Search Results

The Psychemedics homogeneous enzyme immunoassay (HEIA) for phencyclidine in hair is an enzyme immunoassay system for the preliminary qualitative detection of phencyclidine in human head and body hair using a phencyclidine calibrator at 3 ng phencyclidine/10 mg hair for the purpose of identifying phencyclidine use.

This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics phencyclidine homogeneous enzyme immunoassay provides only a preliminary analytical test result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS), is the preferred confirmatory method.

The test consists of two parts; a pre-analytical hair treatment procedure (to extract phencyclidine from the solid hair matrix to a measurable liquid matrix) and the screening assay, the Psychemedics Phencyclidine Homogeneous Enzyme Immunoassay. The screening portion of the test system is based on competition for antibody binding sites between drug in the measurable liquid matrix and drug-labeled recombinant glucose-6-phosphate dehydrogenase (G6PDH). As the antibody binds labeled G6PDH, enzyme activity decreases. In the presence of drug, enzyme activity increases in direct proportion to the drug concentration. Active enzyme reduces nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically The Psychemedics Phencyclidine HEIA consists of reagents R1 (anti-phencyclidine monoclonal antibody with substrate) and R2 (phencyclidine labeled recombinant G6PDH).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with defined numerical targets for sensitivity, specificity, or accuracy. Instead, the performance is described through precision studies and comparison studies using a specific cut-off. For the purpose of this analysis, the reported performance from the comparison study with GC/MS (the preferred confirmatory method) will be presented as the de facto "reported device performance."

• At -100%, -75%, -50%, -25% of cutoff: 8 negative results, 0 positive results.
• At +25%, +50%, +75%, +100% of cutoff: 0 negative results, 8 positive results.
  Inter-Assay Precision:
• At -100%, -75%, -50%, -25% of cutoff: 80 negative results, 0 positive results.
• At +25%, +50%, +75%, +100% of cutoff: 0 negative results, 80 positive results. |
  | Cross-Reactivity | Minimal or no interference from common substances and compounds, except for expected cross-reactants. Expected cross-reactants should have a known equivalent concentration to the 3.0 ng phencyclidine/10 mg hair cutoff. | Cross-Reactive Compounds (≥ 3 ng Phencyclidine/10 mg hair equivalent):
• Venlafaxine: 100% cross-reactivity (3 ng equivalent)
• Rolicyclidine HCl: 37.5% (8 ng equivalent)
• 3-Methoxy-(Aryl Ring) PCP: 30% (10 ng equivalent)
• 4-Hydroxy (Cyclohexyl Ring) PCP: 12% (25 ng equivalent)
• 1-(1-Phenylcyclohexyl)-4-hydroxypiperidine: 6% (50 ng equivalent)
• 1-(1-Phenylcyclohexyl) Morpholine (PCM): 6% (50 ng equivalent)
• Metaphit: 4% (75 ng equivalent)
• Atropine: 3% (100 ng equivalent)
  No Cross-Reactivity: A long list of compounds including Anhydroecgonine Methyl Ester, Bupropion, Cotinine, Cannabinol, etc., showed no cross-reactivity. |
  | Interference | Minimal or no interference from substances that affect the assay at relevant concentrations. | Interfering Compounds (at 100 ng interferent per 10 mg hair):
• Atropine
• Chlorpheniramine Maleate
• Venlafaxine
  No Interference: A long list of compounds including Anhydroecgonine Methyl Ester, Bupropion, Cotinine, Cannabinol, etc., showed no interference. |
  | Sample Shipping Stability | Phencyclidine remains detectable and stable in hair samples after storage and shipping. | 7 phencyclidine positive samples remained positive after approximately 8 months in storage and after shipping twice coast-to-coast. |
  | Recovery | Extraction method should efficiently recover phencyclidine from hair matrix. | Average recovery was approximately 86% complete after extraction for 3 hours. |
  | Cosmetic Treatments | Cosmetic treatments (perm, dye, shampoo, relaxer) should not cause false positives in negative samples, nor false negatives in positive samples. | Negative Samples: 5 phencyclidine-negative head hair samples remained negative after treatment with perm, dye, shampoo, and relaxer.
  Positive Samples: 10 phencyclidine-positive head hair samples remained positive after treatment with perm, dye, shampoo, and relaxer. |
  | Overall Agreement with GC/MS | High concordance between the immunoassay (HEIA) and the confirmatory method (GC/MS) especially for samples around and above the cutoff, recognizing potential discrepancies due to washing procedures for confirmation. | Unwashed GC/MS Comparison:
• HEIA Positive / GC/MS 4.5 ng: 40
• HEIA Negative / GC/MS 4.5 ng: 0
  Washed GC/MS Comparison:
• HEIA Positive / GC/MS 4.5 ng: 35
• HEIA Negative / GC/MS 4.5 ng: 0
  Discordant Results (Positive HEIA/Negative GC/MS after washing): Two samples were positive by HEIA but below cutoff (2.47 and 1.73 ng/10 mg hair) after extended washing for GC/MS. This is attributed to the removal of sweat-derived drug and/or environmental contamination by washing, which is not performed prior to screening. |

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

• Precision Studies:

  • Intra-Assay Precision: 8 replicates per concentration level (negative, cutoff, +/- 25%, 50%, 75%, 100% of cutoff).
  • Inter-Assay Precision: 80 replicates per concentration level (negative, cutoff, +/- 25%, 50%, 75%, 100% of cutoff).
  • Data Provenance: Spiked negative hair with GC/MS validated calibrator and control solutions. The origin of the "negative hair" is not specified but would likely come from in-house or commercial sources. This is a laboratory-controlled study.

• Cross-Reactivity and Interference Studies:

  • The number of samples/tests for each compound is not explicitly stated but implies testing each compound at various concentrations or single key concentrations.
  • Data Provenance: Laboratory-controlled studies using the listed compounds.

• Sample Shipping Stability:

  • 7 phencyclidine positive samples.
  • Data Provenance: Not explicitly stated, but implies real or spiked positive samples tested after storage and shipping.

• Cosmetic Treatments:

  • 5 phencyclidine-negative head hair samples.
  • 10 phencyclidine-positive head hair samples.
  • Data Provenance: In-house laboratory study.

• Comparison Studies (Primary Test Set):

  • Total N = 84 individual hair samples.
  • 40 negative samples (by predicate device and HEIA).
  • 44 positive samples (by predicate device and HEIA).
  • Data Provenance: Collected anonymously from a workplace setting. This indicates retrospective real-world samples. The country of origin is not explicitly stated but assumed to be the U.S. given the FDA submission.

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

The ground truth for the comparison study was established by Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is described as the "preferred confirmatory method."

