510(k) · Cleared
ClearedAffymetrix Gene Profiling Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Affymetrix, Inc. · OVA Complete Gene Expression Profiling Accessory Reagents
Cleared on May 4, 2011 as substantially equivalent to K080995 (Affymetrix, Inc., 2008) after a 195-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- May 4, 2011
- Review
- 195 days
- Class
- Class II
- Product code
- OVA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080995 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK080995 Modification to Affymetrix Genechip Microarray Instrumentation SystemAffymetrix, Inc. · 2008
- This deviceK103112 Affymetrix Gene Profiling ReagentsAffymetrix, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080995 | Modification to Affymetrix Genechip Microarray Instrumentation System | Affymetrix, Inc. | 2008 | — |
| 0 (this device) | K103112 | Affymetrix Gene Profiling Reagents | Affymetrix, Inc. | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080995 | Modification to Affymetrix Genechip Microarray Instrumentation SystemSummary page 12…he Pathwork®D Tissue of Origin-Frozen Test (k080896) and the Affymetrix GeneChip® MicroArray Instrumentation System cleared for RNA analysis (k080995). Both studies evaluated the performance of the Pathwork® Tissue of Origin-Frozen Test with the Gene… | 2008 |
| † | K080896 | Pathwork Diagnostics Tissue of Origin Test | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All OVA devicesOVA Complete Gene Expression Profiling Accessory Reagents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OVA
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · OVA
Too few OVA 510(k)s in any year since 2007 to give a median.
Recalls per year · OVA
No recall names OVA since 2007.
Adverse event reports per year · OVA
No MAUDE report names OVA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103112: Affymetrix Gene Profiling Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103112
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026