# K103112: Affymetrix Gene Profiling Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Affymetrix, Inc.
- Decided: May 4, 2011 after 195 days
- Product code: OVA (Complete Gene Expression Profiling Accessory Reagents)
- 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 K080995 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080995: Modification to Affymetrix Genechip Microarray Instrumentation System, Affymetrix, Inc. (2008) Summary page 12.

## Indications for use
Affymetrix®D Gene Profiting Reagents are intended for the preparation of labeled complementary RNA target from purified total RNA from fresh or frozen clinical tissue specimens for hybridization to Affymetrix GeneChip® microarrays and the measurement of fluorescence signals of labeled RNA target using the Affymetrix GeneChip®D Microarray Instrumentation System. Intended for use with separately FDA-cleared Affymetrix GeneChip microarray assays specifying the use of the Affymetrix Gene Profiling Reagents.

Source page: https://510kreport.com/device/K103112
Methodology: https://510kreport.com/methodology