Atlas FDA

Elecsys Syphilis

FDA 510(k) clearance K160910 · decided 2016-07-28

Clearance details

K-number
K160910
Device name
Elecsys Syphilis
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2016-04-01
Decision date
2016-07-28
Days to decision
118 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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

RecordFirmDate
Access Syphilis (K241427)Beckman Coulter, Inc.2024-09-06
VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534)Ortho Clinical Diagnostics2024-08-28
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BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set (K170413)Bio-Rad Laboratories2017-05-11
Lumipulse G TP-N Immunoreaction Cartridge Set (K153145)Fujirebio Diagnostics,Inc.2016-07-05
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (K153730)Abbott Laboratories2016-06-15
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (K120439)Bio-Rad Laboratories, Inc.2012-03-14
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (K112343)Siemens Healthcare Diagnostics, Inc.2012-01-20
SYPHILIS HEALTH CHECK (K102400)Diagnostics Direct, LLC2011-08-01
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM (K102283)Zeus Scientific, Inc.2011-02-10
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM (K093837)Zeus Scientific, Inc. (Zeus)2010-10-01
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM (K091361)Siemens Healthcare Diagnostics2009-12-16

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