ELECSYS TOXO IGG CALCHECK 5
Device Facts
| Record ID | K092888 |
|---|---|
| Device Name | ELECSYS TOXO IGG CALCHECK 5 |
| Applicant | Roche Diagnostics Corp. |
| Product Code | JJX · Clinical Chemistry |
| Decision Date | Nov 10, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
Indications for Use
The Elecsys Toxo IgG CalCheck, an assayed calibrator control, is intended for use in calibration verification and for use in the verification of the reportable range established by the Elecsys Toxo IgG reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Device Story
Elecsys Toxo IgG CalCheck 5 is a set of 5 lyophilized levels of human anti-Toxoplasma gondii IgG antibodies in a human serum matrix. Used in clinical laboratories to verify calibration and analytical measurement range (AMR) of Elecsys Toxo IgG assays on Elecsys 2010, MODULAR ANALYTICS E170, and cobas e analyzers. Laboratory technicians reconstitute lyophilized vials with distilled/deionized water, then run samples on the analyzer as patient specimens. Results are compared against lot-specific target ranges provided by the manufacturer. If results fall outside specified limits, technicians perform troubleshooting or contact technical support. The device assists laboratories in meeting regulatory requirements for calibration verification and range validation, ensuring the accuracy of patient test results.
Clinical Evidence
Bench testing only. No clinical data. Performance verified via dilution studies (1:1 ratio) confirming values fall within the assay's measuring range. Stability verified via open-vial (4 hours at 20-25°C) and accelerated aging studies (3 weeks at 35°C). Values assigned using WHO anti-Toxoplasma serum (TOXM) 3rd International Standard.
Technological Characteristics
Lyophilized human serum matrix containing human anti-Toxo IgG antibodies. Five concentration levels. Reconstituted with 1.0 mL distilled/deionized water. Traceable to WHO anti-Toxoplasma serum (TOXM), 3rd International Standard. No preservatives. Storage: 2-8°C unopened; 4 hours at 20-25°C reconstituted.
Indications for Use
Indicated for use as an assayed control to verify calibration and assay range for Elecsys Toxo IgG reagent on specified Roche immunoassay analyzers. No specific patient population or contraindications defined as it is a laboratory control product.
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 Toxo IgG CalCheck (K083655)
Related Devices
- K083655 — ELECSYS TOXO IGG CALCHECK · Roche Diagnostics · Feb 12, 2009
- K092585 — ELECSYS RUBELLA IGGA CALCHECK 5 · Roche Diagnostics · Oct 30, 2009
- K090311 — ELECSYS RUBELLA IGG CALCHECK · Roche Diagnostics · May 5, 2009
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
K092888
B. Purpose for Submission:
For 510(k) clearance of a modification of calibration test system to include reportable range verification as an intended use
C. Measurand:
Toxoplasma gondii (T. gondii)
D. Type of Test:
Calibration Verification and Reportable Range Verification Material for Toxoplasma IgG
E. Applicant:
Roche Diagnostics
F. Proprietary and Established Names:
Elecsys Toxo IgG CalCheck 5; Toxo IgG CalCheck 5
G. Regulatory Information:
1. Regulation section:
862.1660- Quality control material (assayed and unassayed)
2. Classifications:
Class I
3. Product codes:
JJX- Quality Control Material (assayed and unassayed)
4. Panel:
75- Clinical Chemistry
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H. Intended Use:
1. Intended use(s):
The Elecsys Toxo IgG CalCheck, an assayed calibrator control, is intended for use in calibration verification and for use in the verification of the reportable range established by the Elecsys Toxo IgG reagent on the indicated Elecsys and cobas e immunoassay analyzers.
2. Indication(s) for use:
The Elecsys Toxo IgG CalCheck, an assayed calibrator control, is intended for use in calibration verification and for use in the verification of the reportable range established by the Elecsys Toxo IgG reagent on the indicated Elecsys and cobas e immunoassay analyzers.
