Atlas FDA

Elecsys Testosterone II

FDA 510(k) clearance K211685 · decided 2022-05-06

Clearance details

K-number
K211685
Device name
Elecsys Testosterone II
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2021-06-02
Decision date
2022-05-06
Days to decision
338 days
Clearance type
Traditional
Product code
CDZ
Device class
1
Regulation number
862.1680
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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
IDS-iSYS Total Testosterone (K252728)Immunodiagnostic Systems Limited2026-04-15
IDS-iSYS Free Testosterone (K240865)Immunodiagnostic Systems Limited2024-10-23
Access SHBG (K233480)Beckman Coulter, Inc.2024-02-08
Access Testosterone (K223405)Beckman Coulter, Inc.2023-01-13
LIAISON Testosterone xt (K201908)DiaSorin, Inc.2020-10-15
ACTIVE® Free Testosterone RIA (K191350)Immunotech S.R.O.2019-12-20
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533)Siemens Healthcare Diagnostics, Inc.2019-08-28
IDS SHBG (K190121)Immunodiagnostic Systems , Ltd.2019-06-17
FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521)Qualigen, Inc.2019-01-29
Free Testosterone AccuBind ELISA Test System (K181017)Monobind, Inc.2018-07-20
FREND Testosterone Test System (K153577)Nanoentek USA, Inc.2016-10-14
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (K151986)Siemens Healthcare Diagnostics, Inc.2016-06-29

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