# K112834: Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit, Urine Uric Acid Standard Kit, Choles

- Pathway: 510(k) (Abbreviated)
- Applicant: Verichem Laboratories, Inc.
- Decided: Mar 28, 2012 after 182 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
Longest line of descent: 1 generation back to K875285 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023268: Phoenix Ise Standard a,B and C for Roche/Avl Systems, Phoenix Diagnostics, Inc. (2002) Summary page 3.
- K875285: Multi-Chemistry Linearity Standard, Verichem Laboratories, Inc. (1988) Summary page 3.
- K110251: Synchron Multi Calibrator, Beckman Coulter, Inc. (2011) Summary page 3.

## Indications for use
The Verichemn ISE Standard Kit is intended for the calibration of sodium, potassium, chloride, lithium, ionized calcium and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Multi-Chemistry Standard Kit is intended for the calibration of sodium, potassium, lactate, chloride, glucose, urea nitrogen, creatinine, calcium, phosphorus, magnesium and triglyceride assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichemn Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichemn Urine Chemistry Standard Kit is intended for the calibration of sodium, potassium, chloride, urea nitrogen, creatinine, calcium, phosphorus and magnesium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichemn Urine Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichemn Cholesterol Standard Kit is intended for the calibration of total cholesterol assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichemn Carbon Dioxide Standard Kit is intended for the calibration of carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For/in vitro diagnostic use only. The Verichemn Electrolyte Standard Kit is intended for the calibration of sodium, potassium, lithium, chloride and ionized calcium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichemn ISE Standard (S4) is intended for the calibration of sodium, potassium, chloride and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K112834
Methodology: https://510kreport.com/methodology