# K041502: Thrombelastograph (Teg) Platelet Mapping Assay

- Pathway: 510(k) (Traditional)
- Applicant: Haemoscope Corp.
- Decided: Sep 1, 2004 after 86 days
- Product code: JOZ (System, Automated Platelet Aggregation)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Thrombelastograph® Coagulation Analyzer (TEG®) - 5000 Series: named in the summary without a submission number
- (no number) Chrono-log Corp. Optical Aggregation Systems and Reagents: named in the summary without a submission number

## Most influential descendants
- K140893: Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay (2015), 0 descendants of its own

## Recalls of this device
- Apr 19, 2022 · Class II · Z-1298-2022: When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition 

## Indications for use
The TEG® Platelet Mapping Assay is intended for use with the Thrombelastograph (TEG) Hemostasis Analyzer to assess platelet function in patients who have received platelet inhibiting drugs such as aspirin, clopidogrel, abciximab, tirofiban, or eptifibatide.

Source page: https://510kreport.com/device/K041502
Methodology: https://510kreport.com/methodology