(173 days)
Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. Status DS ™ Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use. The Status DSTM Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.
Status DS'" Nicotine is a simple one step immunochromatographic test for the rapid, qualitative detection of cotinine, a major metabolite of nicotine.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document describes a qualitative immunoassay for cotinine detection to screen for nicotine exposure. The primary study presented is a substantial equivalence comparison to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative Detection of Cotinine at 500 ng/mL Cutoff | 100% correlation with predicate device (K972481; Auto-Lyte Cotinine EIA) |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: 94 specimens (50 negative and 44 positive).
- Data Provenance: Not explicitly stated, but common for such studies to use clinical samples. No information on country of origin or if it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study does not establish ground truth using human experts. Instead, it compares the new device's results to those of a legally marketed predicate device (K972481; Auto-Lyte Cotinine EIA).
4. Adjudication method for the test set:
- Not applicable, as the 'ground truth' was based on the predicate device's results, not a consensus among human reviewers.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a standalone diagnostic test, not an AI-assisted interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the device. The 100% correlation found was the device's performance compared to a predicate device, without human intervention in the interpretation process described in the study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study was the results obtained from a legally marketed predicate device, the Auto-Lyte Cotinine EIA (K972481).
8. The sample size for the training set:
- Not applicable. This device is an immunoassay, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 862.3220 Carbon monoxide test system.
(a)
Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.(b)
Classification. Class I (general controls). 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.