3. Special condition for use statement(s):
To be used with the Elecsys Toxo IgG assay
4. Special instrument requirements:
Elecsys 2010, MODULAR ANALYTICS E170 or cobas e (411 and 601) analyzers
I. Device Description:
The Elecsys Toxo IgG CalCheck 5 set contains five lyophilized levels of human anti-Toxo IgG antibodies in a solution of human serum protein and has the appropriate matrix characteristics for the analyte. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Upon reconstitution, the control material is used in the verification of calibration as well as the verification of the reportable range for Elecsys Toxo IgG on the Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411 and cobas e 601 immunoassay analyzers.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Elecsys Toxo IgG CalCheck
2. Predicate 510(k) number(s):
K083655
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3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Proposed Device (K092888) | Predicate (K083655) |
| Matrix/Format | Human Serum/Lyophilized | Same |
| Reactive Component | Anti-Toxo IgG antibody | Same |
| Handling | Reconstitute the contents of each vial with exactly 1.0 mL distilled or deionized water. Allow bottle to stand closed for 15 minutes. Mix gently by inversion to ensure homogeneity. | Same |
| Stability | Unopened: Store at 2-8°C until expiration date
Reconstituted: Store at 20 – 25°C for up to 4 hours | Same |
| Differences | | |
| --- | --- | --- |
| Item | Proposed Device (K092888) | Predicate (K083655) |
| Intended Use | Verification of calibration and verification of the reportable range established by the Elecsys Toxo IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and the cobas e (411 and 601) immunoassay analyzer | Verification of calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and the cobas e immunoassay analyzer |
| Levels | Five | Three |
K. Standard/Guidance Document Referenced (if applicable):
This 510(k) Premarket Notification was prepared and referenced the guidance document, "Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material: (June 7, 2007)"
I. Test Principle:
Not applicable – Calibrator
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility: Not applicable
b. Linearity/assay reportable range:
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To verify the reportable range of the Elecsys 2010, MODULAR ANALYTICS E170 or cobas e analyzers using Elecsys Toxo IgG CalCheck 5, a dilution study was performed using the Elecsys Toxo IgG CalCheck Levels 1 and 5.
# Dilution Study
CalCheck 1, CalCheck 2, CalCheck 4 and CalCheck 5 were mixed in a 1:1 ratio and measured in two-fold determination. The average was then calculated. The predetermined specification was that the diluted value had to fall within the measuring range.
Results showed that CalCheck dilution values were within the assay's measuring range after dilution, as follows:
| Sample | Value after 1:1 Dilution [IU/mL] | Average 1:1 Dilution [IU/mL] |
| --- | --- | --- |
| CalCheck 1 + CalCheck 2 | 1.72 | 1.68 |
| CalCheck 1 + CalCheck 2 | 1.64 | |
| CalCheck 4 + CalCheck 5 | 545 | 527.5 |
| CalCheck 4 + CalCheck 5 | 510 | |
Both CalCheck dilution values are within the assay's measuring range after dilution.
c. Traceability, Stability, Expected values (controls, calibrators, or methods)
The Elecsys Toxo IgG CalCheck is standardized against the same master calibration curve as the calibrators used for the Elecsys Toxo IgG test system (Elecsys Toxo IgG Reagent and Calibrators, k073501). Serum/plasma comparisons performed demonstrate equivalency of the specimen types. Please refer to pages 62-71 of the original Elecsys Toxo IgG Test System submission, K073501, for this information.
# Analyte Value Assignment
Values for Toxo IgG CalCheck 5 were calibrated against the WHO anti-Toxoplasma serum (TOXM), 3rd International Standard for $T.$ gondii from the National Institute for Biological Standards and Control (NIBSC), UK. Values are assigned using a minimum of four Elecsys 2010/ cobas e 411 analyzers and four MODULAR ANALYTICS E170/ cobas e601 analyzers. Two independent series of analyses are performed for each instrument. The target value of each CalCheck is the median over 6 -8 series (i.e., 0.175 - 650 IU/mL) of the respective CalCheck.
# Stability
Open Vial Stability and Accelerated stability studies were performed in order to verify the stability claims for the Elecsys Toxo IgG CalCheck 5. The data was generated using Toxo IgG master calibrators, which have the same composition and target values as Toxo IgG CalCheck 5.
