(14 days)
Not Found
Not Found
No
The summary describes a standard immunoassay for measuring a specific biomarker and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative measurement of CK-MB antigen, which is explicitly stated as "intended strictly for in vitro use as an aid in patient management and the assessment of prognosis of myocardial infarction." It does not provide therapy.
Yes
The device is described as an "aid in patient management and the assessment of prognosis of myocardial infarction," which indicates its use in diagnosing a medical condition.
No
The device description explicitly states it is a "clinical device for use with the IMMULITE® Automated Immunoassay Analyzer," indicating it is a component or assay used with a hardware analyzer, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is "intended strictly for in vitro use".
- Measurement: It measures a substance (creatine kinase isoenzyme MB antigen) in a biological sample (serum or heparinized plasma).
- Purpose: The measurement is used "as an aid in patient management and the assessment of prognosis of myocardial infarction," which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
IMMULITE® Turbo CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in patient management and the assessment of prognosis of myocardial infarction.
Product codes
JHX
Device Description
IMMULITE® Turbo CK-MB is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 9 1999
510(k) Summary 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 of Clinical Affairs | |
| Date of Preparation: | May 25, 1999 |
| Device Name: | |
| Trade: | IMMULITE® Turbo CK-MB |
| Catalog Number: | LSKCP1 (100 tests), LSKCP5 (500 tests) |
| Common: | Reagent system for the determination of creatine kinase |
| isoenzyme MB (CK-MB) in serum or heparinized plasma. | |
| Classification: | Class II device, 75-JHX (21 CFR 862.1215) |
| Manufacturer: | Diagnostic Products Corporation |
| 5700 West 96th Street | |
| Los Angeles, California 90045-5597 | |
| Sole U.S. Importer: | Diagnostic Products Corporation |
| 5700 West 96th Street | |
| Los Angeles, California 90045-5597 | |
| Establishment Registration | |
| Number | DPC's Registration Number is 2017183 |
| Description of Device: | IMMULITE® Turbo CK-MB is a clinical device for use |
| with the IMMULITE® Automated Immunoassay Analyzer. |
1
Intended Use of the Device:
IMMULITE® Turbo CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in serum or heparinized plasma. It is intended strictly for in vitro use 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® Turbo CK-MB.
Edward L. Schein
Edward M. Levine, Ph.D. Director of Clinical Affairs
1/25/55
Date
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized birds in flight. The birds are arranged in a row, with the first bird being the largest and the third bird being the smallest.
9 1999 JUN
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Re: K991797 Trade Name: Immulite Turbo CK-MB Regulatory Class: II Product Code: JHX Dated: May 25, 1999 Received: May 26, 1999
Dear Dr. Levine:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Device Name: IMMULITE® Turbo CK-MB
Indications For Use:
IMMULITE® Turbo CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in patient management and the assessment of prognosis of myocardial infarction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-