510(k) · Cleared
Recalled · Class II · 2017Fastpack Vitamin D; Immunoassay, Calibrators, Controls, Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qualigen, Inc. · MRG System, Test, Vitamin D
Cleared on Jul 3, 2013 as substantially equivalent to K112725 (DiaSorin, Inc., 2012) after a 189-day review. Its family tree reaches back 3 generations to 2004. It has been recalled 2 times.
- Decided
- Jul 3, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- MRG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K032844 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK032844 Liaison 25 OH Vitamin DDiaSorin, Inc. · 2004 · Recalled
- 2 generations backK071480 Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen…DiaSorin, Inc. · 2007
- 1 generation backK112725 Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc. · 2012
- This deviceK123983 Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersQualigen, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032844 | Liaison 25 OH Vitamin D | DiaSorin, Inc. | 2004 | 4 |
| −2 | K071480 | Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set… | DiaSorin, Inc. | 2007 | — |
| −1 | K112725 | Liaison 25 OH Vitamin D Total Assay | DiaSorin, Inc. | 2012 | — |
| 0 (this device) | K123983 | Fastpack Vitamin D; Immunoassay, Calibrators, Controls, Verifiers | Qualigen, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K112725 | Liaison 25 OH Vitamin D Total AssaySummary page 4…DiaSorin LIAISON® 25 OH D Inmmunoassay Vitamin D TOTAL Assay (K112725) Intended Use! for the in-vitro quantitative for the quantitative Indications for Use determination of total 25… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2017 | Class II | Z-3112-2017 | Under Investigation by firm | Specific lots have been reported to produce falsely lower than expected results for Vitamin D |
| Nov 8, 2013 | Class II | Z-0550-2014 | Process change control | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 5 other devices also cite its predicate K112725.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
FastPack® Vitamin D Immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The FastPack® Vitamin D Immunoassay is intended for use with the FastPack® Analyzer. FastPack® Vitamin D Calibrator Kit is used for calibrating the quantitative FastPack® Vitamin D Immunoassay on the…
Read the full statement (121 words)
FastPack® Vitamin D Immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The FastPack® Vitamin D Immunoassay is intended for use with the FastPack® Analyzer.
FastPack® Vitamin D Calibrator Kit is used for calibrating the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
FastPack® Vitamin D Control Kit is used for quality control of the FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
FastPack® Vitamin D Method Verification Kit is used in the quantitative verification of calibration and assay range of the quantitative FastPack® Vitamin D Immunoassay on the FastPack® Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123983: Fastpack Vitamin D; Immunoassay, Calibrators, Controls, Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123983
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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