# K042169: Stanbio Laboratory Sirrus Clinical Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Stanbio Laboratory
- Decided: Mar 14, 2005 after 215 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- 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 K920402 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920402: Roche Cobas Mira Plus, Roche Diagnostic Systems, Inc. (1992) Summary page 1.

## Most influential descendants
- K110520: Biolis 12I (2012), 0 descendants of its own

## Indications for use
The Sirrus® Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes to include Glucose, Cholesterol, and Triglycerides.

Source page: https://510kreport.com/device/K042169
Methodology: https://510kreport.com/methodology