• The document implies that the GC/MS analysis itself establishes the ground truth, rather than human experts interpreting the GC/MS results.
• Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in the traditional sense of image or clinical interpretation is not directly applicable here. The GC/MS instrument and its operating/interpreting technicians (who are typically highly qualified analytical chemists or toxicologists) serve to establish the "ground truth" through a validated analytical method.

4. Adjudication Method for the Test Set

• The adjudication method is a direct comparison between the investigational device (Psychemedics HEIA) and the GC/MS confirmatory assay.
• Initially, samples were identified as positive or negative using the predicate device (Psychemedics phencyclidine microplate assay, K111928) and then tested with the HEIA device. The HEIA results were then compared to the GC/MS confirmatory assay.
• For discordant results (e.g., HEIA positive, GC/MS negative after washing), explanations are provided regarding the effect of washing on GC/MS results. This suggests that GC/MS is the ultimate arbiter, even with these nuances. There is no mention of a human consensus or additional adjudicator comparing the HEIA and GC/MS results and making a final decision beyond what the GC/MS represents as the "confirmed analytical result."

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that requires human interpretation based on images or complex clinical data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.

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

• Yes, the primary performance evaluation is a standalone performance study.
• The Psychemedics HEIA for Phencyclidine in Hair is an automated enzyme immunoassay system. Its performance is evaluated directly against the GC/MS confirmatory method without human interpretation as part of the assay itself. The results (positive/negative) are generated directly by the assay and optical reader.

7. The Type of Ground Truth Used

• The primary ground truth used is Gas Chromatography/Mass Spectrometry (GC/MS) confirmation. This is a highly specific and sensitive analytical method for drug detection and quantification, considered the "gold standard" for confirmation in forensic toxicology.
• The document refers to it as the "preferred confirmatory method" and states that "a more specific alternative chemical method must be used in order to obtain a confirmed analytical result" after the preliminary immunoassay.

8. The Sample Size for the Training Set

• The document does not explicitly state a sample size for a "training set."
• Immunoassays are typically developed and optimized through iterative processes based on analytical chemistry principles and validation against known standards, rather than machine learning training sets in the computational sense.
• The calibrators and control materials used for assay setup and validation are prepared from "drug stocks purchased from a commercial vendor," implying a controlled manufacturing and quality assurance process, not a data-driven training set.

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

• As there is no distinct "training set" in the machine learning sense, the concept of establishing ground truth for it is not applicable.
• However, the underlying data for the calibrators and controls used in assay development and daily operation have their concentrations "confirmed by GC/MS." This ensures the accuracy of the reference materials against which the immunoassay is designed to perform.

Ask a specific question about this device

For In Vitro Diagnostic Use.

The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 10 ng/mL in neat oral fluid collected by Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of PCP in human oral fluid with clinical analyzers. This assay is calibrated against PCP.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result. particularly when preliminary positive results are used.

The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an in vitro diagnostic test to detect the presence of PCP in human oral fluid samples collected by Quantisal or Quantisal II Oral Fluid Collection Device.

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

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a separate table or section with numerical targets. Instead, it presents performance characteristics and implies that the observed results met the requirements for substantial equivalence. The key performance indicators evaluated were precision, interference, linearity/recovery, stability, calibration duration, and method comparison.

For the purpose of this analysis, I will infer the acceptance criteria from common expectations for FDA-cleared diagnostic devices, particularly for qualitative and semi-quantitative assays, and present the reported device performance against these implicit criteria.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a series of laboratory performance studies to demonstrate the substantial equivalence of the SEFRIA PCP Oral Fluid Enzyme Immunoassay.

1. Sample size used for the test set and the data provenance:

   • Precision (Quantitative Test Set): For each concentration level (0 ng/mL, 2.5 ng/mL, 5 ng/mL, 7.5 ng/mL, 10 ng/mL, 12.5 ng/mL, 15 ng/mL, 17.5 ng/mL, 20 ng/mL), there were 60 determinations.
     • Data Provenance: Drug-free negative oral fluid was "spiked" to target concentrations. This is a controlled laboratory study, not directly from human patients. The "Data for the candidate device used with Quantisal II device were reported in K181135" indicates that some results, specifically for Quantisal II, were referenced from a previous submission, suggesting a mix of new and previously generated data on the device platform.
   • Interference - Orally Used Endogenous Compounds: For each compound tested (e.g., Teeth Whitener, Cigarette), samples were prepared by volunteers using the substance, then spiked with PCP at ±25% of the cutoff. The exact number of samples for each compound is not specified, but the conclusion states "No interference was observed with any of the compounds," implying sufficient testing.
     • Data Provenance: Oral fluid collected from "volunteers" after use of substances. This implies prospective collection in a controlled setting.
   • Linearity/Recovery: Multiple pools were created by serial dilution. Each pool was tested in triplicate. (Number of distinct samples not explicitly stated, but 13 concentration levels were tested in triplicate for 39 total runs of the assay).
     • Data Provenance: Drug-free oral fluid pools spiked with PCP. Controlled laboratory study.
   • PCP Stability in Oral Fluid: Samples spiked with PCP were stored and tested periodically. The exact number of samples per time point is not specified but referenced baseline concentration results.
     • Data Provenance: Spiked drug-free negative oral fluid. Controlled laboratory study.
   • Calibration Duration: Samples spiked with PCP at ±25% of the cutoff were tested at time points up to 14 days. Exact number of samples per time point not specified.
     • Data Provenance: Spiked drug-free negative oral fluid. Controlled laboratory study.
   • Method Comparison (Clinical Test Set): 80 deidentified, unaltered clinical oral fluid samples.
     • Data Provenance: Obtained from drug treatment facilities. This indicates retrospective collection from human subjects in a real-world clinical setting.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Precision, Interference, Linearity/Recovery, Stability, Calibration Duration: For these analytical studies, the ground truth was established by carefully controlled spiking concentrations of PCP, confirmed by mass spectrometry (LC-MS/MS) before collection (for precision) or by reference methods. This doesn't involve "experts" in the clinical sense, but rather relies on the accuracy of the laboratory's preparation and analytical techniques.
   • Method Comparison: For the 80 clinical samples, the ground truth was established by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). This is a highly sensitive and specific confirmatory analytical method and acts as the gold standard, so no human experts are used for this type of ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication methods (like 2+1 or 3+1 consensus by experts) are typically used in studies involving subjective interpretation, such as imaging or pathology, where human readers create the initial "truth."
   • In this context, where the ground truth is established by objective analytical methods (LC-MS/MS, or precisely prepared spiked samples), there is no human adjudication process described or needed. The analytical results are the ground truth.

