The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum or plasma.

Device Description

The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

AI/ML Overview

This is a 510(k) premarket notification for in vitro diagnostic calibrators and controls used with the ARCHITECT® i System for quantitative determination of human insulin. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for device performance as would be expected for a diagnostic algorithm. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here's the information that can be extracted, along with explanations for the missing data:

Acceptance Criteria and Device Performance

This submission does not define specific performance metrics like sensitivity, specificity, accuracy, or AUC for an algorithm. Instead, it demonstrates similarity in intended use, methodology, binding protein, assay protocols, and traceability/standardization to legally marketed predicate devices. The "acceptance criteria" are implicitly met by demonstrating these similarities and the fact that the FDA granted substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence Aspects)	Reported Device Performance (ARCHITECT® Insulin Calibrators & Controls)
Calibrators
Intended Use	For calibration of ARCHITECT® i System for quantitative determination of human insulin in human serum and plasma.
Methodology	CMIA (Chemiluminescent Microparticle Immunoassay)
Binding Protein	Insulin
Assay Protocols	Direct, quantitative immunoassay
Traceability/Standardization	Relative Light Unit (RLU) matched to Primary Calibrators. Referenced to World Health Organization (WHO) Insulin 1st. International Reference Preparation, 66/304.
Controls
Intended Use	For verification of accuracy and precision of ARCHITECT® i System for quantitative determination of human insulin in human serum or plasma.
Methodology	CMIA (Chemiluminescent Microparticle Immunoassay)
Binding Protein	Insulin
Assay Protocol	Direct, quantitative immunoassay
Levels	3 levels: Low, Medium, and High (targets: 8, 40, 120 μU/mL).

Note: The "performance" here refers to the characteristics that make the device equivalent to existing devices, not clinical performance metrics typical of a diagnostic AI.

Additional Information

Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of an algorithm evaluation. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and intended use, not through a performance study on a specific dataset. Therefore, N/A.
- There is no mention of specific data provenance (e.g., country of origin, retrospective/prospective) because individual patient data samples are not the focus of this type of submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This type of submission (for in vitro diagnostic calibrators and controls) does not involve establishing ground truth from experts for a diagnostic algorithm.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable for this type of medical device submission.
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:
- N/A. This device is a calibrator and control for an automated immunoassay system, not an AI-assisted diagnostic algorithm that involves human reader interpretation. Therefore, no MRMC study or effect size related to human reader improvement is relevant or performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "device" itself (calibrators and controls) is used to ensure the performance of an automated immunoassay system (ARCHITECT® i System). The performance of the calibrators and controls is inherently "standalone" in that they are materials used by an instrument, not an algorithm being evaluated for clinical diagnostic interpretation. However, the concept of "standalone performance" as it applies to a diagnostic algorithm is N/A here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For calibrators, the "ground truth" implicitly refers to the accuracy of the assigned values, which are traceable to the World Health Organization (WHO) Insulin 1st. International Reference Preparation, 66/304. This is a reference standard.
- For controls, the "ground truth" refers to the expected values (targets of 8, 40, 120 μU/mL) used to verify accuracy and precision, which are established against primary controls. This is a reference standard/primary control assignment.
The sample size for the training set:
- N/A. This submission is for calibrators and controls, not a machine learning model. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.

Summary

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APR 1 4 2006

K060359

This is a Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of CFR.

The assigned 510(k) Number is: Company/Contact Person Hideo G. Noda Denka Seiken Co., Ltd. 3-4-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo, Japan 103-0025 Operator Number: 9053049 Establishment Registration Number: 3003871639 Date Prepared: Dec 19, 2005

Device Name

Calibrators

Trade Name: ARCHITECT® Insulin Calibrators (A-F) Common Name: Calibrator Device Classification: 21 CFR 862:1150 Class II Classification Panel: Clinical Chemistry Product Code: JIT

Controls

Trade Name: ARCHITECT® Insulin Controls (Low, Medium, and High) Common name: Quality Control Material (Assayed) Single (Specified) analyte Device Classification: 1 CFR 862:1660 Class I Classification Panel: Clinical Chemistry Product Code: JJX

Legally marketed device to which equivalency is claimed: ADIVA Centaure and ACS: 180 Insulin

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Indications for Use

Koco359 510(k) Number (if known) All

Device Name: ARCHITECT® Insulin Calibrators and Controls

Indications For Use:

Intended Use and Indications for use

The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

______________________________________________________________________________________________________________________________________________________________________________ Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 CFR 801 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)

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Description of the Device

Calibrators

The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

Controls

Comparison of Technological Characteristics:

The ARCHITECT® Insulin Calibrators (A-F) is substantially equivalent to the ADIVA Centaur and ACS 180 Insulin Calibrators (K021535).

