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The Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4 Methylenedioxymethamphetamine (MDMA) is an in vitro diagnostic test that is intended for the qualitative detection of Methamphetamine (calibrated with Methamphetamine) and MDMA (calibrated with MDMA) 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 with deuterated internal standards is the preferred method. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained. This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

The Omega Laboratories Hair Drug Screening Assays for Methamphetamine_3,4-methylenedioxymethamphetamine (Meth_MDMA) is a test system using ELISA reagents and micro-plate reader for the qualitative detection of Methamphetamine and 3,4- Methylenedioxymethamphetamine (MDMA) in head and body hair samples at or above 500 pg/mg.

Here's a breakdown of the acceptance criteria and study information for the Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4-Methylenedioxymethamphetamine (MDMA), based on the provided text:

Acceptance Criteria and Reported Device Performance

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The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test that is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in human head and body hair. To confirm a screen positive result. a more specific alternate chemical method, such as Gas ChromatographyMass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained. This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

The Omega Laboratories Hair Drug Screening Assays are test systems that utilize ELISA assays for the qualitative detection of morphine and related opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in head hair samples. The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone provide only preliminary analytical test results. A more specific 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 or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone)

Indications for Use: The device is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in human head and body hair. It's for single laboratory use only and not for sale to anyone. 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 for confirmation of screen positive results.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a set of quantified thresholds. Instead, it demonstrates performance studies to show "substantial agreement" with a predicate device and ensures reliable qualitative detection at the cutoff. Based on the provided performance studies, here's an interpretation of the implied acceptance and the reported performance.

Implicit Acceptance Criterion: The device should consistently and accurately identify positive and negative samples around the cutoff concentration (300 pg/mg) and show substantial agreement with GC/MS confirmation. It should also demonstrate precision, specificity, and stability under various conditions.

• 208/208 (100%) agreement for Negative (70), 50% above cutoff (116) by GC/MS.
• Near Cutoff Negative (9): 2 Positive by ELISA, 7 Negative by ELISA.
• Near Cutoff Positive (24): 24 Positive by ELISA, 1 Negative by ELISA.
  Overall strong agreement, with expected variability near cutoff. Discordant samples were mostly near the cutoff. |
  | Agreement with GC/MS (Oxycodone) | High concordance with GC/MS, especially for high positive and negative samples. Few discordant results, particularly near cutoff. | Out of 483 samples (after exclusions):
• 361/361 (100%) agreement for Negative (140), 50% above cutoff (221) by GC/MS.
• Near Cutoff Negative (14): 6 Positive by ELISA, 8 Negative by ELISA.
• Near Cutoff Positive (94): 94 Positive by ELISA, 2 Negative by ELISA.
  Overall strong agreement, with expected variability near cutoff. Discordant samples were mostly near the cutoff. |
  | Agreement with GC/MS (Hydrocodone) | High concordance with GC/MS, especially for high positive and negative samples. Few discordant results, particularly near cutoff. | Out of 500 samples (after exclusions):
• 343/343 (100%) agreement for Negative (142), 50% above cutoff (201) by GC/MS.
• Near Cutoff Negative (25): 8 Positive by ELISA, 17 Negative by ELISA.
• Near Cutoff Positive (110): 110 Positive by ELISA, 6 Negative by ELISA.
  Overall strong agreement, with expected variability near cutoff. Discordant samples were mostly near the cutoff. |
  | Cross-Reactivity | Minimal cross-reactivity with unrelated compounds. Structurally similar compounds may show some cross-reactivity as expected, but this should be characterized. | Detailed tables provided showing percent cross-reactivity for numerous compounds. Structurally similar opiates/opioids show varying degrees of cross-reactivity. Unrelated compounds generally showed no interference at high concentrations (e.g., NEG result at -50% CO for many compounds, turning POS at +125% and +150% CO, indicating no false positive at low concentrations). Specific opiate/oxycodone related compounds did show cross-reactivity, which is characterized. |
  | Interfering Compounds | No false positive or false negative results due to common interfering substances that are not drugs of abuse. | For both Opiates and Oxycodone assays, a large panel of structurally related and unrelated compounds were tested. Generally, non-cross-reactive compounds did not cause false positives at relevant concentrations (-50% CO was NEG). Structurally similar compounds that could cross-react turned POS, as expected for the assay. No tested samples produced a negative result when expected to be positive. |
  | Calibrator and Control Stability | Calibrators and controls should be stable for a defined period while maintaining accuracy. | Calibrator stock solution for morphine and oxycodone was stable for one year (within 10% of target value). |
  | Storage Stability (Hair Samples) | Drug analytes in hair samples should remain stable over reasonable storage periods. | Opiates stable for 3 years; Oxycodone and Hydrocodone stable for 2 years. Mean change in concentration ranged from -5% to +7% for various analytes. |
  | Shipping Stability | Temperature and humidity variations during shipping should not adversely affect test results. | Average mean % change in screening result prior to and after shipping was 1.9%. Four out of 260 samples showed different screening results but were all near the cutoff (±50%), where variability is expected. |
  | Cosmetic Treatment Effects | Acknowledgement and characterization of the impact of cosmetic treatments on drug detection. The ELISA protocol itself should not introduce new artifacts related to treatment. | Cosmetic treatments can reduce drug amounts. The study shows the ELISA protocol is not an exception. Bleach, Dye, Permanent, Relaxer, and Shampoo treatments all showed varying effects, mostly decreasing concentrations. Changes at cutoff were observed (e.g., Dyeing Opiates: 57 Pos to Neg, 110 Neg to Pos due to change at cutoff level; Shampoo Oxycodone/Hydrocodone: Pos to Neg). Cross-reactivity was noted for specific treatments (e.g., Permanent with Hydrocodone to Opiates). |
  | Environmental Contamination | The assay should be able to distinguish between true positive samples and those with external contamination, facilitated by a methanol wash. | Analytically negative samples exposed to drugs remained negative after methanol wash. Clinically positive samples remained positive after methanol wash. This indicates the methanol wash procedure mitigates false positives from external contamination. |

