ABBOTT ARCHITECT FOLATE

K984301 · Abbott Laboratories · CGN · Feb 5, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984301
• Device Name: ABBOTT ARCHITECT FOLATE
• Applicant: Abbott Laboratories
• Product Code: CGN · Clinical Chemistry
• Decision Date: Feb 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Intended Use

The Abbott 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 on the Abbott ARCHITECT™ i System. Measurements obtained by this device aid in the diagnosis and treatment of megaloblastic anemia.

Device Story

The Abbott 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 (tripotassium EDTA, lithium heparin, or sodium heparin), and red blood cell (tripotassium EDTA) samples. The device quantifies folate levels to assist clinicians in diagnosing and treating megaloblastic anemia. It is intended for professional use in clinical laboratory settings. The system utilizes specific calibrators and controls to ensure analytical accuracy and precision. By providing quantitative folate measurements, the device supports clinical decision-making regarding patient nutritional status and hematological health.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing the ARCHITECT Folate assay to the BioRad Quantaphase II Folate Radioassay. Study included 333 serum samples and 160 whole blood samples. Correlation analysis using Least Squares and Passing-Bablok regression demonstrated substantial equivalence, with correlation coefficients (r) of 0.927 for serum and 0.929 for whole blood.

Technological Characteristics

Chemiluminescent microparticle folate binding protein assay. Analyte detection via chemiluminescence. Compatible with Abbott ARCHITECT™ i System. Sample types: serum, plasma (tripotassium EDTA, lithium heparin, sodium heparin), and red blood cells (tripotassium EDTA).

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

• BioRad Quantaphase II Folate Radioassay

Submission Summary (Full Text)

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FEB 5 1999

## 510(k) Summary Abbott ARCHITECT™ Folate 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, (tripotassium EDTA, lithium heparin, or sodium heparin) and red blood cells (tripotassium EDTA). The ARCHITECT Folate assay is calibrated with Abbott ARCHITECT Folate Calibrators. Abbott 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 BioRad Quantaphase II 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 BioRad Quantaphase II Folate Radioassay is for the quantitative determination of folate in human serum, plasma, and whole blood.

| Sample | Regression Method | n | r | Slope (95%CI) | Intercept(95% CI) |
|-------------|-------------------|-----|-------|-------------------|-----------------------|
| Serum | Least Squares | 333 | 0.927 | 0.97 (0.92, 1.01) | 0.44 (0.02, 0.87) |
| | Passing-Bablok | 333 | 0.927 | 1.08 (1.05, 1.12) | -0.18 (-0.47, 0.06) |
| Whole Blood | Least Squares | 160 | 0.929 | 1.00 (0.94, 1.06) | 36.04 (4.62, 67.46) |
| | Passing-Bablok | 160 | 0.929 | 1.14 (1.09, 1.20) | -18.83 (-40.97, 3.59) |

In conclusion, these data demonstrate that the ARCHITECT Folate assay is as safe and effective as, and is substantially equivalent to, the BioRad Quantaphase II Folate Radioassay.

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Prepared and Submitted December 1, 1998 by: Laura Granitz Senior Regulatory Specialist 1-847-938-0092

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Abbott Laboratories ADD Regulatory Affairs 200 Abbott Park Road Abbott Park, IL 60064-3537

CHITBCT Folats 510(k)

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FEB 5 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Laura L. Granitz Senior Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostic Division Dept. 9V6 Building AP31 200 Abbott Park Road Abbott Park, Illinois 60064

| Re: | K984301 | | |
|-------------------|--------------------------|---------------|-----|
| Trade Name: | Abbott ARCHITECT™ Folate | | |
| Regulatory Class: | II | Product Code: | CGN |
| | II | | JIS |
| | I | | JJX |
| Dated: | January 20, 1999 | | |
| Received: | January 21, 1999 | | |

Dear Ms. Granitz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 498430 l Device Name: Abbott ARCHITECT™ Folate

Indications For Use:

The Abbott 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 on the Abbott ARCHITECT™ i System. Measurements obtained by this device aid in the diagnosis and treatment of megaloblastic anemia.

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Concurrence of CDRH, Office of Device Evaluanon/(ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984301

Prescription Use
(Per 21 CFR 801.109)
(Qptional Format 1-2-96)
OR
Over-The-Counter Use***_***_