# K040535: Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Mar 29, 2004 after 27 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K052010: HBA1C Linearity Set (2005), 2 descendants of its own
- K121534: Cone-Trol Hemoglobin A1C Control Set (2012), 1 descendant of its own
- K162514: Multichem A1c (2016), 0 descendants of its own

## Indications for use
CLINIQA LiniCAL TM Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Beckman Coulter Synchron® System for Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Cholinesterase, Creatine Kinase, Creatine Kinase MB, Lactate Dehydrogenase, Lipase, Gamma Glutamyl Tranferase, and Pancreatic Amylase at five useful concentrations.

Source page: https://510kreport.com/device/K040535
Methodology: https://510kreport.com/methodology