Atlas FDA

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack

FDA 510(k) clearance K233581 · decided 2024-05-08

Clearance details

K-number
K233581
Device name
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Applicant
Ortho Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2023-11-07
Decision date
2024-05-08
Days to decision
183 days
Clearance type
Traditional
Product code
DHA
Device class
2
Regulation number
862.1155
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Bridgend, GB
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ortho Clinical Diagnostics

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

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
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
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790)Abbott Laboratories2023-05-19
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
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