IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6

K060929 · Diagnostic Products Corporation · CDD · Apr 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060929
• Device Name: IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
• Applicant: Diagnostic Products Corporation
• Product Code: CDD · Clinical Chemistry
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Indications for Use

The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia. The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

Device Story

IMMULITE 2500 Vitamin B12 and Folic Acid are solid-phase, two-site chemiluminescent enzyme immunoassays designed for use on the IMMULITE 2500 Automated Analyzer. The system processes patient serum, plasma, or whole blood samples to provide quantitative measurements of Vitamin B12 or Folic Acid. These assays are utilized in clinical laboratory settings by trained personnel. The analyzer automates the immunoassay process, producing results that clinicians use to aid in the diagnosis and treatment of anemias, including megaloblastic anemia and those associated with gastrointestinal malabsorption. By providing rapid, automated quantitative data, the device assists healthcare providers in identifying nutritional deficiencies and monitoring therapeutic interventions, ultimately supporting patient management for anemia-related conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance comparisons to the predicate IMMULITE 2000 systems.

Technological Characteristics

Solid-phase, two-site chemiluminescent enzyme immunoassay. Designed for use with the IMMULITE 2500 Automated Analyzer. Analyte detection via chemiluminescence. System is intended for professional in vitro diagnostic use.

Indications for Use

Indicated for use by trained laboratory professionals for the performance of immunoassays on the IMMULITE 2500 Automated Immunoassay Analyzer, including the measurement of Vitamin B12 and Folic Acid.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• IMMULITE 2500 Automated Immunoassay Analyzer (K033234)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: k060929

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 SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
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 was for

the addition of the IMMULITE® 2500 Vitamin B12 and IMMULITE® 2500 Folic Acid to the previously cleared (K033234) IMMULITE 2500 Automated Immunoassay Analyzer. In addition, the incubation times of these assays are being changed to provide a more rapid time to first result.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, technology, test protocol, performance, assay principle, stability and reagents.
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. FMECA
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 or Statement 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.