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The OraQuick Ebola Rapid Antigen Test is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens within the Ebolavirus genus but does not differentiate between these viruses. Testing with the OraQuick Ebola Rapid Antigen Test must only be performed when public health authorities have determined the need for this test. Testing for Ebola Virus Disease (EVD) must be performed in accordance with current guidelines provided by the appropriate public health authorities that address appropriate biosafety conditions, interpretation of test results, and coordination of testing, results and patient management with public health authorities. The OraQuick Ebola Rapid Antigen Test is intended for use with specimens from:

• individuals with epidemiological risk factors with signs and symptoms of EVD or
• . recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD.

EVD is a nationally notifiable condition and must be reported to public health authorities in accordance with local, state, and federal regulations.

The OraQuick Ebola Rapid Antigen Test is intended for use with venipuncture whole blood and fingerstick whole blood specimens as an aid in diagnosis of EVD in patients suspected of and with signs or symptoms consistent with EVD who have epidemiological risk factor(s) for Ebolavirus exposure (e.g., contact with a known or suspected case, travel to a geographic location at a time when Ebolavirus transmission was known or suspected to have occurred). Performance of the device with Ebolavirus positive fingerstick whole blood was established in a non-human primate model.

The OraQuick Ebola Rapid Antigen Test is intended for use with cadaveric oral fluid collected from recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD. Cadaveric oral fluid should be collected directly with the device or collected with oral swabs in viral transport media. The OraQuick Ebola Rapid Antigen Test is intended as an aid in the determination of EVD as the cause of death to inform decisions on safe handling of cadavers to prevent disease transmission.

The OraQuick Ebola Rapid Antigen Test results are presumptive, definitive identification of EVD requires performing additional testing and confirmation procedures in consultation with public health and/or other authorities to whom reporting is required.

Negative results were observed in individuals with low levels of circulating virus, therefore negative results do not preclude infection with viruses within the Ebolavirus genus.

The level of Ebolavirus antigens that would be present in EVD clinical specimens from individuals with early systemic infection is unknown. Test performance of the OraQuick Ebola Rapid Antigen Test is associated with the level of Ebolavirus antigens in the patient; therefore, the test is not intended for use in an asymptomatic population for massscreening purposes (e.g., as the sole means of EVD control at airports or bordercrossings) or for testing of individuals at risk of exposure without observable signs of infection.

The OraQuick Ebola Rapid Antigen Test is intended for use by experienced personnel who have documented device specific training offered by OraSure Technologies Inc., training in the correct use of recommended personal protective equipment (PPE) and expertise in infectious disease diagnostic testing, including the safe handling of clinical specimens potentially containing Ebolavirus. The test is intended for use by laboratory professionals or healthcare workers who have demonstrated availability of biosafety equipment, access to patient containment facilities, and established procedures (e.g., SOP) for coordinating testing, results and patient management with public health authorities consistent with state, local and federal recommendations and guidelines.

The OraQuick Ebola Rapid Antigen Test is a manually performed, visually read immunoassay for the qualitative detection of Ebola virus in human venipuncture whole blood, fingerstick whole blood and cadaveric oral fluid. The OraQuick Ebola Rapid Antigen Test is comprised of both a single-use test device and a vial containing a pre-measured amount of a buffered developer solution. The single-use test devices consist of a plastic housing that protects the assay test strip with the reagents. The assay strip can be viewed through the test device result window. The test result window has indicated zones for the Ebolavirus specific Test Line and the Control Line of the test. The test consists of a sealed pouch with two separate compartments for each of the following two components:

• 1. OraQuick Ebola Rapid Antigen Test
• 2. Developer Vial

The OraQuick Ebola Rapid Antigen Test further contains the following materials for the sample processing:

• 1. Test Stand
• 2. Micropipettes capable of pipetting 20ul of sample

The OraQuick Ebola Rapid Antigen Test kit must be used with the OraQuick Ebola Rapid Antigen Test Kit Controls and a Visual Reference Panel (available separately). The OraQuick Ebola Rapid Antigen Test Kit Controls contain:

• 1. One Ebola positive control vial (orange capped)
• 2. One Ebola negative control vial (white capped)

The positive control contains 0.25mL of Ebola recombinant VP40 equivalent to a moderate positive result and is diluted in a defibrinated pool of normal human plasma negative for Ebolavirus. The negative control contains 0.25 mL of defibrinated pool of normal human plasma negative for Ebolavirus. The controls do not contain infectious Ebolavirus material.

