# K110818: Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests

- Pathway: 510(k) (Traditional)
- Applicant: Polymedco, Inc.
- Decided: Sep 8, 2011 after 168 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- 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
The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the Poly-Chem 90 analyzer. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to measure the total calcium level in human serum on the Poly-Chem 90 analyzer. 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 Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90 analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K110818
Methodology: https://510kreport.com/methodology