# K041009: Raichem Calcium (Ocpc) Liquid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Jun 25, 2004 after 67 days
- Product code: CIC (Cresolphthalein Complexone, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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
- Jun 7, 2006 · Not classified · Z-1176-06: Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.

## Indications for use
This reagent is intended for the quantitative determination of Calcium in serum, heparinized plasma, or urine. For in vitro diagnostic use only. This calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The intended patient population may be adult, pediatric, and neonatal.

Source page: https://510kreport.com/device/K041009
Methodology: https://510kreport.com/methodology