# K944458: Accu-Chek Instant Plus Choloesterol Test

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 6, 1996 after 541 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AccuMeter Cholesterol Self Test: named in the summary without a submission number

## Most influential descendants
- K051376: Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose (2005), 0 descendants of its own

## Indications for use
Both systems are used to measure total cholesterol in whole blood.

Source page: https://510kreport.com/device/K944458
Methodology: https://510kreport.com/methodology