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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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