# K003846: Accu-Chek Inform Meter

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 19, 2001 after 97 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have 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
- K121679: Accu-Chek Inform II Blood Glucose Monitoring System (2012), 5 descendants of its own
- K133741: ACCU-CHEK Performa Blood Glucose Monitoring System (2014), 3 descendants of its own
- K170079: Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System (2017), 2 descendants of its own
- K182046: Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System (2018), 0 descendants of its own
- K182047: Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System (2018), 0 descendants of its own

## Recalls of this device
- Jun 30, 2004 · Not classified · Z-1060-04: Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
- Jun 30, 2004 · Not classified · Z-1061-04: Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

Source page: https://510kreport.com/device/K003846
Methodology: https://510kreport.com/methodology