(204 days)
The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is an in vitro diagnostic test that is intended for the qualitative detection of Cocaine at or above 500 pg/mg in human head and body hair. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained. This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.
Not Found
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are demonstrated through various performance studies showing the device's agreement with a reference method (GC/MS) and its precision. Specific quantitative acceptance criteria for parameters like sensitivity, specificity, and accuracy are not explicitly stated with numerical targets, but the overall conclusion is based on "substantial agreement" and "acceptability."
| Acceptance Criteria | Reported Device Performance (Omega Assay vs. GC/MS or internal controls) |
|---|---|
| Precision (Intra-assay) | 11/11 correct results for all tested concentrations (negative, -75%, -50%, -25% below cutoff, and +25%, +50%, +75%, +100% above cutoff). |
| Precision (Inter-assay) | 220/220 correct results for all tested concentrations (negative, -75%, -50%, -25% below cutoff, and +25%, +50%, +75%, +100% above cutoff) over 20 non-consecutive runs. (Precision deemed acceptable if %CV < 15% - specific %CV values not provided, but overall results indicate acceptability). |
| Agreement with Reference Method (GC/MS) | Out of 424 samples: - 122 GC/MS Negative (<50 pg/mg) correctly identified as Negative by ELISA. - 3 GC/MS Negative (<250 pg/mg) correctly identified as Negative by ELISA. - 34 GC/MS Negative (250-499 pg/mg) correctly identified as Negative by ELISA. - 24 GC/MS Positive (500-750 pg/mg) correctly identified as Positive by ELISA. - 210 GC/MS Positive (>750 pg/mg) correctly identified as Positive by ELISA. - 31 GC/MS Negative (250-499 pg/mg) identified as Positive by ELISA (discordant). (Specific sensitivity/specificity/accuracy metrics are not provided in percentage form, but raw counts are given.) |
| Cross-Reactivity | Structurally similar compounds (Benzoylecgonine isopropyl ester, Cocaethylene, Cocaine, Benzoylecgonine, Meta-Hydroxybenzoylecgonine, Ecgonine, Norbenzoylecgonine, Norcocaine, Norcocaethylene, Ecgonine methyl ester, Anhydroecgonine methyl ester) demonstrated varying degrees of cross-reactivity. The report notes that these contributed to a positive ELISA result, but GC/MS confirmation would differentiate them. |
| Interfering Compounds | Structurally unrelated compounds did not interfere with the assay. Only structurally cross-reactive compounds produced a positive response. No expected positive samples produced a negative result. |
| Calibrator and Control Validation | Successfully demonstrated validation and stability of in-house prepared calibrator and control solutions, traceable to NIST standards. |
| Stability (Long-term storage) | Mean variance in concentration of combined cocaine + metabolites was -23% over ~2 years. Largest decrease was -46%, largest increase was 17%. General trend of decreasing cocaine and increasing benzoylecgonine noted. |
| Shipping Effects | No adverse effect on head hair samples and no discordant results (pre- and post-shipping) when exposed to extreme temperatures and humidity. Average percent change in positive cocaine GC/MS results was +5% for all locations combined. |
| Cosmetic Treatment Effects | Device is not an exception to the phenomenon that cosmetic treatments can reduce drug amounts. Four initially positive ELISA assays reported negative after treatment (bleach or perm). |
| Environmental Contamination | Acknowledged that preliminary positive results could be due to environmental contamination, emphasizing the need for GC/MS confirmation to distinguish true positives. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: For the agreement study, 424 hair samples were used.
- Data Provenance: The origin of the data (e.g., country of origin, retrospective or prospective) is not specified in the provided text. It only states that testing was performed on "body and head hair samples from different ages, gender, ethnicities and hair color."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The ground truth for the agreement study was established using Gas Chromatography/Mass Spectrometry (GC/MS), which is a "more specific alternate chemical method" and "the preferred method with deuterated internal standards." This implies analysis by qualified laboratory personnel, but their specific number or qualifications (e.g., experience level) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: The text states, "Each specimen was divided into two aliquots and one was used for screening and the other for GC/MS confirmation." This indicates that any discrepancies between the ELISA screening and the GC/MS confirmation would be resolved by the GC/MS result, as it is considered the "reference method" and "preferred method." There is no explicit mention of a multi-reader adjudication panel (like 2+1 or 3+1). The GC/MS acts as the definitive adjudicator.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. This study evaluates an in vitro diagnostic test (ELISA assay), not a device that assists human readers in interpreting images or other data. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting with AI vs. without AI assistance is not applicable to this type of device and was not performed.
6. Standalone Performance Study
- Was it done?: Yes. The document presents standalone performance data for the ELISA assay against the GC/MS reference method. The "Agreement" section (Table 4a and 4b) directly compares the results of the Omega Laboratories Hair Drug Screening Assay (algorithm only, without human intervention in the interpretation of the assay result itself) to the GC/MS ground truth. The precision studies also represent standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The primary ground truth used for the agreement study and for confirming screen positive results is Gas Chromatography/Mass Spectrometry (GC/MS) results, specifically mentioned as operating in the selected ion monitoring (SIM) mode with deuterated internal standards. This is a highly accurate and accepted analytical chemistry method for drug detection and quantification.
