510(k) Report

510(k) · Cleared

Cleared

Magnesium Assay

K111915510(k) TraditionalCleared Dec 2, 2011149-day reviewClass I21 CFR 862.1495

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sekisui Diagnostics P.E.I., Inc. · JGJ Photometric Method, Magnesium

Cleared on Dec 2, 2011 as substantially equivalent to K944407 (Olympus America, Inc., 1994) after a 149-day review. Its family tree reaches back 1 generation to 1994.

Decided
Dec 2, 2011
Review
149 days
Class
Class I
Product code
JGJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K944407 (1994). No later device cites it as a predicate yet.

K944407 · Olympus Magnesium Reagent · Olympus America, Inc. · 1994 · recalled19901995200020052010
K944407 · Olympus Magnesium Reagent · Olympus America, Inc. · 1994 · recalled0
  1. Root · 1 generation backK944407 Olympus Magnesium ReagentOlympus America, Inc. · 1994 · Recalled
  2. This deviceK111915 Magnesium AssaySekisui Diagnostics P.E.I., Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944407Olympus Magnesium ReagentOlympus America, Inc.19941
0 (this device)K111915Magnesium AssaySekisui Diagnostics P.E.I., Inc.2011—
FIG. 1 — Lineage of K111915, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K944407Olympus Magnesium Reagent
Summary page 2
…Magnesium Reagent 0SR6189 Magnesium Assay K944407 l~ayeMagnesium Magnesium…
Olympus America, Inc.19941

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?

  • Its one ancestor has a recall.

How does its category compare?

All JGJ devices

JGJ Photometric Method, Magnesium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · JGJ

2in 2018

2007: 12009: 22011: 12012: 12017: 22018: 2
2007high 2 (2009) · low 0 (2008)2026

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

2012: 12013: 12015: 12016: 12019: 12020: 22021: 12022: 12024: 1
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JGJ

22in 2025

2008: 12009: 42010: 42011: 132012: 222013: 262014: 42015: 242016: 42017: 182018: 212019: 312020: 342021: 332022: 422023: 312024: 172025: 22
2007high 42 (2022) · low 0 (2007)2025

MAUDE reports naming product code JGJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—01
20092—04
20100—04
20111—013
20121—122
20130—126
20140—04
20150—124
20160—14
20172—018
20182—021
20190—131
20200—234
20210—133
20220—142
20230—031
20240—117
20250—022
20260—0—

What is it indicated for?

The Sekisui Magnesium Assay is intended for the quantitative measurement of magnesium in human serum and plasma (Lithium Heparin) on automated clinical chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomnagnesemia and hypermagnesemia. This device is intended for professional use and IN VITRO diagnostic use only.

Indications for use as stated in the FDA summary.

More from Sekisui Diagnostics P.E.I., Inc.

6 FDA decisions under this applicant name. See the company

  • K202644AcetaminophenSekisui Diagnostics P.E.I., Inc. · 2022
  • K182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc. · 2019
  • K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc. · 2019
  • K173206SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc. · 2018
  • K163078DC-Uibc-CalSekisui Diagnostics P.E.I., Inc. · 2016

Recent decisions in JGJ

The JGJ category page

  • K181748MagnesiumAbbott Laboratories · 2018
  • K173294MagnesiumAbbott Laboratories · 2018
  • K162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd. · 20171 recall
  • K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc. · 2017
  • K122302Ace Magnesium RegentAlfa Wassermann Diagnostics Technologies, LLC · 2012

https://510kreport.com/device/K111915 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111915: Magnesium Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111915

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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