(140 days)
Not Found
No
The summary describes a standard immunoassay system for measuring PTH levels. There is no mention of AI, ML, or any computational methods beyond basic statistical analysis for performance evaluation.
No
This device is an immunoassay system designed to quantitatively determine intact parathyroid hormone levels, which is used for diagnostic purposes. It does not directly treat or alleviate a disease.
Yes
The intended use explicitly states that the device is "indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy." This directly indicates its role as a diagnostic tool.
No
The device description explicitly states that the system comprises reagents, calibrators, and immunoassay analyzers (hardware). This indicates it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: The description details reagents and analyzers used to perform the test on human serum and plasma, further confirming the in vitro nature of the device.
- Performance Studies: The performance studies describe testing on "human EDTA plasma samples" and "human EDTA plasma and serum samples," which are biological specimens.
- Predicate Devices: The listed predicate devices (K992680 Elecsys Parathyroid Hormone Test System and K053533 Immulite®/Immulite® 1000 Turbo Intact PTH) are also IVD devices for measuring PTH.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.
Product codes
CEW, JIT
Device Description
The Access Intact PTH reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of intact parathyroid hormone (PTH) levels in human serum and plasma.
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
The summary of clinical studies states that PTH concentrations were measured in subjects aged 19-67 years.
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
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Summary of Performance Studies
Summary of Analytical Studies:
Imprecision: Tested for concentrations from approximately 12 to 1400 pg/mL. Total imprecision ranged from 2.8% to 6.4% CV for the routine mode and 3.1% to 10.6% CV for the intraoperative mode.
Dilution Recovery (Linearity): Multiple dilutions of EDTA plasma samples were analyzed in the routine mode and intraoperative modes. Mean % recovery ranged from 91% to 103% for the routine mode and 85% to 98% for the intraoperative mode.
Methods Comparison:
- Comparison of 500 values using the Access Intact PTH assay routine mode and a commercially available immunoassay system: Range of observations=16-2627 pg/mL, Intercept=-11.5 pg/mL, Slope=1.09, Correlation coefficient (r)=0.99.
- Comparison of 493 values using the Access Intact PTH assay routine mode and the intraoperative mode on the Access Immunoassay system: Range of observations=13-2848 pg/mL, Intercept=9.69 pg/mL, Slope=0.94, Correlation coefficient (r)=1.00.
- Comparison of 393 values using the Access Intact PTH intraoperative mode and a commercially available immunoassay system: Range of observations=8-2453 pg/mL, Intercept=0.13 pg/mL, Slope=0.87, Correlation coefficient (r)=1.00.
Analytical Specificity: No significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, and triglycerides) in either the routine or intraoperative modes.
Stability: Intact PTH reagents stable for 28 days after opening. Intact PTH calibrators single use only. Calibration stable for 28 days.
Summary of Clinical Studies:
To establish a reference range, PTH concentrations were measured in 289 matched human EDTA plasma and serum samples from apparently healthy male and female subjects aged 19-67 years. Samples collected during three time periods in two geographic latitudes. Additional testing performed to exclude individuals with abnormal serum calcium, creatinine or 25-hydroxyvitamin D. A 95% non-parametric reference interval of 12-88 pg/mL was determined. Routine and intraoperative mode reference intervals are equivalent.
Key Metrics
Imprecision (CV): Ranged from 2.8% to 6.4% CV for routine mode and 3.1% to 10.6% CV for intraoperative mode.
Mean % recovery (Linearity): Ranged from 91% to 103% for routine mode and 85% to 98% for intraoperative mode.
Correlation coefficient (r): 0.99, 1.00, 1.00 (for methods comparisons).
Predicate Device(s)
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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510(k) SUMMARY
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.
The assigned 510(k) number is: K061190
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1383 Fax: (952) 368-7610 Contact: Valynda Machen
Date Prepared: August 15, 2006
Device Names
| Proprietary Name: | Intact PTH and Intact PTH Calibrators on the Access® Immunoassay Systems |
|---|---|
| Common Name: | Parathyroid Hormone Test |
| Classification Name: | Radioimmunoassay, Parathyroid Hormone |
Predicate Device(s)
Elecsys Parathyroid Hormone Test System Roche Diagnostics Corporation 9115 Hague Rd Indianapolis, IN 46250
510(k) Number: K992680
Immulite®/Immulite® 1000 Turbo Intact PTH Diagnostic Products Corporation Corporate Offices 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900
510(k) Number: K053533
SEP 15 2006
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Device Description
The Access Intact PTH reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of intact parathyroid hormone (PTH) levels in human serum and plasma.
