CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160

K080607 · Roche Diagnostics Corp. · JIX · May 12, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080607
• Device Name: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
• Applicant: Roche Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Calibrator for automated systems (C.f.a.s.) Proteins is for use in the calibration of the quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

Device Story

Calibrator for Automated Systems (C.f.a.s.) Proteins is a liquid, ready-to-use calibrator consisting of pooled human sera with chemical and biological additives. It is used in clinical chemistry laboratories to calibrate quantitative Roche assays on Roche automated analyzers. The device provides lot-specific analyte concentrations used to establish calibration curves for clinical chemistry testing. It is operated by laboratory technicians or clinical staff. The output is a set of reference values used by the analyzer to calculate patient sample concentrations, ensuring accuracy and traceability to reference materials like CRM 470. It benefits patients by ensuring the accuracy of diagnostic test results.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated through real-time shelf-life testing (up to 25 months), simulated shipping, and open-bottle stability studies. Acceptance criteria were defined as ±10% recovery of the assigned value. Traceability for Alpha-1 Acid Glycoprotein was established against ERM-DA470 (CRM 470).

Technological Characteristics

Liquid, ready-to-use pooled human serum matrix with chemical/biological additives. Traceable to CRM 470. Stability: 24-month shelf life at 2-8°C. Standalone calibrator material for use with Roche automated chemistry systems.

Indications for Use

Indicated for use in the calibration of quantitative Roche clinical chemistry assays on Roche automated analyzers. For prescription use.

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

• Calibrator for Automated Systems (C.f.a.s.) Proteins (k011226)

Submission Summary (Full Text)

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

A. 510(k) Number:
k080607

B. Purpose for Submission:
α 1-Acid glycoprotein has been added as a constituent to the previously cleared multi-analyte Roche Calibrator for Automated Systems (C.f.a.s.) Proteins.

C. Measurand:
Calibrator materials for analytes are listed in section J. 3. below.

D. Type of Test:
Not applicable

E. Applicant:
Roche Diagnostics Corporation

F. Proprietary and Established Names:
Calibrator for Automated Systems (C.f.a.s.) Proteins

G. Regulatory Information:
1. Regulation section:
21 § 862.1150, Calibrator
2. Classification:
Class II
3. Product code:
JIX
4. Panel:

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Clinical Chemistry (75)

## H. Intended Use:

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

2. Indication(s) for use:
The Calibrator for automated systems (C.f.a.s.) Proteins is for use in the calibration of the quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

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

4. Special instrument requirements:
For use with the Roche automated chemistry systems listed in the package insert

## I. Device Description:

Calibrator for Automated systems (C.f.a.s.) Proteins is a liquid ready-to-use calibrator for use in the calibration of quantitative clinical chemistry assays. The concentrations of the analytes are lot specific and are indicated in the calibrator labeling. C.f.a.s. Proteins is specified for use with Roche system reagents.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
Calibrator for Automated Systems (C.f.a.s.) Proteins

2. Predicate K number(s):
k011226

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers. | For use in the calibration of quantitative Roche immunoturbidimetric methods on clinical chemistry analyzers |
| Format | Same | Pooled human sera with constituents added as required to obtain desired component levels. |
| Levels | Same | Single Level |
| Reagent Composition | Same | Liquid ready-to-use |
| Matrix | Same | Human serum with chemical and biological additives. |
| Traceability | Same | Traceability of the target values is given in the respective instructions for use of the system reagents. |
| Value Assignment | Same | Traceable through Master Lot to standards or reference methods. |
| Stability | Same | • Unopened: Stable at 2-8°C until expiration date. • Opened: Stable for 1 month at 2-8°C, with exceptions noted in labeling. |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Standardization of C4, IgA-2, and C3c | Standardization path modified to adjust the set point of the master calibrator according to recovery of CRM 470 material. | The standardization path used a method comparison of samples run against the C.f.a.s. Master Lot calibration and those same samples analyzed using CRM 470. Results were compared and set points |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | for the Master Lot were adjusted to those of CRM 470. |
| Constituent Concentration | Tolerance range of Ferritin and CRP concentrations were increased. | Set point below measuring range requiring dilution of high samples. |
| Constituents of the calibrators. | Anti-Streptolysin O and Ceruloplasmin are still present in the device, but are no longer used in calibration. Alpha-1 acid glycoprotein is a new constituent. | ASO and Ceruloplasmin were calibrated using the predicate. No Alpha-1 acid glycoprotein. |

## Constituent Analytes

| C.f.a.s. Proteins | C.f.a.s. Proteins (Predicate Device) |
| --- | --- |
| α1-antitrypsin | α1-antitrypsin |
| Included but no longer value assigned | ASLO |
| C3c | C3c |
| C4 | C4 |
| Included but no longer value assigned | Ceruloplasmin |
| C-Reactive Protein | C-Reactive Protein |
| Haptoglobin | Haptoglobin |
| No longer a constituent | Prealbumin |
| Transferrin | Transferrin |
| Ferritin | Ferritin |
| IgG | IgG |
| IgA | IgA |
| IgM | IgM |
| Alpha 1-Acid glycoprotein | - |

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

Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final

## L. Test Principle:

Not applicable

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

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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

| Control or Calibrator | Standard for Traceability |
| --- | --- |
| α1-Acid Glycoprotein | Protein reference preparation ERM® - DA470 (CRM 470) |

Value Assignment

The value assignment takes place in an internal laboratory on several analyzers. Each analyzer runs 3-4 independent series. An independent series includes full calibration using a new calibrator vial and sample vial. After verifying the data for the samples are within tolerance, the mean is used as set point.

Stability

Three different lots were tested for shelf-life stability in real time, and simulated shipping and open bottle stability testing. The data are measured in 2-fold determinations. The percent recovery is calculated based on the assigned value. The acceptance criterion is ±10% of the assigned value. α1-Acid Glycoprotein met the stability criterion of ±10% of the assigned value for all of the conditions in the protocol.

Real Time Stability testing- shelf life: The C.f.a.s. Proteins is stored at +2 to +8°C. Recovery studies are performed on freshly opened bottles after manufacturing, 7 months, 13 months, 19 months, and 25 months. Results are compared to the assigned values and acceptance criteria are ±10%.

Stress Testing and Open Bottle Stability Testing: After real time stability testing, simulated shipping and open bottle stability are tested. Protein recovery is compared to the reference material (fresh C.f.a.s. Proteins) up to 25 months. Results are compared to the assigned values and acceptance criteria are ±10%.

The stability data provided verifies that C.f.a.s. Proteins is stable for a shelf life claim of 24 months.

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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:
Not applicable

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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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