Atlas FDA

VITROS XT Chemistry Products TRIG-CHOL Slides

FDA 510(k) clearance K190490 · decided 2019-03-27

Clearance details

K-number
K190490
Device name
VITROS XT Chemistry Products TRIG-CHOL Slides
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2019-02-28
Decision date
2019-03-27
Days to decision
27 days
Clearance type
Traditional
Product code
CHH
Device class
1
Regulation number
862.1175
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rochester, NY, US
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
Lipids (K251091)Truvian Health2025-12-30
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (K232404)Medicon Hellas S.A2024-08-09
Cholesterol2 (K203597)Abbott Ireland Diagnostics Division2022-06-30
Extended Lipid Panel Assay (K181373)Laboratory Corporation of America Holdings2018-10-18
Mission Lipid Panel Monitoring System (K180504)ACON Laboratories, Inc.2018-03-28
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (K163406)ACON Laboratories, Inc.2017-07-11
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (K151545)Polymer Technology Systems, Inc.2016-12-22
Cholesterol (K150654)Randox Laboratories, Ltd.2015-09-29
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (K132031)Axis-Shield Poc AS2014-03-21
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (K130200)Abaxis, Inc.2013-02-15
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K122757)Alfa Wassermann Diagnostic Technologies, Inc.2012-10-05
EON CHOLESTEROL REAGENT (K120202)Vital Diagnostics Pty., Ltd.2012-07-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19