IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

K033234 · Diagnostic Products Corp. · DHA · Dec 12, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033234
• Device Name: IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
• Applicant: Diagnostic Products Corp.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The DPC IMMULITE 2500 analyzer is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does the IMMULITE 2000. The intent of the systems is to impart the same automation to the same array of immunoassays in the same hospital and commercial laboratory settings as the IMMULITE 2000. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the predicate system, IMMULITE 2000.

Device Story

Automated immunoassay analyzer; processes patient serum/urine samples using chemiluminescent technology. System utilizes conveyor to move antibody-coated polystyrene beads through processing steps: sample/reagent addition, incubation, substrate addition, photon counting. Employs competition or immunometric (sandwich) assays with alkaline phosphatase-labeled reagents. Cleavage of phosphate ester dioxetane produces light; photomultiplier tube quantifies photon emission proportional to analyte concentration. Operated by medical laboratory personnel in clinical/hospital settings. Provides quantitative results for HCG and TSH to assist in clinical decision-making. Calibration uses manufacturer-provided master curves adjusted via 2-point customer instrument correlation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and performance data for specific assays (hCG and TSH) demonstrating equivalent performance to the predicate IMMULITE 2000 system.

Technological Characteristics

Automated random-access chemiluminescent immunoassay analyzer. Materials: 1/4 inch polystyrene antibody-coated beads. Detection: Photomultiplier tube (350–500 nm spectral response). Energy: Electrical (37°C incubation). Connectivity: PC-based interface, barcode reader, dual port RAM. Software: Automated control of pipetting, incubation, and photon counting. Calibration: Stored master curve with 2-point adjustment.

Indications for Use

Indicated for use by medical laboratory personnel in hospital and commercial laboratory settings to perform automated immunoassays on patient samples for a broad range of analytes, including hCG and TSH.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• IMMULITE 2000 (k970227)

Submission Summary (Full Text)

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K033234

# IMMULITE® 2500 Automated Immunoassay Analyzer 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

| Name: | Diagnostic Products Corporation | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Address: | 5700 West 96th Street<br>Los Angeles, California 90045-5597 | | |
| Telephone Number: | [phone] | | |
| Facsimile Number: | [phone] | | |
| Contact Person: | Edward M. Levine, Ph.D.<br>Director, Clinical Affairs | | |
| Date of Preparation: | October 2, 2003 | | |
| Device Name:<br>Trade: | IMMULITE® 2500 | | |
| Catalog Number: | IM5LITE | | |
| CFR: | A discrete photometric chemistry analyzer for<br>clinical use is a device intended to duplicate manual<br>analytical procedures by performing automatically<br>various steps such as pipetting, preparing filtrates,<br>heating, and measuring color intensity. This device<br>is intended for use in conjunction with certain<br>materials to measure a variety of analytes. Different<br>models of the device incorporate various<br>instrumentation such as microanalysis apparatus,<br>double beam, single, or dual channel photometers,<br>and bichromatic 2-wavelength photometers. Some<br>models of the device may include reagent-<br>containing components that may also serve as<br>reaction units. | | |
| Common: | Discrete photometric chemistry analyzer for clinical<br>use. | | |
| Classification: | Class I device, JJE (21 CFR 862.2160) | | |
| Panel: | Clinical Chemistry | | |

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| Manufacturer: | Corporate Headquarters:<br>Diagnostic Products Corporation<br>5700 West 96th Street<br>Los Angeles, CA 90045 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | Instrument Manufacturer:<br>DPC Instrument Systems Division<br>62 Flanders Bartley Road<br>Flanders, NJ 07836<br>(Formerly DPC Cirrus Inc.) |
| Establishment Registration Number: | DPC Headquarters Registration Number: 2017183<br>DPC Instrument Systems Division Registration Number: 2247117 |
| Substantially Equivalent Predicate Device: | IMMULITE 2000 (K970227) |
| Description of Device: | IMMULITE 2500 Automated Immunoassay Analyzer |

### Intended Use of the Device:

These modifications do not change the indications for use, nor the intended use from the IMMULITE 2000 to the IMMULITE 2500. The IMMULITE 2500 analyzer is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE 2000. The intent of the system is to impart the same automation to the same array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE 2000. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the predicate system, IMMULITE 2000.

### Technology:

The IMMULITE 2500 uses ¼ inch polystyrene antibody coated beads and assay specific antibody or antigen labeled with alkaline phosphatase. The chemiluminescent detection system is a phosphate ester stabilized dioxetane. Cleavage of the phosphate ester by alkaline phosphatase results in the decomposition of the dioxetane and the emission of photons, which are quantified by a luminometer and are proportional to the quantity of analyte present.

### Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for the IMMULITE 2500 Automated Immunoassay Analyzer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 2 2003

Edward Levine, Ph.D. Director, Clinical Affairs Diagnostics Products Corporation 5700 West 96th Street Los Angeles, CA 90045

Re: k033234 Trade/Device Name: IMMULITE® 2500 Automated Immunoassay Analyzer Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA; JLW; JJE Dated: October 3, 2003 Received: October 6, 2003

Dear Dr. Levine:

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 your 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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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). You may obtain other general information on your responsibilities under the Act 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.

Sincercly yours,

Steven Putman

Steven 1. 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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#### 510(k) Number (if known): _ KO 33 2 3 4 IMMULITE® 2500 Automated Immunoassay Analyzer Device Name:

Indications For Use:

The DPC IMMULITE 2500 analyzer is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE 2000. The intent of the system is to impart the same automation to the same array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE 2000. Examples of the array of assays to be used with the DPC IMMULITE 2500 are two for which data in support of a claim of substantial equivalence have been submitted to FDA: hCG (product code: DHA) and TSH (JLW). The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the predicate system, IMMULITE 2000.

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Concurrence of CDRH, Office of Device Evaluation i

Carol C Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033234
OR10(k).
Over-The-Counter Use

Prescription Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)