510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge

K060090510(k) TraditionalCleared Feb 27, 200646-day reviewClass II21 CFR 862.1690Recalls 1

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

Dade Behring, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone

Cleared on Feb 27, 2006 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.

Decided
Feb 27, 2006
Review
46 days
Class
Class II
Product code
JLW
Recalls
1
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 2 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK060090 Dimension Vista Thyroid Stimulating Hormone Flex Reagent CartridgeDade Behring, Inc. · 2006
  2. Descendant · cites it directly · 2 of its ownK081074 Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with…Siemens Healthcare Diagnostics, Inc. · 2008 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK243570 Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge…Siemens Healthcare Diagnostics · 2025
  4. Descendant · cites it directly · 0 of its ownK140859 Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK140842 Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K081074Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691Siemens Healthcare Diagnostics, Inc. · 2008 · cites it directly2descendants
  • K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…Siemens Healthcare Diagnostics · 2025 · 2 generations on0descendants
  • K140859Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants
  • K140842Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060090Dimension Vista Thyroid Stimulating Hormone Flex Reagent CartridgeDade Behring, Inc.2006—
+1K081074Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF…Siemens Healthcare Diagnostics, Inc.20083
+2K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)…Siemens Healthcare Diagnostics2025—
+1K140859Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista…Siemens Healthcare Diagnostics, Inc.20143
+2K140842Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci…Siemens Healthcare Diagnostics, Inc.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201420
202510
FIG. 1 — Lineage of K060090, 2006–2025Source: 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
Get a 510(k) Report

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? (4)

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

NumberDeviceApplicantDecidedDescendants
K081074Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691Siemens Healthcare Diagnostics, Inc.20082
K140859Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…Siemens Healthcare Diagnostics, Inc.20140

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

Recalls of this device

DateClassRecallRoot causeReason
May 10, 2013Class IIZ-1884-2013Device DesignA rare variant of TSH, identified in a small cluster of patients, is not detected.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K081074 (Siemens Healthcare Diagnostics, Inc., 2008) has gone furthest, with 2 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.

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 Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

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/K060090 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060090: Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060090

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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