4. 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 (comparing human readers with and without AI assistance) is not applicable to an in vitro diagnostic device like an enzyme immunoassay, which is a standalone automated analytical test. The "readers" here are the instruments and their output, not human interpreters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance studies described are inherently "standalone." The SEFRIA PCP Oral Fluid Enzyme Immunoassay is an automated system (used with clinical analyzers like the Beckman Coulter AU480). All performance characteristics (precision, linearity, method comparison, etc.) evaluate the device's analytical output without human intervention in the interpretation of the primary result. Human intervention comes after the preliminary positive result, where confirmation by GC-MS or LC-MS/MS is required.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Primary Ground Truth: For the method comparison and for confirming spiked concentrations, the analytical gold standard was Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
   • Other Ground Truths: For precision, linearity/recovery, stability, and calibration duration, the ground truth was established by precisely prepared spiked samples with known concentrations, often verified by LC-MS/MS.

7. The sample size for the training set:

   • The document describes performance validation studies for the device, not the development or training of a machine learning model. Therefore, a "training set" in the context of AI/ML is not explicitly mentioned or relevant here. The device is an enzyme immunoassay, which operates on chemical reactions and optical detection, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • As there's no mention of a machine learning "training set," this question is not applicable. The assay's "learning" or optimization would have occurred during its internal development and formulation, not through an enumerated "training set" in the context of an FDA submission for an in vitro diagnostic immunoassay.

Ask a specific question about this device

The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10 ng/mL in neat oral fluid collected with the Quantisal II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of PCP in human oral fluid with clinical analyzers. This assay is calibrated against PCP. This in vitro diagnostic device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.

The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is a sensitive in vitro diagnostic test to detect the presence of PCP in human oral fluid samples collected with the Quantisal II Oral Fluid Collection Device.

Quantisal II Oral Fluid Collection Device is a collection system comprised of a dual pad collector and transport vials. The dual pad collector is separated after collection of oral fluid from a subject's mouth enabling each specimen-saturated collection pad to be placed into its own transport vial. The split specimen (referred to as "A" and "B") allows for one sample to be tested in a screening assay and confirmed by a quantitative laboratory method (such as liquid chromatography tandem mass spectrometry [LC-MS/MS] and the second sample to be stored for secondary confirmation if needed.

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

Device Name: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate list with pass/fail values. Instead, it describes various performance studies and their results. The implicit acceptance criteria are that the device performs reliably and consistently, and that its results correlate well with a confirmatory method (LC-MS/MS).

However, based on the provided tables, we can infer some key performance metrics and their results:

• 0, 2.5, 5, 7.5 ng/mL (negative concentrations): 60/60 Negative.
• 12.5, 15, 17.5, 20 ng/mL (positive concentrations): 60/60 Positive.
• 10 ng/mL (Cutoff): 29-32 Negative / 28-31 Positive (expected result at cutoff).
  Semi-Quantitative (Quantisal II "A" & "B"):
• Mean concentrations for spiked samples are close to the expected values (e.g., 0.5 ng/mL for 0 ng/mL, 20.2 ng/mL for 20 ng/mL), demonstrating accurate semi-quantification. At the cutoff (10 ng/mL), results show an appropriate split between negative and positive calls, consistent with the nature of a cutoff analysis. |
  | Specificity/Cross-Reactivity | Ability to exclusively determine PCP without significant interference from structurally and functionally similar compounds. Compounds spiked to yield PCP equivalent of 10 ng/mL. | Cross-Reactive (Positive at 10 ng/mL equivalence): Amitriptyline, Chlorpromazine, Clomipramine, Cyclobenzaprine, Diphenhydramine, Doxepin, 4-Hydroxyphencyclidine (PCHP - 11.76% cross-reactivity), Imipramine, Methoxetamine, Thioridazine.
  **Non-Cross-Reactive (Negative at 15 ng/mL). This indicates excellent diagnostic agreement. |

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

The document describes several test sets for different performance characteristics:

• Precision/Cutoff Characterization:
  • Sample Size: 60 determinations at each of 9 concentration levels (0, 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20 ng/mL) for both "A" and "B" collectors. This totals 60 x 9 x 2 = 1080 individual tests across 15 days, two runs per day, with two collections per run.
  • Data Provenance: Drug-free negative urine spiked to specific concentrations. The origin of the urine itself is not specified but it's an artificially prepared test set.
• Specificity and Cross-Reactivity:
  • Sample Size: Not explicitly stated as a number of individual test runs per compound, but implies sufficient testing to determine cross-reactivity for 18 listed compounds.
  • Data Provenance: Drug-free oral fluid spiked with various compounds. Origin of the oral fluid is not specified, but it's an artificially prepared test set.
• Interference – Structurally Unrelated Compounds:
  • Sample Size: Not explicitly stated, but includes testing for over 70 compounds.
  • Data Provenance: Drug-free oral fluid containing PCP at ±25% of the cutoff, spiked with potential interferents. Origin of the oral fluid is not specified, but it's an artificially prepared test set.
• Interference – Endogenous Compounds and Exogenous Compounds:
  • Sample Size: Not explicitly stated for spiked compounds. For orally used products, likely tested with volunteers (number not specified for this specific section, but volunteer numbers are mentioned in other collection device studies).
  • Data Provenance: Drug-free oral fluid containing PCP at ±25% of the cutoff (for spiked compounds) or collected from volunteers after substance use.
• Interference – pH:
  • Sample Size: Not explicitly stated, but tested across 9 pH values (3.0 to 11.0).
  • Data Provenance: Drug-free oral fluid containing PCP at ±25% of the cutoff, adjusted to various pH values.
• Linearity/Recovery:
  • Sample Size: 13 concentration levels, each tested in triplicate for both "A" and "B" collectors. This totals 13 x 3 x 2 = 78 individual tests.
  • Data Provenance: Drug-free oral fluid pooled and spiked with high concentrations of PCP, then serially diluted.
• Calibration Duration:
  • Sample Size: Not explicitly stated, but tested at multiple time points up to 14 days.
  • Data Provenance: Drug-free negative oral fluid spiked with PCP at ±25% of the cutoff.
• PCP Stability in Oral Fluid:
  • Sample Size: Not explicitly stated, but tested by LC-MS/MS at multiple time points and storage conditions.
  • Data Provenance: Drug-free negative oral fluid spiked with PCP at +50% of the cutoff.
• Sample Transportation Stability:
  • Sample Size: Not explicitly stated, but tested in replicates of two against a reference sample across varying temperatures.
  • Data Provenance: Drug-free negative oral fluid spiked with PCP at ±50% of the cutoff.
• Sample Recovery:
  • Sample Size: Not explicitly stated.
  • Data Provenance: Drug-free negative oral fluid spiked with PCP at ±25% and +50% of the cutoff.
• Quantisal II Sample Volume:
  • Sample Size: 50 oral fluid samples from healthy volunteers and an additional 75 oral fluid samples from known drug users. Total = 125 unique samples.
  • Data Provenance: Prospective collection from healthy volunteers and known drug users. Country of origin not specified.
• Quantisal II Sample Collection Time:
  • Sample Size: 50 oral fluid samples from volunteers and 75 oral fluid samples from known drug users. Total = 125 unique samples.
  • Data Provenance: Prospective collection from healthy volunteers and known drug users. Country of origin not specified.
• Method Comparison:
  • Sample Size: 80 de-identified, unaltered clinical oral fluid samples.
  • Data Provenance: Retrospective and prospective. "Obtained from drug treatment facilities." Country of origin not specified, but likely within the US, given the FDA submission. The samples are clinical, not contrived.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of human experts to establish ground truth for any of the test sets in the traditional sense of medical image interpretation or clinical diagnosis.
• For chemical assays, "ground truth" is typically established by reference methods or by precisely known concentrations of analytes.

