(37 days)
Not Found
No
The document describes a quantitative turbidimetry assay for measuring complement proteins and does not mention any AI or ML components.
No
The device is described as a reagent and calibrator system used for the quantitative determination of Complement C3 and C4 concentrations in human serum or plasma. This is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the quantitative determination of Complement C3 and C4 concentrations in human serum or plasma, which provides data used in diagnosing and monitoring various medical conditions. The performance studies show comparisons to established chemistry test systems, confirming its role in diagnostic testing.
No
The device description clearly states that the device is a "reagent kit" containing "cartridges" and "bottles," which are physical components, not software. The intended use also describes the use of these reagents in conjunction with a physical system (SYNCHRON LX® Systems).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of Complement C3 and C4 concentration in human serum or plasma. This is a diagnostic measurement performed in vitro (outside the body) on biological samples.
- Device Description: The device consists of reagents and a calibrator used in conjunction with a system (SYNCHRON LX® Systems) to perform these tests. This aligns with the typical components of an IVD system.
- Performance Studies: The document describes performance studies like method comparison and imprecision, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The listed predicate devices are also described as reagents and calibrators for similar tests, further indicating that this device falls within the IVD category.
The core function of the device is to analyze biological samples (serum or plasma) to provide diagnostic information (concentration of C3 and C4), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CZW, DBI, JIT
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, linearity, and imprecision experiments.
SYNCHRON LX Systems C3 and C4 Method Comparison Study Results:
LX C3 Reagent vs IMMAGE C3 Reagent: Slope = 1.025, Slope Confidence = 0.023, Intercept = 2.307, Intercept Confidence = 2.783, r = 0.992, n = 134.
LX C4 Reagent vs IMMAGE C4 Reagent: Slope = 1.001, Slope Confidence = 0.027, Intercept = 0.938, Intercept Confidence = 0.717, r = 0.985, n = 160.
SYNCHRON LX System C3 Estimated Imprecision:
Within-Run Imprecision: Serum Control 1 (Mean 55.6 mg/dL, SD 0.97 mg/dL, % C.V. 1.75, N 80), Serum Control 2 (Mean 170.8 mg/dL, SD 2.20 mg/dL, % C.V. 1.29, N 80), Serum Control 3 (Mean 237.4 mg/dL, SD 2.27 mg/dL, % C.V. 0.96, N 80), Serum Pool 1 (Mean 28.9 mg/dL, SD 0.49 mg/dL, % C.V. 1.71, N 80).
Total Imprecision: Serum Control 1 (Mean 55.6 mg/dL, SD 1.21 mg/dL, % C.V. 2.19, N 80), Serum Control 2 (Mean 170.8 mg/dL, SD 2.44 mg/dL, % C.V. 1.43, N 80), Serum Control 3 (Mean 237.4 mg/dL, SD 2.92 mg/dL, % C.V. 1.23, N 80), Serum Pool 1 (Mean 28.9 mg/dL, SD 0.57 mg/dL, % C.V. 1.98, N 80).
LX System C4 Reagent Imprecision Results:
Within-Run Imprecision: Serum Control 1 (Mean 25.1 mg/dL, SD 0.40 mg/dL, % C.V. 1.59, N 80), Serum Control 2 (Mean 38.0 mg/dL, SD 0.50 mg/dL, % C.V. 1.32, N 80), Serum Control 3 (Mean 50.1 mg/dL, SD 0.85 mg/dL, % C.V. 1.70, N 80), Serum Pool 1 (Mean 9.5 mg/dL, SD 0.23 mg/dL, % C.V. 2.37, N 80), Serum Pool 2 (Mean 70.3 mg/dL, SD 1.07 mg/dL, % C.V. 1.53, N 80).
