ELECSYS ANTI-TPO CALSET

K103171 · Roche Diagnostics · JIX · Feb 11, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103171
• Device Name: ELECSYS ANTI-TPO CALSET
• Applicant: Roche Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Feb 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Elecsys® Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys® Anti-TPO CalSet is a lyophilized calibrator for the quantitative Elecsys Anti-TPO assay. It consists of sheep anti-TPO antibodies in a human serum matrix at two concentration levels (approx. 35 IU/mL and 350 IU/mL). The product requires reconstitution with distilled or deionized water before use. It is intended for use by laboratory professionals on Roche Elecsys and cobas e immunoassay analyzers. The device includes barcode cards and sheets to provide lot-specific calibration values to the analyzer. By calibrating the assay, the device ensures accurate quantitative determination of thyroid peroxidase antibodies, which aids clinicians in the diagnosis of autoimmune thyroid diseases.

Clinical Evidence

No clinical data. Bench testing only, including stability studies for unopened lyophilized, opened reconstituted, and on-board stability to support expiration claims.

Technological Characteristics

Lyophilized sheep anti-TPO antibodies in human serum matrix. Two levels: approx. 35.0 IU/mL and 350 IU/mL. Traceable to NIBSC 66/387. Reconstituted with 1.5 mL distilled/deionized water. Used on Elecsys and cobas e immunoassay analyzers. No software or electronic components.

Indications for Use

Indicated for use as a calibrator for the quantitative Elecsys Anti-TPO assay on specified Roche immunoassay analyzers. No specific patient population or contraindications defined for this calibrator product.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Elecsys® Anti-TPO test system (k051890)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k103171

B. Purpose for Submission:
Modified device (from liquid to lyophilized material)

C. Measurand:
Calibrator for Thyroid Autoantibody

D. Type of Test:
Not Applicable

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Elecsys® Anti-TPO CalSet

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIX: Calibrator, Multi-analyte Mixture | Class II | 21 CFR § 862.1150, Calibrator | Chemistry (75) |

H. Intended Use:

1. Intended use(s):
Elecsys® Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.

2. Indication(s) for use:
Same an Intended Use.

3. Special conditions for use statement(s):
For Prescription use only.

4. Special instrument requirements:
Elecsys® 2010 Analyzer (k961481)
MODULAR ANALYTICS E170 (k961481/A003)
Cobas e 411 Analyzer (k062279)
Cobas e 601 Analyzer (k060373)

I. Device Description:
The Elecsys® Anti-TPO CalSet is a lyophilized product consisting of sheep anti-TPO antibodies in a human serum matrix in two concentration ranges (approximately 35 IU/mL and 350 IU/mL). The CalSet includes a barcode card, calibrator barcode sheet, 4 empty labeled snap-cap bottles, 2X6 bottle labbels. The exact lot-specific calibrator values are encoded in the barcode as well as printed in the enclosed (or electronically available) calibrator barcode sheet. The CalSet package consists 4 bottles (reconstitution volume: 1.5 mL/bottle): 2 bottles for calibrator 1, and 2 bottles for calibrator 2, and can be used with all reagent lots.

J. Substantial Equivalence Information:

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1. Predicate device name(s): Elecsys® Anti-TPO test system [Includes the calibrator, Elecsys Anti-TPO CalSet (liquid form)]
2. Predicate 510(k) number(s): k051890
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | New Device | Predicate Device |
| | k103171 | k051890 |
| | Elecsys® Anti-TPO CalSet | Elecsys® Anti-TPO test system (includes the Anti-TPO CalSet calibrator) |
| Technology | Electrochemiluminescence | Same |
| Analyte | Anti-TPO antibodies (sheep) | Same |
| International Reference standard material | Traceable to NIBSC (National Institute for Biological Standards and Controls) 66/387 International Standard | Same |
| Matrix | Human serum | Same |
| Levels and Corresponding Concentrations | Two Calibrator 1: approx. 35.0 IU/mL Calibrator 2: approx. 350 IU/mL | Same |
| Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| | k103171 | k051890 |
| | Elecsys® Anti-TPO CalSet | Elecsys® Anti-TPO test system (includes the Anti-TPO CalSet calibrator) |
| Intended Use | Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers. | The Elecsys Anti-TPO immunoassay is for the in vitro quantitative determination of antibodies to thyroid peroxidase in human serum and plasma. The anti-TPO determination is used as an aid in the diagnosis of autoimmune thyroid diseases. |