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Sizes:

  • Intra-assay Precision: 11 replicates per concentration level (for Opiates & Oxycodone), 10 replicates per concentration level (for Hydrocodone).
  • Inter-assay Precision: 220 samples per concentration level (for Opiates & Oxycodone), 100 samples per concentration level (for Hydrocodone) tested over 20 non-consecutive days.
  • Agreement Studies (with GC/MS):
    • Opiates: 226 head and body hair samples (176 head hair, 50 body hair).
    • Oxycodone & Hydrocodone: 530 head and body hair samples (240 head hair in Study 1, 240 head hair in Retrospective Study 2, 50 body hair in Study 3). Note: Actual N for Oxycodone was 483 (due to exclusions) and for Hydrocodone was 500 (due to exclusions).
  • Cross-reactivity: 3 replicates per compound, per concentration level.
  • Interfering Compounds: 3 replicates per compound, per concentration level (-50% CO, +125% CO, +150% CO).
  • Storage Stability: 54 samples varying in ethnic origin, hair color, and curvature.
  • Shipping Study: 260 head hair samples (155 confirmed positive, 100 screened negative, 5 below cutoff).
  • Cosmetic Treatment: 176 hair specimens (112 positive for opiates/oxycodone, 64 negative).
  • Environmental Contamination: A set of drug-free hair samples and a set of known positive samples. (Exact numbers not specified, but implied to be sufficient for the qualitative determination described).

• Data Provenance: The document does not explicitly state the country of origin for the human hair samples used in the test sets. It mentions "body and head hair samples from different ages, gender, ethnicities and hair color," but no geographical origin.

• Retrospective/Prospective: The agreement studies included a "retrospective analysis Study 2" for Oxycodone and Hydrocodone, implying some of the data was collected previously. Other studies (Precision, Study 1 for Agreement, Storage, Shipping, etc.) appear to be prospectively conducted for this submission, although this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the test set (agreement studies) was established using Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode as the preferred method, with deuterated internal standards. This is an instrumental, objective method, not dependent on human expert interpretation in the same way an imaging study would be. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth doesn't directly apply in this context. The validity of GC/MS as a "more specific alternate chemical method" implies its established status as a gold standard in drug testing.