Comparison with predicate: Calibrators

Similarities:

Calibrator	Device	Predicate
Intended Use	The ARCHITECT® Insulincalibrators are forcalibration of theARCHITECT® i Systemwhen used for thequantitative determination ofhuman insulin in humanserum and plasma.	For in vitro diagnostic use inthe calibrating the ADIVACentaur® or ACS 180®Insulin assays.
Methodology	CMIA (ChemiluminescentMicroparticle Immunoassay)	ChemiluminescentMicroparticle Immunoassay
Binding Protein	Insulin	Insulin
Assay Protocols	Direct, quantitativeimmunoassay	Direct, quantitativeimmunoassay
Traceability/Standardization	Relative Light Unit (RLU)matched to PrimaryCalibrators. Thecalibrators of theARCHITECT Insulin arereferenced to the WorldHealth Organization (WHO)	Referenced to the WorldHealth Organization (WHO)Insulin 1st. InternationalReference Preparation,66/304.Assigned values of

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Insulin 1st. InternationalReference Preparation,66/304	calibrators are traceable tothis standardization
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Comparison with predicate: Controls

The ARCHITECT® Insulin Controls (Low, Medium and High) are substantially equivalent to the Bayer Ligand Plus 1, 2, 3 Controls (K030452).

Comparison with predicate: Controls

Similarities:

Controls	Device	Predicate
Intended Use	The ARCHITECT® InsulinControls are for theverification of the accuracyand precision of theARCHITECT® i Systemwhen used for thequantitative determination ofhuman insulin in humanserum and plasma.	For the in vitro diagnosticuse to monitor the precisionand accuracy ofimmunochemistry andprocedures for ADIVACentaur® and ACS 180®Systems.
Methodology	ChemiluminescentMicroparticle Immunoassay(CMIA)	ChemiluminescentMicroparticle Immunoassay
Binding Protein	Insulin	Insulin
Assay Protocol	Direct, quantitativeimmunoassay	Direct, quantitativeimmunoassay
Levels	3 levels Low, Medium andHigh: targets: 8, 40,120 μU/mL.	3 levels (Ligand 1, 2, 3).

Comparison with predicate: Calibrators

Differences:

Calibrators	Device	Predicate
Platform	ARCHITECT® i System	ADIVA Centaur® or ACS180®
Matrix	Acetate buffer with sodium	Buffered saline with

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	azide and preservatives	casein, potassiumthiocyanate (3.89%),sodium azide andpreservatives
Calibration Range/Levels	6 levels: 0, 3, 10, 30, 100,and 300 µU/mL,	High and Low level, perassigned value card
Assay Sample Type	Serum and plasma	Serum

Comparison with predicate: Controls

Differences:

Control	Device	Predicate
Platform	ARCHITECT® i System	ADIVA Centaur® or ACS180°
Matrix	Acetate buffer withpreservatives	Lypholized, MultiConstituent Controls.
		Human serum with
		nonhuman contents added,
		no preservatives or
		stabilizers
Traceability	Primary Controls	Not given
Value Assignment	Relative Light Unit (RLU)matched to PrimaryControls.	Adjusted to the level listed
		in expected values of assay
		package insert.
Assay Sample Type	Serum and plasma	Serum

Conclusion:

As summarized above the ARCHITECT® Insulin Calibrators (A-F) and Controls (Low, Medium, and High) are substantially equivalent to the ADIVA Centaur® and ACS: 180® Insulin Calibrators (K021535) and Bayer Ligand Plus 1, 2, 3 Controls (K030452).

Substantial equivalence for the calibrators has been demonstrated as recommended by the FDA Guidance for Industry "Abbreviated 510(k) Submission for In Vitro Calibrators" (issued on: Feb 22, 1999) and for controls as recommended by the FDA Guidance for Industry "Points To Consider Document On Assayed and Unassayed Quality Control Material" (Draft Guidance Released for comment on February 3, 1999).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text is in all capital letters and is written in a sans-serif font.

Public Health Service

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

APR 1 4 2006

Mr. Toshimi Matsunaga Denka Seiken Co., Ltd. 1-2-2 Minamihoncho, Gosen-shi Niigata, Japan 959-1695

Re: K060359

Trade/Device Name: ARCHITECT® Insulin Calibrators and Controls Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: February 2, 2006 Received: March 2, 2006

Dear Mr. Matsunaga:

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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Albert G. A.

Alberto Gutierrez, 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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Indications for Use

510(k) Number (if known) NA K060359

Device Name: ARCHITECT® Insulin Calibrators and Controls

Indications For Use:

Intended Use and Indications for use

The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

Prescription Use(Part 21 CFR 801 Subpart D)	YES
	AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)	NO

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device
Evaluation and Safety

K060359

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.