(258 days)
Not Found
No
The device description and performance studies focus on a standard immunoassay technology and do not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative determination of parathyroid hormone to aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism."
No
The device description clearly outlines physical reagents (Lite Reagent, Solid Phase Reagent, Master Curve card, Calibrator, etc.) and specifies its use with the ADVIA Centaur XP system, which is a hardware analyzer. This indicates it is a diagnostic assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use..." This is the primary indicator that the device is an IVD.
Furthermore, the description of the device as an assay for the quantitative determination of a substance (iPTH) in biological samples (EDTA plasma or serum) to aid in the diagnosis of medical conditions (hyperparathyroidism and hypoparathyroidism) aligns perfectly with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Centaur iPTH assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
Product codes (comma separated list FDA assigned to the subject device)
CEW
Device Description
The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.
The ADVIA Centaur iPTH reagent kit contains the following:
. ReadyPack® primary reagent pack containing ADVIA Centaur Lite and Solid Phase Reagent)
ADVIA Centaur iPTH Master Curve card.
Materials Required but Not Provided
- iPTH Calibrator .
Optional Reagents - ADVIA Centaur Multi-Diluent 11 .
- iPTH 1, 2, 3 quality control material .
- iPTH Master Curve Material .
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)
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, interfering and cross-reacting substances, and method comparison.
a. Precision
Precision estimates were computed according to CLSI document EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline. Within run and total imprecision were evaluated by testing one EDTA plasma (patient) pool, five (5) Medical Decision Pools (iPTH spiked into human EDTA plasma pools), two levels of calibrators, and 3 levels of commercial control materials. Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days for a total of 80 replicates.
b. Interfering Substances
Interference by hemoglobin, triglycerides (Intralipids), bilirubin, and biotin was evaluated in the ADVIA Centaur iPTH assay at three levels of PTH. There was no indication of interference (
§ 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
510(k) Summary of Safety and Effectiveness for the
ADVIA® Centaur Intact Parathyroid (iPTH) Assay
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. 510(k) Number: K/2198)
B. Date of Preparation: March 8, 2013
C. Proprietary and Established Names:
ADVIA® Centaur Intact Parathyroid Hormone (iPTH) Assay
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Philip Liu, Senior Manager, Regulatory Affairs and Compliance Office: (914) 524-2443 Fax: (914) 524-3579
E. Regulatory Information:
-
- Regulation section: 21 CFR § 862.1545
-
- Classification: Class II
-
- Product Code: CEW, Parathyroid Hormone Test System
-
- Panel: Clinical Chemistry
F. Predicate Device:
The ADVIA® Centaur iPTH Assay is substantially equivalent to the Abbott Architect Intact PTH Assay cleared under 510(k) K063232
G. Device Description:
The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.
The ADVIA Centaur iPTH reagent kit contains the following:
- . ReadyPack® primary reagent pack containing ADVIA Centaur Lite and Solid Phase Reagent)
- ADVIA Centaur iPTH Master Curve card .
Siemens Healthcare Diagnostics ADVIA Centaur iPTH Premarket Notification 510(k) March, 2013
1
1
Materials Required but Not Provided
- iPTH Calibrator .
Optional Reagents
- ADVIA Centaur Multi-Diluent 11 .
- iPTH 1, 2, 3 quality control material .
- iPTH Master Curve Material .
