510(k) DEN240035

ConcizuTrace ELISA by Randox Laboratories, Ltd. — Product Code SES

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 22, 2025
Date Received: July 1, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Non-Factor Replacement Product Test System
Device Class: Class II
Regulation Number: 864.7298
Review Panel: HE
Submission Type

A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products that are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with bleeding disorders, including hemophilia, in human blood specimens to ensure appropriate therapy in accordance with the approved non-factor replacement product labeling.

Other clearances by Randox Laboratories, Ltd.

K230890 — ISE Electrodes (September 8, 2023)
K182042 — Randox Calcium (Ca) (October 23, 2018)
K162200 — Randox RX Daytona Plus Magnesium (MG) (April 28, 2017)
K152085 — Liquid CO2-2 (LCO2-2) (February 24, 2016)
K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
K150654 — Cholesterol (September 29, 2015)
K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE ( (January 9, 2014)
K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (November 21, 2013)
K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3 (October 23, 2013)
K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPIN (August 8, 2013)