ELECYS SHBG CALCHECK

K031698 · Roche Diagnostics Corp. · JJX · Aug 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031698
• Device Name: ELECYS SHBG CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys® SHBG CalCheck is used in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Device Story

Elecsys SHBG CalCheck is a lyophilized calibration verification product; consists of SHBG spiked into human/horse serum matrix at three defined concentration levels (low, mid, high). Used in clinical laboratory settings by technicians to verify calibration of Elecsys SHBG reagent on Elecsys 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. The device provides a mechanism to confirm that the analyzer's calibration remains within established performance specifications across the measuring range. Results from the CalCheck are compared against expected values to ensure assay accuracy and reliability for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only; traceability established against 1st International Standard for SHBG (NIBSC 95/560).

Technological Characteristics

Lyophilized product; matrix consists of human serum and horse serum; contains SHBG analyte. Designed for use on Elecsys 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. No specific energy source or connectivity; standalone calibration verification material.

Indications for Use

Indicated for verification of calibration for Elecsys SHBG reagent on specified Elecsys immunoassay analyzers.

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® proBNP CalCheck (K020883)

Submission Summary (Full Text)

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

A. 510(k) Number: K031698
B. Analyte: Sex Hormone-Binding Globulin (SHBG)
C. Type of Test: N/A
D. Applicant: Roche Diagnostics Corporation
E. Proprietary and Established Names: Elecsys® SHBG CalCheck

F. Regulatory Information:
1. Regulation section: §862.1660, Single (Specified) Analyte Controls (Assayed and Unassayed)
2. Classification: Class I
3. Product Code: JJX
4. Panel: 75

G. Intended Use:
1. Indication(s) for use:
For use in the verification of the calibration established by the Elecsys SHBG reagent on Elecsys 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
2. Special condition for use statement(s): None
3. Special instrument Requirements: None

H. Device Description:
Elecsys® SHBG CalCheck calibration verification solution comprises three levels – low, mid, and high – each with a defined SHBG concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys® SHBG CalCheck is a lyophilized product manufactured using SHBG in human serum/ horse serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels.

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# I. Substantial Equivalence Information:

1. Predicate device name(s): Elecsys® proBNP CalCheck.
2. Predicate K number(s): K020883
3. Comparison with predicate:

The Elecsys® SHBG CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® proBNP CalCheck (K020883)

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

FDA guidance “Points to Consider Guidance Document on Assayed and Unassayed Quality Control Materials”.

# K. Test Principle: NA

# L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: NA
b. Linearity/assay reportable range: NA
c. Traceability (controls, calibrators, or method): The values were standardized against the 1st International Standard for SHBG from the National Institute for Biological Standards and Control (NIBSC) code 95/560.
d. Detection limit: NA
e. Analytical specificity: NA
f. Assay cut-off: NA

2. Comparison studies:
a. Method comparison with predicate device: NA
b. Matrix comparison: NA

3. Clinical studies:
a. Clinical sensitivity: NA
b. Clinical specificity: NA
c. Other clinical supportive data (when a and b are not applicable): NA

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4. Clinical cut-off: NA
5. Expected values/Reference range: NA

# Proposed Mean and Target Ranges

Target Values given below are target values for each level of the Elecsys SHBG CalCheck solutions. These values are valid for all lots of CalCheck solutions listed. Lots: 123456oo, 123456o1, 123456o2

| Level | Value | Range | Unit |
| --- | --- | --- | --- |
| Check 1 | 20.0 | 15.8 – 24.2 | nmol/l |
| Check 2 | 81.1 | 64.1 – 98.1 | nmol/l |
| Check 3 | 163 | 128.8 -197.2 | nmol/l |

# M. Conclusion:

Based on the information provided, I recommend that the Roche Diagnostics Corporation Elecsys® SHBG CalCheck, be found substantially equivalent to the predicate device (K020883) Elecsys® proBNP CalCheck.