(151 days)
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay and does not mention any AI or ML components in the device description, performance studies, or key metrics.
No
Explanation: This device is for in vitro diagnostic use, meaning it aids in diagnosis by analyzing samples outside the body, rather than directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the assay is "for in vitro diagnostic use" and "is intended to be used to aid in the differential diagnosis of hyperparathyroidism, or disorders of calcium metabolism."
No
The device description clearly outlines physical reagents (Lite Reagent, Solid Phase Reagent, Calibrators) and is intended for use with a specific hardware system (ADVIA Centaur XP system), indicating it is an in vitro diagnostic assay with physical components, 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 Hormone (PTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma..."
This statement clearly identifies the device as being used outside of the body (in vitro) for diagnostic purposes.
N/A
- Intended Use / Indications for Use: The ADVIA Centaur® Intact Parathyroid Hormone (PTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or disorders of calcium metabolism. This assay can be used intra-operatively.
- Product codes: CEW
- Device Description: The ADVIA Centaur PTH assay consists of a Primary Reagent ReadyPack and Calibrators.
- ADVIA Centaur PTH Primary Reagent ReadyPack:
- ADVIA Centaur PTH Lite Reagent: Acridinium ester-labeled mouse monoclonal anti-human PTH antibody (~0.6 mg/L) in buffered saline with mouse gamma globulin, bovine serum albumin, and preservatives.
- ADVIA Centaur PTH Solid Phase Reagent: Biotinylated mouse monoclonal anti-human PTH antibody bound to streptavidin-coated paramagnetic particles (~0.4 g/L) in buffered saline with bovine gamma globulin, bovine serum albumin, and preservatives.
- ADVIA Centaur PTH Calibrator:
- ADVIA Centaur PTH Low and High Calibrators: After reconstitution, low or high levels of intact PTH synthetic peptide in buffered saline with human EDTA plasma (10%), surfactants, and preservatives.
- ADVIA Centaur PTH Primary Reagent ReadyPack:
- 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 (Exclusion criteria states "Specimens from pediatric subjects ( 2000 pg/mL (> 212 pmol/L).
- Stability: Onboard stability of reagents is 28 days with a calibration interval of 21 days.
- Clinical Study (for Intra-operative use): Confirmed effectiveness for IO use. Based on the Miami criterion (50% or greater drop in PTH level from baseline to 10 min post-excision), the ADVIA Centaur PTH showed:
- Primary Endpoint Positive Agreement = 29/29 = 100%
- Primary Endpoint Overall Agreement = 29/30 = 96.7%
- One discrepant subject where the local device failed the Miami criterion, but the ADVIA Centaur PTH assay passed.
- Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.): Correlation (r = 0.99 for method comparison), Recovery (mean 102.8% for dilution), %CV for precision, %XR for cross-reactivity, Positive Agreement (100%), Overall Agreement (96.7%).
- Predicate Device(s): K133601
- 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2017
SIEMENS HEALTHCARE DIAGNOSTICS INC. DARIUS DARUWALA SENIOR SPECIALIST, REGULATORY AFFAIRS 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K163658
Trade/Device Name: ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: II Product Code: CEW Dated: April 24, 2017 Received: April 25, 2017
Dear Darius Daruwala:
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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Kellie B. Kelm -S
for 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
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Indications for Use
510(k) Number (if known) K163658
Device Name
ADVIA Centaur® Intact Parathyroid Hormone (PTH) Assay
Indications for Use (Describe)
The ADVIA Centaur® Intact Parathyroid Hormone (PTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, or disorders of calcium metabolism. This assay can be used intra-operatively.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: K163658
Date Prepared 1.
May 22, 2017
Applicant Information 2.
| Contact: | Darius Daruwala
Regulatory Affairs Senior Specialist |
|----------|---------------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc
511 Benedict Avenue
Tarrytown, NY 10591-5097 |
| Phone: | 914-524-2812 |
| Fax: | 914-524-3579 |
| Email: | darius.daruwala@siemens.com |
Regulatory Information 3.
Table 1. Regulatory Information for ADVIA Centaur PTH Assay
| Trade Name | ADVIA Centaur® Intact Parathyroid Hormone (PTH) |
|---|---|
| Model Numbers | 10699154 (1-pack); 10699155 (5-pack) |
| Common Name | Immunoassay, intact parathyroid hormone |
| Classification Name | Parathyroid Hormone Test System |
| FDA Classification | Class II |
| Review Panel | Clinical Chemistry (75) |
| Product Code | CEW |
| Regulation Number | 862.1545 |
Predicate Device Information 4.
