(72 days)
Not Found
No
The summary describes a standard immunoassay for measuring parathyroid hormone and does not mention any AI or ML components in its operation or analysis.
No.
This device is for in vitro diagnostic use to quantitatively determine intact parathyroid hormone (iPTH) levels to aid in diagnosis, not for treating a disease or 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," which identifies it as a diagnostic device.
No
The device description clearly indicates it is an in vitro diagnostic assay using reagents and paramagnetic latex particles, which are physical components, not software.
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 statement directly identifies the device as an IVD.
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 and ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
Product codes
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.
Precision: Evaluated following CLSI guideline EP5-A2. Two replicates of each of 7 samples including 4 EDTA plasma pools and 3 levels of commercial control materials were assayed in duplicate over the course of 20 days, on 2 instruments using 2 lots of reagent, two runs per day, for a total of 40 runs and 80 replicates.
Example results:
| Sample | MEAN (pg/mL) | Within Run %CV | Total %CV |
|---|---|---|---|
| Pool 1 | 16.1 | 7.1 | 7.7 |
| Control 1 | 38.7 | 3.6 | 4.7 |
| Pool 2 | 62.8 | 2.7 | 3.7 |
| Control 2 | 185 | 2.4 | 3.2 |
| Control 3 | 663 | 2.2 | 2.8 |
| Pool 3 | 839 | 3.0 | 3.9 |
| Pool 4 | 1698 | 2.3 | 3.2 |
Detection Limits: Limit of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) were estimated per CLSI EP17-A2.
Results:
| LoB | LoD | LoQ |
|---|---|---|
| 0.1 pg/mL | 2.7 pg/mL | 6.3 pg/mL |
Linearity / Assay Range: Evaluated following CLSI EP6-A. Twelve test concentrations (pools) ranging from 4.4 to 2021 pg/mL were prepared.
Regression statistics: v= 0.98x - 4.98, R = 1.00
High Dose Hook Effect: Tested with a hook sample prepared to ~144,000 pg/mL. No high dose hook was observed.
Interfering Substances: Evaluated for hemoglobin, triglycerides, bilirubin, and biotin using two patient plasma pools. 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
FEB - ち 2014
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: K133601
B. Date of Preparation: February 4, 2014
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, Ph.D. 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, Parathvroid Hormone Test System
-
- Panel: Clinical Chemistry
F. Predicate Device:
The ADVIA® Centaur Intact Parathyroid Hormone (iPTH) Assay using the ADVIA Centaur XP was cleared under 510(k) K121981. The assay is also being marketed on the instrument family member, ADVIA Centaur, following FDA's Replacement Reagent and Instrument Family Policy (December 11, 2003).
G. 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 and ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
H. 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
1
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
I. Description of Device Modification
The modification to the ADVIA Centaur iPTH assay is due to the qualification of new . polyclonal goat anti-human PTH antibody pools:
- Newly qualified pool for polyclonal goat anti-human PTH N- terminal antibody . (Lite Reagent) produced by Siemens (Elkhart).
- Newly qualified pool for polyclonal goat anti-human PTH C- terminal antibody . (Solid Phase Reagent) produced by Siemens (Elkhart).
J. Comparison of Predicate Device and Modified Device:
The following table provides a comparison between the Predicate ADVIA Centaur iPTH assay (with the current polyclonal antibody pools) and the modified ADVIA Centaur iPTH assay with the newly-qualified polyclonal antibody pools.
| | Modified Device:
ADVIA Centaur Intact PTH Assay | Predicate Device:
ADVIA Centaur 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* and ADVIA Centaur XP
systems | Same
- ADVIA Centaur was added after
clearance following the guidelines of the
FDA's Replacement Reagent and
Instrument Family Policy |
| Indications for
Use | This assay is intended to be used to
aid in the differential diagnosis of
hyperparathyroidism and
hypoparathyroidism. | Same |
| Sample type | EDTA Plasma, Serum | Same |
| Measurement | Quantitative | Same |
| Operating
Principle | Sandwich immunoassay | Same |
| Technology | Chemiluminescence | Same |
| Detection
Antibody | Goat polyclonal antibody conjugated
to Acridium Ester | Same |
2
| Item | Modified Device:
ADVIA Centaur Intact PTH Assay | Predicate Device:
ADVIA Centaur Intact PTH Assay |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Capture
Antibody | Goat polyclonal antibody conjugated
to biotin directly coupled to
streptavidin magnetic particles | Same |
| Assay Range | 6.3 - 1900 pg/mL | 5.5 - 1900 pg/mL |
| Sample Volume | 200 it is not possible to generate a valid JSON from the image. The image contains a table with text and numerical data, but it does not conform to the structure of a JSON object or array. JSON requires key-value pairs or a structured array of objects, which is not present in the image. Therefore, I cannot provide a valid JSON output based on the image. Instead, I will return | |
K. Standard/Guidance Document Referenced:
- CLSI Guideline EP5-A2: Evaluation of Precision Performance of Qualitative . Measurement Methods
- CLSI Guideline EP17-A2: Evaluation of Detection Capability for Clinical . Laboratory Measurement Procedures
- . CLSI Guideline EP6-A: Evaluation of the Linearity of Qualitative Measurement Methods
- CLSI Guideline C28-A3c: Defining, Establishing, and Verifying Reference . Intervals in the Clinical Laboratory: Approved Guideline
- CLSI Guideline EP7-A2: Interference Testing in Clinical Chemistry; Approved . Guideline
- . Medical devices - Application of risk management to medical devices (ANSI/AAMI/ISO 14971:2007/(R) 2010)
L. Performance Characteristics
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, interfering and cross-reacting substances, and method comparison.
