(67 days)
Not Found
No
The description focuses on automated immunoassay procedures and chemiluminescent detection, with no mention of AI or ML technologies.
No
The device is an automated immunoassay system intended to measure analytes in patient samples for diagnostic purposes, not for treating any condition or disease.
Yes
The device is an automated immunoassay system that measures analytes in patient samples. This process provides information about a patient's health status, which is used for medical diagnosis.
No
The device description clearly states it is an "Automated Immunoassay Analyzer" and describes physical processes like pipetting, heating, and measuring color intensity, indicating it is a hardware device with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "automated immunoassay system intended to assay the same broad range of analytes in patient samples". This means it is used to test samples taken from patients (in vitro) to diagnose or monitor medical conditions.
- Device Description: The description details how the device performs analytical procedures on samples, such as pipetting, heating, and measuring color intensity, to quantify analytes. This is a core function of an IVD.
- Care Setting and User: The device is intended for use by "medical laboratory personnel in hospital and commercial laboratory settings," which are typical environments for IVD testing.
- Predicate Device: The predicate device, IMMULITE 2000 (K970227), is also an automated immunoassay analyzer, further confirming the IVD nature of this type of device.
The description explicitly states that it assays analytes in patient samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DHA, JLW, JJE
Device Description
IMMULITE 2500 Automated Immunoassay Analyzer
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
medical laboratory personnel, hospital and commercial laboratory settings
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
IMMULITE 2000 (K970227)
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
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
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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 | ||
| Los Angeles, California 90045-5597 | |||
| Telephone Number: | (310) 645-8200 | ||
| Facsimile Number: | (310) 645-9999 | ||
| Contact Person: | Edward M. Levine, Ph.D. | ||
| Director, Clinical Affairs | |||
| Date of Preparation: | October 2, 2003 | ||
| Device Name: | |||
| Trade: | IMMULITE® 2500 | ||
| Catalog Number: | IM5LITE | ||
| CFR: | 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 microanalysis 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. | |||
| Common: | Discrete photometric chemistry analyzer for clinical | ||
| use. | |||
| Classification: | Class I device, JJE (21 CFR 862.2160) | ||
| Panel: | Clinical Chemistry |
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| Manufacturer: | Corporate Headquarters:
Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | Instrument Manufacturer:
DPC Instrument Systems Division
62 Flanders Bartley Road
Flanders, NJ 07836
(Formerly DPC Cirrus Inc.) |
| Establishment Registration Number: | DPC Headquarters Registration Number: 2017183
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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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). 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)