# K033471: Phospholin ES and Calcium Chloride

- Pathway: 510(k) (Traditional)
- Applicant: R2 Diagnostics, Inc.
- Decided: Feb 4, 2004 after 93 days
- Product code: GGW (Test, Time, Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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 K863594 (1986). 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)
- K863594: Actin FSL Activated PTT Reagent, American Dade (1986) Summary page 1.
- (no number) Stago Calcium Chloride: named in the summary without a submission number

## Indications for use
The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.

Source page: https://510kreport.com/device/K033471
Methodology: https://510kreport.com/methodology