510(k) · Cleared
ClearedLOCI Total Vitamin D Total Assay, LOCI VITD CAL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · MRG System, Test, Vitamin D
Cleared on Mar 16, 2017 as substantially equivalent to K110586 (Siemens Healthcare Diagnostics, Inc., 2011) after a 212-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 16, 2017
- Review
- 212 days
- Class
- Class II
- Product code
- MRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950469 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 3 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 2 generations backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- 1 generation backK110586 Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc. · 2011 · Recalled
- This deviceK162298 LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −3 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −2 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| −1 | K110586 | Advia Centaur Vitamin D Total Assay | Siemens Healthcare Diagnostics, Inc. | 2011 | 7 |
| 0 (this device) | K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Siemens Healthcare Diagnostics | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 MRG? 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 MRG device
- #1 K221817 ALFIS Vitamin D, ALFIS-3 Analyzerscore 8.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110586 | Advia Centaur Vitamin D Total AssaySummary page 5…: o Clinical Chemistry o Clinical Chemistry 3. Identification of the Predicate Devices: ADVIA Centaur Vitamin D Total (VitD) Assay - K110586 Siemens Healthcare Diagnostics LOCI Vitamin D Total Assay LOCI VITD CAL 510(k) Premarket Notification AD… | 2011 |
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K110586.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MRG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRG
120in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRG
29in 2025
MAUDE reports naming product code MRG, 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 | — | 1 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 227 | 0 | 1 |
| 2012 | 3 | 122 | 3 | 23 |
| 2013 | 7 | 231 | 1 | 21 |
| 2014 | 6 | 159 | 0 | 14 |
| 2015 | 3 | 264 | 0 | 18 |
| 2016 | 3 | 147 | 2 | 14 |
| 2017 | 3 | 120 | 0 | 21 |
| 2018 | 2 | — | 2 | 75 |
| 2019 | 1 | — | 0 | 38 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 2 | — | 0 | 22 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 2 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LOCI Vitamin D Total assay is an in vitro diagnostic test for the quantitative measurement of total 25(OH)vitamin D
in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements
of vitamin D are used in the assessment of vitamin D sufficiency.
The LOCI VITD CAL is an in vitro diagnostic product for the calibration of the Vitamin D (VITD) Total assay on the
Dimension® EXL™ integrated chemistry system with LOCI® module.
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/K162298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162298: LOCI Total Vitamin D Total Assay, LOCI VITD CAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162298
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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