510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Advia Centaur TSH3-Ultra Method

K083844510(k) TraditionalCleared May 8, 2009135-day reviewClass II21 CFR 862.1690Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Healthcare Diagnostics · JLW Radioimmunoassay, Thyroid-Stimulating Hormone

Cleared on May 8, 2009 after a 135-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 4 times.

Decided
May 8, 2009
Review
135 days
Class
Class II
Product code
JLW
Recalls
4
Predicates
0

9 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2015: 2 descendants cleared2016: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK083844 Advia Centaur TSH3-Ultra MethodSiemens Healthcare Diagnostics · 2009
  2. Descendant · cites it directly · 7 of its ownK150403 ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc. · 2015 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK151792 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
  4. Descendant · cites it directly · 1 of its ownK233050 ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2024
  5. Descendant · cites it directly · 1 of its ownK162698 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2017
  6. Descendant · 2 generations on · 0 of its ownK251543 Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2015: 22016: 12017: 22023: 12024: 22026: 1
2015high 2 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all
  • K150403ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc. · 2015 · cites it directly7descendants
  • K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Siemens Healthcare Diagnostics, Inc. · 2015 · 2 generations on4descendants
  • K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2024 · cites it directly1descendant
  • K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2017 · cites it directly1descendant
  • K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083844Advia Centaur TSH3-Ultra MethodSiemens Healthcare Diagnostics2009—
+1K150403ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc.20151
+2K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc.201522
+1K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.2024—
+1K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.2017—
+2K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201720
202310
202420
202610
FIG. 1 — Lineage of K083844, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)score 11.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150403ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc.20157
K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.20241
K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20171
K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator…Sysmex America, Inc.20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 10, 2014Class IIZ-1654-2014Device DesignSamples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
Apr 10, 2014Class IIZ-1653-2014Device DesignSamples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
May 10, 2013Class IIZ-1881-2013Device DesignA rare variant of TSH, identified in a small cluster of patients, is not detected.
Jul 25, 2012Class IIZ-2313-2012Nonconforming Material/ComponentDecrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K150403 (Siemens Healthcare Diagnostics, Inc., 2015) has gone furthest, with 7 descendants of its own.

How does its category compare?

All JLW devices

JLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JLW

1in 2025

2008: 52009: 22010: 12012: 12013: 12014: 12015: 32016: 32017: 42019: 12022: 12023: 12024: 22025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JLW

194in 2017

2008: 143 days median2015: 142 days median2016: 238 days median2017: 194 days median
2007high 238 (2016) · low 142 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JLW

2in 2025

2007: 12010: 12011: 12012: 32016: 12018: 42019: 12020: 22024: 22025: 2
2007high 4 (2018) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JLW

103in 2025

2007: 192008: 102009: 412010: 342011: 1672012: 1442013: 1682014: 1552015: 2032016: 1832017: 2352018: 2492019: 2162020: 1452021: 1462022: 1372023: 1622024: 1692025: 103
2007high 249 (2018) · low 10 (2008)2025

MAUDE reports naming product code JLW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—119
20085143010
20092—041
20101—134
20110—1167
20121—3144
20131—0168
20141—0155
201531420203
201632381183
201741940235
20180—4249
20191—1216
20200—2145
20210—0146
20221—0137
20231—0162
20242—2169
20251—2103
20261—0—

More from Siemens Healthcare Diagnostics

344 FDA decisions under this applicant name. See the company

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  • P000021/S047Dimension TPSA Flex reagent cartridgeSiemens Healthcare Diagnostics · 2025

Recent decisions in JLW

The JLW category page

  • K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2026
  • K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex…Siemens Healthcare Diagnostics · 2025
  • K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc. · 2024
  • K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2024
  • K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP…Siemens Healthcare Diagnostics, Inc. · 20231 recall

https://510kreport.com/device/K083844 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083844: Advia Centaur TSH3-Ultra Method.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083844

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026