510(k) · Cleared
ClearedAccuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Aug 23, 2005 as substantially equivalent to K944458 (Boehringer Mannheim Corp., 1996) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 23, 2005
- Review
- 89 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944458 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944458 Accu-Chek Instant Plus Choloesterol TestBoehringer Mannheim Corp. · 1996
- This deviceK051376 Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus…Roche Diagnostics · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944458 | Accu-Chek Instant Plus Choloesterol Test | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K051376 | Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol… | Roche Diagnostics | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 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 CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944458 | Accu-Chek Instant Plus Choloesterol TestSummary page 1…erol. 3) Predicate The AccuChek Instant Plus Dual Testing System is substantially equivalent to device the AccuChek Instant Plus System described in both K944458 and K944459. 4) Device The AccuChek Instant Plus system had each parameter (cholesterol and Description glucose) cl… | 1996 |
| * | K944459 | Accu-Chek Instant Plus G-C/DM Blood Glucose Monitoring SystemSummary page 1…redicate The AccuChek Instant Plus Dual Testing System is substantially equivalent to device the AccuChek Instant Plus System described in both K944458 and K944459. 4) Device The AccuChek Instant Plus system had each parameter (cholesterol and Description glucose) cleared separa… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The AccuChek® Instant Plus Dual Testing System is designed to quantitatively measure cholesterol and glucose in capillary whole blood. The AccuChek Instant Glucose Test Strips are for use in home and professional settings for testing glucose in whole blood. The AccuChek Instant Cholesterol Test Strips are for use by health care professionals and for home use by people with diabetes for cholesterol screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051376: Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051376
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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