# K041898: Cliniqa Liquid QC TDM Controls Levels 1,2 & 3/Cliniqa Linical TDM Calibration Verifiers Levels a-E for Olympus AU System

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Aug 16, 2004 after 33 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CLINIQA Liquid QCTM TDM Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material. Three assayed levels of Acetaminophen, Amikacin, Carbamazepine, Digoxin, Disopyramide, Ethosuximide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Salicylate,Theophylline, Tobramycin, Valproic Acid and Vancomycin are provided. CLINIQA LiniCALIMTDM Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems TM for Acetaminophen, Amikacin, Caffeine, Carbamazepine, Digoxin, Disopyramide, Gentamicin, Lidocaine, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Primidone, Procainamide, Quinidine, Theophylline, Tobramycin, Valproic Acid and Vancomycin at five useful concentrations

Source page: https://510kreport.com/device/K041898
Methodology: https://510kreport.com/methodology