# K020369: Elecsys Anti-TG Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 6, 2002 after 30 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K924862 (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)
- K963147: Elecsys Calcheck TSH, Boehringer Mannheim Corp. (1996) Summary page 1.

## Most influential descendants
- K132391: Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB Calibration Verificatin Material (2013), 0 descendants of its own

## Indications for use
Elecsys® Anti-Tg CalCheck calibration verification solutions comprise three levels - low, mid, and high each with a defined Anti-Tg concentration. The low-solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys® Anti-Tg CalCheck is intended for use in the verification of the calibration established by the Elecsys® Anti-Tg reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Source page: https://510kreport.com/device/K020369
Methodology: https://510kreport.com/methodology