ABBOTT AXSYM FOLATE

K972232 · Abbott Laboratories · CGN · Jun 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972232
• Device Name: ABBOTT AXSYM FOLATE
• Applicant: Abbott Laboratories
• Product Code: CGN · Clinical Chemistry
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Intended Use

Abbott AxSYM® Folate is an Ion Capture Assay intended to measure the vitamin folic acid in serum, plasma, and red blood cells. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

Device Story

AxSYM Folate is an ion capture assay for quantitative measurement of folate in human serum, plasma, or red blood cells. Device utilizes Abbott AxSYM System instrumentation; requires Abbott Folate calibrators and controls for accuracy/precision verification. Used in clinical laboratory settings by trained personnel. Output is a quantitative folate concentration (ng/mL). Results assist clinicians in diagnosing and monitoring megaloblastic anemia.

Clinical Evidence

Bench testing only. Correlation study comparing AxSYM Folate to IMx Folate assay. Serum samples (n=261): correlation coefficient 0.979, slope 0.991, y-intercept 0.5 ng/mL. Red blood cell samples (n=145): correlation coefficient 0.906, slope 0.885, y-intercept 39.7 ng/mL.

Technological Characteristics

Ion capture assay technology. Designed for use on the Abbott AxSYM System. Measures folate in serum, plasma, or red blood cells. Dynamic range 0.9 to 20 ng/mL.

Indications for Use

Indicated for the quantitative determination of folate in human serum, plasma, or 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

• IMx® Folate assay

Submission Summary (Full Text)

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JUN 2 4 1997

## 510(k) Summary Abbott AxSYM® Folate

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

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

AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma, or red blood cells. AxSYM Folate is calibrated with Abbott Folate calibrators. Abbott Folate controls are assayed for the verification of the accuracy and precision of the AxSYM System.

Substantial equivalence has been demonstrated between the AxSYM Folate assay and the IMx® Folate assay. The intended use of both assays is for the quantitative determination of folate in human serum, plasma, or red blood cells. The dynamic ranges of the IMx Folate and AxSYM Folate assays are 0.82 to 20 ng/mL and 0.9 to 20 ng/mL respectively. A correlation analysis between these two assays is as follows:

| Sample Type | n | Correlation<br>Coefficient | Slope | Standard Error<br>of Y Estimate | Y-Intercept<br>(ng/mL) |
|-----------------|-----|----------------------------|-------|---------------------------------|------------------------|
| Serum | 261 | 0.979 | 0.991 | 0.864 | 0.5 |
| Red Blood Cells | 145 | 0.906 | 0.885 | 43.290 | 39.7 |

In conclusion, these data demonstrate that the AxSYM Folate assay is as safe and effective as, and is substantially equivalent to the IMx Folate assay.

Prepared and Submitted June 13, 1997 by:

Abbott Laboratories Laura L. Granitz [phone] Senior Regulatory Specialist ADD Regulatory Affairs 200 Abbott Park Road Abbott Park, IL 60064

AxSYM Folate 510(k) June 1997 Fol-sii.lwp

Section II Page l

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JUN 2 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Laura L. Granitz Regulatory Specialist Abbott Laboratories, Inc. 200 Abbott Park Road, Dept. 09V6, Bldg. AP31 Abbott Park, Illinois 60064-3537

Re : K972232 Abbott AxSYM® Folate Regulatory Class: II Product Code: CGN Dated: June 13, 1997 Received: June 16, 1997

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 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. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: I General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) ville 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/dsmamain.html".

Sincerely yours,
Steven Litman

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):

KG72332

Abbott AxSYM® Folate Device Name: _________________________________________________________________________________________________________________________________________________________________

· Indications For Use:

f

Abbott AxSYM® Folate is an Ion Capture Assay intended to measure the vitamin folic acid in serum, plasma, and red blood cells. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

The H. Liggadon
(Division Sign-Off)

**Prescription Use**
(Per 21 CFR 801.109) ✓

vision of Olinical Laboratory ver-The-Counter Use

(Optional Format 1-2-96)