# K010362: Accu-Chek Comfort Curve Test Strip

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 7, 2001 after 29 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
64 later devices descend from it; 1 cites it directly.
1 of 65 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043474: Accu-Chek Aviva System (2005), 63 descendants of its own
- K060620: Accu-Chek Aviva Test Strips (2006), 46 descendants of its own
- K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System (2011), 44 descendants of its own
- K111353: Accu-Check Combo System (2012), 37 descendants of its own
- K141929: Accu-Chek Connect Diabetes Management App (2015), 33 descendants of its own

## Recalls of this device
- Jun 27, 2006 · Not classified · Z-1377-06: The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results.
- Feb 10, 2006 · Not classified · Z-0571-06: There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose
- Feb 10, 2006 · Not classified · Z-0572-06: There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose
- Feb 10, 2006 · Not classified · Z-0573-06: There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose
- Feb 10, 2006 · Not classified · Z-0566-06: There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose
- Feb 12, 2003 · Not classified · Z-0715-03: Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

Source page: https://510kreport.com/device/K010362
Methodology: https://510kreport.com/methodology