510(k) · Cleared
Recalled · Class II · 2017GSP Instrument and GSP Neonatal HTSH Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Sep 3, 2009 as substantially equivalent to K935047 (Wallac OY, 1994) and 1 other predicate after a 157-day review. Its family tree reaches back 1 generation to 1991. It has been recalled 4 times.
- Decided
- Sep 3, 2009
- Review
- 157 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905710 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK905710 Pharmacia Delfia Neonatal HTSH KitPharmacia, Inc. · 1991
- This deviceK090846 GSP Instrument and GSP Neonatal HTSH KitPerkinelmer, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905710 | Pharmacia Delfia Neonatal HTSH Kit | Pharmacia, Inc. | 1991 | — |
| 0 (this device) | K090846 | GSP Instrument and GSP Neonatal HTSH Kit | Perkinelmer, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JLW device
- #1 K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K935047 | Auto DelfiaSummary page 1…Fluorometer for clinical use (RHO) Product Code: Thyroid stimulating hormone radioimmunoassay (JLW) Predicate device: AutoDELFIA instrument (K93 5047) AutoDELFIA Neonatal hTSH kit (K9057 10) Device Description: The GSP instrument (genetic s… | 1994 |
| * | K905710 | Pharmacia Delfia Neonatal HTSH KitSummary page 1…roid stimulating hormone radioimmunoassay (JLW) Predicate device: AutoDELFIA instrument (K93 5047) AutoDELFIA Neonatal hTSH kit (K9057 10) Device Description: The GSP instrument (genetic screening processor) is a fully automated… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2017 | Class II | Z-1107-2017 | Component change control | 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 axle can be observed as deposits of… |
| Jun 27, 2012 | Class II | Z-2121-2012 | Component design/selection | 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 | Nonconforming Material/Component | 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 for a normal sample. |
| Oct 24, 2011 | Not classified | Z-0603-2012 | Device Design | 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, resulting in failure to identify… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K935047.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JLW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JLW
194in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JLW
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLW
103in 2025
MAUDE reports naming product code JLW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 19 |
| 2008 | 5 | 143 | 0 | 10 |
| 2009 | 2 | — | 0 | 41 |
| 2010 | 1 | — | 1 | 34 |
| 2011 | 0 | — | 1 | 167 |
| 2012 | 1 | — | 3 | 144 |
| 2013 | 1 | — | 0 | 168 |
| 2014 | 1 | — | 0 | 155 |
| 2015 | 3 | 142 | 0 | 203 |
| 2016 | 3 | 238 | 1 | 183 |
| 2017 | 4 | 194 | 0 | 235 |
| 2018 | 0 | — | 4 | 249 |
| 2019 | 1 | — | 1 | 216 |
| 2020 | 0 | — | 2 | 145 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 1 | — | 0 | 137 |
| 2023 | 1 | — | 0 | 162 |
| 2024 | 2 | — | 2 | 169 |
| 2025 | 1 | — | 2 | 103 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090846: GSP Instrument and GSP Neonatal HTSH Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090846
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026