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The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for drugs of abuse testing. This device is for prescription use only.

The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The device is for prescription use only.

An oral fluid specimen is collected by placing a cellulose pad affixed to a polypropylene stem under the tongue of an individual until a defined volume of saliva has saturated the cellulose pad. The defined volume taken up by the cellulose pad is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then transferred into a polypropylene tube (provided) containing 3 mL of preservative buffer. The tube is stoppered with provided cap. The specimen is ready for storage and transport.

The Quantisal™ Oral Fluid Collection Device collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer contained in the provided transport tube. This results in a 1 to 4 dilution factor.

The Quantisal™ Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The subject device is substantially equivalent to the predicate device (K200801) as they share the same design, materials, and functionality. The primary difference lies in the updated "Indications for Use" to broaden the scope beyond a specific list of drugs, relying on the established performance data of representative analytes from the predicate device.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance is based on the substantial equivalence to a legally marketed predicate device (K200801) and the device's ability to maintain the stability of various drug analytes in oral fluid samples. The acceptance criteria are implicitly related to maintaining drug stability and collection efficiency demonstrated in the previous submission.

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

The document refers to performance studies submitted and cleared in K200801 for sample volume, collection time, drug recovery, and clinical specimen studies. For the extended refrigerated sample stability, the samples were low positive samples (+50% cutoff). The exact number of samples used for each test (sample size for the test set) is not explicitly stated in this document, as it refers back to the K200801 submission. The provenance of the data (country of origin, retrospective/prospective) and detailed sample sizes are also not provided in this document but would have been part of the K200801 submission.

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

This information is not provided in the current 510(k) summary. The ground truth for drug detection and quantification would typically be established by the analytical methods themselves (LC-MS/MS, GC-MS), which are considered definitive. Expert interpretation might come into play during method development or result validation, but details are not given here.

4. Adjudication Method for the Test Set

This information is not applicable in the context of analytical device performance studies where objective measurements (e.g., drug concentrations by LC-MS/MS or GC-MS) establish the "ground truth." Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies involving human interpretation.

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

No, an MRMC comparative effectiveness study was not applicable and therefore not done. This device is an oral fluid collection device, not an AI-assisted diagnostic tool that requires human interpretation. The performance relates to its ability to collect and preserve samples for subsequent laboratory analysis.

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

This question is not applicable as the device is a collection device, not an algorithm. Its performance is evaluated based on its physical properties for collection, preservation, and chemical stability of the analytes.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations (drug recovery, stability) was established using definitive analytical methods: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and Gas chromatography-mass spectrometry (GC-MS). These methods are considered the gold standard for identifying and quantifying drugs, serving as the "pathology" equivalent in this context.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. As a physical collection device, it does not rely on machine learning or algorithms that require training data. All mentioned studies are performance evaluations.

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

As there is no training set, this question is not applicable.

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The Quantisal™ II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for drugs of abuse testing. This device is for prescription use only.

The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The device is for prescription use only.

An oral fluid specimen is collected by placing a split collector containing two cellulose pads affixed to a polypropylene stem under the tongue of an individual until a defined volume of saliva has saturated the cellulose pad. The defined volume taken up by the cellulose pads is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then separated into two specific pads/stems (Collector 1 and 2) and transferred into two separate polypropylene tubes (provided) both containing 3 mL of preservative buffer (Labelled A and B). The tubes are stoppered with provided caps. The specimen is ready for storage and transport.

The design of the split collector allows for the simultaneous collection of 2 aliquot to be used for screening and confirmation testing and the other aliquot to be stored as retain sample for potential confirmation testing.

The Quantisal II Oral Fluid Collection Device collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer contained in the provided transport tube. This results in a 1 to 4 dilution factor.

The provided document describes a 510(k) premarket notification for the Quantisal™ II Oral Fluid Collection Device. This device is intended for the collection, preservation, and transport of oral fluid specimens for drugs of abuse testing. The submission claims substantial equivalence to a predicate device (K183048).

