510(k) Report

510(k) · Cleared

Recalled · 2004

Accu-Chek Inform Meter

K003846510(k) TraditionalCleared Mar 19, 200197-day reviewClass II21 CFR 862.1345Recalls 2

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

Roche Diagnostics Corp. · LFR Glucose Dehydrogenase, Glucose

Cleared on Mar 19, 2001 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.

Decided
Mar 19, 2001
Review
97 days
Class
Class II
Product code
LFR
Recalls
2
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared200020052010201520202025
  1. This deviceK003846 Accu-Chek Inform MeterRoche Diagnostics Corp. · 2001
  2. Descendant · cites it directly · 5 of its ownK121679 Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics · 2012 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK133741 ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics · 2014 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK170079 Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B…Tyson Bioresearch, Inc. · 2017
  5. Descendant · 4 generations on · 0 of its ownK182046 Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B…Tyson Bioresearch, Inc. · 2018
  6. Descendant · 4 generations on · 0 of its ownK182047 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C…Tyson Bioresearch, Inc. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 12017: 12018: 2
2012high 2 (2018) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all
  • K121679Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics · 2012 · cites it directly5descendants
  • K133741ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics · 2014 · 2 generations on3descendants
  • K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose…Tyson Bioresearch, Inc. · 2017 · 3 generations on2descendants
  • K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose…Tyson Bioresearch, Inc. · 2018 · 4 generations on0descendants
  • K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose…Tyson Bioresearch, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003846Accu-Chek Inform MeterRoche Diagnostics Corp.2001—
+1K121679Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics20123
+2K133741ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics20141
+3K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood…Tyson Bioresearch, Inc.2017—
+4K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood…Tyson Bioresearch, Inc.2018—
+4K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood…Tyson Bioresearch, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
201710
201820
FIG. 1 — Lineage of K003846, 2001–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121679Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics20125

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 30, 2004Not classifiedZ-1060-04OtherExposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
Jun 30, 2004Not classifiedZ-1061-04OtherExposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K121679 (Roche Diagnostics, 2012) has gone furthest, with 5 descendants of its own.

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—

More from Roche Diagnostics Corp.

621 FDA decisions under this applicant name. See the company

  • P990056/S046Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2026
  • P000027/S045Elecsys Free Psa Immunoassay/Calset/CalcheckRoche Diagnostics Corp. · 2026
  • P000027/S044Elecsys free PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S045Elecsys total PSA assayRoche Diagnostics Corp. · 2026
  • P990056/S044Elecsys Total Psa Immunoassay and Total Psa CalsetRoche Diagnostics Corp. · 2025

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/K003846 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003846: Accu-Chek Inform Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003846

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026