510(k) · Cleared
ClearedEnzygnost F+2 (Monoclonal) Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · MIF Prothrombin Fragment 1.2
Cleared on Dec 10, 2004 as substantially equivalent to K922934 (Behring Diagnostics, Inc., 1992) after a 72-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Dec 10, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- MIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922934 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK922934 Enzygnost F 1+2Behring Diagnostics, Inc. · 1992
- This deviceK042687 Enzygnost F+2 (Monoclonal) Test KitDade Behring, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922934 | Enzygnost F 1+2 | Behring Diagnostics, Inc. | 1992 | — |
| 0 (this device) | K042687 | Enzygnost F+2 (Monoclonal) Test Kit | Dade Behring, Inc. | 2004 | — |
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 MIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K922934 | Enzygnost F 1+2Summary page 1…3. FDA Classification Name: Fibrinogen/Fibrin degradation products assay 4. Predicate Device: EnzygnostTM F1+2 micro test kit (K922934) 5. Device Description: The EnzygnostTM F1+2 Test Kit is an enzyme immunoassay based on the sandwich principle in microti… | 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?
- Its one ancestor has no recall.
How does its category compare?
All MIF devicesMIF Prothrombin Fragment 1.2: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIF
FDA has decided no MIF device since 2007.
Median 510(k) review, days · MIF
Too few MIF 510(k)s in any year since 2007 to give a median.
Recalls per year · MIF
No recall names MIF since 2007.
Adverse event reports per year · MIF
No MAUDE report names MIF since 2007.
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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Enzygnost F1 +2 (monoclonal) is an enzyme immunoassay for the quantitative
determination of human prothrombin F1 +2 in plasma. Measurement of F1+2 is used as
an aid in the diagnosis, monitoring, and evaluation of acquired or hereditary blood
coagulation disorders. It is indicated as an aid in assessing risk of thrombosis and in
monitoring efficacy of anticoagulant therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042687 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042687: Enzygnost F+2 (Monoclonal) Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042687
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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