510(k) · Cleared
Recalled · 2009Accu-Chek Aviva Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 11, 2006 as substantially equivalent to K043474 (Roche Diagnostics Corp., 2005) after a 156-day review. Its family tree reaches back 2 generations to 2001. 1 of the 50 devices in its family, counting itself, has a Class I recall. 46 later devices descend from it. It has been recalled once.
- Decided
- Aug 11, 2006
- Review
- 156 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010362 (2001). 3 ancestors in all. 46 later devices descend from it, 2 citing it directly. 1 of the 50 devices in this family, counting this one, has a Class I recall.
- 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 deviceK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006
- Descendant · cites it directly · 44 of its ownK101299 Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011
- Descendant · 2 generations on · 37 of its ownK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- Descendant · 3 generations on · 33 of its ownK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- Descendant · 4 generations on · 32 of its ownK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 21 of its ownK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology7 generations on · 2020
Most influential descendants
Showing 5 of 46 · See all- K101299Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011 · cites it directly44descendants
- K111353Accu-Check Combo SystemRoche Diagnostics · 2012 · 2 generations on37descendants
- K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · 3 generations on33descendants
- K150910ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · 4 generations on32descendants
- K160629InPenCompanion Medical, Inc. · 2016 · 5 generations on21descendants
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) | K060620 | Accu-Chek Aviva Test Strips | Roche Diagnostics Corp. | 2006 | — |
| +1 | K101299 | Accu-Chek Aviva Plus Blood Glucose Monitoring System | Roche Diagnostics | 2011 | — |
| +2 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| +3 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| +4 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
| +5 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 5 | 1 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K043474 | Accu-Chek Aviva SystemSummary page 1…system Classification name: 75, LFR, Glucose Dehydrogenase, glucose 3) Predicate The Roche Diagnostics ACCU-CHEK Aviva system cleared under K043474 device on April 27, 2005. 4) Device The ACCU-CHEK Aviva Test Strips are stored within a desiccated vial.… | 2005 |
What descends from it? (46)
See all 462 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2009 | Not classified | Z-1593-2009 | Other | The lancet cap may be missing, which could result in an unintended lancet stick to the user. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K101299 (Roche Diagnostics, 2011) has gone furthest, with 44 descendants of its own.
- 9 other devices also cite its predicate K043474.
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.
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 Aviva Test Strips are used with the ACCU-CHEK Aviva meter. The ACCU-CHEK Aviva test system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060620: Accu-Chek Aviva 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/K060620
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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