(70 days)
Not Found
No
The summary describes a standard immunoassay kit and system for measuring parathyroid hormone levels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the chemical and analytical aspects of the assay.
No
The device is an in vitro diagnostic immunoassay that measures parathyroid hormone levels, which is used for diagnosis and monitoring, not for treating a condition.
Yes
The device is intended for the quantitative determination of parathyroid hormone levels, which are used in the differential diagnosis of hypercalcemia and hypocalcemia, and as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism. This explicitly states its use in diagnosis and monitoring, which are functions of a diagnostic device.
No
The device description clearly states it is an "assay" containing "reagents" for a "two-site chemiluminometric assay." This indicates a chemical-based laboratory test, which is a hardware-dependent process, 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's for the "quantitative determination of intact parathyroid hormone in serum, EDTA plasma, and heparinized plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The measurements are used in the "differential diagnosis of hypercalcemia and hypocalcemia" and as an "aid in monitoring therapeutic intervention." These are diagnostic and monitoring purposes, which are key functions of IVDs.
- Device Description: It describes an "assay," which is a common term for a laboratory test performed in vitro.
- Predicate Device: The mention of a predicate device (K962598) is common for IVDs seeking regulatory clearance, indicating it's being compared to a previously approved IVD.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone Immunoassay is intended for use with the Nichols Advantage Specialty System for the quantitative determination of intact parathyroid hormone in serum, EDTA plasma, and heparinized 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. Measurements of intact parathyroid hormone levels are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions."
Product codes (comma separated list FDA assigned to the subject device)
CEW
Device Description
The Nichols Advantage Intact PTH assay contains sufficient reagents for 100 tests. The assay is a two-site chemiluminometric assay specific for Intact PTH.
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)
- Crossreactivity to human PTH 7-84 was determined to be equimolar in the assay.
- Crossreactivity to human PTHrP 1-40 was determined to not cross react in the assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) Summary 11.0
This summary of safety and effectiveness is being submitted in accordance with the requirement: of SMDA 1990 and 21 CFR 807.92.
1. Name of Manufacturer, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673 Phone: 949-940-7260 FAX: 949-940-7313 Contact Person: Jimmy Wong, Manager of Clinical and Technical Affairs Date Prepared: March 25, 2004
2. Device Name:
| Trade/Proprietary Name: | Nichols Advantage® Chemiluminescence Intact Parathyroid
Hormone |
|-------------------------|----------------------------------------------------------------------------------|
| Common Name: | Radioimmunoassay, Parathyroid Hormone |
| Classification Name: | Parathyroid hormone test system |
| 3. Classification: | Class II
Regulation Number: 862.1545
Product Code: CEW, Clinical Chemistry |
| Predicate Device: | Nichols Advantage Chemiluminescence Intact Parathyroid
Hormone |
Device Description: 4.
The Nichols Advantage Intact PTH assay contains sufficient reagents for 100 tests. The assay is a two-site chemiluminometric assay specific for Intact PTH.
Indications for Use: 5.
"The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone Immunoassay is intended for use with the Nichols Advantage Specialty System for the quantitative determination of intact parathyroid hormone in serum, EDTA plasma, and heparinized 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. Measurements of intact parathyroid hormone levels are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions."
6. Comparison to Predicate Device:
- Heparinized plasma was added to the specimen matrix for Intact PTH testing. .
- Use of 6 different blood collection tubes was compared for similarities and differences for . Intact PTH testing, and results of comparative testing yield essentially equivalent results.
- Specimen stabilities have been included in the new labeling for EDTA plasma, . Heparinized plasma, and serum testing.
- New labeling and scientific references supporting use of Intact PTH testing in patients . with chronic kidney diseases were added.
7. Similarities:
- There is no change in technology from the original device cleared under K962598. .
Additional Performance Characteristics 8.
1
- Crossreactivity to human PTH 7-84 was determined to be equimolar in the assay. .
- Crossreactivity to human PTHrP 1-40 was determined to not cross react in the assay. .
Conclusions: The device with modified labeling is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
JUN = 8 2004
Mr. Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 1311 Calle Batido San Clemente, California 92673
K040813 Re:
K040013
Trade/Device Name: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: March 20, 2004 Received: March 30, 2004
Dear Mr. Wong:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaren by (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to they 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de necs that have been that do not require approval of a premarket approval application (PMA). and Coometier fore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerers, mains 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 it may be subject to bach additions (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 1 Icase oc advised that I Driv issualite or our device complies with other requirements of the Act that I Dr has intact and regulations administered by other Federal agencies. You must or any I catal statutes and sequirements, 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).
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogin maketag your courselence of your dever to a legally premarket nothleation: "The PDA misms of basification 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, of If you desire specific information about and approvince of your device, please contact the Office of of questions on the promionon and Safety at (301) 594-3084. Also, please note the In Viro Diagnostic Device Evanances and season ... ... ... ... ... ... ... ... ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . regulation entitied, "Wilsonanaing of responsibilities under the Act from the You may of amall 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040813
Device Name: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone
Indications For Use:
The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone The Nichols Advantage Shemilaninessenos intact Partially System for the immunuassay is intended for ass internethyroid hormone in human EDTA plasma, quantitative uctermination of intast psucements of parathyroid hormone levels are used nepannized plasma and soram mercalcemia (abnormally high levels of calcium in the in the unlerential diagnolo of hyporoulow.levels of calcium in the blood) resulting from blood) and flypodioomia (abhermants of intact parathyroid hormone levels disorucis or odicially and in monitoring therapeutic intervention of secondary are also used an an all infinently occurs in chronic kidney disease. Assay results nypelparathyroldent that took with other clinical data to assist the clinician in making individual patient management decisions.
Prescription Use (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)
Alberto Cals
Division Sign-
Office of In Vitro Diagnos Device Evaluation and S
510(k) K040813
Page 1 of