ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10

K060359 · Denka Seiken Co., Ltd. · JIT · Apr 14, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060359
• Device Name: ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
• Applicant: Denka Seiken Co., Ltd.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 14, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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. 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 Story

Architect Insulin Calibrators and Controls are liquid-based reagents used with the Architect i System. Calibrators (6 levels: 0, 3, 10, 30, 100, 300 µU/mL) calibrate the system for insulin quantification; Controls (3 levels: 8, 40, 120 µU/mL) verify accuracy and precision. Both contain insulin in acetate buffer with sodium azide/antimicrobial preservatives. Used in clinical laboratory settings by trained personnel. Output is used by the Architect i System to generate calibration curves and validate assay performance, ensuring accurate insulin measurement for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed 12-month shelf life at 2-8°C. Traceability established via RLU comparison to WHO Insulin 1st IRP 66/304 with acceptance criteria of +/- 1.5% RLU variation.

Technological Characteristics

Liquid-based calibrators and controls; insulin in acetate buffer; preserved with sodium azide. Designed for use on Architect i System (CMIA platform). Traceable to WHO Insulin 1st IRP 66/304.

Indications for Use

Indicated for use as calibrators and quality control materials for the quantitative determination of human insulin in human serum and plasma on the Architect i System. For prescription use.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Bayer ADVIA Centaur and ACS: 180, Insulin Calibrators (k021535)
• Bayer Ligand Plus 1, 2, 3 Controls (k030452)

Submission Summary (Full Text)

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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.

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.

______________________________________________________________________________________________________________________________________________________________________________ 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

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 and plasma.

### 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® Insulin<br>calibrators are for<br>calibration of the<br>ARCHITECT® i System<br>when used for the<br>quantitative determination of<br>human insulin in human<br>serum and plasma. | For in vitro diagnostic use in<br>the calibrating the ADIVA<br>Centaur® or ACS 180®<br>Insulin assays. |
| Methodology | CMIA (Chemiluminescent<br>Microparticle Immunoassay) | Chemiluminescent<br>Microparticle Immunoassay |
| Binding Protein | Insulin | Insulin |
| Assay Protocols | Direct, quantitative<br>immunoassay | Direct, quantitative<br>immunoassay |
| Traceability<br>/Standardization | Relative Light Unit (RLU)<br>matched to Primary<br>Calibrators. The<br>calibrators of the<br>ARCHITECT Insulin are<br>referenced to the World<br>Health Organization (WHO) | Referenced to the World<br>Health Organization (WHO)<br>Insulin 1st. International<br>Reference Preparation,<br>66/304.<br>Assigned values of |

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| Insulin 1st. International<br>Reference Preparation,<br>66/304 | calibrators are traceable to<br>this standardization |
|----------------------------------------------------------------|------------------------------------------------------|
|----------------------------------------------------------------|------------------------------------------------------|

## 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® Insulin<br>Controls are for the<br>verification of the accuracy<br>and precision of the<br>ARCHITECT® i System<br>when used for the<br>quantitative determination of<br>human insulin in human<br>serum and plasma. | For the in vitro diagnostic<br>use to monitor the precision<br>and accuracy of<br>immunochemistry and<br>procedures for ADIVA<br>Centaur® and ACS 180®<br>Systems. |
| Methodology | Chemiluminescent<br>Microparticle Immunoassay<br>(CMIA) | Chemiluminescent<br>Microparticle Immunoassay |
| Binding Protein | Insulin | Insulin |
| Assay Protocol | Direct, quantitative<br>immunoassay | Direct, quantitative<br>immunoassay |
| Levels | 3 levels Low, Medium and<br>High: targets: 8, 40,<br>120 μU/mL. | 3 levels (Ligand 1, 2, 3). |

## Comparison with predicate: Calibrators

## Differences:

| Calibrators | Device | Predicate |
|-------------|----------------------------|-------------------------------|
| Platform | ARCHITECT® i System | ADIVA Centaur® or ACS<br>180® |
| Matrix | Acetate buffer with sodium | Buffered saline with |

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| | azide and preservatives | casein, potassium<br>thiocyanate (3.89%),<br>sodium azide and<br>preservatives |
|--------------------------|------------------------------------------------|--------------------------------------------------------------------------------|
| Calibration Range/Levels | 6 levels: 0, 3, 10, 30, 100,<br>and 300 µU/mL, | High and Low level, per<br>assigned value card |
| Assay Sample Type | Serum and plasma | Serum |

### Comparison with predicate: Controls

### Differences:

| Control | Device | Predicate |
|-------------------|--------------------------------------------------------------|--------------------------------------------|
| Platform | ARCHITECT® i System | ADIVA Centaur® or ACS<br>180° |
| Matrix | Acetate buffer with<br>preservatives | Lypholized, Multi<br>Constituent Controls. |
| | | Human serum with |
| | | nonhuman contents added, |
| | | no preservatives or |
| | | stabilizers |
| Traceability | Primary Controls | Not given |
| Value Assignment | Relative Light Unit (RLU)<br>matched to Primary<br>Controls. | 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 [phone]. 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 [phone] or [phone] 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.

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.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | YES |
|-------------------------------------------------|--------|
| | AND/OR |
| Over-The-Counter Use<br>(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