8. Sample Size for the Training Set
- Training Set Sample Size: The document describes performance studies, but it does not provide information on a specific training set size for the development of the ELISA assay. This assay likely relies on established biochemical principles and reagent formulation rather than machine learning algorithms that typically require a distinct training set. The various "performance studies" described are for validation, not typically for training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: As no explicit training set is described for this type of immunoassay, the concept of establishing ground truth for a training set in the context of an AI/ML algorithm is not applicable. The assay's development would involve optimizing antibody specificity and binding characteristics against known concentrations of cocaine and its metabolites, with the performance ultimately validated against a gold standard like GC/MS.
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Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 1 of 22
i
510(k) SUMMARY
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: | K131128 |
|---|---|
| Date of Summary: | Nov. 8, 2013 |
| Applicant: | William R. CorlChief Executive OfficerOmega Laboratories, Inc.400 North ClevelandMogadore, OH 44260Tel: 330-628-5748Fax: 330-628-5803 |
NOV 1 3 2013
| Correspondent: | |
|---|---|
| Name: | ROBERT J BARD, JD, CQE, RAC |
| Address: | Omega Laboratories400 North Cleveland, Mogadore, OH 44260 |
| Phone Number: | 248-573-5040 |
| rbard@reglaw.net | |
| Product Name: | |
| Trade Name: | Omega Laboratories Hair Drug Screening Assay for Cocaine andCocaine Metabolites |
| Common Name: | Hair Drug Screening Assay Cocaine and Cocaine Metabolites |
| Regulation Number: | CFR 862.3250 (ProCode DIO) |
| Classification Name: | Cocaine and cocaine metabolite test system |
| Classification Panel: | 91 (Toxicology) |
| Predicate Device: | Omega Laboratories Hair Drug Screening Assay for Cocaine andCocaine Metabolites (K112808); |
| Indication for Use: | The Omega Laboratories Hair Drug Screening Assay for Cocaine andCocaine Metabolites (Cocaine) is an in vitro diagnostic test that isintended for the qualitative detection of Cocaine at or above 500 pg/mgin human head and body hair. To confirm a screen positive result, amore specific alternate chemical method, such as GasChromatography/Mass Spectrometry (GC/MS) operating in the selectedion monitoring (SIM) mode is the preferred method with deuteratedinternal standards. Professional judgment should be applied to anydrug of abuse test result, particularly when presumptive positive resultsare obtained.This test is intended exclusively for single laboratory use only and is notintended for sale to anyone. |
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Page 2 of 22
| Comparison: | When used to qualitatively detect Cocaine and Cocaine Metabolites inhead hair specimens collected with the Omega Specimen CollectionDevice, the Omega assays yield results in substantial agreement withthe predicate device (see Table 1 below). |
|---|---|
| Comparison PerformanceData: | All performance studies demonstrated that the Omega assay is insubstantial agreement with the predicate products.Results obtained from donor specimens showed that the qualitativeresults from the new assays are substantially equivalent to thoseobtained from the predicate devices. |
| ComparisonElement -Similarities | Hair Drug Screening Assay for Cocaine.(Subject devices) | Hair Drug Screening Assay (Cocaine).(Predicate device) |
|---|---|---|
| Laboratory | Omega Laboratories, Inc. | Same. |
| Indication for/Intended Use | The Omega Laboratories Hair DrugScreening Assay for Cocaine and CocaineMetabolites (Cocaine) is an in vitrodiagnostic test that is intended for thequalitative detection of Cocaine at orabove 500 pg/mg in human head and bodyhair. To confirm a screen positive result, amore specific alternate chemical method,such as Gas Chromatography/MassSpectrometry (GC/MS) operating in theselected ion monitoring (SIM) mode is thepreferred method with deuterated internalstandards. Professional judgment shouldbe applied to any drug of abuse test result,particularly when presumptive positiveresults are obtained.This test is intended exclusively for singlelaboratory use only and is not intended forsale to anyone. | Same. |
| Method ofMeasurement | Microplate reader. Read at 450 nm | Same. |
| Matrix | Head and body hair | Head hair |
| Cutoffconcentration | 500 pg Cocaine /mg hair | Same. |
| Assay Principal | ELISA | Same. |
Table 1: Comparison of Omega Laboratories Cocaine Assay vs Omega Laboratories Cocaine Assay
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| ComparisonElement -Similarities | Hair Drug Screening Assay for Cocaine.(Subject devices) | Hair Drug Screening Assay (Cocaine).(Predicate device) |
|---|---|---|
| ExtractionMethod | Utilized acid-methanol vs methanol aloneto facilitate extraction of Cocaine from hair.Proprietary and patent pending method ofpulverizing hair vs cutting the hair intosmall segments prior to acid-methanolextraction. This improved extraction timeswithout loss of efficiency | Same. |
| Table 1: Comparison of Omega Laboratories Cocaine Assay vs Omega Laboratories Cocaine Assay |
|---|
| --------------------------------------------------------------------------------------------- |
Performance Studies
PRECISION : Intra-assay precision studies were performed using 11 replicates of negative head hair samples spiked to the following concentrations of cocaine: 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 and measured in one run. Head hair was used in this study.
