# K981401: Boehringer Mannheim Precinorm Precipath Protein Controls

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: May 18, 1998 after 31 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: 1 generation back to K871027 (1987). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871027: Precinorm (R) Protein, Boehringer Mannheim Corp. (1987) Summary page 1.
- K933589: Boehringer Mannheim Tina-Quant Transferrin Assay, Boehringer Mannheim Corp. (1993) Summary page 1.

## Most influential descendants
- K040280: Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls (2004), 5 descendants of its own
- K041812: Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath Proteins in Urine/CSF (Puc) (2004), 2 descendants of its own
- K050026: Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc (2005), 1 descendant of its own
- K133330: C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein (2013), 0 descendants of its own
- K132156: Randox CSF Controls Levels 2 and 3 (2013), 0 descendants of its own

## Indications for use
For use as a control in the immunoturbidimetric assay of serum proteins. It is well suited for automated analytical procedures. The assigned values for each constituent are obtained on Boehringer Mannheim/Hitachi systems.

Source page: https://510kreport.com/device/K981401
Methodology: https://510kreport.com/methodology