ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET

K103716 · Roche Diagnostics · CGN · May 12, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103716
• Device Name: ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
• Applicant: Roche Diagnostics
• Product Code: CGN · Clinical Chemistry
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Indications for Use

The Elecsys Folate III assay is an in vitro immunoassay for the quantitative determination of folate in human serum and plasma. The electrochemiluminescence immunoassay (ECLIA) is intended for use on Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys Folate RBC Test System is an in vitro diagnostic system for quantitative determination of folate in erythrocytes. It utilizes manually prepared hemolysate samples. The assay employs a competitive electrochemiluminescent immunoassay principle: folate in the sample competes with biotin-labeled folate for binding sites on ruthenium-labeled folate binding protein. The system is operated by laboratory professionals on Elecsys and cobas e immunoassay analyzers. Calibration is performed using the Elecsys Folate RBC CalSet, with verification via the Elecsys Folate RBC CalCheck. Results are generated via an instrument-specific calibration curve and a master curve encoded on the reagent barcode. Healthcare providers use these quantitative measurements to assist in diagnosing and treating anemias. The system provides standardized folate levels, aiding clinical decision-making regarding patient nutritional status and anemia management.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm impact of calibrator matrix and standardization changes; results demonstrated adherence to predetermined acceptance criteria.

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA). Calibrator matrix: hemolysate-based. Analyzers: Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, cobas e 602. Reagent kit format: RBC Folate separated from serum/plasma kit.

Indications for Use

Indicated for use as an aid in the diagnosis and treatment of anemias. For in vitro diagnostic use on Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

Identification

A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

Predicate Devices

• Roche Elecsys Folate III (K082340)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k103716

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.) Roche Elecsys Folate III, k082340.

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 altering the calibrator matrix to hemolysate based and for modifying the standardization process for the calibrators. The sponsor is also changing the format of the test kit so that the RBC Folate reagent kit is now a separate device from the serum/plasma kit. The newly formatted RBC Folate kit now also has separate labeling and instructions for use. Additionally, the newly formatted kit is intended for use on the Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602.

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 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.