LIPOPROTEIN FOR MULTIPLE ANALYTES

K051619 · Bayer Healthcare, LLC · JIX · Aug 1, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051619
• Device Name: LIPOPROTEIN FOR MULTIPLE ANALYTES
• Applicant: Bayer Healthcare, LLC
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 1, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1, Apolipoprotein B, and the Direct HDL assays on the ADVIA IMS Chemistry systems.

Device Story

Lipoprotein Calibrator is a human serum-based solution containing human and nonhuman constituents; used to calibrate Apolipoprotein A1, Apolipoprotein B, and Direct HDL assays on ADVIA IMS Chemistry systems. Device provides six levels for apoA1 and apoB, and a single level for Direct HDL Cholesterol. Calibrator values for apoA1/apoB are traceable to WHO-IFCC international reference materials; Direct HDL values derived from human serum correlation studies versus National Cholesterol Education Program Designated Comparison Method. Product is lyophilized, stable for 24 months unopened at 2-8°C, and stable for 3 days at 2-8°C after reconstitution.

Clinical Evidence

No clinical data. Performance validated via bench testing of three separate lots of calibrator material to ensure stability and accuracy of assigned values.

Technological Characteristics

Lyophilized mixture of human and bovine serum base. Six levels for Apo A1/B; one level for Direct HDL. Stable at 2-8°C until expiration; stable 3 days post-reconstitution at 2-8°C. Used for calibration of ADVIA IMS Chemistry systems.

Indications for Use

Indicated for in vitro diagnostic calibration of Apolipoprotein A1, Apolipoprotein B, and Direct HDL assays on ADVIA IMS Chemistry systems. Prescription use only.

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

• Lipoprotein Calibrator (K031682)

Submission Summary (Full Text)

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

A. 510(k) Number:
k051619

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

C. Measurand:
Calibrators for Apolipoprotein A1 (apoA1), Apolipoprotein B (apoB), and HDL Cholesterol

D. Type of Test:
Calibrator

E. Applicant:
Bayer HealthCare LLC

F. Proprietary and Established Names:
Lipoprotein 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):
See indications for use.

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2. **Indication(s) for use:**

The Bayer Lipoprotein Calibrator is intended for *in vitro* diagnostic use to calibrate Apolipoprotein A1, Apolipoprotein B, and the Direct HDL assays on the ADVIA IMS Chemistry systems.

3. **Special conditions for use statement(s):**

For prescription use

4. **Special instrument requirements:**

For use on the ADVIA IMS Chemistry systems

I. **Device Description:**

Lipoprotein Calibrator is a human serum based solution containing various nonhuman and human constituents.

All human source materials were tested by FDA-approved methods and found to be nonreactive for HBsAg, HCV, and HIV-1/2.

J. **Substantial Equivalence Information:**

1. **Predicate device name(s):**

Bayer Lipoprotein Calibrator

2. **Predicate 510(k) number(s):**

k031682

3. **Comparison with predicate:**

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Calibration of assays | Same |
| Format | A lyophilized mixture of human and bovine serum and bovine constituents has been added to achieve specific concentrations. | Same |
| Analytes Measured | Apolipoprotein A1
Apolipoprotein B
HDL Cholesterol | Apolipoprotein A1
Apolipoprotein B |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Stability | Unopened: Stable at 2-8°C until the expiration date printed on the label | Same |
| Stability | Reconstituted: 3 days at 2-8°C | Same |
| Levels | Six levels for apoA1 and apoB, and a single level for Direct HDL Chol | Six levels for apoA1 and apoB |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Direct HDL Cholesterol | Addition of assigned value | Analyte present in the calibrator but no value was assigned |

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

FDA Guidance “Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators”, February 22, 1999

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 apoA1/apoB values of the calibrator are traceable to the WHO-IFCC international reference materials (SP1-01/SP3-07).

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The values for the Direct HDL Cholesterol were derived from human serum correlation studies versus the Designated Comparison Method of the National Cholesterol Education Program.

Stability testing protocols and acceptance criteria were reviewed and found acceptable. Stability is performed on 3 lots of material. After real time stability studies, the product was assigned 24 months stability. After reconstitution, the calibrator is stable for 3 days at $2 - 8^{\circ}\mathrm{C}$.

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:
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:

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.