(25 days)
Not Found
No
The summary describes a standard immunoassay for measuring parathyroid hormone and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) assay used for the quantitative measurement of parathyroid hormone, which aids in differential diagnosis. It does not directly treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assays are "for in vitro diagnostic use" and serve "as an aid in the differential diagnosis of hypercalcemia and hypocalcemia." This directly aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "solid phase, chemiluminescent enzyme immunometric assay" for use with "Automated Analyzers," indicating it is a laboratory assay kit and associated hardware, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The IMMULITE® Intact PTH and IMMULITE® 2000 Intact PTH assays are for in vitro diagnostic use..."
This statement directly identifies the device as intended for use in examining specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
IMMULITE Intact PTH and IMMULITE 2000 Intact PTH are solid-phase, two-site chemiluminescent enzyme immunometric assays for use with their respective IMMULITE® and IMMULITE 2000 Automated Analyzers and are designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum It is intended strictly for in vitro diagnostic use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Indications For Use: The IMMULITE® Intact PTH and IMMULITE® 2000 Intact PTH assays are for in vitro diagnostic use with their respective analyzers for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Product codes
CEW
Device Description
IMMULITE Intact PTH and IMMULITE 2000 Intact PTH are solid phase, chemiluminescent enzyme immunometric assays for use with their respective IMMULITE and IMMULITE 2000 Automated Analyzers.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
IMMULITE Intact PTH (K011505), IMMULITE 2000 Intact PTH (K011505)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 2 0 2001
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: | October 25, 2001 |
| Device Name:
Trade: | IMMULITE® Intact PTH
IMMULITE® 2000 Intact PTH |
| Catalog Number: | LKPP1 (100 tests), LKPP5 (500 tests)
L2KPP2 (200 tests), L2KPP6 (600 tests) |
| CFR: | 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. |
| Common: | Reagent system for the determination of parathyroid
hormone in plasma and serum. |
| Classification: | Class II device, CEW (21CFR 862.1545) |
| 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 |
1
| Establishment Registration
| Number: | DPC's Registration Number is 2017183 |
|---|---|
| Substantially | |
| Equivalent | |
| Predicate Device: | IMMULITE Intact PTH (K011505) |
| IMMULITE 2000 Intact PTH (K011505) | |
| Description of Device: | IMMULITE Intact PTH and IMMULITE 2000 Intact PTH |
| are solid phase, chemiluminescent enzyme immunometric | |
| assays for use with their respective IMMULITE and | |
| IMMULITE 2000 Automated Analyzers. |
Intended Use of the Device:
IMMULITE Intact PTH and IMMULITE 2000 Intact PTH are solid-phase, two-site chemiluminescent enzyme immunometric assays for use with their respective IMMULITE® and IMMULITE 2000 Automated Analyzers and are designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum It is intended strictly for in vitro diagnostic use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Technology:
IMMULITE Intact PTH is a solid-phase, two-site chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with an affinity-purified murine monoclonal anti-PTH (44-84) anitbody.
The patient sample and alkaline phosphatase-conjugated affinity purified goat polyclonal anti-PTH (1-34) antibody are incubated for approximately 60 minutes at 37℃ in the Test Unit with intermittent agitation, intact PTH in the sample is bound to form an antibody sandwich complex. Unbound conjugate is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of intact PTH in the sample.
IMMULITE 2000 Intact PTH is a solid-phase, two-site chemiluminescent immunometric assay. The solid phase is a polystyrene bead coated with an affinity-purified murine monoclonal anti-PTH (44-84) anitbody.
The patient sample and alkaline phosphatase-conjugated affinity-purified goat polyclonal anti-PTH (1-34) antibody are introduced into the Reaction Tube containing the bead and incubated for approximately 60 minutes at 37℃ with intermittent agitation. During this time, intact PTH in the sample is bound to form an antibody sandwich complex. Unbound conjugate is then removed
2
Technology (continued):
I ecullious? (continued).
by a centrifugal wash, after which substrate is added and the Reaction Tube is incubated for a further 5 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous In the presence of alkanic phosphatase to first stained emission of light, thus improving production by providing a window for multiple readings. The bound complex - and thus also the precision by providing a window for manipes reading PTH in the sample.
Conclusion:
The data presented in this summary of safety and effectiveness is the data that the Food and Drug I lie data presence in this saminal y or substantial equivalence for IMMULITE Intact PTH and IMMULITE 2000 Intact PTH
3
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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines, possibly representing health and human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director, Clinical Affairs Diagnostics Products Corporation 5700 West 96th Street Los Angeles, CA 90045
NOV 2 0 2001
Re: K013566
Trade/Device Name: IMMULITE® Intact PTH and IMMULITE® 2000 intact PTH Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: October 25, 2001 Received: October 26, 2001
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and in your device of substantial equivalence of your device to a legally marketed nouncation. The I Dr interessification 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 1 If you desire specific as 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, (201) 594-1565. I radiations at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on Jour respeal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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
5
NOV 2 0 2001
510(k) Number (if known): Kol 35 صاحاك ك IMMULITE® Intact PTH Device Name: IMMULITE® 2000 Intact PTH
Indications For Use: The IMMULITE® Intact PTH and IMMULITE® 2000 Intact PTH assays are for in vitro diagnostic use with their respective analyzers for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
Thomas C. Thon
Division of Clinical Laboratory Devices KO13566 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQU NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 CFR 801 109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)