(52 days)
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No
The description details a standard immunoassay technology and mentions no AI/ML components or algorithms. The performance studies are based on method comparison, not AI/ML model validation.
No.
This device is an immunoassay intended for the in vitro quantitative determination of intact parathyroid hormone levels, used as an aid in differential diagnosis, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Intact PTH levels can be used to aide in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy," indicating its role in diagnosis.
No
The device description clearly outlines a physical immunoassay kit with reagents and a process involving incubation, washing, and measurement on automated analyzers (ACS:180 and ADVIA Centaur), indicating it is a hardware-based diagnostic test, not software only.
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 device is for the "quantitative determination of intact parathyroid hormone in human EDTA plasma". This involves testing a sample taken from the human body (plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a laboratory-based immunoassay process using reagents and analyzers to measure a substance in a biological sample. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies involve comparing the results of this device with other diagnostic tests (Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) and the ACS:180 iPTH) using human plasma samples. This is a standard practice for validating IVD devices.
- Predicate Device: The mention of a "Predicate Device" (K954418; Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit / Nichols IRMA Intact PTH) which is also an IVD, further supports that this device falls into the same category.
The core function of the device is to analyze a biological sample in vitro to provide information used for diagnosis, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative determination of intact parathyroid hormone in human EDTA plasma on the automated analyzers marketed by Bayer Corporation. Measurements of intact PTH levels are used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
Product codes
CEW, JJX, JIT
Device Description
The ACS:180 Intact PTH assay is a two-site "sandwich" immunoassay using direct, chemiluminometric technology, which uses two affinity purified goat polyclonal antibodies specific for the PTH molecules. The first antibody is directed toward the N-terminal (1-34) antigenic PTH domain and is labeled with acridinium ester (AE). The second antibody is directed toward the C-terminal (39-84) antigenic domain and is labeled with biotin. Patient sample (calibrator or control material) is incubated, for 5 minutes at 37°C with the Lite Reagent (LR) material that contains both the capture and tracer antibody conjugates. An immuno-complex is formed between the intact PTH in the sample and the two antibody conjugates. Subsequently, Solid Phase (SP) reagent is added and incubated for 2.5 minutes at 37°C. The immuno-complex molecule is captured by the streptavidim coated paramagnetic particles in the SP. Following incubation the unbound antibody conjugates are washed away. The chemiluminescent of the immuno-complex signal is measured in a luminometer. A sample with low intact PTH will have a minimum amount of bound AE label, while samples containing high levels of intact PTH will have maximum label complex bound. Thus, a direct relationship exists between the amount of intact PTH present in the sample and the amount of relative light units (RLUs) detected by the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Method comparison studies were conducted for the ACS:180 iPTH compared to the predicate device Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit, and for ADVIA Centaur iPTH compared to the ACS:180 iPTH.
For ACS:180 iPTH vs. Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH):
- Sample size: 100 EDTA plasma samples
- Range: 5.4 to 1969 pg/mL
- Results (linear regression): y (ACS:180) = 0.976 x (Nichols IRMA) - 17 pg/mL
- Correlation coefficient (r): 0.985
- N: 100
- Sy.x: 66
For ADVIA Centaur iPTH vs. ACS:180 iPTH:
- Sample size: 268 EDTA plasma samples
- Range: 9.3 to 1981 pg/mL
- Results (equation): ADVIA Centaur iPTH = 1.03 (ACS:180 iPTH) + 3.36 pg/mL
- Correlation Coefficient (r): 0.994
- N: 252
- Sy: 31
Key Metrics
Correlation coefficient (r) = 0.985 for ACS:180 iPTH vs. Nichols IRMA Intact PTH.
Correlation Coefficient (r) = 0.994 for ADVIA Centaur iPTH vs. ACS:180 iPTH.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
MAR 1 5 2002
Bayer Diagnostics ASC:180 Intact Parathyroid Hormone (iPTH) Immunoassay Section 2: Summary of Safety and Effectiveness
This Summary of Safety and Effectiveness has been prepared in accordance with the requirements of 21 CFR 807.92.
