# K982089: Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Sep 3, 1998 after 80 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951887 (1995). 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)
- K951887: Advantage Test Strips, Boehringer Mannheim Corp. (1995) Summary page 2.
- K954833: Accu-Chek Advantage Test Strips, Boehringer Mannheim Corp. (1996) Summary page 2.

## Recalls of this device
- Jun 27, 2006 · Not classified · Z-1378-06: 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-0568-06: 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-0570-06: 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-0567-06: 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-0569-06: 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 12, 2003 · Not classified · Z-0716-03: Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

## Indications for use
The Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete monitors are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.

Source page: https://510kreport.com/device/K982089
Methodology: https://510kreport.com/methodology