Intended Use
The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
Comparison of Technological Characteristics
| Attribute | Roche Elecsys Parathyroid
Hormone Test System | Immulite/Immulite 1000 Turbo
Intact PTH | Access Intact PTH |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Immunoassay for the in vitro
quantitative determination of intact
parathyroid hormone in human serum
and plasma for the differential
diagnosis of hypercalcemia and
hypocalcemia. | For in vitro diagnostic use with the
IMMULITE and IMMULITE 1000
Analyzers-for the quantitative
measurement of intact parathyroid
hormone (parathyrin, PTH) in EDTA
plasma or serum. It is intended as an
aid in the differential diagnosis of
hypercalcemia and hypocalcemia
and can be used intraoperatively. | The Access Intact PTH
assay is a paramagnetic
particle, chemiluminescent
immunoassay for the
quantitative determination
of intact parathyroid
hormone (parathyrin, PTH)
levels in human serum and
plasma using the Access
Immunoassay Systems. It
is indicated to aid in the
differential diagnosis of
hyperparathyroidism,
hypoparathyroidism, or
hypercalcemia of
malignancy and can be
used intraoperatively. |
| Assay
Principles | Electrochemiluminescence
immunoassay employing the
sandwich principle. | Solid phase, chemiluminescent
immunometric assay. | The Access Intact PTH
assay is a two-site
immunoenzymatic
("sandwich") assay. |
| Solid
Support | Streptavidin coated microparticles. | Bead coated with affinity purified goat
polyclonal anti-PTH (44-84) antibody. | Paramagnetic particles
coated with goat anti-PTH. |
| Detection
System | Chemiluminescent emission. | Chemiluminescent emission. | Utilizes dioxetane-based
chemiluminescent
substrate;
Measures light production
from a chemiluminescent
reaction. |
| Calibrator | 2 point calibration and master curve
provided via the reagent barcode. | Intact PTH Adjustors (Low and High)
of Iyophilized synthetic human intact
PTH in a buffered matrix. | Six levels (0, ~10, ~60,
~300, ~1500, and ~3500
pg/mL) of synthetic PTH
antigen in a buffered
protein solution with
preservatives. |
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Summary of Analytical Studies
Imprecision: Imprecision was tested for concentrations from approximately 12 to 1400 pg/mL. Total imprecision ranged from 2.8% to 6.4% CV for the routine mode and 3.1% to 10.6% CV for the intraoperative mode.
Dilution Recovery (Linearity): Multiple dilutions of EDTA plasma samples were analyzed in the routine mode and intraoperative modes. Mean % recovery ranged from 91% to 103% for the routine mode and 85% to 98% for the intraoperative mode.
Methods Comparison:
A comparison of 500 values using the Access Intact PTH assay routine mode and a commercially available immunoassay system gave the following statistical data using Deming calculations: Range of observations=16-2627 pg/mL, Intercept=-11.5 pg/mL, Slope=1.09, Correlation coefficient (r)=0.99.
A comparison of 493 values using the Access Intact PTH assay routine mode and the intraoperative mode on the Access Immunoassay system gave the following statistical data using Deming calculations: Range of observations=13-2848 pg/mL, Intercept=9.69 pg/mL, Slope=0.94, Correlation coefficient (r)=1.00.
A comparison of 393 values using the Access Intact PTH intraoperative mode and a commercially available immunoassay system gave the following statistical data using Deming calculations: Range of observations=8-2453 pg/mL, Intercept=0.13 pg/mL, Slope=0.87, Correlation coefficient (r)=1.00.
Analytical Specificity: There was no significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, and triglycerides) in either the routine or intraoperative modes.
Stability: Intact PTH reagents are stable for 28 days after opening. Intact PTH calibrators are singe use only. The calibration is stable for 28 days.
Summary of Clinical Studies
To establish a reference range, PTH concentrations were measured in 289 matched human EDTA plasma and serum samples from apparently healthy male and female subjects aged 19-67 years. Because of significant seasonal variations of 25-hydroxyvitamin D, the samples were collected during three time periods in two geographic latitudes. Additional testing was performed to exclude individuals with abnormal serum calcium, creatinine or 25-hydroxyvitamin D. A 95% non-parametric reference interval of 12-88 pg/mL was determined. Routine and intraoperative mode reference intervals are equivalent.
Conclusion
Intact PTH and Intact PTH Calibrators on the Access Immunoassay Systems is substantially equivalent to the Roche Elecsys Parathyroid Hormone Test System and the Immulite/Immulite 1000 Turbo Intact PTH assay for the quantitative determination of intact PTH levels in human serum and plasma.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Valynda Machen Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
SEP 1 5 2006
K061190 Re:
Trade/Device Name: Access Intact PTH Assay Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW, JIT Dated: August 14, 2006 Received: August 16, 2006
Dear Ms. Machen:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ______k061190
Device Name: Access Intact PTH Assay
Indications For Use:
The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of inumanououroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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