(46 days)
Not Found
No
The device description and performance studies describe a standard immunometric assay for measuring PTH levels, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic assay used to measure parathyroid hormone levels, aiding in diagnosis and guiding surgical decisions, not directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use" and "It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia." This clearly indicates its role as a diagnostic device.
No
The device is an in vitro diagnostic assay kit, which is a chemical reagent-based test and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "For in vitro diagnostic use". It also describes the measurement of a substance (PTH) in biological samples (EDTA plasma or serum) to aid in diagnosis.
- Device Description: It describes a laboratory assay (solid-phase, chemiluminescent immunometric assay) that analyzes biological samples.
- Intended User/Care Setting: It specifies use with laboratory analyzers (IMMULITE and IMMULITE 1000 Analyzers) and mentions use in a clinical setting (intraoperatively).
- Performance Studies: The performance studies involve analyzing patient samples and correlating the results with clinical outcomes (diagnosis and treatment success).
- Predicate Device: The predicate device listed is also an IVD assay kit.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively."
Product codes
CEW
Device Description
IMMULITE/IMMULITE 1000 Turbo Intact PTH is a solid-phase, chemiluminescent immunometric assay employing a goat polyclonal anti-PTH (44-84) antibody as the capture antibody and a goat polyclonal anti-PTH (1-34) antibody conjugated to alkaline phosphatase as the detection antibody.
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
Clinical investigations using the IMMULITE/IMMULITE 1000 Turbo Intact PTH (parathyroid hormone) assay during parathyroid surgery were conducted by two groups of researchers, one at the Mayo Clinic, Rochester, Minnesota (Kao PC, et al.) and the second at University of Washington Medical School/Barnes Jewish Hospital, St. Louis Missouri (Johnson LR, et al.).
The researchers at the Mayo Clinic collected blood specimens from 47 parathryroid gland surgery patients during surgery. The schedule for specimen collection was at baseline (prior to removal of abnormal tissue) and 5, 10, and 20 minutes after beginning parathyroid resection. The generally accepted guideline that a 50% or greater decrease from the baseline PTH value suggests complete tumor removal was used. Among 47 parathyroidectomy patients tested with the IMMULITE 1000 Turbo Intact PTH assay, 45 (96%) had their plasma intact PTH (iPTH) levels decrease to =50% decrease in the iPTH value from baseline suggests complete tumor removal. Samples were drawn in the operating room before incision and during the period 10-12 minutes after excision of suspected diseased parathyroid gland tissue. Of the 49 patients in the study group, 46 had a > 50% decrease in iPTH values within the first three post-resection samples. When the control and study groups with similar sex, age, and diagnoses were compared, 44/49 (90%) of the patients in the study group and 49/55 (89%) of the control patients achieved normocalcemia postoperatively. Thus, the surgery guided by intraoperative IMMULITE/MMULITE Turbo Intact PTH measurements had identical physiologic outcomes. Frozen section use in the study group was statistically significantly less (p 50% decrease in iPTH values. 44/49 (90%) of the patients in the study group and 49/55 (89%) of the control patients achieved normocalcemia postoperatively. Frozen section use in the study group was statistically significantly less (p
§ 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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SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 3 2006
Assigned 510(k) Number
The assigned 510(k) number is K053533
Sponsor Name and Address
Diagnostic Products Corporation Corporate Offices 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900 (310) 645-8200
Contact
Deborah L. Morris Director, Clinical and Regulatory Affairs (310) 645-8200 extension 7426 dmorris@dpconline.com
Device Name
Trade Name: Common Name: Classification: DPC Catalog Number: IMMULITE®/IMMULITE® 1000 Turbo Intact PTH Intact Parathyroid Hormone Assay Class II device, CEW 21 CFR 862.1545 LSKPTZ (50 tests)
Description of Device
IMMULITE/IMMULITE 1000 Turbo Intact PTH is a solid-phase, chemiluminescent immunometric assay employing a goat polyclonal anti-PTH (44-84) antibody as the capture antibody and a goat polyclonal anti-PTH (1-34) antibody conjugated to alkaline phosphatase as the detection antibody.
