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

Indications for 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k060359

B. Purpose for Submission:
New device

C. Measurand:
Calibrators and Controls for Insulin assays

D. Type of Test:
Not applicable

E. Applicant:
Denka Seiken Co., LTD.

F. Proprietary and Established Names:
Architect Insulin Calibrators and Controls

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Calibrator, Secondary (JIT) | Class II | 21 CFR 862.1150, Calibrator. | 75 Clinical Chemistry (CH) |
| Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) | Class I | 21 CFR 862.1660, Quality control material (assayed and unassayed). | 75 Clinical Chemistry (CH) |

H. Intended Use:
1. Intended use(s):

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See Indications for use below

2. **Indication(s) for use:**

**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 or plasma.

3. **Special conditions for use statement(s):**

For prescription use

4. **Special instrument requirements:**

Architect i System

I. **Device Description:**

**Calibrators**

The Architect Insulin Calibrators consist of six calibrators (A-F). Calibrator A contains acetate buffer. Calibrators B-F contain insulin in acetate buffer. The calibrators are preserved by sodium azide and other antimicrobial agents. Each Insulin Calibrator kit contains 6 bottles of Calibrators (4.0 mL fill volume) at the following Insulin concentrations: 0, 3, 10, 100 and 300 µU/mL.

**Controls**

The Architect Insulin Controls contain insulin prepared in acetate buffer. The controls are preserved by sodium azide and other antimicrobial agents. Each Insulin Control kit contains 3 bottles of controls (Low, Medium and High) at the following concentrations: 8, 40, and 120 µU/mL.

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# J. Substantial Equivalence Information:

Calibrators

| Predicate | k021535 |
| --- | --- |
| Describe the item being compared | |
| Bayer ADVIA Centaur and ACS: 180, Insulin Calibrators | |

Controls

| Predicate | k030452 |
| --- | --- |
| Describe the item being compared | |
| Bayer Ligand Plus 1, 2, 3 Controls | |

Comparison with Predicate

| Item | Calibrator – Similarities | Predicate |
| --- | --- | --- |
| Intended use | Calibration of quantitative assays for human insulin | Same |
| Method | Chemiluminescent Microparticle Immunoassay (CMIA) | Same |
| Binding Protein | Insulin | Same |
| Traceability | WHO Insulin 1stInternational Reference Preparation 66/304 | Same |
| Calibrator | Calibrator – Differences | Predicate |
| Platform | Architect i System | ADVIA Centaur or ACS 180 |
| Matrix | Acetate buffer with sodium azide and preservatives | Buffered saline with casein, potassium thiocyanate (3.89%), sodium azide and preservatives |
| Concentration | 6 levels: 0, 3, 10, 30 and 100 μU/mL | 2 levels: High & Low |
| | | |

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| Item | Control – Similarities | Predicate |
| --- | --- | --- |
| Intended use | Verification of the accuracy and precision of quantitative assays | Same |
| Method | Chemiluminescent Microparticle Immunoassay (CMIA) | Same |
| Binding Protein | Insulin | Same |
| Levels | Three | Same |
| | | |
| Item | Control – Differences | Predicate |
| Platform | Architect i System | ADVIA Centaur or ACS 180 |
| Matrix | Liquid | Lyophilized |
| Type | Single analyte (insulin) | Multiple analytes |

K. Standard/Guidance Document Referenced (if applicable):

| Document Title | Office | Web Page |
| --- | --- | --- |
| Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft | OIVD | http://www.fda.gov/cdrh/ode/99.html |
| Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final | OIVD | http://www.fda.gov/cdrh/ode/calibrator.html |

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

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b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The primary calibrators and controls were manufactured from the WHO Insulin 1st International Reference Preparation (IRP) 66/304. The Architect Insulin Calibrators and Controls were manufactured by matching to the primary calibrators and controls. Relative light unit (RLU) testing was performed on the Architect i system and RLU values were compared to the corresponding primary calibrators and controls. The sponsor’s acceptance criteria: RLU variation between the Architect Insulin Calibrators and Controls and the primary calibrators and controls must be within +/- 1.5%. The sponsor’s studies show that the Architect Calibrators and Controls are stable for 12 months when stored at 2-8°C. Protocols and acceptance criteria for stability testing were described and found to be acceptable.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

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b. Clinical specificity:
Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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