Case Study – Systems 1

A large leading diagnostic company had a system that required manual manipulation of a variety of reagents to perform immunoassay diagnostic tests. The reagent production was established and the kit components fixed and FDA-approved.

The Requirement :

• To automate the process.
• To eliminate the use of disposable sampling tips.

The Commercial Constraints :

• The reagent packaging had to be retained.
• The presented primary collection vessel was pre-determined
• The reaction vessels had to be retained.
• The instrument was to be designed to attain a commercially viable transfer price.
• An FDA submission was to be restricted to 510(K) equivalence testing.

The Market Constraints :

• The instrument was to be bench-top.
• The instrument should address the ergonomic requirements of the user.
• The industrial design should remain undated throughout its commercial life.

The Solution :

• ITL designed and manufactured an automated immunoassay analyser, the timing and precision of which equalled or bettered that achieved by an experienced laboratory personnel whilst retaining the kit components in their original packaging and aliquots.
• A 510(K) submission was successfully made proving equivalence to the manual assay.