| Drug | Concentrationof Sample(pg/mg) | Number ofReplicates | Results #Negative | Results#Positive |
|---|---|---|---|---|
| Cocaine | 0 (Negative) | 11 | 11 | 0 |
| Cocaine | 125 (-75%) | 11 | 11 | 0 |
| Cocaine | 250 (-50%) | 11 | 11 | 0 |
| Cocaine | 375 (-25%) | 11 | 11 | 0 |
| Cocaine | 625 (+25%) | 11 | 0 | 11 |
| Cocaine | 750 (+50%) | 11 | 0 | 11 |
| Cocaine | 875 (+75%) | 11 | 0 | 11 |
| Cocaine | 1000 (+100%) | 11 | 0 | 11 |
Table 2: Intra-Assay Cocaine Precision Studies (11 replicates/8 concentrations n= 88)
Inter-assay precision studies were performed using negative head hair samples spiked to the following concentrations of cocaine: 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. Eleven replicates of these were prepared and analyzed over 20 non-consecutive. The precision of the assay was deemed to be acceptable if the %CV was less than 15%.
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| Drug | Concentration ofSample (pg/mg) | Number ofReplicates | Results #Negative | Results #Positive |
|---|---|---|---|---|
| Cocaine | 0 (Negative) | 220 | 220 | 0 |
| Cocaine | 125 (-75%) | 220 | 220 | 0 |
| Cocaine | 250 (-50%) | 220 | 220 | 0 |
| Cocaine | 375 (-25%) | 220 | 220 | 0 |
| Cocaine | 625 (+25%) | 220 | 0 | 220 |
| Cocaine | 750 (+50%) | 220 | 0 | 220 |
| Cocaine | 875 (+75%) | 220 | 0 | 220 |
| Cocaine | 1000 (+100%) | 220 | 0 | 220 |
Table 3: Inter-Assay Cocaine Precision Studies (CO=500 pg/mg) (11 replicates/8 concentrations over 20 n= 1760)
AGREEMENT: The method comparison was performed by testing 424 hair samples in three studies with the candidate assay and comparing to the reference method, GC/MS. Each specimen was divided into two aliquots and one was used for screening and the other for GC/MS confirmation. Testing was performed on body and head hair samples from different ages, gender, ethnicities and hair color. The results were:
Table 4a: Cocaine Agreement Studies (n=424)
| ELISA TestResult | GC/MS Negative(<50 pg/mg) | GC/MS Negative(<250 pg/mg) | GC/MS Negative (250-499 pg/mg) | GC/MS Positive (500-750 pg/mg) | GC/MS Positive(>750 pg/mg) |
|---|---|---|---|---|---|
| Positive | 0 | 0 | 31 | 24 | 210 |
| Negative | 122 | 3 | 34 | 0 | 0 |
Table 4b: GC/MS Summary of Discordant Results
'
| ScreeningCutoff(pg/mg) | ELISA Test Result(POS/NEG) | Drug | GC/MS Drug Result(pg/mg) | ||
|---|---|---|---|---|---|
| Cocaine | Benzoylecogonine | Cocaethylene | |||
| 500 | POS | 189 | 83 | 0 | 272 |
| 500 | POS | 227 | 44 | 0 | 271 |
| ScreeningCutoff(pg/mg) | ELISA Test Result(POS/NEG) | Drug | GC/MS Drug Result(pg/mg) | ||
| Cocaine | Benzoylecogonine | Cocaethylene | |||
| 500 | POS | 273 | 0 | 0 | 273 |
| 500 | POS | 219 | 87 | 0 | 306 |
| 500 | POS | 251 | 50 | 0 | 301 |
| 500 | POS | 260 | 50 | 0 | 310 |
| 500 | POS | 230 | 87 | 0 | 317 |
| 500 | POS | 278 | 48 | 0 | 326 |
| 500 | POS | 272 | 65 | 0 | 337 |
| 500 | POS | 334 | 0 | 0 | 334 |
| 500 | POS | 238 | 116 | 0 | 354 |
| 500 | POS | 342 | 0 | 0 | 342 |
| 500 | POS | 313 | 43 | 0 | 356 |
| 500 | POS | 335 | 28 | 0 | 363 |
| 500 | POS | 284 | 106 | 0 | 390 |
| 500 | POS | 294 | 103 | 0 | 397 |
| 500 | POS | 354 | 47 | 0 | 401 |
| 500 | POS | 333 | 79 | 0 | 412 |
| 500 | POS | 364 | 54 | 0 | 418 |
| 500 | POS | 328 | 98 | 0 | 426 |
| 500 | POS | 265 | 118 | 65 | 448 |
| 500 | POS | 424 | 37 | 0 | 461 |
| 500 | POS | 393 | 77 | 0 | 470 |
| 500 | POS | 390 | 85 | 0 | 475 |
| ScreeningCutoff(pg/mg) | ELISA Test Result(POS/NEG) | Drug | GC/MS Drug Result(pg/mg) | ||
| Cocaine | Benzoylecogonine | Cocaethylene | |||
| 500 | POS | 433 | 42 | 0 | 475 |
| 500 | POS | 469 | 0 | 0 | 469 |
| 500 | POS | 444 | 32 | 0 | 476 |
| 500 | POS | 336 | 32 | 94 | 462 |
| 500 | POS | 491 | 0 | 0 | 491 |
| 500 | POS | 453 | 46 | 0 | 499 |
| 500 | POS | 497 | 0 | 0 | 497 |
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Table 4b: GC/MS Summary of Discordant Results
{5}------------------------------------------------
Table 4b: GC/MS Summary of Discordant Results
CROSSREACTIVITY: The Crossreactivity Study demonstrated that the presence of the structurally similar compounds Anhydroecgonine methyl ester, Benzoylecgonine isopropyl ester, Meta-Hydroxybenzoylecgonine, Cocaine, Cocaethylene, Ecgonine, Ecgonine methyl ester, Norbenzoylecgonine, Norcocaine, and Norcocaethylene may contribute to a Cocaine positive ELISA result when utilizing this protocol. Since a GC/MS confirmation is performed on all presumptive positive screening results, these compounds will not confirm as a positive result report. None of the other compounds studied demonstrated any interference with the protocol. Head hair was used in this study.
