510(k) · Cleared
ClearedN Latex STFR Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DDG Transferrin, Antigen, Antiserum, Control
Cleared on Aug 2, 1999 as substantially equivalent to K970718 (R&D Systems, Inc., 1997) after a 117-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Aug 2, 1999
- Review
- 117 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926221 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 DDG? 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 DDG device
- #1 K240987 Access sTfRscore 8.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K970718 | Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)Summary page 1…on, which employ immunoassay techniques for the quantitative measurement of sTfR in human serum or plasma. One such product is the Quantikine IVD human sTfR immunoassay (K970718). N Latex sTfR is substantially equivalent in intended use and results obtained to the Quantikine IVD human sTfR immunoassay. The… | 1997 |
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 6 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 3 other devices also cite its predicate K970718.
How does its category compare?
All DDG devicesDDG Transferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DDG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DDG
114in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DDG
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DDG
1in 2015
MAUDE reports naming product code DDG, 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 | 4 | 114 | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 2 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The N Latex sTfR Reagent is an in vitro diagnostic reagent for the quantitative determination of sTfR in human serum or heparinized plasma using the Behring Nephelometer Systems (BNA, BN100, & BNIl), and aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
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/K991157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991157: N Latex STFR Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991157
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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