4. Adjudication Method for the Test Set

• Adjudication methods like 2+1 or 3+1 (common in medical image reading studies) are not applicable here as the device is a chemical immunoassay, not an AI for image interpretation.
• The ground truth for most analytical performance studies (precision, specificity, linearity, etc.) was established by known spiked concentrations of PCP or other compounds.
• For the Method Comparison study, the ground truth was established by a confirmatory method: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), which is considered the gold standard for drug quantification. There was no "adjudication" between multiple experts; rather, the device's results were compared against the definitive LC-MS/MS measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance on their performance.
• This device is an automated in vitro diagnostic immunoassay for chemical analysis, not a system intended to assist human readers in making a diagnosis from complex data patterns that require human cognitive input.

6. Standalone Performance

• Yes, the studies primarily assessed standalone (algorithm only) performance. The Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay is an automated system run on clinical analyzers (specifically, the Beckman Coulter AU480 chemistry analyzer was used for these studies).
• All the precision, specificity, linearity, stability, and pH interference studies directly demonstrate the standalone performance of the assay and collection device combination.
• The "Method Comparison" study compares the device's standalone output to the LC-MS/MS reference, further confirming its standalone accuracy.

7. Type of Ground Truth Used

The ground truth varied depending on the performance characteristic being evaluated:

• Spiked Concentrations: For precision, specificity, interference, linearity, calibration duration, stability, transportation stability, and sample recovery, the ground truth was based on precisely known concentrations of PCP or other compounds spiked into drug-free oral fluid or urine.
• Confirmatory Method (LC-MS/MS): For the Method Comparison study, the ground truth for clinical samples was established by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), which is the preferred confirmatory method for drug analyses.
• Measured Physical Properties: For sample volume and collection time consistency, the ground truth was established by physical measurements (weighing for volume, stopwatch for time).

8. Sample Size for the Training Set

The document is a 510(k) submission for a diagnostic kit, not an AI/ML model that requires a "training set" in the computational sense. Therefore, there is no specific training set described for the device. The "training" for such devices typically involves the manufacturer's internal development and optimization processes, which are not detailed in a 510(k) summary.

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

As there is no "training set" for an AI/ML model, this question is not applicable. The development of the assay and its reagents would have relied on standard chemical and biological research and development practices, using analytical standards and reference materials to establish optimal performance.

Ask a specific question about this device

The Atellica™ CH Phencyclidine (Pcp) assay is for in vitro diagnostic use in the qualitative or semiquantitative analyses of phencyclidine in human urine using the Atellica CH Analyzer, using a cutoff of 25 ng/mL. The Pcp assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (OC/MS) is the preferred confirmatory method. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometty (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The Atellica CH Pcp assay is a homogenous enzyme immunoassay based on competition between drug in the specimen and drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. G6PDH activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically at 340/410 nm.

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

• At +25%, +50%, +75%, +100% of cutoff (31.25, 37.5, 43.75, 50 ng/mL): 100% Positive results (80/80 replicates).
• At Cutoff (25 ng/mL): Expected to show a mix of positive and negative results, demonstrating it acts as a boundary. | Qualitative Analysis (25 ng/mL cutoff):
• 0 ng/mL: 80 Negative
• 6.25 ng/mL: 80 Negative
• 12.5 ng/mL: 80 Negative
• 18.75 ng/mL: 80 Negative
• 25 ng/mL (Cutoff): 60 Positive / 20 Negative
• 31.25 ng/mL: 80 Positive
• 37.5 ng/mL: 80 Positive
• 43.75 ng/mL: 80 Positive
• 50 ng/mL: 80 Positive

Interpretation: The device meets the criteria by exhibiting clear negative results below the cutoff, clear positive results above the cutoff, and a mixed result at the cutoff, confirming its function as a boundary. |
| Precision/Cutoff Characterization (Semi-Quantitative) | - Demonstrates consistent mean values and acceptable repeatability (SD, CV%) across concentrations.

• Accurately distinguishes negative and positive samples around the cutoff. | Semi-quantitative Analysis (25 ng/mL cutoff):
• 0 ng/mL: Mean 0 ng/mL, 80 Negative
• 6.25 ng/mL: Mean 7 ng/mL, CV 3.8% (Repeatability), CV 7.7% (Within-Lab), 80 Negative
• 12.5 ng/mL: Mean 12 ng/mL, CV 2.2% (Repeatability), CV 4.0% (Within-Lab), 80 Negative
• 18.75 ng/mL: Mean 18 ng/mL, CV 1.8% (Repeatability), CV 3.3% (Within-Lab), 80 Negative
• 25 ng/mL (Cutoff): Mean 25 ng/mL, CV 1.6% (Repeatability), CV 3.4% (Within-Lab), 60 Positive / 20 Negative
• 31.25 ng/mL: Mean 30 ng/mL, CV 2.2% (Repeatability), CV 2.7% (Within-Lab), 80 Positive
• 37.5 ng/mL: Mean 37 ng/mL, CV 1.4% (Repeatability), CV 3.3% (Within-Lab), 80 Positive
• 43.75 ng/mL: Mean 43 ng/mL, CV 1.5% (Repeatability), CV 4.6% (Within-Lab), 80 Positive
• 50 ng/mL: Mean 51 ng/mL, CV 1.3% (Repeatability), CV 4.5% (Within-Lab), 80 Positive

Interpretation: The device shows good semi-quantitative precision with low CVs and correct qualitative interpretation based on its quantitative output. |
| Recovery Study | - Expected % Recovery close to 100% for various spiked Pcp concentrations. | Recovery Study:

• Samples spiked from 4.0 to 80.0 ng/mL. % Recovery ranged from 98.5% to 112.0%.

