# K082562: Applied Biosystems 7500 Fast DX

- Pathway: 510(k) (Traditional)
- Applicant: Applied Biosystems, Inc.
- Decided: Sep 30, 2008 after 26 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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) Affymetrix GeneChip Microarray instrument System: named in the summary without a submission number

## Most influential descendants
- K141220: Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software (2014), 3 descendants of its own
- K181661: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (2019), 2 descendants of its own
- K093383: Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens Minimag (2010), 1 descendant 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 version 1.4 is a real-time nucleic acid amplification and detection system that measures nucleic acid signals from reverse transcribed RNA and converts them to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. The 7500 Fast Dx is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.

Source page: https://510kreport.com/device/K082562
Methodology: https://510kreport.com/methodology