510(k) · Cleared
ClearedMAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen New Industries Biomedical Engineering Co., Ltd. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Jul 14, 2017 as substantially equivalent to K083844 (Siemens Healthcare Diagnostics, 2009) and 1 other predicate after a 290-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Jul 14, 2017
- Review
- 290 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902336 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 4 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 3 generations backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- 2 generations backK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- 1 generation backK151792 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
- This deviceK162698 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK232587 MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence…Shenzhen New Industries Biomedical Engineering Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −4 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −3 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −2 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| −1 | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH… | Siemens Healthcare Diagnostics, Inc. | 2015 | 22 |
| 0 (this device) | K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017 | — |
| +1 | K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay… | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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…Thyroid Stimulating Hormone JJE 862.2160 Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 5. Predicate Devices: K083844, Siemens ADVIA Centaur TSH3 K151792, Siemens Trinidad Immunoassay (IM) System 6. Intended Use: The MAGLUMI 2000 Immunoassa… | 2009 |
| * | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Summary page 5…JJE 862.2160 Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 5. Predicate Devices: K083844, Siemens ADVIA Centaur TSH3 K151792, Siemens Trinidad Immunoassay (IM) System 6. Intended Use: The MAGLUMI 2000 Immunoassay system is an automated, immunoassay a… | 2015 |
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 |
|---|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | 2024 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K232587 (Shenzhen New Industries Biomedical Engineering Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 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. 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?
The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum. The measurement of TSH is used in the diagnosis of thyroid disorders.
The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system’s assay application utilizes chemiluminescents technology for clinical use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162698: MAGLUMI 2000 TSH, MAGLUMI 2000 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/K162698
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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