Analytical Performance
Characteristics and Clinical Utility of
Immunological Assays for Human
7-206 InVitro Immunoglobulin E (IgE) Antibodies I/LA20-A2 08/05/2013 CLSI
and Defined Allergen Specificities;
Approved Guideline - Second
Edition
Recognition List Number: 031 Publication Date: 08/05/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-206: CLSI I/LA20-A2, Analytical Performance Characteristics
and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE)
Antibodies and Defined Allergen Specificities; Approved Guideline - Second Edition.
(InVitro Diagnostics)
Date of Standard: 2009.
Address of Standards Organization:
Clinical Laboratory Standards Institute (CLSI)
950 West Valley Road
Suite 2500
Wayne, PA 19087
CDRH Offices and Divisions Associated with Recognized Standards:
(1) OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2) OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Immunological Assays for Human Immunoglobuline E (IGE) Antibodies of Defined
Allergen Specificity
Processes Affected:
510(k)
Type of Standard:
National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name
Device Product
Class
Code
§878.448021 Powder, Dusting, Surgical
Class 3 KGP22
Regulation
Device Product
Number
Device Name
Class
Code
§866.551023 Ige, Antigen, Antiserum, Control
Class 2 DGC24
§866.551025 Radioimmunoassay, Immunoglobulins (D, E)
Class 2 JHR26
Regulation
Device Product
Number
Device Name
Class
Code
§866.575027 System, Test, Radioallergosorbent (Rast) Immunological Class 2 DHB28
Relevant Guidance:
The Decision Summaries of recently cleared Allergy IVD devices in FDA database may
be considered for use.
Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for
510(k) Clearance
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR878.4480]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES
Subpart E--Surgical Devices
Sec. 878.4480 Absorbable powder for lubricating a surgeon's glove.
(a)Identification. Absorbable powder for lubricating a surgeon's glove
is a powder made from corn starch that meets the specifications for
absorbable powder in the United States Pharmacopeia (U.S.P.) and that is
intended to be used to lubricate the surgeon's hand before putting on a
surgeon's glove. The device is absorbable through biological degradation.
(b)Classification. Class III.
(c)Date PMA or notice of completion of a PDP is required. As of May 28,
1976, an approval under section 515 of the act is required before this
device may be commercially distributed. See 878.3.
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR866.5510]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F--Immunological Test Systems
Sec. 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)Identification. An immunoglobulins A, G, M, D, and E immunological test
system is a device that consists of the reagents used to measure by
immunochemical techniques the immunoglobulins A, G, M, D, an E (serum
antibodies) in serum. Measurement of these immunoglobulins aids in the
diagnosis of abnormal protein metabolism and the body's lack of ability
to resist infectious agents.
(b)Classification. Class II (performance standards).
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR866.5750]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F--Immunological Test Systems
Sec. 866.5750 Radioallergosorbent (RAST) immunological test system.
(a)Identification. A radioallergosorbent immunological test system is a
device that consists of the reagents used to measure by immunochemical
techniques the allergen antibodies (antibodies which cause an allergic
reaction) specific for a given allergen. Measurement of specific allergen
antibodies may aid in the diagnosis of asthma, allergies, and other
pulmonary disorders.
(b)Classification. Class II (performance standards).