FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208

K060774 · Beckman Coulter, Inc. · CGN · Apr 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060774
• Device Name: FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
• Applicant: Beckman Coulter, Inc.
• Product Code: CGN · Clinical Chemistry
• Decision Date: Apr 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Indications for Use

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. Red blood cell (RBC) folate is the best indicator of long term folate stores. A low RBC folate value can indicate a prolonged folate deficiency.

Device Story

Modified folate assay kit; utilizes immunoassay technology for folate measurement. Modifications include: substitution of pH adjustment agents (NaOH to K3PO4); reconfiguration of well-plate materials; removal of human serum albumin (HSA) from folate lysing agent to improve storage stability; update of reference intervals/expected values due to food fortification. Device operates via immunoassay principle; reagents include bovine folate binding protein, mouse monoclonal anti-folate binding protein, and paramagnetic particles. Intended for clinical laboratory use to measure folate levels. Output provides quantitative folate concentration; assists clinicians in assessing folate status. Fundamental scientific technology remains unchanged from previously cleared devices.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of technological characteristics.

Technological Characteristics

Immunoassay-based folate measurement. Reagents: bovine folate binding protein, mouse monoclonal anti-folate binding protein, paramagnetic particles (PMP) coated with goat anti-mouse IgG, K3PO4, ascorbate, HCl. Reconfigured well-plate format. Modifications include removal of HSA from lysing agent. Fundamental technology remains unchanged.

Indications for Use

Indicated for quantitative determination of folic acid in human serum, plasma (heparin), and red blood cells to assess folate status and identify prolonged folate deficiency.

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

• k932887
• k943149
• k955434

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 k060774

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.) k932887, k943149, k955434

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.

1) Material changes for pH adjustment
- NaOH (sodium hydroxide) to K₃PO₄ (potassium phosphate).
- Folic acid alkaline phosphatase (bovine) conjugate and paramagnetic particles (PMP) coated with goat anti-mouse IgG suspended in buffer, with human serum albumin (HSA) buffer to mouse monoclonal anti-folate binding protein, PMP coated with goat anti-mouse IgG, buffer, HSA.
- Sodium ascorbate to Ascorbate and HCl
- Milk folate binding protein (bovine) and mouse monoclonal anti-folate binding protein in buffer with HSA, sodium azide and ProClin to milk folate binding protein (bovine) in buffer and HSA.
- Hydrochloride acid to folic acid alkaline phosphates (bovine) conjugate in buffer and HSA.

2) Reconfiguration of materials in the well-plate.

3) The folate lysing agent is being modified to remove the human serum albumin (HSA) to improve storage temperature.

4) Lastly, the reference intervals/expected values are being updated to reflect the increased normal levels of folate due to folate acid fortification of foods.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and physical characteristics, immunoassay technology, test protocol, performance, assay principle, cutoff level 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
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

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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.