The UniCel Dxl 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

The UniCel Dxl 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel Dxl 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.

The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin 1 (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST seqment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.

The Access® Cortisol Assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.

The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum, using the Access Immunoassay Systems. Levels of estradiol are useful in monitoring ovulatory status. Because Estradiol levels reflect follicular maturation, the measurement of estradiol is a valuable tool in the assessment of sexual development, etiology of amenorrhea, causes of infertility and menopause. Abnormally high levels in males are indicative of feminizing syndromes such as gynecomastia.

The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in human serum or plasma (heparin). Levels of free thyroxine in plasma are thought to reflect the amount of thvroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The Access HYPERsensitive hTSH assay provides in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.

Device Description

The UniCel Dxl 800 Access Immunoassay System is a floor model, microcomputer controlled, random and continuous access analyzer that performs enzyme immunoassays (EIA) utilizing a paramagnetic particle solid phase and chemiluminescent detection.

The UniCel Dxl 800 system represents an evolutionary change to the Access 2 Immunoassay System design. The modifications to the basic Access 2 platform support at least three major improvements desirable to the customer with medium-high testing volume. These are: 1) increased throughput, 2) on-board process monitoring and 3) release of the primary sample tubes back to the laboratory workflow as early as possible. The main modifications to the design include an obstruction feature, larger volume bulk supplies to accommodate higher throughput, the method of vessel handling, incorporation of sensors and encoders at key points for process monitoring and the addition of a sample pipettor and refrigerated on-board sample aliquot storage. Reagent pipetting, fluid handling, reagent chemistry, assay incubation temperature and timing, signal detection and assay data processing are all unchanged from the Access 2 design. The Dxl uses the same Access Immunoassay System assays and calibrators, packaged the same as for Access 2. The formulations of the substrate and wash buffer used with the Access assays are unchanged. There are no changes to the intended uses, technical specifications or final performance specifications and claims for the assays.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the UniCel DxI 800 Access Immunoassay System. The device is an in vitro diagnostic system. The focus of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Access® 2 Immunoassay System).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the UniCel DxI 800 Access Immunoassay System uses the same assays and calibrators as the predicate device (Access 2). It also explicitly mentions: "There are no changes to the intended uses, technical specifications or final performance specifications and claims for the assays." This implies that the acceptance criteria for the UniCel DxI 800 are the same as those established for the Access 2 system.

The study aimed to demonstrate "good correlation" between the Access 2 and DxI systems. For precision and analytical sensitivity, the document states: "Each of the five assays met its established acceptance criteria for precision and analytical sensitivity."

Acceptance Criteria Category	Specific Acceptance Criteria (Implied from predicate device)	Reported Device Performance (UniCel DxI 800)
Method Comparison	Good correlation with predicate device (Access 2) for various analytes	Demonstrated "good correlation" for five representative assays
Precision	Established criteria for precision (same as Access 2 system)	Met its established acceptance criteria for precision for five representative assays
Analytical Sensitivity	Established criteria for analytical sensitivity (same as Access 2 system)	Met its established acceptance criteria for analytical sensitivity for five representative assays
Intended Use	Same as Access 2 Immunoassay System	Same as Access 2 Immunoassay System
Technical Specifications	Same as Access 2 Immunoassay System	Unchanged from Access 2 design (e.g., reagent pipetting, fluid handling, reagent chemistry, assay incubation temperature and timing, signal detection and assay data processing)
Final Performance Specifications and Claims for the Assays	Same as Access 2 Immunoassay System	Unchanged from Access 2 design

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

The document does not explicitly state the sample size used for the test set or the data provenance. It only mentions that "method comparison, precision and analytical sensitivity studies were conducted using five representative assays." Without more detail, we cannot determine the number of samples per assay or their origin, nor if the data was retrospective or prospective.

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

This information is not provided in the given text. The studies mentioned are analytical performance studies (method comparison, precision, analytical sensitivity), which typically involve laboratory measurements and comparisons rather than expert interpretation of results to establish ground truth in the way it might for an imaging AI device. The ground truth for these types of studies would be the measurement obtained by the predicate device (for method comparison) and statistical analysis for precision and analytical sensitivity.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are common in studies involving human interpretation (e.g., clinical trials for diagnostic devices where human reader discrepancies need resolution). Since the studies described are analytical performance studies comparing the new device to a predicate device and evaluating precision/sensitivity, traditional expert adjudication methods are not typically applicable in the same way. The "ground truth" for method comparison would be the result from the predicate device, and for precision/sensitivity, it would be the calculated statistical metrics against pre-defined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC study was not performed, nor would it be relevant for this type of device. The UniCel DxI 800 Access Immunoassay System is an automated in vitro diagnostic analyzer. It does not involve human readers interpreting images or data where AI assistance would affect their performance. The device performs assays independently.

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

Yes, the studies described are, by nature, "standalone" in terms of the device's performance. The device itself (UniCel DxI 800) was tested to directly compare its analytical performance (method correlation, precision, analytical sensitivity) against the predicate device (Access 2) and established criteria. There is no human-in-the-loop component discussed for the performance evaluation of the device itself.

7. The Type of Ground Truth Used:

The ground truth for the studies described would be:

For Method Comparison: The measurements obtained from the legally marketed predicate device (Access 2 system) for the same samples.
For Precision and Analytical Sensitivity: Statistically derived reference values or expected performance ranges, based on established analytical standards and the characteristics of the assays themselves. This is not "expert consensus, pathology, or outcomes data" in the traditional sense, but rather analytical reference points.

