# K974566: Mda Simplastin HTF

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Feb 24, 1998 after 81 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Ortho RecombiPlasTin® Reagent: named in the summary without a submission number

## Recalls of this device
- Mar 7, 2005 · Not classified · Z-0843-05: The ISI labeling for Simplastin HTF on the Coag-a-Mate MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher 

## Indications for use
MDA® Simplastin® HTF is a tissue thromboplastin reagent derived from cultured human cells for use in determination of the prothrombin time (PT) in human plasma.

Source page: https://510kreport.com/device/K974566
Methodology: https://510kreport.com/methodology