The document does not describe an AI/ML device. It details the performance characteristics and studies for a medical device designed for specimen collection, specifically an oral fluid collection device. Therefore, many of the requested criteria related to AI/ML device evaluation (like sample size for test/training sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance) are not applicable or extractable from this document.

However, I can provide information based on the performance characteristics described for this physical device.

Device: Quantisal™ II Oral Fluid Collection Device
Intended Use: Collection, preservation, and transport of oral fluid specimens for drugs of abuse testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" as a pass/fail threshold in a tabular format for each study outcome. Instead, it describes various performance studies conducted and their positive findings, stating that the device is "substantially equivalent" to the predicate. The performance evaluation is based on demonstrating proper sample collection, preservation, and analytical comparability.

Since no explicit quantitative acceptance criteria are given for the studies, I will list the areas of performance evaluation and the conclusions drawn from the studies.

• Results: Most drugs stable for 10 days at 8-25°C and 12 months at 2-8°C in both A and B specimens. Cocaine stable for 5 days at 8-25°C and 1 month at 2-8°C. THC stable for 10 days at 8-25°C and 2 months at 2-8°C. Measured by comparing concentrations over time to initial concentration, with results within ±10% of initial concentration listed as stable intervals. |
  | Sample Transportation Stability | Performed on representative drug analytes and submitted/cleared in K183048. (Implies the device maintains sample integrity during transport). |
  | Clinical Specimens Equivalency | - Study demonstrated equivalency between the two collection pads (A and B) of the device.
• Forty deidentified, unaltered drug-free clinical oral fluid samples and up to forty deidentified, unaltered clinical oral fluid samples containing representative drugs were collected by expectoration and with the Quantisal II device.
• Results: Quantisal II Tube "A" and "B" results were compared to each other, and results from expectorated neat oral fluid and Quantisal II collected samples "matched 100%". |
  | Expectorated Oral Fluid Samples Processed Through Quantisal II (Dipping Study) | - Verified that drug concentrations in oral fluid samples collected by the device are analytically comparable to neat oral fluid samples collected by expectoration.
• At least 60 oral fluid samples for each representative drug (from self-reported drug user patients) collected by expectoration.
• An aliquot of each expectorated sample was processed through the device by dipping.
• Results: 899/900 Quantisal II Oral Fluid Collection Device samples had concentrations that were within ±20% of expectoration concentration. |

2. Sample Size and Data Provenance

Again, this is not an AI/ML device study. The provided data relates to a physical device for sample collection.

• Test Set Sample Size:
  • Oral Fluid Sample Stability: Not explicitly stated as a "test set" size, but samples were evaluated for each representative drug at low positive concentrations. The table shows initial concentrations for 14 drugs.
  • Clinical Specimens Equivalency: At least 40 deidentified, unaltered drug-free clinical oral fluid samples and up to 40 deidentified, unaltered clinical oral fluid samples containing representative drugs.
  • Dipping Study: At least 60 oral fluid samples for each of the 14 representative drugs listed in Table 5-2. (This implies a minimum of 14 drugs * 60 samples = 840 samples). The combined result mentioned "899/900 Quantisal II Oral Fluid Collection Device samples".
• Data Provenance: Clinical research facilities. The document does not specify the country of origin but implies clinical settings where drug users or drug-free individuals provide samples. The studies are retrospective in the sense that they analyze collected samples. The "Clinical Specimens Equivalency" study used "deidentified, unaltered clinical oral fluid samples" collected for comparison.

3. Number of Experts and Qualifications for Ground Truth

Not applicable to this type of device study. The ground truth for drug concentrations was established using analytical gold standards (LC-MS/MS and GC-MS), not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/ML device study requiring human adjudication of results. Analytical methods (LC-MS/MS, GC-MS) were used for quantitative comparison.

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

Not applicable. This is not an AI/ML or imaging interpretation device. There are no "human readers" involved in the primary function or evaluation of this oral fluid collection device.

6. Standalone (Algorithm Only) Performance

Not applicable, as this is a physical medical device and not an algorithm or software. The performance assessed is the device's ability to collect and preserve samples reliably for subsequent laboratory analysis.

