510(k) · Cleared
ClearedAutomated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex America, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Oct 21, 2016 as substantially equivalent to K083844 (Siemens Healthcare Diagnostics, 2009) after a 238-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Oct 21, 2016
- Review
- 238 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083844 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK083844 Advia Centaur TSH3-Ultra MethodSiemens Healthcare Diagnostics · 2009 · Recalled
- This deviceK160541 Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL…Sysmex America, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083844 | Advia Centaur TSH3-Ultra Method | Siemens Healthcare Diagnostics | 2009 | 4 |
| 0 (this device) | K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH… | Sysmex America, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K083844 | Advia Centaur TSH3-Ultra MethodSummary page 5…dicate devices The Sysmex TSH assay kit is substantially equivalent to the ADVIA Centaur TSH3-Ultra (TSH3-UL, Siemens Medical Solutions, Inc., Malvern, PA) cleared under K083844 on May 8, 2009. 807.92 (a)(4): Device Description The HISCL-800 is a fully automated floor model random access immunoassay syste… | 2009 |
| † | K920372 | Acs Total Ige Immunoassay | 1992 |
| † | K122838 | Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek Immunoassay Plus… | 2012 |
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K083844.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Automated Immunoassay System HISCL-800 is a chemiluminescent chemistry analyzer for the determination of analytes in human serum. The HISCL TSH assay Kit is a magnetic particle chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of TSH levels in human serum using the Automated Immunoassay System HISCL-800. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or…
Read the full statement (108 words)
The Automated Immunoassay System HISCL-800 is a chemiluminescent chemistry analyzer for the determination of analytes in human serum.
The HISCL TSH assay Kit is a magnetic particle chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of TSH levels in human serum using the Automated Immunoassay System HISCL-800. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The HISCL TSH Calibrator is used for calibrating the HISCL TSH Assay Kit on the Automated Immunoassay System HISCL-800.
The HISCL Immuno Multi Control is used for quality control of the HISCL TSH Assay Kit on the Automated Immunoassay System HISCL-800.
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/K160541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160541: Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160541
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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