ELECSYS PROLACTIN II CALCHECK 5

K110613 · Roche Diagnostics · JJX · May 12, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110613
• Device Name: ELECSYS PROLACTIN II CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Elecsys Prolactin II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Prolactin II CalCheck 5 is a lyophilized, equine serum-based control material containing prolactin at five target concentrations. Used in clinical laboratory settings on Elecsys and cobas e immunoassay analyzers to verify calibration and assay reportable ranges. The product is reconstituted with distilled or deionized water by laboratory technicians. It is not a primary calibrator or routine control. Value assignment is performed using master calibrators traceable to the 3rd IRP WHO 84/500 international standard, with values assigned via median testing on cobas e 601 analyzers and transferred to other compatible platforms. Healthcare providers use the resulting verification data to ensure the accuracy and linearity of the immunoassay system within the established reportable range.

Clinical Evidence

No clinical data. Bench testing only. Value assignment was validated using cobas e 601 analyzers, with transferability confirmed for Elecsys 2010 and cobas e 411 platforms. Stability testing (real-time and accelerated) confirmed shelf-life and reconstituted stability.

Technological Characteristics

Lyophilized equine serum matrix containing prolactin. Five-level concentration set. Reconstituted with 1.0 mL distilled/deionized water. Stable at 2-8°C unopened; 4 hours at 20-25°C reconstituted. Traceable to 3rd IRP WHO 84/500 international standard.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Prolactin II reagent on Elecsys and cobas e immunoassay analyzers. Not intended as a primary calibrator or routine control material.

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

• Elecsys DHEA-S CalCheck 5 (k103402)

Submission Summary (Full Text)

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

A. 510(k) Number:
k110613

B. Purpose for Submission:
New device

C. Measurand:
Calibration verification and assay range verification material for Prolactin

D. Type of Test:
Not applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys Prolactin II CalCheck 5

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)

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H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The Elecsys Prolactin II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers.

3. Special conditions for use statement(s):

The Elecsys Prolactin II CalCheck 5 is not intended to be used as a primary calibrator or routine control material.

4. Special instrument requirements:

The labeling states that the Elecsys Prolactin II CalCheck 5 are for use with the Elecsys Prolactin II reagent on the Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 test systems

I. Device Description:

The Elecsys Prolactin II CalCheck 5 is a lyophilized product consisting of prolactin in an equine serum matrix. During manufacture, the analyte is spiked at the target concentrations listed below.

| Level | Target Value [μIU/mL] |
| --- | --- |
| Check 1 | < 10 |
| Check 2 | 500 |
| Check 3 | 5000 |
| Check 4 | 7500 |
| Check 5 | 10000 |

J. Substantial Equivalence Information:

1. Predicate device name(s):

Elecsys DHEA-S CalCheck 5

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

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k103402

3. Comparison with predicate:

| Characteristic | Elecsys Prolactin II CalCheck 5 (Candidate Device) | Elecsys DHEA-S CalCheck 5 (K103402) |
| --- | --- | --- |
| Intended Use | The Elecsys Prolactin II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the assay on the indicated Elecsys and cobas e immunoassay analyzers. | Same |
| Analyte | Prolactin | DHEA-S |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion. | Same |
| Stability | Unopened: • Store at 2-8°C until expiration date Reconstituted: • 20-25°C: 4 hours | Unopened: • Same Reconstituted: • Same |
| Matrix | Equine serum matrix | Human serum matrix |

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

None were referenced.

L. Test Principle:

Not applicable.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

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Not applicable

b. Linearity/assay reportable range:

Not applicable

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

## Traceability and value assignment

CalCheck 5 is standardized using internally produced master calibrators which are traceable to the 3rd IRP WHO 84/500 international standard.

Each of the five CalCheck levels is value assigned using a minimum of three cobas e 601. Each sample is tested in duplicate. The target value for each CalCheck is the median of the observed values.

The sponsor experimentally confirmed the values assigned were transferrable to Elecsys 2010/cobas e 411 analyzers. For Elecsys 2010/cobas e 411 analyzers, the same value assignment procedure was performed. The assigned values obtained on these additional analyzers were shown to meet the same acceptance criteria as the E170/e 601/e 602. Additionally, the acceptance criteria for differences between the master platform and additional analyzer platforms (e) were also met. Therefore, the values assigned to the cobas e 601 analyzer/s are transferred and valid for the Elecsys 2010 analyzer/s.

The labeling states that laboratories should establish appropriate acceptance criteria when using this product for its intended use.

## Stability

Real time and accelerated stability testing protocols and acceptance criteria were described and found to be adequate. CalCheck 5 is stable until the expiration date printed on the vial when stored unopened at 2 – 8°C. The reconstituted vials are stable for four hours at 20-25°C. The real time studies are ongoing.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

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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:
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.