510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093957Substantially Equivalent

Architect He4, Architect He4 Calibrators and Architect He4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 Sp54-01,

Fujirebio Diagnostics, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093957 is the FDA 510(k) clearance record for ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,, a class II device, cleared for Fujirebio Diagnostics,Inc. on under FDA product code OIU (Test, Epithelial Ovarian Tumor Associated Antigen (He4)). FDA's definition for product code OIU reads: "An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient...". FDA records list 45 510(k) clearances for Fujirebio Diagnostics,Inc., from to . As of , FDA records show no recalls naming K093957.

Clearance record

Decision date
Received
(85 days to decision)
Product code
OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Fujirebio Diagnostics,Inc. 201 Great Valley Pkwy., Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIU

Trailing 12 months

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

FDA records show no clearances under product code OIU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OIU, 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