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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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