MULTI-LIPID CALIBRATOR

K042550 · Wako Chemicals USA, Inc. · JIX · Nov 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042550
• Device Name: MULTI-LIPID CALIBRATOR
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Multi-Lipid Calibrator is designed to be used with Wako’s assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.

Device Story

Multi-Lipid Calibrator; lyophilized human serum-based material containing HDL-C, LDL-C, Triolein, and Cholesterol. Used in clinical laboratory settings to calibrate Wako assays for lipid panel quantification. Provides reference points for enzymatic and immunoinhibition assay methods. Ensures accuracy of patient lipid measurements by establishing traceability to CDC reference methods. Stability verified via recovery testing at 2-10°C.

Clinical Evidence

No clinical data. Bench testing only. Method comparison studies (N=60) performed against predicate-calibrated assays for Cholesterol, HDL-C, LDL-C, and Triglycerides. Results showed high correlation coefficients (0.9995–1.000) and slopes near 1.0. Stability testing confirmed recovery within ±2.5% of baseline.

Technological Characteristics

Lyophilized human serum containing HDL-C, LDL-C, Triolein, and Cholesterol. Traceable to HECTEF (Total Cholesterol) and CDC Reference Methods (HDL-C, LDL-C, Triglycerides). Storage 2-10°C. No electronic or software components.

Indications for Use

Indicated for use as a reference material for the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum samples when used with Wako's assays.

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:
k042550

B. Purpose For Submission:
Premarket Notification 510(k) of intention to manufacture and market the Wako Chemicals USA, Inc. Multi-Lipid Calibrator.

C. Analyte:
Cholesterol, HDL, LDL, Triglyceride

D. Type of Test: Not Applicable

E. Applicant: Wako Chemicals USA, Inc.

F. Proprietary and Established Names:
Multi-Lipid Calibrator

G. Regulatory Information:
Regulation section:
1. Regulation section: §862.1150, Calibrator
2. Classification: Class II
3. Product Code: JIX
4. Panel: 75 (Chemistry)

H. Intended use(s):
1. Intended use(s)

The Multi-Lipid Calibrator is designed to be used with Wako’s assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.

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2. Indication(s) for use:

The Multi-Lipid Calibrator is designed to be used with Wako's assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.

3. Special condition for use statement(s): For Prescription Use.
4. Special instrument Requirements: Not Applicable

I. Device Description:

The Multi-Lipid Calibrator consists of 4 x 5 mL bottles of lyophilized material containing Human HDL-C concentrate, Human LDL-C concentrate, Triolein, and Cholesterol in human serum. Primary calibrator traceability has been reference to the following: T.Cho: HECTEF (Health Care Technology. Foundation) (P-CHO), HDL-C: CDC Reference Method, LDL-C: CDC Reference Method, TG: Glycerol (Assay method: Gas Chromatograph). This solution is stable until the date printed on the label when stored as directed.

J. Substantial Equivalence Information:

1. Predicate device name(s): Wako's Cholesterol 20R/30R Standard, HDL/LDL Combo Calibrator, Triglyceride Standard Solution A
2. Predicate K number(s): k912024, k001005, k871766
3. Comparison with Predicate:

| | Multi-Lipid Calibrator | Cholesterol 20R/30R Standard | HDL/LDL-C Calibrator | Triglyceride Standard Non-blanking method 300 mg/dL/200 mg/dL | Triglyceride Standard Blanking method 300 mg/dL/ 200 mg/dL |
| --- | --- | --- | --- | --- | --- |
| Format | Lyophilized | Liquid | Lyophilized | Liquid | Liquid |
| Constituents | Human HDL-C Concentrate Human LDL-C Concentrate Triolein 3.39 mmol/L Human Serum | Cholesterol 5.2 mmol/L | Human HDL-C Concentrate Human LDL-C Concentrate | Triolein 3.39 mmol/L | Triolein 3.39 mmol/L |
| Storage | 2-10 °C | 2-10 °C | 2-10 °C | 2-10 °C | 2-10 °C |
| 510(K) # | k042550 | k912024/A | k001005 | k871766 | K010334 |

