510(k) · Cleared
ClearedTransferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-a,CA-0105-a,B,C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Good Biotech Corp. · DDG Transferrin, Antigen, Antiserum, Control
Cleared on Apr 23, 2007 as substantially equivalent to K012393 (Roche Diagnostics Corp., 2001) after a 124-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Apr 23, 2007
- Review
- 124 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951595 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995 · Recalled
- 1 generation backK012393 Tina-Quant Transferrin Ver.2Roche Diagnostics Corp. · 2001
- This deviceK063766 Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H…Good Biotech Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951595 | Roche Cobas Integra Analyzer, Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1995 | 7 |
| −1 | K012393 | Tina-Quant Transferrin Ver.2 | Roche Diagnostics Corp. | 2001 | — |
| 0 (this device) | K063766 | Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model#… | Good Biotech Corp. | 2007 | — |
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 |
|---|---|---|---|
| * | K012393 | Tina-Quant Transferrin Ver.2Summary page 1…rol material (assayed and unassayed) (21 CFR § 862.1660) Predicate Device Trade name, Roche Tina-quant Transferrin ver.2 510(k) number K012393 E-I Description Good Biotech Corp. Transferrin TI… | 2001 |
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 6.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K012393.
How does its category compare?
All DDG devicesDDG Transferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Good Biotech Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA).
Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia
Good Biotech Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples.
Good Biotech Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis.
For In Vitro Diagnostic Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063766 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063766: Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-a,CA-0105-a,B,C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063766
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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