510(k) · Cleared
ClearedMG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JGJ Photometric Method, Magnesium
Cleared on May 1, 1998 as substantially equivalent to K901758 (Roche Diagnostic Systems, Inc., 1990) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- May 1, 1998
- Review
- 29 days
- Class
- Class I
- Product code
- JGJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811194 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK811194 Hitachi 705 Automatic Blood ChemistryBoehringer Mannheim Corp. · 1981
- This deviceK981192 MGAbbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811194 | Hitachi 705 Automatic Blood Chemistry | Boehringer Mannheim Corp. | 1981 | — |
| 0 (this device) | K981192 | MG | Abbott Laboratories | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 JGJ? 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 |
|---|---|---|---|
| * | K901758 | Roche Reagent for MagnesiumSummary page 1…ample. Substantial Equivalence: The Magnesium assay is substantially equivalent to the following devices: » Roche® Cobas Mira®Plus Automated Chemistry Magnesium assay (K901758) for the serum application. Boehringer Mannheim® Magnesium assay (K811194) on the Hitachi® 717 Analyzer for the urine applicati… | 1990 |
| * | K811194 | Hitachi 705 Automatic Blood ChemistrySummary page 1…valent to the following devices: » Roche® Cobas Mira®Plus Automated Chemistry Magnesium assay (K901758) for the serum application. Boehringer Mannheim® Magnesium assay (K811194) on the Hitachi® 717 Analyzer for the urine application. Magnesium 510(k) Section II March 30, 1998 Page 1 MagnesiumE2 wp O 0… | 1981 |
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.
- 1 other device also cites its predicate K901758.
How does its category compare?
All JGJ devicesJGJ Photometric Method, Magnesium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGJ
2in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JGJ
Too few JGJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JGJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGJ
22in 2025
MAUDE reports naming product code JGJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 1 | 22 |
| 2013 | 0 | — | 1 | 26 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 1 | 24 |
| 2016 | 0 | — | 1 | 4 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 0 | — | 1 | 31 |
| 2020 | 0 | — | 2 | 34 |
| 2021 | 0 | — | 1 | 33 |
| 2022 | 0 | — | 1 | 42 |
| 2023 | 0 | — | 0 | 31 |
| 2024 | 0 | — | 1 | 17 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Magnesium assay is used for the quantitation of magnesium in serum, plasma, or urine. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium).
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/K981192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981192: MG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981192
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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