Interpretation: The device demonstrates good analytical recovery of Pcp across a range of concentrations. |
| Method Comparison (Qualitative) | - High agreement (sensitivity and specificity) when compared to the reference method (GC/MS). | Summary of Qualitative Results (compared to GC/MS):

• Atellica Positive / GC/MS Positive: 53
• Atellica Negative / GC/MS Positive: 3 (False Negatives)
• Atellica Positive / GC/MS Negative: 1 (False Positive)
• Atellica Negative / GC/MS Negative: 55

Qualitative Assay Performance for 25 ng/mL cutoff (compared to GC/MS):

• Atellica Pos: 98% Agreement (for samples 38 ng/mL)
• Atellica Neg: 95% Agreement (for samples 38 ng/mL)

Interpretation: The device shows high agreement with the GC/MS reference method, indicating good performance in distinguishing positive and negative samples. |
| Method Comparison (Semi-Quantitative) | - High agreement (sensitivity and specificity) when compared to the reference method (GC/MS). | Summary of Semi-Quantitative Results (compared to GC/MS):

• Atellica Positive / GC/MS Positive: 53
• Atellica Negative / GC/MS Positive: 3 (False Negatives)
• Atellica Positive / GC/MS Negative: 1 (False Positive)
• Atellica Negative / GC/MS Negative: 55

Semi-Quantitative Assay Performance for 25 ng/mL cutoff (compared to GC/MS):

• Atellica Pos: 98% Agreement
• Atellica Neg: 95% Agreement

Interpretation: Similar high agreement as the qualitative assessment for the semi-quantitative mode. |
| Interference (pH, Specific Gravity, Endogenous Compounds, Unrelated Compounds) | - No false positive or false negative results within specified ranges/concentrations for various interfering substances. | Effect of pH: No interference observed across pH 3.1-11.0 for samples at -25% and +25% of cutoff.
Effect of Specific Gravity: No interference observed across SG 1.000-1.030 for samples at -25% and +25% of cutoff.
Effect of Endogenous Compounds: No false response for compounds like Acetone, Ascorbic Acid, Bilirubin, Creatinine, Ethanol, etc., at stated concentrations for samples at -25% and +25% of cutoff.
Effect of Structurally Unrelated Compounds: No false response for numerous drugs (e.g., Acetaminophen, Amitriptyline, Caffeine, Ibuprofen, etc.) at high concentrations for samples at -25% and +25% of cutoff.
Boric Acid: Noted as causing a "false negative result," with the package insert notifying users of this limitation.

Interpretation: The device generally demonstrates good resistance to common interferences, except for Boric Acid, which is acknowledged as a limitation. |
| Cross-Reactivity (Structurally Similar Compounds) | - Quantified cross-reactivity for structurally similar compounds. The specific acceptance criteria for these percentages are not explicitly stated as pass/fail, but rather as performance characteristics to be reported. | Summary of Cross-reactivity: Various compounds showed cross-reactivity ranging from 0.01% (e.g., Diphenhydramine, Doxepin) to 74.38% (trans-4-phenyl-4-Piperidinocyclohexanol), with 4-Methoxyphencyclidine at 8.43%, 1-(1-Phenylcyclohexyl)pyrrolidine (PCPy) at 38.33% and 1-[1-(2-Thienyl)-cyclohexyl]piperidine (TCP) at 58.11%.

Interpretation: The device shows varying degrees of cross-reactivity with structurally similar compounds, which is expected for immunoassay methods. The specific values are provided for user information. |

Study Details:

1. Sample size used for the test set and the data provenance:

   • Precision/Cutoff Characterization: 80 replicates were used for each of the 9 concentration levels tested (a total of 720 measurements). The provenance is not explicitly stated but is implied to be laboratory-prepared urine pools.
   • Recovery Study: 10 samples with varying spiked Pcp concentrations were tested. Provenance is laboratory-prepared drug-free urine spiked with Pcp.
   • Method Comparison: Clinical urine samples were used. The document mentions "Anonymous, discarded clinical urine samples" and refers to "native urine samples." The exact number of clinical samples is not specified numerically, but the contingency tables show totals of 112 for both qualitative and semi-quantitative analysis against GC/MS (53+1+3+55).
   • Interference Studies:
     • pH, Specific Gravity, Endogenous, Unrelated Compounds: Samples spiked at -25% and +25% of the cutoff were used. The number of samples for each interferent is not specified, but typically this involves replicates. The provenance is laboratory-prepared drug-free urine containing target analytes and spiked interferents.
     • Cross-reactivity: Structurally similar compounds were spiked into drug-free urine at indicated levels. The number of samples is not specified. Provenance is laboratory-prepared urine.
   • Data Provenance: The device performance studies appear to be laboratory-based ("clinical urine samples," "drug-free urine pool," "spiked... stock"). There is no mention of country of origin, but given the FDA submission, it's likely US-based or following international standards accepted by the FDA. The nature of the samples ("discarded clinical urine samples," "spiked") indicates a retrospective approach to sample collection for the method comparison, while the other studies are prospective in design (laboratory testing).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the Method Comparison study, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is stated as the "preferred confirmatory method." GC/MS is an objective analytical method; therefore, human experts are not directly involved in establishing the truth for individual samples in the same way they would for image interpretation. The expertise lies in operating and interpreting GC/MS data, but the "ground truth" itself is the chemical analysis result.
   • For other studies (Precision, Recovery, Interference), the ground truth is based on the known concentrations of Pcp in the spiked or prepared samples.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is mentioned as the ground truth for the method comparison was established by GC/MS, a definitive chemical analysis.

4. 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) device for chemical analysis (enzyme immunoassay for Phencyclidine in urine). Therefore, no MRMC comparative effectiveness study was done as it's not applicable for this type of device. There are no human "readers" or "AI assistance" in the context of interpreting results. The device performs the test and provides a result.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, this is effectively a standalone device performance study. The Atellica CH Phencyclidine (Pcp) assay operates as an automated system (Atellica CH Analyzer) without human intervention in the analytical process itself. The performance data presented (precision, recovery, method comparison, interference, cross-reactivity) are all based on the algorithm/instrument's output alone. While human technicians operate the analyzer, the decision-making for a result (positive/negative) is driven by the instrument's measurement against the defined cutoff of 25 ng/mL.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The primary ground truth for the Method Comparison study was Gas Chromatography/Mass Spectrometry (GC/MS) results, which is a definitive analytical method for phencyclidine.
   • For Precision, Recovery, Interference, and Cross-reactivity studies, the ground truth was based on known, prepared concentrations of phencyclidine or interfering substances in urine samples.

7. The sample size for the training set:

   • The document describes performance testing data for the Atellica CH Phencyclidine (Pcp) assay. It does not mention a "training set" in the context of an AI/machine learning model. This is an immunoassay, which is a chemical reaction-based test, not a software algorithm that undergoes training. Therefore, N/A for a training set in the AI sense.