The OraQuick Ebola Visual Reference Panel (VRP) is intended to assist new operators in becoming proficient at reading specimens with antigen levels near the limit of detection of the device. The devices in the VRP do not contain any infectious material. The VRP contains three Quick Ebola Rapid Antigen Test devices that have been designed to represent reading intensities representative of

• 1. A test result near the limit of detection (LoD)
• 2. A low positive test result
• 3. A negative test result

Additional materials required but not provided include

1. Timer

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OraQuick Ebola Rapid Antigen Test are primarily demonstrated through various analytical and clinical performance studies. While explicit pass/fail criteria are not always stated quantitatively (e.g., "must achieve X% PPA"), the reported performance in tables is presented as meeting the expectations for De Novo classification.

Here is a table summarizing the reported device performance, which implies the acceptance criteria established for this device:

Study Details Proving Acceptance Criteria

1. Sample Size and Data Provenance:

• Test Set Sample Sizes:
  • Clinical Sensitivity (Natural Samples):
    • Venous Whole Blood: 25 Ebola positive, 50 Ebola negative samples (retrospective).
    • Cadaveric Oral Fluid (West Africa): 35 comparator PCR positive, 193 comparator PCR negative samples (prospective & retrospective).
    • NHP Study (Fingerstick/Venous): 5 non-human primates, samples collected at multiple time points (pre- and post-exposure, up to day 8).
  • Clinical Sensitivity (Contrived Samples):
    • Venous Whole Blood: 25 individual samples (12 at 1.5x LoD, 13 at 5x LoD), additional negative samples for blinding.
    • Cadaveric Oral Fluid: 20 positive (9 at 1.5x LoD, 10 at 5x LoD), 5 negative samples.
  • Clinical Specificity (Natural Samples):
    • Venous Whole Blood (Non-endemic): 226 samples.
    • Fingerstick Whole Blood (Non-endemic): 249 samples (224 from main cohort, 25 from previous EUA study).
    • Direct Cadaveric Oral Fluid (Endemic): 147 samples (50 from Sierra Leone, 97 from Liberia).
    • VTM Cadaveric Oral Fluid (Non-endemic): 63 matched sets (BD Universal VTM and Σ-Virocult).
  • Reproducibility: Three panel members (negative, 2x LoD, 5x LoD) tested twice daily with each of three lots over 5 days by 3 operators per site (3 sites). Exact N/n values are redacted for specific numbers but overall concordance is provided.
  • Detection Limit (LoD) Confirmation: 20 replicates each for tentative LoD, negative, and moderate positive samples.
  • Analytical Specificity (Reactivity/Cross-Reactivity): 3 replicates for each concentration tested.
  • Interference: 6 or 12 replicates for negative and positive (2x or 4x LoD) samples depending on the interferent.
• Data Provenance:
  • Retrospective/Prospective: A mix of retrospective and prospective studies.
    • Retrospective: Clinical sensitivity studies for venous whole blood and cadaveric oral fluid from West Africa (2014/15 Ebola Zaire outbreak).
    • Prospective: Clinical specificity studies for venous and fingerstick whole blood from a non-endemic U.S. population. NHP study was also prospective.
  • Country of Origin:
    • West Africa (Sierra Leone, Liberia, Guinea) for actual outbreak samples.
    • United States for non-endemic population studies and contrived samples.
    • NHP study performed at a BSL-4 laboratory at (b) (4).
  • Sample Types: Venipuncture whole blood, fingerstick whole blood, cadaveric oral fluid. Contrived samples used both living human matrix and NHP models.

2. Number of Experts and Qualifications:

• Ground Truth for Clinical Samples: Primarily established by RT-PCR assays, which are considered the highly sensitive and specific comparator method for Ebolavirus detection. These PCR tests were validated/EUA-authorized. The document refers to "experienced personnel" for test performance and interpretation, but specific numbers and qualifications of experts establishing the ground truth are not detailed for the natural clinical samples beyond the use of validated PCR methods.
• For Analytical Studies (e.g., LoD, Reproducibility): Operators were "blinded," and studies performed at "three (3) testing sites, two external and one internal." No specific "expert" roles are defined for establishing ground truth in these highly controlled analytical settings where ground truth is pre-defined by the spiked concentrations.

3. Adjudication Method for the Test Set:

• The primary ground truth for clinical samples was RT-PCR results.
• For reproducibility studies, "Sample testing was performed blinded." For LoD confirmation, samples were "randomized and tested by three blinded operators."
• "No replicate testing was performed" for the West African venous whole blood clinical sensitivity study.
• The text does not explicitly mention a multi-expert adjudication method (e.g., 2+1, 3+1) for discordant samples or for establishing a consensus "ground truth" through visual interpretation by multiple human readers. Decisions regarding inclusion/exclusion of samples (e.g., invalid PCR results, low volume samples) were based on specified criteria.

