# K091975: Integrated Laboratory Automation Solution

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Laboratory Automation Solutions, Inc.
- Decided: Mar 10, 2010 after 252 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 K922072 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922072: Kodak Ektachem 250 Analyer, Eastman Kodak Company (1992) Summary page 1.
- K010500: Automated Workcell Control Software, Lab-Interlink, Inc. (2001)

## Indications for use
The Integrated Laboratory Automation Solution (ILAS) is designed to transport clinical patient samples to clinical laboratory analyzers that perform the actual clinical tests. The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and test orders to be performed by the laboratory analyzer. The patient specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each analyzer station to determine if tests are to be run and if so the specimen is switched to a side track supplying the analyzer with the specimen. The ILAS is an accessory to the Vitros 250 automated chemistry analyzer and other similar chemistry automated clinical analyzers. Automated clinical analyzers utilize various methods and technologies for the determination of numerous analytes, such as Glucose and other measurands that may be adaptable to each integrated analyzer. Glucose on the ILAS system is for the quantitative in vitro diagnostic measurement of Glucose in plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K091975
Methodology: https://510kreport.com/methodology