SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS

K970314 · Beckman Instruments, Inc. · MSJ · Apr 21, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970314
• Device Name: SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
• Applicant: Beckman Instruments, Inc.
• Product Code: MSJ · Clinical Chemistry
• Decision Date: Apr 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System. The SYNCHRON LX Systems Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

Device Story

Reagents for quantitative determination of human apolipoprotein A-1 and B in serum or plasma; used on Beckman SYNCHRON LX clinical chemistry analyzers. Input: patient serum/plasma samples. Principle: immunoturbidimetric assay; formation of antigen-antibody complex measured at 340 nm at 37°C. Output: concentration values for ApoA and ApoB. Used in clinical laboratory settings by trained personnel. Results assist clinicians in assessing lipid metabolism and cardiovascular risk profiles.

Clinical Evidence

Bench testing only. Method comparison studies performed against predicate Beckman reagents (n=78 for ApoA, n=73 for ApoB) and NWLRL nephelometric procedures (n=54 each). Results showed high correlation (r=0.9922/0.9970 vs. predicate; r=0.965/0.991 vs. NWLRL). Within-run imprecision studies (n=80 per level) demonstrated %CVs ranging from 1.23% to 2.19%. Stability data supports 24-month shelf-life, 14-day calibration stability, and 30-day on-board stability.

Technological Characteristics

Reagents packaged in polystyrene cartridges. Immunoturbidimetric assay principle. Reaction temperature 37°C; detection wavelength 340 nm. Single-point calibration update. Designed for automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of human apolipoprotein A-1 and apolipoprotein B in serum or plasma samples for clinical chemistry analysis.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• Beckman Apolipoprotein A-1 (APA) Reagent (K862019)
• Beckman Apolipoprotein B (APB) Reagent (K862386)

Submission Summary (Full Text)

{0}

Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents
Summary of Safety & Effectiveness
K970314
Summary of Safety & Effectiveness
SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents
APR 21 1997

## 1.0 Submitted By:

Kathleen M. Jaker
Senior Applications Chemist
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-117
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

## 2.0 Date Submitted:

23 Januray - 1997

## 3.0 Device Name(s):

### 3.1 Proprietary Names

SYNCHRON LX™ Systems Apolipoprotein A-1 (ApoA) Reagent
SYNCHRON LX™ Systems Apolipoprotein B (ApoB) Reagent

### 3.2 Classification Names

Lipoprotein Test System (21 CFR §862.1475)

## 4.0 Predicate Device(s):

| SYNCHRON LX Reagents | Predicate | Predicate Company | Docket Number |
| --- | --- | --- | --- |
| Apolipoprotein A-1 (ApoA) Reagent | Beckman Apolipoprotein A-1 (APA) Reagent | Beckman Instruments, Inc. | K862019 |
| Apolipoprotein B (ApoB) Reagent | Beckman Apolipoprotein B (APB) Reagent | Beckman Instruments, Inc. | K862386 |

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents
Summary of Safety & Effectiveness

## 5.0 Description:

The SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents in conjunction with SYNCHRON Systems APO CAL, are intended for use on Beckman’s SYNCHRON LX Clinical Systems.

## 6.0 Intended Use:

The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

## 7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.

SIMILARITIES with the PREDICATE

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SYNCHRON LX System (ApoA and ApoB) Reagents | Intended Use | Same as Beckman’s Apolipoprotein reagents; quantitative determination of human apolipoproteins A-1 and apolipoprotein B. |
| | Chemical Reaction | Same principle as the predicate; formation of antigen-antibody complex |
| | Antibody | Same source, processing as Beckman Apolipoprotein reagents |
| | Calibration | Same as the ARRAY systems reagents; single point update of manufacturer-determined calibration curve. |

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents
Summary of Safety & Effectiveness
3

# DIFFERENCES from the PREDICATE

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SYNCHRON LX System (ApoA and ApoB) Reagents | Methodology | The SYNCHRON LX reads turbidimetrically and the Immunochemistry systems (ARRAY) read nephelometrically |
| | Measurement Method | The SYNCHRON LX runs the reaction at 37°C and reads an endpoint at 340 nm; the ARRAY Systems run at 26.5°C and read at a peak rate at 450-550 nm |
| | Packaging | The SYNCHRON LX reagents are packaged in polystyrene cartridges; the ARRAY Systems reagents are in glass bottles. |

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents
Summary of Safety & Effectiveness

## 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Beckman Apolipoprotein Reagents (APA and APB) to the SYNCHRON LX Systems Apolipoprotein Reagents (ApoA and ApoB).

### Method Comparison Study #1 Results
#### SYNCHRON LX Systems ApoA & ApoB Reagents

| Reagent (Analyte) | Slope | Intercept (mg/dL) | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- |
| SYNCHRON LX Apolipoprotein A-1 Reagent (ApoA) | 0.953 | 4.1 | 0.9922 | 78 | Beckman's Apolipoprotein APA Reagent |
| SYNCHRON LX Apolipoprotein B Reagent (ApoB) | 0.943 | 7.6 | 0.9970 | 73 | Beckman's APB Reagent |

### Method Comparison Study #2 Results
#### SYNCHRON LX Systems ApoA & ApoB Reagents

| Reagent | Slope | Intercept (mg/dL) | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- |
| SYNCHRON LX Apolipoprotein A-1 Reagent (ApoA) | 1.022 | -3.4 | 0.965 | 54 | NWLRL* Nephelometric Procedure |
| SYNCHRON LX Apolipoprotein B Reagent (ApoB) | 1.006 | 1.7 | 0.991 | 54 | NWLRL* Nephelometric Procedure |

* NWLRL = Northwest Lipid Research Laboratories

apo510k.sse 1/97

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents
Summary of Safety & Effectiveness

Estimated Within-Run Imprecision

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Apolipoprotein A-1 (ApoA) | | | | |
| Level 1 | 94.4 | 2.07 | 2.19 | 80 |
| Level 2 | 121.6 | 2.12 | 1.74 | 80 |
| Level 3 | 145.6 | 1.80 | 1.23 | 80 |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Apolipoprotein B (ApoB) | | | | |
| Level 1 | 59.6 | 0.98 | 1.65 | 80 |
| Level 2 | 96.2 | 1.94 | 2.02 | 80 |
| Level 3 | 132.8 | 1.77 | 1.33 | 80 |

Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| SYNCHRON LX Systems Apolipoprotein ApoA and ApoB | 24 month shelf-life
14 day calibration stability
30 days on-board stability |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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