A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Device Description

The Abbott AxSYM System is a fully automated immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA), and Ion Capture (IC) Immunoassay Technologies. The unique features of the AxSYM System allow it to perform random access, continuous access, and STAT processing of both large and small molecular weight analytes.

AI/ML Overview

The provided text is a 510(k) summary for the Abbott AxSYM® System, seeking substantial equivalence to the Abbott AxSYM II System. The study described focuses on demonstrating this equivalence rather than establishing acceptance criteria for a new device's performance against a predefined clinical metric. Therefore, some of the requested information, such as "acceptance criteria and reported device performance" as typically reported for a clinical performance study, "number of experts," "adjudication method," "MRMC study," "training set size and ground truth establishment," and direct "sample size for the test set," are not explicitly detailed in the provided document in the way they would be for a clinical validation of a diagnostic device.

However, based on the information available, here's a breakdown of what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are based on a comparison to a predicate device (Abbott AxSYM II System). The performance metric used for comparison is the correlation coefficient between the two systems.

Acceptance Criteria (for Substantial Equivalence to AxSYM II)	Reported Device Performance (AxSYM System vs. AxSYM II)
Correlation coefficients for MEIA, FPIA, IC, and REA technologies using patient samples should demonstrate strong agreement, indicative of substantial equivalence.	Correlation coefficients ranged from 0.98 to 0.99 for MEIA, FPIA, Ion Capture, and REA technologies.

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

Sample Size: The document states "patient samples" were used, but the specific number of samples is not provided.
Data Provenance: The country of origin is not specified. The study is inherently retrospective in the sense that it compares a new system to an existing one using collected data, but the collection of the "patient samples" themselves could have been prospective relative to the study. The document doesn't specify if these were newly collected or existing archived samples.

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

This section is not applicable in the traditional sense for this type of substantial equivalence study. The "ground truth" here is the performance of the predicate device (Abbott AxSYM II System). The study aims to show that the new device's results correlate highly with the predicate device's results. There's no mention of human experts establishing a separate ground truth.

4. Adjudication Method for the Test Set

This is not applicable as there was no expert review or adjudication of results for this type of comparison study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The Abbott AxSYM System is an automated immunoassay analyzer, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study and effects on human reader performance are irrelevant to this device.

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

Yes, this was effectively a standalone performance evaluation. The study compared the results generated by the Abbott AxSYM System (the "algorithm/device") directly with the results generated by the Abbott AxSYM II System (the "predicate device"). There is no human intervention in the analytical output that is being compared.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance against the predicate device (Abbott AxSYM II System). The study's objective was to demonstrate that the new AxSYM System's measurements of various analytes using MEIA, FPIA, Ion Capture, and REA technologies correlated extremely well (0.98-0.99) with those obtained from the established AxSYM II System. This is a comparison for substantial equivalence, not a validation against a definitive clinical outcome or pathology.

8. The Sample Size for the Training Set

This information is not provided and is likely not relevant in the context of this 510(k) submission. The AxSYM System is an analytical instrument, not an algorithm that undergoes a "training" phase with a dataset in the machine learning sense. The "training" would be more akin to instrument calibration and assay development, which are internal processes not detailed here.

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

This is not applicable for the reasons stated in point 8.

Summary

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15. 510(k) Summary - Abbott AxSYM® System

FEB | 2 1998

Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information presented in the 510(k) Notification for the Abbott AxSYM System supports a determination of substantial equivalence:

The Abbott AxSYM System is substantially equivalent to the Abbott AxSYM II System in that:

a. Both systems may be used to perform assays for large and small molecular weight analytes.
b. Both systems may be used to perform assays for therapeutic drugs.
Both systems use Microparticle Enzyme Immunoas-ﻦ say (MEIA), Fluorescence Polarization Immunoassay (FPIA), and Ion Capture (IC) Immunoassay Technologies for the quantitation of antigen-antibody and protein binding reactions. Both systems use Radiative Energy Attenuation (REA) Assay Technology to quantitatively measure specific analyte concentrations.
d. Both systems determine unknown concentrations of analytes from a standard curve generated with known analyte concentrations or qualitatively determine analyte concentrations by comparison to an established cutoff value.
e. Both systems utilize a microprocessor for system control, data acquisition and data reduction.

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Both systems automatically process samples in a ranf. dom access mode (tests are processed in a random manner, dependent on the sample presented, and independent of the assay requested) as well as in a continuous access mode (samples may be presented for processing at any time the system is in operation). Both systems also have STAT capability.
When AxSYM MEIA, FPIA, Ion Capture and REA technologies were compared to AxSYM II using patient samples, correlation coefficients ranged from 0.98 to 0.99.

These data support the determination of substantial equivalence of the Abbott AxSYM System to the Abbott AxSYM II System.

Prepared and Submitted January 12, 1998 by:

Abbott Laboratories Patty O'Brien (847) 938-6563 Senior Regulatory Specialist ADD Regulatory Affairs 200 Abbott Park Road Abbott Park, Illinois 60064-3537

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 2 1998

Patty O'Brien . Sr. Regulatory Specialist Abbott Laboratories 200 Abbott Park Road; D-9V6 AP31 Abbott Park, Illinois 60064-3537

Re : K974651 Abbott AxSYM System Requlatory Class: I Product Code: JJE Dated: December 5, 1997 December 8, 1997 Received:

Dear Ms. O'Brien:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 Gutman

· 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: K974651

Device Name: Abbott AxSYM® System

Indications For Use:

21 CFR § 862.2160 Discrete photometric chemistry analyzer for clinical use

(a) Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

(b) Classification. Class I.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974651

(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)
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Regulation Number and Section

§ 862.2160 Discrete photometric chemistry analyzer for clinical use.

(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.