B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

K093631 · Siemens Healthcare Diagnostics · CDD · Feb 12, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093631
• Device Name: B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
• Applicant: Siemens Healthcare Diagnostics
• Product Code: CDD · Clinical Chemistry
• Decision Date: Feb 12, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Indications for Use

The B12 method is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension EXL™ integrated chemistry system. The FOL method is an in vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension EXL ™ integrated chemistry system.

Device Story

Modification of Dimension Vista® Vitamin B12 Flex® and Folate Flex® reagent cartridges for use on Dimension® EXL chemistry system with LOCI® module. Modification involves re-packaging from 12-well to 8-well cartridges; adjustment of sample and reagent volumes; increased assay time; increased test capacity per cartridge; and modified well fill volumes. Device utilizes LOCI® (Luminescent Oxygen Channeling Immunoassay) technology. Intended for clinical laboratory use to measure Vitamin B12 and Folate levels. Performance verified through method comparison, precision, linearity, detection limits, recovery, matrix comparison, and stability testing.

Clinical Evidence

Bench testing only. Studies included method comparison, precision, linearity, detection limits, recovery (manual/automatic dilution), matrix comparison, reference range, interferences, calibration interval, open-well stability, on-board stability, and shelf life. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

LOCI® (Luminescent Oxygen Channeling Immunoassay) technology. 8-well reagent cartridge format. Reagent/sample volume adjustment. Automated chemistry system integration (Dimension® EXL).

Indications for Use

Indicated for use on the Dimension® EXL chemistry system with LOCI® module for the measurement of Vitamin B12 and Folate.

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

• Dimension Vista® Vitamin B12 Flex® reagent cartridge (K071224)
• Dimension Vista® Folate Flex® reagent cartridge (K071224)

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 k093631

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. k071224 (Dimension Vista® Vitamin B12 Flex® reagent cartridge, Dimension Vista® Folate Flex® reagent cartridge).)

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:

a. Re-packaging of the B12 Flex® reagent cartridge and the FOL Flex® reagent cartridge from a 12-well Flex® reagent cartridge to an 8-well Flex® reagent cartridge for use on the Dimension® EXL chemistry system with LOCI® module. The modification of the B12 Flex® reagent cartridge included: sample and reagent volume adjustment, increased assay time, increased number of tests per Flex, and changes in well fill volumes. The modification of the FOL Flex® reagent cartridge included: increased number of tests per Flex and changes in well fill volumes.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample type. Studies included method comparison, precision, linearity, detection limits, recovery, recovery on dilution (manual and automatic), matrix comparison, reference range, interferences, calibration interval, open-well stability, on-board stability, and 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

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. 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.