MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING

K143483 · Sebia · CFF · Jan 8, 2015 · Immunology

Device Facts

Record IDK143483
Device NameMINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
ApplicantSebia
Product CodeCFF · Immunology
Decision DateJan 8, 2015
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 866.5510
Device ClassClass 2

Indications for Use

The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP and the MINICAP FLEX-PIERCING instruments, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The MINICAP and MINICAP FLEX-PIERCING instruments perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa and lambda (free and bound) light chains, respectively. The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually to detect the presence of specific reactions with suspected monoclonal proteins. For In Vitro Diagnostic Use.

Device Story

Device performs automated capillary electrophoresis for immunotyping of human serum. Input: serum samples mixed with specific antisera (anti-IgG, IgA, IgM, and kappa/lambda light chains). Process: samples injected into silica capillaries; separation via electrophoresis in alkaline buffer (pH 9.9); direct detection of proteins via 200 nm absorbance. Output: electrophoregrams visualized via PHORESIS software to identify monoclonal proteins by comparing antisera patterns against reference patterns. Used in clinical laboratories by trained personnel. Benefits: enables qualitative identification of monoclonal components (gammopathies) through automated, standardized separation and detection.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements to assess impact of instrument modification and robotic arm disabling on immunotyping performance.

Technological Characteristics

Capillary electrophoresis system; automated instrument platform; includes robotic arm for sample handling (disabled for specific immunotyping assays); supports capped tube testing; software-controlled analysis.

Indications for Use

Indicated for the qualitative identification of monoclonal proteins (immunotyping) in human serum or urine using capillary electrophoresis on the MINICAP and MINICAP FLEX-PIERCING instruments. Intended for use by clinical laboratory professionals.

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 To: THE FILE RE: DOCUMENT NUMBER K143483 SEBIA MINICAP Immunotyping Using the MINICAP and the MINICAP FLEX-PIERCING This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II 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 SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) SEBIA MINICAP Immunotyping using the MINICAP (k082388) and the MINICAP FLEX-PIERCING (k133344) 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 (labeling changes are permitted as long as they do not affect the intended use). 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: addition of a new instrument family member, MINICAP FLEX-PIERCING, which is adapted for capped tube testing. The added robotic arm is disabled for the Immunology IgG, IgA, IgM, Kappa, and Lambda analytes for Immunotyping tests. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance 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 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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