Atlas FDA

Elecsys HSV-1 IgG (08948844160)

FDA 510(k) clearance K220923 · decided 2022-10-12

Clearance details

K-number
K220923
Device name
Elecsys HSV-1 IgG (08948844160)
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2022-03-31
Decision date
2022-10-12
Days to decision
195 days
Clearance type
Traditional
Product code
MXJ
Device class
2
Regulation number
866.3305
Medical specialty
Microbiology
Advisory committee
Microbiology
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
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (K213987)Biokit, S.A.2023-09-20
ADVIA Centaur Herpes-1 IgG (K181333)Biokit, S.A.2018-08-23
SeraQuest Herpes Type 1 Specific IgG (K162276)Quest International, Inc.2016-10-01
Theranos Herpes Simplex Virus-1 IgG Assay (K143236)Theranos, Inc.2015-07-02
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (K131334)Gold Standard Diagnostics2014-02-28
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (K120625)Roche Diagnostics2012-07-25
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (K120959)Bio-Rad Laboratories2012-06-22
ZEUS ELISA HSV GC-I IGG TEST SYSTEM (K103363)Zeus Scientific, Inc.2011-04-26
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K090409)Bio-Rad Laboratories2009-05-08
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG (K081685)DiaSorin, Inc.2008-11-18
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM (K072178)Zeus Scientific, Inc.2008-05-30
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G (K071511)Focus Diagnostics, Inc.2007-10-05

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