ELECSYS N-MID OSTEOCALCIN CALCHECK 5

K112104 · Roche Diagnostics · JJX · Aug 25, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112104
• Device Name: ELECSYS N-MID OSTEOCALCIN CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.

Device Story

Lyophilized human serum matrix spiked with osteocalcin; used to verify calibration and assay range of Elecsys N-MID Osteocalcin reagent on Elecsys/cobas e immunoassay analyzers. Reconstituted with distilled/deionized water by laboratory personnel. Provides five levels of target values; reagent lot-specific. Not for use as primary calibrator or control material.

Clinical Evidence

No clinical data. Performance was evaluated through bench testing, specifically focusing on value assignment and stability testing.

Technological Characteristics

Lyophilized human serum matrix; five-level concentration; reconstituted with 1.0 mL water. Analyte: Osteocalcin. Stability: 18 months at 2-8°C (unopened), 5 hours at 20-25°C (reconstituted). Traceable to in-house reference standard.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys N-MID Osteocalcin reagent on Elecsys and cobas e immunoassay analyzers. For prescription use.

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:
k112104

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for Osteocalcin

D. Type of Test:
Quality control materials

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys N-MID Osteocalcin 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:
Single (specified) analyte controls (assayed and unassayed) (JJX)
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 N-MID Osteocalcin 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 N-MID Osteocalcin reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use.

3. Special conditions for use statement(s):

For prescription use.

Limitations: Elecsys N-MID Osteocalcin CalCheck 5 is not intended to be used as primary calibrator or control material.

4. Special instrument requirements:

Elecsys and cobas e immunoassay analyzers including the Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 analyzer platforms.

I. Device Description:

The Elecsys N-MID Osteocalcin CalCheck 5 is a lyophilized product consisting of osteocalcin in a human serum matrix. During the manufacture, the analyte is spiked into the matrix at the desired concentration levels. This solution is used to verify the calibration established with the Elecsys N-MID Osteocalcin CalSet and to verify the assay range established by the Elecsys N-MID Osteocalcin Reagent on the indicated Elecsys and cobas e immunoassay analyzers. The labeling states: 'All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved.'

Target values listed below for Elecsys N-MID Osteocalcin CalCheck 5 provided on the value sheet are reagent lot-specific, and are based on and established using results from multiple analyzers and assay runs.

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| Level | Target Value (ng/dL) |
| --- | --- |
| Check 1 | ≤ 2.00 |
| Check 2 | 10.5 |
| Check 3 | 130 |
| Check 4 | 208 |
| Check 5 | 271 |

## J. Substantial Equivalence Information:

1. Predicate device name(s):
Elecsys DHEA-S CalCheck 5

2. Predicate 510(k) number(s):
k103402

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Characteristics | Elecsys N-MID Osteocalcin CalCheck 5 (Candidate Device) | Elecsys DHEA-S CalCheck 5 (K103402) |
| Intended Use | An assayed control for use in calibration verification and for use in the verification of the assay range. | Same |
| 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, and then mix gently by inversion. | Same |
| Stability | Unopened: Store at 2-8°C until expiration date (18 months) | Same |
| Matrix | Human serum | Same |
| Differences | | |
| Analyte | Osteocalcin | DHEA-S |
| Stability | Reconstituted: 20-25°C, 5 hours | Reconstituted: 20-25°C, 4 hours |

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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:

Not applicable.

b. Linearity/assay reportable range:

Not applicable.

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

Traceability: The Elecsys N-MID Osteocalcin CalCheck5 is traceable to the in-house reference standard which is osteocalcin in analyte-free human serum matrix to generate a master calibrator curve on the cobas e 601 analyzer.

Value Assignment: For each Elecsys N-MID Osteocalcin CalCheck5 lot manufactured, the CalChecks are run in duplicate on at least three cobas e 601 analyzers. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations of the respective CalCheck. The assigned range for each CalCheck is ± 30% of assigned value. Reagent lot-specific values are assigned for each lot of Elecsys N-MID Osteocalcin CalCheck5 in combination with each Elecsys N-MID Osteocalcin reagent lot available. For additional analyzers, the same value assignment procedure is performed. The assigned values obtained on additional analyzers are compared to those obtained on the cobas e 601.

Stability: The shelf life for the Elecsys N-MID Osteocalcin CalCheck5 is determined to be 18 months when stored at 2-8°C on the cobas e 601 analyzer in an accelerated study. Real time shelf life stability is on-going. The reconstituted (open vial) Elecsys N-MID Osteocalcin CalCheck5 when stored at 20-25°C has a 5 hour stability claim. The CalCheck products are not stored on-board the analyzers, therefore no on-board stability claims are made. Stability study protocols and acceptance criteria were described and found to be acceptable.

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

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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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