Atlas FDA

ROMA Calculation Tool Using Elecsys Assays

FDA 510(k) clearance K153607 · decided 2016-06-15

Clearance details

K-number
K153607
Device name
ROMA Calculation Tool Using Elecsys Assays
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2015-12-17
Decision date
2016-06-15
Days to decision
181 days
Clearance type
Traditional
Product code
ONX
Device class
2
Regulation number
866.6050
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Lumipulse G ROMA (K160090)Fujirebio Diagnostics,Inc.2016-05-16
ARCHITECT ROMA (K151502)Fujirebio Diagnostics,Inc.2016-04-28
OVA1 Next Generation (K150588)Vermillion, Inc.2016-03-18
ROMA (HE4 EIA + ARCHITECT CA 125 II) (K103358)Fujirebio Diagnostics,Inc.2011-09-01
OVA1 TEST (DEN090004)Vermillion2009-09-11

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01