IMMULITE IGF Control Module, IMMULITE Gastrin Control Module

K150132 · Siemens Healthcare Diagnostics · JJX · Apr 13, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150132
• Device Name: IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

IMMULITE® IGF Control Module is an assayed, bi-level control intended for use with IMMULITE 1000 and IMMULITE 2000 IGF-I, and IMMULITE 1000 and IMMULITE 2000 IGFBP-3 assays. It is intended as an aid in monitoring day-to-day assay performance. IMMULITE Gastrin Control Module is an assayed, bi-level control intended for use with the IMMULITE/IMMULITE 1000 and IMMULITE 2000 Gastrin assay. It is intended as an aid in monitoring day-to-day assay performance.

Device Story

IMMULITE IGF and Gastrin Control Modules are lyophilized, bi-level quality control materials used to monitor the performance of IMMULITE 1000 and 2000 immunoassay systems. The IGF module contains IGF-I and IGFBP-3 in a protein buffer matrix; the Gastrin module contains synthetic human G-17 gastrin in a buffer matrix. These controls are reconstituted by laboratory personnel and processed on the IMMULITE platforms alongside patient samples. The system measures the control values, which are then compared against established target ranges to verify assay precision and accuracy. By identifying potential shifts or trends in assay performance, these controls assist clinicians in ensuring the reliability of patient test results, thereby supporting accurate clinical decision-making for conditions related to IGF-I, IGFBP-3, and Gastrin levels.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and open-vial) support a 3-year shelf life at 2-8°C and 30-day stability at -20°C after reconstitution. Value assignment was performed using a minimum of 100 control points across 3 kit lots and 3 instruments on IMMULITE/IMMULITE 1000 and IMMULITE 2000 platforms.

Technological Characteristics

Lyophilized, bi-level control materials. IGF module: protein buffer matrix. Gastrin module: buffer matrix with synthetic human G-17 gastrin. Stability testing per CEN 13640. Value assignment via reference controls. No electronic or software components; used on IMMULITE 1000/2000 immunoassay systems.

Indications for Use

Indicated for use as an assayed, bi-level quality control material for monitoring the performance of IMMULITE 1000 and 2000 IGF-I, IGFBP-3, and Gastrin assays in a clinical laboratory setting.

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.

Predicate Devices

• IMMULITE® SHBG Controls (K955440)

Submission Summary (Full Text)

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

A. 510(k) Number:
k150132

B. Purpose for Submission:
New Device

C. Measurand:
Quality Control material for IMMULITE IGF-I and IGFBP-3 assays
Quality Control material for IMMULITE Gastrin assay

D. Type of Test:
Not applicable

E. Applicant:
Siemens Healthcare Diagnostics Inc

F. Proprietary and Established Names:
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module

G. Regulatory Information:
1. Regulation section:
21CFR § 862.1660, Quality Control Material (assayed and unassayed)
2. Classification:
Class I, Reserved
3. Product code:
JJX

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4. Panel:
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):
See indications for use statements below.

2. Indication(s) for use:
IMMULITE IGF Control Module is an assayed, bi-level control intended for use with IMMULITE/IMMULITE 1000 and IMMULITE 2000 IGF-I, and
IMMULITE/IMMULITE 1000 and IMMULITE 2000 IGFBP-3 assays. It is intended as an aid in monitoring day-to-day assay performance.

IMMULITE Gastrin Control Module is an assayed, bi-level control intended for use with the IMMULITE/IMMULITE 1000 and IMMULITE 2000 Gastrin assay. It is intended as an aid in monitoring day-to-day assay performance.

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
IMMULITE/IMMULITE 1000 and IMMULITE 2000

I. Device Description:

IMMULITE IGF Control Module contains one set of 2 vials, each 4.0mL after reconstitution with distilled or deionized water, containing lyophilized IGF-I and IGFBP-3 in a protein buffer matrix with preservatives.

IMMULITE Gastrin Control Module contains one set of 2 vials, each 2.0mL after reconstitution with distilled or deionized water, containing lyophilized synthetic-human G-17 gastrin in a buffer matrix with preservatives.

The sponsor has the following caution statement in their labeling: Each human donor unit used to manufacture this control was tested by FDA approved methods or equivalent and found to be non-reactive for Syphilis, Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1 /HIV-2.