4. MRMC Comparative Effectiveness Study:

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly performed or reported in the sense of comparing human reader performance with AI assistance vs. without AI assistance. This device is a lateral flow immunoassay, a manually performed and visually read test, with "no software or instrument components." Therefore, the concept of "AI assistance" in reading or interpreting results does not apply to this device. Human readers are the sole interpreters of the visual lines on the test strip.

5. Standalone Performance:

• This device is a standalone diagnostic test in the context of its operation. Its "performance" refers to the accuracy of the device itself (the visual readout by a human operator) compared to a reference method (RT-PCR). There is no "human-in-the-loop" performance beyond the human visually interpreting the device's result. The robust human factors and usability studies assess the human's ability to correctly operate and read the device.

6. Type of Ground Truth Used:

• Expert Consensus: Not explicitly stated as the primary ground truth method, though trained personnel perform the visual interpretations.
• Pathology: Not used.
• Outcomes Data: Not directly stated as the ground truth. The primary ground truth for validation of clinical performance (sensitivity and specificity) is RT-PCR results, typically from samples collected from patients with signs, symptoms, and epidemiological risk factors. For cadaveric studies, PCR results from cadaveric oral fluid samples served as the comparator.
• Contrived Samples: A significant portion of the analytical and some clinical sensitivity studies utilized contrived samples with pre-defined concentrations of Ebolavirus or recombinant antigens. These concentrations represent the "ground truth" for those specific studies.
• NHP Infected Status: For the NHP study, "infected status" (based on viral challenge) was also used as a comparator for PPA.

7. Sample Size for the Training Set:

• The document describes a De Novo submission for a diagnostic device, which typically means it is the device, not a component developed using machine learning that requires a separate training set.
• As a manually read, lateral flow immunoassay without AI/machine learning components, the concept of a "training set" for an algorithm is not applicable. The "training" described relates to operator training (e.g., "device specific training offered by OraSure Technologies Inc.") and the use of a Visual Reference Panel to help operators become proficient in reading results, especially low-intensity lines. This refers to training human operators, not a machine learning model.

8. How Ground Truth for Training Set was Established:

• Given it's a visually read immunoassay with no AI/ML, there isn't an algorithm "training set" in the modern ML sense.
• For the Visual Reference Panel (VRP), which aids in human operator training, the VRP contains devices designed to represent specific reading intensities (LoD, low positive, negative). The "ground truth" for these VRP devices is their pre-designed antigen concentration levels during manufacturing to achieve those target visual intensities. The stability section for the VRP mentions "Target Reading Level 1+" and "Target Reading Level 3+", implying these were established by the manufacturer to calibrate visual interpretation.

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The Compound W® Freeze Off™ Plantar Wart Removal System is indicated for over-the-counter treatment of common and plantar warts.

The Compound W® Freeze Off™ Plantar Wart Removal System is a cryosurgical system for the treatment of common warts and plantar warts. It consists of:

• A canister filled with a liquid mixture of the compressed gases dimethyl O ether, propane and isobutane
• 12 Disposable Applicators O
• 1 Pumice Stone o
• o 12 Foot Comfort Pads
• 1 Reusable Activator that releases the cryogen into the applicator O
• An illustrated description of how to use the product with common and o plantar warts

This device is a portable cryosurgical system comprised of a canister containing cryogen and an applicator that is saturated with cryogen and then applied tan the wart to be treated.

The provided text is a 510(k) summary for the Compound W® Freeze Off™ Plantar Wart Removal System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study report. Therefore, much of the requested information about acceptance criteria, detailed study design, and performance metrics for this specific device is not available in the provided text.

Here's an attempt to address the points based on the available information:

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

The document does not specify quantitative acceptance criteria or a direct performance study for the new device (Compound W® Freeze Off™ Plantar Wart Removal System). Instead, it relies on demonstrating substantial equivalence to previously approved devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a specific "test set" for the new device. The submission relies on the established safety and effectiveness data of the predicate devices. Therefore, no information on sample size, data provenance, or study type for a test set of this specific device is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No specific test set for the new device is described, and thus no expert ground truthing process is mentioned in this submission.

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

Not applicable. No specific test set for the new device is described, and thus no adjudication method is mentioned.

