ABBOTT AXSYM FOLATE by ABBOTT LABORATORIES

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 Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Abbott AxSYM® Folate device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are established by demonstrating substantial equivalence to the IMx® Folate assay, a legally marketed predicate device. The primary performance metric is the correlation between the new AxSYM Folate assay and the predicate IMx Folate assay.

Acceptance Criteria (Substantial Equivalence to IMx Folate)	Reported Device Performance (AxSYM Folate vs. IMx Folate)
Correlation Coefficient (r)
Serum: Close to 1.0	Serum: 0.979
Red Blood Cells: Close to 1.0	Red Blood Cells: 0.906
Slope
Serum: Close to 1.0	Serum: 0.991
Red Blood Cells: Close to 1.0	Red Blood Cells: 0.885
Y-Intercept (ng/mL)
Serum: Close to 0.0	Serum: 0.5
Red Blood Cells: Close to 0.0 (but value is higher)	Red Blood Cells: 39.7
Standard Error of Y Estimate
Serum: Low value, indicating good fit	Serum: 0.864
Red Blood Cells: Low value, indicating good fit	Red Blood Cells: 43.290
Intended Use	Quantitative determination of folate in human serum, plasma, or red blood cells.
Dynamic Range	Comparable to IMx Folate (0.82 to 20 ng/mL)

Note on "Acceptance Criteria" for Slope, Y-Intercept, and Standard Error: While not explicitly stated as numerical targets in the text, for substantial equivalence, the expectation is that these values demonstrate a strong agreement and linearity between the new device and the predicate. The "reported device performance" are the values obtained and presented as sufficient for substantial equivalence.

Study Details

Sample size used for the test set and the data provenance:
- Serum: 261 samples
- Red Blood Cells: 145 samples
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study evaluates the performance of a diagnostic assay against a predicate assay, not against a "ground truth" established by human experts in the traditional sense (like image interpretations). The predicate device (IMx Folate) itself serves as the reference standard for comparison.
Adjudication method for the test set:
- Not applicable. This is a comparison of quantitative measurements from two different lab assays, not a subjective interpretation requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a study comparing an automated diagnostic assay to a predicate assay, not involving human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Yes, this is a standalone study. The AxSYM Folate assay is an automated in vitro diagnostic (IVD) device, and its performance is evaluated directly against another automated IVD device (IMx Folate). There is no "human-in-the-loop" aspect to the measurement or its comparison.
The type of ground truth used:
- The "ground truth" in this context is the results obtained from the predicate device, the IMx® Folate assay. Substantial equivalence is demonstrated by the agreement of results between the new device and the predicate. The IMx Folate assay itself is presumed to be a validated and legally marketed method for folate determination.
The sample size for the training set:
- Not specified. This document only describes the performance study comparing the AxSYM Folate assay to the predicate IMx Folate assay. Information regarding the development and internal validation (which might involve training sets for the assay's calibration or internal algorithms) is not provided.
How the ground truth for the training set was established:
- Not specified, as information on a distinct "training set" and its ground truth establishment is not included in this summary. The "calibration" of AxSYM Folate is mentioned as being performed with "Abbott Folate calibrators," implying internal standards are used during the device's operational setup.

Summary

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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.

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	CorrelationCoefficient	Slope	Standard Errorof Y Estimate	Y-Intercept(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 (847) 938-0092 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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

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)

Regulation Number and Section

§ 862.1295 Folic acid test system.

(a)
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.(b)
Classification. Class II.