IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...

K111938 · Immunodiagnostic Systems , Ltd. · JJX · Feb 14, 2012 · Clinical Chemistry

Device Facts

• Record ID: K111938
• Device Name: IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 14, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IDS-iSYS IGFBP-3 controls set is a quality control material device intended for medical purposes for use in the IDS-iSYS IGFBP-3 assay on the IDS-iSYS multi discipline automated analyzer to monitor the accuracy and quality of the IDS-iSYS IGFBP-3 assay. The IDS-iSYS IGFBP-3 calibration verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS IGFBP-3 assay when performed on the IDS-iSYS multi-disciplined automated analyzer. The IDS-iSYS hGH calibration verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS hGH assay when performed on the IDS-iSYS multi-disciplined automated analyzer.

Device Story

The IDS-iSYS IGFBP-3 Control Set and Calibration Verifiers (IGFBP-3 and hGH) are in vitro diagnostic materials used to monitor assay performance and verify calibration on the IDS-iSYS Multi-Discipline Automated Analyzer. These products serve as quality control and calibration verification tools for clinical laboratory professionals. By providing known values for comparison, they allow clinicians to assess the accuracy and stability of the IDS-iSYS IGFBP-3 and hGH assays. This ensures the reliability of patient test results, supporting accurate clinical decision-making regarding growth hormone and IGFBP-3 levels. The devices are used in a laboratory environment as part of standard quality assurance workflows.

Clinical Evidence

No clinical data. Bench testing only. Includes stability studies (accelerated and real-time), traceability to international standards (NISBC 93/560 and 98/574), and value assignment validation across multiple analyzer units.

Technological Characteristics

Materials: Bovine serum albumin, phosphate buffer, sodium azide. Form factor: Lyophilized powder or ready-to-use liquid. Energy source: N/A (reagent/control material). Connectivity: N/A (used on IDS-iSYS analyzer). Sterilization: N/A. Software: N/A (assay-specific control material).

Indications for Use

Indicated for use as quality control material and calibration verification material for the IDS-iSYS IGFBP-3 and hGH assays on the IDS-iSYS Multi-Discipline Automated Analyzer. Intended for professional, prescription-only use in clinical laboratory settings to monitor assay accuracy and verify calibration.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k111938

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for insulin-like growth factor binding protein-3 (IGFBP-3) and human growth hormone (hGH).

D. Type of Test:
Quality control materials

E. Applicant:
Immunodiagnostic Systems Limited

F. Proprietary and Established Names:
IDS-iSYS IGFBP-3 Calibration Verifiers
IDS-iSYS IGFBP-3 Control Set
IDS-iSYS hGH Calibration Verifiers

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJX | Class I, reserved | 21 CFR 862.1660
Quality Control Material | Clinical Chemistry (75) |

H. Intended Use:
1. Intended use(s):
Refer to indication for use below.

{1}

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

The IDS-iSYS IGFBP-3 controls set is a quality control material device intended for medical purposes for use in the IDS-iSYS IGFBP-3 assay on the IDS-iSYS multi discipline automated analyzer to monitor the accuracy and quality of the IDS-iSYS IGFBP-3 assay.

The IDS-iSYS IGFBP-3 calibration verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS IGFBP-3 assay when performed on the IDS-iSYS multi-disciplined automated analyzer.

The IDS-iSYS hGH calibration verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS hGH assay when performed on the IDS-iSYS multi-disciplined automated analyzer.

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

None

4. **Special instrument requirements:**

IDS-iSYS automated analyzer platform

I. **Device Description:**

The IDS-iSYS IGFBP-3 calibration verifier is lyophilized bovine serum albumin in a buffer with sodium azide as a preservative.

The IDS-iSYS IGFBP-3 control set is a lyophilized phosphate BSA matrix containing IGFBP-3 and sodium azide as a preservative.

The IDS-iSYS hGH calibration verifier is ready to use bovine serum albumin in a buffer with sodium azide as a preservative.

**IDS-iSYS IGFP-3 Calibration Verifiers**

| Level | Target Value (ng/mL) | Target Range (ng/mL) |
| --- | --- | --- |
| 0 | <LOQ | <LOQ |
| 1 | 512.5 | 400 – 600 |
| 2 | 5125 | 4000 – 6000 |
| 3 | 8400 | 6500 - 9500 |

IDS-iSYS IGFP-3 Control Set

{2}

3

| Level | Target Value (ng/mL) | Target Range (ng/mL) |
| --- | --- | --- |
| 1 | 2050 | 1250 – 2850 |
| 2 | 4100 | 3000 - 5200 |
| 3 | 6150 | 5000 - 7300 |

IDS-iSYS hGH Calibration Verifiers.

| Level | Target Value (ng/mL) | Target Range (ng/mL) |
| --- | --- | --- |
| 1 | 10 | 8 – 12 |
| 2 | 50 | 45 - 55 |
| 3 | 90 | 81 - 99 |

