# K993853: K-Assay Multi-Analyte Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Dec 27, 1999 after 45 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
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.

## Recalls of this device
- Jul 19, 2017 · Class II · Z-3138-2017: The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.

## Indications for use
The K-ASSAY Multi-Analyte Calibrator is intended to be used for the calibration of the following K-ASSAY immunoturbidimetric assays for quantitating serum proteins: Alpha-1 Antitrypsin, Alpha-1 Acid Glycoprotein, C3, C4, IgA, IgG, IgM, Haptoglobin, Transferrin.

Source page: https://510kreport.com/device/K993853
Methodology: https://510kreport.com/methodology