The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum and EDTA 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. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

Device Description

The Nichols Advantage® Bio-Intact PTH (1-84) assay is a fluorescence immunometric assay for quantifying PTH in human serum or plasma.

AI/ML Overview

The provided text describes a Special 510(k) submission for the "Nichols Advantage Bio-Intact PTH (1-84)" immunoassay. This submission focuses on
labeling changes and new clinical performance data rather than establishing new acceptance criteria or presenting a comprehensive study of the device meeting pre-defined acceptance criteria.

The submission outlines changes to the "Expected Values section" in the labeling and includes a reference range study. It also details a new clinical performance study. However, it does not explicitly state acceptance criteria in numerical or qualitative terms, nor does it present a formal study demonstrating the device meets such criteria with specific performance metrics against those criteria.

Therefore, the requested information elements related to specific acceptance criteria and a study proving the device meets them cannot be directly extracted from the provided text in the typical format you might expect for a pre-market submission focused on efficacy.

However, I can provide the available information from the text, interpreting the clinical performance study as the closest equivalent to a study demonstrating device performance.

Here's the breakdown of what can be extracted, and where information is not available:

Acceptance Criteria and Device Performance

Since specific acceptance criteria are not explicitly stated in the provided text, I will interpret the outcomes of the clinical performance study as the "reported device performance." The purpose of this study was to provide clinicians and laboratories with new information to interpret PTH results, particularly for establishing a local reference range.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Clinical Performance Study)
(Not explicitly defined in the text)	Scattergram generated by plotting serum calcium (x-axis) versus Bio-Intact PTH (y-axis) on `n=63` patients with surgically confirmed primary hyperparathyroidism, `n=6` patients with hypoparathyroidism, `n=3` patients with hypercalcemia due to malignancy, and `n=276` normal individuals.

Study Details (Clinical Performance Study)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: n=63 patients with surgically confirmed primary hyperparathyroidism, n=6 patients with hypoparathyroidism, n=3 patients with hypercalcemia due to malignancy, and n=276 normal individuals.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text refers to it as a "Study was performed," suggesting it could be prospective, but this is not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth for the patient groups (e.g., "surgically confirmed primary hyperparathyroidism") is implied to be clinical diagnosis, but the involvement of specific experts in establishing this for the test set is not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is an in vitro diagnostic immunoassay (a laboratory test for measuring PTH levels), not an AI/imaging device that would typically involve human "readers" or an MRMC study comparing human performance with and without AI assistance. Therefore, this type of study was not applicable and not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is an in vitro diagnostic immunoassay. Its "performance" is inherently standalone in the sense that the assay itself measures the analyte. Human involvement comes in collecting samples, running the assay, and interpreting the raw result in a clinical context. The clinical performance study described assesses the device's ability to differentiate patient populations based on its PTH measurements, which is effectively its standalone performance in that context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the patient cohorts appears to be clinical diagnosis, with some explicitly stated as "surgically confirmed." For "normal individuals," the ground truth would be the absence of relevant disease or symptoms.
The sample size for the training set:
- This submission describes a clinical performance study on specific patient cohorts intended to provide data for interpretation, particularly for developing local reference ranges. It does not mention a "training set" in the context of machine learning model development. The data appears to be for characterizing performance across specific clinical conditions, not for training a predictive algorithm.
How the ground truth for the training set was established:
- As there is no mention of a "training set" in this context, this information is not applicable.

Summary

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K033302

JAN 2 6 2004

Special 510(k) Nichols Advantage Bio-Intact PTH (1-84) Date Prepared: 1/23/04

Special 510k Summary 11.0

11.0 - Special 510K Summary
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

of SMDA 1990 and 21 OF N 007.02.

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 FAX: 949-940-1010
Contact Person: Jimmy Wong, Manager of Clinical and Technical Affairs Date Prepared: Jan. 23, 2004

2. Device Name:

Trade/Proprietary Name: Common Name: Classification Name: Classification: 3.

