510(k) · Cleared
ClearedN Antisera to Human Transferrin
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 Mar 16, 2006 as substantially equivalent to K972840 (Behring Diagnostics, Inc., 1997) after a 135-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Mar 16, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926272 (1993). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK926272 Beckman Transferrin KitBeckman Instruments, Inc. · 1993
- 1 generation backK972840 N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
- This deviceK053075 N Antisera to Human TransferrinDade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK182095 Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo) · 2018
- Descendant · cites it directly · 0 of its ownK081299 Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK063322 Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator…Dade Behring, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K182095Tina-quant Transferrin ver.2 (urine application)Roche Diagnostics Operations (Rdo) · 2018 · cites it directly0descendants
- K081299Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1…Siemens Healthcare Diagnostics, Inc. · 2008 · cites it directly0descendants
- K063322Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control…Dade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926272 | Beckman Transferrin Kit | Beckman Instruments, Inc. | 1993 | — |
| −1 | K972840 | N Antiserum to Human Transferrin | Behring Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K053075 | N Antisera to Human Transferrin | Dade Behring, Inc. | 2006 | — |
| +1 | K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | 2018 | — |
| +1 | K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System… | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K972840 | N Antiserum to Human TransferrinSummary page 1…Immunology Product Code: DDG 3. Identification of the Legally Marketed Device: NAntisera to Human Transferrin- K972840 4. Device Description: Proteins contained in human body fluids form immune complexes in an immunochemical… | 1997 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182095 (Roche Diagnostics Operations (Rdo), 2018) has gone furthest, with 0 descendants of its own.
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?
In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine by means of immunonephelometery on the BNTM Systems. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053075 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053075: N Antisera to Human Transferrin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053075
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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