K171408 is an FDA 510(k) clearance for the Carbon Monoxide Breath Sensor System (COBSS). Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.
Submitted by Carrot Sense, Inc. (Redwood City, US). The FDA issued a Cleared decision on September 29, 2017 after a review of 140 days - within the typical 510(k) review window.
This device falls under the Toxicology FDA review panel, regulated under 21 CFR 868.1430 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.
View all Carrot Sense, Inc. devices
NCT03148613
Completed
Interventional
Industry-sponsored
Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit
Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit
| Condition studied |
Smoking, Tobacco |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
David Utley, MD |
| Sponsor |
David Utley, MD
(industry)
|
Started 2017-02-02
→
Primary completion 2017-03-15
→
Completed 2017-08-30
Primary outcome
Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices
Secondary outcome
User Documentation Assessment With Questionnaire With Observer Ratings
View full study on ClinicalTrials.gov