510(k) · Cleared
ClearedEsa Biosciences Inc. Vitamin D HPLC Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esa Biosciences, Inc. · MRG System, Test, Vitamin D
Cleared on May 7, 2008 as substantially equivalent to K032844 (DiaSorin, Inc., 2004) after a 243-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- May 7, 2008
- Review
- 243 days
- Class
- Class II
- Product code
- MRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032844 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK032844 Liaison 25 OH Vitamin DDiaSorin, Inc. · 2004 · Recalled
- This deviceK072536 Esa Biosciences Inc. Vitamin D HPLC TestEsa Biosciences, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032844 | Liaison 25 OH Vitamin D | DiaSorin, Inc. | 2004 | 4 |
| 0 (this device) | K072536 | Esa Biosciences Inc. Vitamin D HPLC Test | Esa Biosciences, Inc. | 2008 | — |
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 8.8 · 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 |
|---|---|---|---|
| * | K032844 | Liaison 25 OH Vitamin DSummary page 1…Vitamin D Test System 21CFR 862.1825 Product Code: MRG Predicate Device: LIASON® 25 OH Vitamin D Assay 510(k) 032844 Statement of Intended Use: The ESA Biosciences Inc. Vitamin D HPLC test is for the quantitativ… | 2004 |
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.
- 2 other devices also cite its predicate K032844.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ESA Biosciences Inc. Vitamin D HPLC test is for the quantitative determination of 25-hydroxyvitamin D in human serum or EDTA-plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072536: Esa Biosciences Inc. Vitamin D HPLC Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072536
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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