(76 days)
The SYNCHRON LX Systems Immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G 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 Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with dinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
The SYNCHRON LX Systems Immunoglobulin M (Ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M 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 Immunoglobulin G, A, and M (Ig-G, Ig-A, Ig-M) Reagents in conjunction with SYNCHRON LX Calibrator 1, are intended for use on Beckman's SYNCHRON LX Clinical Systems.
The provided 510(k) summary describes the SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The performance data focuses on method comparison, imprecision, and stability studies.
Here's an analysis of the acceptance criteria and study data based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance metrics in a formal, separate table. However, equivalence is demonstrated by comparing the new device's performance to the predicate devices through method comparison studies. The implicit acceptance criteria for method comparison would be a strong correlation (r-value close to 1) and a slope close to 1 with an intercept close to 0, indicating a close agreement with the predicate. For imprecision, lower Coefficients of Variation (CV%) indicate better precision. Stability claims are also presented, which serve as performance claims that must be met.
| Performance Metric | Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance (SYNCHRON LX™ Reagents) |
|---|---|---|
| Method Comparison | ||
| Ig-G Reagent: Slope | Close to 1.0 | 0.928 |
| Ig-G Reagent: Intercept | Close to 0 | 72.7 |
| Ig-G Reagent: r | Close to 1.0 (e.g., >0.95 or >0.98) | 0.9970 |
| Ig-A Reagent: Slope | Close to 1.0 | 0.924 |
| Ig-A Reagent: Intercept | Close to 0 | 0.68 |
| Ig-A Reagent: r | Close to 1.0 (e.g., >0.95 or >0.98) | 0.9962 |
| Ig-M Reagent: Slope | Close to 1.0 | 1.051 |
| Ig-M Reagent: Intercept | Close to 0 | -17.19 |
| Ig-M Reagent: r | Close to 1.0 (e.g., >0.95 or >0.98) | 0.9914 |
| Imprecision (Ig-M) | Low %CV (e.g., <5-10% for clinical assays) | |
| Ig-M Reagent: Level 1 %CV | N/A (implied clinical acceptability) | 3.9 |
| Ig-M Reagent: Level 2 %CV | N/A (implied clinical acceptability) | 2.2 |
| Stability | Met claimed duration | |
| Shelf-life | 24 months | 24 months |
| Calibration Stability | 14 days | 14 days |
| On-board Stability | 60 days | 60 days |
Note: The specific numerical acceptance criteria for slope, intercept, and r-value are not explicitly stated in the document, but are generally understood in the context of method comparison studies for medical devices. The reported r-values (0.9970, 0.9962, 0.9914) are very high, demonstrating strong correlation. The slopes are close to 1, and intercepts are relatively small compared to the typical ranges of these analytes, suggesting good agreement.
2. Sample Size Used for the Test Set and Data Provenance
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Sample Sizes for Method Comparison (Test Set):
- Ig-G Reagent: n = 82
- Ig-A Reagent: n = 78
- Ig-M Reagent: n = 72
These numbers represent individual patient samples used to compare the new device's results against the predicate method.
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Data Provenance: The document does not explicitly state the country of origin. Given that Beckman Instruments, Inc. is based in Brea, California, and the submission is to the FDA, it is highly probable the data was generated in the United States. The studies are retrospective in the sense that they are comparing the performance of a new reagent to an existing, already commercialized predicate method on collected samples, rather than a prospective clinical trial with patient outcomes.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (reagents for quantitative determination of immunoglobulins) does not typically involve human expert interpretation of images or clinical assessments to establish ground truth. The "ground truth" for the test set is established by the results obtained from the predicate device (Beckman's Immunoglobulin IGG, IGA, IGM Reagents), which are already considered established and accurate. Therefore, no external experts are used for ground truth determination in this context.
4. Adjudication Method
Not applicable. As described above, no human expert interpretation requiring adjudication is involved. The comparison is against an established quantitative assay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not relevant for this type of in-vitro diagnostic (IVD) reagent. These studies are typically performed for imaging devices or software that assist human readers in diagnosis. This submission is for a quantitative assay that directly measures immunoglobulin levels.
6. Standalone Performance Study
Yes, in a sense. The method comparison, imprecision, and stability studies demonstrate the standalone analytical performance of the SYNCHRON LX™ Systems Immunoglobulin reagents. This means the algorithm (the reagent and instrument system) is evaluated on its own ability to accurately and precisely measure the target analytes. There is no "human-in-the-loop" aspect to this type of assay in the way it would apply to AI-assisted diagnostics.
7. Type of Ground Truth Used
The ground truth for the method comparison studies is the quantitative results obtained from the predicate device's established method. For imprecision, the ground truth is the true concentration of the control samples used, and the goal is to show consistency around that true value. For stability, the ground truth is that the reagent should maintain its performance within acceptable limits over the claimed storage and operational periods.
8. Sample Size for the Training Set
The document does not specify a "training set" in the context of machine learning or AI algorithms. This is an IVD reagent submission, not an AI/ML device. The development of such reagents involves extensive R&D and optimization, but the concept of a "training set" as used in AI is not applicable here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The development and optimization of the reagent formulations and assay parameters are based on standard biochemical and analytical chemistry principles, aiming to accurately and precisely quantify immunoglobulins.
