# K050983: Irma Trupoint Creatinine Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corporation
- Decided: May 16, 2005 after 27 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K943754 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943754: Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control Product, Bionostics, Inc. (1994) Summary page 1.
- K030942: Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry Control, Medical Analysis Systems, Inc. (2003) Summary page 1.

## Indications for use
The IRMA TRUpoint TM Creatinine Control Kit is for use on the IRMA TRUpoint TM Blood Analysis System to perform Quality Control assays for Creatinine on the IRMA TRUpoint TM Blood Analysis System.

Source page: https://510kreport.com/device/K050983
Methodology: https://510kreport.com/methodology