510(k) · Cleared
ClearedBioPlex 2200 25-OH Vitamin D Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · MRG System, Test, Vitamin D
Cleared on Jun 22, 2018 as substantially equivalent to K141114 (Bio-Rad Laboratories, 2015) after a 109-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Jun 22, 2018
- Review
- 109 days
- Class
- Class II
- Product code
- MRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021163 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK021163 Octeia 25-Hydroxy Vitamin DImmunodiagnostic Systems, Ltd. · 2002 · Recalled
- 2 generations backK123660 25-OH Vitamin D ElisaEuroimmun US · 2013
- 1 generation backK141114 Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin…Bio-Rad Laboratories · 2015
- This deviceK180577 BioPlex 2200 25-OH Vitamin D KitBio-Rad Laboratories · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021163 | Octeia 25-Hydroxy Vitamin D | Immunodiagnostic Systems, Ltd. | 2002 | 2 |
| −2 | K123660 | 25-OH Vitamin D Elisa | Euroimmun US | 2013 | — |
| −1 | K141114 | Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin D… | Bio-Rad Laboratories | 2015 | — |
| 0 (this device) | K180577 | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories | 2018 | — |
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 |
|---|---|---|---|
| * | K141114 | Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin D Calibrator Set…Summary page 4…detail as a basis for a determination of substantial equivalence for the BioPlex 2200 25-OH Vitamin D kit. The BioPlex 2200 25-OH Vitamin D was originally cleared under K141114. Bio-Rad has modified the kit by re-assigning the calibrators and standardizing the assay in accordance with the Vitamin D Standa… | 2015 |
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 16 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
BioPlex 2200 25-OH Vitamin D Kit
The BioPlex 2200 25-OH Vitamin D Kit is a multiplex flow competitive immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum. The BioPlex 2200 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.
The BioPlex 2200 25-OH Vitamin D kit is intended for use with the Bio-Rad BioPlex 2200 System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180577: BioPlex 2200 25-OH Vitamin D Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180577
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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