510(k) Report

FDA product code · Clinical chemistry

Complete Gene Expression Profiling Accessory Reagents

OVAClass II21 CFR 862.2570510(k) exempt1 decision since 20110 recalls

FDA lists OVA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2011. No recall names this code.

Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and optimized for preparation of labeled complementary RNA (cRNA) target using total RNA isolated from…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of OVA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OVA

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OVA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OVA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which OVA devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K103112Affymetrix Gene Profiling ReagentsAffymetrix, Inc. · 20111generation

What has FDA decided in OVA lately?

  • K103112Affymetrix Gene Profiling ReagentsAffymetrix, Inc. · 2011

The one OVA decision →

Related product codes

Other codes under 21 CFR 862.2570.

OUE Micro Total Analysis Instrument SystemPHG Droplet Digital Pcr SystemOOI Real Time Nucleic Acid Amplification SystemPCA Dna Genetic AnalyzerPQQ Data Acquisition SoftwareNSU Instrumentation For Clinical Multiplex Test…OTA Mass Spectrometer For Clinical Multiplex Test…