The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency.

The ARCHITECT 25-OH Vitamin D Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of 25-hvdroxyvitamin D (25-OH Vitamin D) in human serum and plasma.

The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of 25-hydroxyvitamin D (25-OH Vitamin D) in human serum and plasma.

For in vitro diagnostic use.
Prescription Use

Device Description

The ARCHITECT 25-OH Vitamin D assay is a delayed one-step immunoassay including a sample pre-treatment for the quantitative determination of vitamin D in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.

Sample and pre-treatment reagent are combined. An aliquot of the pre-treated sample is combined with assay dijuent and paramagnetic anti-vitamin D coated microparticles to create a reaction mixture. Vitamin D present in the sample binds to anti-vitamin D coated microparticles. After incubation a biotinylated vitamin D anti-Biotin acridinium-labeled conjugate complex is added to the reaction mixture and binds to unoccupied binding sites of the anti-vitamin D coated microparticles. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vitamin D in the sample and the RLUs detected by the ARCHITECT i System optics.

AI/ML Overview

The provided 510(k) summary for the ARCHITECT 25-OH Vitamin D assay focuses on demonstrating substantial equivalence to a predicate device rather than establishing comprehensive acceptance criteria with specific thresholds for performance metrics.

Here's an analysis of the available information structured to address your points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (LIAISON® 25 OH Vitamin D TOTAL) in terms of Precision, Linearity, and Interferences	Precision: Substantially equivalent to predicate.
	Linearity: Substantially equivalent to predicate.
	Interferences: Substantially equivalent to predicate.
Correlation with Predicate Device	Correlation Coefficient: 0.93
Slope of Regression Analysis (vs. Predicate)	Slope: 0.97
Intercept of Regression Analysis (vs. Predicate)	Intercept: -1.07

Note: The document states that the ARCHITECT 25-OH Vitamin D assay is "substantially equivalent to the LIAISON® 25 OH Vitamin D TOTAL assay in terms of precision, linearity and interferences." However, specific numerical acceptance criteria (e.g., precision CV% < X%, linearity within Y% deviation) are not explicitly defined in this summary. The reported performance is primarily presented as the correlation with the predicate device.

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

The document does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the sample collection).

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

This type of information is not applicable to this submission, as the "ground truth" for evaluating the ARCHITECT 25-OH Vitamin D assay's performance is based on its correlation with a legally marketed predicate device (LIAISON® 25 OH Vitamin D TOTAL), not on expert consensus or interpretation of images/data. The predicate device's results serve as the reference.

4. Adjudication Method for the Test Set

This is not applicable. As stated above, the evaluation relies on a comparison to a predicate device, not on expert adjudication of a test set.

5. 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 is not applicable. The ARCHITECT 25-OH Vitamin D assay is an in vitro diagnostic (IVD) immunoassay for quantitative determination of a biomarker. It is not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

Yes, the study described is a standalone performance study of the ARCHITECT 25-OH Vitamin D assay. It evaluates the device's analytical performance on its own, comparing its results to a predicate device. There is no "human-in-the-loop" component in the assay's function.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) used for evaluating the ARCHITECT 25-OH Vitamin D assay's performance was the results obtained from the LIAISON® 25 OH Vitamin D TOTAL assay. This represents a comparison to a legally marketed, previously cleared device.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For an immunoassay like this, the "training" equivalent would typically involve assay development and optimization using various formulations and reagent concentrations, rather than a distinct "training set" of patient samples in the way an AI algorithm would have. The performance data presented is likely from a validation or testing set.

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

As noted in point 8, a distinct "training set" with established ground truth in the context of an AI algorithm is not directly applicable here. The development and optimization of the immunoassay would have involved internal analytical validation using reference materials and potentially patient samples, with their values determined by established methods or reference assays. However, the document does not detail this process explicitly. The "ground truth" for the performance evaluation described is the predicate device's results.

Summary

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NOV 23 2011

ARCHITECT 25-OH Vitamin D

510(k) Summary (Summary of Safety and Effectiveness)

This summary of the 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: K110619

Preparation Date: November 16th, 2011

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: Vitamin D test system Trade Name: ARCHITECT 25-OH Vitamin D Immunoassay Common Name: Vitamin D test system Governing Requlation: 862.1825 Device Classification: Class II Product Code: MRG

Calibrators:

Trade Name: ARCHITECT 25-OH Vitamin D Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Chemistry Product Code: JIT

Controls:

Trade Name: ARCHITECT 25-OH Vitamin D Controls (Low, Medium and High) Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Chemistry Product Code: JJX

Legally marketed device to which equivalency is claimed: LIAISON® 25 OH Vitamin D TOTAL (K071480)

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Intended Use of Device:

The ARCHITECT 25-OH Vitamin D Calibrators are for the calibration of the ARCHITECT i Svstem when used for the quantitative determination of 25-hvdroxyvitamin D (25-OH Vitamin D) in human serum and plasma.

Description of Device:

Comparison of Technological Characteristics:

The ARCHITECT 25-OH Vitamin D assav is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma.

The LIAISON® 25 OH Vitamin D TOTAL Assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of the 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA-plasma or lithium heparin plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjuction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population.

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Summary Performance:

The ARCHITECT 25-OH Vitamin D assay is substantially equivalent to the LIAISON® 25 OH Vitamin D TOTAL assay in terms of precision, linearity and interferences as demonstrated in non-clinical performance data in this 510(k) submission.

The ARCHITECT 25-OH Vitamin D demonstrated substantially equivalent performance to the LIAISON® 25 OH Vitamin D TOTAL with a correlation coefficient of 0.93, a slope of 0.97 and an intercept of -1.07.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

NOV 2 3 2011

Biokit S.A c/o Joan Guixer Can Male S/N Llissa D'Amunt, Barcelona · Spain 08186

Re: K110619

Trade Name: Architect 25-OH Vitamin D Assay, Architect 25-OH Vitamin D Calibrators, Architect 25-OH Vitamin D Controls Regulation Number: 21 CFR §862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Codes: MRG, JIT, JJX Dated: November 18, 2011 Received: November 22, 2011

Dear Joan 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, 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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Indication for Use

510(k) Number (if known): 上川口 6 Г 9

Device Name: ARCHITECT 25-OH Vitamin D Reagents, ARCHITECT 25-OH Vitamin D Calibrators (A-F) and ARCHITECT 25-OH Vitamin D Controls (Low, Medium and High)

Indication for Use:

Reagents

Calibrators

The ARCHITECT 25-OH Vitamin D Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of 25-hydroxywitamin D (25-OH Vitamin D) in human serum and plasma.

Controls

For in vitro diagnostic use.

Prescription Use . X (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)

ARS

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110619

Regulation Number and Section

§ 862.1825 Vitamin D test system.

(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.