510(k) · Cleared
Recalled · 2007Thyro Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thryotec · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Jul 25, 2003 as substantially equivalent to K990658 (Little Nell Labs, Inc., 1999) after a 123-day review. Its family tree reaches back 3 generations to 1993. It has been recalled once.
- Decided
- Jul 25, 2003
- Review
- 123 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930007 (1993). 4 ancestors in all, the oldest K853717 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK930007 Immulite TSH Third Generation ControlDiagnostic Products Corp. · 1993
- 2 generations backK960195 Thyrochek One-Step Rapid TSH AssayFranklin Diagnostics, Inc. · 1996
- 1 generation backK990658 Thyrochek One-Step Whole Blood Rapid TSH AssayLittle Nell Labs, Inc. · 1999
- This deviceK030912 Thyro TestThryotec · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930007 | Immulite TSH Third Generation Control | Diagnostic Products Corp. | 1993 | — |
| −2 | K960195 | Thyrochek One-Step Rapid TSH Assay | Franklin Diagnostics, Inc. | 1996 | — |
| −1 | K990658 | Thyrochek One-Step Whole Blood Rapid TSH Assay | Little Nell Labs, Inc. | 1999 | — |
| 0 (this device) | K030912 | Thyro Test | Thryotec | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 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? (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 |
|---|---|---|---|
| * | K990658 | Thyrochek One-Step Whole Blood Rapid TSH AssaySummary page 1…l: [email protected] SubstantiallyEquivalent Devices: Product: ThyroChek One-Step Whole Blood Rapid TSH Assay Manufacturer: Little Ne11 Labs, Inc. K990658 Page 8 of 21… | 1999 |
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 24, 2007 | Not classified | Z-0646-2007 | Other | Positive control showed little or no positive line. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 4 ancestors 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.
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 ThyroTest is a whole blood, qualitative assay for the detection of an increased level of TSH (Thyroid Stimulating Hormone). An increase level of TSH can be an indication of primary hypothyroidism. For Professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030912: Thyro Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030912
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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