510(k) · Cleared
ClearedMict TSH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magnabiosciences, LLC · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Mar 9, 2012 as substantially equivalent to K052301 (Qualigen, Inc., 2006) after a 357-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Mar 9, 2012
- Review
- 357 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942566 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K052301 | Fastpack TSH ImmunoassaySummary page 1…Classification Name: Quantitative Determination of TSH in Human Serum 3. Predicate Qualigen FastPack® TSH (K052301) device 4. Device The MICT® TSH Immunoassay for the quantitative determination of TSH description in… | 2006 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K052301.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro
quantitative determination of TSH in human serum. The measurements of
thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in
the diagnosis of thyroid or pituitary disorders. The MICT System is intended for
use in clinical laboratories.
The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro
quantitative determination of TSH in human serum. The measurements of
thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in
the diagnosis of thyroid or pituitary disorders. The MICT System is intended for
use in clinical laboratories.
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/K110761 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110761: Mict TSH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110761
Report an extraction error
Are you the manufacturer?
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