510(k) K101185
K101185 is an FDA 510(k) premarket notification submitted by Iris Molecular Diagnostics for the device "NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY". The FDA issued a decision of Substantially Equivalent on September 20, 2011. The device falls under product code OWM (Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers), a Class II device regulated under 21 CFR 866.6040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2011
- Date Received
- April 28, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
- Device Class
- Class II
- Regulation Number
- 866.6040
- Review Panel
- PA
- Submission Type
Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer.