# K170299: Ion PGM Dx System

- Pathway: 510(k) (Traditional)
- Applicant: Life Technologies Corporation
- Decided: Jun 22, 2017 after 142 days
- Product code: PFF (High Throughput Dna Sequence Analyzer)
- Device class: 2
- Regulation: 21 CFR 862.2265
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K123989: Illumina MiSeqDx Platform. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5.

## Recalls of this device
- Sep 26, 2019 · Class II · Z-0186-2020: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same loc
- Sep 26, 2019 · Class II · Z-0185-2020: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same loc
- Sep 26, 2019 · Class II · Z-0188-2020: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same loc
- Sep 26, 2019 · Class II · Z-0187-2020: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same loc

## Indications for use
The Ion PGM™ Dx Instrument System is composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction, and the ancillary instrumentation necessary for sample processing. This instrument system is used in conjunction with the instrument-specific Ion PGM™ Dx Library Kit, Ion OneTouch™ Dx Template Kit, Ion PGM™ Dx Sequencing Kit, and Ion 318™ Dx Chip Kit, and data analysis software. The Ion PGM™ Dx Instrument System is intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM™ Dx Instrument System is not intended for whole genome or de novo sequencing.

Source page: https://510kreport.com/device/K170299
Methodology: https://510kreport.com/methodology