510(k) · Cleared
Recalled · Class II · 2021Accu-Chek Inform II Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 11, 2012 as substantially equivalent to K003846 (Roche Diagnostics Corp., 2001) and 2 other predicates after a 126-day review. Its family tree reaches back 2 generations to 2001. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 11, 2012
- Review
- 126 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010362 (2001). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 1 generation backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- This deviceK121679 Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics · 2012
- Descendant · cites it directly · 3 of its ownK133741 ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK170079 Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B…Tyson Bioresearch, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK182046 Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B…Tyson Bioresearch, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK182047 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C…Tyson Bioresearch, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK130138 Super Sani-Cloth/ Accu-Chek Inform II SystemRoche Diagnostics Corp. · 2013
Most influential descendants
Showing 5 of 5 · See all- K133741ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics · 2014 · cites it directly3descendants
- K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose…Tyson Bioresearch, Inc. · 2017 · 2 generations on2descendants
- K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose…Tyson Bioresearch, Inc. · 2018 · 3 generations on0descendants
- K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose…Tyson Bioresearch, Inc. · 2018 · 3 generations on0descendants
- K130138Super Sani-Cloth/ Accu-Chek Inform II SystemRoche Diagnostics Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −1 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| 0 (this device) | K121679 | Accu-Chek Inform II Blood Glucose Monitoring System | Roche Diagnostics | 2012 | — |
| +1 | K133741 | ACCU-CHEK Performa Blood Glucose Monitoring System | Roche Diagnostics | 2014 | 1 |
| +2 | K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood… | Tyson Bioresearch, Inc. | 2017 | — |
| +3 | K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood… | Tyson Bioresearch, Inc. | 2018 | — |
| +3 | K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood… | Tyson Bioresearch, Inc. | 2018 | — |
| +1 | K130138 | Super Sani-Cloth/ Accu-Chek Inform II System | Roche Diagnostics Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
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 NBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003846 | Accu-Chek Inform MeterSummary page 1….1345) Product Codes: LFR, Glucose Dehydrogenase 1JX, Single (specified) analyte controls (assayed and unassayed) 3) Predicate The ACCU-CHEK Inform System presented in k003846 is the predicate for device - the ACCU-CHEK Inform 1l system. The controls solutions presented in the ACCU-CHEK Aviva 510(k) sub… | 2001 |
| * | K043474 | Accu-Chek Aviva SystemSummary page 1…orm System presented in k003846 is the predicate for device - the ACCU-CHEK Inform 1l system. The controls solutions presented in the ACCU-CHEK Aviva 510(k) submission (k043474) are the predicate for the ACCU-CHEK Inform Il control solutions. The Nova StatStrip Glucose Linearity Kit (receiving clearance… | 2005 |
| * | K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsSummary page 1…CHEK Aviva 510(k) submission (k043474) are the predicate for the ACCU-CHEK Inform Il control solutions. The Nova StatStrip Glucose Linearity Kit (receiving clearance in k060345) is the predicate for the ACCU-CHEK Inform II Linearity Kit. Continued on next page 1/6 510(k) Summary, Continu… | 2006 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2021 | Class II | Z-2354-2021 | Package design/selection | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy… |
| Feb 11, 2016 | Class II | Z-1172-2016 | Software Design Change | Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an… |
| Mar 6, 2013 | Class II | Z-1113-2013 | Device Design | Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K133741 (Roche Diagnostics, 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. The ACCU-CHEK Inform II…
Read the full statement (161 words)
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121679 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121679: Accu-Chek Inform II Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121679
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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