ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

K060027 · Biokit, S.A. · JJX · Jan 26, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060027
• Device Name: ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
• Applicant: Biokit, S.A.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma. ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma. For in vitro diagnostic use.

Device Story

ARCHITECT DHEA-S Calibrators and Controls are liquid, human serum-based reagents containing synthetic DHEA-S and sodium azide preservative. Calibrators provide reference points (0, 5, 12, 60, 300, 1500 µg/dL) for the ARCHITECT i System; controls provide verification of accuracy and precision at target levels (10, 100, 1000 µg/dL). Used in clinical laboratory settings by trained personnel to support DHEA-S assay performance. The system utilizes Chemiluminescent Microparticle Immunoassay (CMIA) technology. Output is used by clinicians to monitor DHEA-S levels, aiding in the assessment of adrenal function.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed 6-month shelf life at 2-8°C. Gravimetric preparation and RLU variation testing (acceptance criteria +/- 1.5%) were performed to verify calibrator and control values.

Technological Characteristics

Human serum-based matrix; synthetic DHEA-S analyte; sodium azide preservative. Calibrators: 6 levels (0-1500 µg/dL). Controls: 3 levels (10-1000 µg/dL). Designed for ARCHITECT i2000/i2000sr instrument platforms. Chemiluminescent Microparticle Immunoassay (CMIA) principle. Storage: 2-8°C.

Indications for Use

Indicated for use as calibrators and controls for the quantitative determination of DHEA-S in human serum and plasma on the ARCHITECT i System. For prescription use only.

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

• DPC IMMULITE® DHEA-SO4 Calibrators and Controls (K935806)

Submission Summary (Full Text)

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

A. 510(k) Number:
k060027

B. Purpose for Submission:
Clearance of new device

C. Measurand:
Controls and Calibrators for dehydroepiandrosterone sulfate (DHEA-S) assay

D. Type of Test:
Not applicable. This submission is for clearance of controls and calibrators.

E. Applicant:
BIOKIT S.A.

F. Proprietary and Established Names:
ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

G. Regulatory Information:

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

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H. Intended Use:

1. Intended use(s):

Calibrators

The ARCHITECT® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.

Controls

The ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.

2. Indication(s) for use:

Calibrators

The ARCHITECT® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.

Controls

The ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.

3. Special conditions for use statement(s):

For Prescription use only.

4. Special instrument requirements:

The ARCHITECT® DHEA-S Calibrators and Controls are designed to be used for the calibration of the ARCHITECT® DHEA-S on the ARCHITECT® i2000 or i2000sr instrument platform. The instrument system was 510k cleared through submission number K983212.

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# I. Device Description:

Calibrator A contains human serum nonreactive for HBsAg, anti-HIV-1/HIV-2, HIV NAT, anti-HBc, HCV NAT, and anti-HCV. Calibrators B-F contain purified synthetic DHEA-S in human serum nonreactive for HBsAg, anti-HIV-1/HIV-2, HIV NAT, anti-HBc, HCV NAT, and anti-HCV. Preservative: Sodium azide. Each DHEA-S Calibrator kit contains 6 bottles of Calibrators (a 2.0 ml fill volume per bottle) with the following DHEA-S concentrations: 0, 5, 12, 60, 300, and 1500 µg/dL.

The controls contain purified synthetic DHEA-S in human serum nonreactive for HBsAg, anti-HIV-1/HIV-2, HIV NAT, anti-HBc, HCV NAT, and anti-HCV. Preservative: Sodium azide. Each DHEA-S control kit contains 3 bottles of controls (a 4.0 ml fill volume per bottle) with the following target concentrations (low, Medium, and High): 10, 100, and 1000 µg/dL.

# J. Substantial Equivalence Information:

| Predicate | K935806 |
| --- | --- |
| Describe the item being compared | |
| DPC IMMULITE® DHEA-SO4 Calibrators and Controls | |
| Similarities - Calibrators | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The ARCHITECT® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA -S in human serum and plasma. | DHEA-SO4 For the quantitative determination of dehydroepiandrosterone sulfate in serum. |
| System Methodology | Chemiluminescent Microparticle Immunoassay (CMIA) | Chemiluminescent a solid phase enzyme immunoassay |
| Assay Protocols | Competitive assay | Competitive assay |
| Matrix | DHEA-S (synthetic) in human serum with preservative. (SodiumAzide) | Lyophilized DHEA -SO4 in human serum with preservative |
| Differences - Calibrators | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Platform | ARCHITECT i System | Immulite 2000 Analyzer |
| Calibration Range/Levels | 0, 5, 12, 60, 300, and 1500 µg/dL | 15-1,000 µg/dL |

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| Similarities - Controls | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The ARCHITECT® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA -S in human serum and plasma. | DHEA-SO4 For the quantitative determination of dehydroepiandrosterone sulfate in serum. |
| System Methodology | Chemiluminescent Microparticle Immunoassay (CMIA) | Chemiluminescent a solid phase enzyme immunoassay |
| Assay Protocols | Competitive assay | Competitive assay |
| Matrix | DHEA-S (synthetic) in human serum with preservative. (SodiumAzide) | Lyophilized DHEA -SO4 in human serum with preservative |
| Differences - Controls | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Platform | ARCHITECT i System | Immulite 2000 Analyzer |
| Matrix | Single constituent, DHEA -S (synthetic) in human serum with preservative. (Sodium Azide) | Multi constituent, Human serum based tri-level control containing over 25 constituents commonly measured by immunoassay. |
| Levels | 10, 100, and 1000 μg/dL | Three levels, see package insert for measured values |
| Assay sample type | Serum and plasma | Serum |

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

| STANDARDS |
| --- |
| Title and Reference Number |
| Interference Testing in Clinical Chemistry; Approved Guideline (CLSI EP 7-A) |
| Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline (CLSI EP5-A) |
| GUIDANCE | | | |
| --- | --- | --- | --- |
| Document Title | Office | Division | Web Page |
| Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final | OIVD | | http://www.fda.gov/cdrh/ode/calibrator. |
| Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft | OIVD | | http://www.fda.gov/cdrh/ode/99. |

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L. Test Principle:

Not applicable. This submission is for calibrators and controls.

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):

Primary calibrators and controls are prepared gravimetrically by adding Synthetic DHEA-S obtained from a commercial source to a human serum-based matrix. The secondary calibrators and controls are also prepared gravimetrically by adding Synthetic DHEA-S obtained from a commercial source to a human serum-based matrix. Relative light unit (RLU) testing is performed and RLU values are compared to the corresponding Primary Calibrator or Control. The sponsor's acceptance criteria is that RLU variation must be within +/- 1.5%.

Target values for secondary calibrators are 0, 5, 12, 60, 300, and 1500 µg/dL DHEA-S. Target values for secondary controls are 10, 100, and 1000 µg/dL DHEA-S.

The DHEA-S Calibrators and Controls are stable for 6 months if stored at 2 to 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

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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:
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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