# K131556: Diazyme Lipoprotein (a) Calibrator Set, Control Set

- Pathway: 510(k) (Special)
- Applicant: Diazyme Laboratories
- Decided: Jun 26, 2013 after 28 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982708 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082488: Diazyme LP (a) Assay, General Atomics (2009) Summary page 2.

## Indications for use
The Diazyme Lipoprotein (a) Calibrator Set is intended for use in establishing the calibration curve for the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only. The Diazyme Lipoprotein (a) Control Set is intended for use in monitoring the quality control of results obtained with the Diazyme Lipoprotein (a) Assay reagents by turbidimetry. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K131556
Methodology: https://510kreport.com/methodology