# K152061: IMMULITE 2000 TSI Assay,  IMMULITE 2000 TSI Calibration Verification Material

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 3, 2016 after 223 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001015 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092229: Thyretain TM Tsi Reporter Bioassay, Diagnostic Hybrids, Inc. (2010) Summary page 5.
- K080092: Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab, Roche Diagnostics Corp. (2008) Summary page 5.
- K080643: Elecsys Anti-TSHR Calcheck, Roche Diagnostics (2008) Summary page 5.

## Recalls of this device
- Aug 11, 2022 · Class II · Z-1820-2022: An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed 

## Indications for use
The IMMULITE® 2000 TSI (thyroid-stimulating immunoglobulins) Assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of thyroid stimulating autoantibodies specific to thyroid stimulating hormone receptors (TSHR) in human serum (including Serum Separator tubes) or plasma (K2-EDTA or lithium heparin). The IMMULITE® 2000 TSI Assay is for use on the IMMULITE® 2000 system. The measurement of thyroid stimulating autoantibodies, in conjunction with other clinical and laboratory findings, is used as an aid in the diagnosis of patients suspected of having Graves' disease. The IMMULITE® TSI Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE® TSI Assay on the IMMULITE® 2000 Systems.

Source page: https://510kreport.com/device/K152061
Methodology: https://510kreport.com/methodology