510(k) · Cleared
ClearedDimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · DDG Transferrin, Antigen, Antiserum, Control
Cleared on Aug 8, 2008 as substantially equivalent to K053075 (Dade Behring, Inc., 2006) and 2 other predicates after a 92-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Aug 8, 2008
- Review
- 92 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K955858 (1996). 8 ancestors in all, the oldest K926272 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK955858 N/T Protein Control SY/L, M and HBehring Diagnostics, Inc. · 1996
- 2 generations backK991704 N/T Protein Control LCDade Behring, Inc. · 1999
- 1 generation backK032237 N/T Protein ControlDade Behring, Inc. · 2003
- This deviceK081299 Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955858 | N/T Protein Control SY/L, M and H | Behring Diagnostics, Inc. | 1996 | — |
| −2 | K991704 | N/T Protein Control LC | Dade Behring, Inc. | 1999 | — |
| −1 | K032237 | N/T Protein Control | Dade Behring, Inc. | 2003 | — |
| 0 (this device) | K081299 | Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System… | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K053075 | N Antisera to Human TransferrinSummary page 1…Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Antisera to Human Transferrin- K053075 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control LC - K032237 Siem… | 2006 |
| * | K012470 | Modification to N Protein Standard SLSummary page 1…5) 3. Identification of the Legally Marketed Device: Dade Behring N Antisera to Human Transferrin- K053075 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control LC - K032237 Siemens Healthcare Diagnostics Inc. 510(k) Notification Di… | 2001 |
| * | K032237 | N/T Protein ControlSummary page 1…ice: Dade Behring N Antisera to Human Transferrin- K053075 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control LC - K032237 Siemens Healthcare Diagnostics Inc. 510(k) Notification Dimension Vista® System TRF Flex® reagent cartridge Dimen… | 2003 |
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 12 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K053075.
How does its category compare?
All DDG devicesDDG Transferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. PROT3 CON is an assayed intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the…
Read the full statement (185 words)
The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
PROT3 CON is an assayed intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of a 1-Microglobulin (A1 MIC), specialty Albumin (sALB*), Immunoglobulin G (IGG -C*), Microalbumin (MALB) and Transferrin (TRF-U**).
*For Cerebrospinal fluid (CSF)
**For urine
PRQOT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:
a -Acid Glycoprotein (AMAG) and Immunoglobulin G (IGG) [serum/plasma] and (IGG-C) [cerebrospinal fluid]
a -Antitrypsin (A1AT) Immunoglobulin G Subclass 1 (IGG1)
Bz-Microglobulin (B2MIC) Immunoglobulin G Subclass 2 (IGG2)
C3 Complement (C3) Immunoglobulin G Subclass 3 (IGG3)
C4 Complement (C4) Immunoglobulin G Subclass 4 (IGG4)
Ceruloplasmin (CER) Immunoglobulin M (IGM)
Haptoglobin (HAPT) Prealbumin (PREALB)
Hemopexin (HPX) Retinol Binding Protein (RBP)
Homocysteine (HCYS) soluble Transferrin Receptor (STFR)
Immunoglobulin A (IGA) Transferrin (TRF) [serum/plasma] and Immunoglobulin E (IGE) (TRF-U) [urine]
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/K081299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081299: Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081299
Report an extraction error
Are you the manufacturer?
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