ABBOTT ARCHITECT FOLATE

K023397 · Abbott Laboratories · CGN · Dec 16, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023397
• Device Name: ABBOTT ARCHITECT FOLATE
• Applicant: Abbott Laboratories
• Product Code: CGN · Clinical Chemistry
• Decision Date: Dec 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Intended Use

The ARCHITECT® Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay used for the quantitative determination of folate in human serum, plasma, and red blood cells on the ARCHITECT i System. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

Device Story

The ARCHITECT Folate assay is a chemiluminescent microparticle folate binding protein assay designed for use on the Abbott ARCHITECT i System. It processes human serum, plasma, and red blood cell samples to provide quantitative folate measurements. The system utilizes automated immunoassay technology to measure folate levels, which clinicians use to diagnose and monitor megaloblastic anemia. The device is intended for professional use in clinical laboratory settings. Results are provided to healthcare providers to inform clinical decision-making regarding patient nutritional status and anemia management.

Clinical Evidence

Clinical evidence consists of a method comparison study between the ARCHITECT Folate assay and the predicate Bio-Rad Quantaphase II B12/Folate Radioassay. The study analyzed 241 serum samples and 244 whole blood samples. Correlation coefficients (r) were 0.904 for both sample types. Regression analysis (Least Squares and Passing-Bablok) demonstrated performance comparability between the subject and predicate devices.

Technological Characteristics

Chemiluminescent microparticle folate binding protein immunoassay. Designed for use on the automated ARCHITECT i System. Measures folate concentration via light emission proportional to the amount of folate in the sample. Standard laboratory diagnostic equipment.

Indications for Use

Indicated for the quantitative determination of folate in human serum, plasma, and red blood cells to aid in the diagnosis and treatment of megaloblastic anemia.

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

• Bio-Rad Quantaphase II B12/Folate Radioassay

Submission Summary (Full Text)

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## 510(k) Summary Abbott ARCHITECT® Folate

K02397

## Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT Folate constitutes data supporting a substantially equivalent determination.

The ARCHITECT Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, and red blood cells. The ARCHITECT Folate assay is calibrated with ARCHITECT Folate Calibrators. ARCHITECT Folate Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.

Substantial equivalence has been demonstrated between the ARCHITECT Folate assay and the Bio-Rad Quantaphase II® B12/Folate Radioassay. The intended use of the ARCHITECT Folate assay is for the quantitative determination of folate in human serum, plasma, and red blood cells. The intended use of the Bio-Rad Quantaphase II B12/Folate Radioassay is for the quantitative determination of folate in human serum, plasma, and whole blood. A correlation analysis between the two assays yielded the following results.

| Sample | Regression Method | n | r | Slope | Intercept |
|-------------|-------------------|-----|-------|-------|-----------|
| Serum | Least Squares | 241 | 0.904 | 0.93 | 1.4 |
| | Passing-Bablok | 241 | 0.904 | 1.05 | -0.0 |
| Whole Blood | Least Squares | 244 | 0.904 | 1.05 | -54.7 |
| | Passing-Bablok | 244 | 0.904 | 1.10 | -69.9 |

n = number of specimens

r = correlation coefficient

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In conclusion, these data demonstrate that the ARCHITECT Folate assay is as safe and effective as, and is substantially equivalent to, the Bio-Rad Quantaphase II B12/Folate Radioassay.

Prepared and Submitted October 4, 2002 by:

Margarett Durocher 10/4/02

Margaret Prochniak, M Senior Regulatory Specialist ADD Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

Abbott Laboratories Diagnostics Division Department 9V6, Building AP 34-2 200 Abbott Park Road Abbott Park, IL 60064-6187

ARCHITECT Folate 510(k) September 2002 ARCHITECT Folate 510(k).doc

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 2098 Gaither Road

Rockville MD 20850

1 6 2002

Ms. Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Dept 9V6, Bldg. AP34-2 200 Abbott Park Road Abbott, IL 60064-6187

k023397 Re: Trade/Device Name: Abbott ARCHITECT® Folate Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: Class II Product Code: CGN; JIS; JIS; JJX Dated: October 4, 2002 Received: October 9, 2002

Dear Ms. Prochniak:

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 (21 CFR Part 820).

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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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Applicant: Abbott Laboratories

23397 510(k) Number (if known): K

Abbott ARCHITECT® Folate Device Name:

Indications For Use:

The ARCHITECT® Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay used for the quantitative determination of folate in human serum, plasma, and red blood cells on the ARCHITECT i System. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023397

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)