ABBOTT ARCHITECT B12 by ABBOTT LABORATORIES

The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Device Description

The ARCHITECT B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma (tripotassium EDTA). The ARCHITECT B12 assay is calibrated with Abbott ARCHITECT B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study used to demonstrate substantial equivalence for the Abbott ARCHITECT™ B12 assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Abbott ARCHITECT™ B12 assay are implicitly derived from demonstrating substantial equivalence to a legally marketed predicate device, the AxSYM® B12 Assay. Substantial equivalence is shown through a statistical comparison of results from both assays.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (ARCHITECT B12 vs. AxSYM B12)
Least Squares Linear Regression:
Correlation Coefficient (r) should be strong (e.g., typically > 0.9)	0.956
Slope should be close to 1 (indicating proportional agreement)	0.96 (95% CI of 0.93 to 0.98)
Intercept should be close to 0 (indicating minimal systematic bias)	-27 pg/mL (95% CI of -42 to -12)
Passing-Bablok Linear Regression:
Correlation Coefficient (r) should be strong (e.g., typically > 0.9)	0.956
Slope should be close to 1 (indicating proportional agreement)	0.91 (95% CI of 0.89 to 0.93)
Intercept should be close to 0 (indicating minimal systematic bias)	-7 pg/mL (95% CI of -18 to 2)
Quantitative determination of vitamin B12 in human serum and plasma over the specified range	Demonstrated over the range of 60 to 2000 pg/mL, yielding the statistical results above.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 544 serum specimens.
Data Provenance: Not explicitly stated (e.g., country of origin). The study used "serum specimens," which implies human samples. The study appears to be retrospective in nature, as it's a comparison of an existing assay (AxSYM B12) with a new assay (ARCHITECT B12) using a collected set of samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of in-vitro diagnostic (IVD) assay comparison study does not typically involve human experts establishing "ground truth" in the same way as, for example, an imaging study. The "ground truth" here is the measurement obtained from the predicate device (AxSYM B12 Assay), which is already an FDA-cleared and accepted method for quantitative determination of B12. Therefore, no human experts were used to establish ground truth for this test set; rather, the predicate device served as the reference.

4. Adjudication Method for the Test Set

Not applicable. As described above, the comparison is directly between two quantitative assays, with the predicate assay serving as the reference. There's no need for human adjudication of results in this context.

5. 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 an in-vitro diagnostic device (an assay for vitamin B12), not an imaging or interpretive AI device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study described is essentially a standalone performance evaluation of the ARCHITECT B12 assay. It directly compares the results generated by the new assay (which operates without human interpretation of the final B12 value) to an established predicate assay. The human component is limited to collecting the samples and running them on both automated systems.

7. The Type of Ground Truth Used

The ground truth used is the measurements obtained from a legally marketed predicate device, the AxSYM® B12 Assay. This is a form of reference standard comparison, where the established performance of an existing device serves as the benchmark.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. For this type of IVD, the development and initial validation of the assay (e.g., establishing reagents, calibration curves, and internal controls) would typically happen during product development before the 510(k) submission. The 544 specimens described are for the clinical validation/equivalence study (i.e., the test set) comparing the new device to the predicate.

9. How the Ground Truth for the Training Set Was Established

Since there is no explicit mention of a "training set" for an AI model in this document, the concept of establishing ground truth for a training set as typically understood in AI development does not directly apply. For the development of the ARCHITECT B12 assay itself, the internal "ground truth" would have been established through rigorous analytical performance studies (e.g., accuracy, precision, linearity, limit of detection, interference studies) using certified reference materials or established laboratory methods, but these details are not provided in this summary. The 510(k) summary focuses on demonstrating substantial equivalence to an existing device rather than the foundational development of the assay's methodology.

Summary

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3 33 FEB

510(k) Summary

Abbott ARCHITECT™ B12

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™ B12 constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the ARCHITECT B12 assay and the AxSYM® B12 Assay. The intended use of both assays is for the quantitative determination of vitamin B12 in human serum and plasma. A least squares linear regression analysis between these two assays, using 544 serum specimens, over the range of 60 to 2000 pg/mL, vielded a correlation coefficient of 0.956, a slope of 0.96 (95% Confidence Interval [CI] of 0.93 to 0.98), and an intercept of -27 pg/mL (95% CI of -42 to -12). Passing-Bablok linear regression analysis between these two assays gave a correlation coefficient of 0.956, a slope of 0.91 (95% CI of 0.89 to 0.93), and an intercept of -7 pg/mL (95% CI of -18 to 2).

In conclusion, these data demonstrate that the ARCHITECT B12 assay is as safe and effective as, and is substantially equivalent to, the AxSYM® B12 Assay.

Prepared and Submitted November 16, 1998 by: Laura Granitz Senior Regulatory Specialist 1-847-938-0092

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

ARCHITECT B12 510(k) November, 1998 B12 510k.doc

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Public Health Service

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3 1099 FEB

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: K984108

Trade Name: Abbott ARCHITECT™ B12 Regulatory Class: II Product Code: LIG Dated: November 16, 1998 Received: November 17, 1998

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 (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/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

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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984108 510(k) Number (if known):_ Device Name: Abbott ARCHITECT™ B12

Indications For Use:

Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984108

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use U

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Regulation Number and Section

§ 862.1810 Vitamin B

12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.