MULTI-CHEM CALIBRATOR A

K042551 · Wako Chemicals USA, Inc. · JIX · Nov 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042551
• Device Name: MULTI-CHEM CALIBRATOR A
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Multi-Chem Calibrator A is designed to be used with Wako’s assays to determine the points of reference that are used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium in human serum.

Device Story

Multi-Chem Calibrator A is a liquid, ready-to-use aqueous solution containing Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium. It serves as a reference material to calibrate clinical chemistry assays for these analytes in human serum. Used in clinical laboratory settings, the calibrator allows healthcare providers to establish reference points for diagnostic testing. By ensuring accurate calibration of Wako assays, the device supports precise quantification of serum analytes, aiding clinicians in diagnosing and monitoring metabolic and mineral-related conditions.

Clinical Evidence

No clinical studies were performed. Substantial equivalence was established through analytical method comparison studies against predicate devices. Correlation coefficients for Calcium, Fe, UIBC, Inorganic Phosphorus, and Magnesium ranged from 0.9990 to 0.9998, with slopes near 1.0, demonstrating analytical performance equivalent to the predicate standards.

Technological Characteristics

Liquid calibrator for in vitro diagnostic use. Designed for use with specific Wako clinical chemistry assays for serum analytes (Calcium, FE, UIBC, Inorganic Phosphorus, Magnesium).

Indications for Use

Indicated for use as a reference standard for the determination of Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium in human serum samples.

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.

Submission Summary (Full Text)

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

A. 510(k) Number: k042551

B. Purpose For Submission:

Premarket Notification (510(k)) of intention to manufacture and market the Wako Chemicals USA, Inc. Multi-Chem Calibrator A.

C. Analyte: Calcium, FE, UIBC, Inorganic Phosphorus, Magnesium

D. Type of Test: Not Applicable

E. Applicant: Wako Chemicals USA, Inc.

F. Proprietary and Established Names: Multi-Chem Calibrator A

G. Regulatory Information:

1. Regulation section: §862.1150, Calibrator, Multi-Analyte Mixture
2. Classification: Class II
3. Product Code: JIX
4. Panel: 75 (Chemistry)

H. Intended use(s):

1. Intended use(s)

The Multi-Chem Calibrator A is designed to be used with Wako’s assays to determine the points of reference that are used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium in human serum.

2. Indication(s) for use:

The Multi-Chem Calibrator A is designed to be used with Wako’s assays to determine the points of reference that are used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium in human serum.

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

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4. Special instrument Requirements: Not Applicable

I. Device Description:

The Multi-Chem Calibrator A is liquid and ready to use. It consists of 4 x 5 mL bottles of aqueous solution containing Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium. This solution is stable until the date printed on the label when stored as directed. Calibrator traceability was stated as certified by the Japan Calibration Service System (JCSS).

J. Substantial Equivalence Information:

1. Predicate device name(s): Wako's Calcium, Fe, UIBC, Inorganic Phosphorus and Magnesium Standards.
2. Predicate K number(s): k872051, k984119, k871764, k871762
3. Comparison with Predicate:

| | Multi-Chem Calibrator A | Calcium | Fe | UIBC | Inorganic Phosphorus | Magnesium |
| --- | --- | --- | --- | --- | --- | --- |
| Format | Liquid | Liquid | Liquid | Liquid | Liquid | Liquid |
| Constituents | Ammonium iron (II) Sulfate 0.0017%
Calcium Carbonate 2.5 mmol/L
Magnesium Chloride 2.1 mmol/L
Potassium Dihydrogen Phosphate 3.2 mmol/L
Sodium Benzoate 0.1%
Aqueous Solution | Calcium Carbonate 2.5 mmol/L | Iron Sulfate 0.0017% | Iron Sulfate 0.0017% | Potassium Phosphate 3.2 mmol/L | Magnesium 2.1 mmol/L |
| Storage | 2-10° C | 2-10° C | 2-10° C | 2-10° C | 2-10° C | 2-10° C |
| 510(K) # | k042551 | k872051 | k984119 | k984119 | k871764 | K871762 |

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

Calibrator traceability was stated as certified by the Japan Calibration Service System (JCSS).

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 (controls, calibrators, or method):

The Waco Multi-Chem Calibrator is traceable to the following referenced standards:

Primary Standard

| Item | Primary Standard or Method |
| --- | --- |
| Ca: | Calcium Standard Solution (Ca 1000) |
| Fe: | Iron Standard Solution (Fe 1000) |
| Phos: | Phosphate Ion Standard Solution (PO₄³⁻ 1000) |
| Mg: | Magnesium Standard Solution (Mg 1000) |

Multi Chem Calibrator A

| Item | Assigned Value | Method |
| --- | --- | --- |
| Ca: | 10 mg/dL | Assayed by 0-cresolphthalein complexone method |
| Fe: | 200 μg/dL | Assayed by bathophenanthroline direct method |
| Phos: | 10 mg/dL | Assayed by molybdate direct method |
| Mg: | 5 mg/dL | Assayed by enzymatic method |

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:

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The Multi-Chem Calibrator A is designed to be used with Wako's assays to determine the points of reference that are used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus, and Magnesium in human serum.

The safety and effectiveness of the Multi-Chem Calibrator A is demonstrated by its substantial equivalence to Wako's Calcium, Fe, UIBC, Inorganic Phosphorus and Magnesium Standards. The calibration materials are used to calibrate instruments to determine the points of reference. The following are results of the comparison studies against the predicates:

Calcium (Calcium-HR2 reagent)

| | n | 80 |
| --- | --- | --- |
| | Correlation coefficient | 0.9997 |
| | Slope | 1.0065 |
| | Intercept | -0.0187 |

Fe (L-type Fe reagent)

| | n | 70 |
| --- | --- | --- |
| | Correlation coefficient | 0.9998 |
| | Slope | 0.9931 |
| | Intercept | -0.0304 |

UIBC (L-type UIBC reagent)

| | n | 60 |
| --- | --- | --- |
| | Correlation coefficient | 0.9990 |
| | Slope | 1.0021 |
| | Intercept | -0.6674 |

Phosphorus (phosphorus-HR2 regent)

| | n | 80 |
| --- | --- | --- |
| | Correlation coefficient | 0.9997 |
| | Slope | 1.0043 |
| | Intercept | 0.0059 |

Phosphorus (phosphorus-HA regent)

| | n | 80 |
| --- | --- | --- |
| | Correlation coefficient | 0.9998 |
| | Slope | 1.0068 |
| | Intercept | -0.0124 |

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Magnesium (phosphorus-HR2 regent)

| | n | 80 |
| --- | --- | --- |
| | Correlation coefficient | 0.9993 |
| | Slope | 0.9717 |
| | Intercept | -0.0159 |

3. Clinical studies:
a. Clinical sensitivity:
Clinical studies are not typically submitted for this device type.
b. Clinical specificity:
Clinical studies are not typically submitted for this device type.
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:

Multi Chem Calibrator A

| Item | Assigned Value | Method |
| --- | --- | --- |
| Ca: | 10 mg/dL | Assayed by 0-cresolphthalein complexone method |
| Fe: | 200 μg/dL | Assayed by bathophenanthroline direct method |
| Phos: | 10 mg/dL | Assayed by molybdate direct method |
| Mg: | 5 mg/dL | Assayed by enzymatic method |

N. Conclusion:

The submitted material in this premarket notification is complete and supports a substantial equivalence decision.