HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278

K041926 · Diagnostic Chemicals , Ltd. · JIX · Nov 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041926
• Device Name: HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.

Device Story

HDL/LDL-Advance Calibrator is a lyophilized human serum-based product used to calibrate HDL and LDL cholesterol assays. The device is reconstituted with deionized water by laboratory personnel in a clinical chemistry setting. It contains HDL added gravimetrically from certified primary material and LDL derived from an in-house human serum pool. Values are assigned via repeated testing using commercially available assays. The calibrator ensures the accuracy of clinical chemistry analyzers when measuring lipoprotein levels, which aids clinicians in assessing patient lipid profiles and cardiovascular risk.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum matrix; reconstituted with deionized water. Contains HDL (gravimetrically added from certified primary material) and LDL (human serum pool). Stability: 7 days at 2-8°C post-reconstitution. All human source material tested non-reactive for HBsAg, HCV, and HIV-1/2.

Indications for Use

Indicated for in vitro diagnostic use to calibrate HDL and LDL cholesterol assays in human serum.

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 ASSAY ONLY TEMPLATE

A. 510(k) Number:
k041926

B. Purpose for Submission:
Clearance of new calibrator for a device

C. Measurand:
Low and High Density Lipoproteins (LDL and HDL)

D. Type of Test:
Calibrator

E. Applicant:
Diagnostic Chemicals Limited

F. Proprietary and Established Names:
HDL/LDL-Advance Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1150, Calibrator
2. Classification:
Class II
3. Product code:
JIX, Calibrator, multi-analyte mixture
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL
Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low

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density lipoprotein.

2. **Indication(s) for use:**
see intended use above

3. **Special conditions for use statement(s):**
For in vitro diagnostic use

4. **Special instrument requirements:**
See k041927 and k041928 for information on the HDL and LDL assays

I. **Device Description:**
The HDL/LDL-Advance Calibrator is provided lyophilized (to be reconstituted with deionized water). For more information on traceability and matrix, see Traceability below.

All human source material was tested and found non-reactive for HBsAg, HCV, and HIV-1/2 by an FDA-approved method.

J. **Substantial Equivalence Information:**
1. **Predicate device name(s):**
Roche Multi Analyte Calibrator
2. **Predicate 510(k) number(s):**
k011658
3. **Comparison with predicate:**

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Calibration of assays | |
| contents | 4 x 2 mL lyophilized human serum | 3 x 1 mL lyophilized human serum |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| analytes | HDL and LDL | HDL, LDL, and apolipoprotein |

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

None referenced

L. Test Principle:

Not applicable. This submission is for clearance of a calibrator.

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):

The calibrator contains HDL and LDL in a human serum matrix. The calibrators are purchased from a commercial source and distributed by the sponsor. Calibrators are included with the assays (see k041927 and k041928 for information on the assays).

The HDL is added gravimetrically to the calibrator from a certified primary material. LDL is added from an in-house human serum pool. The values are assigned by repeated testing by commercially available assays.

Stability testing protocols and acceptance criteria were reviewed and found acceptable. After reconstitution, the calibrator is stable for 7 days at $2 - 8^{\circ}\mathrm{C}$.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

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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

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.