# K983047: Accu-Chek HQ System

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Feb 5, 1999 after 157 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924475 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924475: Accudata Glucose Test Station, Boehringer Mannheim Corp. (1992) Summary page 1.

## Recalls of this device
- Jun 22, 2006 · Not classified · Z-1365-06: The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.

## Indications for use
The Accu-Chek HQ system is a bedside unit that can help health care professionals provide quality patient care by measurement of glucose on an Accu-Chek monitor, and by automating the record keeping associated with blood glucose and quality control tests.

Source page: https://510kreport.com/device/K983047
Methodology: https://510kreport.com/methodology