7. Type of Ground Truth Used

The ground truth for the performance studies was established through:

• Analytical Gold Standards: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography—Mass Spectrometry (GC-MS) were used to quantify drug concentrations in collected samples, serving as the "ground truth" for drug levels.
• Comparisons: "Analytical comparability" to neat oral fluid samples collected by expectoration was also used as a ground truth for assessing collection efficiency. The borosilicate glass vial was also verified to provide "analytical truth."

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI/ML algorithm that undergoes a training phase.

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

Not applicable, as there is no "training set" for this physical device.

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For In Vitro Diagnostic Use.

The Immunalysis SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 30 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 oxycodone in human oral fluid with clinical analyzers. This assay is calibrated against oxycodone.

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 Oxycodone 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 SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is an in vitro test to detect the presence of oxycodone in human oral fluid samples collected by Quantisal II Oral Fluid Collection Device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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For In Vitro Diagnostic Use.

The Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 50 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 methamphetamine in human oral fluid with clinical analyzers. This assay is calibrated against d-methamphetamine.

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 Methamphetamine 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 Methamphetamine Oral Fluid Enzyme Immunoassay is an in-vitro test to detect the presence of methamphetamine in human oral fluid samples collected by Quantisal or Quantisal II Oral Fluid Collection Device.

The provided document describes the performance characteristics of the Immunalysis SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay for the detection of methamphetamine in human oral fluid. This is a medical device, and the data presented supports its substantial equivalence to a legally marketed predicate device (LZI Oral Fluid Methamphetamine Enzyme Immunoassay [K131652]).

The document details various studies, primarily focusing on analytical performance rather than diagnostic accuracy involving human subjects. Therefore, many of the typical acceptance criteria and study aspects for AI-powered diagnostic devices (e.g., expert consensus for ground truth, MRMC studies, human-in-the-loop performance) are not applicable here. This device performs a chemical analysis.

Here's an analysis based on the provided text, addressing the relevant points:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of in-vitro diagnostic device are generally defined by demonstrating analytical performance metrics such as precision, specificity, linearity, and stability, with results falling within acceptable ranges. Substantial equivalence is often shown by comparing these metrics to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an in-vitro diagnostic device, the "acceptance criteria" are implied by the expected performance common for such assays, aiming for high agreement with confirmed methods and consistent results. The document states a design goal of ">95% agreement" for method comparison.

