Atlas FDA

VITROS Immunodiagnostic Products Syphilis Reagent Pack

FDA 510(k) clearance K241534 · decided 2024-08-28

Clearance details

K-number
K241534
Device name
VITROS Immunodiagnostic Products Syphilis Reagent Pack
Applicant
Ortho Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2024-05-30
Decision date
2024-08-28
Days to decision
90 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Bridgend, GB
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
Access Syphilis (K241427)Beckman Coulter, Inc.2024-09-06
Elecsys Syphilis (K211302)Roche Diagnostics2021-07-20
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
Elecsys Syphilis (K160910)Roche Diagnostics2016-07-28
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
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017)Ortho-Clinical Diagnostics2023-01-24
VITROS Anti-HBe (P100001/S016)Ortho-Clinical Diagnostics2019-06-19
VITROS Anti-HBc (P030024/S029)Ortho-Clinical Diagnostics2019-06-19
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027)Ortho-Clinical Diagnostics2018-10-16
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026)Ortho-Clinical Diagnostics2018-07-02