# K141220: Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software

- Pathway: 510(k) (Special)
- Applicant: Thermo Fisher Scientific (Life Technologies Holdin
- Decided: May 22, 2014 after 10 days
- Product code: NSU (Instrumentation For Clinical Multiplex Test Systems)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K082562 (2008). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082562: Applied Biosystems 7500 Fast DX, Applied Biosystems, Inc. (2008) Summary page 1.

## Most influential descendants
- K181661: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (2019), 2 descendants of its own
- K252243: Fastplex™ BCR-ABL (p210) %IS digital PCR Kit (2026), 0 descendants of its own
- K221869: BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (2023), 0 descendants of its own

## Indications for use
The Applied Biosystems 7500 Fast Dx Real-Time PCR instrument with the SDS Software is a real-time nucleic acid amplification and five color fluorescence detection system for use with FDA cleared or approved tests on human-derived specimens. The 7500 Fast Dx Real-Time PCR instrument and SDS Software are intended for use in combination with in vitro diagnostic tests labeled for use on this instrument. The 7500 Fast Dx instrument is intended for use by laboratory professionals trained in laboratory techniques, procedures, and on use of the system.

Source page: https://510kreport.com/device/K141220
Methodology: https://510kreport.com/methodology