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

Intended 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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APR 2 1 2006

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: k060774

### Submitter's Name and Address

Beckman Coulter. Inc. 1000 Lake Hazeltine Drive Chaska. MN 55318 Telephone: [phone] Fax: [phone] Contact: Carolyn Anderson

Date Prepared: March 20, 2006

### Device Names

Folate on the Access® Immunoassay Systems Proprietary Name:

- Common Name: Folate test system
Classification Name: Folic Acid test system

#### Predicate Device

Access Folate Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

510(k) Numbers: k932887, k943149, k955434

#### Device Description

The Access Folate reagents, Access Folate Calibrators, Access Folate Lysing Agent, Folate Calibrator S0 and the Access Immunoassay Analyzers (Access, Access 2, Synchron LX® 725, UniCel Dxl™ 800, and UniCel DxC 600i) comprise the Access Immunoassay Systems for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells.

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# Intended 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.

| Attribute | Access Folate Assay | Access Folate Assay (modified) |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Intended Use | Quantitative determination of folic acid levels in human serum, plasma (heparin) or 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 and 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. | Same |
| Methodology | Chemiluminescent immunoassay (two step competitive binding receptor assay) | Same |
| Product type | Reagent | Same |
| Sample type | Human serum, plasma (heparin) or red blood cells | Same |
| Assay components | Reagent pack, calibrators, lysing agent, Folate Calibrator S0 | Same |
| Solid Phase | Goat anti-mouse capture antibody coupled to paramagnetic particles | Same |
| Conjugate | Folic acid-alkaline phosphatase conjugate | Same |
| Calibrators | Folate (pteroylglutamic acid) in buffered matrix at levels of 0 and approximately 1.0, 2.5, 5.0, 10.0, and 20.0 ng/mL (2.3, 5.7, 11.3, 22.7, and 45.3 nmol/L) | Same |
| Reportable Range | Serum folate: 0.5 – 20 ng/mL | Serum folate: 0.5 – 20 ng/mL |
| Sample Size | 55 μL | 55 μl |

# Comparison of Technological Characteristics

# Summary of Technological Characteristics

The device modification consists of a change in buffers for pH adjustment and the reestablishment of the reference interval to reflect the prevalence of folic acid fortification of foods. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. The modification does not affect the safety and efficacy of the device.

## Conclusion

The modified Access Folate on the Access Immunoassay Systems is substantially equivalent to the Access Folate assay for the quantitative determination folic acid levels in human serum, plasma (heparin) and red blood cells.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carolyn Anderson Schior Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

APR 2 1 2006

Re: k060774

Trade/Device Name: Access Folate on the Access® Immunoassay Systems Regulation Number: 21 CFR& 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN Dated: March 20, 2006 Received: March 22, 2006

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto Gutt

Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

## 510(k) Number (if known):

Device Name: Access Folate on the Access® Immunoassay Systems

## 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. A low RBC folate value can indicate a prolonged folate deficiency.

Prescription Use

:

AND/OR

alary

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Hemen

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