510(k) Report

510(k) · Cleared

Cleared

Modification to Access Hypersensitive HTSH Assay

K042281510(k) SpecialCleared Sep 16, 200423-day reviewClass II21 CFR 862.1690

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

Beckman Coulter, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone

Cleared on Sep 16, 2004 as substantially equivalent to K023093 (Beckman Coulter, Inc., 2002) and 2 other predicates after a 23-day review. Its family tree reaches back 2 generations to 1993. 6 later devices descend from it.

Decided
Sep 16, 2004
Review
23 days
Class
Class II
Product code
JLW
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K925637 (1993). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2019: 2 descendants cleared2017: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant clearedK925637 · Access HTSH Assay · Bio-Rad Laboratories, Inc. · 1993K023093 · Access Hypersensitive HTSH Assay · Beckman Coulter, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K023093 · Access Hypersensitive HTSH Assay · Beckman Coulter, Inc. · 2002K925637 · Access HTSH Assay · Bio-Rad Laboratories, Inc. · 19930
  1. Root · 2 generations backK925637 Access HTSH AssayBio-Rad Laboratories, Inc. · 1993
  2. 1 generation backK023093 Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2002
  3. This deviceK042281 Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2004
  4. Descendant · cites it directly · 4 of its ownK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
  5. Descendant · 2 generations on · 3 of its ownK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK140496 Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate…Beckman Coulter, Inc. · 2014 · Recalled
  7. Descendant · cites it directly · 0 of its ownK190298 DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access…Beckman Coulter Biomedical GmbH · 2019 · Recalled
  8. Descendant · 4 generations on · 0 of its ownK192064 LIAISON Vitamin B12DiaSorin, Inc. · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12014: 12017: 12019: 2
2009high 2 (2019) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc. · 2009 · cites it directly4descendants
  • K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 2 generations on3descendants
  • K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc. · 2014 · 3 generations on1descendant
  • K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH · 2019 · cites it directly0descendants
  • K192064LIAISON Vitamin B12DiaSorin, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K925637Access HTSH AssayBio-Rad Laboratories, Inc.1993—
−1K023093Access Hypersensitive HTSH AssayBeckman Coulter, Inc.2002—
0 (this device)K042281Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc.2004—
+1K090588Power Processor Sample Processing System with Generic Connection Module…Beckman Coulter, Inc.2009—
+2K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc.20112
+3K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc.20144
+1K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate…Beckman Coulter Biomedical GmbH20194
+4K192064LIAISON Vitamin B12DiaSorin, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201410
201710
201920
FIG. 1 — Lineage of K042281, 1993–2019Source: 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), 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. #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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K023093Access Hypersensitive HTSH Assay
Summary page 1
…Access® HYPERsensitive hTSH Assay Product Classification II - JLW and Code: Predicate Device: Access ® HYPERsensitive hTSH Assay - K023093, K954825, K925637 Device Description: The Access® hTSH assay consists of the…
Beckman Coulter, Inc.2002—
*K954825Access Hypersensitive TSH Reagents on the Access Immunoassay Analyzer
Summary page 1
…cess® HYPERsensitive hTSH Assay Product Classification II - JLW and Code: Predicate Device: Access ® HYPERsensitive hTSH Assay - K023093, K954825, K925637 Device Description: The Access® hTSH assay consists of the reagent p…
Bio-Rad Laboratories, Inc.1995—
*K925637Access HTSH Assay
Summary page 1
…ification II - JLW and Code: Predicate Device: Access ® HYPERsensitive hTSH Assay - K023093, K954825, K925637 Device Description: The Access® hTSH assay consists of the reagent pack and c…
Bio-Rad Laboratories, Inc.1993—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc.20094
K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH20190
K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc.20170

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 11 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K090588 (Beckman Coulter, Inc., 2009) has gone furthest, with 4 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—

What is it indicated for?

The Access HYPERsensitive hTSH Assay provides in vitro quantitative measurement of the human thyroid-stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH Assay is indicated for use with patients where an assessment of their thyroid status is desired. This assay is capable of providing 3rd generation (HYPERsensitive hTSH) and/or the 2nd generation (Fast hTSH) results.

Indications for use as stated in the FDA summary.

More from Beckman Coulter, Inc.

456 FDA decisions under this applicant name. See the company

  • K262597Access BNP IIBeckman Coulter, Inc. · 2026
  • K261109Access MeMed BVBeckman Coulter, Inc. · 2026
  • K262109Access NT-proBNPBeckman Coulter, Inc. · 2026
  • K252169Access BNP IIBeckman Coulter, Inc. · 2026
  • K254059Access anti-HBc IgMBeckman Coulter, Inc. · 2026

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/K042281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042281: Modification to Access Hypersensitive HTSH Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042281

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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