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J. Substantial Equivalence Information:

1. Predicate device name(s):
IMMULITE SHBG Controls

2. Predicate 510(k) number(s):
k955440

3. Comparison with predicate:
IMMULITE IGF Control Module:

| SIMILARITIES | | |
| --- | --- | --- |
| | Candidate Device
IMMULITE IGF Control Module | Predicate Device
IMMULITE SHBG Controls
k955440 |
| Intended Use | It is intended for use as quality control material in monitoring day-to-day assay performance. | Same |
| Form | Lyophilized | Same |
| Stability | Stable unopened until the expiration date | Same |
| Levels | 2 | Same |
| Matrix | Bovine protein/buffer matrix with preservatives | Same |
| DIFFERENCES | | |
| --- | --- | --- |
| | Candidate Device
IMMULITE IGF Control Module | Predicate Device
IMMULITE SHBG Controls
k955440 |
| Analyte(s) | IGF-I and IGFBP-3 | SHBG |
| Storage | -20°C for 30 days after reconstitution (aliquoted) | 2 -8°C for 30 days after reconstitution or at -20°C |

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IMMULITE Gastrin Control Module:

| SIMILARITIES | | |
| --- | --- | --- |
| | Candidate Device
IMMULITE Gastrin Control Module | Predicate Device
IMMULITE SHBG Controls
k955440 |
| Intended Use | It is intended for use as quality control material in monitoring day-to-day assay performance. | Same |
| Form | Lyophilized | Same |
| Levels | 2 | Same |
| Stability | Stable unopened until the expiration date | Same |
| DIFFERENCES | | |
| --- | --- | --- |
| | Candidate Device
IMMULITE® Gastrin Control Module | Predicate Device
IMMULITE SHBG Controls
k955440 |
| Analyte | Gastrin | SHBG |
| Matrix | Buffered matrix | Non-human (bovine)protein/buffer matrix |
| Storage | -20°C for 30 days after reconstitution (aliquoted) | 2 -8°C for 30 days after reconstitution or at -20°C for 6 months (aliquoted) |

K. Standard/Guidance Document Referenced (if applicable):
Not applicable

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):

Traceability and Value assignment:

The IMMULITE IGF-I controls are value assigned using assigned reference controls. The assigned reference controls are prepared using IGF-I and IGFBP-3 antigen stock. Human Recombinant IGF-I antigen and IGF-I/IGFBP-3 positive human serum are used. IGF-I and IGF BP-3 antigens are sourced from commercially available vendors with high purity. IGF controls are required to have a minimum of 100 control points from at least 3 kit lots and 3 instruments on both IMMULITE/IMMULITE 1000 and IMMULITE 2000 platforms and for both IGF-I and IGFBP-3. The control mean values are based on the calculated averaged values from all the instruments. Control mean values and 2 SD control ranges for one reagent lot are shown below.

IGF-I:

| Control Level | Mean (ng/mL) | 2SD Range (ng/mL) |
| --- | --- | --- |
| 1 | 91 | 73-109 |
| 2 | 277 | 222-332 |

IGFBP-3:

| Control Level | Mean (ng/mL) | 2SD Range (ng/mL) |
| --- | --- | --- |
| 1 | 1.10 | 0.86 – 1.34 |
| 2 | 4.4 | 3.6 – 5.2 |

The IMMULITE Gastrin controls are value assigned using assigned reference controls. The assigned reference controls are prepared using gastrin antigen stock. Gastrin antigen is sourced from a commercially available vendor with high purity. Gastrin controls are required to have a minimum of 100 control points from at least 3 kit lots and 3 instruments on both IMMULITE/IMMULITE 1000 and IMMULITE 2000 platforms. The control mean values are based on the calculated averaged values from all the instruments. Control mean values and 2 SD control ranges for one reagent lot are shown below.

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Gastrin:

| Control Level | Mean (pg/mL) | 2SD Range (pg/mL) |
| --- | --- | --- |
| 1 | 94 | 82 - 106 |
| 2 | 364 | 306 – 422 |

## Stability:

Shelf-Life and Open Vial Stability testing protocols and acceptance criteria for the IMMULITE IGF Control Module were described and found to be adequate. The real time stability study shows study results up to 3 years when stored at 2 - 8 °C supporting the claim of 3 years shelf life from date of manufacture when stored at 2 - 8 °C prior to opening. The open vial stability study shows study results up to 35 days at –20°C supporting the claim of 30 days after opening and reconstitution if aliquoted and frozen immediately at –20°C.

Shelf-Life and Open Vial Stability testing protocols and acceptance criteria for the IMMULITE Gastrin Control Module were described and found to be adequate. The real time stability study shows study results up to 3 years when stored at 2 - 8 °C supporting the claim of 3 years shelf life from date of manufacture when stored at 2 - 8 °C prior to opening. The open vial stability study shows study results up to 35 days at –20°C supporting the claim of 30 days after opening and reconstitution if aliquoted and frozen immediately at –20°C.

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

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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:
See individual package insert

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.