H. Intended Use / Indications for Use:
The ADVIA Centaur iPTH assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
l. Substantial Equivalence Information:
Both the ADVIA Centaur iPTH assay (New Device) and Abbott Architect Intact PTH assay (Predicate Device cleared under K063232) employ prepackaged reagents for use on automated test systems. A comparison of the important similarities and differences of these assays is shown in the following tables:
Similarities:
| Item | New Device:
ADVIA Centaur Intact PTH
Assay | Predicate Device:
Abbott Architect Intact PTH Assay |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in the
quantitative determination of
intact parathyroid hormone (iPTH)
in EDTA plasma or serum using
the ADVIA Centaur systems | For in vitro chemiluminescent
microparticle immunoassay (CMIA) for
the quantitative determination of
intact parathyroid hormone (PTH) in
human serum and plasma on the
ARCHITECT i System |
| Indications for
Use | This assay is intended to be used
to aid in the differential diagnosis
of hyperparathyroidism and
hypoparathyroidism. | In conjunction with serum calcium levels,
this assay may be used as an aid in the
differential diagnosis of hypercalcemia,
hypocalcemia, or parathyroid disorders. |
| Sample type | EDTA Plasma, Serum | Serum and Plasma |
| Measurement | Quantitative | Same |
| Operating
Principle | Sandwich immunoassay | Same |
| Technology | Chemiluminescence | Same |
| Detection
Antibody | Goat polyclonal antibody
conjugated to Acridium Ester | Goat polyclonal antibody conjugated to
Acridium |
| Capture
Antibody | Goat polyclonal antibody
conjugated to biotin directly
coupled to streptavidin magnetic
particles | Goat polyclonal antibody coated to
microparticles |
| Interference | No significant interference by
hemolysis, icterus (bilirubin) | No significant interference from
hemoglobin, bilirubin, triglycerides or |
2
| Item | New Device:
ADVIA Centaur Intact PTH Assay | Predicate Device:
Abbott Architect Intact PTH Assay |
|--------------------------|----------------------------------------------------------|--------------------------------------------------------|
| | triglycerides, or biotin at tested
levels | protein at tested levels |
| Expected Values | 13.8 - 85.0 pg/mL (plasma)
12.4 - 76.8 pg/mL (serum) | 8.7 - 77.1 pg/mL |
| Calibration | 2 Point | 6 Point |
| Calibrators | Siemens iPTH Calibrators | ARCHITECT Intact PTH Calibrators |
| Number of
calibrators | Two (2) levels | Six (6) levels |
| Use of Controls | Yes (recommended) | Same |
| Number of
controls | Three levels | Same |
| Detection
Antibody | Goat polyclonal antibody
conjugated to Acridium Ester | Same |
Differences:
| Item | New Device:
ADVIA Centaur Intact PTH
Assay | Predicate Device:
Abbott Architect Intact PTH Assay |
|--------------------------|--------------------------------------------------|--------------------------------------------------------|
| Assay Range | 5.5 – 1900 pg/mL | 3.0 – 3000 pg/mL (Routine)
4.0 – 2500 pg/mL (STAT) |
| Sample Volume | 200 μL | 150 μL |
| Calibrators | Siemens iPTH Calibrators | ARCHITECT Intact PTH Calibrators |
| Calibration | 2 Point | 6 Point |
| Number of
calibrators | Two (2) levels | Six (6) levels |
J. Test Principle
The ADVIA Centaur Intact PTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology. PTH in the sample reacts with the first antibody which is a polyclonal goat anti-human PTH (N-terminal 1-34) antibody labeled with acridinium ester. This complex is then captured by the solid phase (a second antibody which is a biotinylated polyclonal goat anti-human PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles). Unbound materials are then removed by washing. Acid Reagent and Base Reagent are then added to initiate the chemiluminescent reaction. A direct relationship exists between the amount of PTH present in the patient sample and the amount of relative light units (RLUs) detected by the system.
Siemens Healthcare Diagnostics ADVIA Centaur iPTH Premarket Notification 510(k) March, 2013
3
K. Performance Characteristics
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, interfering and cross-reacting substances, and method comparison.
a. Precision
Precision estimates were computed according to CLSI document EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline. Within run and total imprecision were evaluated by testing one EDTA plasma (patient) pool, five (5) Medical Decision Pools (iPTH spiked into human EDTA plasma pools), two levels of calibrators, and 3 levels of commercial control materials. Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days for a total of 80 replicates.
| Within Run | Total | |||||
|---|---|---|---|---|---|---|
| Sample | MEAN | |||||
| pg/mL | SD | %CV | SD | %CV | ||
| Patient Pool | 16.7 | 0.8 | 4.6 | 1.5 | 9.2 | |
| Low Calibrator | 33.0 | 2.0 | 6.0 | 2.3 | 6.9 | |
| Control 1 | 45.2 | 2.0 | 4.4 | 3.2 | 7.0 | |
| Medical Decision Pool 1 | 47.3 | 1.4 | 2.9 | 2.3 | 4.8 | |
| Medical Decision Pool 2 | 97.3 | 2.8 | 2.9 | 3.9 | 4.0 | |
| Medical Decision Pool 3 | 175.6 | 4.8 | 2.7 | 10.5 | 6.0 | |
| Control 2 | 196.6 | 6.8 | 3.5 | 8.3 | 4.2 | |
| Control 3 | 691.0 | 17.8 | 2.6 | 24.5 | 3.5 | |
| Medical Decision Pool 4 | 699.8 | 20.1 | 2.9 | 24.4 | 3.5 | |
| High Calibrator | 807.7 | 23.1 | 2.9 | 37.7 | 4.7 | |
| Medical Decision Pool 5 | 1802.9 | 46.7 | 2.6 | 57.7 | 3.2 |
b. Interfering Substances
Interference by hemoglobin, triglycerides (Intralipids), bilirubin, and biotin was evaluated in the ADVIA Centaur iPTH assay at three levels of PTH. There was no indication of interference (