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

The Waco Multi-Lipid Calibrator is traceable to the following referenced standard: Primary Standard

Total Cholesterol HECTEF (Health Care Technology Foundation) (P-CHO)

HDL-C: CDC Reference Method

LDL-C: CDC Reference Method

TG: Glycerol (Assay method: Gas Chromatograph)

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-Lipid Calibrator is traceable to the following referenced standards:

Primary Standard

| Item | Primary Standard or Method |
| --- | --- |
| Total Cholesterol | HECTEF (Health Care Technology. Foundation) (P-CHO) |
| HDL-C: | CDC Reference Method |
| LDL-C: | CDC Reference Method |
| TG: | Glycerol (Assay method: Gas Chromatograph). |

Secondary Standard (Working Standard)

| Item | Method |
| --- | --- |
| Total Cholesterol | Assayed by enzymatic method |
| HDL-C | Assayed by immunoinhibition method |
| LDL-C | Assayed by enzyme selective protection method |
| TG | Assayed by enzymatic method (glycerol blanking method) |
| | Assayed by enzymatic method (non-blanking method) |

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Multi Lipid Calibrator

| Item | Assigned Value | Method |
| --- | --- | --- |
| Cholesterol | 200 mg/dL | Assayed by enzymatic method |
| HDL-C | 53 mg/dL | Assayed by immuno inhibition method |
| LDL-C | 127 mg/dL | Assayed by enzyme selective protection method |
| Triglyceride | 300 mg/dL | Assayed by enzymatic method (glycerol blanking method) |
| | | Assayed by enzymatic method (non-blanking method) |

Determination: Based on the US CDC reference methods.

The stability of the product was tested over time and the results were compared to the start point of time 0. Percent recoveries were calculated. No recoveries exceeded $\pm 2.5\%$ from time 0. The product is stable until the date printed on the label when stored at $2 - 10^{\circ}\mathrm{C}$.

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:

The Multi-Lipid Calibrator is designed to be used with Wako's assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum. The safety and effectiveness of the Multi-Chem Calibrator B is demonstrated by its substantial equivalency to Wako's Cholesterol 20R/30R Standard, HDL/LDL Combo Calibrator, Triglyceride Standard Solution A.

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:

Cholesterol (L-Type Cholesterol H reagent)

| | N | 60 |
| --- | --- | --- |
| | Correlation coefficient | 0.9996 |
| | Slope | 1.0236 |
| | Intercept | 0.6192 |

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HDL-C (L-Type HDL-C reagent)

| | N | 60 |
| --- | --- | --- |
| | Correlation coefficient | 0.9995 |
| | Slope | 0.9959 |
| | Intercept | 0.2445 |

LDL-C (L-Type LDL-C reagent)

| | n | 60 |
| --- | --- | --- |
| | Correlation coefficient | 0.9996 |
| | Slope | 0.9923 |
| | Intercept | 0.6913 |

Triglyceride (L-Type Triglyceride reagent)

| | N | 60 |
| --- | --- | --- |
| | Correlation coefficient | 1.000 |
| | Slope | 1.0125 |
| | Intercept | 0.0936 |

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 Lipid Calibrator

| Item | Assigned Value | Method |
| --- | --- | --- |
| Cholesterol | 200 mg/dL | Assayed by enzymatic method |
| HDL-C | 53 mg/dL | Assayed by immunoinhibition method |
| LDL-C | 127 mg/dL | Assayed by enzyme selective protection method |
| Triglyceride | 300 mg/dL | Assayed by enzymatic method (glycerol blanking method) |
| | | Assayed by enzymatic method (non-blanking method) |

Determination: Based on the US CDC reference methods.

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N. Conclusion:

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