EXL ANEM CAL, MODEL RC640

K093645 · Siemens Healthcare Diagnostics · JIX · Mar 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093645
• Device Name: EXL ANEM CAL, MODEL RC640
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12) and LOCI Folate (FOL) methods on the Dimension® EXL™ integrated chemistry system and the Ferritin (FERR) method on the Dimension® clinical chemistry system.

Device Story

Dimension EXL Anemia Calibrator is a multi-analyte, liquid, frozen, bovine serum albumin-based product; contains human liver-derived ferritin, Vitamin B12, and Folate. Used in clinical laboratory settings to calibrate Vitamin B12, Folate, and Ferritin assays on Dimension EXL integrated chemistry systems. Calibrator kit includes ten vials across five levels. Healthcare professionals use the calibrator to establish assay traceability and ensure accurate patient sample measurement. Human source materials are tested for HbsAg, anti-HCV, and HIV-1/2.

Clinical Evidence

No clinical data. Bench testing only. Stability and value assignment protocols were validated; traceability established using USP grade materials and WHO IS 94/572 standards.

Technological Characteristics

Multi-analyte, liquid, frozen, bovine serum albumin-based matrix. Contains human liver-derived ferritin, USP grade Vitamin B12, and Folate. Five-level kit configuration. Storage: -25 to -15°C (unopened); 30-day stability at 2-8°C (thawed/unopened).

Indications for Use

Indicated for the calibration of Ferritin, Vitamin B12, and Folate assays on Dimension EXL integrated chemistry systems and Dimension clinical chemistry systems.

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

• Dimension Vista® LOCI 4 Calibrator (k071224)

Submission Summary (Full Text)

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

A. 510(k) Number:
k093645

B. Purpose for Submission:
New device

C. Measurand:
Calibrator materials for vitamin B12, folate, and ferritin

D. Type of Test:
Not applicable

E. Applicant:
Siemens Healthcare Diagnostics, Inc

F. Proprietary and Established Names:
Dimension EXL Anemia Calibrator

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIX | Class II | 21CFR§862.1150 | Chemistry 75 |

H. Intended Use:

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

2. Indication(s) for use:
The ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12) and LOCI Folate (FOL) methods on the Dimension® EXL™

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integrated chemistry system and the Ferritin (FERR) method on the Dimension® clinical chemistry system.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Dimension® EXL™

I. Device Description:

Dimension EXL™ Anemia Calibrator is a multi-analyte, liquid, frozen bovine serum albumin based product containing ferritin from human liver, Vitamin B12 and Folate. The kit consists of ten vials, two each of five levels containing 2.0 mL per vial for Level A, B, C, D, & E.

All human source materials used to produce this product have been tested for HbsAg, anti-HCV, HIV-1 and HIV-2 and found to be non-reactive by FDA licensed tests.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension Vista® LOCI 4 Calibrator

2. Predicate 510(k) number(s)

k071224

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| | Candidate Device | Predicate Device (k071224) |
| Item | Dimension Anemia Calibrator | Dimension Vista® LOCI 4 calibrator k071224 |
| Intended Use | EXL ANEM CAL is an in vitro diagnostic product for the calibration of the Ferritin (FERR), LOCI Vitamin B12 (B12), and LOCI Folate (FOL) methods on the Dimension EXL™ integrated chemistry system. | LOCI 4 CAL is an in vitro diagnostic product for calibration of the Ferritin (FERR), Vitamin B12 (B12) and Folate (FOL) methods on the Dimension Vista® System. |
| Form | frozen liquid, bovine serum | frozen liquid, bovine serum |

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| | albumin | albumin |
| --- | --- | --- |
| Levels | 5 | 5 |
| Stability and storage | ANEMIA CAL is stored at -25 to -15°C. ANEMIA CAL is stable, thawed and unopened for 30 days @ 2-8°C | LOCI 4 CAL is stored at -20 to -10°C. LOCI 4 CAL is stable, thawed and unopened for 30 days @ 2-8°C |
| Differences | | |
| --- | --- | --- |
| | Candidate Device | Predicate Device (k071224) |
| Name of the device | Dimension Anemia Calibrator | Dimension Vista® LOCI 4 calibrator |
| Instrumentation | ANEMIA CAL is for use on the Dimension® EXL™ integrated chemistry system. | LOCI 4 Cal is for use on the Dimension Vista® System. |

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

None referenced

# L. Test Principle:

Not applicable

# 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):

United States Pharmacopoeia (USP) grade B12 and Folate in a B12/Folate depleted human serum matrix are used to make anchor pools. The Ferritin Master Pool bottle values are traceable to an anchor pool prepared from WHO IS 94/572. The concentrations are verified by testing patient samples with values across the method's

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assay range.

Standard values are assigned to a master calibrator lot using USP grade B12 and Folate into a bovine serum albumin matrix. Values are them assigned to the commercial calibrator (bovine serum albumin matrix at target concentration) verses master calibrator using chemistry analyzers calibrated with the master pool. Each level is tested on multiple analyzers multiple times. Acceptance criteria and protocol for assigning the value were provided and found to be acceptable.

The sponsor provided protocols and acceptance criteria to establish the stability of the product, closed and open vial. Un-open calibrators stored frozen at -25 to -15°C are stable for 12 months. Un-open thawed calibrators stored at 2-8°C are stable for 30 days. Open vial stability is 30 days when recapped immediately after use and stored at 2-8°C.

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

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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:

An example of the lot specific target values are as follows:

| Level | Target |
| --- | --- |
| B12 | pg/mL |
| 1 | 0 |
| 2 | 200 |
| 3 | 500 |
| 4 | 1000 |
| 5 | 2100 |
| Folate | ng/mL |
| 1 | 0 |
| 2 | 2.5 |
| 3 | 5.0 |
| 4 | 10.0 |
| 5 | 21.0 |
| Ferritin | ng/mL |
| 1 | 0 |
| 2 | 27 |
| 3 | 156 |
| 4 | 510 |
| 5 | 1080 |

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.