8. How the ground truth for the training set was established:

   • As this is not an AI/machine learning device, the concept of a "training set" and its associated ground truth establishment is not applicable. The device's performance is based on its fixed chemical assay design.

Ask a specific question about this device

The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of PCP in human urine with automated clinical chemistry analyzers. This assay is calibrated against PCP. This in-vitro diagnostic device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.

The Immunalysis PCP Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays.

1. The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant antibodies to Phencyclidine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes phencyclidine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
2. All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators are summarized as follows:

Table 1 Immunalysis Multi-Drug Calibrators
Analyte, Multi-Drug Calibrators, Level 1, Level 2, Level 3, Level 4
Benzoylecgonine, 150ng/mL, 300ng/mL, 500ng/mL, 1000ng/mL
Morphine, 100ng/mL, 300ng/mL, 500ng/mL, 1000ng/mL
PCP, 12.5ng/mL, 25ng/mL, 50ng/mL, 100ng/mL

Acceptance Criteria and Device Performance for Immunalysis PCP Urine Enzyme Immunoassay

This document describes the acceptance criteria and study results for the Immunalysis PCP Urine Enzyme Immunoassay, an in-vitro diagnostic device intended for the qualitative and semi-quantitative analysis of PCP in human urine. All reported testing used a Beckman Coulter AU 400e instrument unless otherwise specified.

1. Table of Acceptance Criteria & Reported Device Performance

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

• Precision/Cutoff Characterization Study: 80 determinations for each of the 9 concentration levels, totaling 720 determinations.
• Specificity and Cross-Reactivity Study: Concentrations were tested to a level that would yield a positive result (equivalent to the cutoff). The specific number of determinations per compound is not explicitly stated but implied to be sufficient for result generation.
• Interference Study (Structurally Non-Similar Compounds, Endogenous Compounds, pH, Specific Gravity, Boric Acid): Not explicitly stated, but for each compound/parameter, measurements were taken at -25% and +25% of the cutoff concentration.
• Linearity/Recovery: Not explicitly stated, but 11 data points (expected concentrations) were used for the linearity curve.
• Method Comparison: 80 clinical urine samples (40 positive, 40 negative) were used.
• Calibrator Stability Studies: Data for Day 0, 8, 16, 24, 32, 40 (closed vial) and Day 0, 19, 26, 33, 41, 60 (open vial) for all 4 calibrator levels.

Data Provenance:

• Precision/Cutoff Characterization, Specificity, Interference, Linearity/Recovery: These studies appear to be laboratory-based experiments, likely conducted in the US (Immunalysis Corporation is based in Pomona, CA). The data is prospective as it was generated to evaluate the device.
• Method Comparison: "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories" were used. This indicates the data is retrospective, and likely from the US, given the company's location.

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

The document does not mention the use of human experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable, as human experts were not used to establish 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

Not applicable. This is an in-vitro diagnostic assay for qualitative and semi-quantitative analysis of a substance in urine, not for interpretation by human readers.

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

Yes, the studies described (Precision, Specificity, Interference, Linearity, Method Comparison, Calibrator performance) represent standalone performance of the Immunalysis PCP Urine Enzyme Immunoassay device. The device itself is an automated chemical analyzer-based test.

7. The Type of Ground Truth Used

• Precision/Cutoff Characterization, Specificity, Interference, Linearity/Recovery, Calibrator Stability: Ground truth was established by preparing samples with known, spiked concentrations of PCP or other compounds in drug-free urine.
• Method Comparison: Ground truth was established by confirmation with Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS), which are considered definitive analytical methods.

8. The Sample Size for the Training Set

This document describes a premarket notification for an immunoassay that operates based on established chemical reactions, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable to this device.

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

Not applicable, as there is no "training set" for this type of immunoassay.

Ask a specific question about this device

CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine is a rapid test for the qualitative detection of Phencyclidine and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 25ng/mL and 500ng/mL. respectively.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

The CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine test uses immunochromatographic assays for phencyclidine and methylenedioxymethamphetamine. The test is a lateral flow, one step system for the qualitative detection of phencyclidine and methylenedioxymethamphetamine in human urine.

The provided document describes the performance characteristics of the "CR3 Keyless Split Sample Cup Phencyclidine - Methylenedioxymethamphetamine" device, a rapid test for the qualitative detection of Phencyclidine (PCP) and Methylenedioxymethamphetamine (MDMA) in human urine.

Here's an analysis based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or overall agreement. However, it presents the results of several performance studies that demonstrate the device's capabilities, particularly around the established cut-off concentrations.

For the purpose of this analysis, we can infer the "acceptance criteria" from the performance reported in the "Precision" and "Lay-user study" sections, generally looking for high agreement around non-cutoff concentrations and a predictable range of positive/negative results at the cutoff.

Implied Acceptance Criteria and Reported Performance:

Ask a specific question about this device

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 (

Ask a specific question about this device

The RapidFRET Oral Fluid Assay for PCP is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Phencyclidine at 10 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.

The RapidFRET Oral Fluid PCP Calibrator Set and RapidFRET Oral Fluid PCP Control Set are intended for use only with the RapidFRET Oral Fluid Assay for PCP and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

The RapidFRET Oral Fluid Assay for PCP is an In Vitro Diagnostic competitive immunoassay used to detect PCP in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy. The assay is performed on the RapidFRET Integrated Workstation.

Here's a summary of the acceptance criteria and study details for the Biophor Diagnostics, Inc. RapidFRET Oral Fluid Assay for PCP, based on the provided text:

Acceptance Criteria and Device Performance

• RapidFRET POS / GC/MS POS: 119
• RapidFRET NEG / GC/MS NEG: 126
• RapidFRET POS / GC/MS NEG: 1 (Sample was 9 ng/mL PCP by GC/MS, which is below the 10 ng/mL assay cutoff)
• RapidFRET NEG / GC/MS POS: 0 |
  | Cross-Reactivity | Minimal false positive results due to structurally related or unrelated compounds, OTC/prescription medications, and drugs of abuse. | Only 4-HydroxyPCP (620 ng/mL) and PCM (310 ng/mL) were found to cross-react below 10,000 ng/mL at concentrations equivalent to the cutoff in the absence of PCP, indicating high specificity. |
  | Analytical Specificity (Interfering Substances) | No significant interference from common substances (foods, dental products, pH variations, biological components, medications). | All tested compounds and pH variations (HSA, ethanol, baking soda, whole blood, hemoglobin, hydrogen peroxide, sodium chloride, cholesterol, denture adhesive, ascorbic acid, bilirubin, IgA, IgG, IgM, mouthwash, cough syrup, cranberry juice, orange juice, toothpaste, chewing tobacco, cigarettes, chewing gum, hard candy, teeth whitening strips, cola, water, antacid, coffee, tea) at specified concentrations resulted in NEG when spiked with 5 ng/mL PCP and POS when spiked with 15 ng/mL PCP, indicating no significant interference. |

