Piccolo Express- CMP Waived

Abaxis submitted their CMP disk to the FDA MANY years ago to be evaluated for waived status when performed on Lithium heparin whole blood. (Abaxis has many other Waived status disks on the market.) We've been using the CMP for at least 15 years in the ED and Micro-hospital setting. To the best of my knowledge, this is the only waived CMP on the market. These have been real workhorses for us, running Comprehensive Metabolic Panel, Basic Metabolic Panel, MetLyte 8 Panel (includes total CK), Liver Panel Plus (includes Amylase and GGT), and Hepatic Function Panel (our only non-Waived panel) disks.

There is a hardware/disk integrity check (iQC - Intelligent QC) that is performed upon startup and with every test. There is a requirement to capture the iQC (hard copy or electronic) for the first patient test of the day of testing to demonstrate that the meter (it is classified as a meter) is working properly. (We happen to capture the iQC for every patient and QC test within our LIS, eliminating the failure point of failing to capture just the first patient test of the day.) This requirement was imposed by the FDA to obtain and maintain Waived status. (The dirty little secret is that if the iQC fails, there will be no patient results reported.) Assay time is approximately 12 minutes.

Points of failure:

I think you will like them for your setting.