Atlas FDA

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

FDA 510(k) clearance K230790 · decided 2023-05-19

Clearance details

K-number
K230790
Device name
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2023-03-22
Decision date
2023-05-19
Days to decision
58 days
Clearance type
Traditional
Product code
DHA
Device class
2
Regulation number
862.1155
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Iriving, TX, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abbott Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581)Ortho Clinical Diagnostics2024-05-08
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690)Shenzhen Yhlo Biotech Co., Ltd.2023-12-11
Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937)Abbott Laboratories2023-06-05
Access Total ßhCG (5th IS) (K221990)Beckman Coulter, Inc.2022-12-27
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221)Diazyme Laboratories, Inc.2021-12-13
Elecsys HCG STAT (K203227)Roche Diagnostics2021-08-18
ADVIA Centaur® Total hCG assay (K200210)Siemens Healthcare Diagnostics, Inc.2021-07-13
MAGLUMI 2000 HCG/ß-HCG (K192547)Shenzhen New Industries Biomedical Engineering Co., Ltd.2020-01-17
Atellica IM Total hCG (ThCG) (K192790)Siemens Healthcare Diagnostics, Inc.2019-10-30
Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317)Abbott Laboratories2017-10-23
Diazyme DZ-Lite Total beta-hCG Test System (K163418)Diazyme Laboratories2017-08-18
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002)Abbott Point of Care, Inc.2015-04-16

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