SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI

K032035 · Beckman Coulter, Inc. · CZW · Aug 7, 2003 · Immunology

Device Facts

• Record ID: K032035
• Device Name: SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
• Applicant: Beckman Coulter, Inc.
• Product Code: CZW · Immunology
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

C3 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C3 concentration in human serum or plasma by rate turbidimetry. C4 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C4 concentration in human serum or plasma by turbidimetry. The Beckman Coulter SYNCHRON LX® Systems Calibrator 1 (CAL 1), used in conjunction with SYNCHRON LX reagents, is intended for the calibration of the immunoprotein tests on SYNCHRON LX Systems.

Device Story

The SYNCHRON LX Systems C3 and C4 reagents are liquid-stable, in vitro diagnostic reagents used for the quantitative measurement of complement components in human serum or plasma. The device operates via turbidimetric analysis (rate turbidimetry for C3; turbidimetry for C4) on the SYNCHRON LX spectrophotometric system. The system requires calibration using the LX Calibrator 1. The process involves mixing patient samples with reagents, measuring light absorbance changes, and calculating concentration based on the calibration curve. The output is a quantitative concentration value provided to clinicians to assist in assessing complement levels. The device is intended for professional use in clinical laboratories. It provides diagnostic information regarding complement protein concentrations, which are relevant to various immunological conditions.

Clinical Evidence

Bench testing only. Precision (NCCLS EP5-A): C3 total %CV 1.23-2.19%; C4 total %CV 1.68-3.09%. Linearity: r=0.999 (C3), r=0.9988 (C4). Method comparison (NCCLS EP9-A) vs. predicate: C3 (N=146, r=0.993), C4 (N=179, r=0.991). Matrix comparison (EDTA, sodium/lithium heparin) showed r ≥ 0.97. No clinical sensitivity/specificity studies performed.

Technological Characteristics

Reagent kit includes reaction buffer and polyclonal goat antibodies. Measurement via rate turbidimetry/turbidimetry at 340 nm. Automated, random-access spectrophotometric analysis. Traceable to IFCC BCR-470. Measuring range: 10-350 mg/dL (C3), 5-120 mg/dL (C4).

Indications for Use

Indicated for the quantitative determination of Complement C3 and C4 concentrations in human serum or plasma. Used in clinical laboratory settings for diagnostic testing.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Predicate Devices

• Beckman IMMAGE® Complement C3 and C4 Reagents (K964842)
• Beckman Calibrator 1 (K771603, K791341)

Submission Summary (Full Text)

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K 63203)

# 510(k) Summary SYNCHRON LX® Systems Complement C3 Reagent, Complement C4 Reagent and LX Calibrator 1

### 1.0 Submitted By:

Kim Walker Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### Date Submitted: 2.0

June 30, 2003

#### 3.0 Device Name(s):

#### 3.1 Proprietary Names

SYNCHRON LX® Systems Complement C3 (C3) Reagent SYNCHRON LX® Systems Complement C4 (C4) Reagent SYNCHRON LX® Systems Calibrator 1 (CAL1)

#### 3.2 Classification Name

Complement components immunological test system (21 CFR § 866.5240) Clinical Chemistry Test Systems Calibrator (21 CFR § 862.1150)

#### Predicate Device: 4.0

| Candidate | Predicate | Manufacturer | Docket<br>Number |
|---------------------------------|-------------------------------------------------|--------------------|--------------------|
| LX Systems C3<br>and C4 Reagent | Beckman IMMAGE Complement C3<br>and C4 Reagents | Beckman<br>Coulter | K964842 |
| LX CAL 1 | Beckman Calibrator 1 | Beckman<br>Coulter | K771603<br>K791341 |

*Beckman Coulter, Inc., Brea, CA

## 5.0 Description:

The SYNCHRON LX® C3 and C4 Reagents are designed for optimal performance on the SYNCHRON LX® Systems. The reagent kit contains two 100-test cartridges that are packaged separately from the associated calibrators. The LX CAL 1 kit contains four 3 mL - bottles.