a. Precision
Precision was evaluated following CLSI guideline EP5-A2. Two replicates of each of 7 samples including 4 EDTA plasma pools and 3 levels of commercial control materials were assayed in duplicate over the course of 20 days, on 2 instruments using 2 lots of reagent, two runs per day, for a total of 40 runs and 80 replicates. A representative lot is summarized below:
| Sample | MEAN (pg/mL) | Within Run %CV | Total %CV |
|---|---|---|---|
| Pool 1 | 16.1 | 7.1 | 7.7 |
| Control 1 | 38.7 | 3.6 | 4.7 |
| Pool 2 | 62.8 | 2.7 | 3.7 |
| Control 2 | 185 | 2.4 | 3.2 |
| Control 3 | 663 | 2.2 | 2.8 |
Siemens Healthcare Diagnostics ADVIA Centaur iPTH Traditional 510(k) K133601
3
| Sample | MEAN (pg/mL) | Within Run %CV | Total %CV |
|---|---|---|---|
| Pool 3 | 839 | 3.0 | 3.9 |
| Pool 4 | 1698 | 2.3 | 3.2 |
b. Detection Limits
The Limit of Blank (LoB), Limit of Detection (LoD), and the Limit of Quantitation (LoQ) were estimated per CLSI EP17-A2. The LoB was calculated non-parametrically. The LoQ was estimated as the dose corresponding to 20% Total CV using the precision profile method.
A single experimental design was used to generate the data for LoB, LoD and LoQ. Multi-Diluent 11 (assay specific diluent) was used as the blank. Five test samples were prepared by spiking analyte into diluent and/or diluting plasma samples to obtain the following approximate concentrations: 1, 2, 5, 10, and 15 pg/mL. These samples were tested at n=6 x 2 instruments x 5 days for a total of n=60 per reagent lot (2 reagents lots were used).
The results are as follows:
| LoB | LoD | LoQ |
|---|---|---|
| 0.1 pg/mL | 2.7 pg/mL | 6.3 pg/mL |
c. Linearity / Assay Range
Linearity across the assay range was evaluated following the guidelines of CLSI EP6-A. Twelve test concentrations (pools) ranging from 4.4 to 2021 pg/mL were prepared by dilution of high and low concentration pools. Testing of the pools across the assay range was done with one reagent lot.
The regression statistics (Observed vs. Expected Values with weighed linear fit) for the linearity study were as follows:
v= 0.98x - 4.98, R = 1.00
d. High Dose Hook Effect
High dose hook effect was tested. A hook sample was prepared by spiking iPTH stock into diluent to achieve a concentration of approximately 144,000 pg/mL. The hook sample was tested in triplicate with 2 reagent lots. No high dose hook was observed for either reagent lot.
e. Interfering Substances
Interference by hemoglobin, triglycerides, bilirubin, and biotin was evaluated using two patient plasma pools with endogenous iPTH concentrations of ~20 pg/mL and ~200 pg/mL. There was no indication of interference (≤ 10% effect) up to the interferent levels claimed.
