# K140893: Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay

- Pathway: 510(k) (Traditional)
- Applicant: Coramed Technologies, LLC
- Decided: Jan 3, 2015 after 270 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041502 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041502: Thrombelastograph (Teg) Platelet Mapping Assay, Haemoscope Corp. (2004) Summary page 4.

## Indications for use
The CORA PlateletMapping System consists of the CORA analyzer and the CORA PlateletMapping Assay Cartridge. The CORA Platelet Mapping System is intended for in vitro diagnostic use to provide qualitative assessment of platelet function. The CORA System records the kinetic changes in a sample of heparinized whole blood as the sample clots. The CORA System PlateletMapping Assay Cartridge provides four channels of dried-in-place reagents, HKH (Kaolin with Heparinase), Activator F, AA and ADP (one reagent in each channel). In combination, MA parameter results from these four reagents are used to calculate the parameters platelet % Inhibition and % Aggregation for AA and ADP. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System with CORA PlateletMapping Assay Cartridge is indicated for use with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluation with the CORA PlateletMapping System is used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions.

Source page: https://510kreport.com/device/K140893
Methodology: https://510kreport.com/methodology