## J. Substantial Equivalence Information:

1. Predicate device name(s):
Elecsys hGH CalCheck 5

2. Predicate 510(k) number(s):
k103221

3. Comparison with predicate:

| Characteristic | IDS-iSYS IGFBP-3 Control Set (New Device) | IDS-iSYS IGFBP-3 Calibration Verifiers (New Device) | IDS-iSYS hGH Calibration Verifiers (New Device) | Elecsys hGH CalSet (Predicate Device) k103221 |
| --- | --- | --- | --- | --- |
| Intended use/Indications for use | Same | Same | Same | Assayed quality control material for use in calibration verification and assay verification. |
| Unopened Stability | Same | Same | Same | Store at 2-8°C until expiration date |
| Analyte | IGFBP-3 | IGFBP-3 | hGH | hGH |
| Levels | 3 | 4 | 3 | 5 |
| Matrix | Bovine serum albumin | Buffered protein | Bovine serum albumin | Human serum matrix |
| Format | Lyophilized | Lyophilized | Ready to use liquid form | Lyophilized |
| Reconstituted Stability | Not applicable | On the analyzer: up to 2.5 hours | On the analyzer: up to 2.5 hours | On the analyzer: up to 5 hours |

{3}

4

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

Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control Material

L. Test Principle

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/Assay Reportable Range:

Not applicable

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

Traceability

The IDS-iSYS IGFBP-3 control set is traceable to the NISBC 93/560 international standard.

The IDS-iSYS IGFBP-3 calibration verifier is traceable to the NISBC 93/560 international standard.

The IDS-iSYS hGH calibration verifier is traceable to the NISBC 98/574 international standard.

Value Assignment:

IDS-iSYS IGFBP-3 control set concentrations are value assigned on three different iSYS analyzers, with a minimum of three runs for a total of at least 15 runs. The controls are quantitated with the associated lot-specific calibrators, and are analyzed with all batches of cartridges on the market.

Results of the controls must be $\pm 1$ SD of each other (to show no bias between batches of cartridges). Once assay kits are assembled, a kit will be brought to the quality control department for a final validation check, and the final assigned ranges for each control are designated as the assigned value $\pm 3\mathrm{SD}$.

IDS-iSYS IGFBP-3 Calibration Verifiers

Four levels of calibrator verifiers were used to validate the calibration of the IDS-

{4}

iSYS and validate the range of the analytical measurement. Each lot-specific value assignment was tested in three runs on at least three different IDS-iSYS analyzers in triplicate. The assigned target value of each calibrator verifier was defined as the mean of all the runs for each calibrator verifier. The following are the expected values for each calibrator verifier respectively: 512.5 ng/mL, 5125 ng/mL, and 8400 ng/mL.

## IDS-iSYS hGH Calibration Verifiers

Three levels of calibrator verifiers were used to validate the calibration of the IDS-iSYS and validate the range of the analytical measurement. Each lot-specific value assignment was tested in three runs on at least three different IDS-iSYS analyzers in triplicate. The assigned target value of each calibrator verifier was defined as the mean of all the runs for each calibrator verifier. The following are the expected values for each calibrator verifier: 10 ng/mL, 50 ng/mL, and 90 ng/mL.

## Stability:

IDS-iSYS IGFBP-3 Control Set real time stability studies are performed on the control material at 3 month intervals for a minimum of 15 months.

An accelerated stability study was performed to simulate a shelf life of 6 months at normal storage conditions of 2-8°C. Stability data supports this package insert claim and percent recoveries met the stated acceptance criteria of 90-110% of concentration based on unstressed material.

IDS-iSYS IGFBP-3 Calibration Verifiers stability testing was performed on the IDS-iSYS automated analyzer.

- Shelf-life stability
The accelerated stability testing supports an initial shelf-life claim of 6 months at 2-8°C. Real time testing at 2-8°C is on-going.

- Stability after reconstitution :
- Real time testing was performed and supports the following claims:
Reconstituted IDS-iSYS IGFBP-3 calibration verifiers are stable for up to 2.5 hours on the board the IDS-iSYS. The IDS-iSYS IGFBP-3 calibration verifiers are not stored on board the analyzer.

IDS-iSYS hGH Calibration Verifiers stability testing was performed on the IDS-iSYS automated analyzer.

- Shelf-life stability
The accelerated stability testing supports an initial shelf-life claim of 6 months at 2-8°C. Real time testing at 2-8°C is on-going.

- In use stability:
Real time testing was performed and supports the following claims:

{5}

The IDS-iSYS hGH calibration verifiers are stable for up to 2.5 hours on the board the IDS-iSYS. The IDS-iSYS hGH calibration verifiers are not stored on board the analyzer.

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

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:

{6}

Not applicable

**N. Proposed Labelling:**

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.

7