Atlas FDA

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control

FDA 510(k) clearance K153730 · decided 2016-06-15

Clearance details

K-number
K153730
Device name
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2015-12-28
Decision date
2016-06-15
Days to decision
170 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Abbott Park, IL, 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
Access Syphilis (K241427)Beckman Coulter, Inc.2024-09-06
VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534)Ortho Clinical Diagnostics2024-08-28
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
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
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30