Table 5a: Cross reactivity of Omega Laboratories, Inc. Cocaine ELISA with Structurally Similar Compounds
| Compound | Approximate Concentrationof Compound (pg/mg)Equivalent to 500pg/mgCocaine Cutoff Control | Percent Crossreactivity (%) |
|---|---|---|
| (n=3) | ||
| Benzoylecgonine isopropylester | 300 | 166.7 |
| Cocaethylene | 375 | 133.3 |
| Cocaine | 500 | 100.0 |
| Benzoylecgonine | 600 | 83.3 |
| Meta-Hydroxybenzoylecgonine | 700 | 71.4 |
| Ecgonine | 80000 | 0.6 |
| Norbenzoylecgonine | 150000 | 0.3 |
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Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 7 of 22
| Compound | Approximate Concentrationof Compound (pg/mg)Equivalent to 500pg/mgCocaine Cutoff Control | Percent Crossreactivity (%) |
|---|---|---|
| (n=3) | ||
| Norcocaine | 250000 | 0.2 |
| Norcocaethylene | 250000 | 0.2 |
| Ecgonine methyl ester | 105000 | 0.48 |
| Anhydroecgonine methyl ester | 250000 | 0.2 |
| Anhydroecgonine | Not achieved at highest spike concentration.4000000 pg/mg | |
| Atropine | Not achieved at highest spike concentration.4000000 pg/mg |
Table 5a: Cross reactivity of Omega Laboratories, Inc. Cocaine ELISA with Structurally Similar Compounds
Although the percent cross-reactivity for Ecognine. Norcocaine. Norcocaine, Norcocaine, Norcocaethylene, Econine methyl ester and Anhydroecgonine methyl ester could be considered "low", they have been validated and are sufficiently high enough to produce a "positive" result at these testing concentrations. With the levels of cross-reactivity presented in the table above, these compounds demonstrate positive interference at -50%, +125% and +150% of the cut-off. To demonstrate that these drugs are sufficiently cross-reactive, the table below mathematically re-expresses the percent cross-reactivities as cocaine equivalent concentrations at -50% of the cut-off (250 pg/mg), using Anhydroecgonine methyl ester as an example. This was accomplished by multiplying the (Observed Cross-reactivity) by the (Tested Concentration pg/mg) and adding the 250 pg/mg cocaine present in the sample at -50% of the cut-off.
Example: Anhydroecgonine methyl ester spiked at 400,000 pg/mg into -50% of the cut-off cocaine control sample.
For this calculation we used 0.2% for the Anhydroecqonine methyl ester percent cross-reactivity.
(0.2/100) X (400,000 pg/mg tested concentration) = 800 pg/mg cocaine equivalents.
800 pg/mg cocaine equivalents + 250 pg/mg Cocaine present at -50% of the cutoff = 1050 pg/mg combined equivalent cocaine concentration.
This observed concentration is greater than the 500 pg/mg cocaine cutoff control. Similar calculations can be made for +125% and 150% of the cut-off.
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Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 8 of 22
Effect of Interfering Compounds: A variety of structurally related and unrelated compounds were tested for interference at 10000ng/ml (400000pd/mg) in the Omeda Laboratories, Inc. ELISA Cocaine Screening Protocol. Negative hair extracts were spiked with Cocaine at -50% (250pg/mg), +125% (625pd/mg) and +150% (750pg/mg) of the Cocaine Cutoff Concentration (500pg/mg). These were then additionally spiked with 10000ng/ml (40000pg/mg) of the structurally related compounds unless otherwise noted. The absorbances were compared to the 500 pg/mg Cocaine cutoff control (CO). Only those compounds that were structurally cross reactive interfered in the assay. These structurally related compounds produced a positive response due to significant cross-reactivity. Compounds tested that were not structurally cross-reactive did not interfere with the assay at any of the tested concentrations. No tested samples produced a negative result when expected to be positive. The analysis was performed in triplicate. Head hair was used for this study.
