The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders.

The ARCHITECT Intact PTH Calibrators are for the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma.

The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

For in vitro diagnostic use.

Device Description

The ARCHITECT Intact PTH assay is a two-step sandwich immunoassay for the quantitative determination of intact PTH in human serum and plasma using CM1A technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent, and anti-PTH coated paramagnetic microparticles are combined. Intact PTH present in the sample binds to anti-PTH coated microparticles. After washing, the anti-PTH acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of intact PTH in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of intact PTH in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT Intact PTH calibration.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantifiable acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, accuracy thresholds). Instead, the primary acceptance criterion appears to be substantial equivalence to the predicate device, the ROCHE® Elecsys Parathyroid Hormone Test System (K992680). The performance is reported in terms of correlation coefficients.

Acceptance Criterion (Implicit)	Reported Device Performance (ARCHITECT iPTH vs. ROCHE Elecsys PTH)
Substantial Equivalence in Performance (ROUTINE protocol)	Correlation Coefficient = 0.99
Substantial Equivalence in Performance (STAT protocol)	Correlation Coefficient = 0.99
Substantial Equivalence in Performance (Clinical)	Correlation Coefficient = 0.99

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size used for the performance comparison studies (non-clinical or clinical). It only states that the ARCHITECT Intact PTH assay 'demonstrated substantially equivalent performance to the Roche Elecsys PTH'.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given text. The studies appear to be comparative performance studies against a predicate device, which itself acts as the "ground truth" for comparison, rather than requiring independent expert-established ground truth. This is common for IVD devices where the performance is benchmarked against an existing, approved method.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the study design is a comparison to a predicate device, a complex adjudication method for establishing ground truth is likely not applicable in the same way it would be for, for example, an imaging AI device interpreting images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size: This type of study and effect size is not applicable as this is an in vitro diagnostic (IVD) immunoassay device, not an AI device designed to assist human readers (e.g., radiologists). The device itself performs the measurement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are inherently standalone performance evaluations of the ARCHITECT Intact PTH assay. The device measures intact PTH quantitatively from human serum and plasma directly. There is no "human-in-the-loop" component in the assay's primary function of determining the hormone concentration. The output is a numerical value, not an interpretation requiring human input for its primary function.

7. The Type of Ground Truth Used

The "ground truth" used for these studies was the performance of the legally marketed predicate device: The ROCHE® Elecsys Parathyroid Hormone Test System (K992680). The ARCHITECT Intact PTH assay's results were compared directly against those produced by the Roche Elecsys PTH system.

8. The Sample Size for the Training Set

This information is not provided in the given text. This device is an immunoassay, not a machine learning or AI algorithm that typically has a separate "training set." The development of the assay (e.g., optimizing reagents, establishing calibration curves) is a different process than "training" an AI model.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is generally not applicable in the context of a traditional immunoassay. For such devices, "ground truth" typically refers to the results obtained from a reference method or validated predicate device during performance evaluation, not a "training set" ground truth in the AI sense. The "ground truth" for calibrators and controls would have been established through a robust process of analytical characterization and traceability to higher-order reference materials, but the document does not detail this.

Summary

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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.

K063232 The Assigned 510(k) Number is:

Preparation Date: October 17, 2006

Applicant Name:

Mr. Joan Guixer Director of Quality Assurance and Regulatory Affairs Biokit S.A. Llica d'Amunt Barcelona, Spain 08186

Device Name:

Reagents Classification Name: Parathyroid Hormone test system Trade Name: ARCHITECT® iPTH Immunoassay Common Name: iPTH test Governing Regulation: 862.1545 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CEW

Calibrators:

Classification Name: Calibrator, Secondary Trade Name: ARCHITECT® iPTH Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT

Controls:

Classification Name: Single (specified) analyte controls (assayed and unassayed) Trade Name: ARCHITECT® iPTH Controls Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX

ARCHITECT iPTH 510k Submission 510k_Summary Final Page 1 of 3

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Legally marketed device to which equivalency is claimed:

The ROCHE® Elecsys Parathyroid Hormone Test System (K992680) is used as the predicate device.

Intended Use of Device:

The ARCHITECT® Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma.

The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

Indications for use of the device:

The ARCHITECT Intact PTH assay as an aid in the differential diagnosis of hypercalcemia, hypocalcemia and parathyroid disorders.

Description of Device:

Comparison of Technological Characteristics:

The ARCHITECT Intact PTH assay is a chemiluminescent microparticle immunoassay (CMIA) method for the quantitative determination of the intact PTH in human serum or plasma. The ROCHE Elecsys PTH assay uses streptavidin-coated microparticles for the determination of the routine intact PTH in human serum and plasma.

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Summary of Non-Clinical Performance:

The ARCHITECT Intact PTH assay is substantially equivalent to the Roche Elecsys PTH.

The ARCHITECT Intact PTH demonstrated substantially equivalent performance to the Roche Elecsys PTH for the ROUTINE protocol with a correlation coefficient of 0.99 and for the STAT protocol with a correlation coefficient of 0.99.

Summary of Clinical Performance:

The ARCHITECT Intact PTH demonstrated substantially equivalent performance to the Roche Elecsys PTH with a correlation coefficient of 0.99.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

BioKit S.A. c/o Mr. Joan Guixer Quality Assurance and Regulatory Affairs Can Male s/n Llica dAmunt Barcelona, Spain 08186

JUN 1 9 2007

Re: K063232

Trade/Device Name: Architect Intact PTH Reagents, Calibrators (A-F) and Controls (Low, Medium, High) Regulation Number: 21 CFR §862.1545 Regulation Name: Parathyroid hormone test system, Regulatory Class: Class II Product Code: CEW, JJX, JIT Dated: May 21, 2007 Received: May 24, 2007

Dear Mr. Guixer:

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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Page 2 -

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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., 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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ARCHITECT Intact PTH Indications for Use Statement ADMIN 5.0

510(k) Number (if known):

Device Name: ARCHITECT® Intact PTH REAGENTS, CALIBRATORS (A-F) and CONTROLS (LOW, MEDIUM, HIGH)

Indications for Use: Reagents

The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders.

Calibrators

The ARCHITECT Intact PTH Calibrators are for the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma.

Controls

The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

For in vitro diagnostic use.

Prescription Use × (Part 21 CFR 801 Subpart D) 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)

gnostic Devices (CIVD)
Carol C. Benson
on Sign-Off

ARCHITECT iPTH 510k Submission Indications_for_Use_Statement_Fina!

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Tice of In Vitro Diagnostic Device Coluation and Safety

K063232

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.