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: The table shows totals of 279-294 samples per PCP concentration level for evaluating precision across different lots and days. This implies several hundred unique test measurements.
   • Correlation with GC/MS: n = 246 neat oral fluid samples.
   • Cross-Reactivity & Analytical Specificity: Not explicitly stated as one single test set size, but involves:
     • 175 different compounds for cross-reactivity.
     • A list of common substances and pH levels for analytical specificity.
   • Data Provenance:
     • "Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for PCP." This indicates prospective collection from volunteers.
     • Country of origin is not explicitly stated, but the submission is to the U.S. FDA, typically implying data relevant to the U.S. market.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/mentioned for this type of in vitro diagnostic device study. The ground truth for drug concentration is established analytically, not through expert interpretation of images or clinical findings.

3. Adjudication method for the test set:

   • Not applicable/mentioned for this type of in vitro diagnostic device study. Ground truth (PCP concentration) is determined by an objective, gold-standard chemical method (GC/MS or LC/MS/MS).

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that relies on human readers interpreting output. The read-out and interpretation (positive/negative) is automated based on the assay's cutoff.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance studies described are essentially standalone for the device. The RapidFRET Oral Fluid Assay for PCP, when run on the RapidFRET Integrated Workstation, provides an automated qualitative screen (positive/negative) for PCP. Human intervention is limited to sample collection, loading, and interpreting the instrument's P/N result (with subsequent confirmation by GC/MS or LC/MS/MS). The assay itself is an "algorithm only" in the sense that it mechanically and chemically determines the result based on a pre-defined cutoff.

6. The type of ground truth used:

   • Analytical Confirmation (GC/MS): For the "Correlation with GC/MS" study, Gas Chromatography/Mass Spectrometry (GC/MS) was used as the confirmatory method to establish the true PCP concentration in the samples. The text also mentions LC/MS/MS as another specific alternate chemical method for confirmation. This represents a gold-standard analytical method.

7. The sample size for the training set:

   • Not explicitly stated for a training set in the context of machine learning. This is an immunoassay, not a machine learning algorithm that requires a distinct training set. The development of the assay, its reagents, and its cutoff would be optimized through internal research and development, which implicitly involves testing various formulations and parameters to achieve desired performance characteristics.

8. How the ground truth for the training set was established:

   • Not applicable in the context of a "training set" for a traditional immunoassay. The performance of the assay (e.g., sensitivity, specificity, cutoff) is established empirically through experimentation, using precisely prepared samples with known concentrations of PCP (spiked samples) and confirmed clinical samples (by GC/MS). The cutoff (10 ng/mL) is a predefined analytical threshold, not learned from a dataset.

Ask a specific question about this device

The Psychemedics Microplate EIA for Phencyclidine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of phencyclidine in human head and body hair samples using a phencyclidine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone. The Psychemedics EIA Phencyclidine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GC/MS) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.

The test consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Phencyclidine. The drug is recovered from the hair using a patented method (U.S. Patent #8.084.215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including phencyclidine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-phencyclidine, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

Here's a breakdown of the acceptance criteria and the study details for the Psychemedics Microplate EIA for Phencyclidine in Hair, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

• EIA Positive, GC/MS ≤ -10% of Cutoff: 0
• EIA Positive, GC/MS Between -10% and -50% of Cutoff: 0
• EIA Positive, GC/MS Between -50% and Cutoff: 2
• EIA Positive, GC/MS Between Cutoff and +50%: 8
• EIA Positive, GC/MS Between +50% and +100%: 7
• EIA Positive, GC/MS > +100% of Cutoff: 46
• EIA Negative, GC/MS ≤ -10% of Cutoff: 140
• EIA Negative, GC/MS Between -10% and -50% of Cutoff: 1
• EIA Negative, GC/MS Between -50% and Cutoff: 13
• EIA Negative, GC/MS Between Cutoff and +50%: 0
• EIA Negative, GC/MS Between +50% and +100%: 0
• EIA Negative, GC/MS > +100% of Cutoff: 0 |
  | Agreement with Predicate Device | High agreement in classifying samples as positive or negative compared to the predicate device (Psychemedics Phencyclidine Assay, K011275). | Agreement with Predicate:
• EIA Positive, Predicate Negative: (Data missing in table)
• EIA Positive, Predicate Positive: (Data missing in table, likely refers to 'C' in table)
• EIA Negative, Predicate Negative: 364
• EIA Negative, Predicate Positive: (Data missing in table) |
  | Precision | Consistent results (intra-assay and inter-assay) across different concentrations relative to the cutoff (negative control, various percentages above/below cutoff). | Intra-Assay:
• B₀ (-100%): 15 NEG, 0 POS
• -75%: 15 NEG, 0 POS
• -50%: 15 NEG, 0 POS
• -25%: 15 NEG, 0 POS
• +25%: 0 NEG, 15 POS
• +50%: 0 NEG, 15 POS
• +75%: 0 NEG, 15 POS
• +100%: 0 NEG, 15 POS
  Inter-Assay:
• B₀ (-100%): 75 NEG, 0 POS
• -75%: 75 NEG, 0 POS
• -50%: 75 NEG, 0 POS
• -25%: 75 NEG, 0 POS
• +25%: 0 NEG, 75 POS
• +50%: 0 NEG, 75 POS
• +75%: 0 NEG, 75 POS
• +100%: 0 NEG, 75 POS |
  | Cosmetic Treatment Effects | Cosmetic treatments (bleach, permanent wave, dye, relaxer, shampoo) should not convert PCP-negative samples to positive, nor convert PCP-positive samples to negative. | Negative Samples: All 20 samples per treatment (bleach, perm, dye, relaxer, shampoo) remained negative after treatment (total 100 samples).
  Positive Samples: No samples positive for PCP became negative after cosmetic treatment (12 samples per treatment type, total 60 samples). Average B/B₀ x 100 values before and after treatment showed minimal change. |
  | Contamination Effects | The device should accurately identify contamination and distinguish it from actual drug use (ingestion). | PCP in Water Contamination:
• 8 samples soaked in 1000 ng phencyclidine/mL water.
• Post-wash, remaining PCP ranged from 3.3 to 16.4 ng/10 mg hair.
• After applying the wash criterion, all were determined contaminated, not positive for ingestion.
  PCP in Saline Contamination:
• 8 samples soaked in 1000 ng phencyclidine/mL saline.
• Post-wash, remaining PCP ranged from 0.7 to 3.0 ng/10 mg hair.
• Seven samples were negative without wash criterion.
• One sample at cutoff was determined contaminated after applying wash criterion. |
  | Cross-reactivity | Minimal cross-reactivity with structurally similar compounds, and no cross-reactivity with a wide range of other substances. | Cross-reactivity observed:
• 1-(1-Phenylcyclohexyl)morpholine (PCM): 5.0% (at 60 ng/10 mg hair)
• Metaphit: 30% (at 10 ng/10 mg hair)
  No cross-reactivity: 64 other compounds.
  No interference with 128 compounds at +/- 50% of cutoff. |
  | Recovery | Recovery of PCP from hair of PCP users should be substantially equivalent to the predicate device. | Reported as "substantially equivalent to the method of the predicate device." |
  | Calibrator/Control Stability | Calibrator and control solutions should remain stable for a specified period. | Stability of PCP in methanol in the presence of other drugs of abuse shown to exceed 1 year. |

