K232603 is an FDA 510(k) clearance for the CamAPS FX. Classified as Interoperable Automated Glycemic Controller (product code QJI), Class II - Special Controls.
Submitted by Camdiab , Ltd. (London, GB). The FDA issued a Cleared decision on May 23, 2024 after a review of 269 days - an extended review cycle.
This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1356 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.
View all Camdiab , Ltd. devices
NCT00910767
Completed
Interventional
Closing the Loop in Adults With Type 1 Diabetes
A Randomised, 2-period Cross-over Study to Assess the Feasibility of Overnight Computer-based Glucose Control Based on Continuous Subcutaneous Glucose Monitoring, and Compare it With Conventional Pump Therapy in Adults With Type 1 Diabetes
| Condition studied |
Type 1 Diabetes |
| Study design |
Crossover |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Mark L Evans, MD FRCP |
| Sponsor |
University of Cambridge
|
Started 2009-02-01
→
Primary completion 2009-07-01
Primary outcome
Percentage of plasma glucose values in target (3.9 - 8.0 mmol/L)
Secondary outcome
Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
Study completed - no results published.
This trial concluded in 2009 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov