N APOLIPOPROTEIN STANDARD SERUM

K041870 · Dade Behring, Inc. · JIX · Jul 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041870
• Device Name: N APOLIPOPROTEIN STANDARD SERUM
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

For calibration of the Apolipoprotein A-I and Apolipoprotein B assays on BN™ Systems.

Device Story

N Apolipoprotein Standard Serum is a lyophilized human serum-based calibrator containing stabilizers and preservatives. It is used in clinical laboratory settings to establish reference curves for the quantitative determination of Apolipoprotein A-I and Apolipoprotein B assays on BN™ Systems. The calibrator is reconstituted by laboratory personnel and used to calibrate the analytical system, ensuring accurate measurement of patient samples. This process supports clinical decision-making regarding lipid metabolism and cardiovascular risk assessment.

Clinical Evidence

No clinical data. Performance was established via bench testing, specifically stability studies. Stability was evaluated over three lots at 2° to 8° C, demonstrating no significant change in recovery for at least 36 months (unopened) and 15 days once reconstituted.

Technological Characteristics

Lyophilized reagent; human serum matrix; immunonephelometric assay principle; calibrated against WHO reference preparations SP1-01 and SP3-07; compatible with Dade Behring BN Systems.

Indications for Use

Indicated for the calibration of Apolipoprotein A-I and Apolipoprotein B assays on Dade Behring BN Systems.

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

• Randox Laboratories Apolipoprotein Calibrator (K023158)

Submission Summary (Full Text)

{0}

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

A. 510(k) Number: K041870

B. Purpose for Submission: This Premarket Notification provides information demonstrating that Dade Behring’s N Apolipoprotein Standard Serum is substantially equivalent to products that were in commercial distribution prior to May 28, 1976 or since cleared through the 510(k) process.

C. Analyte: N Apolipoprotein Standard Serum

D. Type of Test: Calibrator, immunonephelometric assay

E. Applicant: Dade Behring Inc

F. Proprietary and Established Names:
Proprietary – N Apolipoprotein Standard Serum
Established Name - lipoprotein calibrator

G. Regulatory Information:
1. Regulation section: 21 CFR 862.1150
2. Classification: Class II
3. Product Code: JIX
4. Panel: 75

H. Intended Use:
1. Intended use(s): Establishment of reference curves for the quantitative immunonephelometric determination of Apolipoprotein AI and Apolipoprotein B assays using BN Systems
2. Indication(s) for use: For Calibration of the Apolipoprotein A-I and B assays on BN Systems
3. Special condition for use statement(s): For prescription use only
4. Special instrument Requirements: This calibrator is for use on the Dade Behring BN Systems

{1}

Page 2 of 3

I. Device Description: N Apolipoprotein Standard Serum is a lyophilized reagent prepared from human serum. The concentration of the Apolipoprotein AI and B were calibrated against the IRP SP1-01 and IRP SP3-07 and are lot dependent.

J. Substantial Equivalence Information:

1. Predicate device name(s): Randox Laboratories Apolipoprotein Calibrator
2. Predicate K number(s): K023158
3. Comparison with predicate:

| Predicate Comparisons | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For the calibration of Apolipoprotein A-I and Apolipoprotein B assays Dade Behring BN Systems. | Apolipoprotein Calibrator based on the lyophilized human serum for use in the calibration of Apolipoprotein A-I and Apolipoprotein B assays. The constituent concentrations of the Randox Laboratories Limited Apolipoprotein Calibrator are present at 1 level. |
| Matrix | Stabilized reagent prepared from pooled human serum. | Stabilized reagent prepared from pooled human serum. |
| Analytes | Apolipoprotein A-I, B | Apolipoprotein A-I, B |
| Form | Lyophilized | Lyophilized |

K. Standard/Guidance Document Referenced (if applicable): ODE Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)", dated January 10, 1997..

L. Test Principle: Immunonephelometric

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: n/a
b. Linearity/assay reportable range: n/a

{2}

Page 3 of 3

c. Traceability (controls, calibrators, or method): N Apolipoprotein Standard Serum is prepared from pooled human serum from selected healthy donors. N Apolipoprotein Standard Serum is calibrated against the international (WHO) reference preparation SP1-01 for Apolipoprotein A-I and SP3-07 for Apolipoprotein B. Stability was evaluated by testing N Apolipoprotein Standard Serum in duplicate at each time point for a total of three lots. The standard was evaluated at the recommended storage temperature of 2 to 8 °C. Stability testing supports no significant change in recovery for at least 36 months, and for 15 days, once reconstituted.

d. Detection limit: n/a

e. Analytical specificity: n/a

f. Assay cut-off: n/a

2. Comparison studies:

a. Method comparison with predicate device:

b. Matrix comparison: Stabilized reagent prepared from pooled human serum.

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.