Total Imprecision: Serum Control 1 (Mean 25.1 mg/dL, SD 0.46 mg/dL, % C.V. 1.82, N 80), Serum Control 2 (Mean 38.0 mg/dL, SD 0.64 mg/dL, % C.V. 1.68, N 80), Serum Control 3 (Mean 50.1 mg/dL, SD 1.09 mg/dL, % C.V. 2.17, N 80), Serum Pool 1 (Mean 9.5 mg/dL, SD 0.29 mg/dL, % C.V. 3.09, N 80), Serum Pool 2 (Mean 70.3 mg/dL, SD 1.34 mg/dL, % C.V. 1.91, N 80).
C3 Anticoagulant Study Summary (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
C4 Anticoagulant Study Summary (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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5240 Complement components immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: (714) 961-4912 FAX: (714) 961-4123
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
Number |
|---------------------------------|-------------------------------------------------|--------------------|--------------------|
| LX Systems C3
and C4 Reagent | Beckman IMMAGE Complement C3
and C4 Reagents | Beckman
Coulter | K964842 |
| LX CAL 1 | Beckman Calibrator 1 | Beckman
Coulter | K771603
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.
1
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 | ||
| Reagent | Sample Type | |
| Reference Range | ||
| Antibody Source | ||
| Liquid Stable Reagent | Same as | |
| Beckman IMMAGE | ||
| C3 Reagent | ||
| LX System C4 | ||
| Reagent | Sample Type | |
| Reference Range | ||
| Antibody Source | ||
| Liquid Stable Reagent | Same as | |
| Beckman IMMAGE | ||
| C4 Reagent | ||
| LX System CAL 1 | Human Serum Preparation | |
| Liquid Stable Calibrator | Same as Beckman | |
| CAL 1 |
Similarities to the Predicate
Differences From The Predicate
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| LX System C3 | ||
| Reagent | Analytical Range | The LX C3 range is 10-350 mg/dL whereas |
| the IMMAGE C3 range is 50-500mg/dL | ||
| Assay Method | The LX C3 uses rate turbidimetry whereas | |
| the IMMAGE uses rate nephelometry | ||
| Initial dilution range | The LX C3 uses a 1:20 dilution initially and | |
| the IMMAGE C3 uses a 1:36 dilution. | ||
| Extended dilution range | The LX C3 does not have an extended | |
| range whereas the IMMAGE C3 does. | ||
| LX System C4 | ||
| Reagent | Analytical Range | The LX C4 range is 5-120 mg/dL whereas |
| the IMMAGE C4 range is 10-130 mg/dL | ||
| Assay Method | The LX C4 uses turbidimetry whereas the | |
| IMMAGE uses rate nephelometry | ||
| Initial dilution range | The LX C4 uses a 1:20 dilution initially and | |
| the IMMAGE C4 uses a 1:36 dilution. | ||
| Extended dilution range | The LX C4 does not have an extended | |
| range whereas the IMMAGE C4 does. | ||
| LX System CAL 1 | Intended Use | The LX CAL 1 is used with the LX Systems |
| (a spectrophotometer) whereas the | ||
| Beckman CAL 1 is used with the IMMAGE | ||
| 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.
2
Equivalence is demonstrated through method comparison, linearity, and imprecision experiments.
| Candidate | Slope | Slope
Confidence | Intercept | Intercept
Confidence | r | n | Predicate
Method |
|------------------|-------|---------------------|-----------|-------------------------|-------|-----|-------------------------|
| LX C3
Reagent | 1.025 | 0.023 | 2.307 | 2.783 | 0.992 | 134 | IMMAGE
C3
Reagent |
| LX C4
Reagent | 1.001 | 0.027 | 0.938 | 0.717 | 0.985 | 160 | IMMAGE
C4
Reagent |
SYNCHRON LX Systems C3 and C4 Method Comparison Study Results
SYNCHRON LX System C3 and C4 Estimated Imprecision
| Sample | Mean (mg/dL) | SD
(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
(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 |
3
| Anticoagulant | Level of Anticoagulant
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
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.
4
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.
5
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
6
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