# K050955: Lifesign Dxpress, Model LSR2000

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jan 23, 2006 after 283 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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 K993065 (1999). 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)
- K993065: Acon Combo Pregnancy, ACON Laboratories, Inc. (1999) Summary page 1.

## Indications for use
Reflectance photometer for the measurement of concentration of analyte in various assays manufactured by PBM. The concentration is measured by density of light reflectance. Reflectance photometer for a reading of test signal instead of visual reading in various qualitative assays manufactured by PBM. StatusFirst TM hCG Serum/Urine test is in vitro diagnostic use for a qualitative detection of Human Chorionic Gonadotropin(hCG) in serum or urine for the detection of pregnancy.

Source page: https://510kreport.com/device/K050955
Methodology: https://510kreport.com/methodology