510(k) · Cleared
ClearedFrend TSH (Reagent Cartridge)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanoentek USA, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Mar 14, 2014 as substantially equivalent to K972586 (Tosoh Medics, Inc., 1997) after a 260-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 14, 2014
- Review
- 260 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972586 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972586 Aia-Pack TSH 3RD-Gen AssayTosoh Medics, Inc. · 1997 · Recalled
- This deviceK131928 Frend TSH (Reagent Cartridge)Nanoentek USA, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972586 | Aia-Pack TSH 3RD-Gen Assay | Tosoh Medics, Inc. | 1997 | 1 |
| 0 (this device) | K131928 | Frend TSH (Reagent Cartridge) | Nanoentek USA, Inc. | 2014 | — |
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? (1)
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 |
|---|---|---|---|
| * | K972586 | Aia-Pack TSH 3RD-Gen AssaySummary page 2…cology (DCTD)) Product Code(s): JLW Radioimmunoassay, Thyroid Stimulating Hormone Other codes used by predicate devices: None Predicate Devices: TOSOH ST AlA-PACK TSH (K972586) Indications for Use: 510(k) Number: K1 31928 Device Name: FIREND Tm TSH Indications for Use: FIREND Tm TSH is designed for i… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
FREND TSH is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulating Hormone (thyrotropin or TSH) in human serum and lithium heparin plasma using the FREND system.
FREND TSH is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in the diagnosis of thyroid disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131928: Frend TSH (Reagent Cartridge).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131928
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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