8. The Sample Size for the Training Set:

This information is not applicable as described in the provided text. The UniCel DxI 800 is an immunoassay system, not an AI/ML-driven device that undergoes a "training" phase with a dataset in the way a machine learning algorithm would. Its performance is based on its hardware design, reagents, and established assay protocols.

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

This information is not applicable for the same reasons as #8. There is no "training set" or "ground truth for a training set" in the context of this device's development and validation, as described in the submission. The device implements specific chemical and mechanical processes for analysis.

Summary

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JAN 2 8 2003

Confidential

9 510(K) SUMMARY

(Page 1 of 2)

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number _

Date Prepared: November 8, 2002

Submitter	Contact Person
Beckman Coulter, Inc	Lynn S. Weist
Diagnostics Division	Staff Regulatory Affairs Specialist
1000 Lake Hazeltine Drive	Phone: 952-368-1271
Chaska, MN 55318	Fax: 952-368-7610

General Information

Trade Name	UniCel™ DxI 800 Access® Immunoassay System
Common Name	Discrete photometric chemistry analyzer for clinical use
Classification Name	Discrete photometric chemistry analyzer for clinical use
Legally Marketed (Predicate)Device	Access® 2 Immunoassay System, Manufactured byBeckman Coulter, Inc., (K922823 "Add to File" Letter,dated May 18, 2001 and PMA SupplementP980041/S001, cleared October 1, 2002)

Device Description

Intended Use

Substantial Equivalence Comparison

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(Page 2 of 2)

on-board process monitoring and 3) release of the primary sample tubes back to the laboratory workflow as early as possible.

The main modifications to the design include an obstruction feature, larger volume bulk supplies to accommodate higher throughput, the method of vessel handling, incorporation of sensors and encoders at key points for process monitoring and the addition of a sample pipettor and refrigerated on-board sample aliquot storage.

Reagent pipetting, fluid handling, reagent chemistry, assay incubation temperature and timing, signal detection and assay data processing are all unchanged from the Access 2 design. The Dxl uses the same Access Immunoassay System assays and calibrators, packaged the same as for Access 2. The formulations of the substrate and wash buffer used with the Access assays are unchanged. There are no changes to the intended uses, technical specifications or final performance specifications and claims for the assays.

Supporting Data

In order to demonstrate that the Dxl system is substantially equivalent to the Access 2, method comparison, precision and analytical sensitivity studies were conducted using five representative assays. Method correlation studies demonstrated good correlation between the Access 2 and Dxl systems on each of the five assays. Each of the five assays met its established acceptance criteria for precision and analytical sensitivity.

Conclusion

The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the UniCel Dxl 800 Access Immunoassay System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lynn S. Weist Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

JAN 28 2003

Re: K023764 Trade/Device Name: UniCel™ Dxl 800 Access® Immunoassay System Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JJE, CEC, CGR, CHP, JLW Dated: November 8, 2002 Received: November 12, 2002

Dear Ms. Weist:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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ATTACHMENT B: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K003 76

PAGE 1 OF 1

Device Name: UniCel™ Dxl 800 Access® Immunoassay System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Veronican R. Celuin por Dr. Jean Cooper (

(Optional Format 3-10-98)

Division of Clinical Laboratory De 510(k) Number

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510(k) Number (if known):

Device Name: AccuTnl™ and AccuTnl Calibrators on the Access® Immunoassay Systems

Indications For Use:

Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST seqment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	1023764
---------------	---------

Prescription Use(Per 21 CFR 801.109)	OR	Over-The Counter Use
------------------------------------------	----	----------------------

(Optional Format 1-2-96)

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Access® Cortisol on the Access® Immunoassay Systems

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature
(Division Sign-Off)
Division of Clinical Laborat

510(k) Number	K023764
---------------	---------

Prescription Use (Per 21 CFR 801.109)		OR	Over-The Counter Use ______
---------------------------------------	----------------------------------------------	----	-----------------------------

(Optional Format 1-2-96)

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Page 1 of 1

510(k) Number (if known):

Device Name: Access® Estradiol on the Access® Immunoassay Systems

Indications For Use:

The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum, using the Access Immunoassay Systems.

Levels of estradiol are useful in monitoring ovulatory status. Because Estradiol levels reflect follicular maturation, the measurement of estradiol is a valuable tool in the assessment of sexual development, etiology of amenorrhea, causes of infertility and menopause. Abnormally high levels in males are indicative of feminizing syndromes such as gynecomastia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Melvin for Jean Cooper
(Division Sign-Off)

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use

Division of Clinical Laboratory Devices

510(k) Number

(Optional Format 1-2-96)

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510(k) Number (if known):

Device Name: Access® Free T4 on the Access® Immunoassay Systems

Indications For Use:

A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in human serum or plasma (heparin). Levels of free thyroxine in plasma are thought to reflect the amount of thvroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Clinical Laboratory Deview 510(k) Number OR Over-The Counter Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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Page 1 of 1

510(k) Number (if known):

Device Name: Access® HYPERsensitive hTSH on the Access® Immunoassay Systems

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vp Calun for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devi

Clinical Laboratory Devices
510(k) Number K023764

Prescription Use (Per 21 CFR 801.109) Over-The Counter Use

(Optional Format 1-2-96)

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.