# K961481: Elecsys 2010 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 14, 1996 after 57 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Boehringer Mannheim ES300 Immunoassay system: named in the summary without a submission number

## Most influential descendants
- K060373: Cobas 6000 Series System (2006), 18 descendants of its own
- K100853: Cobas 8000 Modular Series Analyzer (2010), 9 descendants of its own
- K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck (2006), 9 descendants of its own
- K191899: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (2019), 3 descendants of its own
- K140505: Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material (2014), 3 descendants of its own

## Recalls of this device
- Jul 5, 2017 · Class II · Z-0499-2018: A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
- Jul 15, 2016 · Class II · Z-0095-2017: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarif
- May 21, 2014 · Class II · Z-1790-2014: Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
- Jan 31, 2012 · Not classified · Z-1218-2012: Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring rang
- Jun 24, 2008 · Not classified · Z-0165-2009: A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
- Mar 21, 2008 · Not classified · Z-0868-2008: Possible mismatch between patient and result.

## Indications for use
The Elecsys 2010 analyzer is an immunoassay analyzer intended for the in vitro quantitative and qualitative determination of analytes in human serum and plasma

Source page: https://510kreport.com/device/K961481
Methodology: https://510kreport.com/methodology