(87 days)
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No
The summary describes a reagent and calibrator for quantitative determination of apolipoproteins on a clinical chemistry analyzer. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on method comparison and imprecision, typical for laboratory assays, not AI/ML model performance metrics.
No
The device is described as a reagent for quantitative determination of apolipoproteins in serum or plasma, used with clinical chemistry analyzers, which is an in vitro diagnostic (IVD) tool, not a therapeutic device.
Yes
This device is intended for the "quantitative determination of human apolipoprotein A-1 in serum or plasma" and "quantitative determination of human apolipoprotein B in serum or plasma," which is a measurement used to aid in diagnosis.
No
The device description explicitly states it is a reagent intended for use with clinical chemistry analyzers, indicating it is a chemical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the reagents are for the "quantitative determination of human apolipoprotein A-1 in serum or plasma" and "quantitative determination of human apolipoprotein B in serum or plasma." This indicates the device is used to analyze biological samples (serum or plasma) in vitro (outside the body) to provide diagnostic information.
- Device Description: The description confirms the reagents are used "on Beckman's SYNCHRON LX Clinical Systems," which are laboratory analyzers designed for clinical testing.
- Performance Studies: The performance studies describe method comparisons with existing reagents and a nephelometric procedure, as well as imprecision and stability studies. These are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The mention of predicate devices (K862019 and K862386) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory clearance of new IVDs.
The core function of analyzing biological samples to provide quantitative results for diagnostic purposes clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 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 Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B 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)
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Device Description
The SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents in conjunction with SYNCHRON Systems APO CAL, are intended for use on Beckman's SYNCHRON LX Clinical Systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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, stability, and imprecision experiments that results obtained from the Beckman Apolipoprotein Reagents (APA and APB) to the SYNCHRON LX Systems Apolipoprotein Reagents (ApoA and ApoB).
Method Comparison Study #1 Results SYNCHRON LX Systems ApoA & ApoB Reagents:
- SYNCHRON LX Apolipoprotein A-1 Reagent (ApoA) compared to Beckman's Apolipoprotein APA Reagent. Slope: 0.953, Intercept: 4.1 mg/dL, r: 0.9922, n: 78.
- SYNCHRON LX Apolipoprotein B Reagent (ApoB) compared to Beckman's APB Reagent. Slope: 0.943, Intercept: 7.6 mg/dL, r: 0.9970, n: 73.
Method Comparison Study #2 Results SYNCHRON LX Systems ApoA & AnoB Reagents: - SYNCHRON LX Apolipoprotein A-1 Reagent (ApoA) S compared to NWLRL* Nephelometric Procedure. Slope: 1.022, Intercept: -3.4 mg/dL, r: 0.965, n: 54.
- SYNCHRON LX Apolipoprotein B Reagent (ApoB) compared to NWLRL* Nephelometric Procedure. Slope: 1.006, Intercept: 1.7 mg/dL, r: 0.991, n: 54.
Estimated Within-Bun Imprecision for Apolipoprotein A-1 (ApoA): - Level 1: Mean 94.4 mg/dL, S.D. 2.07 mg/dL, %C.V. 2.19, N 80.
- Level 2: Mean 121.6 mg/dL, S.D. 2.12 mg/dL, %C.V. 1.74, N 80.
- Level 3: Mean 145.6 mg/dL, S.D. 1.80 mg/dL, %C.V. 1.23, N 80.
Stability Study Results for SYNCHRON LX Systems Apolipoprotein ApoA and ApoB: Product Claim: 24 month shelf-life, 14 day calibration stability, 30 days on-board stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Summary of Safety & Effectiveness SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents
PR 21 1997
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
2.0 Date Submitted:
23 Januray - 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON LX™ Systems Apolipoprotein A-1 (ApoA) Reagent SYNCHRON LX™ Systems Apolipoprotein B (ApoB) Reagent
3.2 Classification Names
Lipoprotein Test System (21 CFR §862.1475)
4.0 Predicate Device(s):
| SYNCHRON LX
Reagents | Predicate | Predicate
Company | Docket
Number |
|--------------------------------------|------------------------------------------------|------------------------------|------------------|
| Apolipoprotein A-1
(ApoA) Reagent | Beckman
Apolipoprotein A-1
(APA) Reagent | Beckman
Instruments, Inc. | K862019 |
| Apolipoprotein B
(ApoB) Reagent | Beckman
Apolipoprotein B
(APB) Reagent | Beckman
Instruments, Inc. | K862386 |
1
Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents Summary of Safety & Effectiveness
Description: 5.0
The SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents in conjunction with SYNCHRON Systems APO CAL, are intended for use on Beckman's SYNCHRON LX Clinical Systems.
