Laboratory | Omega Laboratories, Inc. | Psychemedics Corp. |
| Indication for/Intended Use | The Omega Laboratories Hair Drug Screening Assay forCarboxy-THC (THCA) is an in vitro diagnostic test that isintended to be used for the determination of the presenceof cannabinoids in human head and body hair samples.The Omega Laboratories Hair Drug Screening Assay forCarboxy-THC utilizes the International DiagnosticsSystems Corp. enzyme linked immunosorbent assay(ELISA) for THC Metabolite Testing Kit, for the qualitativedetection of THCA at or above 1 pg/mg of hair for thepurpose of identifying the use of cannabinoids.The Omega Laboratories Hair Drug Screening Assay forCarboxy-THC provides only preliminary analytical testresults and must be used in combination with a morespecific alternate chemical method in order to obtain aconfirmed result. Gas Chromatograph- MassSpectrometry operating in the selected ion monitoring(SIM) mode or GC/MS/MS in selected reaction mode(SRM) is used as the confirmation method, along withdeuterated internal standards.Omega plans to perform this test at one site. Omega hasnot performed an evaluation of reproducibility at differentlaboratories. | The Psychemedics Microplate EIA for Cannabinoids in Hair isan enzyme immunoassay (EIA) for the preliminary qualitativedetection of cannabinoids in human head and body hairsamples using a 11-nor-9-Carboxy- Δ9-THC calibrator at 10pg/10 mg hair cutoff for the purpose of identifying marijuanause. This is an in vitro diagnostic device 2 intended exclusivelyfor Psychemedics use only and is not intended for sale toanyone.The Psychemedics Chemiluminscent Microplate EIA forCannabinoids assay provides only a preliminary analytical testresult. A more specific alternative chemical method must beused in order to obtain a confirmed analytical result. GasChromatography/Mass Spectrometry/Mass Spectrometry(GC/MS/MS) is the preferred confirmatory method. Clinicalconsideration and professional judgment should be exercisedwith any drug of abuse test result, particularly when thepreliminary result is positive. |
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Cannahinoids in Hair EIA anisto diec Micr F
| Appendix A: Comparison of Omega Laboratories THCA Assay vs Psychemedics Microplate EIA for Cannabinoids in Hair | ||
|---|---|---|
| ComparisonElement -Similarities | Hair Drug Screening Assay for THCA (Subjectdevices) | Psychemedics Microplate EIA for Cannabinoids in Hair(K111929)Primary Predicate |
| Micro-plate | International Diagnostics Systems Corp Forensic HumanDrugs of AbuseHTC Metabolite ELISA for Hair Test IDS -4800-OM | Psychemedics Corp.Chemiluminscent Microplate EIA for Cannabinoids assay. |
| Method ofMeasurement | Microplate reader. Read at 450 nm | Microplate reader. Read at 450 nm |
| Matrix | Head and body hair | Head and body hair |
| Cutoffconcentration | 1 pg THCA /mg hair | 10 pg THCA /10 mg hair |
| Assay Principal | Enzyme linked immunosorbent assay (ELISA) | EIA (Qualitative chemiluminescent enzyme immunoassay EIA) |
| ExtractionMethod | Utilized acid-methanol vs methanol alone to facilitateextraction of THCA from hair.Proprietary and patent pending method of pulverizing hairvs cutting the hair into small segments prior to acid-methanol extraction. This improved extraction timeswithout loss of efficiency | Proprietary extraction method |
Page 7 of 7
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 5, 2012
Omega Laboratories, Inc. c/o Robert J. Bard 400 North Cleveland Mogadore, Ohio 44260
Re: K122759
Trade/Device Name: Omega Laboratories Hair Drug Screening Assay Carboxy – THC (THCA) Regulation Number: 21 CFR §862.3870
Regulation Name: Cannabinoid test system
Regulatory Class: Class II
Product Code: LDJ
Dated: October 4, 2012
Received: October 5, 2012
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 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 Part 801); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDeyices/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson 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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Indications for Use
510(k) Number (if known): K122759
Device Name: Omega Laboratories Hair Drug Screening Assay for Carboxy-THC (THCA)
Indications for Use:
The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC (THCA) is an in vitro diagnostic that is intended to be used for the determination of the presence of cannabinoids in human head and body hair samples. The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC utilizes the International Diagnostic Systems Corp. enzyme linked immunosorbant assay (ELISA) for THC Metabolite Testing Kit, for the qualitative detection of THCA at or above 1 pg/mg of hair for the purpose of identifying the use of cannabinoids.
The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC provides only preliminary analytical test results and must be used in combination with a more specific alternate chemical method in order to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is used as the confirmation method, along with deuterated internal standards.
Omega plans to perform this test at one site. Omega has not performed an evaluation of reproducibility at different laboratories.
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 Schinleber
Division Sign-Off
Office of In Vitro Diagnostics and Radiological Health
510(k) K122759
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).