ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK

K060755 · Roche Diagnostics Corp. · CDD · Apr 10, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060755
• Device Name: ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: CDD · Clinical Chemistry
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Indications for Use

The Vitamin B12 assay is a Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Device Story

The Elecsys Vitamin B12 Test System is an in vitro diagnostic immunoassay used on Roche Elecsys 2010 and MODULAR ANALYTICS E170 analyzers. It utilizes a competitive electrochemiluminescence immunoassay (ECLIA) principle; Vitamin B12 in the patient sample competes with biotin-labeled Vitamin B12 for binding sites on a ruthenium-labeled intrinsic factor complex. The system includes the assay reagent, CalSet II for calibration, and CalCheck for calibration verification. The device is operated by laboratory professionals in clinical settings. Results are determined via an instrument-specific calibration curve generated by 2-point calibration and a master curve provided via reagent barcode. Clinicians use the quantitative Vitamin B12 measurements to diagnose and monitor anemias associated with gastrointestinal malabsorption. The system provides standardized results to assist in clinical decision-making regarding patient nutritional status and anemia management.

Clinical Evidence

Bench testing only. Precision, linearity, and shelf life studies performed to validate impact of NaOH concentration modification. Results documented in product insert.

Technological Characteristics

Competitive electrochemiluminescence immunoassay (ECLIA). Analyte: Vitamin B12. Reagents include ruthenium-labeled intrinsic factor and biotin-labeled Vitamin B12. Platform: Elecsys 2010 and MODULAR ANALYTICS E170. Calibration: 2-point calibration with master curve via barcode. Calibrators/CalCheck: Lyophilized human serum matrix. Connectivity: Automated analyzer integration.

Indications for Use

Indicated for the in vitro quantitative determination of Vitamin B12 in human serum and plasma to aid in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

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.

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 K060755

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:

... an approximately 10% increase in [NaOH], done to minimize the impact of high protein concentrations on measurements. Our information on the predicate indicates a concentration of 1.0 M NaOH. This submission indicates a concentration of 0.9 M NaOH for the predicate. The proposed device has a concentration of 1.0 M NaOH.

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

precision and shelf life. This proposed device demonstrates a decrease in precision relative to the predicate and a decreased shelf life.

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

The company used a FMEA (bottom up) analysis. The results of this analysis indicated that the company should confirm the precision, linearity, and stability. Risk analysis further indicated that the company should institute process controls and verification before releasing manufacturing lots for sale.

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 company completed new precision, linearity, and shelf life studies. The results of these studies were documented in the proposed product insert.

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).

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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.