UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100

K023764 · Beckman Coulter, Inc. · JJE · Jan 28, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023764
• Device Name: UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
• Applicant: Beckman Coulter, Inc.
• Product Code: JJE · Clinical Chemistry
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended 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.

Device Story

Floor-model, microcomputer-controlled, random/continuous access analyzer; performs enzyme immunoassays (EIA) using paramagnetic particle solid phase and chemiluminescent detection. Input: human body fluid samples (serum, plasma, urine). Operation: automated reagent pipetting, fluid handling, incubation, and signal detection. Output: quantitative/qualitative analyte concentrations. Used in clinical laboratories by trained personnel. Modifications from predicate (Access 2) include increased throughput, on-board process monitoring, improved vessel handling, and refrigerated on-board sample aliquot storage. System utilizes external computer for UI and instrument direction. Healthcare providers use results for clinical decision-making regarding diagnosis and treatment of various diseases.

Clinical Evidence

Bench testing only. Method comparison, precision, and analytical sensitivity studies conducted using five representative assays. Studies demonstrated good correlation between the UniCel Dxl 800 and the Access 2 predicate system. All five assays met established acceptance criteria for precision and analytical sensitivity.

Technological Characteristics

Floor-model, microcomputer-controlled analyzer. Uses paramagnetic particle solid phase and chemiluminescent detection. Features include refrigerated on-board sample aliquot storage, automated vessel handling, and sensors/encoders for process monitoring. Connectivity via external computer for UI and instrument control. No changes to reagent chemistry, incubation, or signal detection compared to predicate.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to perform quantitative, semi-quantitative, or qualitative determination of various analytes in human body fluids (serum, plasma, urine) to aid in the diagnosis, treatment, and monitoring of various clinical conditions, including thyroid disease, cardiac muscle damage, and reproductive status.

Regulatory Classification

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.

Predicate Devices

• Access® 2 Immunoassay System (K922823)

Submission Summary (Full Text)

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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: [phone] |
| Chaska, MN 55318 | Fax: [phone] |

#### 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)<br>Device | Access® 2 Immunoassay System, Manufactured by<br>Beckman Coulter, Inc., (K922823 "Add to File" Letter,<br>dated May 18, 2001 and PMA Supplement<br>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,

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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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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 [phone]. 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 [phone] or [phone] 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:

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

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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.

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

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

| Prescription Use<br>(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:

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)

(Division Sign-Off)
Division of Clinical Laborat

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

| Prescription Use (Per 21 CFR 801.109) | <img alt="check mark" src="check_mark.png"/> | 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)

OR

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:

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.

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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:

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.

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#### 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)

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