Nichols Advantage® Bio-Intact PTH (1-84) Parathyroid hormone immunoassay Radioimmunoassay, Parathyroid Hormone Class II Regulation Number: 862.1545 Product Code: CEW, Clinical Chemistry

Nichols Advantage Bio-Intact PTH (1-84) K013992 Predicate Device: 4.
Predicate Device: 5. Device Description. The Nierole Havemily in escence immunometric assay for quantifying PTH in human serum or plasma.
PTH in human serum or plasma.
Intended Use: The Nichols Advantage® Bio-Intact PTH (1-84) immunometic assay is ్. Intended for use with the Nichols Advantage Specialty System to measure the levels of Intended for use will the Nielbis Advantage - Specifical of parathyroid hormone paratifying normone in Scrain and Leansis of hypercalcemia (abnormally high levels of levels are used in the unterentia (abnormally low levels of calcium in the blood) calcidin in the blood) and inypocalcem. Assay results should be used in conjunction resulting iron disorders of odloidin metalonion in making individual patient management decisions.
7 Conclusions: The Nichols Advantage Bio-Intact PTH (1-84) assay (FDA 510k K013992 Conclusions: The Nichols Auvantage Bio Intact The (de new information and labeling.

Changes to the Expected Values section were made in the labeling. A new reference range Oneliges to the Expoctod the results of that study were included in the new labeling. Study was performed, and the Nichols Bio-Intact PTH (1-84) assay are being Olimicians, and faberatery access that they can make informed decisions on how to conduct provided the new information of the such information can be used to interpret PTH ther own reliefice rango ottation and on original covariates that can affect calcium metabolism and results. New information is the brond hormone levels, and literature references that pertain to this topic.

The Special 510(k) includes new data on the clinical performance of the test performed on The Opeoful o ro(in) inola00 new clinical disorders of calcium metabolism. Serum calcium and PTH testing was performed on n=63 patients with surgically confirmed primary r TTT testing was porfernou "owith hypoparathyroidism, n=3 patients with hypercalcemia riyo mathyroldion, and n=276 normal individuals. By plotting the serum calcium (x-axis) uue to manghanty, and 11-270 normal scattergram was created. The scattergram serves versus the Bio into in the differential and hypocalcemia when both Bio-Intact PTH (1-84) and calcium testing are performed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 6 2004

Mr. Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673

K033302 Re:

Trade/Device Name: Nichols Advantage Bio-Intact PTH (1-84) Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: December 19, 2003 Received: December 31, 2003

Dear Mr. Wong:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon - 1 (x) pe instantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard) the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, in other with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (710t) that do not request to the general controls provisions of the Act. The I ou may, dicrerere, maines of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (soral controls. Existing major regulations affecting your device can may be subject to such adultions retires in Regulations (CFR), Parts 800 to 895. In addition, FDA oe found in The 21, 21, 21, 2017 device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Drivisation of our device complies with other requirements of the Act that I DA has made a devel ministered by other Federal agencies. You must of any I cut all the Act's requirements, including, but not limited to: registration and listing (21 comply writtle and the 11th 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) This letter will anow you to oegin maing of substantial equivalence of your device to a legally prematics notification: "Tics Dr. I 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 you desire specific nevertising of your device, please contact the Office of of questions on the promote and Safety at (301) 594-3084. 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 Tou may oount oner getierers, 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.

Jean 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

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Indications for Use Statement 3.0

INDICATIONS FOR USE STATEMENT

510(k) Number:

Electrical (RTU 1 & 2)

Device Name:

Nichols Advantage Bio-Intact PTH (1-84)

3307

Indications for Use Statement: The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System thindhomethous of parathyroid hormone in serum and EDTA plasma. to measurements of parathyroid hormone levels are used in the differential diagnosis of Mcasarements of parathylord northerels of calcium in the blood) and hypocalcemia nyporcalcomia (abnormally in the blood) resulting from disorders of calcium (abmornially low levelo 'er bandle be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

(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)

Over-The-Counter Use
(Optional Format 1-2-96)

Carol C Benson for Jean Cooper, DUM
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K033302 SPECIAL

Date Printed: 10/10/2003 Created by Jimmy Wong

Regulation Number and Section

§ 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.