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 a cryosurgical device for wart removal, not an imaging or diagnostic AI device. Therefore, MRMC studies and AI assistance metrics are not relevant or mentioned.

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

Not applicable. This is a medical device, not an algorithm, and its use inherently involves human interaction for application.

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

For the predicate devices, the ground truth for establishing safety and effectiveness would have been based on clinical outcomes data (e.g., wart clearance rates, adverse events) from their original clinical studies. However, the provided document does not detail these for the predicates, only states that their safety and effectiveness were established.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device that utilizes a training set in the conventional sense.

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

Not applicable. This is not an AI/algorithm-based device.

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The Histofreezer® Wart Removal System is indicated for over-the-counter treatment of common warts and plantar warts.

The Histofreezer® Wart Removal System is a cryosurgical system for the treatment of warts. It consists of: A canister filled with a liguid mixture of the compressed gases dimethyl ether, propane 0 and isobutane o Custom applicators O An illustrated description of how to use the product

The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria. The document is a 510(k) summary for the Histofreezer® Wart Removal System, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new performance study with explicit acceptance criteria.

The main points of the document are:

• Device Name: Histofreezer® Wart Removal System
• Intended Use: Over-the-counter treatment of common warts and plantar warts.
• Basis for Equivalence: Substantial equivalence to the prescription Histofreezer® device (K911420, K924114, K971392) for the same indications, and commercial predicate devices (Wartner Wart Removal System, Compound W Gel, Clear Away Liquid, Clear Away One Step for Kids, Rite Aid Wart Liquid, Suave Hairspray) regarding labeling, safety, and intended use.
• Technological Characteristics: Both the proposed device and the predicate device are portable cryosurgical systems using a canister with cryogen and an applicator.
• Conclusion: The device is deemed safe, effective, and substantially equivalent to the predicate devices.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets them from the given text.

To address the specific points of your request, based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document asserts substantial equivalence based on intended use, technological characteristics, and safety/labeling similarities rather than presenting a performance study with defined criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No test set or performance data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is mentioned.
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 device is a physical cryosurgical system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth is described for a performance study.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is described.

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The OTI Benzodiazepines Intercept® MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device using a 1.0 ng/mL cutoff. FOR IN VITRO DIAGNOSTIC USE.

The OTI Benzodiazepines Intercept® MICRO-PLATE EIA provides only a preliminary analytical test result. A more specific alternative chemical method should be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry/mass spectrometry (GC/MS/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.

The OT1 Benzodiazepines Intercept® MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. Specimen or standard is added to an EIA well in combination with an enzyme-labeled hapten derivative. In an ELA well containing an oral fluid specimen positive for benzodiazepines, there is a competition between the drug and the enzymelabeled hapten to bind the antibody fixed onto the EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 mm is inversely proportional to the amount of benzodiazepines present in the specimen or calibrator/control. Because currently there are no SAMHSA assigned cutoffs for benzodiazepines testing using oral fluid, OTI recommends a cutoff of 1.0 ng/mL when testing oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. This cutoff is within the limit of detection by the OTI Benzodiazepines Intercept® MICRO-PLATE EIA.

Here's an analysis of the provided text regarding the OTI Benzodiazepines Intercept® MICRO-PLATE EIA, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet. Instead, it presents performance characteristics of the proposed device alongside those of a legally marketed predicate device (Abuscreen ONLINE® kit for Benzodiazepines). The implication is that the proposed device's performance should be "essentially equivalent" to the predicate. Therefore, the "acceptance criteria" are inferred to be the performance ranges/values of the predicate device for each characteristic, and the "reported device performance" is the measured performance of the OTI Benzodiazepines Intercept® MICRO-PLATE EIA.

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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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The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is intended for use in the collection, preservation, and transport of oral specimens. Oral specimens collected with the Intercept™ Oral Specimen Collection Device can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs.

The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosae. The Pad is placed in contact with the gingival mucosa (between the lower cheek and gum) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the Pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

This document pertains to the Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device. It is a collection device, so the performance criteria focuses on the ability to collect and preserve samples for subsequent drug testing, rather than direct diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria for the device's performance in a table format, nor does it present specific performance data from a study.

However, the core of the submission (K011057) is a claim of substantial equivalence to a predicate device (OraSure® Oral Specimen Collection Device; K970357). The "performance" in this context is implicitly tied to demonstrating that the new device can effectively collect and preserve samples for the same range of drug detection as the predicate and extend this capability to additional drugs when paired with specific assays.

