# K162606: Elecsys TSH assay, cobas e 801 Immunoassay analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jan 23, 2017 after 126 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915195 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961491: Elecsys TSH Assay, Boehringer Mannheim Corp. (1996) Summary page 4.

## Most influential descendants
- K223690: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (2023), 0 descendants of its own

## Recalls of this device
- Aug 13, 2019 · Class II · Z-0044-2020: AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results
- Mar 15, 2019 · Class II · Z-1249-2019: The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and
- Apr 3, 2018 · Class II · Z-2136-2018: The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe fun

## Indications for use
cobas e 801 immunoassay analyzer is intended for the in-vitro determination of analytes in body fluids. Elecsys TSH immunoassay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid or pituitary disorders. The Elecsys TSH immunoassay is an electrochemiluminescence immunoassay 'ECLIA', which is intended for use on the cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K162606
Methodology: https://510kreport.com/methodology