510(k) · Cleared
ClearedThyrochek One-Step Whole Blood Rapid TSH Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Little Nell Labs, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Jun 2, 1999 as substantially equivalent to K853717 (Nichols Institute Diagnostics, 1985) and 2 other predicates after a 93-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Jun 2, 1999
- Review
- 93 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930007 (1993). 3 ancestors in all, the oldest K853717 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930007 Immulite TSH Third Generation ControlDiagnostic Products Corp. · 1993
- 1 generation backK960195 Thyrochek One-Step Rapid TSH AssayFranklin Diagnostics, Inc. · 1996
- This deviceK990658 Thyrochek One-Step Whole Blood Rapid TSH AssayLittle Nell Labs, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK030912 Thyro TestThryotec · 2003 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K030912Thyro TestThryotec · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930007 | Immulite TSH Third Generation Control | Diagnostic Products Corp. | 1993 | — |
| −1 | K960195 | Thyrochek One-Step Rapid TSH Assay | Franklin Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K990658 | Thyrochek One-Step Whole Blood Rapid TSH Assay | Little Nell Labs, Inc. | 1999 | — |
| +1 | K030912 | Thyro Test | Thryotec | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K853717 | Allegro TM HS-TSH Immunoassay SystemSummary page 1…idation studies which compare the performance of the whole blood rapid TSH assay at detecting TSH > 5 micro IU/ml to that of predicate medical devices, including second (K853717) and third (K930007) generation TSH immunoassays, and to a serum-based lateral flow immunochromatographic assay (K960195). The re… | 1985 |
| * | K930007 | Immulite TSH Third Generation ControlSummary page 1…h compare the performance of the whole blood rapid TSH assay at detecting TSH > 5 micro IU/ml to that of predicate medical devices, including second (K853717) and third (K930007) generation TSH immunoassays, and to a serum-based lateral flow immunochromatographic assay (K960195). The results obtained are a… | 1993 |
| * | K960195 | Thyrochek One-Step Rapid TSH AssaySummary page 1…of predicate medical devices, including second (K853717) and third (K930007) generation TSH immunoassays, and to a serum-based lateral flow immunochromatographic assay (K960195). The results obtained are as follows: 1. Quantitative recovery data demonstrates analytic sensitivity between 4.06-5.62 micro 1… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030912 | Thyro Test | 2003 | 0 |
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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030912 (Thryotec, 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The ThyroChek whole blood, rapid TSH assay is a visual, non-instrument, qualitative, solid-phase, lateral flow, two-site immunochromatographic assay for identifiying capillary or venous blood samples that contain TSH>5 microlU/ml. The test is intended for use as an in-vitro diagnostic device by medical professionals to screen for primary hypothryoidism. it is not indicated for use as a screening method for neonatal hypothyroidism.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990658 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990658: Thyrochek One-Step Whole Blood Rapid TSH Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990658
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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