## 6.0 Intended Use:

C3 reagent, when used in conjunction with SYNCHRON LX® Svstems and Calibrator 1, is intended for quantitative determination of Complement C3 concentration in human serum or plasma by rate turbidimetry.

C4 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C4 concentration in human serum or plasma by turbidimetry.

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The Beckman Coulter SYNCHRON LX® Systems Calibrator 1 (CAL 1), used in conjunction with SYNCHRON LX reagents, is intended for the calibration of the immunoprotein tests on SYNCHRON LX Systems.

# Comparison to Predicate(s): 7.0

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

| Reagent | Aspect/Characteristic | Comments |
|-------------------------|----------------------------------------------------------------------------|-----------------------------------------|
| LX System C3<br>Reagent | Sample Type<br>Reference Range<br>Antibody Source<br>Liquid Stable Reagent | Same as<br>Beckman IMMAGE<br>C3 Reagent |
| LX System C4<br>Reagent | Sample Type<br>Reference Range<br>Antibody Source<br>Liquid Stable Reagent | Same as<br>Beckman IMMAGE<br>C4 Reagent |
| LX System CAL 1 | Human Serum Preparation<br>Liquid Stable Calibrator | Same as Beckman<br>CAL 1 |

Similarities to the Predicate

# Differences From The Predicate

| Reagent | Aspect/Characteristic | Comments |
|-------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| LX System C3<br>Reagent | Analytical Range | The LX C3 range is 10-350 mg/dL whereas<br>the IMMAGE C3 range is 50-500mg/dL |
| | Assay Method | The LX C3 uses rate turbidimetry whereas<br>the IMMAGE uses rate nephelometry |
| | Initial dilution range | The LX C3 uses a 1:20 dilution initially and<br>the IMMAGE C3 uses a 1:36 dilution. |
| | Extended dilution range | The LX C3 does not have an extended<br>range whereas the IMMAGE C3 does. |
| LX System C4<br>Reagent | Analytical Range | The LX C4 range is 5-120 mg/dL whereas<br>the IMMAGE C4 range is 10-130 mg/dL |
| | Assay Method | The LX C4 uses turbidimetry whereas the<br>IMMAGE uses rate nephelometry |
| | Initial dilution range | The LX C4 uses a 1:20 dilution initially and<br>the IMMAGE C4 uses a 1:36 dilution. |
| | Extended dilution range | The LX C4 does not have an extended<br>range whereas the IMMAGE C4 does. |
| LX System CAL 1 | Intended Use | The LX CAL 1 is used with the LX Systems<br>(a spectrophotometer) whereas the<br>Beckman CAL 1 is used with the IMMAGE<br>or ARRAY Systems (nephelometers) |

## 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.

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Equivalence is demonstrated through method comparison, linearity, and imprecision experiments.

| Candidate | Slope | Slope<br>Confidence | Intercept | Intercept<br>Confidence | r | n | Predicate<br>Method |
|------------------|-------|---------------------|-----------|-------------------------|-------|-----|-------------------------|
| LX C3<br>Reagent | 1.025 | 0.023 | 2.307 | 2.783 | 0.992 | 134 | IMMAGE<br>C3<br>Reagent |
| LX C4<br>Reagent | 1.001 | 0.027 | 0.938 | 0.717 | 0.985 | 160 | IMMAGE<br>C4<br>Reagent |

SYNCHRON LX Systems C3 and C4 Method Comparison Study Results

SYNCHRON LX System C3 and C4 Estimated Imprecision

| Sample | Mean (mg/dL) | SD<br>(mg/dL) | % C.V. | N |
|------------------------|--------------|---------------|--------|----|
| Within-Run Imprecision | | | | |
| Serum Control 1 | 55.6 | 0.97 | 1.75 | 80 |
| Serum Control 2 | 170.8 | 2.20 | 1.29 | 80 |
| Serum Control 3 | 237.4 | 2.27 | 0.96 | 80 |
| Serum Pool 1 | 28.9 | 0.49 | 1.71 | 80 |
| Total Imprecision | | | | |
| Serum Control 1 | 55.6 | 1.21 | 2.19 | 80 |
| Serum Control 2 | 170.8 | 2.44 | 1.43 | 80 |
| Serum Control 3 | 237.4 | 2.92 | 1.23 | 80 |
| Serum Pool 1 | 28.9 | 0.57 | 1.98 | 80 |

