WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2

K040918 · Wako Chemicals USA, Inc. · JJX · May 17, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040918
• Device Name: WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Wako Quality control is intended for use as an assay quality control serum to monitor the precision of laboratory testing procedures for the Wako Lipid assays such as Triglyceride, HDL-Cholesterol, LDL-Cholesterol, Total Cholesterol, Phospholipids, Apolipoproteins, NEFA C, Free Cholesterol and beta Lipoprotein.

Device Story

Wako Lipid Control is a liquid quality control serum; used in clinical laboratories to monitor precision of lipid assay procedures. Product consists of human-matrix control material provided in two levels; stored at 2-8 °C. Device serves as a reference to verify laboratory testing performance for specific lipid analytes.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid human-matrix quality control serum; 2 levels; 5ml vial volume; storage 2-8 °C.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for lipid assays, including Total Cholesterol, LDL-Cholesterol, Triglycerides, NEFA C, Free Cholesterol, and beta-Lipoprotein.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

A. 510(k) Number: K040918
B. Purpose for Submission: Notification of intent to manufacture and market the device: Lipid Control
C. Analyte: Lipids – Triglyceride, HDL-Cholesterol, LDL-Cholesterol, Total Cholesterol, Phospholipids, Apolipoproteins, NEFA C, Free Cholesterol and beta Lipoprotein.
D. Type of Test: n/a
E. Applicant: Wako Chemicals USA, Inc
F. Proprietary and Established Names: Wako Lipid Control – Quality Control Material

G. Regulatory Information:
1. Regulation section: 21 CFR 862.1660
2. Classification: Class I
3. Product Code: JJX
4. Panel: 75

H. Intended Use:
1. Intended use(s): The Wako Quality control is intended for use as an assay quality control serum to monitor the precision of laboratory testing procedures for the Wako Lipid assays such as Triglyceride, HDL-Cholesterol, LDL-Cholesterol, Total Cholesterol, Phospholipids, Apolipoproteins, NEFA C, Free Cholesterol and beta Lipoprotein.
2. Indication(s) for use: The Wako Quality control is intended for use as an assay quality control serum to monitor the precision of laboratory testing procedures for the Wako Lipid assays such as Triglyceride, HDL-Cholesterol, LDL-Cholesterol, Total Cholesterol, Phospholipids, Apolipoproteins, NEFA C, Free Cholesterol and beta Lipoprotein.
3. Special condition for use statement(s): none
4. Special instrument Requirements: none

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I. Device Description: Quality Control Material (Assayed and unassayed)

J. Substantial Equivalence Information:

1. Predicate device name(s): Wako Prealbumin Control
2. Predicate K number(s): k040226
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Control for human lipid assays | Control for human prealbumin |
| Differences | | |
| Item | Device | Predicate |
| Form | Liquid | Liquid |
| Levels | 2 levels | 2 levels |
| Vial volume | 5ml | 5ml |
| Matrix | Human | Human |
| Storage | 2-8 °C | 2-10 °C |

K. Standard/Guidance Document Referenced (if applicable): No standard or guidance was listed

L. Test Principle: N/A

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method): None provided
d. Detection limit: N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:

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a. Method comparison with predicate device: NA
b. Matrix comparison: NA

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable): N/A

4. Clinical cut-off: N/A
5. Expected values/Reference range: N/A

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.