• 0-37.5 ng/mL: 100% Negative (60/60)
• 50 ng/mL (Cutoff): 26 Neg/34 Pos
• 62.5-100 ng/mL: 100% Positive (60/60)
  Quantisal II Pad A:
• 0-37.5 ng/mL: 100% Negative (60/60)
• 50 ng/mL (Cutoff): 34 Neg/26 Pos
• 62.5-100 ng/mL: 100% Positive (60/60)
  Quantisal II Pad B:
• 0-37.5 ng/mL: 100% Negative (60/60)
• 50 ng/mL (Cutoff): 31 Neg/29 Pos
• 62.5-100 ng/mL: 100% Positive (60/60) |
  | Precision (Semi-Quantitative) | Mean concentration values close to expected spiked concentrations, and consistent classification. | Quantisal: Mean concentrations generally close to spiked values (e.g., 50 ng/mL mean 50.2 ng/mL). Classification performance similar to qualitative.
  Quantisal II Pad A: Mean concentrations generally close to spiked values (e.g., 50 ng/mL mean 48.6 ng/mL). Classification performance similar to qualitative.
  Quantisal II Pad B: Mean concentrations generally close to spiked values (e.g., 50 ng/mL mean 49.0 ng/mL). Classification performance similar to qualitative. |
  | Specificity/Cross-Reactivity | Minimal to no cross-reactivity with structurally unrelated compounds; expected cross-reactivity with structurally similar compounds. | - Structurally Similar: Varies. High cross-reactivity with MDMA (90.9%), (±)-3,4-Methylenedioxyethylamphetamine (45.5%), PMMA (180.2%), and some with d,l-Methamphetamine (45.5%), l-Ephedrine (1.2%), Fenfluramine (1.0%), MDA (0.8%), Methylone (0.2%), PMA (1.5%), d-Pseudoephedrine (0.3%), l-Pseudoephedrine (0.1%), d-Amphetamine (0.6%), l-Methamphetamine (0.7%).
• Structurally Unrelated: No interference observed at tested high concentrations (Table 9 shows a wide range of compounds tested up to 40,000 ng/mL). |
  | Interference (Endogenous/Exogenous) | No interference from common endogenous or exogenous substances. | No interference observed for a wide range of endogenous (e.g., Albumin, Bilirubin, Hemoglobin, Salivary-alpha-amylase) and exogenous (e.g., Acetylsalicylic Acid, Caffeine, Alcohol, Mouthwash, Toothpaste) compounds at tested levels. |
  | Interference (pH) | Performance maintained across physiological pH range. | No interference observed across pH 3.0-11.0. |
  | Linearity/Recovery | Recovery percentage within an acceptable range (e.g., 90-110%) across the linear range. | Linear range confirmed for 20-200 ng/mL. Recovery percentages: Quantisal (93.9-107.9%), Quantisal II "A" (96.8-104.0%), Quantisal II "B" (96.2-109.2%). |
  | Methamphetamine Stability | Stability of analyte in collected samples over time under specified storage conditions. | Oral fluid samples stable for up to 12 months at 2°C - 8°C. Data for 10-day stability at ambient temperature (8°C - 25°C) referenced in previous submissions (K183048, K200801). |
  | Calibration Duration | Consistent performance over defined calibration interval. | Achieved acceptance criteria up to 10 days. Recommended frequency: 7 days. |
  | Method Comparison (Qualitative & Semi-Quantitative) | Agreement with confirmatory method (LC-MS/MS) greater than 95%. | Achieved 100% agreement (40/40) for both positive and negative results when compared to LC-MS/MS across all three collection devices (Quantisal, Quantisal II "A", Quantisal II "B"). The total samples tested were 80, partitioned into 40 positive and 40 negative categories by LC-MS/MS. |

2. Sample Size and Data Provenance:

• Precision Study: 60 determinations for each concentration level, replicating across 15 days, 2 runs/day, 2 collection devices/run (N=60 per conc.). An additional 20-day study on 3 reagent lots for repeatability.
  • Provenance: Not explicitly stated (e.g., country of origin). The study states "Drug free negative oral fluid was spiked," implying a controlled laboratory setting (prospective creation of samples).
• Specificity and Cross-Reactivity: Compounds spiked into drug-free pooled oral fluid.
  • Provenance: Controlled laboratory (prospective creation of samples).
• Interference (Structurally Unrelated): Compounds spiked into drug-free oral fluid containing methamphetamine at ±25% of cutoff.
  • Provenance: Controlled laboratory (prospective creation of samples).
• Interference (Endogenous/Exogenous): Spiking into drug-free oral fluid; "Additional orally used products were tested by collecting oral fluid... from volunteers after use of the substances."
  • Provenance: Mix of controlled laboratory (prospective creation) and possibly prospective volunteer studies.
• Interference (pH): Spiked samples at various pH levels.
  • Provenance: Controlled laboratory (prospective creation of samples).
• Linearity/Recovery: Serially diluted spiked samples.
  • Provenance: Controlled laboratory (prospective creation of samples).
• Methamphetamine Stability: Spiked samples stored over time.
  • Provenance: Controlled laboratory (prospective creation of samples).
• Calibration Duration: Spiked samples tested over time.
  • Provenance: Controlled laboratory (prospective creation of samples).
• Method Comparison: 80 deidentified, unaltered clinical oral fluid samples collected by Quantisal II Oral Fluid Collection Devices.
  • Provenance: "Obtained from clinical research facilities," suggesting real-world clinical samples, likely retrospective. Country of origin not specified.

