CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL

K110061 · Siemens Healthcare Diagnostics · JJX · Sep 21, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110061
• Device Name: CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 21, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

For in vitro diagnostic use as a control for calibration verification of the IMMULITE Unconjugated Estriol (uE3) assays on the IMMULITE/IMMULITE 1000 and 2000 systems. The calibration verification material is assayed control with four levels. The analyte levels for IMMULITE 1000 are 0.00, 0.016, 2.70, and 11.2 ng/mL and 0.00, 0.19, 2.90, and 12.0 ng/mL for IMMULITE 2000 systems. The matrix is estriol in processed horse serum. For in vitro diagnostic use. For prescription use only.

Device Story

IMMULITE® Unconjugated Estriol (uE3) Calibration Verification Material (CVM) is a liquid, ready-to-use control consisting of four levels of unconjugated estriol in processed horse serum with preservative. It is used in clinical laboratory settings to verify the calibration and reportable range of IMMULITE® uE3 assays on IMMULITE/IMMULITE® 1000 and 2000 systems. The device is operated by laboratory technicians. The healthcare provider uses the output (recovery of control values) to monitor system performance, ensure assay accuracy, and validate that the instrument's calibration remains within established specifications. This verification process helps ensure the reliability of patient test results, supporting clinical decision-making in pregnancy monitoring.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed 6-month shelf life at 2-8°C. Expected values established via 40 replicates per level across three kit lots and three systems (IMMULITE/IMMULITE 1000 or 2000). Traceability established to internal reference calibrators, which are traceable to human samples assigned via GC-MS.

Technological Characteristics

Liquid, ready-to-use control material. Matrix: processed horse serum with preservative. Four levels of unconjugated estriol. Storage: 2-8°C. Intended for use with IMMULITE/IMMULITE 1000 and 2000 systems. No electronic or software components.

Indications for Use

Indicated for use as a quality control material for calibration verification of IMMULITE Unconjugated Estriol (uE3) assays on IMMULITE/IMMULITE 1000 and 2000 systems. Intended for prescription use in clinical laboratory settings.

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

• ADVIA Centaur® Enhanced Estradiol Master Curve Material (K102904)

Submission Summary (Full Text)

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

A. 510(k) Number:
k110061

B. Purpose for Submission:
New device

C. Measurand:
Quality control material for unconjugated estriol assay

D. Type of Test:
Not applicable

E. Applicant:
Siemens Healthcare Diagnostics

F. Proprietary and Established Names:
IMMULITE unconjugated Estriol (uE3) Calibration Verification Material

G. Regulatory Information:

1. Regulation section:
21 CFR §862.1660, Quality Control Material (Assayed and Unassayed)

2. Classification:
Class I, reserved

3. Product code:
JJX - Single (Specified) Analyte Controls (Assayed and Unassayed)

4. Panel:
75 Clinical Chemistry

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H. Intended Use:

1. Intended use(s):

Refer to indications for use below

2. Indication(s) for use:

For in vitro diagnostic use as a control for calibration verification of the IMMULITE Unconjugated Estriol (uE3) assays on the IMMULITE/IMMULITE 1000 and 2000 systems.

The calibration verification material is assayed control with four levels. The analyte levels for IMMULITE 1000 are 0.00, 0.016, 2.70, and 11.2 ng/mL and 0.00, 0.19, 2.90, and 12.0 ng/mL for IMMULITE 2000 systems. The matrix is estriol in processed horse serum.

3. Special conditions for use statement(s):

For in vitro diagnostic use. For prescription use only.

4. Special instrument requirements:

The IMMULITE Unconjugated Estriol (uE3) Calibration Verification Material (CVM) is intended for use with the IMMULITE/IMMULITE 1000 and 2000 systems.

I. Device Description:

The IMMULITE uE3 CVM consists of one set of four vials, 2 mL each, containing low, intermediate, and high levels of unconjugated estriol in processed horse serum, with preservative. The first level is an unconjugated estriol-free sample. The IMMULITE uE3 CVM levels are supplied in liquid form, ready to use.

| IMMULITE uE3 CVM | Target Value (ng/mL) | |
| --- | --- | --- |
| | IMMULITE/IMMULITE 1000 | IMMULITE 2000 |
| Level 1 | 0.00 | 0.00 |
| Level 2 | 0.16 | 0.19 |
| Level 3 | 2.70 | 2.90 |
| Level 4 | 11.2 | 12.0 |

J. Substantial Equivalence Information:

1. Predicate device name(s):

ADVIA Centaur Enhanced Estradiol (eE2) Master Curve Material

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

k102904

3. Comparison with predicate:

| Item | Device (k110061) | Predicate (k102904) |
| --- | --- | --- |
| Indications for use | For use in calibration verification of the assay. | Same |
| Format | Liquid, ready for use | Lyophilized |
| Matrix | Horse serum | Human serum |
| Analyte | Estriol | Estradiol |
| Instrument | IMMULITE/IMMULITE 1000, and 2000 systems | ADVIA Centaur XP systems |
| Stability | Unopened
Store at 2-8°C until expiration date
Opened
Use immediately after opening, discard after use | Unopened
Store at 2-8°C until expiration date
Opened
2-8°C for 14 days
On-board
6 hours |
| Levels | 4 | 6 |

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

1. Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrator; Final Guidance for Industry.
2. CLSI EP14-A2. Evaluation of Matrix Effects; Approved Guideline.

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

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

Traceability

The IMMULITE Unconjugated Estriol (uE3) Calibration Verification Material is traceable to an internal reference calibrator. Reference calibrators are traceable to individual human samples assigned with GC-MS values.

Expected Values and Value Ranges

Expected values for the IMMULITE uE3 CVM are determined by analyses of 40 replicates at each control level using three kit lots and three systems (IMMULITE/IMMULITE 1000 or IMMULITE 2000 systems). Pre-determined acceptance criteria for analyte recovery must be met for each calibrator lot. Calibrator assigned values are lot dependent as specified in the product labeling.

Stability

Stability testing protocols and acceptance criteria for the IMMULITE uE3 CVM were reviewed and found acceptable. The manufacturer claims a shelf life stability of 6 months at the recommended storage temperatures of 2-8°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

b. Matrix comparison:

Not applicable

3. Clinical studies:

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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:
The expected values are provided in the labeling for each specific lot.

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.