(22 days)
Not Found
No
The description focuses on standard immunoassay technology and makes no mention of AI or ML.
No
The device is described as being for "in vitro diagnostic use" to measure substances in patient samples as an "aid in patient management" or "aid in the diagnosis," indicating its purpose is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "for in vitro diagnostic use."
No
The device description clearly states that the devices are solid-phase, two-site chemiluminescent enzyme immunoassays for use with an automated analyzer, indicating they are hardware-based in vitro diagnostic devices, not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: All three listed components (IMMULITE 2500 CK-MB, IMMULITE 2500 Myoglobin, and IMMULITE 2500 STAT Troponin I) explicitly state they are "for in vitro diagnostic use".
- Device Description: The descriptions detail the technology used (chemiluminescent enzyme immunoassay) and that they are for use with an automated analyzer, which is typical for in vitro diagnostic tests.
- Predicate Devices: The listed predicate devices (K022118, K991796, K991795) are also IVD devices, indicating that the current device is in the same category.
The core function of these devices is to analyze biological samples (plasma or serum) outside of the body ("in vitro") to provide information for the diagnosis and management of medical conditions (myocardial infarction). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Product codes (comma separated list FDA assigned to the subject device)
JHX; MMI; DDR
Device Description
2500 CK-MB is a solid-phase, two-site IMMULITE chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
IMMULITE 2500 Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated 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
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
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.
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
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
JAN 2 1 2004
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:
Address: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Facsimile Number: | (310) 645-8200
(310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D.
Director, Clinical Affairs |
| Date of Preparation: | December 24, 2003 |
| Device Name:
Trade: | IMMULITE® 2500 CK-MB |
| Catalog Number: | L5KCP2 (200 tests), L5KCP6 (600 tests) |
| CFR: | A creatine phosphokinase/creatine kinase or isoenzymes test
system is a device intended to measure the activity of the enzyme
creatine phosphokinase or its isoenzymes (a group of enzymes
with similar biological activity) in plasma and serum.
Measurements of creatine phosphokinase and its isoenzymes are
used in the diagnosis and treatment of myocardial infarction and
muscle diseases such as progressive, Duchenne-type muscular
dystrophy. |
| Common: | Reagent system for the determination of creatine kinase
isoenzyme MB (CK-MB) in serum or heparinized plasma. |
| Classification: | Class II device, JHX (21CFR 862.1215) |
| Panel: | Clinical Chemistry |
| CLIA Complexity
Category: | We believe the category to be moderate, based on previous
classification of analogous tests. |
| Manufacturer: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| Establishment Registration
Number: | DPC's Registration Number is 2017183 |
1
Substantially Equivalent Predicate Device:
IMMULITE/IMMULITE 1000 Turbo CK-MB (K022118)
Description of Device:
2500 CK-MB is a solid-phase, two-site IMMULITE chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
Intended Use of the Device:
IMMULITE 2500 CK-MB is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer and is intended strictly for in vitro diagnostic use for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
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 IMMULITE 2500 CK-MB.
2
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: | |
| Facsimile Number: | (310) 645-8200 |
| (310) 645-9999 | |
| Contact Person: | Edward M. Levine, Ph.D. |
| Director, Clinical Affairs | |
| Date of Preparation: | December 24, 2003 |
| Device Name: | |
| Trade: | IMMULITE® 2500 Myoglobin |
| Catalog Number: | L5KMY2 (200 tests), L5KMY6 (600 tests) |
| CFR: | A myoglobin immunological test system is a device that consists |
| of the reagents used to measure by immunochemical techniques | |
| the myoglobin (an oxygen storage protein found in muscle) in | |
| serum and other body fluids. Measurement of myoglobin aids in | |
| the rapid diagnosis of heart or renal disease. | |
| Common: | Reagent system for the determination of myoglobin in serum and |
| plasma. | |
| Classification: | Class II device, DDR (21CFR 866.5680) |
| Panel: | Clinical Chemistry |
| CLIA Complexity | |
| Category: | We believe the category to be moderate, based on previous |
| classification of analogous tests. | |
| Manufacturer: | Diagnostic Products Corporation |
| 5700 West 96th Street | |
| Los Angeles, California 90045-5597 | |
| Establishment Registration | |
| Number: | DPC's Registration Number is 2017183 |
| Substantially | |
| Equivalent |
3
IMMULITE/IMMULITE 1000 Turbo Myoglobin (K991796) Predicate Device: IMMULITE 2500 Myoglobin is a solid-phase, two-site Description of Device: chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
Intended Use of the Device:
IMMULITE 2500 Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer and is intended strictly for in vitro diagnostic use for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
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 IMMULITE 2500 Myoglobin.
4
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: | December 24, 2003 |
| Device Name: | |
| Trade: | IMMULITE® 2500 STAT Troponin I |
| Catalog Number: | L5KSTI2 (200 tests), L5KSTI6 (600 tests) |
| CFR: | Device intended to measure the activity of the enzyme creatine |
| kinase isoenzymes (a group of enzymes with similar biological | |
| activity) in plasma and serum. Measurements of creatine | |
| phosphokinase isoenzymes are used in the diagnosis and | |
| treatment of myocardial infarction and muscle diseases such as | |
| progressive, Duchenne-type muscular dystrophy. | |
| Common: | Reagent system for the determination of troponin I in serum and |
| plasma. | |
| Classification: | Class II device, MMI (21CFR 866.1215) |
| Panel: | Clinical Chemistry |
| CLIA Complexity | |
| Category: | We believe the category to be moderate, based on previous |
| classification of analogous tests. | |
| Manufacturer: | Diagnostic Products Corporation |
| 5700 West 96th Street | |
| Los Angeles, California 90045-5597 | |
| Establishment Registration | |
| Number: | DPC's Registration Number is 2017183 |
| Substantially |
5
Equivalent Predicate Device:
IMMULITE/IMMULITE 1000 Turbo Troponin I (K991795)
Description of Device:
IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
Intended Use of the Device:
IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer and is intended strictly for in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
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 IMMULITE 2500 STAT Troponin I.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping wavy lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 1 2004
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597
Re: K034055 Trade/Device Name: Immulite® 2500 CK-MB Immulite® 2500 Myoglobin Immulite® 2500 STAT Troponin I Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHX; MMI; DDR Dated: December 24, 2003 Received: December 30, 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).
7
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.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Ko34055
510(k) Number (if known): . . . . IMMULITE® 2500 CK-MB Device Name: IMMULITE® 2500 Myoglobin IMMULITE® 2500 STAT Troponin I
Indications For Use:
The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benembi Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Prescription Use
(Per 21 CFR 801.109)510(k) K034655 Over-The-Counter Use
(Optional Format 1-2-96)