# K042281: Modification to Access Hypersensitive HTSH Assay

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 16, 2004 after 23 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925637 (1993). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023093: Access Hypersensitive HTSH Assay, Beckman Coulter, Inc. (2002) Summary page 1.
- K954825: Access Hypersensitive TSH Reagents on the Access Immunoassay Analyzer, Bio-Rad Laboratories, Inc. (1995) Summary page 1.
- K925637: Access HTSH Assay, Bio-Rad Laboratories, Inc. (1993) Summary page 1.

## Most influential descendants
- K090588: Power Processor Sample Processing System with Generic Connection Module, Model: 4210 (2009), 4 descendants of its own
- K110413: Power Processor Sample Processing System with Generic Connections (2011), 3 descendants of its own
- K140496: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (2014), 1 descendant of its own
- K190298: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (2019), 0 descendants of its own
- K192064: LIAISON Vitamin B12 (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K042281
Methodology: https://510kreport.com/methodology