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
|---|---|---|---|
| (-) 11-nor-9-carboxy-delta8-Tetrahydrocannabinol | NEG | POS | POS |
| (-) 11-nor-9-carboxy-delta9-Tetrahydrocannabinol | NEG | POS | POS |
| R (-) Amphetamine | NEG | POS | POS |
| (-) Cotinine | NEG | POS | POS |
| (-) Cotinine -N-oxide | NEG | POS | POS |
| (-) Isoproterenol | NEG | POS | POS |
| (-) Methamphetamine | NEG | POS | POS |
| (-) Nicotine | NEG | POS | POS |
| (-) Phenylephrine | NEG | POS | POS |
| (-)-Alpha-methadol | NEG | POS | POS |
| (+) Amphetamine | NEG | POS | POS |
| (+) Isoproterenol | NEG | POS | POS |
| (+) Methamphetamine | NEG | POS | POS |
| (+) Pseudoephedrine | NEG | POS | POS |
| (+/-) 11-nor-9-carboxy-delta9-Tetrahydrocannabinol | NEG | POS | POS |
| (+/-) 2,5-Dimethoxy- 4- | NEG | POS | POS |
| Inc. Cocaine ELISA Assay | |||
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| bromoamphetamine | |||
| (+/-) Alphaprodine | NEG | POS | POS |
| (+/-) Ketamine | NEG | POS | POS |
| (+/-) MBDB | NEG | POS | POS |
| (+/-) MDA | NEG | POS | POS |
| (+/-) MDEA | NEG | POS | POS |
| (+/-) MDMA | NEG | POS | POS |
| (+/-) Metanephrine | NEG | POS | POS |
| (+/-) Metoprolol | NEG | POS | POS |
| (+/-) Norcotinine | NEG | POS | POS |
| (+/-) Propanolol | NEG | POS | POS |
| (+/-) Trans-3'-Hydroxycotinine | NEG | POS | POS |
| 11-Hydroxy-delta9-Tetrahydrocannabinol | NEG | POS | POS |
| 19-Nortestosterone(Nandrolone) | NEG | POS | POS |
| 1R,2S (-) Ephedrine | NEG | POS | POS |
| 1S,2R (+) Ephedrine | NEG | POS | POS |
| 2-Oxo-3-hydroxy-LSD | NEG | POS | POS |
| 3-methoxynaltrexone | NEG | POS | POS |
| 3-Trans-Hydroxy-norcotinine | NEG | POS | POS |
| 4-Acetoamidophenol | NEG | POS | POS |
| 4-Hydroxy-Phencyclidine | NEG | POS | POS |
| 5,5-Diphenylhydantoin | NEG | POS | POS |
| Inc. Cocaine ELISA Assay | |||
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| 6-Acetyl-codeine | NEG | POS | POS |
| 6-Monoacetylmorphine | NEG | POS | POS |
| 7-Aminoclonazepam | NEG | POS | POS |
| 7-Aminonitrazepam | NEG | POS | POS |
| Acebutolol | NEG | POS | POS |
| Acetophenetidin | NEG | POS | POS |
| Acetopromazine | NEG | POS | POS |
| Acetylsalicyclic acid | NEG | POS | POS |
| Alfentanil | NEG | POS | POS |
| Alpha-Ergocryptine | NEG | POS | POS |
| Alprazolam | NEG | POS | POS |
| 7-Aminoflunitrazepam | NEG | POS | POS |
| Aminorex | NEG | POS | POS |
| Amitriptyline | NEG | POS | POS |
| Amobarbital | NEG | POS | POS |
| Amoxicillin | NEG | POS | POS |
| Anhydroecgonine | NEG | POS | POS |
| Anhydroecgonine methyl ester | POS | POS | POS |
| Anileridine | NEG | POS | POS |
| Apomorphine | NEG | POS | POS |
| Atenolol | NEG | POS | POS |
| Atropine | NEG | POS | POS |
| Azaperone | NEG | POS | POS |
| 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |||
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Benzoylecgonine | POS | POS | POS |
| Benzoylecgonine isopropylester | POS | POS | POS |
| Betamethasone | NEG | POS | POS |
| Boldenone | NEG | POS | POS |
| Bumetanide | NEG | POS | POS |
| Bupivicaine | NEG | POS | POS |
| Buprenorphine | NEG | POS | POS |
| Buspirone | NEG | POS | POS |
| Butabarbital | NEG | POS | POS |
| Butalbital | NEG | POS | POS |
| Caffeine | NEG | POS | POS |
| Cannabidiol | NEG | POS | POS |
| Cannabinol | NEG | POS | POS |
| Carbamazepine | NEG | POS | POS |
| Carisoprodol | NEG | POS | POS |
| Chlordiazepoxide | NEG | POS | POS |
| Chlorpromazine | NEG | POS | POS |
| Cimeterol | NEG | POS | POS |
| Clenbuterol | NEG | POS | POS |
| Clomipramine | NEG | POS | POS |
| Clonazepam | NEG | POS | POS |
| Clonidine | NEG | POS | POS |
| Inc. Cocaine ELISA Assay | |||
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Clozapine | NEG | POS | POS |
