510(k) · Cleared
ClearedN Antiserum to Human Transferrin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · DDG Transferrin, Antigen, Antiserum, Control
Cleared on Oct 17, 1997 as substantially equivalent to K926272 (Beckman Instruments, Inc., 1993) after a 77-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Oct 17, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926272 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926272 Beckman Transferrin KitBeckman Instruments, Inc. · 1993
- This deviceK972840 N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK053075 N Antisera to Human TransferrinDade Behring, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK182095 Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo) · 2018
- Descendant · 2 generations on · 0 of its ownK081299 Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK063322 Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator…Dade Behring, Inc. · 2007
Most influential descendants
Showing 4 of 4 · See all- K053075N Antisera to Human TransferrinDade Behring, Inc. · 2006 · cites it directly3descendants
- K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo) · 2018 · 2 generations on0descendants
- K081299Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…Siemens Healthcare Diagnostics, Inc. · 2008 · 2 generations on0descendants
- K063322Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control…Dade Behring, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926272 | Beckman Transferrin Kit | Beckman Instruments, Inc. | 1993 | — |
| 0 (this device) | K972840 | N Antiserum to Human Transferrin | Behring Diagnostics, Inc. | 1997 | — |
| +1 | K053075 | N Antisera to Human Transferrin | Dade Behring, Inc. | 2006 | — |
| +2 | K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | 2018 | — |
| +2 | K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System… | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
| +2 | K063322 | Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1… | Dade Behring, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | K926272 | Beckman Transferrin KitSummary page 1…ferrin FDA has classified N Antiserum to Human Transferrin into Class [l (866.5880). 3. Identification of the legally marketed device: Beckman Transferrin(TRF) Reagent -K926272 4. Proposed Device Description: The proposed product, N Antiserum to Human Transferrin is an in vitro diagnostic reagent intende… | 1993 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053075 | N Antisera to Human Transferrin | 2006 | 3 |
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?
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?
N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.
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/K972840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972840: N Antiserum to Human Transferrin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972840
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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