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Beckman Instruments, Inc., Section 510(k) Notification Beckman Instruments, Ino., Josefiel Cro(x) Abilitation
SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents Summary of Safety & Effectiveness
MAR - 6 1997
Summary of Safety & Effectiveness
SYNCHRON LX™ Systems Immunoglobulin G, A, and M (Ig-G, Ig-A, & Ig-M) Reagents
1.0 Submitted By:
Kathleen M. Jaker Senior Applications Chemist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-117 Brea, California 92822-8000 Telephone: (714) 961-3970 FAX: (714) 961-4457
Date Submitted: 2.0
18 December 1996
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON LX™ Systems Immunoglobulin G (Ig-G) Reagent SYNCHRON LX™ Systems Immunoglobulin A (Ig-A) Reagent SYNCHRON LX™ Systems Immunoglobulin M (Ig-M) Reagent
3.2 Classification Names
Immunoglobulin G Test System (21 CFR §866.5510) Immunoglobulin A Test System (21 CFR 5866.5510) Immunoglobulin M Test System (21 CFR 5866.5510)
4.0 Predicate Device(s):
| SYNCHRON LXReagents | Predicate | PredicateCompany | DocketNumber |
|---|---|---|---|
| Immunoglobulin G(Ig-G) Reagent | BeckmanImmunoglobulin G(IGG) Reagent | BeckmanInstruments, Inc. | K771603 |
| Immunoglobulin A(Ig-A) Reagent | BeckmanImmunoglobulin A(IGA) Reagent | BeckmanInstruments, Inc. | K771603 |
| Immunoglobulin M(Ig-M) Reagent | BeckmanImmunoglobulin M(IGM) Reagent | BeckmanInstruments, Inc. | K771603 |
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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents Summary of Safety & Effectiveness
Description: 5.0
The SYNCHRON LX™ Systems Immunoglobulin G, A, and M (Ig-G, Ig-A, Ig-M) Reagents in conjunction with SYNCHRON LX Calibrator 1, are intended for use on Beckman's SYNCHRON LX Clinical Systems.
6.0 Intended Use:
The SYNCHRON LX Systems Immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G 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 Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with dinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
The SYNCHRON LX Systems Immunoglobulin M (Ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M 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.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON LXSystemsImmunoglobulin(Ig-G, Ig-A, & Ig-M)Reagents | Intended Use | Same as BeckmanImmunoglobulin reagents;quantitative determination ofhuman immunoglobulins |
| Chemical Reaction | Same principle as theImmunoglobulin BeckmanReagents; formation ofantigen-antibody complex | |
| Antibody | Same source, antibody,processing, and buffer asBeckman Immunoglobulinreagents | |
| Range Expansion | Same as the BeckmanImmunochemistry (ARRAY)System which expands usablerange with alternate sampledilution ratios | |
| Calibration | Same as the BeckmanImmunoglobulin reagents;single point update ofmanufacturer-determinedcalibration curve. |
SIMILARITIES to the PREDICATE
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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents
Summary of Safety & Effectiveness
| Reagent | DIFFERENCES from the PREDICATEAspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON LXSystemsImmunoglobulin(Ig-G, Ig-A, & Ig-M)Reagents | Methodology | The SYNCHRON LX readsturbidimetrically and theARRAY Systems readnephelometrically |
| Measurement Method | The SYNCHRON LX runs thereaction at 37°C and reads anendpoint at 340 nm; theARRAY Systems run at26.5°C and read at a peakrate at 450-550 nm | |
| Antigen Excess Checking | The SYNCHRON LXReagents ere designed so thathigh antigen concentration willnot report in range; theARRAY Systems add extraantibody to observe foradditional activity. | |
| Sample Diluent | The SYNCHRON LX uses atris buffer for sample dilution;the ARRAY Systems use aphosphate buffered diluent. | |
| Reagent Storage | The SYNCHRON LX reagentsare stored refrigeratedonboard the instrument; theARRAY Systems reagents arestored at room temperatureonboard the instrument/refrigerated when not in use. | |
| Packaging | The SYNCHRON LX reagentsare packaged in polystyrenecartridges; the ARRAYSystems reagents are in glassbottles. |
DIEFERENCES from the PREDICATE
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Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of The battline in the receiver test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Beckman Immunoglobulin Reagents (IGG, IGA, IGM) to the SYNCHRON LX Systems Immunoglobulin Reagents (Ig-G, Ig-A, lg-M).
| Reagent | Slope | Intercept | r | n | Predicate Method |
|---|---|---|---|---|---|
| SYNCHRON LXImmunoglobulin GReagent (Ig-G) | 0.928 | 72.7 | 0.9970 | 82 | Beckman'sImmunoglobulinIGG Reagent |
| SYNCHRON LXImmunoglobulin AReagent (Ig-A) | 0.924 | 0.68 | 0.9962 | 78 | Beckman'sImmunoglobulinIGA Reagent |
| SYNCHRON LXImmunoglobulin MReagent (Ig-M) | 1.051 | -17.19 | 0.9914 | 72 | Beckman'sImmunoglobulinIGM Reagent |
Method Comparison Study Results SYNCHRON LX Systems In-G. Ia-A. & la-M Reagents
Estimated Within-Run Imprecision
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| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Immunoglobulin M (Ig-M) Reagent | ||||
| Level 1 | 46.6 | 1.8 | 3.9 | 80 |
| Level 2 | 103.5 | 2.3 | 2.2 | 80 |
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Stability Study Results
| Reagent | Product Claim |
|---|---|
| SYNCHRON LX SystemsImmunoglobulin G, A, & M Reagents | 24 month shelf-life14 day calibration stability60 days on-board stability |
This summary of safety and effectiveness is being submitted in accordance with the This Summary of Saley and Onootivenoes is of 1990 and the implementing regulation 21 CFR 807.92.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).