(108 days)
DPC Coat-A-Count® Intact PTH IRMA
Not Found
No
The device description and performance studies focus on a standard chemiluminescent immunoassay method, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) immunoassay designed for the quantitative determination of parathyroid hormone (PTH) in patient samples. It provides diagnostic information by measuring a biomarker, but it does not directly treat or alleviate a disease, injury, or condition.
Yes
The device quantitatively determines intact human parathyroid hormone, and these measurements are explicitly stated as being "used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism." This indicates its role in identifying or distinguishing medical conditions.
No
The device description clearly outlines a chemiluminescent immunoassay (CLIA) method involving reagents, solid phases, antibodies, and a LIAISON® Analyzer, which is a hardware instrument. This is 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 that the LIAISON® N-tact™ PTH Assay is for the "quantitative determination of intact human parathyroid hormone in serum or EDTA plasma." It also mentions its use in the "differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (serum or plasma) from the human body to provide information for diagnostic purposes.
- Device Description: The description details a "chemiluminescent immunoassay (CLIA)" method, which is a common technique used in in vitro diagnostic testing to measure the presence and concentration of substances in biological samples.
- Quality Control: The mention of the "LIAISON® N-tact™ PTH Control Set" being used as an "assayed quality control sample to monitor the accuracy and precision" further supports its use in a laboratory setting for diagnostic testing.
- Performance Studies: The detailed performance studies (analytical sensitivity, functional sensitivity, linearity, precision, recovery, correlation with predicate device, reference ranges) are typical evaluations performed for in vitro diagnostic devices to demonstrate their analytical and clinical performance.
All these elements align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The LIAISON® N-tact™ PTH Assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the quantitative determination of intact human parathyroid hormone in serum or EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.
The LIAISON® N-tact™ PTH Control Set is intended for use as an assayed quality control sample to monitor the accuracy and precision of the DiaSorin LIAISON® N-tact™ PTH immunoassay.
Product codes (comma separated list FDA assigned to the subject device)
CEW, JJX
Device Description
The method for quantitative determination of PTH is a direct, two site, sandwich type chemiluminescence immunoassay (CLIA). Affinity-purified antibody to the 39-84 amino acid sequence of PTH is coated to the solid phase. The second affinity-purified antibody to the 1-34 region is conjugated to an isoluminol derivative. During the incubation, PTH binds to the solid phase, and is subsequently bound by the isolumino! conjugated antibody. After the incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of PTH present in calibrators, controls, or samples.
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)
PERFORMANCE DATA: A summary of performance data is shown below.
| Parameter | Performance Results |
|---|---|
| Sensitivity (Analytical) | 1.0 pg/mL |
| Sensitivity (Functional) | 2.1 pg/mL |
| Assay Range | 2.5 - 2000.0 pg/mL |
| Total Precision (%CV) |
§ 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
K0334-26
DiaSorin LIAISON® N-tact™ PTH 510(k) Premarket Notification
FEB 1 2 2004
510(k) SUMMARY
SUBMITTED BY:
David M. Ikeda DiaSorin, Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 651.351.5592 Voice 651.351.5669 Fax October 22, 2003
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| NAME OF DEVICE:
Trade Name: | LIAISON® N-tact™ PTH Assay
LIAISON® N-tact™ PTH Control Set |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Common Names/Descriptions: | Automated chemiluminescent
immunoassay for the quantitative
determination of human parathyroid
hormone (PTH) in serum or plasma. |
| Classification Name: | Parathyroid hormone test system |
PREDICATE DEVICE:
DPC Coat-A-Count® Intact PTH IRMA
INTENDED USE: The LIAISON® N-tact™ PTH Assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the quantitative determination of intact human parathyroid hormone in serum or EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.
The LIAISON® N-tact™ PTH Control Set is intended for use as an assayed quality control sample to monitor the accuracy and precision of the DiaSorin LIAISON® N-tact™ PTH immunoassay.
98
1
DEVICE DESCRIPTION: The method for quantitative determination of PTH is a direct, two site, sandwich type chemiluminescence immunoassay (CLIA). Affinity-purified antibody to the 39-84 amino acid sequence of PTH is coated to the solid phase. The second affinity-purified antibody to the 1-34 region is conjugated to an isoluminol derivative. During the incubation, PTH binds to the solid phase, and is subsequently bound by the isolumino! conjugated antibody. After the incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of PTH present in calibrators, controls, or samples.
| Assay /
Feature | DPC | Coat-A-Count® PTH
Assay* | LIAISON® N-tact™ PTH Assay |
|--------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Human Parathyroid Hormone | Human Parathyroid Hormone | Human Parathyroid Hormone |
| Intended
Use | | FOR IN VITRO DIAGNOSTIC
USE.
Coat-A-Count® Intact PTH IRMA
is an immunoradiometric assay
designed for the quantitative
measurement of intact
parathyroid hormone
(parathyrin, PTH) in serum. It is
intended strictly for in vitro
diagnostic use as an aid in the
differential diagnosis of
hypercalcemia and
hypocalcemia | FOR IN VITRO DIAGNOSTIC
USE.
The LIAISON® N-tact™ PTH
Assay is a chemiluminescent
immunoassay to be used with
the LIAISON® Analyzer for the
quantitative determination of
intact human parathyroid
hormone in serum or EDTA
plasma. Measurements of
parathyroid hormone levels are
used in the differential
diagnosis of hypercalcemia and
hypocalcemia resulting from
disorders of calcium
metabolism. Assay results
should be used in conjunction
with other clinical and
laboratory data to assist the
clinician in making individual
patient management decisions |
TECHNOLOGICAL COMPARISON TO PREDICATE:
2
| Antisera | Polyclonal specific for PTH (44- 84) | Polyclonal specific for PTH (39- 84) |
|---|---|---|
| Tracer | 125I-labelled polyclonal antibody | |
| to PTH (1-34) | Chemiluminescent ABEI | |
| labeled polyclonal antibody to | ||
| PTH (1-34) | ||
| Standards | Seven lyophilized serum based | |
| controls to be reconstituted in | ||
| water representing | ||
| concentrations from 0 to 3000 | ||
| pg/mL | Stored Master Curve based on | |
| 10 points, derived from serum | ||
| based standards representing | ||
| concentrations from 2.5 to 2000 | ||
| pg/mL. | ||
| Kit | ||
| Controls | Two concentrations of | |
| lyophilized controls | Two concentrations of | |
| lyophilized controls |
PERFORMANCE DATA: A summary of performance data is shown below.
| Parameter | Performance Results |
|---|---|
| Sensitivity (Analytical) | 1.0 pg/mL |
| Sensitivity (Functional) | 2.1 pg/mL |
| Assay Range | 2.5 - 2000.0 pg/mL |
| Total Precision (%CV) |