4. Adjudication Method for the Test Set

Since the ground truth for the test set was established by GC/MS, an instrumental method, human adjudication methods like "2+1" or "3+1" are not applicable. The GC/MS results serve as the definitive reference. Discordant results between the ELISA and GC/MS were reported and analyzed, but not "adjudicated" by human experts in the sense of consensus building for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is an in vitro diagnostic (IVD) hair drug screening assay, not an AI-powered diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not relevant and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is an ELISA assay, which is a laboratory-based, instrumental test. The results are generated by the assay (the "algorithm" in a chemical sense) detecting the presence of analytes above a cutoff. The "human-in-the-loop" aspect exists in performing the lab procedures, running the instrument, and interpreting the qualitative (positive/negative) output based on the cutoff. The performance studies (precision, agreement) inherently reflect the standalone performance of the assay. There's no separate "human-in-the-loop" performance that would be contrasted with pure "algorithm only" performance beyond the standard lab process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used for agreement studies was Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode. This is a highly specific and sensitive analytical method widely considered a confirmatory or gold standard in toxicology for identifying and quantifying substances.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an algorithm or AI model development. This device is an immunoassay (ELISA), which is an analytical chemical test. Its performance is based on the specificity and reactivity of antibodies and other chemical components, not on a machine learning model trained on data. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. The development and optimization of the assay would typically involve extensive R&D and validation steps, but these are not referred to as "training" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, the concept of a "training set" for an AI/ML algorithm does not apply to this ELISA-based in vitro diagnostic device. The ground truth for the validation/performance studies was established by GC/MS, as detailed in point 7.

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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.

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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."

• 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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The Omega Laboratories Hair Drug Screening Assay Phencyclidine is an in vitro diagnostic test that is intended to be used for the determination of the presence of PCP in human hair from the head and body. The Omega Laboratories Hair Drug Screening Assay utilizes an enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose of identifying the use of PCP. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.

This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.

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

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

After the extraction treatment, the test sample is added to a well of the coated micro strip plate and enzyme conjugate is added, followed by incubation. During this phase the enzyme-labeled drug conjugate competes with drug in the sample for a limited number of binding sites on the antibody-coated micro wells. The two bind in proportion to their concentrations. A wash solution is applied to remove any unbound materials. Enzyme substrate solution containing a chromagen is added. The reaction is stopped with an acid and the absorbance is read using a plate reader at 450 nm. A background reading is also taken at 630 nm. Color intensity is inversely proportional to the amount of drug present in the sample. For the screening of PCP in hair, an enzyme linked immunosorbent assay (ELISA) procedure has been established.

Acceptance Criteria and Device Performance for Omega Laboratories Hair Drug Screening Assay Phencyclidine (K131181)

The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is an in vitro diagnostic test for the qualitative detection of PCP in human head and body hair at or above 300 pg/mg.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria (e.g., target true positive rate, true negative rate, or specific ranges for precision values) against which the study results are directly measured. However, the studies demonstrate the precision, agreement with a reference method, and robustness of the assay. The performance is reported in terms of observed precision and agreement rates.

• ELISA Positive / GC/MS Positive (>300 pg/mg): 38 + 162 = 200 samples
• **ELISA Negative / GC/MS Negative (

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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.

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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The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is a laboratory developed test that is intended to be used for the determination of the presence of Cocaine in human hair from the head. The Omega Laboratories Hair Drug Screening Assay Cocaine utilizes the International Diagnostics Systems Corp. One-Step enzyme linked immunosorbent assay (ELISA) for Cocaine Testing Kit, for the qualitative detection of Cocaine at or above 500 pg/mg of hair for the purpose of identifying the use of Cocaine. 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 Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites, is a test system using ELISA reagents and microplate reader for the qualitative detection of Cocaine and Cocaine Metabolites in hair samples at or above 500 pg/mg.

