VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668

K061464 · Ortho-Clinical Diagnostics, Inc. · JMO · Jun 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061464
• Device Name: VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Indications for Use

VITROS Chemistry Products TIBC Kit with VITROS Chemistry Products Fe Slides quantitatively measures total iron-binding capacity (TIBC) in serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning. VITROS Chemistry Products Calibrator Kit 4 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP. For in vitro diagnostic use only.

Device Story

VITROS TIBC assay measures total iron-binding capacity in serum samples. Process involves pretreating sample with excess iron citrate to saturate apotransferrin sites; applying sample to alumina column to adsorb unbound iron; depositing eluate onto VITROS Fe Slide. System performs two reflection density measurements at 600 nm at one and five minutes. Software uses two-point rate math model to calculate TIBC based on reflectance change. Used in clinical laboratory settings by trained personnel. Output provides quantitative TIBC values to assist physicians in diagnosing anemia-related conditions and iron poisoning.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance claims following internal procedural updates.

Technological Characteristics

In vitro diagnostic reagent kit for TIBC analysis. Fundamental scientific technology unchanged. Performance claims updated based on internal calibrator value assignment and reportable range procedures.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of TIBC in serum to aid in differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

Regulatory Classification

Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Predicate Devices

• VITROS TIBC assay (K931493)

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: DOCUMENT NUMBER K041464

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
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 MODIFICATIONS, including 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 internal updates (i.e., value assignment procedure of TIBC in calibrator and procedures for determining reportable range) and updated performance claims for the TIBC Analysis using the VITROS Chemistry Products TIBC Kit.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and 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.

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 modifications 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.