(37 days)
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.
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.
This is a 510(k) premarket notification for in vitro diagnostic devices. These submissions typically do not contain detailed acceptance criteria and study designs in the same way that studies for AI/ML-based medical devices or devices undergoing clinical trials might. Instead, they focus on demonstrating substantial equivalence to a predicate device through performance data.
Based on the provided text, here's an analysis of the "acceptance criteria" and "study" information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet. Instead, it presents performance data (method comparison, imprecision, and anticoagulant studies) to demonstrate the device's characteristics and its equivalence to the predicate.
Here's an attempt to structure the provided performance data, inferring the underlying objectives:
| Performance Metric | Inferred Acceptance Criteria (Implicit) | Reported Device Performance (SYNCHRON LX) |
|---|---|---|
| Method Comparison (C3) | Slope approximately 1.0, Intercept approximately 0, r (correlation) close to 1.0, Confidence Intervals indicating precision around these values, demonstrating equivalence to IMMAGE C3 Reagent. | Slope: 1.025 (Confidence: 0.023)Intercept: 2.307 (Confidence: 2.783)r: 0.992n: 134 samples (compared to IMMAGE C3 Reagent) |
| Method Comparison (C4) | Slope approximately 1.0, Intercept approximately 0, r (correlation) close to 1.0, Confidence Intervals indicating precision around these values, demonstrating equivalence to IMMAGE C4 Reagent. | Slope: 1.001 (Confidence: 0.027)Intercept: 0.938 (Confidence: 0.717)r: 0.985n: 160 samples (compared to IMMAGE C4 Reagent) |
| C3 Imprecision (Within-Run) | Low % C.V. (Coefficient of Variation) indicating good repeatability. | Serum Control 1: Mean 55.6 mg/dL, SD 0.97, % C.V. 1.75Serum Control 2: Mean 170.8 mg/dL, SD 2.20, % C.V. 1.29Serum Control 3: Mean 237.4 mg/dL, SD 2.27, % C.V. 0.96Serum Pool 1: Mean 28.9 mg/dL, SD 0.49, % C.V. 1.71 |
| C3 Imprecision (Total) | Low % C.V. indicating good reproducibility. | Serum Control 1: Mean 55.6 mg/dL, SD 1.21, % C.V. 2.19Serum Control 2: Mean 170.8 mg/dL, SD 2.44, % C.V. 1.43Serum Control 3: Mean 237.4 mg/dL, SD 2.92, % C.V. 1.23Serum Pool 1: Mean 28.9 mg/dL, SD 0.57, % C.V. 1.98 |
| C4 Imprecision (Within-Run) | Low % C.V. indicating good repeatability. | Serum Control 1: Mean 25.1 mg/dL, SD 0.40, % C.V. 1.59Serum Control 2: Mean 38.0 mg/dL, SD 0.50, % C.V. 1.32Serum Control 3: Mean 50.1 mg/dL, SD 0.85, % C.V. 1.70Serum Pool 1: Mean 9.5 mg/dL, SD 0.23, % C.V. 2.37Serum Pool 2: Mean 70.3 mg/dL, SD 1.07, % C.V. 1.53 |
| C4 Imprecision (Total) | Low % C.V. indicating good reproducibility. | Serum Control 1: Mean 25.1 mg/dL, SD 0.46, % C.V. 1.82Serum Control 2: Mean 38.0 mg/dL, SD 0.64, % C.V. 1.68Serum Control 3: Mean 50.1 mg/dL, SD 1.09, % C.V. 2.17Serum Pool 1: Mean 9.5 mg/dL, SD 0.29, % C.V. 3.09Serum Pool 2: Mean 70.3 mg/dL, SD 1.34, % C.V. 1.91 |
| C3 Anticoagulant Study | Y ≈ X, r close to 1.0, demonstrating minimal interference from specified anticoagulants. | Lithium Heparin: Y = 0.966X + 0.28; r = 0.985Sodium Heparin: Y = 0.979X - 0.95; r = 0.979EDTA: Y = 0.855X + 5.27; r = 0.988 |
| C4 Anticoagulant Study | Y ≈ X, r close to 1.0, demonstrating minimal interference from specified anticoagulants. | Lithium Heparin: Y = 0.899X + 1.21; r = 0.978Sodium Heparin: Y = 0.900X + 0.76; r = 0.992EDTA: Y = 0.967X + 0.34; r = 0.985 |
2. Sample Size for the Test Set and Data Provenance:
- Method Comparison:
- C3 Reagent: n = 134 samples
- C4 Reagent: n = 160 samples
- Imprecision Studies:
- For each sample type (Serum Controls, Serum Pools) in both C3 and C4, N = 80 measurements were performed (this seems to combine within-run and total imprecision measurements, implying 80 distinct runs/samples for each data point).
