(14 days)
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No
The summary describes a standard immunoassay for measuring a specific analyte (PTH) using a chemiluminescent method on an automated analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an "in vitro" diagnostic assay to measure parathyroid hormone levels, intended as an "aid in the differential diagnosis." It does not directly treat or prevent a disease, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states it is "intended strictly for in vitro use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia." This explicitly indicates its role in diagnosis.
No
The device description clearly states it is a "solid-phase, two-site chemiluminescent enzyme immunometric assay" and a "clinical device for use with the IMMULITE® Automated Immunoassay Analyzer, Reagent system". This indicates a physical assay and hardware components, not a software-only 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".
- Device Description: The "Device Description" also refers to it as a "clinical device for use with the IMMULITE® Automated Immunoassay Analyzer, Reagent system for the determination of intact PTH in EDTA plasma or serum." This describes a laboratory test performed on biological samples outside of the body.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended strictly for in vitro use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Product codes (comma separated list FDA assigned to the subject device)
CEW
Device Description
IMMULITE® Turbo Intact PTH is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer, Reagent system for the determination of intact PTH in EDTA plasma or serum.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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): 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.
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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.
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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).
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§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.
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K 992105
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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: Address:
Telephone Number: Facsimile Number:
Contact Person:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Edward M. Levine, Ph.D. Director of Clinical Affairs
IMMULITE® Turbo Intact PTH
(310) 645-8200
(310) 645-9999
June 21, 1999
LSKPTZ (50 tests)
EDTA plasma or serum.
5700 West 96th Street
Date of Preparation:
Device Name: Trade:
Catalog Number:
Common:
Classification:
Manufacturer:
Sole U.S. Importer:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Los Angeles, California 90045-5597
Diagnostic Products Corporation
Establishment Registration Number:
Description of Device:
DPC's Registration Number is 2017183
Class II device, 75-CEW (21CFR 862.1545)
IMMULITE® Turbo Intact PTH is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer,
Reagent system for the determination of intact PTH in
1
Intended Use of the Device:
IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or It is intended strictly for in vitro use as an aid in the differential diagnosis of serum. hypercalcemia and hypocalcemia.
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 Intact PTH.
Edward A. Levine, Ph.D.
Edward M. Levine, Ph.D. Director of Clinical Affairs
6/21/99
Date
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL -6 1999
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostics Products Corporation 5700 West 96th Street Los Angeles. California 90045-5597
Re: K992105
Trade Name: IMMULITE® Turbo Intact PTH Regulatory Class: II Product Code: CEW Dated: June 21, 1999 Received: June 22, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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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 @ffice 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 Toutman
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
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510(k) Number (if known): 449105 Device Name: IMMULITE® Turbo Intact PTH
Indications For Use:
IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended strictly for in vitro use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Coofer
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992105
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
i
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-
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