| Cocaethylene | POS | POS | POS |
| Cocaine | POS | POS | POS |
| Codeine | NEG | POS | POS |
| Corticosterone | NEG | POS | POS |
| Cortisone | NEG | POS | POS |
| Cotinine-N-beta-D-Glucuronide | NEG | POS | POS |
| Cyclobenzaprine | NEG | POS | POS |
| d,I-N-Desmethylvenlafaxine | NEG | POS | POS |
| Delta8-Tetrahydrocannabinol | NEG | POS | POS |
| Delta9-Tetrahydrocannabinol | NEG | POS | POS |
| Deoxycorticosterone | NEG | POS | POS |
| Desalkyiflurazepam | NEG | POS | POS |
| Desipramine | NEG | POS | POS |
| Desmethyldoxepin (cis/trans) | NEG | POS | POS |
| Despropionyl-fentanyl | NEG | POS | POS |
| Dexamethasone | NEG | POS | POS |
| Dextromethorphan | NEG | POS | POS |
| Diazepam | NEG | POS | POS |
| Dibucaine | NEG | POS | POS |
| Dihydrocodeine | NEG | POS | POS |
| Dihydroergotamine | NEG | POS | POS |
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Dihydromorphine | NEG | POS | POS |
| Diphenhydramine | NEG | POS | POS |
| Diphenoxylate | NEG | POS | POS |
| Diprenorphine | NEG | POS | POS |
| Dothiepin (cis/trans) | NEG | POS | POS |
| Doxepin | NEG | POS | POS |
| Doxylamine | NEG | POS | POS |
| Droperidol | NEG | POS | POS |
| Ecgonine | POS | POS | POS |
| Ecgonine methyl ester | POS | POS | POS |
| EDDP | NEG | POS | POS |
| Effexor (Venlafaxine) | NEG | POS | POS |
| EMDP | NEG | POS | POS |
| Ergonovine | NEG | POS | POS |
| Erythromycin | NEG | POS | POS |
| Estazolam | NEG | POS | POS |
| Ethacrynic acid | NEG | POS | POS |
| Ethopropazine | NEG | POS | POS |
| Ethylmorphine | NEG | POS | POS |
| Fenfluramine | NEG | POS | POS |
| Fentanyl | NEG | POS | POS |
| Flumethasone | NEG | POS | POS |
| Flunitrazepam | NEG | POS | POS |
| Inc. Cocaine ELISA Assay | |||
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Fluphenazine | NEG | POS | POS |
| Flurazepam | NEG | POS | POS |
| Furosemide | NEG | POS | POS |
| Gentamicin | NEG | POS | POS |
| Gluthimide | NEG | POS | POS |
| Haloperidol | NEG | POS | POS |
| Heroin | NEG | POS | POS |
| Hexobarbital | NEG | POS | POS |
| HMMA | NEG | POS | POS |
| Hydrochlorothiazide | NEG | POS | POS |
| Hydrocodone | NEG | POS | POS |
| Hydrocortisone | NEG | POS | POS |
| Hydromorphone | NEG | POS | POS |
| (+/-) 4-Hydroxyephedrine | NEG | POS | POS |
| Hydroxymethamphetamine | NEG | POS | POS |
| Ibogaine | NEG | POS | POS |
| Ibuprofen | NEG | POS | POS |
| Imipramine | NEG | POS | POS |
| Ketoprofen | NEG | POS | POS |
| LAAM | NEG | POS | POS |
| Labetalol | NEG | POS | POS |
| LAMPA (1000ng/ml) | NEG | POS | POS |
| Levorphanol | NEG | POS | POS |
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| L-Hyoscyamine | NEG | POS | POS |
| Lidocaine | NEG | POS | POS |
| Lorazepam | NEG | POS | POS |
| LSD | NEG | POS | POS |
| Lysergic acid | NEG | POS | POS |
| Lysergol | NEG | POS | POS |
| Maprotiline | NEG | POS | POS |
| Meperidine | NEG | POS | POS |
| Mephentermine | NEG | POS | POS |
| Mepivacaine | NEG | POS | POS |
| Metaphit | NEG | POS | POS |
| Metaproterenol | NEG | POS | POS |
| Metaraminol | NEG | POS | POS |
| Methadone | NEG | POS | POS |
| Methohexital | NEG | POS | POS |
| Methoxyphenamine | NEG | POS | POS |
| Methylergonovine | NEG | POS | POS |
| Methylphenidate | NEG | POS | POS |
| m-Hydroxybenzoylecgonine | POS | POS | POS |
| Mianserin | NEG | POS | POS |
| Midazolam | NEG | POS | POS |
| Monensin | NEG | POS | POS |
| Morphine | NEG | POS | POS |
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Morphine-3-betaglucuronide | NEG | POS | POS |
| Morphine-6-betaglucuronide | NEG | POS | POS |
| Nadolol | NEG | POS | POS |
| Nalmefene | NEG | POS | POS |
| Nalorphine | NEG | POS | POS |
| Naloxone-3-beta-D-glucuronide | NEG | POS | POS |
