K Number
K023764
Device Name
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
Date Cleared
2003-01-28

(77 days)

Product Code
Regulation Number
862.2160
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The document describes a microcomputer-controlled immunoassay system with standard laboratory automation features and data processing, but there is no mention of AI or ML technologies.

No.
The device is described as an "in vitro diagnostic device" used for the determination of various analyte concentrations in human body fluids, primarily to aid in diagnosis and treatment, not to directly treat or cure a disease.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "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." It also explicitly mentions aiding in the "diagnosis and treatment of myocardial infarction and cardiac muscle damage."

No

The device is described as a floor model, microcomputer controlled, random and continuous access analyzer that performs enzyme immunoassays. It includes hardware components like a sample pipettor, refrigerated on-board sample aliquot storage, and utilizes paramagnetic particle solid phase and chemiluminescent detection. While it has software for the user interface and instrument control, it is fundamentally a hardware system with integrated software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The UniCel Dxl 800 Access Immunoassay System is an in vitro diagnostic device..." and "...The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory."
  • Function: The device is used for the "quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids." This is a core function of IVD devices, which analyze samples taken from the human body to provide information about a person's health.
  • Specific Assays: The document describes several specific assays performed by the system (Access AccuTnl, Access® Cortisol Assay, Access Estradiol assay, Access Free T4 assay, Access HYPERsensitive hTSH assay). The intended uses of these assays are all related to diagnosing or monitoring medical conditions based on the analysis of human body fluids.
  • Clinical Laboratory Use: The intended user/care setting is the "clinical laboratory," which is where IVD devices are typically used.

Therefore, based on the provided text, the UniCel Dxl 800 Access Immunoassay System is clearly an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MMI, JJE, CEC, CGR, CHP, JLW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K922823

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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

SubmitterContact Person
Beckman Coulter, IncLynn S. Weist
Diagnostics DivisionStaff Regulatory Affairs Specialist
1000 Lake Hazeltine DrivePhone: 952-368-1271
Chaska, MN 55318Fax: 952-368-7610

General Information

Trade NameUniCel™ DxI 800 Access® Immunoassay System
Common NameDiscrete photometric chemistry analyzer for clinical use
Classification NameDiscrete photometric chemistry analyzer for clinical use
Legally Marketed (Predicate)
DeviceAccess® 2 Immunoassay System, Manufactured by
Beckman Coulter, Inc., (K922823 "Add to File" Letter,
dated May 18, 2001 and PMA Supplement
P980041/S001, cleared October 1, 2002)

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.

Intended Use

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.

Substantial Equivalence Comparison

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,

1

(Page 2 of 2)

  1. 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.

2

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).

3

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

4

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:

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.

(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

5

510(k) Number (if known):

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

Indications For Use:

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.

(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) Number1023764
------------------------

| Prescription Use

(Per 21 CFR 801.109)OROver-The Counter Use
--------------------------------------------------------------------

(Optional Format 1-2-96)

6

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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

Indications For Use:

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.

(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) NumberK023764
------------------------
Prescription Use (Per 21 CFR 801.109)OROver-The Counter Use ______
----------------------------------------------------------------------------------------------------------------------

(Optional Format 1-2-96)

7

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)

OR

Over-The Counter Use

Division of Clinical Laboratory Devices

510(k) Number

(Optional Format 1-2-96)

8

510(k) Number (if known):

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

Indications For Use:

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.

(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)

9

Page 1 of 1

510(k) Number (if known):

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

Indications For Use:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

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)

26