- Anticoagulant Studies: The number of samples for each anticoagulant type is not explicitly stated, but Deming Regression Analysis was performed.
- Data Provenance: Not explicitly mentioned (e.g., country of origin). The studies appear to be prospective in nature, as they involve testing the new device against a predicate or evaluating its performance characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This type of information is not applicable to this submission. This device is an in vitro diagnostic (IVD) reagent for quantitative measurement of C3 and C4 proteins in human serum or plasma. The "ground truth" here is the actual concentration of these proteins, as measured by a established, legally marketed predicate device (Beckman IMMAGE C3 and C4 Reagents) or by control materials with known values. There are no human "experts" establishing a subjective "ground truth" for the test set of an IVD.
4. Adjudication Method for the Test Set:
Not applicable. As the "ground truth" is based on quantitative measurements by a predicate device or control materials, there is no need for human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This submission is for an IVD reagent and calibrator, not an AI/ML-based diagnostic imaging or detection system that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone diagnostic test in the sense that its performance is evaluated directly through its ability to accurately measure analyte concentrations. It doesn't involve a human-in-the-loop for interpretation beyond standard laboratory procedures for running the assay and reviewing results. It's essentially an "algorithm only" in that the chemical reactions and optical detection on the SYNCHRON LX System constitute its operational mechanism.
7. The type of ground truth used:
The ground truth for the performance studies is established by:
- Predicate Method: For method comparison studies, the results obtained from the new SYNCHRON LX C3/C4 Reagents are compared to those obtained from the legally marketed Beckman IMMAGE C3/C4 Reagents. The IMMAGE system (nephelometry) serves as the reference method.
- Known Control Values: For imprecision studies, commercial Serum Control materials with established target values are used, along with Serum Pools. These controls inherently have known or very well-characterized concentrations, which act as the ground truth for evaluating variability.
8. The sample size for the training set:
Not applicable. This submission is for a traditional IVD reagent, not an AI/ML device that requires a training set. The "development" of the reagent relies on chemical formulation and optimization, not machine learning from a data set.
9. How the ground truth for the training set was established:
Not applicable. (See point 8).
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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: (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 | DocketNumber |
|---|---|---|---|
| LX Systems C3and C4 Reagent | Beckman IMMAGE Complement C3and C4 Reagents | BeckmanCoulter | K964842 |
| LX CAL 1 | Beckman Calibrator 1 | BeckmanCoulter | K771603K791341 |
*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 C3Reagent | Sample TypeReference RangeAntibody SourceLiquid Stable Reagent | Same asBeckman IMMAGEC3 Reagent |
| LX System C4Reagent | Sample TypeReference RangeAntibody SourceLiquid Stable Reagent | Same asBeckman IMMAGEC4 Reagent |
| LX System CAL 1 | Human Serum PreparationLiquid Stable Calibrator | Same as BeckmanCAL 1 |
Similarities to the Predicate
Differences From The Predicate
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| LX System C3Reagent | Analytical Range | The LX C3 range is 10-350 mg/dL whereasthe IMMAGE C3 range is 50-500mg/dL |
| Assay Method | The LX C3 uses rate turbidimetry whereasthe IMMAGE uses rate nephelometry | |
| Initial dilution range | The LX C3 uses a 1:20 dilution initially andthe IMMAGE C3 uses a 1:36 dilution. | |
| Extended dilution range | The LX C3 does not have an extendedrange whereas the IMMAGE C3 does. | |
| LX System C4Reagent | Analytical Range | The LX C4 range is 5-120 mg/dL whereasthe IMMAGE C4 range is 10-130 mg/dL |
| Assay Method | The LX C4 uses turbidimetry whereas theIMMAGE uses rate nephelometry | |
| Initial dilution range | The LX C4 uses a 1:20 dilution initially andthe IMMAGE C4 uses a 1:36 dilution. | |
| Extended dilution range | The LX C4 does not have an extendedrange whereas the IMMAGE C4 does. | |
| LX System CAL 1 | Intended Use | The LX CAL 1 is used with the LX Systems(a spectrophotometer) whereas theBeckman CAL 1 is used with the IMMAGEor 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 | SlopeConfidence | Intercept | InterceptConfidence | r | n | PredicateMethod |
|---|---|---|---|---|---|---|---|
| LX C3Reagent | 1.025 | 0.023 | 2.307 | 2.783 | 0.992 | 134 | IMMAGEC3Reagent |
| LX C4Reagent | 1.001 | 0.027 | 0.938 | 0.717 | 0.985 | 160 | IMMAGEC4Reagent |
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 |
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| Anticoagulant | Level of AnticoagulantTested | 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 AnticoagulantTested | 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 (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
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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
§ 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).