RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3— 510(k) K110534

Clearance details

Applicant

Randox Laboratories Limited

Product code

Code JJY

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

2011-02-25

Decision date

2012-01-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Crumlin, GB

• K162530 — Multichem IA Plus2017-03-31
• K163629 — Audit MicroControls Linearity FD Tumor Markers II2017-03-10
• K163015 — Liquichek Tumor Marker Control-Level 1 +3 more2017-01-10
• K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit2016-01-28
• K150300 — Liquichek Cardiac Markers Plus Control LT2015-12-11

• K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
• K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT2023-10-05
• K221550 — Evidence MultiSTAT DOA Urine MultiPlex2023-10-05
• K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP)2017-04-21
• K161691 — Direct LDL Cholesterol (LDL)2017-03-20

• Z-0412-2020 — Randox Liquid Cardiac Controls Catalogue Number CQ5051Class II·Terminated·Randox Laboratories, Limited·20191004
• Z-0413-2020 — Randox Liquid Cardiac Controls Catalogue Number CQ5052.Class II·Terminated·Randox Laboratories, Limited·20191004
• Z-0414-2020 — Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.Class II·Terminated·Randox Laboratories, Limited·20191004
• Z-1461-2020 — Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.Class II·Terminated·Response Biomedical Corp.·20190315
• Z-1785-2019 — Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053Class II·Terminated·Randox Laboratories Ltd.·20190311
• Z-0380-2019 — Liquid Cardiac Control, CQ5051Class II·Terminated·Randox Laboratories Ltd.·20181002
• Z-0381-2019 — Liquid Cardiac Control, CQ5052Class II·Terminated·Randox Laboratories Ltd.·20181002
• Z-0382-2019 — Liquid Cardiac Control, CQ5053Class II·Terminated·Randox Laboratories Ltd.·20181002
• Z-2575-2018 — Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.Class II·Terminated·Randox Laboratories Ltd.·20180608
• Z-0937-2018 — Liquid Cardiac Control CQ5053Class II·Terminated·Randox Laboratories, Limited·20170808
• Z-0762-2017 — The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.Class II·Terminated·Randox Laboratories·20160916

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110534.