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The UPlink™ Oral Fluid Drug Test is a rapid immunoassay intended for use with the UPlink™ Analyzer for the qualitative detection of opiates in oral fluid using a 40 ng/mL cutoff. FOR IN VITRO DIAGNOSTIC USE.

The UPlink™ Test System provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when a preliminary, positive result is observed.

UPlinkTM is the trademark name for a new, rapid, onsite testing technology. The basis for the test is Up-Converting Phosphor Technology (UPT). UPT particles are small nanospheres composed of rare earth metals that are labeled with antibodies against targeted drugs of abuse. Similar particles have been used for decades in display screens such as televisions or fluorescent light bulbs. Different from the particles used in televisions, UPT particles are excited by infrared light and up-convert the energy to give a visible emission. This is an anti-stokes shift that does not exist in nature. In addition, just like current display screens, UPT particles are available in different colors to allow multiplexing and do not fade or photobleach.

The UPlink™ Test, in conjunction with the UPlink™ Analyzer and oral fluid collection device, is a lateral flow, panel immunoassay for the rapid qualitative measurement of opiates in oral fluid. The UPlinkTM collection device gathers the oral fluid sample for analysis from the mouth and into a test cassette, The UPlink™ Analyzer measures the intensity of the signal line(s) on the cassette and converts it to a qualitative result(s).

The test consists of a protective cassette housing containing a lateral flow strip of plastisbacked nitrocellulose that has been impregnated with test and reference lines. Phosphor particles conjugated with analyte-specific antibodies are dried into a pad adjoined to the nitrocellulose strip and in physical contact with both the strip and an overlying absorbent pad. With addition of the oral fluid sample to the cassette, the phosphor-antibody complexes move with the sample by capillary action to contact the test line. When opiates are present in the oral fluid sample, the drug with the phosphorantibody conjugate during flow and the phosphor-antibody-drug complexes will not bind further to the analyte derivative on the test line. As a result, subsequent excitation of the URink™ Analyzer will not produce a signal. If no drug is present in the sample, phosphor-antibody complexes will bind to the test line, giving a high signal strength at the test line is inversely proportional to the amount of opiates present in the sample. The assay reference band is not influenced by the presence or absence of drug in the oral fluid, and therefore, will be present in all reactions.

The UP oral fluid collection device consists of a cellulose sponge donut contained in aplastic housing with a removable handle. The collector is used to continuously swab the mouth between the cheek and gum for 1 to 2 minutes. As sample is collected, the cellulose sponge expands, ensuring that an adequate amount of sample is obtained in each collection. The collection device is inserted into the an accquate and pushed down to crack a small ampoule of buffer, followed by removal of the handle so the test cassette can be inserted into the UPIinkTM Analyzer.

The UPIink™ Analyzer is a portable instrument containing a laser source that interrogates the test strip for signals produced by the test and reference lines. Detection of a signal for the reference line indicates the validity of the test. The intensity of the signal for the test line is indirectly proportional to the concentration of the analyte. The test strip's lot specific calibration curve is contained in a barcode on each cassette. By its use the instrument converts the measured signal into a positive or negative result that is displayed to the user.

The UPlink™ Test System is a rapid immunoassay for the qualitative detection of opiates in oral fluid using a 40 ng/mL cutoff, intended for in vitro diagnostic use. It provides a preliminary analytical test result, with Gas chromatography/mass spectrometry (GC/MS) being the preferred confirmatory method.

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

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary only explicitly states the acceptance criteria for the predicate device, which is 90% agreement as compared to GC/MS. The performance of the UPlink™ Test System is then compared to this benchmark.

Detailed Clinical Accuracy Performance for UPlink™ Test System (compared to GC/MS/MS):

• Study 1: Poppy Seed Ingestion

  • Agreement: 100% (30/30 individuals rendered a positive result by Uplink and were confirmed positive by GC/MS/MS).
  • GC/MS/MS Range: 72-440 ng/mL codeine and 560-2640 ng/mL morphine.

