The Calais Human Milk Analyzer is FOR INVESTIGATIONAL USE ONLY.
The performance characteristics of the product have not been established.
The Calais Analyzer and control samples have not been cleared by the FDA. The FDA has determined it is a medical device. While we are preparing our FDA filing for submission, the device is for Investigational Use Only and should not under any circumstances be used to diagnose or treat any medical condition.
MIR vs. NIR
You may be considering a laboratory-type analyzer that does not use MIR (Mid Infra Red) Spectroscopy. Please be aware that MIR is the only method that has been validated by the leading international organization, the AOAC.
And what is the AOAC?
AOAC® Official MethodsSM Program
The AOAC Official MethodsSM Program is designed to provide fully validated methods that can be used with confidence by regulatory agencies, regulated industry, product testing laboratories, and academic institutions. Official MethodsSM validation provides the highest level of confidence in a method. Official MethodsSM are often used for regulatory purposes and, as such, are cited in the U.S. Code of Federal Regulations. Official MethodsSM are subjected to an eight or more laboratory collaborative study (to demonstrate between-laboratory reproducibility of results) according to internationally recognized standards and receive rigorous scientific review of performance results. A report of the validation results are reviewed and approved by a Methods Committee, General Referee, Safety and Statistical Advisors, and two Official Methods Board representatives. Methods are typically validated in 9 to 18 months. Approved Official MethodsSM are published in the Official Methods of Analysis of AOAC INTERNATIONAL and supporting data is published in the Journal of AOAC INTERNATIONAL. Both proprietary and nonproprietary methods can be validated in this program.
Adoption of a method is based on the demonstration of its reliability and practicality by completion of a successful collaborative study. (From the AOAC website at http://www.aoac.org/vmeth/newsmtd.htm)
Overview of Methods Approval
Mid infrared analysis is now a standard method, referred to as IDF Standard 141B (IDF, 1996) and AOAC method 972.16 (AOAC, 1995) 1
"Analytical attributes and factors that affect the accuracy of protein testing in milk. With the exception of instrumental and sample factors, compared to MIR techniques, little work has been done to assess the performance of the NIR instruments for the analysis of milk and to thoroughly evaluate the physicochemical and biologic factors that may influence the response of the NIR analysis." 2
1 Official Methods of Analysis, 16th Edition., 4th Revision, 1998. AOAC International, Gaithersburg, MD, Method 972.16.
2 Advanced Dairy Chemistry: Proteins. By Patrick Fox, Third Edition, Part A. ISBM 0-306-47271-6 Copyright 2003.