510(k) K103112
K103112 is an FDA 510(k) premarket notification submitted by Affymetrix, Inc. for the device "AFFYMETRIX GENE PROFILING REAGENTS". The FDA issued a decision of Substantially Equivalent on May 4, 2011. The device falls under product code OVA (Complete Gene Expression Profiling Accessory Reagents), a Class II device regulated under 21 CFR 862.2570. Affymetrix, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2011
- Date Received
- October 21, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Complete Gene Expression Profiling Accessory Reagents
- Device Class
- Class II
- Regulation Number
- 862.2570
- Review Panel
- CH
- Submission Type
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 specific clinical tissue specimens for hybridization to and measurement of fluorescently-labeled cRNA targets using a specified and cleared microarray instrumentation system. They may also include specified exogenous controls intended to monitor amplification and labeling processes.