# K101460: Loci 8 Calibrator, Model KC 646

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jul 9, 2010 after 44 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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: 2 generations back to K910198 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962041: Acs LH2 Immunoassay, Ciba Corning Diagnostics Corp. (1996) Summary page 1.
- K992981: Elecsys Estradiol Calset II, Roche Diagnostics Corp. (1999) Summary page 1.

## Recalls of this device
- Nov 9, 2017 · Class II · Z-1184-2018: An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2

## Indications for use
LOCI B CAL is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2) methods on the Dimension Vista™ systems.

Source page: https://510kreport.com/device/K101460
Methodology: https://510kreport.com/methodology