# K051376: Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 23, 2005 after 89 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944458 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944458: Accu-Chek Instant Plus Choloesterol Test, Boehringer Mannheim Corp. (1996) Summary page 1.
- K944459: Accu-Chek Instant Plus G-C/DM Blood Glucose Monitoring System, Boehringer Mannheim Corp. (1996) Summary page 1.

## Indications for use
The AccuChek® Instant Plus Dual Testing System is designed to quantitatively measure cholesterol and glucose in capillary whole blood. The AccuChek Instant Glucose Test Strips are for use in home and professional settings for testing glucose in whole blood. The AccuChek Instant Cholesterol Test Strips are for use by health care professionals and for home use by people with diabetes for cholesterol screening.

Source page: https://510kreport.com/device/K051376
Methodology: https://510kreport.com/methodology