ADVIA Centaur Intact Parathyroid Hormone (iPTH)
Predicate Device Name: ADVIA Centaur Intact Parathyroid Hormone (iPTH)
510(k) Number: K133601
Intended Use / Indications for Use 5.
ADVIA Centaur Intact Parathyroid Hormone (PTH)
The ADVIA Centaur Intact Parathyroid Hormone (PTH) reagent is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma using the ADVIA Centaur XP system.
4
510(k) Summary of Safety and Effectiveness
This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or disorders of calcium metabolism. This assay can be used intraoperatively.
Device Description 6.
| Table 2. Summary of Ingredients of the ADVIA Centaur PTH Assay Components | ||
|---|---|---|
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur PTH Primary Reagent ReadyPack (included in assay kit) | ||
| ADVIA Centaur PTH Lite | ||
| Reagent | 10.0 mL/pack | Acridinium ester-labeled mouse monoclonal |
| anti-human PTH antibody (~0.6 mg/L) in | ||
| buffered saline with mouse gamma globulin, | ||
| bovine serum albumin, and preservatives | ||
| ADVIA Centaur PTH | ||
| Solid Phase Reagent | 20.0 mL/pack | Biotinylated mouse monoclonal anti-human |
| PTH antibody bound to streptavidin-coated | ||
| paramagnetic particles (~0.4 g/L) in buffered | ||
| saline with bovine gamma globulin, bovine | ||
| serum albumin, and preservatives | ||
| ADVIA Centaur PTH Calibrator (included in assay kit) | ||
| ADVIA Centaur PTH Low | ||
| and High Calibrators | 1.0 mL/vial | After reconstitution, low or high levels of intact |
| PTH synthetic peptide in buffered saline with | ||
| human EDTA plasma (10%), surfactants, and | ||
| preservatives |
Purpose of the Submission 7.
The purpose of this submission is a premarket notification for a new device: ADVIA Centaur Intact Parathyroid Hormone (PTH) assay.
8. Comparison of Candidate Device and Predicate Device
| Item | ADVIA Centaur Intact Parathyroid
Hormone (PTH) Assay
(Candidate Device) | ADVIA Centaur Intact Parathyroid
Hormone (iPTH) Assay
(Predicate Device) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in the
quantitative determination of intact
parathyroid hormone (PTH) in human
serum and plasma using the ADVIA
Centaur XP system. | For in vitro diagnostic use in the
quantitative determination of intact
parathyroid hormone (iPTH) in
EDTA plasma or serum using the
ADVIA Centaur systems. |
| Indications for Use | This assay is intended to be used to
aid in the differential diagnosis of
hyperparathyroidism,
hypoparathyroidism, or disorders of
calcium metabolism. This assay can be
used intra-operatively. | This assay is intended to be used to
aid in the differential diagnosis of
hyperparathyroidism and
hypoparathyroidism. |
| Measurement | Quantitative | Same |
Table 3. Comparison of ADVIA Centaur PTH Assay to Predicate
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| ltem | ADVIA Centaur Intact Parathyroid
Hormone (PTH) Assay
(Candidate Device) | ADVIA Centaur Intact Parathyroid
Hormone (iPTH) Assay
(Predicate Device) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Chemiluminescence | Same |
| Assay Protocol | Sandwich immunoassay | Same |
| Traceability/
Standardization | Internal standards. Values have been
assigned to correlate to the Predicate
device. | Same |
| Specimen Type | Human serum and plasma | Same |
| Sample Volume | 50 uL | 200 µL |
| Measuring Range | 6.3 to 2000 pg/mL | 6.3 — 1900 pg/mL |
| Calibration | 2-point calibration | Same |
| Detection Antibody | Mouse monoclonal antibody
conjugated to Acridium Ester in the
Lite Reagent | Goat polyclonal antibody
conjugated to Acridium Ester in the
Lite Reagent |
| Capture Antibody | Biotinylated mouse monoclonal anti-
human PTH antibody with
streptavidin-coated paramagnetic
particles pre-formed in Solid Phase
Reagent | Biotinylated goat polyclonal anti-
human PTH antibody with
streptavidin-coated paramagnetic
particles pre-formed in Solid Phase
Reagent |
| Expected Values | 18.4 - 80.1 pg/mL (plasma)
18.5 – 88.0 pg/mL (serum) | 13.8 - 85.0 pg/mL (plasma)
12.4 - 76.8 pg/mL (serum) |
Standard/Guidance Document References 9.
