(148 days)
For in vitro diagnostic workplace use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use single-drug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
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Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
The provided text is a 510(k) summary for the LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate. This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed performance studies against specific acceptance criteria. While it mentions the device's intended use and performance characteristics, it does not provide a dedicated section outlining specific acceptance criteria or a detailed study proving the device meets them in the manner typically seen for novel device approvals.
Therefore, many of the requested items cannot be directly extracted from this document. However, I will infer and present the information that is available or implicitly stated.
Inferred Acceptance Criteria & Reported Performance:
The primary "acceptance criteria" for a 510(k) device like this hinge on its ability to provide qualitative screening results for Opiate at a specific cut-off value and to do so reliably for its intended use and user group. The reported performance is primarily descriptive of its function rather than a quantitative measurement against a pre-defined threshold.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative Screening for Opiate at a specific cut-off value | Provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. |
| Intended Use Environment | For in vitro diagnostic workplace use. |
| User Proficiency | Operable by individuals with no prior laboratory testing education or experience, provided they receive specified training, demonstrate competency, and understand potential for false positive/negative results. |
| Integration with Instrument | The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument. (This implies proper function and communication between the module and the instrument is an unstated criterion). |
| Confirmation Need | Provides only a preliminary result; a more specific alternate chemical method (e.g., GC/MS) is needed for confirmed analytical results. (This is a limitation that must be met, not a performance metric per se, but it defines the scope of its "acceptance" as a screening tool). |
Detailed Breakdown for Study and Criteria:
Since the document is a 510(k) and not a full clinical study report, specific details regarding sample sizes, ground truth establishment, expert qualifications, and detailed statistical analyses are not included in the provided text.
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A table of acceptance criteria and the reported device performance:
(See table above) -
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. (It's a 510(k), not a study report).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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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/mentioned. This is an in vitro diagnostic device for substance detection, not an AI-assisted diagnostic imaging or interpretation tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is inherently a "standalone" test system (albeit with a required instrument). It provides a result based on chemical reaction detection. The "human-in-the-loop" aspect comes from the user performing the test and interpreting the preliminary result, but the device itself generates the screening result without human interpretation of raw data. The document does not describe separate algorithm-only performance testing beyond the intended use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- While not explicitly stated for a "test set," the document implicitly refers to Gas Chromatography/Mass Spectroscopy (GC/MS) as the "preferred confirmation method" for analytical results. This strongly suggests that GC/MS would be the gold standard or ground truth for confirming the presence and concentration of opiates in human saliva during validation studies for such a device.
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The sample size for the training set:
- Not applicable/specified. This type of device does not typically involve a "training set" in the machine learning sense. Its performance is based on chemical assay characteristics, not learned patterns.
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How the ground truth for the training set was established:
- Not applicable. (See #8).
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).