# K992086: Olympus Serum Protein Multicalibrator 2

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Aug 19, 1999 after 59 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intended for use with Olympus reagents for the establishment of reference points used in the deterdination of values for specific constituents found in human serum. The five constituents are ceruloplasmin, alpha—l—acidglycop_rqtein, alpha—l—antitrypsin, haptoglobin and berLa—2-microglebulin.

Source page: https://510kreport.com/device/K992086
Methodology: https://510kreport.com/methodology