510(k) · Cleared
Recalled · 200425-Hydroxyvitamin D 125I Ria Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LCI Automated Radioimmunoassay Systems, For Clinical Use
Cleared on Nov 16, 1998 as substantially equivalent to K953567 (Incstar Corp., 1996) after a 32-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 16, 1998
- Review
- 32 days
- Class
- Class I
- Product code
- LCI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953567 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK953567 Incstar 25-Hydroxyvitmin D 1251 RiaIncstar Corp. · 1996 · Recalled
- This deviceK983617 25-Hydroxyvitamin D 125I Ria KitDiaSorin, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK123131 ST Aia-Pack 25-OH Vitamin D, ST Aia-Pack 25-OH Vitamin D Calibrator…Tosoh Bioscience, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK150270 ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator…Tosoh Bioscience, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See all- K123131ST Aia-Pack 25-OH Vitamin D, ST Aia-Pack 25-OH Vitamin D Calibrator Set, Aia-Pack 25-OH…Tosoh Bioscience, Inc. · 2013 · cites it directly1descendant
- K150270ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH…Tosoh Bioscience, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953567 | Incstar 25-Hydroxyvitmin D 1251 Ria | Incstar Corp. | 1996 | 1 |
| 0 (this device) | K983617 | 25-Hydroxyvitamin D 125I Ria Kit | DiaSorin, Inc. | 1998 | — |
| +1 | K123131 | ST Aia-Pack 25-OH Vitamin D, ST Aia-Pack 25-OH Vitamin D Calibrator Set… | Tosoh Bioscience, Inc. | 2013 | — |
| +2 | K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set… | Tosoh Bioscience, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 LCI? 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? (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 |
|---|---|---|---|
| * | K953567 | Incstar 25-Hydroxyvitmin D 1251 Ria Our OCR of the scanned summary read K853567, FDA’s number for DJP Unipolar (Biotronik Sales, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “25-Hydroxyvitamin D ¹²⁵I RIA Kit”. | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123131 | ST Aia-Pack 25-OH Vitamin D, ST Aia-Pack 25-OH Vitamin D Calibrator Set, Aia-Pack 25-OH… | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2004 | Not classified | Z-0705-05 | Other | An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K123131 (Tosoh Bioscience, Inc., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LCI devicesLCI Automated Radioimmunoassay Systems, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCI
FDA has decided no LCI device since 2007.
Median 510(k) review, days · LCI
Too few LCI 510(k)s in any year since 2007 to give a median.
Recalls per year · LCI
No recall names LCI since 2007.
Adverse event reports per year · LCI
No MAUDE report names LCI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FOR IN VITRO DIAGNOSTIC USE.
This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.
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/K983617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983617: 25-Hydroxyvitamin D 125I Ria Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983617
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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