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The Oratect Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below.

These products are for in vitro diagnostic use and intended for prescription point of care use.

The Orated® Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Samples for confirmatory testing should be collected with the Oratect® Oral Fluid Collection Tube (50 mL polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.

The Oratect® Oral Fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The test principle is a competitive lateral flow immunochromatographic assay. The presence of analyte will produce a negative signal.

Acceptance Criteria and Device Performance for Oratect® Oral Fluid Drug Screen Devices

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the document consistently uses "Accuracy results against reference method >90%" as the performance metric for the subject device and "Accuracy results against reference method >89%" for the predicate. For the purpose of this summary, we will infer the acceptance criterion to be >90% accuracy against a reference method.

The reported device performance based on the "Accuracy" row in the comparison table is also >90% against reference method.

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The CEDIA® Opiate OFT Assay is intended for use in the qualitative determination of opiate in human oral fluid at a cutoff concentration of 30 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against morphine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.

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

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

In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (enzyme donor) of β-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragment free to form active enzyme. If the analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive β-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.

The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.

This document describes the acceptance criteria and the study performance for the CEDIA® Opiate OFT Assay, a device intended for the qualitative determination of opiates in human oral fluid.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria based on the reported "accurate" recovery and "no significant" interference/cross-reactivity, along with high concordance/sensitivity/specificity values.

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

The document does not explicitly state the exact sample size for the "test set" used in the method comparison study. It only mentions "The overall concordance between the CEDIA® Opiate OFT Assay and GC/MS is 97.6%."

Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study comparing the new assay's results against a confirmatory method (GC/MS).

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

This device is an in vitro diagnostic (IVD) assay, not an imaging or interpretation device that typically relies on human experts for ground truth establishment in the same way clinical diagnostic studies might.

For IVD assays like this, the "ground truth" for the test set is established by a confirmatory analytical method, in this case, Gas Chromatography/Mass Spectrometry (GC/MS). Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as it would apply to interpretive tasks (e.g., radiologists reading images) is not directly applicable here. The experts involved would be the laboratory personnel performing and interpreting the GC/MS results, who are qualified to operate and interpret results from such sophisticated analytical equipment.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by a confirmatory analytical method (GC/MS), not by human expert consensus or adjudication in the traditional sense. Discordant results between the CEDIA® Opiate OFT Assay and GC/MS would be resolved by the GC/MS result, which is considered the "gold standard" for confirmation.

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

No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic assay, and its performance is evaluated based on its analytical characteristics and concordance with a reference method, not human reader performance.

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

Yes, a standalone performance evaluation was done. The study assesses the performance of the CEDIA® Opiate OFT Assay itself, comparing its results directly to the GC/MS confirmatory method without human interpretation as an intermediate step. The assay provides a "preliminary analytical test result" which then requires confirmation by GC/MS or LC-MS/MS.

7. The Type of Ground Truth Used

The type of ground truth used is confirmatory analytical testing, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The document states: "A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods."

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or "training data" in the conventional sense used for machine learning algorithms. This is an immunoassay, and its development involves analytical validation, not a distinct training phase with a labeled dataset in the way AI/ML devices do. The performance characteristics are established through various analytical studies (precision, cutoff characterization, interference, specificity, method comparison).

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

Not applicable. As mentioned above, this is an immunoassay and does not have a "training set" in the context of machine learning. The assay mechanism is based on biochemical reactions and genetic engineering (recombinant DNA technology), not on learning from a dataset.

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The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system to detect opiates in human saliva with a cutoff of 30 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte Morphine are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for opiate drugs. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

The Opiate Oral Fluid Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/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.

LZI's Oral Fluid Opiate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Opiate in oral fluid with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the saliva sample for a fixed amount of specific antibody. In the absence of free drug from the saliva sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.

The provided text describes the LZI Opiate Oral Fluid Homogeneous Enzyme Immunoassay. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device rather than explicitly stating acceptance criteria in a quantitative table. However, the "Comparison to Predicate Device" section implicitly outlines key performance characteristics that are likely considered for equivalence. The study described focuses on analytical performance, specifically to demonstrate accuracy around the specified cutoff.

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

The provided text does not explicitly state a sample size for a "test set" in the context of a clinical performance study. The studies described appear to be analytical performance studies rather than clinical trials with patient samples.

