# K102016: Precicontrol Clinchem Multi 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 1, 2010 after 44 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: 3 generations back to K811832 (1981). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042389: Modification to Precinorm Universal Plus and Precipath Universal Plus Control Sera, Roche Diagnostics Corp. (2004) Summary page 2.

## Most influential descendants
- 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

## Indications for use
PreciControl clinChem Multi 1 and 2 are for use in quality control by monitoring accuracy and precision for the guantitative methods as specified in the value sheets.

Source page: https://510kreport.com/device/K102016
Methodology: https://510kreport.com/methodology