# K981706: Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/MG Cal, LDL Cal, MC Cal, Upro Cal, and Ise Calibrator Levels 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 9, 1998 after 56 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K103403: Multiconstituent Calibrator (2011), 0 descendants of its own

## Recalls of this device
- Apr 24, 2008 · Not classified · Z-0950-2009: An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium Calibrator lot number 54187M200. Use of the incorrect Magnesium CAL 2 value causes quality control 
- Aug 10, 2007 · Not classified · Z-0288-2008: Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.
- Dec 23, 2005 · Not classified · Z-0516-06: The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened exp

## Indications for use
An Abbott Clinical Chemistry Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Source page: https://510kreport.com/device/K981706
Methodology: https://510kreport.com/methodology