510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112624Substantially Equivalent

Elecsys He4, Elecsys He4 Calset, Elecsys Precicontrol He4, Elecsys He4 Calcheck 5

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112624 is the FDA 510(k) clearance record for ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5, a class II device, cleared for Roche Diagnostics 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 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K112624.

Clearance record

Decision date
Received
(368 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
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
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