(76 days)
Not Found
No
The summary describes reagents for quantitative determination of immunoglobulins using standard clinical chemistry analyzers. There is no mention of AI/ML in the intended use, device description, or performance studies. The performance metrics are standard for chemical assays (slope, intercept, r, imprecision, stability).
No
This device is for the quantitative determination of human immunoglobulins, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the reagents are intended for the "quantitative determination of human immunoglobulin G, A, and M in serum or plasma," which is a diagnostic purpose to measure specific biomarkers in patient samples.
No
The device description explicitly states that the device is a reagent intended for use with clinical chemistry analyzers, which are hardware devices. The performance studies also focus on the analytical performance of the reagent, not software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of human immunoglobulin G, A, and M in serum or plasma. This is a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: It describes reagents used in conjunction with clinical chemistry analyzers, which are instruments used for in vitro diagnostic testing.
- Performance Studies: The performance studies involve method comparison and imprecision experiments, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability in analyzing biological samples.
- Predicate Devices: The mention of predicate devices with K numbers (K771603) indicates that this device is being compared to previously cleared IVD devices by a regulatory body like the FDA.
All these factors strongly indicate that the SYNCHRON LX Systems Immunoglobulin G, A, and M Reagents are intended for use as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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.
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
Not Found
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 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).
Method Comparison Study Results:
- SYNCHRON LX Immunoglobulin G Reagent (Ig-G): Slope = 0.928, Intercept = 72.7, r = 0.9970, n = 82
- SYNCHRON LX Immunoglobulin A Reagent (Ig-A): Slope = 0.924, Intercept = 0.68, r = 0.9962, n = 78
- SYNCHRON LX Immunoglobulin M Reagent (Ig-M): Slope = 1.051, Intercept = -17.19, r = 0.9914, n = 72
Estimated Within-Run Imprecision for Immunoglobulin M (Ig-M) Reagent:
- Level 1: Mean = 46.6 mg/dL, S.D. = 1.8 mg/dL, %C.V. = 3.9, N = 80
- Level 2: Mean = 103.5 mg/dL, S.D. = 2.3 mg/dL, %C.V. = 2.2, N = 80
Stability Study Results:
- Product Claim: 24 month shelf-life, 14 day calibration stability, 60 days on-board stability
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
§ 866.5510 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).
0
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 LX
Reagents | Predicate | Predicate
Company | Docket
Number |
|------------------------------------|----------------------------------------------|------------------------------|------------------|
| Immunoglobulin G
(Ig-G) Reagent | Beckman
Immunoglobulin G
(IGG) Reagent | Beckman
Instruments, Inc. | K771603 |
| Immunoglobulin A
(Ig-A) Reagent | Beckman
Immunoglobulin A
(IGA) Reagent | Beckman
Instruments, Inc. | K771603 |
| Immunoglobulin M
(Ig-M) Reagent | Beckman
Immunoglobulin M
(IGM) Reagent | Beckman
Instruments, Inc. | K771603 |
1
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 LX | ||
| Systems | ||
| Immunoglobulin | ||
| (Ig-G, Ig-A, & Ig-M) | ||
| Reagents | Intended Use | Same as Beckman |
| Immunoglobulin reagents; | ||
| quantitative determination of | ||
| human immunoglobulins | ||
| Chemical Reaction | Same principle as the | |
| Immunoglobulin Beckman | ||
| Reagents; formation of | ||
| antigen-antibody complex | ||
| Antibody | Same source, antibody, | |
| processing, and buffer as | ||
| Beckman Immunoglobulin | ||
| reagents | ||
| Range Expansion | Same as the Beckman | |
| Immunochemistry (ARRAY) | ||
| System which expands usable | ||
| range with alternate sample | ||
| dilution ratios | ||
| Calibration | Same as the Beckman | |
| Immunoglobulin reagents; | ||
| single point update of | ||
| manufacturer-determined | ||
| calibration curve. |
SIMILARITIES to the PREDICATE
2
Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents
Summary of Safety & Effectiveness
| Reagent | DIFFERENCES from the PREDICATE
Aspect/Characteristic | Comments |
|------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SYNCHRON LX
Systems
Immunoglobulin
(Ig-G, Ig-A, & Ig-M)
Reagents | Methodology | The SYNCHRON LX reads
turbidimetrically and the
ARRAY Systems 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 |
| | Antigen Excess Checking | The SYNCHRON LX
Reagents ere designed so that
high antigen concentration will
not report in range; the
ARRAY Systems add extra
antibody to observe for
additional activity. |
| | Sample Diluent | The SYNCHRON LX uses a
tris buffer for sample dilution;
the ARRAY Systems use a
phosphate buffered diluent. |
| | Reagent Storage | The SYNCHRON LX reagents
are stored refrigerated
onboard the instrument; the
ARRAY Systems reagents are
stored at room temperature
onboard the instrument/
refrigerated when not in use. |
| | Packaging | The SYNCHRON LX reagents
are packaged in polystyrene
cartridges; the ARRAY
Systems reagents are in glass
bottles. |
DIEFERENCES from the PREDICATE
3
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 LX | |||||
| Immunoglobulin G | |||||
| Reagent (Ig-G) | 0.928 | 72.7 | 0.9970 | 82 | Beckman's |
| Immunoglobulin | |||||
| IGG Reagent | |||||
| SYNCHRON LX | |||||
| Immunoglobulin A | |||||
| Reagent (Ig-A) | 0.924 | 0.68 | 0.9962 | 78 | Beckman's |
| Immunoglobulin | |||||
| IGA Reagent | |||||
| SYNCHRON LX | |||||
| Immunoglobulin M | |||||
| Reagent (Ig-M) | 1.051 | -17.19 | 0.9914 | 72 | Beckman's |
| Immunoglobulin | |||||
| IGM 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 |
4
Stability Study Results
| Reagent | Product Claim |
|---|---|
| SYNCHRON LX Systems | |
| Immunoglobulin G, A, & M Reagents | 24 month shelf-life |
| 14 day calibration stability | |
| 60 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.