510(k) · Cleared
Recalled · Class II · 2019Elecsys TSH assay, cobas e 801 Immunoassay analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Jan 23, 2017 as substantially equivalent to K961491 (Boehringer Mannheim Corp., 1996) after a 126-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jan 23, 2017
- Review
- 126 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915195 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK915195 Enzymun-Test TSHBoehringer Mannheim Corp. · 1992
- 1 generation backK961491 Elecsys TSH AssayBoehringer Mannheim Corp. · 1996
- This deviceK162606 Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics · 2017
- Descendant · cites it directly · 0 of its ownK223690 iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash…Shenzhen Yhlo Biotech Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915195 | Enzymun-Test TSH | Boehringer Mannheim Corp. | 1992 | — |
| −1 | K961491 | Elecsys TSH Assay | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | 2017 | — |
| +1 | K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K961491 | Elecsys TSH AssaySummary page 4…II JJE Product Codes JLW Predicate Devices Elecsys 2010/ Elecsys TSH K961491 For cobas e 801 and Elecsys TSH, the establishment registration number for… | 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 |
|---|---|---|---|
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2019 | Class II | Z-0044-2020 | Process change control | AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results |
| Mar 15, 2019 | Class II | Z-1249-2019 | Device Design | The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment. |
| Apr 3, 2018 | Class II | Z-2136-2018 | Process design | The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 20.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223690 (Shenzhen Yhlo Biotech Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K961491.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
cobas e 801 immunoassay analyzer is intended for the in-vitro determination of analytes in body fluids.
Elecsys TSH immunoassay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid or pituitary disorders. The Elecsys TSH immunoassay is an electrochemiluminescence immunoassay 'ECLIA', which is intended for use on the cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162606: Elecsys TSH assay, cobas e 801 Immunoassay analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162606
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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