510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153607Substantially Equivalent

ROMA Calculation Tool Using Elecsys Assays

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

K153607 is the FDA 510(k) clearance record for ROMA Calculation Tool Using Elecsys Assays, a class II device, cleared for Roche Diagnostics on under FDA product code ONX (Ovarian Adnexal Mass Assessment Score Test System). FDA's definition for product code ONX reads: "An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test isn...". FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K153607.

Clearance record

Decision date
Received
(181 days to decision)
Product code
ONX Ovarian Adnexal Mass Assessment Score Test System
Regulation
21 CFR 866.6050
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONX

Trailing 12 months

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

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