• Study 2: Codeine Ingestion (16 mg)

  • GC/MS/MS Combined Morphine & Codeine (ng/mL) | Uplink Negative | Uplink Positive |
    |---------------------------------------------------|---------------------|---------------------|
    | 16.9-38.8 | 8 | 5 |
    | 40-56 | 8 | 3 |
    | > 60 | 6 | 8 |

• Study 3: Non-drug users and Drug Rehabilitation/Treatment Centers

  • GC/MS/MS Combined Morphine & Codeine (ng/mL) | Uplink Negative | Uplink Positive |
    |---------------------------------------------------|---------------------|---------------------|
    | None detected* | 119 | 22 |
    | 3.6-28** | 7 | 1 |
    | 8.4-60*** | 2 | 4 |
    | >72*** | 2 | 13 |

  • * Almost all samples were evaluated for the presence of 6-mam; none was found.

  • ** All samples were evaluated for the presence of 6-mam; none was found.

  • *** Almost all samples were evaluated for the presence of 6-mam; all samples but one contained > 4.4 ng/mL of 6-mam.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: A total of 238 oral fluid samples across three separate studies.
  • Study 1: 30 individuals
  • Study 2: Number of individuals not explicitly stated, but results are presented across concentration ranges.
  • Study 3: 170 samples
• Data Provenance: Not explicitly stated regarding country of origin. The studies involve "individuals who ingested poppy seed filling," "individuals ingested 16 mgs of codeine," and "a mixture of non-drug users and individuals enrolled in drug rehabilitation or drug treatment centers." This suggests prospective collection for the first two studies, and a mix of prospective and potentially retrospective (for drug treatment center patients) for the third study. All data appears to be clinical in nature.

3. Number of Experts and their Qualifications for Ground Truth

• The ground truth was established by Gas chromatography/mass spectrometry (GC/MS or GC/MS/MS), which is a laboratory analytical method, not human expert interpretation in this context. Therefore, the concept of "number of experts" and their "qualifications" for establishing this specific ground truth is not applicable. The GC/MS/MS results are considered the objective gold standard for drug detection and quantification.
  • The document implies that laboratory personnel are qualified to perform and interpret GC/MS/MS results, but no specific number or qualifications are given.

4. Adjudication Method for the Test Set

• No human adjudication method is described for the test set. The UPlink™ Test System results were directly compared against the objective GC/MS/MS results.

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

• No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is an automated, objective test system, not an imaging or diagnostic tool requiring human interpretation that could be "improved with AI assistance." It produces a qualitative (positive/negative) result via an attached analyzer.

6. Standalone Performance

• Yes, the performance data presented is for the standalone (algorithm only without human-in-the-loop performance) of the UPlink™ Test System. The UPlink™ Analyzer reads the test strip and converts the measured signal into a positive or negative result, which is then compared to GC/MS/MS. There is no human interpretation involved in the device's output.

7. Type of Ground Truth Used

• The type of ground truth used is laboratory analytical gold standard: Gas chromatography/mass spectrometry (GC/MS or GC/MS/MS). This method is the "preferred confirmatory method" and is used as the basis for comparison for the UPlink™ Test System.

8. Sample Size for the Training Set

• The document does not provide any information regarding a distinct "training set" for the UPlink™ Test System. The system's "lot specific calibration curve is contained in a barcode on each cassette," implying that the device is calibrated, but the data used for establishing this calibration or any model training is not disclosed in this summary. This is typical for a premarket notification for an in vitro diagnostic device from this era, where traditional analytical validation rather than machine learning model validation was the norm.

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

• As no training set is explicitly mentioned or detailed, there is no information on how its ground truth would have been established. For devices relying on calibration curves, the ground truth for calibration would involve known concentrations of analytes (opiates) measured by a reference method (likely GC/MS/MS) during the manufacturing or development process.

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