IRON STANDARD

K052002 · Roche Diagnostics Corp. · JIT · Aug 22, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052002
• Device Name: IRON STANDARD
• Applicant: Roche Diagnostics Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers. For Prescription Use only

Device Story

Iron Standard is a single-level, ready-to-use aqueous solution of Ferrous Ammonium Sulfate Hexahydrate; used as a calibrator for quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers. The product is gravimetrically prepared and assigned a target value of 500 µg/dL, traceable to NIST SRM 937 Iron Metal. It is intended for professional use in clinical laboratory settings to ensure the accuracy of UIBC assay measurements. The healthcare provider uses the calibrator to establish the calibration curve on the analyzer, which subsequently affects the accuracy of patient iron binding capacity results used in clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Stability verified via real-time (up to 12 months) and accelerated (5 days at 45°C) studies. Traceability established against NIST SRM 937 Iron Metal. Performance confirmed by comparing new batch replicates against NIST standards and previously released lots on Hitachi analyzers.

Technological Characteristics

Aqueous solution of Ferrous Ammonium Sulfate Hexahydrate. Single-level calibrator. Ready-to-use. Storage at 15-25°C. Traceable to NIST SRM 937.

Indications for Use

Indicated for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.

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® C-Peptide Calset (K033873)

Submission Summary (Full Text)

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

A. 510(k) Number:
k052002

B. Purpose for Submission:
New device; originally sold as part of an Unsaturated Iron Binding Capacity (UIBC) assay kit which was pre-amendment. Currently, the Iron Standard is marketed separately from the assay and Roche Diagnostics is submitting a retrospective submission.

C. Measurand:
Calibrator for Iron

D. Type of Test:
Calibrator

E. Applicant:
Roche Diagnostics

F. Proprietary and Established Names:
Iron Standard

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

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75 – Clinical Chemistry

H. Intended Use:

1. Intended use:
See Indications for use

2. Indications for use:
Iron Standard is for use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers.

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

4. Special instrument requirements:
Roche clinical chemistry analyzers

I. Device Description:
The Iron Standard is a single level product consisting of a gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate.

J. Substantial Equivalence Information:

1. Predicate device name:
Elecsys C-Peptide Calset

2. Predicate 510(k) number:
k033873

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Characteristic | Iron Standard | Predicate device Elecsys C-Peptide Calset |
| Intended Use | For use in the calibration of quantitative Unsaturated Iron Binding Capacity (UIBC) assays on Roche clinical chemistry analyzers | For calibrating the quantitative Elecsys C-Peptide assay on the Elecsys immunoassay systems. |

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| Similarities | | |
| --- | --- | --- |
| Characteristic | Iron Standard | Predicate device Elecsys C-Peptide Calset |
| Levels | One | Two |
| Differences | | |
| --- | --- | --- |
| Characteristic | Iron Standard | Predicate device Elecsys C-Peptide Calset |
| Format | Aqueous solution | Lyophilized |
| Handling | Ready to use | Add exactly 1.0 mL distilled water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding the formation of foam. |
| Stability | Unopened: Store at 15-25°C until expiration date Opened: 15-25°C until expiration date | Unopened: Store at 2-8°C until expiration date Reconstituted: -20°C: 1 month (freeze only once) On the analyzers at 20-25°C: use only once |
| Matrix | Gravimetrically prepared aqueous solution of Ferrous Ammonium Sulfate Hexahydrate. | Equine serum with added synthetic C-Peptide |

# 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

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b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

A master calibrator is developed that has values assigned that are traceable to the method "gold standard". Iron Standard is a gravimetrically prepared product with a target value of 500 µg/dL. This product is assayed and compared to a NIST standard prepared from SRM 937, Iron Metal (Clinical).

Values are confirmed on Hitachi analyzers using the Iron or UIBC reagent kit. The reagent is calibrated using the 500 µg/dL NIST standard. Replicates of the new batch of Iron Standard are run, followed by replicates of the NIST standard and replicates of a previously released lot of Iron Standard. The new product, the NIST Standard, and the previously released lot of Iron Standard met the sponsor's acceptance criteria.

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Two studies were performed in order to verify the stability claims for the new Iron Standard.

| Stability | Unopened | Opened |
| --- | --- | --- |
| Iron Standard | Store at 15–25°C until expiration date | 15–25°C: until expiration date |
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Study 1: Real Time Stability. The Iron product is stored at 15-25°C for 6 months, 9 months and 12 months. The Iron reagent is calibrated using the 500 µg/dL NIST standard. Using a Hitachi 917, testing is performed at 6, 9 and 12 months on replicates of the new batch of Iron Standard, followed by replicates of the NIST standard and replicates of a previously released lot of Iron Standard. The new product, the NIST Standard, and the previously released lot of Iron Standard met the sponsor's acceptance criteria.

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Study 2: Accelerated Stability: At the 11th month of a 12 month shelf life, the Iron product is incubated for 5 days at 45°C and equilibrated to the labeled storage temperature, 15-25°C. The Iron reagent is calibrated using 500 µg/dL NIST standard. Using a Hitachi 917, replicates of the new batch of Iron Standard are run, followed by replicates of the NIST standard and replicates of a previously released lot of Iron Standard. The new product, the NIST Standard, and the previously released lot of Iron Standard met the sponsor's acceptance criteria.

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The results of the real time and accelerated stability studies support the claim of a 12 month expiration date.

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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:

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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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