IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH

K133404 · Phadia AB · DGC · Feb 24, 2014 · Immunology

Device Facts

Record IDK133404
Device NameIMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
ApplicantPhadia AB
Product CodeDGC · Immunology
Decision DateFeb 24, 2014
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 866.5510
Device ClassClass 2
AttributesPediatric

Indications for Use

The ImmunoCAP Total IgE assay is an in vitro quantitative assay for the measurement of total immunoglobulin E (IgE) in human serum or plasma. Measurement of total IgE is intended as an aid in the clinical diagnosis of IgE mediated allergic disorders. The assay is intended for use on Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000 instruments.

Device Story

ImmunoCAP Total IgE system is an automated in vitro diagnostic assay for measuring total IgE in human serum or plasma. The device utilizes anti-IgE antibodies covalently coupled to an ImmunoCAP solid phase. Patient samples are incubated with the solid phase; after washing, enzyme-labeled anti-IgE antibodies are added to form a complex. Following further incubation and washing, a developing agent is added. The resulting fluorescence, measured by Phadia 100, 250, 1000, 2500, or 5000 instruments, is directly proportional to the IgE concentration in the sample. The instrument software automatically processes assay steps, calculates results via a calibration curve, and provides quantitative output to clinical laboratory personnel. This information assists clinicians in diagnosing IgE-mediated allergic disorders. The system includes ImmunoCAP Total IgE Control LMH for performance monitoring.

Clinical Evidence

No clinical data provided; submission relies on design control activities and verification of labeling modifications to demonstrate that the fundamental scientific technology remains unchanged from the predicate device.

Technological Characteristics

In vitro quantitative immunoassay. Components: anti-IgE covalently coupled to ImmunoCAP, enzyme-labeled anti-IgE antibodies, calibrators, and controls. Detection principle: fluorescence measurement proportional to IgE concentration. Compatible with Phadia 100, 250, 1000, 2500, and 5000 instrument platforms. Automated processing and calculation via instrument software.

Indications for Use

Indicated for the quantitative measurement of total IgE in human serum or plasma to aid in the clinical diagnosis of IgE-mediated allergic disorders in patients.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} SPECIAL 510(k): Device Modification OIR Review Memorandum To: THE FILE RE: DOCUMENT NUMBER K133404 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): 1. The name and 510(k) number of the PHADIA's previously cleared device UNICAP Total IgE assay/Pharmacia Total IgE Controls LMH, cleared under k964152. 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials. 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the labeling format of the Device Package Insert (Directions for Use). The change combines three current Package Inserts into one assay specific Package Insert. The new Package Insert is for use of ImmunoCAP Total IgE on Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000 instruments. Besides merging the documents, there are typographical, format and minor changes in the Package Insert. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. 6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure (and Class III Summary for Class III devices). The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
Innolitics

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