ELECSYS HCG STAT CALCHECK 5

K093700 · Roche Diagnostics Corp. · JJX · Mar 4, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093700
• Device Name: ELECSYS HCG STAT CALCHECK 5
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys HCG STAT 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 HCG STAT reagent on the indicated Elecs and cobas e immunoassay analyzers.

Device Story

Elecsys HCG STAT CalCheck 5 is a lyophilized, human serum-based control material containing HCG analyte at five specific target concentrations. Used in clinical laboratory settings to verify calibration and assay range of Elecsys HCG STAT reagent on Elecsys 2010, cobas e411, and cobas e601 analyzers. Product is reconstituted with distilled or deionized water by laboratory personnel. Output is a measured value compared against established target ranges to ensure analyzer performance. Benefits include ensuring accuracy and linearity of HCG testing within the clinical diagnostic workflow.

Clinical Evidence

No clinical data. Performance evaluation was limited to value assignment and reliance on stability studies previously cleared in K092168 due to identical formulation.

Technological Characteristics

Lyophilized human serum matrix; five-level concentration set. Analyte: HCG. Reconstitution: 1.0 mL distilled/deionized water. Stability: 2-8°C unopened; 4 hours at 20-25°C reconstituted. Analyzers: Elecsys 2010, cobas e411, cobas e601. Traceable to NIBSC 75/589.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys HCG STAT 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 HCG+β CalCheck 5 (K092168)

Submission Summary (Full Text)

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

A. 510(k) Number:
k093700

B. Purpose for Submission:
New Device

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

D. Type of Test:
Not applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecys HCG STAT CalCheck 5

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJX | Class I, reserved | 21CFR§862.1660 | Clinical Chemistry |

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
The Elecsys HCG STAT 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

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HCG STAT reagent on the indicated Elecs and cobas e immunoassay analyzers.

3. Special conditions for use statement(s):

The Elecsys HCG STAT 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 CalChecks are for use with the Elecsys HCG STAT reagent kit on the Elecs 2010, cobas e411 and cobas e601 test systems.

I. Device Description:

The Elecs HCG STAT CalCheck 5 is a lyophilized product consisting of HCG in human serum matrix. During manufacture, the analyte is spiked into the matrix at the target concentrations listed below. Cal Check Level 1 contains no analyte.

| Elecs HCG Stat Cal Check 5 Level | Target Value mIU/mL |
| --- | --- |
| Check 1 | < 0.500 |
| Check 2 | 3.85 |
| Check 3 | 4310 |
| Check 4 | 6750 |
| Check 5 | 8400 |

The human source materials were 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 or cleared in compliance with the European Directive 98/70/EC, Annex II, List A.

J. Substantial Equivalence Information:

1. Predicate device name(s)

Elecs HCG+β CalCheck 5

2. Predicate K number(s)

k092168

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Characteristic | Elecs HCG STAT CalCheck 5 (Candidate Device) | Elecs HCG+β CalCheck (k092168) |
| Intended Use | Calibration Verification Material | 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, mix gently by inversion. | Same |
| Stability | Unopened: store at 2-8°C until expiration date. Reconstituted: 20-25°C: 4 hours | Same |
| Matrix | Human serum matrix | Same |
| Levels | Five | Same |
| Differences | | |
| --- | --- | --- |
| Characteristic | Elecs HCG STAT CalCheck 5 (Candidate Device) | Elecs HCG+β CalCheck (k092168) |
| Reagent | The Elecsys HCG STAT CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecs HCG STAT reagent on the indicated Elecs and cobas e immunoassay analyzers. | The Elecs HCG+β CalCheck 5 is an assayed control for use in calibration verification and for use in verification of the assay range established by the Elecs HCG+β reagent on the indicated Elecs and cobas e immunoassay analyzers |

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

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

L. Test Principle:

Not applicable

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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 and value assignment
Elecys HCG STAT CalCheck5 is standardized using internally produced master calibrators which are traceable to the 4th International Standard for HCG (NIBSC) 75/589.
Each of the five CalCheck levels is value assigned using four Elecys 2010/cobas e411 and e601 analyzers. Each sample is tested in duplicate. The target value of each CalCheck is the median of the observed values.
The labeling states that laboratories should establish appropriate acceptance criteria when using the CalCheck for its intended use.
Stability
The Elecys HCG STAT CalCheck 5 formulation is identical to the Elecys HCG+β CalCheck 5, the stability studies presented and cleared in the HCG+β CalCheck 5 submission, k092168, apply. The Elecys HCG STAT 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.
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:
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.

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