[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.4010]

[Page 219]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
                Subpart E--Specimen Preparation Reagents
 
Sec. 864.4010  General purpose reagent.


    (a) A general purpose reagent is a chemical reagent that has general 
laboratory application, that is used to collect, prepare, and examine 
specimens from the human body for diagnostic purposes, and that is not 
labeled or otherwise intended for a specific diagnostic application. It 
may be either an individual substance, or multiple substances 
reformulated, which, when combined with or used in conjunction with an 
appropriate analyte specific reagent (ASR) and other general purpose 
reagents, is part of a diagnostic test procedure or system constituting 
a finished in vitro diagnostic (IVD) test. General purpose reagents are 
appropriate for combining with one or more than one ASR in producing 
such systems and include labware or disposable constituents of tests; 
but they do not include laboratory machinery, automated or powered 
systems. General purpose reagents include cytological preservatives, 
decalcifying reagents, fixative and adhesives, tissue processing 
reagents, isotonic solutions and pH buffers. Reagents used in tests for 
more than one individual chemical substance or ligand are general 
purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, substrates 
for enzyme immunoassay (EIA)).
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 864.9. If the device is 
not labeled or otherwise represented as sterile, it is exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.

[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
62 FR 62260, Nov. 21, 1997; 66 FR 38789, July 25, 2001]