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

This is an in-vitro diagnostic (IVD) device for chemical analysis, not an imaging AI or clinical decision support system that relies on human expert interpretation of complex clinical data. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists, pathologists) is not directly applicable.

For the analytical studies performed, the "ground truth" is established very precisely through:

• Spiking concentrations: Known amounts of methamphetamine or other compounds are added to drug-free oral fluid. The exact concentration is the ground truth.
• LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry): This is a highly accurate and widely accepted gold-standard method for confirming drug presence and concentration in biological samples. The results from LC-MS/MS served as the "ground truth" for the method comparison study. The laboratory performing this analysis would follow strict protocols and be staffed by trained analytical chemists or toxicologists, but no "expert consensus" process among multiple human interpreters is involved as it would be for an image-based diagnosis.

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

Not applicable. Ground truth for an IVD drug test is established by precise chemical methods (spiking, LC-MS/MS), not through subjective 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:

Not applicable. This is an automated enzyme immunoassay (chemical test), not an AI-powered diagnostic assist tool for human readers/interpreters. There are no human "readers" in the loop.

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

The device (assay performed on a clinical analyzer) functions as a standalone test. Its performance is reported solely based on its analytical output against the chemically defined ground truth (spiked concentrations, LC-MS/MS).

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

The ground truth was established through:

• Known Spiked Concentrations: For precision, specificity, interference, linearity, stability, and calibration studies.
• Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS): For the method comparison study, LC-MS/MS results served as the definitive ground truth for "deidentified, unaltered clinical oral fluid samples".

8. The sample size for the training set:

Not applicable. This device is an enzyme immunoassay, a biochemical assay, not a machine learning/AI model that requires a "training set" in the computational sense. Its "training" is inherent in the chemical reactions and calibration curves established by the manufacturer, validated through the performance studies described.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The assay's analytical characteristics are determined through standard laboratory validation practices using materials with known characteristics (e.g., calibrated standards, spiked samples).

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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.

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For In Vitro Diagnostic Use

The Quantisal Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), cocaine and its metabolite benzoylecgonine, morphine, codeine, oxycodone, hydrocodone, 6-acetylmorphine, phencyclidine, amphetamine, buprenorphine, methadone, benzodiazepines and tramadol.

The Quantisal Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), cocaine and its metabolite benzoylecgonine, morphine, codeine, oxycodone, 6-acetylmorphine, phencyclidine, amphetamine, methamphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.

An oral fluid specimen is collected by placing a cellulose pad affixed to a polypropylene stem (Collector) under the tongue of an individual until a defined volume of saliva has saturated the cellulose pad. The defined volume taken up by the cellulose pads is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then transferred into a provided polypropylene tube containing a specific volume of preservative buffer. The tube is stoppered with provided caps. The specimen is ready for storage or transport.

The Quantisal Oral Fluid Collection System collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer. This results in a 1 to 4 dilution factor.

Immunalysis Quantisal Oral Fluid Collection Device is sold as a stand-alone collection device.

Here's a breakdown of the acceptance criteria and study information for the Quantisal™ Oral Fluid Collection Device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Volume Consistency: 75 oral fluid samples from known drug users. Data provenance is not specified beyond "known drug users." This sounds like prospective collection for the study.
• Sample Collection Time: 75 oral fluid samples from known drug users. Data provenance is not specified beyond "known drug users." This sounds like prospective collection for the study.
• Drug Recovery: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples, not human subjects.
• Oral Fluid Sample Extraction Efficiency and Stability: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
• Sample Transportation Stability: Drug-free negative oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
• Borosilicate Glass Vial Stability: Drug-free expectorated oral fluid spiked with drugs. This is an in vitro study using laboratory-prepared samples.
• Expectorated Oral Fluid Samples Processed Through Quantisal (Dipping Study): At least 60 de-identified, unaltered drug-containing oral fluid samples. Provenance is "collected by expectoration (spitting) at clinical research facility." This indicates prospective collection of clinical samples.
• Drug Free Clinical Specimens: At least 40 de-identified, unaltered drug-free clinical oral fluid samples. Provenance is "obtained from clinical research facility." This indicates prospective collection of clinical samples.