Siemens Healthcare Diagnostics ADVIA Centaur iPTH Traditional 510(k) K133601
4
| Interfering
Substance | Conc. | Test
Sample
(pg/mL) | Control
Sample
(pg/mL) | % Bias |
|---------------------------|------------|---------------------------|------------------------------|--------|
| Hemoglobin | 500 mg/dL | 30.9 | 29.6 | 4% |
| | | 203 | 204 | -1% |
| Triglycerides | 3000 mg/dL | 27.4 | 25.7 | 7% |
| | | 153 | 148 | -4% |
| Conjugated
Bilirubin | 40 mg/dL | 31.8 | 29.8 | 7% |
| | | 212 | 211 | 0% |
| Unconjugated
Bilirubin | 40 mg/dL | 24.1 | 22.5 | 7% |
| | | 197 | 183 | 8% |
| Biotin | 1000 ng/mL | 32.6 | 30.0 | 8% |
| | | 222 | 236 | 6% |
f. Cross reacting Substances
Cross reactivity was evaluated using a plasma sample with endogenous iPTH and an assay specific Multi-diluent 11 (buffered goat serum with no analyte). No cross reactivity was observed at the highest levels tested with the exception of the PTH 7 -84 fragment (~ 51%).
| Cross reactant | Conc.
(pg/mL) | Multi-Dil 11
IPTH Dose
(pg/mL) | %Cross
Reactivity | IPTH Dose
(pg/mL) | %Cross
Reactivity |
|-----------------|------------------|--------------------------------------|----------------------|----------------------|----------------------|
| PTH 1-34 | 300 | 0.0 | -0.2 | 33.9 | 0.1 |
| PTH 39-68 | 100,000 | 0.1 | 0.0 | 22.2 | 0.0 |
| PTH 39-84 | 100,000 | 2.7 | 0.0 | 17.5 | 0.0 |
| PTH 44-68 | 100.000 | 0.0 | 0.0 | 23.4 | 0.0 |
| PTH 53-84 | 100,000 | 2.0 | 0.0 | 27.1 | 0.0 |
| Calcitonin | 100,000 | 0.0 | 0.0 | 33.1 | 0.0 |
| PTH 7-84 | 300 | 130 | 33 | 192 | 51 |
| Beta-Cross Laps | 1000 | 0.5 | 0.0 | 35.8 | 0.2 |
| Osteocalcin | 50,000 | 0.2 | 0.0 | 34.7 | 0.0 |
g. Method Comparison
Method Comparison studies were done with 106 unaltered native matched serum and plasma samples to demonstrate equivalence to the Predicate (ADVIA Centaur iPTH assay). The ADVIA Centaur iPTH assay shows good correlation in sample results compared to the Predicate.
| System (y) | N | Regression
Equation* | R** | Sample Range
(pg/mL) |
|-------------------------------------|---------|-------------------------|------|-------------------------|
| ADVIA Centaur iPTH
(EDTA Plasma) | 106 | $y = 0.98x + 10.6$ | 1.00 | 11.8 - 1862 |
| ADVIA Centaur iPTH
(Serum) | 105 *** | $y =1.00x + 5.0$ | 1.00 | 9.8 - 1868 |
x =Predicate (ADVIA Centaur iPTH Assay)
- Passing & Bablok
** Least Squares Linear regression
*** Sample outside of assay range was excluded
5
h. Expected Values
The reference range of the Predicate was verified following the guidelines of CLSI C28-A3c. Forty (40) plasma and 40 serum samples obtained from apparently healthy individuals (calcium and inorganic phosphorus results within their respective reference ranges) were tested using 2 reagent lots across 4 instruments. The results are as follows:
| % Within Range | ||||
|---|---|---|---|---|
| Plasma | Serum | |||
| Range | Lot 1 | Lot 2 | Lot 1 | Lot 2 |
| 12 85 | ||||
| pg/mL | 100.0% | 100.0% | 97.5% | 95.0% |
i. Stabilitv
The on board stability of the reagent is 28 days with a calibration interval of 14 days. The ADVIA Centaur Intact PTH assay reagent is stable until the date printed on the label when stored at 2-8°C.
M. Conclusions
Comparative testing of the modified ADVIA Centaur iPTH assay is substantially equivalent in principle and performance to the Predicate Device, ADVIA Centaur Intact PTH assay, cleared under 510(k) K121981.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines extending from the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2014
SIEMENS HEALTHCARE DIAGNOSTICS INC. DR. PHILIP LIU SENIOR MANAGER, REGULATORY AFFAIRS 511 BENEDICT AVE. TARRYTOWN NY 10591
Re: K133601
Trade/Device Name: ADVIA Centaur Intact Parathyroid Hormone (iPTH) Assay Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: II Product Code: CEW Dated: December 30, 2013 Received: December 31, 2013
Dear Dr. Liu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
7
Page 2—Dr. Liu
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133601
Device Name
ADVIA Centaur® Intact Parathyroid Hormone (iPTH) assay
Indications for Use (Describe)
The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE SECT THE CONFORT FOR FOR FOR FOR MANAGE ONLY FOR CONSTITUTION OF CONSULTION OF CONSULTION OF Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
9
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