# Open Vial Stability:
The Elecsys Toxo IgG CalCheck 5 test material and reference material were tested in duplicate. The test material was reconstituted and stored for 5 hours at $25^{\circ}\mathrm{C}$ (in an
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open vial). The reference material was a freshly reconstituted set of Elecsys Toxo IgG CalCheck 5. The recovery was calculated as a percent of the reference value.
The acceptance criterion is recovery of 90-110% of the reference material value.
The results for the Reconstituted (Open Vial) Stability for Elecsys Toxo IgG CalCheck 5 were as follows:
| Sample | Mean (IU/mL) | Percent of Reference |
| --- | --- | --- |
| Reference: | | |
| Level 1 | 0.0 | - |
| Level 2 | 2.83 | - |
| Level 3 | 326 | - |
| Level 4 | 504 | - |
| Level 5 | 605 | - |
| | | |
| Test Material: | 5 hours open at 25°C | |
| Level 1 | 0.0 | - |
| Level 2 | 2.88 | 102 |
| Level 3 | 318 | 98 |
| Level 4 | 494 | 98 |
| Level 5 | 615 | 102 |
The data support the package insert claims that reconstituted Elecsys Toxo IgG CalCheck 5 is stable up to 4 hours at 20-25°C.
## Accelerated Stability
The Elecsys Toxi IgG CalCheck 5 test material was stored at 35°C for 3 weeks. The reference material was a freshly reconstituted set of CalChecks stored at 2-8°C. After 3 weeks, the test and reference materials were tested in duplicate. The recovery was calculated as a percent of the reference value. The acceptance criterion was recovery of 90-110% of the reference material value.
Results for accelerated stability studies were as follows:
| Sample | Mean (IU/mL) | Percent of Reference |
| --- | --- | --- |
| Reference: | 3 weeks at 2-8°C | |
| Level 1 | 0.06 | - |
| Level 2 | 2.79 | - |
| Level 3 | 319 | - |
| Level 4 | 497 | - |
| Level 5 | 622 | - |
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| Test Material: | 3 weeks at 35°C | |
| --- | --- | --- |
| Level 1 | 0.12 | - |
| Level 2 | 2.85 | 102 |
| Level 3 | 320 | 100 |
| Level 4 | 497 | 100 |
| Level 5 | 607 | 98 |
The accelerated stability model employed supports a shelf-life claim of 29 months when the Toxo IgG CalCheck 5 materials are stored under normal storage conditions of $2 - 8^{\circ}\mathrm{C}$ .
d. Detection limit:
Not applicable, Calibrator material with assigned values..
e. Analytical specificity:
Not applicable.
f. Assay cut-off:
The assay cut-off was determined using master calibrators for the assay that has values assigned that are traceable to the World Health Organizations (WHO) standards. The sponsor used the WHO anti-Toxoplasma serum (TOXM), 3rd International Standard for $T.$ gondii from NIBSC, UK. Two independent series of analyzes were performed on the Elecsys 2010, cobas e 411, and the MODULAR ANALYTICS E170/ cobas e601 analyzers. The samples were run in duplicate and the target values were calculated as the median of the determined values. This fulfils the requirements of demonstrating a target values for the Toxo IgG CalCheck levels calibrators.
| Instruments Used in Value Assignment | ≥3 Elecsys 2010 analyzers ≥6 series per analyzer | |
| --- | --- | --- |
| | Toxo IgG CalCheck 5 Level | Toxo IgG Target Value (IU/mL) |
| Specific Procedure | Level 1 | 0 |
| Values | Level 2 | 3 |
| | Level 3 | 325 |
| | Level 4 | 520 |
| | Level 5 | 650 |
| Assigned Target Values and Ranges | Level 1 (Lot 179227) | ≤1 |
| | Level 2 (Lot 152734) | 2.73 (1.91 α 3.55) |
| | Level 3 (Lot 179229) | 315 (221 α 410) |
| | Level 4 (Lot 179230) | 500 (350 α 650) |
| | Level 5 (Lot 179231) | 610 (427 α 793) |
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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:
Representative values were assigned to the product. The Anti HBs CalCheck is composed of calibration verification solutions consisting of five CalCheck solutions; very low, low, medium, high and very high, each with a defined Toxo IgG CalCheck level (as shown in the table below). This information is included in the package insert.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The information submitted in this premarket notification is complete and supports a substantial equivalent decision.
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