510(k) · Cleared
ClearedNichols Advantage Chemiluminescence Ferritin Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · DBF Ferritin, Antigen, Antiserum, Control
Cleared on Feb 2, 1999 as substantially equivalent to K905770 (Ciba Corning Diagnostics Corp., 1991) after a 71-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Feb 2, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- DBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905770 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK905770 Ciba Corning Acs Ferritin ImmunoassayCiba Corning Diagnostics Corp. · 1991
- This deviceK984186 Nichols Advantage Chemiluminescence Ferritin ImmunoassayNichols Institute Diagnostics · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905770 | Ciba Corning Acs Ferritin Immunoassay | Ciba Corning Diagnostics Corp. | 1991 | — |
| 0 (this device) | K984186 | Nichols Advantage Chemiluminescence Ferritin Immunoassay | Nichols Institute Diagnostics | 1999 | — |
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 DBF? 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 DBF device
- #1 K193650 LIAISON Ferritinscore 2.0 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K905770 | Ciba Corning Acs Ferritin ImmunoassaySummary page 1…munological Test System 3. Predicate Device: We claim substantial equivalence to the Chiron Diagnostics ACS:/ 80® Automated Chemiluminescence System Ferritin +C Assay (K905770, Cleared March 12, 1991). 4. Device Description: The Nichols Advantage® Ferritin Assay is a two-site chemiluminescence assay fo… | 1991 |
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 no recall.
How does its category compare?
All DBF devicesDBF Ferritin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBF
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DBF
Too few DBF 510(k)s in any year since 2007 to give a median.
Recalls per year · DBF
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DBF
1in 2025
MAUDE reports naming product code DBF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nichols Advantage® Chemiluminescence Ferritin Immunoassay is designed for use with the Nichols Advantage® Specialty System for the quantitative determination of ferritin in hunan serum or plasma. This assay is intended to aid in the diagnosis of iron deficiency anemia and iron overload.
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/K984186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984186: Nichols Advantage Chemiluminescence Ferritin Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984186
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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