• Spike Recovery Study: Used samples "spiked" with known concentrations of morphine. The number of samples/replicates is not specified.
• Precision Study: Conducted using "three levels of controls repeatedly" (number of replicates not specified).
• Specificity/Cross-reactivity: Tested "various, common prescription drugs and abused drugs." (Number of drugs and concentrations not specified).
• Method Comparison with GC/MS: Compared 118 oral fluid specimens. The provenance (country of origin, retrospective/prospective) of these 118 specimens is not stated.

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

Not applicable. The ground truth for the analytical studies was established through:

• Known concentrations: For the spike recovery study.
• Reference method (GC/MS): For the method comparison study. GC/MS results are considered the "gold standard" for drug confirmation. No human experts were involved in establishing the ground truth for these analytical performance studies in this context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The studies are objective analytical performance evaluations.

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 an automated, homogeneous enzyme immunoassay for detecting opiates. It does not involve human readers interpreting images or data where AI assistance would be a factor.

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

Yes, the studies described are standalone analytical performance evaluations of the device's ability to detect opiates. The "algorithm" here refers to the immunoassay's chemical reaction and measurement process.

7. The Type of Ground Truth Used

• Known concentrations: For spike recovery (morphine concentration).
• GC/MS (Gas Chromatography/Mass Spectrometry): For the method comparison study, GC/MS served as the definitive method for confirming the presence and concentration of opiates in oral fluid specimens.

8. The Sample Size for the Training Set

Not explicitly stated. This device is an immunoassay, not a machine-learning algorithm in the modern sense that typically involves a distinct "training set" for model development. The development of such assays involves iterative optimization of reagents and conditions, which would utilize various "samples" during R&D, but not in the formalized machine learning "training set" context.

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

Not applicable in the machine learning sense. The "ground truth" during the development of this immunoassay would involve:

• Using known concentrations of morphine and its metabolites.
• Testing known positive and negative oral fluid samples (potentially characterized by GC/MS).
• Optimizing reagent concentrations and reaction conditions to achieve desired sensitivity, specificity, and cutoff performance.

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The Cozart EIA Cocaine Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for cocaine and metabolites in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/ml. in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample.

This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.

The Cozart EIA Cocaine Oral Fluid Kit is a laboratory based test for the detection of cocaine and metabolites in human oral fluid using a cutoff equivalent to 30ng/mL. The Cozart EIA Cocaine Oral Fluid Kit is a competitive ELISA for the detection of cocaine and its metabolites in human oral fluid. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 5, 10 and 50ng/ml benzoylecgonine in oral fluid matrix).

Here's a summary of the acceptance criteria and study details for the Cozart EIA Cocaine Oral Fluid Kit, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 177 samples.
   • Data Provenance: Not explicitly stated, but the context of clinical and forensic samples suggests human samples. The country of origin is not specified, but the manufacturer is based in the UK. The study appears to be retrospective, as existing samples were tested.

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

   • Not applicable for this type of in-vitro diagnostic (IVD) device. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical method, not human expert consensus, for drug detection.

3. Adjudication Method for the Test Set:

   • Not applicable. The reference method (GC/MS) served as the definitive ground truth, and the device's results were compared directly to it. There was no mention of human adjudication between different readers or methods beyond the GC/MS.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC study was not done. This device is an in-vitro diagnostic kit, not an imaging or diagnostic algorithm requiring human interpretation of output.

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

   • Yes, this was a standalone performance study. The Cozart EIA Cocaine Oral Fluid Kit is a laboratory-based test that provides a qualitative result based on its biochemical reactions and spectrophotometric reading. Its performance was evaluated directly against GC/MS without human intervention in the interpretation of the kit's results.

6. The Type of Ground Truth Used:

   • analytical reference method, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The text explicitly states: "The device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS)." and "96% overall agreement as compared with GC/MS". GC/MS is widely considered the "gold standard" for confirmatory drug testing.

7. Sample Size for the Training Set:

   • Not explicitly stated. The document describes a "method comparison" study as the primary performance evaluation. For a competitive ELISA kit, internal calibration and validation (which might involve a "training" equivalent) would have been performed by the manufacturer during its development, but details regarding a distinct "training set" sample size are not provided in this 510(k) summary.

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

   • Not explicitly stated. Given that performance for the test set was established against GC/MS, it is highly probable that any internal development, calibration, or "training" (if applicable for this type of device) would also have referenced GC/MS or highly purified standards of cocaine and its metabolites at known concentrations.

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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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