Indications for Use
"For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively."
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Manufacturing Site
IMMULITE® IMMULITE® 1000 Turbo Intact PTH assay is manufactured by Diagnostic Products Corporation at the following locations:
Diagnostic Products Corporation Reagent Manufacturing Division 5700 West 96th Street Los Angeles, CA 90045-5597 FDA Establishment #: 2017183
Diagnostic Products Corporation Corporate Offices 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900 FDA Establishment #: 3005250747
Performance Equivalence
Substantial equivalence assessment for intra-operative use of the IMMULITE/IMMULITE 1000 Turbo Intact PTH assay is based upon comparison to clinical data. The IMMULITE/IMMULITE 1000 Turbo Intact PTH assay kit has not changed from its original FDA clearance on July 6, 1999 (K992105). The IMMULITE/IMMULITE 1000 Turbo Intact PTH assay results were compared to clinical data when patient samples were tested in the IMMULITE/IMMULITE 1000 Turbo assay and results reported during parathyroid surgery. This comparison to clinical data was performed by two groups of researchers, Kao PC, et al. at the Mayo Clinic, Rochester Minnesota and Johnson LR, et al. at Washington University School of Medicine/Barnes Jewish Hospital, St. Louis, Missouri. Results were reported in peer reviewed journals.
Kao PC, van Heerden JA, Farley DR, et al. Intraoperative monitoring of parathyroid hormone with a rapid automated assay that is commerciallv available. Annal of Clin & Lab Science 2002;32(3):244-251.
Johnson LR, Doherty G, Lairmore T, et al. Evaluation of the performance and clinical impact of a rapid intraoperative parathyroid hormone assay in conjunction with preoperative imaging and concise parathyroidectomy. Clin Chem 2001:47(5):919-925.
Summary of Clinical Investigations
Clinical investigations using the IMMULITE/IMMULITE 1000 Turbo Intact PTH (parathyroid hormone) assay during parathyroid surgery were conducted by two groups of researchers, one at the Mayo Clinic, Rochester, Minnesota (Kao PC, et al.) and the second at University of Washington Medical School/Barnes Jewish Hospital, St. Louis Missouri (Johnson LR, et al.).
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The researchers at the Mayo Clinic collected blood specimens from 47 parathryroid gland surgery patients during surgery. The schedule for specimen collection was at baseline (prior to removal of abnormal tissue) and 5, 10, and 20 minutes after beginning parathyroid resection. The generally accepted guideline that a 50% or greater decrease from the baseline PTH value suggests complete tumor removal was used. Among 47 parathyroidectomy patients tested with the IMMULITE 1000 Turbo Intact PTH assay, 45 (96%) had their plasma intact PTH (iPTH) levels decrease to 50% decrease in iPTH values within the first three post-resection samples. When the control and study groups with similar sex, age, and diagnoses were compared, 44/49 (90%) of the patients in the study group and 49/55 (89%) of the control patients achieved normocalcemia postoperatively. Thus, the surgery guided by intraoperative IMMULITE/MMULITE Turbo Intact PTH measurements had identical physiologic outcomes. Frozen section use in the study group was statistically significantly less (p 50% decrease from baseline (before incision) with complete tumor removal.
IMMULITE/IMMULITE 1000 Turbo Intact PTH assay's performance including measuring range, precision, analytical sensitivity, and correspondence to clinical status, makes this test suitable for the intended intraoperative monitoring purpose.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Public Health Service
FEB 3 2006 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Deborah L. Morris Director, Clinical and Regulatory Affairs Diagnostic Products Corporation 5210 Pacific Concourse Drive Los Angeles, CA 90045
Re: K053533 Trade/Device Name: IMMULITE®/IMMULITE® 1000 Turbo Intact PTH Regulation Number: 21 CFR& 1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: December 16, 2005 Received: December 20, 2005
Dear Ms. Morris:
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, pour 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
IMMULITE®/IMMULITE® 1000 Turbo Intact PTH Device Name:
Indications For Use:
"For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers — for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively."
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alan Chappell
Vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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