510(k) · Cleared
ClearedCliniqa Liquid QC TDM Controls Levels 1,2 & 3/Cliniqa Linical TDM Calibration Verifiers Levels a-E for Olympus AU System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cliniqa Corporation · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 16, 2004 after a 33-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 16, 2004
- Review
- 33 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (105 words)
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041898: Cliniqa Liquid QC TDM Controls Levels 1,2 & 3/Cliniqa Linical TDM Calibration Verifiers Levels a-E for Olympus AU System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041898
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026