# K061549: Amniostat-FLM-PG

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Oct 18, 2006 after 135 days
- Product code: JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio)
- Device class: 2
- Regulation: 21 CFR 862.1455
- 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 K822150 (1982). 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)
- K822150: Amnistat-FLM, Hana Biologics, Inc. (1982) Summary page 1.

## Indications for use
The AmnioStat-FLM-PG Kit is intended to be used for the immunological detection of phosphatidylglycerol (PG) in amniotic fluid to determine fetal lung maturity of the fetus collected from transabdominal or vaginal pool samples.

Source page: https://510kreport.com/device/K061549
Methodology: https://510kreport.com/methodology