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

• No specific information is provided regarding the number or qualifications of experts for establishing ground truth.
• For spiked samples, the "ground truth" is the known concentration of the spiked drugs, as determined by laboratory methods.
• For clinical samples (Dipping Study and Drug-Free Clinical Specimens), the ground truth was established by LC-MS/MS or GC-MS analysis of the expectorated (neat) oral fluid samples, which are high-accuracy analytical methods typically used in forensic or clinical toxicology laboratories. This is considered an analytical ground truth rather than an expert consensus based on visual assessment or interpretation.

4. Adjudication Method for the Test Set

• Not applicable as this is a device for specimen collection and preservation, with performance evaluated by objective analytical methods (LC-MS/MS, GC-MS) rather than subjective human assessment requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation devices where human readers are involved in making decisions, and the AI's impact on human performance is assessed. This device is a collection tool, not an interpretive one.

6. Standalone (Algorithm Only) Performance

• This device is not an algorithm or AI in the traditional sense. It's a physical collection device. Its "standalone" performance refers to its ability to collect, preserve, and transport samples effectively, and this was evaluated by the various laboratory performance studies (e.g., drug recovery, stability, comparison to expectorated samples). The analytical tests (LC-MS/MS, GC-MS) were performed on the collected samples to determine the device's performance.

7. The Type of Ground Truth Used

• Analytical Ground Truth:
  • For spiked samples and stability studies: The known concentration of drugs in the prepared solutions.
  • For clinical samples (Dipping Study and Drug Free Clinical Specimens): The drug concentrations (or absence of drugs) as determined by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS) of the neat/expectorated oral fluid. These are highly accurate, gold-standard analytical methods for drug quantification and identification.

8. The Sample Size for the Training Set

• This device does not involve a "training set" in the context of machine learning or algorithms. It is a physical device, and its performance is evaluated through a series of analytical and clinical studies as described.

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

• Not applicable, as there is no training set for this type of device.

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The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a homogeneous enzyme immunoassay for the qualitative analysis of carisoprodol metabolite, Meprobamate, at a cutoff of 280 ng/mL in human urine. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.

The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA 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 drug of abuse test result, particularly when preliminary positive results are used.

The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a sensitive in vitro diagnostic test intended for use in laboratories for the qualitative analysis of Meprobamate at a cutoff of 280 ng/mL in human urine with automated clinical chemistry analyzers.

Carisoprodol (N-isopropylmeprobamate, Soma, ingredient of Soma Compound, Somadril®) is a carbamate derivative first synthesized in 1959 and used clinically as a muscle relaxant and sedative. Carisoprodol is known to be metabolized to meprobamate and hydroxyl-meprobamate.

The assay is based on the competition of carisoprodol labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free Meprobamate in the urine sample for the fixed amount of sheep anti-carisoprodol antibody binding sites. In the absence of the free Meprobamate in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.

The provided document describes the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA, an in vitro diagnostic device for the qualitative analysis of carisoprodol metabolite, Meprobamate, in human urine. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Performance Characteristics" section (G).

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Based on the studies described, the acceptance criteria can be inferred from the reported performance. The document doesn't explicitly state "acceptance criteria" values in a separate table, but rather presents the study results which are implicitly considered acceptable for substantial equivalence.

