# K090846: GSP Instrument and GSP Neonatal HTSH Kit

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: Sep 3, 2009 after 157 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905710 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935047: Auto Delfia, Wallac OY (1994) Summary page 1.
- K905710: Pharmacia Delfia Neonatal HTSH Kit, Pharmacia, Inc. (1991) Summary page 1.

## Recalls of this device
- Jan 5, 2017 · Class II · Z-1107-2017: The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the ax
- Jun 27, 2012 · Class II · Z-2121-2012: Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT
- Jan 9, 2012 · Not classified · Z-1116-2012: GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs
- Oct 24, 2011 · Not classified · Z-0603-2012: Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. This may cause a false negative screening result being reported for 17-OHP,

## Indications for use
This kit is intended for the quantitative determination of human thyroid stimulating hormone (hTSH) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument. The GSP TM Instrument is a fully automated, high throughput batch analyzer for time resolved analysis of samples in microtitration plates. It is in intended for in vitro quantitative / qualitative determination of analytes in body fluids.

Source page: https://510kreport.com/device/K090846
Methodology: https://510kreport.com/methodology