510(k) · Cleared
ClearedDimension TRNF Flex Reagent Cartridge
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 Feb 4, 2000 as substantially equivalent to K780913 (Beckman Instruments, Inc., 1978) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Feb 4, 2000
- Review
- 45 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K780913 (1978). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK780913 Additional Reagents Kits for Imm. SystemBeckman Instruments, Inc. · 1978
- This deviceK994294 Dimension TRNF Flex Reagent CartridgeDade Behring, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780913 | Additional Reagents Kits for Imm. System | Beckman Instruments, Inc. | 1978 | — |
| 0 (this device) | K994294 | Dimension TRNF Flex Reagent Cartridge | Dade Behring, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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? (2)
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 |
|---|---|---|---|
| * | K780913 | Additional Reagents Kits for Imm. SystemSummary page 1…Product: TRNF Flex® Reagent Cartridge FDA Classification Name: Transferrin, Antigen, Antiserum, Control; 82DDG Predicate Device: Beckman Array® Transferrin (TRF) method (K780913; K922273) Device Description: The TRNF Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, t… | 1978 |
| * | K922273 | Array (R) 360Summary page 1…TRNF Flex® Reagent Cartridge FDA Classification Name: Transferrin, Antigen, Antiserum, Control; 82DDG Predicate Device: Beckman Array® Transferrin (TRF) method (K780913; K922273) Device Description: The TRNF Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimet… | 1992 |
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?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K780913.
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 TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994294: Dimension TRNF Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994294
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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