This 510(k) summary describes a new diagnostic device, the Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites, and its substantial equivalence to a predicate device. Below is a breakdown of the requested information based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list numerical acceptance criteria in the format typically seen for sensitivity, specificity, or accuracy targets. Instead, it states that the device demonstrated "substantial agreement" and "substantially equivalent" performance to the predicate device across various performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size used for the test set during performance characteristic studies. It mentions "donor specimens" but doesn't provide a numerical count.

The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a laboratory-developed test, the data would likely originate from samples processed within Omega Laboratories or collected specifically for their studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. For a substance abuse test, ground truth is typically established through a confirmation method.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not specify an adjudication method. For confirmation of presumptive positive results, it states: "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." This implies a confirmatory testing approach rather than an expert adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for imaging-based diagnostic devices where human interpretation is a key component. The Omega assay is a laboratory-developed test using ELISA, where the result is determined by the assay itself, not by human interpretation of complex images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was effectively done. The performance characteristic studies described (Detection Limits, Precision, Agreement, etc.) evaluate the performance of the assay itself (the "algorithm only") in detecting cocaine and its metabolites in hair samples. The statement that the test is "intended exclusively for in-house laboratory use only" and "offers this laboratory developed test as a service to its clients" further supports that it's the device's analytical performance being assessed, not human interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary ground truth described for confirming screen positive results is a more specific alternate chemical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode with deuterated internal standards. This is a highly sensitive and specific analytical method widely considered the gold standard for confirming drug presence in toxicology.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This type of detail is more relevant for machine learning or AI-driven devices. For a traditional immunoassay, there isn't a "training set" in the same sense; instead, the assay's parameters are developed and optimized during its creation, and then validated through performance studies.

9. How the Ground Truth for the Training Set Was Established

As no training set is described in the context of this immunoassay, there is no information on how its ground truth was established. For the validation of the device, the ground truth was established by GC/MS as described above.

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The Omega Laboratories Hair Drug Screening Assays are test systems that utilize ELISA assays for the qualitative detection of morphine and related opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in head hair samples.

The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone provide only preliminary analytical test results. A more specific 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 or GC/MS/MS in selected reaction mode (SRM) 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.

These laboratory developed tests are intended exclusively for in-house professional use only and are not intended for sale to anyone. Omega offers these laboratory developed tests as services to its clients.

The Omega Laboratories Hair Drug Screening Assays for Opiates, Oxycodone and Hydrocodone are test systems using ELISA reagents and micro-plate reader for the qualitative detection of Opiates, Oxycodone and Hydrocodone in hair samples at or above 300 pg/mg.

The provided text describes a 510(k) submission for a hair drug screening assay. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a new, unique device. Therefore, many of the requested sections (e.g., acceptance criteria table, detailed sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies) are not explicitly present in the provided document, as a different type of evidence is required for a substantial equivalence claim for an immunoassay.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

For devices demonstrating substantial equivalence through comparison to predicate devices, the "acceptance criteria" are generally that the new device's performance characteristics (precision, analytical sensitivity, interference, antibody cross-reactivity, and qualitative results in donor specimens) are "in substantial agreement" with or "substantially equivalent" to the predicate. Specific numerical thresholds for these criteria are not provided in this summary, as is common for this type of submission.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size: The document mentions "Results obtained from donor specimens," but does not specify the sample size for these donor specimens.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a diagnostic assay, it's highly probable these were controlled prospective studies conducted at the manufacturer's or a contract research organization's laboratory, likely within the US, but this is not stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable or required for an immunoassay 510(k) submission focused on analytical performance and substantial equivalence. The "ground truth" for a performance study of such a device generally refers to the confirmed analytical result, typically established by a gold standard method (like GC/MS or GC/MS/MS), not by human expert interpretation like in imaging studies.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" for an immunoassay's analytical performance is based on chemical or instrumental confirmation, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is an ELISA-based qualitative drug screening assay, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers. Therefore, an MRMC study or AI assistance is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable in the AI sense. The device is a standalone assay system (reagents and micro-plate reader) that provides a qualitative result. Its performance is determined analytically, independent of direct human interpretation influencing the primary result. However, it provides "preliminary analytical test results," explicitly stating that "A more specific alternate chemical method must be used in order to obtain a confirmed result." This implies it's a screening tool, not a definitive diagnostic, and further human interpretation of confirmed results would occur elsewhere.