The following recognized standards from Clinical Laboratory Standards Institute (CLSI) were used as a basis of the study procedures described in this submission:
- Evaluation of Precision of Quantitative Measurement Procedures; Approved S Guideline - Third Edition (CLSI EP05-A3, 2014; Recognition Number 7-251)
- S Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline (CLSI EP06-A, 2003; Recognition Number 7-193)
- Interference Testing in Clinical Chemistry: Approved Guideline Second Edition S (CLSI EP07-A2, 2005; Recognition Number 7-127)
- S Measurement Procedure Comparison And Bias Estimation Using Patient Samples --Third Edition (CLSI EP9-A3, 2013; Recognition Number 7-245)
- Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: S Approved Guideline -- Second Edition (CLSI EP17-A2, 2013; Recognition Number 7-233)
- S Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition (CLSI EP28-A3c - formerly C28-A3c, 2010; Recognition Number 7-224)
- S Medical devices – Application of risk management to medical devices (ANSI/AAMI/ISO 14971:2007/(R)2010; Recognition Number 5-70)
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10. Performance Characteristics: ADVIA Centaur PTH
10.1 Precision
A 20-day precision study was performed according to CLSI EP5-A2. Six EDTA plasma samples and three levels of controls were tested.
| Sample | Mean | | Repeatability
(Within-Run) | | | Within-Lab
(Total Precision) | | |
|------------------------------------|---------|----------|-------------------------------|----------------|------|---------------------------------|----------------|------|
| | (pg/mL) | (pmol/L) | SD
(pg/mL) | SD
(pmol/L) | % CV | SD
(pg/mL) | SD
(pmol/L) | % CV |
| Sample 1 | 16.9 | 1.79 | 0.9 | 0.09 | 5.16 | 1.1 | 0.12 | 6.78 |
| Sample 2 | 50.3 | 5.34 | 1.4 | 0.15 | 2.78 | 2.3 | 0.24 | 4.57 |
| Sample 3 | 146.4 | 15.52 | 1.9 | 0.20 | 1.30 | 2.9 | 0.30 | 1.95 |
| Sample 4 | 409.2 | 43.37 | 6.8 | 0.72 | 1.67 | 16.9 | 1.79 | 4.13 |
| Sample 5 | 596.3 | 63.20 | 7.3 | 0.78 | 1.23 | 9.7 | 1.02 | 1.62 |
| Sample 6 | 1080.4 | 114.52 | 11.8 | 1.25 | 1.09 | 25.1 | 2.66 | 2.32 |
| ADVIA Centaur PTH Quality Controls | | | | | | | | |
| Control 1 | 41.6 | 4.41 | 0.4 | 0.04 | 0.91 | 1.4 | 0.15 | 3.36 |
| Control 2 | 235.9 | 25.00 | 1.9 | 0.20 | 0.81 | 4.4 | 0.46 | 1.85 |
| Control 3 | 874.0 | 92.64 | 8.0 | 0.85 | 0.92 | 18.4 | 1.96 | 2.11 |
10.2 Linearity
A linearity study was performed according to CLSI EP06-A using 11 serially diluted samples spanning the assay range. The mean was taken from each sample tested in triplicate. As presented below, the bias from the linear fit estimate was 2000 pg/mL (> 212 pmol/L).
10.11 Stability
The onboard stability of the ADVIA Centaur PTH reagents is 28 days with a calibration interval of 21 days. Unopened reagents and calibrators are stable until the date printed on the box label when stored at 2-8°C.
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10.12 Clinical Study
A clinical study was performed to confirm the effectiveness of the ADVIA Centaur® Intact Parathyroid Hormone (PTH) assay for Intra-operative (IO) use. Sets of specimens from 30 subjects that qualified for the primary endpoints (described below), that met the inclusion criteria, and which were not excluded based on exclusion criteria, were analyzed using the ADVIA Centaur PTH assay on the Centaur XP system.
The following Inclusion/exclusion criteria were used:
Inclusion Criteria
- Patients undergoing parathyroid surgery with intra-operative parathyroid (PTH) . testing.
- Patients who have available preoperative calcium and PTH measurements .
- Patients who have baseline PTH and PTH monitored on the day of surgery on a . clinical PTH test device cleared by the FDA for use intra-operatively.
Exclusion Criteria
- Patients who do not meet inclusion criteria.
- Specimens for which handling and storage quidelines aren't followed.
- Specimens which do not have sufficient quantity available for testing.
- Specimens from pediatric subjects (