Invader Factor II
FDA 510(k) K100943 · Hologic, Inc.
510(k) numberK100943
Submission
- Device name
- Invader Factor II
- Applicant
- Hologic, Inc.
Malborough, MA, US - Received
- April 6, 2010
- Decision date
- June 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPR – Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7280
- Specialty
- Hematology
In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Other 510(k)s with product code NPR
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|---|---|---|---|
| K250218 | Xpert® FII & FVNPR · Special | Cepheid | 02/21/2025SE |
| K223046 | Xpert® FII & FVNPR · Special | Cepheid® | 02/15/2023SE |
| K172913 | cobas Factor II and Factor V TestNPR · Traditional | Roche Molecular Systems, Inc. | 01/12/2018SE |
| K033612 | Factor II (Prothrombin) G20210A KitNPR · Traditional | Roche Diagnostics Corp. | 12/18/2003SE |
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Questions and answers
When was Invader Factor II cleared by the FDA?
Invader Factor II (K100943) received a 510(k) decision of Substantially Equivalent on June 2, 2011, 422 days after the submission was received.
What is the product code of K100943?
The FDA product code is NPR – Test, Factor Ii G20210a Mutations, Genomic Dna Pcr, a Class II (moderate risk) device regulated under 21 CFR 864.7280.