ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS

K091123 · Siemens Healthcare Diagnostics · JJX · Aug 14, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091123
• Device Name: ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 14, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ADVIA® Centaur DHEAS Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA® Centaur Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

Device Story

ADVIA Centaur DHEAS Master Curve Materials (MCM) consist of 5 levels of DHEAS concentrations (0, 60, 300, 900, 1500 µg/dL) in delipidated, steroid-stripped, human defibrinated plasma. Used in clinical laboratory settings to verify calibration and reportable range of the ADVIA Centaur DHEAS assay. Liquid, ready-to-use format. Healthcare professionals use the output to confirm assay performance within the reportable range. Benefits include ensuring accuracy of patient DHEAS test results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) support 18-month unopened shelf life and 60-day open-vial stability at 2-8°C. Value assignment performed using ADVIA Centaur analyzers and reference lots.

Technological Characteristics

Liquid, human defibrinated plasma matrix, steroid-stripped, delipidated. Five concentration levels. Traceable to internal standard using purified DHEAS. Storage 2-8°C.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration and reportable range of the ADVIA Centaur Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

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

• VALIDATE Thyroid Calibration Verification Test Set (K062501)

Submission Summary (Full Text)

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

A. 510(k) Number:
k091123

B. Purpose for Submission:
New Device

C. Measurand:
Dehydroepiandrosterone sulfate (DHEAS)

D. Type of Test:
Calibration verification material for the ADVIA® Centaur Systems DHEAS assay

E. Applicant:
Siemens Healthcare Diagnostics Inc.

F. Proprietary and Established Names:
ADVIA® Centaur DHEAS Master Curve Materials

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:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
See Indication(s) for use below.
2. Indication(s) for use:
The ADVIA Centaur (DHEAS) Master Curve Materials are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur Systems Dehydroepiandrosterone sulfate (DHEAS) assay.
3. Special conditions for use statement(s):
For In Vitro Diagnostic Use; For Prescription Use Only; To be used with the ADVIA Centaur Systems DHEAS assay; Not to be used as routine quality control material or as calibration material

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4. Special instrument requirements: Not applicable

I. Device Description:

The ADVIA Centaur (DHEAS) Master Curve Materials (MCM) are 5 levels of varying concentrations of DHEAS in delipidated, steroid stripped, human defibrinated plasma with preservative. The MCM have expected values (lot specific) of approximately 0, 60, 300, 900 and 1500 µg/dL. The MCM (1.0 mL per vial) are liquid and ready to use.

All human source materials used in the preparation of the proposed device were tested using FDA-approved methods and found to be non-reactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody to HIV-1/2.

J. Substantial Equivalence Information:

1. Predicate device name(s): Maine Standards Company, VALIDATE Thyroid Calibration Verification Test Set
2. Predicate 510(k) number(s): k062501
3. Comparison with predicate:

| Item | Device | Predicate (k062501) |
| --- | --- | --- |
| Similarities | | |
| Intended use | For in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur Systems Dehydroepiandrosterone sulfate (DHEAS) assay. | For in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in chemistry systems for the following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol. |
| Form | Liquid | same |
| Differences | | |
| Analytes | DHEAS | T3, T4, TSH and Cortisol |
| Matrix | Human plasma | Human serum |
| Storage | 2 to 8 °C | -10 to -20 °C |
| Stability | Unopened—until expiration date on the vial label
Opened—60 days | Unopened—until expiration date on storage container |

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

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

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# 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 ADVIA Centaur DHEAS Master Curve Material are traceable to an internal standard manufactured using purified DHEAS.

Value assignment: Each of the five MCM levels is value assigned using one ADVIA Centaur analyzer, one lot of calibrators and one lot of the ADVIA Centaur DHEAS reagent. At least 3 vials are assayed for each level. MCM 1 is assayed in replicates of 10 on 2 separate runs. For MCM 2 through 5, a "nested test" protocol was used where the samples are assayed with alternating samples of the lot to be value assigned "test lot" and the reference lot used to confirm value assignment. Twenty replicates of the test lot and 20 replicates of the reference lot are assayed. The target values are given in the table below:

| MCM Level | Concentration (μg/dL) |
| --- | --- |
| MCM 1 | 0 |
| MCM 2 | 60 |
| MCM 3 | 300 |
| MCM 4 | 900 |
| MCM 5 | 1500 |

Stability: The unopened stability of the ADVIA Centaur DHEAS MCM was determined using accelerated studies and real-time studies. The sponsor currently has real-time data supporting 108 weeks of closed vial stability when the product is stored at 2 to $8^{\circ}\mathrm{C}$ . The sponsor will claim 18 months of unopened shelf life at 2 to $8^{\circ}\mathrm{C}$ .

The open vial stability was determined using real-time studies. The sponsor currently has data supporting 9 weeks of open-vial stability when the product is stored at 2 to $8^{\circ}\mathrm{C}$ . The sponsor will claim 60 days of open vial stability at 2 to $8^{\circ}\mathrm{C}$

The sponsor presented data for the in-use stability of the product. The data supports the claim that the ADVIA Centaur DHEAS MCM are stable up to 8

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hours when stored at 20 to 25 °C. The sponsor will claim 8 hours of in-use stability at 20 to 25 °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:
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:
Assigned values for the ADVIA Centaur DHEAS MCM are provided in the DHEAS lot specific target value sheet.

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.