| Naltrexone | NEG | POS | POS |
| Naltriben | NEG | POS | POS |
| Naproxen | NEG | POS | POS |
| N-Desmethylclomipramine | NEG | POS | POS |
| N-Desmethylflunitrazepam | NEG | POS | POS |
| N-Desmethyltramadol | NEG | POS | POS |
| N-Desmethyltrimipramine | NEG | POS | POS |
| Neomycin | NEG | POS | POS |
| Nitrazepam | NEG | POS | POS |
| Norbenzoylecgonine | POS | POS | POS |
| Norbuprenorphine | NEG | POS | POS |
| Norcocaethylene | POS | POS | POS |
| Norcocaine | POS | POS | POS |
| Norcodeine | NEG | POS | POS |
| Nordiazepam | NEG | POS | POS |
| Norfentanyl | NEG | POS | POS |
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Nor-LAAM | NEG | POS | POS |
| Nor-LSD/Nor-ISO-LSD | NEG | POS | POS |
| Normeperidine | NEG | POS | POS |
| Normeperidinic acid | NEG | POS | POS |
| Normorphine | NEG | POS | POS |
| Noroxycodone | NEG | POS | POS |
| Noroxymorphone | NEG | POS | POS |
| Norpropoxyphene | NEG | POS | POS |
| Nortriptyline | NEG | POS | POS |
| Noscapine | NEG | POS | POS |
| O-Desmethyltramadol | NEG | POS | POS |
| Oxazepam | NEG | POS | POS |
| Oxprenolol | NEG | POS | POS |
| Oxycodone | NEG | POS | POS |
| Oxymorphone | NEG | POS | POS |
| p-Acetamidophenyl-beta-D-glucuronide | NEG | POS | POS |
| Papaverine | NEG | POS | POS |
| Pemoline | NEG | POS | POS |
| Penicillin G | NEG | POS | POS |
| Pentazocine | NEG | POS | POS |
| Pentobarbital | NEG | POS | POS |
| Perphenazine | NEG | POS | POS |
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Phendimetrazine | NEG | POS | POS |
| Phenelzine | NEG | POS | POS |
| Phenobarbital | NEG | POS | POS |
| Phenothiazine | NEG | POS | POS |
| Phentermine | NEG | POS | POS |
| Phenylbutazone | NEG | POS | POS |
| Phenylethyamine | NEG | POS | POS |
| Phenylpropanolamine | NEG | POS | POS |
| Phencyclidine | NEG | POS | POS |
| R,R (-)-Pseudoephedrine | NEG | POS | POS |
| Phencyclidine Morpholine | NEG | POS | POS |
| PMA | NEG | POS | POS |
| PMMA | NEG | POS | POS |
| Prednisolone | NEG | POS | POS |
| Prilocaine | NEG | POS | POS |
| Prochlorperazine | NEG | POS | POS |
| Progesterone | NEG | POS | POS |
| Promazine | NEG | POS | POS |
| Promethazine | NEG | POS | POS |
| Propiomazine | NEG | POS | POS |
| Propionylpromazine | NEG | POS | POS |
| Propoxyphene | NEG | POS | POS |
| Protriptyline | NEG | POS | POS |
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Quinidine | NEG | POS | POS |
| R (+) Methcathinone | NEG | POS | POS |
| R (-) Epinephrine | NEG | POS | POS |
| R (+) Cathinone | NEG | POS | POS |
| Salbutamol | NEG | POS | POS |
| Secobarbital | NEG | POS | POS |
| Sertraline | NEG | POS | POS |
| Stanazaloi | NEG | POS | POS |
| Streptomycin | NEG | POS | POS |
| Sulfadimethoxine | NEG | POS | POS |
| Sulfamethazine | NEG | POS | POS |
| Sulfathiazole | NEG | POS | POS |
| Temazepam | NEG | POS | POS |
| Terbutaline | NEG | POS | POS |
| Tetracycline | NEG | POS | POS |
| Thebaine | NEG | POS | POS |
| Theophylline | NEG | POS | POS |
| Thioridazine | NEG | POS | POS |
| Tramadol | NEG | POS | POS |
| Triamcinolone | NEG | POS | POS |
| Triazolam | NEG | POS | POS |
| Trifluoperazine | NEG | POS | POS |
| Trifluopromazine | NEG | POS | POS |
| Compound | -50% CO(250pg/mg) | +125% CO(625pg/mg) | +150% CO(750pg/mg) |
| Trimeprazine | NEG | POS | POS |
| Trimipramine | NEG | POS | POS |
| Tylosin | NEG | POS | POS |
| Tyramine | NEG | POS | POS |
| Yohimbic acid | NEG | POS | POS |
| Yohimbine | NEG | POS | POS |
| Zolpidem | NEG | POS | POS |
| Zopiclone | NEG | POS | POS |
Table 5b: Interferences of Structurally Related and Unrelated Compounds on the Omega Laboratories, Inc. Cocaine ELISA Assay
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Omega Laboratories, Inc.
Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 13 of 22
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Table 5b: Interferences of Structurally Related and Unrelated Compounds on the Omega Laboratories. Inc. Cocaine ELISA Assay
CALIBRATOR AND CONTROL: The Omega Laboratories, Inc. ELISA Cocaine Screening Protocol utilizes in-house prepared calibrator and control solutions. This study successfully demonstrated the validation and stability of these solutions and the traceability to NIST standards.
While the typical urine drugs of abuse controls challenge the cutoff calibrator with concentrations of ± 25% of the cutoff calibrator in nanograms, the hair testing industry utilizes -50% and +100% in picograms. Example -25% of a nanogram is larger than -50% of a picogram. Head hair was used in this study.
STABILITY: The Stability Study demonstrated that the mean variance on the concentration of combined cocaine+ cocaine metabolites in 50 head hair samples when stored for an extended period of approximately 2 years was -23%.
Additionally, the largest decrease and increase for combined cocaine metabolites was -46% and 17%, respectively. The general trend of decreasing cocaine and increasing benzovlecgonine may be consistent with non-enzymatic hydrolysis of cocaine to benzoylecgonine. Head hair was used in this study.
| Study Observation | Cocaine | Benzoylecgonine | Norcocaine | Cocaethylene |
|---|---|---|---|---|
| AverageConcentration(pg/mg) | 5123 | 1262 | 287 | 438 |
| Mean Change in % | -23 | 5 | 5 | 2 |
| Range inConcentration | 369 - 35666 | 36 - 9499 | 39 - 1963 | 24 - 2101 |
Table 6: Cocaine Stability Study Summary of Results
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Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 21 of 22
| Study Observation | Cocaine | Benzoylecgonine | Norcocaine | Cocaethylene |
|---|---|---|---|---|
| (pg/mg) | ||||
| % Max and Mindecrease | -50% and -5% | -47% and -2% | -30% and -0.4% | -41% and 0% |
| % Max and Minincrease | 18% and 4% | 59% and 1% | 47% and 2% | 135% and 0% |
| Number thatdecreased inconcentration | 45 | 18 | 16 | 17 |
| Number thatincreased inconcentration | 5 | 32 | 20 | 16 |
SHIPPING: A total of 200 hair samples were use in the study; 100 positive samples and 100 negative samples. Head hair was used in this study.
The Shipping Study demonstrated that there was no adverse effect on head hair samples that would affect the screening assay when samples are exposed to extreme temperatures and variations in humidity that might occur during sample transport. The average percent change in Positive Cocaine sample GC/MS results prior to shipping and after shipping was +5% for all locations combined.
Additionally, there were no discordant results pre- and post-shipping (as confirmed by GC/MS).
COSMETIC TREATMENT: Numerous studies have demonstrated that the use of cosmetic treatments can reduce the amount of drugs and metabolites detected in hair specimens. This effect is completely dependent upon the nature of the hair specimen and the treatment used, and is independent of the method of analysis. This study demonstrates that the Omega Laboratories, Inc. ELISA Cocaine Screening Assay is not an exception to this phenomenon.
Sixty six hair specimens previously determined to be negative for cocaine were obtained and the ethnic origin, hair color and curvature were documented. One hundred and ten hair specimens potentially positive for cocaine were obtained and the ethnic origin, hair color and curvature were documented. Each specimen was divided into 2 aliquots. One aliquot was analyzed by the ELISA protocol and by the GC/MS confirmation method.
Of the 176 treated specimens, four initially POSITIVE ELISA assays (one bleach and three permanent) reported NEG ELISA results after treatment.
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 samples that were positive due to external exposure. Head hair was used for this study.
CONCLUSION:
The comparison of results of the proposed assay and GC/MS for Cocaine metabolites in head and body hair samples showed the results to be substantially equivalent
The candidate Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites is substantially equivalent to the predicate Omega Laboratories Hair Drug Screening Assay for Cocaine and
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Omega Laboratories, Inc. 510(k) Summary Omega Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Page 22 of 22
Cocaine Metabolites (Cocaine) predicate device based on acceptable performance studies, including precision, specificity, interference (including cosmetic effects) and removal of environmental contamination.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/22/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Content Center .. WO66-G608 Silver Spring, MD 20993-0002
November 13, 2013
Omega Laboratories, Inc. C/O Robert J. Bard, JD 400 North Cleveland MOGADORE OH 44260
Re: K131128
Trade/Device Name: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO Dated: September 18, 2013 Received: October 1, 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 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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Page 2-Mr. Bard
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/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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Indications for Use
510(k) Number: K131128
Device Name: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites
Indications for Use:
The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is an in vitro diagnostic test that is intended for the qualitative detection of Cocaine at or above 500 pg/mg in human head and body hair. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.
This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.
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 Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k): K131128
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).