# K060280: Ichem 100 Urine Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Iris International, Inc.
- Decided: Jun 13, 2006 after 131 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K943592 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030600: Aution Jet AJ-4270 Urine Analyzer, International Remote Imaging Systems (2003) Summary page 1.

## Recalls of this device
- Dec 8, 2014 · Class II · Z-0649-2016: Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.

## Indications for use
The iChem100 Urine Chemistry Analyzer (iChem100) is a semi-automated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, uroDilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.

Source page: https://510kreport.com/device/K060280
Methodology: https://510kreport.com/methodology