510(k) · Cleared

Cleared

Access Hypersensitive HTSH Assay

K023093510(k) TraditionalCleared Nov 25, 200268-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 Nov 25, 2002 as substantially equivalent to K925637 (Bio-Rad Laboratories, Inc., 1993) and 1 other predicate after a 68-day review. Its family tree reaches back 1 generation to 1993. 7 later devices descend from it.

Decided: Nov 25, 2002
Review: 68 days
Class: Class II
Product code: JLW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K925637 (1993). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK925637 Access HTSH AssayBio-Rad Laboratories, Inc. · 1993
This deviceK023093 Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2002
Descendant · cites it directly · 6 of its ownK042281 Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2004
Descendant · 2 generations on · 4 of its ownK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
Descendant · 3 generations on · 3 of its ownK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
Descendant · 4 generations on · 1 of its ownK140496 Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate…Beckman Coulter, Inc. · 2014 · Recalled
Descendant · 2 generations on · 0 of its ownK190298 DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access…Beckman Coulter Biomedical GmbH · 2019 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004high 2 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 7 · See all

K042281Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2004 · cites it directly6descendants
K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc. · 2009 · 2 generations on4descendants
K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 3 generations on3descendants
K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc. · 2014 · 4 generations on1descendant
K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925637	Access HTSH Assay	Bio-Rad Laboratories, Inc.	1993	—
0 (this device)	K023093	Access Hypersensitive HTSH Assay	Beckman Coulter, Inc.	2002	—
+1	K042281	Modification to Access Hypersensitive HTSH Assay	Beckman Coulter, Inc.	2004	—
+2	K090588	Power Processor Sample Processing System with Generic Connection Module…	Beckman Coulter, Inc.	2009	—
+3	K110413	Power Processor Sample Processing System with Generic Connections	Beckman Coulter, Inc.	2011	2
+4	K140496	Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…	Beckman Coulter, Inc.	2014	4
+2	K190298	DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate…	Beckman Coulter Biomedical GmbH	2019	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2009	1	0
2011	1	0
2014	1	0
2017	1	0
2019	2	0

FIG. 1 — Lineage of K023093, 1993–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K925637	Access HTSH Assay Summary page 1 …Systems. Substantial Equivalence Comparison The Access HYPERsensitive hTSH assay is substantially equivalent to the previously cleared Access HYPERsensitive hTSH assay (K925637 and K954825). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicat…	Bio-Rad Laboratories, Inc.	1993	—
*	K954825	Access Hypersensitive TSH Reagents on the Access Immunoassay Analyzer Summary page 1 …bstantial Equivalence Comparison The Access HYPERsensitive hTSH assay is substantially equivalent to the previously cleared Access HYPERsensitive hTSH assay (K925637 and K954825). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicate assays inc…	Bio-Rad Laboratories, Inc.	1995	—

Also cleared against K925637: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042281	Modification to Access Hypersensitive HTSH Assay	Beckman Coulter, Inc.	2004	6

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?

None of the 2 ancestors has a recall.
Of its descendants, K042281 (Beckman Coulter, Inc., 2004) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K925637.

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

2007high 5 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JLW

194in 2017

2007high 238 (2016) · low 142 (2015)2026

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

Recalls per year · JLW

2in 2025

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

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

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 Access HYPERsensitive hTSH assay provides in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023093 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023093: 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/K023093

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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