LX System C3 Reagent Imprecision Results

# LX System C4 Reagent Imprecision Results

| Sample | Mean (mg/dL) | SD<br>(mg/dL) | % C.V. | N |
|------------------------|--------------|---------------|--------|----|
| Within-Run Imprecision | | | | |
| Serum Control 1 | 25.1 | 0.40 | 1.59 | 80 |
| Serum Control 2 | 38.0 | 0.50 | 1.32 | 80 |
| Serum Control 3 | 50.1 | 0.85 | 1.70 | 80 |
| Serum Pool 1 | 9.5 | 0.23 | 2.37 | 80 |
| Serum Pool 2 | 70.3 | 1.07 | 1.53 | 80 |
| Total Imprecision | | | | |
| Serum Control 1 | 25.1 | 0.46 | 1.82 | 80 |
| Serum Control 2 | 38.0 | 0.64 | 1.68 | 80 |
| Serum Control 3 | 50.1 | 1.09 | 2.17 | 80 |
| Serum Pool 1 | 9.5 | 0.29 | 3.09 | 80 |
| Serum Pool 2 | 70.3 | 1.34 | 1.91 | 80 |

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| Anticoagulant | Level of Anticoagulant<br>Tested | Deming Regression Analysis |
|-----------------|----------------------------------|------------------------------|
| Lithium Heparin | 14 Units/mL | Y = 0.966X + 0.28; r = 0.985 |
| Sodium Heparin | 14 Units/mL | Y = 0.979X - 0.95; r = 0.979 |
| EDTA | 1.5 mg/mL | Y = 0.855X + 5.27; r = 0.988 |

C3 Anticoagulant Study Summary

# C4 Anticoagulant Study Summary

| Anticoagulant | Level of Anticoagulant<br>Tested | Deming Regression Analysis |
|-----------------|----------------------------------|------------------------------|
| Lithium Heparin | 14 Units/mL | Y = 0.899X + 1.21; r = 0.978 |
| Sodium Heparin | 14 Units/mL | Y = 0.900X + 0.76; r = 0.992 |
| EDTA | 1.5 mg/mL | Y = 0.967X + 0.34; r = 0.985 |

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure with three wavy lines emanating from the head, resembling a bird in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kim Walker Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-104 Brea, California 92822-8000

AUG - 7 2003

Senior Regulatory Affairs Special
Beckman Coulter, Inc.
200 S. Kraemer Boulevard
M/S W-104
Brea, California 92822-8000

AUG - 7 2003

Re: k032035

Trade/Device Name: SYNCHRON LX® Systems Complement C3 Reagent, Complement C4 Reagent and LX Calibrator 1 Regulation Number: 21 CFR § 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: II Product Code: CZW, DBI, JIT Dated: June 30, 2003 Received: July 2, 2003

Dear Ms. Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 长の32つミデ

SYNCHRON LX® Systems Device Name: Complement C3 Reagent, Complement C4 Reagent and LX Calibrator 1

Indications for Use:

C3 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1. is intended for quantitative determination of Complement C3 concentration in human serum or plasma by rate turbidimetry.

C4 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C4 concentration in human serum or plasma by turbidimetry.

The Beckman Coulter SYNCHRON LX® Systems Calibrator 1 (CAL 1), used in conjunction with SYNCHRON LX reagents, is intended for the calibration of the immunoprotein tests on SYNCHRON LX Systems.

J. Reeves for J. Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_10032035

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

OR

Over-the-Counter Use Optional Format 1-2-96