Elecsys TSH assay, cobas e 801 Immunoassay analyzer— 510(k) K162606

Name: FDA 510(k) clearance K162606
Creator: U.S. Food and Drug Administration
Published: 2017-01-23

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K162606 for Elecsys TSH assay, cobas e 801 Immunoassay analyzer, Substantially Equivalent on 2017-01-23. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JLW
Device class: Class 2
Regulation: 21 CFR 862.1690
Advisory panel: Clinical Chemistry
Date received: 2016-09-19
Decision date: 2017-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K162606

K-number listed on FDA's recall record

Z-0044-2020 — AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001Class II·Terminated·Roche Diagnostics Operations, Inc.·20190813
Z-1249-2019 — cobas e 801 immunoassay analyzerClass II·Terminated·Roche Diagnostics Corporation·20190315
Z-2136-2018 — cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.Class II·Terminated·Roche Diagnostics Corporation·20180403

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162606.

Data sourced from openFDA. This site is unofficial and independent of the FDA.