2. Sample size used for the test set and the data provenance

• Precision/Cutoff Characterization: For each of the three product lots, 80 determinations were made at each concentration level across 10 days (2 runs/day, 4 replicates). Total for this study: 3 lots x 9 concentrations x 80 determinations/concentration = 2160 determinations (or 3 lots x 80 samples at each of 9 levels = 2160 total samples, if each replicate is considered a sample). The data provenance is not specified, but it involved "drug free urine" spiked with meprobamate. This suggests laboratory-prepared samples.
• Specificity and Cross-Reactivity: The sample size for each compound tested is not explicitly stated, but compounds were "spiked into drug free urine."
• Interference (Structurally Unrelated / Endogenous & Preservatives / pH / Specific Gravity): The sample size for each compound/condition is not explicitly stated, but compounds were "spiked into drug-free negative urine" containing meprobamate at specific concentrations.
• Urine Elimination Study: 10 subjects were used. The samples were "self-reported single dose users" and collected their own urine. Data provenance is not explicitly stated in terms of country, but implies prospective collection for the study.
• Method Comparison: 167 de-identified, unaltered leftover clinical urine samples. Data provenance is "obtained from clinical testing laboratories," indicating retrospective use of existing clinical samples. Country of origin is not specified.

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

For the quantitative results in the precision and method comparison studies, the ground truth was established by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), a highly accurate analytical chemistry method. This is a laboratory instrumental method, not dependent on human experts for qualitative interpretation in the way imaging studies might be. While trained laboratory personnel operate and validate LC-MS/MS, the "ground truth" itself is based on the chemical analysis, not expert consensus reading of a visual output.

For the qualitative interpretation of the Immunalysis assay results (Positive/Negative call at cutoff), this is determined automatically by the instrument based on the measured signal relative to the cutoff value, not by human experts adjudicating results.

Therefore, for this type of in vitro diagnostic device, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not directly applicable.

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

Not applicable. This is an analytical immunoassay where the result (positive/negative) is determined by the instrument against an established cutoff, or by a confirmatory lab method (LC-MS/MS). There is no human interpretative step 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

Not applicable. This is an IVD immunoassay, not an AI-assisted diagnostic imaging device that involves human reader interpretation.

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

Yes, the device's performance characteristics (precision, specificity, interference, calibration, stability) and the method comparison were evaluated for the "Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA" as a standalone analytical test. The device itself is an automated immunoassay intended for use with automated clinical chemistry analyzers. As an IVD, its function is essentially "algorithm only" in the sense that it relies on chemical reactions and optical readings, with the interpretation (positive/negative) being determined by the instrument based on programmed parameters (e.g., cutoff).

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

The ground truth for the quantitative concentration of meprobamate/carisoprodol in urine samples was established using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS), which is considered the gold standard confirmatory method for drug testing. This falls under the category of a highly accurate, analytical laboratory test.

8. The sample size for the training set

The document does not describe a separate "training set" for the device development. This is typical for an immunoassay where the assay's chemical formulation, antibody properties, and cutoff are developed based on laboratory analytical studies and calibration, rather than on a large dataset of patient samples in the way a machine learning algorithm is trained. The studies described are performance validation studies.

9. How the ground truth for the training set was established

As there's no explicitly described "training set" in the context of an algorithm or machine learning, the concept of establishing ground truth for such a set is not applicable here. The ground truth for the analytical and validation studies was established through precisely prepared spiked samples (for precision, specificity, interference) and confirmatory LC-MS/MS analysis for clinical samples (method comparison, urine elimination study).

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The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid specimens for tetrahydrocannabinol (THC), benzoylecgonine, cocaine, oxycodone, hydrocodone, bacetylmorphine, phencyclidine, amphetamine, buprenorphine, methadone, benzodiazepines and tramadol. This device is for prescription use only.

The Quantisal II Oral Fluid Collection Device is intended for the collection, preservation and transport of oral fluid. An oral fluid specimen is collected by placing two cellulose pads affixed to a polypropylene stem (Collector) under the tongue of an individual until a defined volume of saliva has saturated the cellulose pads. The defined volume taken up by the cellulose pads is indicated by coloration (blue) in a window on the stem (volume adequacy). The collector is then separated into two specific pads/stems and transferred into two separate polypropylene tubes (provided) both containing a specific volume of preservative buffer. The tubes are stoppered with provided caps. The specimens are then ready for storage or transport. The design of two specific pads/stems allows for one aliquot to be used for screening and confirmation testing and the other aliquot to be stored as retain sample for potential second chance testing. The Quantisal II Oral Fluid Collection System collects 1 mL of neat oral fluid and dilutes it with 3 mL of preservative buffer. This results in a 1 to 4 dilution factor. Immunalysis Quantisal II Oral Fluid Collection Device is sold as a stand-alone collection device.

