510(k) · Cleared
ClearedVitros Immunodiagnostics Products/TSH Reagent Pack (Gem. 1001)/TSH Calibrators (Gem.C001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Dec 16, 1996 after a 33-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 16, 1996
- Review
- 33 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK964558 Vitros Immunodiagnostics Products/TSH Reagent Pack (Gem. 1001)/TSH…Johnson & Johnson Clinical Diagnostics, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK081543 Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators…Ortho-Clinical Diagnostics, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK083173 Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators…Ortho-Clinical Diagnostics · 2008 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K081543Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600…Ortho-Clinical Diagnostics, Inc. · 2008 · cites it directly3descendants
- K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Ortho-Clinical Diagnostics, Inc. · 2018 · 2 generations on1descendant
- K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · 3 generations on0descendants
- K083173Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600…Ortho-Clinical Diagnostics · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964558 | Vitros Immunodiagnostics Products/TSH Reagent Pack (Gem. 1001)/TSH Calibrators… | Johnson & Johnson Clinical Diagnostics, Inc. | 1996 | — |
| +1 | K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600… | Ortho-Clinical Diagnostics, Inc. | 2008 | 39 |
| +2 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 20 |
| +3 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
| +2 | K083173 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600… | Ortho-Clinical Diagnostics | 2008 | 26 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600… | 2008 | 3 |
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?
- Of its descendants, K081543 (Ortho-Clinical Diagnostics, Inc., 2008) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K964558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964558: Vitros Immunodiagnostics Products/TSH Reagent Pack (Gem. 1001)/TSH Calibrators (Gem.C001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964558
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026