7. The Type of Ground Truth Used

The document explicitly states: "A more specific 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 or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards."

Therefore, the ground truth for this device's performance comparison is established using confirmatory analytical methods (GC/MS or GC/MS/MS), which are considered the gold standard for drug detection. This is not expert consensus, pathology, or outcomes data in the typical sense for medical imaging or clinical trials.

8. The Sample Size for the Training Set

The document is for a 510(k) of an ELISA assay, not an AI/ML model. Therefore, the concept of a "training set" for model development is not applicable in the way it would be for an AI device. The assay development would involve optimizing reagent formulations and protocols, but not "training" a machine learning algorithm on data.

9. How the Ground Truth for the Training Set was Established

As explained in point 8, the concept of a "training set" is not applicable in the context of this device's chemistry-based assay development.

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The Omega Laboratories Hair Drug Screening Assay Methamphetamine and ,4-Methylenedioxymethamphetamine (MDMA) is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (Meth MDMA) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit for the qualitative detection of Methamphetamine and MDMA at or above 500 pg/mg of hair for the purpose of identifying the use of Methamphetamine and MDMA. D-Methamphetamine is used as the standard for the assay. 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 Omega Laboratories Hair Drug Screening Assays for Opiates, Oxycodone and Hydrocodone are test systems using ELISA reagents and micro-plate reader for the qualitative detection of Opiates, Oxycodone and Hydrocodone in hair samples at or above 300 pg/mg.

Here's a breakdown of the acceptance criteria and study information for the Omega Laboratories Hair Drug Screening Assay for Methamphetamine and MDMA, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity thresholds). Instead, the primary acceptance criterion appears to be "substantial agreement" and "substantial equivalence" with the predicate device, Quest Diagnostics HairCheck-DT (Amphetamines) K051161.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify exact sample sizes for the "donor specimens" or "performance characteristic studies." It generically refers to "donor specimens."
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be presented as comparative performance against a predicate device rather than on a pre-existing dataset. The term "donor specimens" implies prospective collection for the purpose of the study, but this is not definitively stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a drug screening assay, the "ground truth" would typically be established by a more specific, confirmatory method. The document mentions: "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." However, it doesn't specify if experts were involved in interpreting these GC/MS results for the purpose of establishing ground truth for the study, nor their number or qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study typically applies to imaging or diagnostic interpretation tasks where multiple human readers assess cases, and the technology's impact on their performance is measured. This device is a laboratory assay.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The "Omega Laboratories Hair Drug Screening Assay" is an automated ELISA-based test system, and the performance studies inherently assess its standalone accuracy in detecting Methamphetamine and MDMA in hair samples. There is no mention of a human-in-the-loop component for the screening portion of the assay. The indication for use does mention that "Professional judgment should be applied to any drug of abuse test result," particularly for presumptive positives, and that GC/MS confirmation is preferred, implying human oversight in the overall diagnostic process, but the performance studies focus on the assay's output itself.

7. The Type of Ground Truth Used

The ground truth used for confirmation of screen positive results is a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode with deuterated internal standards. For the purpose of the performance studies (e.g., agreement), the results of the predicate device (Quest Diagnostics HairCheck-DT) were used as a comparative benchmark to demonstrate equivalence.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a laboratory assay, not a machine learning algorithm that requires a separate "training set." The development of such assays involves analytical validation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of this traditional laboratory assay.

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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.

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 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.

Acceptance Criteria and Device Performance for Omega Laboratories Hair Drug Screening Assay (PCP)

This document outlines the acceptance criteria and study results for the Omega Laboratories Hair Drug Screening Assay (PCP), an enzyme immunoassay for the qualitative detection of phencyclidine (PCP) in hair. The information is extracted from the provided Premarket Notification - 510(k) Summary of Safety and Effectiveness (K101009).

1. Table of Acceptance Criteria and Reported Device Performance

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