# K060564: Infiniti System

- Pathway: 510(k) (Traditional)
- Applicant: AutoGenomics, Inc.
- Decided: Feb 7, 2007 after 341 days
- Product code: NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr)
- Device class: 2
- Regulation: 21 CFR 864.7280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roche Factor V Leiden Kit: named in the summary without a submission number
- (no number) Roche Factor II (Prothrombin) G20210A: named in the summary without a submission number
- (no number) Affymetrix GeneChip® Microarray Instrumentation System: named in the summary without a submission number

## Most influential descendants
- K073014: Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin (2008), 4 descendants of its own
- K101683: Infiniti CYP2C19 Assay (2010), 3 descendants of its own
- K123891: Spartan RX CYP2C19 Test System (2013), 1 descendant of its own
- K220026: Genomadix Cube CYP2C19 System (2023), 0 descendants of its own
- K132978: Impact DX Factor V Leiden and Factor II Genotyping Test (2014), 0 descendants of its own

## Indications for use
The INFINITI System Assay for Factor II & Factor V is an in vitro diagnostic device that consists of reagents and instrumentation which includes polymerase chain reaction (PCR) primers, hybridization matrices, a thermal cycler, an imager, and software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI System Assay for Factor II & Factor V is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The INFINITI System Assay for detection and genotyping of Factor II & Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Source page: https://510kreport.com/device/K060564
Methodology: https://510kreport.com/methodology