Implicit Acceptance Criteria (derived from the text):

• Preservation Capability: Ability to preserve the collected specimen.
• Transport Capability: Ability to transport the specimen securely to a laboratory. | "Both devices share major components (collection apparatus and transport containing a preservative solution) and are intended for collecting an oral fluid specimen, and for containing and transporting that specimen." This implies the new device performs these core functions comparably to the predicate. |
  | II. Compatibility with Downstream Assays (Extended Use) | - Detection of Cocaine & Metabolites: Compatibility with assays for these substances.
• Detection of Cannabinoids: Compatibility with assays for these substances.
• Detection of Phencyclidine: Compatibility with assays for this substance.
• Detection of Amphetamine: Compatibility with assays for this substance.
• Detection of Methamphetamine: Compatibility with assays for this substance.
• Detection of Opiates: Compatibility with assays for these substances.
• Detection of Barbiturates: Compatibility with assays for these substances.
• Detection of Methadone: Compatibility with assays for these substances. | "The oral specimens collected with the Intercept™ device, however, can be used to detect cocaine and cocaine metabolites, cannabinoids, phencyclidine, amphetamine, methamphetamine, opiates, barbiturates and methadone with the OraSure Technologies Intercept™ MICRO-PLATE EIAs as demonstrated in the premarket notifications for the assays (K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010)." This indicates successful validation of compatibility with specific assays. |

2. Sample Size and Data Provenance for Test Set:

The provided 510(k) summary does not detail a specific "test set" sample size or data provenance for a direct clinical performance study of the collection device itself.

Instead, the submission relies on:

• Substantial Equivalence: By claiming substantial equivalence to the OraSure® Oral Specimen Collection Device (K970357), it implicitly asserts that the new device performs similarly for its core functions.
• Referenced PMA/510(k)s for Assays: For the extended detection capabilities, the document refers to multiple separate premarket notifications (K001197, K000399, K992918, K002375, K993208, K981341, K001976, K002010) for the OraSure Technologies Intercept™ MICRO-PLATE EIAs. The performance data for detecting the specific drugs with oral specimens collected by this device would be detailed within those referenced assay submissions.

Therefore, without access to those referenced documents, we cannot provide details on the test set sample size or data provenance for the drug detection capabilities.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

The document does not mention the use of experts to establish ground truth specifically for the collection device's performance in this 510(k) summary. This is consistent with a substantial equivalence claim for a collection device, where the focus is on physical and functional similarity to an already cleared device, and the analytical performance (e.g., drug detection accuracy) is tied to the separate assays.

4. Adjudication Method for Test Set:

Not applicable, as no direct "test set" and ground truth establishment by experts for the collection device itself is described.

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

Not applicable. The Intercept™ Oral Fluid Drug Test Oral Specimen Collection Device is a collection device, not an AI-assisted diagnostic tool or a device that requires human interpretation in the way an imaging AI might. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This device is a manual specimen collection device and does not involve an algorithm for standalone performance. Its "performance" is its ability to successfully collect and preserve an oral fluid specimen for laboratory analysis.

7. Type of Ground Truth Used:

For the collection device's core functionality, the "ground truth" is implied by its functional equivalence to the predicate device and its ability to deliver a specimen suitable for subsequent laboratory analysis.

For the drug detection claims, the ground truth would be established during the development and validation of the specific EIAs (Enzyme Immunoassays) as detailed in the referenced K numbers. This type of ground truth typically involves:

• Analytical Standards: Known concentrations of drugs and their metabolites.
• Spiked Samples: Oral fluid samples to which known amounts of drugs have been added.
• Clinical Samples with Confirmed Results: Oral fluid samples from actual subjects, where drug presence/absence and concentration have been independently confirmed by more definitive methods (e.g., GC/MS or LC/MS-MS, considered the gold standard for drug testing).

8. Sample Size for the Training Set:

The document does not specify a training set sample size. As a collection device, it does not typically involve traditional machine learning "training sets" in the same way an AI diagnostic algorithm would. Its design and functional validation would be based on engineering principles, materials science, and compatibility testing with chemical assays.

9. How Ground Truth for Training Set Was Established:

Not applicable, as a traditional "training set" with ground truth in the context of an algorithm or machine learning is not described or relevant for this type of device. The "ground truth" for the device's design and functionality would be based on:

• Established methods for oral fluid collection.
• Chemical stability validation for the preservative solution ensuring drug integrity.
• Compatibility testing with the OraSure Technologies Intercept™ MICRO-PLATE EIAs (which themselves would have their own established ground truth).

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