510(k) Report

510(k) · Cleared

Recalled · 2006

Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test Strips

K982089510(k) TraditionalCleared Sep 3, 199880-day reviewClass II21 CFR 862.1345Recalls 7

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boehringer Mannheim Corp. · LFR Glucose Dehydrogenase, Glucose

Cleared on Sep 3, 1998 as substantially equivalent to K951887 (Boehringer Mannheim Corp., 1995) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 7 times.

Decided
Sep 3, 1998
Review
80 days
Class
Class II
Product code
LFR
Recalls
7
Predicates
2

Its longest line of descent runs back 1 generation to K951887 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK951887 · Advantage Test Strips · Boehringer Mannheim Corp. · 1995199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K951887 · Advantage Test Strips · Boehringer Mannheim Corp. · 19950
  1. Root · 1 generation backK951887 Advantage Test StripsBoehringer Mannheim Corp. · 1995
  2. This deviceK982089 Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test StripsBoehringer Mannheim Corp. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K951887Advantage Test StripsBoehringer Mannheim Corp.1995—
0 (this device)K982089Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test StripsBoehringer Mannheim Corp.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K982089, 1995–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K951887Advantage Test Strips
Summary page 2
…other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Accu-Chek Advantage Test Strip (k951887 and k954833). Blood glucose concentrations can be expressed two ways, as whole blood glucose or as plasma (or serum) glucose. Th…
Boehringer Mannheim Corp.1995—
*K954833Accu-Chek Advantage Test Strips
Summary page 2
…ts in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Accu-Chek Advantage Test Strip (k951887 and k954833). Blood glucose concentrations can be expressed two ways, as whole blood glucose or as plasma (or serum) glucose. The concentrat…
Boehringer Mannheim Corp.1996—

Also cleared against K951887: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 27, 2006Not classifiedZ-1378-06OtherThe 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, 2006Not classifiedZ-0568-06OtherThere 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 readings.
Feb 10, 2006Not classifiedZ-0570-06OtherThere 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 readings.
Feb 10, 2006Not classifiedZ-0567-06OtherThere 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 readings.
Feb 10, 2006Not classifiedZ-0569-06OtherThere 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 readings.
Feb 10, 2006Not classifiedZ-0573-06OtherThere 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 readings..
Feb 12, 2003Not classifiedZ-0716-03OtherCrack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 3 other devices also cite its predicate K951887.

How does its category compare?

All LFR devices

LFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFR

1in 2015

2007: 12009: 12011: 62012: 132013: 32014: 32015: 1
2007high 13 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFR

161in 2014

2011: 296 days median2012: 152 days median2013: 212 days median2014: 161 days median
2007high 296 (2011) · low 152 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFR

1in 2012

2007: 32008: 12009: 42011: 12012: 1
2007high 4 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFR

827in 2025

2007: 23,8192008: 6,5842009: 10,8232010: 4,8652011: 3,8022012: 3,3412013: 3,8212014: 3,9602015: 3,3662016: 2,1452017: 1032018: 1082019: 1082020: 1322021: 1642022: 1012023: 1032024: 1712025: 827
2007high 23,819 (2007) · low 101 (2022)2025

MAUDE reports naming product code LFR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—323,819
20080—16,584
20091—410,823
20100—04,865
2011629613,802
20121315213,341
2013321203,821
2014316103,960
20151—03,366
20160—02,145
20170—0103
20180—0108
20190—0108
20200—0132
20210—0164
20220—0101
20230—0103
20240—0171
20250—0827
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K951887

3 other devices cite the same predicate.

  • K973662Accu-Chek (R)Complete System/Meter & Accu-Chek Advantage Test Strips/Accu-Chek Advantage H Test StripsBoehringer Mannheim Corp. · 19972 recalls
  • K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997
  • K962295Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996

More from Boehringer Mannheim Corp.

345 FDA decisions under this applicant name. See the company

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K983047Accu-Chek HQ SystemBoehringer Mannheim Corp. · 19991 recall
  • K984419Elecsys Ige CalcheckBoehringer Mannheim Corp. · 1999
  • K984425Modification of Preciset Serum Proteins CalibratorBoehringer Mannheim Corp. · 1999
  • K984372Elecsys Calcheck Troponin TBoehringer Mannheim Corp. · 1998

Recent decisions in LFR

The LFR category page

  • K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories · 2015
  • K142089Accu-Chek Aviva Expert SystemRoche Diagnostics Corporation · 2014
  • K133537EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemEps Bio Technology Corp. · 2014
  • K131727Cera-Chek 1070 Blood Glucose Monitoring SystemCeragem Medisys, Inc. · 2014
  • K131366Accu-Chek Aviva Expert Blood Glucose Monitoring SystemRoche Diagnostics Operations, Inc. · 2013

https://510kreport.com/device/K982089 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982089: Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982089

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026