510(k) · Cleared
ClearedInvader Factor II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Cleared on Jun 2, 2011 as substantially equivalent to K033612 (Roche Diagnostics Corp., 2003) after a 422-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jun 2, 2011
- Review
- 422 days
- Class
- Class II
- Product code
- NPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033612 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK033612 Factor II (Prothrombin) G20210A KitRoche Diagnostics Corp. · 2003 · Recalled
- This deviceK100943 Invader Factor IIHologic, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033612 | Factor II (Prothrombin) G20210A Kit | Roche Diagnostics Corp. | 2003 | 2 |
| 0 (this device) | K100943 | Invader Factor II | Hologic, 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 NPR? 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 NPR device
- #1 K250218 Xpert® FII & FVscore 9.5 · 3 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K033612 | Factor II (Prothrombin) G20210A KitSummary page 2…e Information: I. Predicate device name(s): Factor 11 (Prothrombin) G20210OA, Roche 2. Predicate 510(kW number(s): Roche, K033612 3. Comparison with predicate: Product Name Factor II(rothrombin) 20210A Invader' Factor… | 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?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate K033612.
How does its category compare?
All NPR devicesNPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NPR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPR
Too few NPR 510(k)s in any year since 2007 to give a median.
Recalls per year · NPR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPR
1in 2019
MAUDE reports naming product code NPR, 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 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 1 | — | 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 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Invader® Factor II test is an in vitro diagnostic test intended for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene in isolated genomic DNA obtained from whole blood potassium EDTA samples from patients with suspected thrombophilia.
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/K100943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100943: Invader Factor II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100943
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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