[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.3210]

[Page 264-265]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866_IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                     Subpart D_Serological Reagents
 
Sec. 866.3210  Endotoxin assay.

    (a) Identification. An endotoxin assay is a device that uses 
serological techniques in whole blood. The device is intended for use in 
conjunction with other laboratory findings and clinical assessment of 
the patient to aid in the risk assessment of critically ill patients for 
progression to severe sepsis.
    (b) Classification. Class II (special controls). The special control 
for this

[[Page 265]]

device is the FDA guidance entitled ``Class II Special Controls Guidance 
Document: Endotoxin Assay.'' See Sec. 866.1(e) for the availability of 
this guidance document.

[68 FR 62008, Oct. 31, 2003. Redesignated at 70 FR 53069, Sept. 7, 2005]