1. Submitter Information
| Contact person: | Kenneth T. Edds, Ph.D. |
|---|---|
| Address: | Bayer Diagnostics Corporation |
| 511 Benedict Ave. | |
| Tarrytown, NY 10591 | |
| Phone: (914) 524-2446 | |
| FAX: (914) 524-2500 | |
| e-mail: ken.edds.b.@bayer.com | |
| Date Summary Prepared: | January 9, 2002 |
- Device Information
| Proprietary Name: | ACS:180 and ADVIA Centaur Intact PTH
Immunoassay |
|-------------------|-----------------------------------------------------|
| Common Name: | iPTH |
| Classification: | immunological test system |
Classification: Class: CFR: Product Code:
immunological test system Class II Device 21 CFR 862.1545 CEW
3. Predicate Device Information
Name:
Manufacturer:
Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit / Nichols IRMA Intact PTH
Nichols Institute Diagnostics 33608 Ortega Highway San Juan Capistrano, Ca
510(k) Number:
1
4. Device Description
The ACS:180 Intact PTH assay is a two-site "sandwich" immunoassay using direct, chemiluminometric technology, which uses two affinity purified goat polyclonal antibodies specific for the PTH molecules. The first antibody is directed toward the N-terminal (1-34) antigenic PTH domain and is labeled with acridinium ester (AE). The second antibody is directed toward the C-terminal (39-84) antigenic domain and is labeled with biotin. Patient sample (calibrator or control material) is incubated, for 5 minutes at 37°C with the Lite Reagent (LR) material that contains both the capture and tracer antibody conjugates. An immuno-complex is formed between the intact PTH in the sample and the two antibody conjugates. Subsequently, Solid Phase (SP) reagent is added and incubated for 2.5 minutes at 37°C. The immuno-complex molecule is captured by the streptavidim coated paramagnetic particles in the SP. Following incubation the unbound antibody conjugates are washed away. The chemiluminescent of the immuno-complex signal is measured in a luminometer. A sample with low intact PTH will have a minimum amount of bound AE label, while samples containing high levels of intact PTH will have maximum label complex bound. Thus, a direct relationship exists between the amount of intact PTH present in the sample and the amount of relative light units (RLUs) detected by the system.
5. Statement of Intended Use
The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative determination of intact parathyroid hormone in human EDTA plasma on the automated analyzers marketed by Bayer Corporation. Measurements of intact PTH levels are used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
6. Summary of Technological Characteristics
The ACS:180 Intact PTH immunoassay is similar to the predicate device Nichols IRMA Intact PTH Assay Kit in the assay principles and performance characteristics. The ACS:180 Intact PTH immunoassay differs from the predicate device in its intended use on an automated analyzer as compared to a manual coated tube technique. In the automated method a chemiluminogenic (acridinium ester) labeled antibody replaces the radiolabeled antibody in the manual method. The automated method also offers a shorter incubation time, 7.5 minutes compared to 22 hours.
7. Method Comparison
The data represented in this document is organized into two components:
-
- Comparison of the ACS:180 iPTH to the predicate device Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit (K954418) results in section 4.
- Comparison of the ADVIA Centaur to the ACS:180 used transference. Transference is a method 2. recommended by NCCLS (C28-A, How to Define Reference Intervals in the Clinical Laboratory; Approved Guideline). This document discusses and provides guidelines for "transference of s reference interval for an analyte measured by a different analytical system, different method or different instrument. Results are in section 5.
2
ACS:180 iPTH vs. Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH)
Substantial equivalence to the Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit, cleared under K954418, is based on method comparison using 100 EDTA plasma samples in the range of 5.4 to 1969 pg/mL. The results using a linear regression are listed below:
y (ACS:180) = 0.976 x (Nichols IRMA) - 17 pg/mL Correlation coefficient ( r ) = 0.985 N = 100 Sy.x = 66
ADVIA Centaur iPTH vs. ACS:180 iPTH
For 268 EDTA plasma samples in the range of 9.3 to 1981 pg/mL, the relationship between the ADVIA Centaur iPTH assay and the ACS:180 iPTH assay is described by the equation:
:
ADVIA Centaur iPTH = 1.03 (ACS:180 iPTH) + 3.36 pg/mL Correlation Coefficient ( r ) = 0.994 N = 252 Sy = 31
3
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 5 2002
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097
Re: K020217
Trade/Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Intact PTH Assay Regulation Number: 21 CFR 862.1545; 21 CFR 862.1660; 21 CFR 862.1150 Regulation Name: Parathyroid hormone test system; Quality control Material (assayed and unassayed); Calibrator Regulatory Class: Class II; Class I, Class II Product Code: CEW; JJX; JIT Dated: January 18, 2002 Received: January 22, 2002
Dear Dr. Edds:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave and have 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 for ass stated in the encreat , 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 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 Part 801); 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.
4
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The IDA inding of succeantly of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and 1 If you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 809.10 for in vito diagnostions on the promotion and advertising of your device, (201) 594-4568. Traditionally, 2011 proce at (301) 594-4639. Also, please note the regulation prease connact the Ornov or Somphises researce to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Solasss "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page i
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Intact PTH Assay
Indications for Use:
The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative determination of intact parathyroid hormone in human EDTA plasma on the automated ACS:180 and decemmation or maor paradifiere net.Raver Corporation. Intact PTH levels can be used to aide in the All VIA Cenada analyzolo marketed of Bosn, hypoparathyroidism, or hypercalcemia of malignancy.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use
| (Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K020217 |
|---|---|
| --------------- | --------- |