# K032237: N/T Protein Control

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 5, 2003 after 46 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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: 2 generations back to K955858 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991704: N/T Protein Control LC, Dade Behring, Inc. (1999) Summary page 1.

## Most influential descendants
- K081299: Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista (2008), 0 descendants of its own

## Indications for use
N/T Protein Control LC is intended for use as an assayed accuracy and precision control for immunochemical determination of IgA, IgG and IgM in CSF, transferrin and a,-microglobulin in urine, albumin and total protein in urine and CSF using the BNTM Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTime System.

Source page: https://510kreport.com/device/K032237
Methodology: https://510kreport.com/methodology