510(k) · Cleared
ClearedNofact IX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R2 Diagnostics, Inc. · GJT Plasma, Coagulation Factor Deficient
Cleared on Dec 19, 2011 as substantially equivalent to K933432 (American Bioproducts Co., 1993) after a 444-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Dec 19, 2011
- Review
- 444 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933432 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK933432 Stago Factor IX-Deficient PlasmaAmerican Bioproducts Co. · 1993
- This deviceK102908 Nofact IXR2 Diagnostics, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933432 | Stago Factor IX-Deficient Plasma | American Bioproducts Co. | 1993 | — |
| 0 (this device) | K102908 | Nofact IX | R2 Diagnostics, Inc. | 2011 | — |
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 GJT? 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 GJT device
- #1 K222831 CRYOcheck Factor VIII Deficient Plasma with VWFscore 6.6 · 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 |
|---|---|---|---|
| * | K933432 | Stago Factor IX-Deficient PlasmaSummary page 1…e Name: NoFact IX Classification Name: Plasma, Factor Deficient (21CFR 864.7290, Product Code GJT) 3) Predicate Device(s) Stago IX Deficient Plasma (K(933432) 4) Device Description(s) NoFact IX Deficient Plasma is a human plasma inmmodepleted of Factor IX and intended for the quantita… | 1993 |
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?
- Its one ancestor has no recall.
How does its category compare?
All GJT devicesGJT Plasma, Coagulation Factor Deficient: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GJT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GJT
444in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GJT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GJT
1in 2025
MAUDE reports naming product code GJT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 444 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
NoFact IXDeficient Plasma is a human plasma immunodepleted of Factor IXand intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102908: Nofact IX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102908
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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