This document describes product testing for the Immunalysis Quantisal II Oral Fluid Collection Device, a medical device for collecting and preserving oral fluid samples for drug testing. This is not an AI/ML device, and therefore the details usually associated with an AI/ML device's acceptance criteria and study (such as MRMC studies, human reader improvement with AI assistance, or sample sizes for training sets) are not applicable.

However, based on the provided text, we can extract details regarding the device's performance characteristics and how its acceptance was established.

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance

• Sample Volume: 50 oral fluid samples from volunteers (country not specified, likely US since FDA submission), 75 oral fluid samples from known drug users (country not specified, likely US since FDA submission). Retrospective.
• Sample Collection Time: 50 oral fluid samples from volunteers, 75 oral fluid samples from known drug users. Retrospective.
• Drug Recovery (In Vitro): Oral fluid spiked with drugs at specific concentrations. Number of samples not explicitly stated but implied to be sufficient for LC-MS/MS or GC-MS testing. This is an in-vitro study.
• Oral Fluid Sample Extraction Efficiency and Stability: Oral fluid spiked with drugs. Number of samples not explicitly stated. This is an in-vitro study.
• Sample Transportation Stability: Oral fluid spiked with drugs. Number of replicates not explicitly stated for each condition, but tested in "replicates of two" within the variable temperature range. This is an in-vitro study with simulated transport conditions.
• Borosilicate Glass Vial Stability: Oral fluid spiked with drugs, initial concentration analyzed, then tested with three vials sequentially. This is an in-vitro study.
• Clinical Specimens:
  • Drug-Free: 40 deidentified, unaltered clinical oral fluid samples collected by expectoration and Quantisal II for each drug class/analyte. (Total 40 drug-free per drug x 15 drugs = 600 samples for the device, and 600 for expectoration).
  • Containing Drug: 40 deidentified, unaltered clinical oral fluid samples (except for Hydrocodone with 18 samples) obtained from clinical research facility, collected by expectoration and Quantisal II for each drug class/analyte. (Total ~578 samples for the device, and ~578 for expectoration).
  • Provenance: Clinical research facility, "deidentified, unaltered" samples. Country of origin not explicitly stated but implied to be within the US given FDA submission. Retrospective (samples "obtained").
• Expectorated Oral Fluid Samples Processed Through Quantisal II (Dipping Study): At least 60 deidentified, unaltered drug-containing oral fluid samples collected by expectoration from a clinical research facility. A minimum of 10 samples for each drug were within ±50% of the confirmation cutoffs. Total of 900 paired results were analyzed (Implied: 60 samples x 15 drugs = 900 measurements, or 60 samples for an undisclosed mix of drugs). Retrospective (samples "collected").

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

This is not applicable as this is a device for collecting samples for chemical analysis, not an AI/ML diagnostic interpretation. The "ground truth" for the drug concentrations was established through quantitative laboratory methods (LC-MS/MS or GC-MS), which are considered objective analytical techniques rather than expert consensus.

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

Not applicable. Ground truth was established by laboratory instrumentation (LC-MS/MS or GC-MS), not human 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

Not applicable. This is not an AI/ML diagnostic device that involves human readers or interpretation of medical images.

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

Not applicable. This is a collection device, not an algorithm. The reported performance is the device's ability to collect, preserve, and transport samples for subsequent laboratory analysis.

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

The ground truth for the presence and concentration of drugs in oral fluid samples was established using quantitative analytical methods: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS). These are highly sensitive and specific laboratory techniques considered gold standards for drug detection and quantification in biological matrices. For the clinical specimens, the "clinical truth" was defined by the expectorated neat oral fluid sample analyzed by LC-MS/MS or GC-MS.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set." The studies were designed to validate the physical and chemical performance of the collection device.

9. How the ground truth for the training set was established

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

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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.

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