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Agreement Testing (compared to GC/MS):
     • Total samples: 229 samples (140 negative, 24 below cutoff, 15 between cutoff and +100% of cutoff, 46 >100% of cutoff).
     • Body hair samples: 15% of the total samples.
   • Agreement Testing (compared to Predicate Device):
     • Total samples: An additional 224 negative samples were compared to the predicate. (There appear to be missing values/errors in the provided table for positive comparisons).
   • Precision Studies:
     • Intra-Assay: 15 replicates per concentration level (total 8 levels tested).
     • Inter-Assay: 75 replicates per concentration level (total 8 levels tested).
   • Cosmetic Treatment Studies:
     • Negative samples: 100 samples (20 per treatment type: bleach, permanent wave, dye, relaxer, shampoo; 10 samples per brand for each treatment).
     • Positive samples: 60 samples (12 per treatment type: bleach, permanent wave, dye, relaxer, shampoo; 6 samples per brand for each treatment).
   • Contamination Study: 16 hair samples (8 soaked in water-PCP, 8 soaked in saline-PCP).
   • Cross-reactivity and Interference Studies: 66 compounds for cross-reactivity (2 showed cross-reactivity, 64 did not), and 128 compounds for interference.
   • Data Provenance: Not explicitly stated, but the submission is from a US company (Psychemedics Corporation, Culver City, CA). The context of a 510(k) submission generally implies prospective collection for performance evaluation or retrospective analysis of samples typical for the intended use.
   • Retrospective/Prospective: Not explicitly stated. The nature of the studies (e.g., controlled spiking for precision, controlled cosmetic treatments, contamination studies) suggests a mix of controlled experimental prospective studies and likely retrospective collection of clinical samples for agreement testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The ground truth for the test set (primarily for agreement studies) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical chemical method, not human expert consensus. GC/MS is considered the gold standard for confirming drug presence and concentration in forensic and clinical toxicology. Therefore, no human experts were used to establish this analytical ground truth.

3. Adjudication method for the test set:

   • Not applicable/mentioned for the analytical ground truth (GC/MS). For the comparison between the new device and the predicate, there's no mention of an adjudication process; it's a direct comparison of results.

4. 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) device, specifically an immunoassay for drug detection. It does not involve human readers interpreting results in the way an imaging AI typically would. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the performance studies described (Agreement with GC/MS, Precision, Cosmetic Treatment Effects, Contamination Effects, Cross-reactivity) represent the standalone performance of the Psychemedics Microplate EIA for Phencyclidine. The device provides a preliminary analytical test result. While a human is involved in running the assay and interpreting the preliminary qualitative result, the performance data presented are inherent to the assay's chemical and enzymatic reactions (the "algorithm" in a broad sense for IVDs). However, it's crucial to note the stated intended use that positive results must be confirmed by GC/MS, implying a human-in-the-loop for definitive diagnosis, but the reported performance metrics are for the assay itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Analytical Ground Truth: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the ground truth for confirming the presence and concentration of phencyclidine in hair samples. This is a highly accurate chemical method, considered the definitive standard for such measurements.

7. The sample size for the training set:

   • The document describes device performance studies for a submitted medical device (Psychemedics Microplate EIA). These types of submissions typically focus on validation studies (test sets) rather than detailing the full development and "training" of the assay, especially since it's a traditional immunoassay, not a machine learning algorithm in the modern sense. Therefore, no specific "training set" sample size is mentioned or applicable in the context of this traditional immunoassay device. The assay design and formulation would have been optimized during development, but this wouldn't be referred to as a "training set" in the way it is for AI.

8. How the ground truth for the training set was established:

   • As stated above, the concept of a "training set" and associated "ground truth" doesn't directly apply here as it would for an AI/ML-based device. The assay components and their interactions (e.g., antibodies, substrates, reagents) are designed based on known biochemical principles and then validated through performance testing against established analytical methods like GC/MS and predicate devices.

Ask a specific question about this device

The CEDIA® Phencyclidine (PCP) OFT Assay is intended for use in the qualitative determination of phencyclidine in human oral fluid at a cutoff concentration of 3 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against PCP and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Phencyclidine (PCP) OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

Microgenics CEDIA® PCP OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CEDIA® Phencyclidine (PCP) OFT Assay:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria (e.g., "sensitivity must be >95%"). Instead, it describes performance in qualitative terms. However, based on the stated "Method Comparison" results, we can infer the implicit acceptance criteria that the device should demonstrate high concordance, sensitivity, and specificity with a confirmed method.

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

The document does not explicitly state the sample size used for the test set in the "Method Comparison" study that determined 100% concordance, sensitivity, and specificity. It also does not specify the country of origin for the data or whether it was retrospective or prospective.

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 human experts to establish ground truth for the test set. Instead, the ground truth was established by confirmatory analytical methods (GC/MS).

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established through analytical methods (GC/MS), not through expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.

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

Yes, the studies presented are standalone performance evaluations of the assay itself. The "Method Comparison" directly compares the device's output to the gold standard (GC/MS) without human interpretation as an intermediate step.

7. The Type of Ground Truth Used:

The ground truth used for the "Method Comparison" study was Gas Chromatography/Mass Spectrometry (GC/MS). The document also mentions Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as an alternative preferred confirmatory method.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size used for any training set. This is typical for an immunoassay, as it's not a machine learning model that undergoes explicit "training" on a dataset in the same way. The assay's performance is established through analytical validation studies on samples.

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

Not applicable in the context of "training set" for a machine learning model. For the assay's development and validation, the ground truth for samples used in analytical studies (e.g., precision, cutoff characterization, interference, specificity) would have been established through controlled spiking of known concentrations or independent confirmatory methods such as GC/MS for validation of spiked samples. The document implies that the assay was calibrated against PCP.

Ask a specific question about this device