6.0 Intended Use:
The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 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 Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B 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 | ||
| System (ApoA and | ||
| ApoB) Reagents | Intended Use | Same as Beckman's |
| Apolipoprotein reagents; | ||
| quantitative determination of | ||
| human apolipoproteins A-1 | ||
| and apolipoprotein B. | ||
| Chemical Reaction | Same principle as the | |
| predicate; formation of | ||
| antigen-antibody complex | ||
| Antibody | Same source, processing as | |
| Beckman Apolipoprotein | ||
| reagents | ||
| Calibration | Same as the ARRAY systems | |
| reagents; single point update | ||
| of manufacturer-determined | ||
| calibration curve. |
SIMILARITIES with the PREDICATE
2
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON LX | ||
| System (ApoA and | ||
| ApoB) Reagents | Methodology | The SYNCHRON LX reads |
| turbidimetrically and the | ||
| Immunochemistry systems | ||
| (ARRAY) 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 | ||
| Packaging | The SYNCHRON LX reagents | |
| are packaged in polystyrene | ||
| cartridges; the ARRAY | ||
| Systems reagents are in glass | ||
| bottles. |
DIFFEBENCES from the PREDICATE
ﺔ – ﺍﻟﻤﺤﺘﻤﻠﺔ
3
Summary of Performance Data: 8.0
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, stability, and imprecision experiments that results obtained from the Beckman Apolipoprotein Reagents (APA and APB) to the SYNCHRON LX Systems Apolipoprotein Reagents (ApoA and ApoB).
Method Comparison Study #1 Results SYNCHRON LX Systems ApoA & ApoB Reagents
| Reagent
(Analyte) | Slope | Intercept
(mg/dL) | r | n | Predicate
Method |
|-----------------------------------------------------|-------|----------------------|--------|----|--------------------------------------------|
| SYNCHRON LX
Apolipoprotein A-1
Reagent (ApoA) | 0.953 | 4.1 | 0.9922 | 78 | Beckman's
Apolipoprotein
APA Reagent |
| SYNCHRON LX
Apolipoprotein B
Reagent (ApoB) | 0.943 | 7.6 | 0.9970 | 73 | Beckman's APB
Reagent |
Method Comparison Study #2 Results SYNCHRON LX Systems ApoA & AnoB Reagents
| Reagent | Slope | Intercept (mg/dL) | r | n | Predicate Method |
|---|---|---|---|---|---|
| SYNCHRON LX | |||||
| Apolipoprotein A-1 | |||||
| Reagent (ApoA) | 1.022 | -3.4 | 0.965 | 54 | NWLRL* |
| Nephelometric | |||||
| Procedure | |||||
| SYNCHRON LX | |||||
| Apolipoprotein B | |||||
| Reagent (ApoB) | 1.006 | 1.7 | 0.991 | 54 | NWLRL* |
| Nephelometric | |||||
| Procedure |
- NWLRL = Northwest Lipid Research Laboratories
4
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Apolipoprotein A-1 (ApoA) | ||||
| Level 1 | 94.4 | 2.07 | 2.19 | 80 |
| Level 2 | 121.6 | 2.12 | 1.74 | 80 |
| Level 3 | 145.6 | 1.80 | 1.23 | 80 |
Estimated Within-Bun Imprecision
| |
The Comments of the management to be in the many of the many of the may be
Bench at any as a m an an an an an an any and |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | 1180180
185 11 5 11 15 13 13 13
Manuk
: | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------------------------------------------------------|--|
| Apolipoprotein B (ApoB | | | | | |
| ever · | | | | | |
| evel 2 | | | 2.02 | | |
| revel .* | | | | | |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| SYNCHRON LX Systems Apolipoprotein | |
| ApoA and ApoB | 24 month shelf-life |
| 14 day calibration stability | |
| 30 days on-board stability |
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. ールは、バイト