510(k) · Cleared
Recalled · 2008Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/MG Cal, LDL Cal, MC Cal, Upro Cal, and Ise Calibrator Levels 1 and 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jul 9, 1998 after a 56-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 9, 1998
- Review
- 56 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK981706 Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/MG Cal, LDL Cal, MC Cal…Abbott Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK103403 Multiconstituent CalibratorAbbott Laboratories · 2011
Most influential descendants
Showing 1 of 1 · See all- K103403Multiconstituent CalibratorAbbott Laboratories · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981706 | Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/MG Cal, LDL Cal, MC Cal, Upro Cal… | Abbott Laboratories | 1998 | — |
| +1 | K103403 | Multiconstituent Calibrator | Abbott Laboratories | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103403 | Multiconstituent Calibrator | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2008 | Not classified | Z-0950-2009 | Error in labeling | An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium Calibrator lot number 54187M200. Use of the incorrect Magnesium CAL 2 value causes quality control and patient magnesium results to be… |
| Aug 10, 2007 | Not classified | Z-0288-2008 | Material/Component Contamination | Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard. |
| Dec 23, 2005 | Not classified | Z-0516-06 | Other | The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103403 (Abbott Laboratories, 2011) has gone furthest, with 0 descendants of its own.
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?
An Abbott Clinical Chemistry Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
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/K981706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981706: Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/MG Cal, LDL Cal, MC Cal, Upro Cal, and Ise Calibrator Levels 1 and 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981706
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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