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| Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| Calibrator Material Form (Format) | Lyophilized | Liquid |
| Stability and storage | **Unopened:**
• Store at 2-8°C until expiration date

**Reconstituted:**
• at 2-8°C: 7 days
• at -20°C: 8 weeks (freeze only once)
• on the analyzers at 20-25°C: use only once | **Unopened:**
• Store at 2-8°C until expiration date

**Opened:**
• at 2-8°C: 6 weeks
• at 20-25°C on Elecsys 1010/2010: up to 5 hours
• MODULAR ANALYTICS E170: use only once |
| Analyzer | Roche Elecsys 2010, MODULAR ANALYTICS E170 (Elecsys module), and cobas e immunoassay platforms (cobas e 411 and cobas e 601 analyzers). | Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. |
| Handling | Dissolve carefully the contents of one bottle by adding exactly 1.5 mL of distilled or deionized water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding the formation of foam. Transfer the reconstituted calibrator into the empty labeled snap-cap bottles supplied.

Elecsys 2010 and cobas e 411 analyzers: The calibrators should only be left on the analyzers during calibration at 20-25°C. Perform only one | The reagents in the kit are ready for use and supplied in the bottles compatible with the system.

Elecsys 1010/2010 analyzers: The Elecsys calibrators Cal1 and Cal2 and the Elecsys controls PC A-TPO1 and PC A-TPO2 should only be left on the analyzers at 20-25°C during calibration/quality control. After use, close the bottles as soon as possible and store at 2-8°C.

Ensure that no calibration |

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| Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| | calibration procedure per aliquot. If necessary, freeze in aliquots; see section on MODULAR ANALYTICS E170 and cobas e 601 analyzers. | and control solution is trapped in the opened snap-cap. Because of possible evaporation effects, not more than 5 calibration/quality control procedures per bottle set should be performed. |
| | MODULAR ANALYTICS E170 and cobas e 601 analyzers: Unless the entire volume is necessary for calibration on the analyzer, transfer aliquots of the reconstituted calibrator into empty snap-cap bottles (CalSet Vials). Attach the supplied labels to these additional bottles. Store the aliquots for later use at -20°C. Perform only one calibration procedure per aliquot. | MODULAR ANALYTICS E170 analyzer: Unless the entire volume is necessary for calibration and quality control on the analyzer, transfer aliquots of the ready-for-use calibrators and controls into empty snap-cap bottles (CalSet Vials/Control Set Vials). Attach the supplied labels to these additional bottles. Store the aliquots for later use at 2-8°C. Perform only one calibration or control procedure per aliquot. All information required for correct operation is read in via the respective reagent barcodes. |
| Packaged and sold | Packaged and sold separately | Packaged as part of the Elecsys® Anti-TPO Test System |

K. Standard/Guidance Document Referenced (if applicable):
Not applicable

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable

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b. Linearity/assay reportable range:
Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The calibrator is traceable to the reference material NIBSC (National Institute for Biological Standards and Controls) 66/387 International Standard.
Stability
Studies for unopened lyophilized, opened reconstituted and opened on-board stability testings supports the following CalSet expiration date claims:
Unopened calibrator lyophilized bottles: 18 months at 2-8°C (real time stability testing is on-going to support future 36 months claim)
Opened reconstituted calibrator: 7 days at 2-8°C; 8 weeks (freeze only once) at -20°C; and use only once on the analyzers at 20-25 °C up to 5 hours.

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 and specificity:
Not applicable.
b. Other clinical supportive data (when a. is 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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