510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101185Substantially Equivalent

Nucleic Acid Detection Immunoassay (Nadia) Psa Assay

Iris Molecular Diagnostics, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101185 is the FDA 510(k) clearance record for NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY, a class II device, cleared for Iris Molecular Diagnostics on under FDA product code OWM (Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers). FDA's definition for product code OWM reads: "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". FDA records list one 510(k) clearance for Iris Molecular Diagnostics. As of , FDA records show no recalls naming K101185.

Clearance record

Decision date
Received
(510 days to decision)
Product code
OWM Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
Regulation
21 CFR 866.6040
Device class
Class II
Review panel
Immunology
Applicant
Iris Molecular Diagnostics 2075 Corte Del Nogal, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWM

Trailing 12 months

FDA records hold no clearances under product code OWM in the trailing twelve months.

FDA records show no clearances under product code OWM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OWM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260