510(k) · Cleared
Recalled · 2007Ammonia/Ethanol/CO2 Calibrator, Control Normal, Control Abnormal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jul 16, 2003 as substantially equivalent to K952282 (Roche Diagnostic Systems, Inc., 1995) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 3 times.
- Decided
- Jul 16, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951595 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995 · Recalled
- This deviceK031880 Ammonia/Ethanol/CO2 Calibrator, Control Normal, Control AbnormalRoche Diagnostics Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951595 | Roche Cobas Integra Analyzer, Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1995 | 7 |
| 0 (this device) | K031880 | Ammonia/Ethanol/CO2 Calibrator, Control Normal, Control Abnormal | Roche Diagnostics Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 JIX? 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
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 |
|---|---|---|---|
| * | K952282 | Roche Ammonia/Ethanol/CO2 CalibratorSummary page 2…ied in the enclosed value sheet. Predicate We claim substantial equivalence to the currently marketed Device Ammonia/EthanoVC02 Calibrator (K952282) and Ammonia/Ethanol/C02 Controls (K95 1595).… | 1995 |
| * | K951595 | Roche Cobas Integra Analyzer, Reagent CassettesSummary page 2…e We claim substantial equivalence to the currently marketed Device Ammonia/EthanoVC02 Calibrator (K952282) and Ammonia/Ethanol/C02 Controls (K95 1595). 25 DEPARTMENT OF HEAL… | 1995 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2007 | Not classified | Z-0377-2008 | Process design | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. |
| Nov 14, 2007 | Not classified | Z-0378-2008 | Process design | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. |
| Nov 14, 2007 | Not classified | Z-0379-2008 | Process design | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031880: Ammonia/Ethanol/CO2 Calibrator, Control Normal, Control Abnormal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031880
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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