NAMSA Chemistry Jeopardy

Acronym Antics

100

FDA

what is the acronym for food and Drug Administration

200

MDR

What is the acronym for Medical device Regulatioin

300

 GCMS

What  is the acronym for Gas Chromatography Mass Spectometry

400

ICP

What is the acronym for Inductively Coupled Plasma

500

LCMS

what is the acronym for 

Liquid chromatography–mass spectrometry

Pop Hits and Customer Fits

100

Chemical Entities without a tentative or confirmed identity.

What are unknowns?

200

the amount of testing article needed for chemistry testing to be conducted

What is sample requirements?

300

the term commonly used by NAMSA indicating the point in time when tat starts for testing

What is login?

400

a statement received from a regulatory agency such as the FDA listing problems with the submission

what is a deficiency?

500

this is one of the differentiation characteristics listed in the namsa playbook for chemical characterization

• Are the largest medical device CRO
• Were the first CRO to start testing for chemical characterization and helped develop the standards used today
• Understand the complexity of extractions of medical devices to allow for a suitable extract needed for instrumentation such as Gas Chromatography, Liquid Chromatography, Inductively Coupled Plasma, etc.

ISO 10993-18

100

Water is this type of solvent

what is a polar solvent

200

Hexane is this type of solvent

what is a non polar solvent

300

This is a common temperature used for the exhaustive extraction of metals in hexane

what is 50 degrees celsius

400

the name of the threshold at or above which a chemist should begin to identify a particular leachable and/or extractable and report it for potential toxicological assessment.

What is AET or analytical evaluation threshold?

500

the Annex where one finds the discussion of toxicological equivalency in 10993-18

What is Annex C?

Miscellaneous

100

this is body temperature in celsius

what is 37 C

200

The testing portal utilized by customers in Obernburg and Lyon

What is NAMSA 360

300

these are the 2 cities where NAMSA has chemical characterization laboratories

what are Toledo/Northwood and Obernburg

400

this is the year NAMSA was founded

what is 1967

500

this term is utilized to address the overall biocompatibility of a medical device

what is biological safety?