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.

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.

AI/ML Overview

The provided text describes the SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents. It details method comparison studies, imprecision data, and stability information. However, it does not explicitly state specific acceptance criteria in a quantifiable fashion that the device must meet. Instead, it presents performance data and implies that this data demonstrates substantial equivalence to predicate devices.

Therefore, I cannot fully complete the table for "Acceptance Criteria" as it is not explicitly provided in the document in a numerical, predefined target format. I will fill in the "Reported Device Performance" based on the study results.

Here is an analysis based on the information provided:

1. Table of (Implicit) Acceptance Criteria and Reported Device Performance

As stated, explicit numerical acceptance criteria are not presented in the document. The document's purpose is to demonstrate substantial equivalence to predicate devices and generally acceptable performance for in vitro diagnostic devices. The reported device performance is from method comparison and imprecision studies.

Performance Metric	Implied Acceptance Criteria (Based on general IVD expectations & predicate comparison)	Reported Device Performance (SYNCHRON LX™ Systems)
Method Comparison (vs. Beckman Predicate)
ApoA Slope	Close to 1.0	0.953
ApoA Intercept (mg/dL)	Close to 0	4.1
ApoA Correlation Coefficient (r)	High (e.g., >0.95)	0.9922
ApoB Slope	Close to 1.0	0.943
ApoB Intercept (mg/dL)	Close to 0	7.6
ApoB Correlation Coefficient (r)	High (e.g., >0.95)	0.9970
Method Comparison (vs. NWLRL Nephelometric Procedure)
ApoA Slope	Close to 1.0	1.022
ApoA Intercept (mg/dL)	Close to 0	-3.4
ApoA Correlation Coefficient (r)	High (e.g., >0.95)	0.965
ApoB Slope	Close to 1.0	1.006
ApoB Intercept (mg/dL)	Close to 0	1.7
ApoB Correlation Coefficient (r)	High (e.g., >0.95)	0.991
Imprecision (ApoA %C.V.)
ApoA Level 1	Low (e.g., <5-10%)	2.19%
ApoA Level 2	Low (e.g., <5-10%)	1.74%
ApoA Level 3	Low (e.g., <5-10%)	1.23%
Imprecision (ApoB %C.V.)
ApoB Level 1	Low (e.g., <5-10%)	Data obscured in document
ApoB Level 2	Low (e.g., <5-10%)	Data partially obscured or not fully presented (shows 2.02)
ApoB Level 3	Low (e.g., <5-10%)	Data obscured in document
Stability	Meet product claims	24-month shelf-life, 14-day calibration stability, 30-day on-board stability

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (n):
- Method Comparison Study #1: 78 for ApoA, 73 for ApoB.
- Method Comparison Study #2: 54 for ApoA, 54 for ApoB.
- Within-Run Imprecision (ApoA): 80 for each level.
- Within-Run Imprecision (ApoB): Not fully clear due to obscured data, but likely a similar number per level.
Data Provenance: Not explicitly stated (e.g., retrospective/prospective, country of origin). The studies appear to be laboratory-based performance evaluations, likely using clinical samples, but details are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device and study. The "ground truth" for these studies is the measurement provided by the established predicate devices or reference methods (Beckman's existing Apolipoprotein reagents and NWLRL Nephelometric Procedure). There's no involvement of clinical experts establishing a diagnosis/ground truth for individual cases.

4. Adjudication Method for the Test Set

Not applicable. This study involves quantitative biochemical measurements compared against reference methods, not subjective assessments requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic interpretation tasks involving human readers, which is not the nature of this device or its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented is for the device (reagents and SYNCHRON LX™ Systems) operating in a standalone, automated fashion. The reported results (slope, intercept, correlation, %CV) represent the algorithm/system's performance directly. There is no "human-in-the-loop" component described for the measurement process itself.

7. The Type of Ground Truth Used

The ground truth in these studies is established by comparison to predicate methods or established reference laboratory procedures:
- Beckman's Apolipoprotein APA Reagent (for ApoA) and Beckman's APB Reagent (for ApoB).
- Northwest Lipid Research Laboratories (NWLRL) Nephelometric Procedure.
These are considered established methods for quantitatively determining apolipoprotein levels.

8. The Sample Size for the Training Set

This information is not applicable. The SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents are chemical reagents for diagnostic assays, not machine learning algorithms that require a "training set" in the conventional sense. The "training" for such systems would involve calibration and quality control procedures, but not a dataset as described for an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated in point 8.

Summary

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K970314

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 LXReagents	Predicate	PredicateCompany	DocketNumber
Apolipoprotein A-1(ApoA) Reagent	BeckmanApolipoprotein A-1(APA) Reagent	BeckmanInstruments, Inc.	K862019
Apolipoprotein B(ApoB) Reagent	BeckmanApolipoprotein B(APB) Reagent	BeckmanInstruments, Inc.	K862386

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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:

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 LXSystem (ApoA andApoB) Reagents	Intended Use	Same as Beckman'sApolipoprotein reagents;quantitative determination ofhuman apolipoproteins A-1and apolipoprotein B.
	Chemical Reaction	Same principle as thepredicate; formation ofantigen-antibody complex
	Antibody	Same source, processing asBeckman Apolipoproteinreagents
	Calibration	Same as the ARRAY systemsreagents; single point updateof manufacturer-determinedcalibration curve.

SIMILARITIES with the PREDICATE

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Reagent	Aspect/Characteristic	Comments
SYNCHRON LXSystem (ApoA andApoB) Reagents	Methodology	The SYNCHRON LX readsturbidimetrically and theImmunochemistry systems(ARRAY) 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
	Packaging	The SYNCHRON LX reagentsare packaged in polystyrenecartridges; the ARRAYSystems reagents are in glassbottles.

DIFFEBENCES from the PREDICATE

ﺔ – ﺍﻟﻤﺤﺘﻤﻠﺔ

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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	PredicateMethod
SYNCHRON LXApolipoprotein A-1Reagent (ApoA)	0.953	4.1	0.9922	78	Beckman'sApolipoproteinAPA Reagent
SYNCHRON LXApolipoprotein BReagent (ApoB)	0.943	7.6	0.9970	73	Beckman's APBReagent

Method Comparison Study #2 Results SYNCHRON LX Systems ApoA & AnoB Reagents

Reagent	Slope	Intercept (mg/dL)	r	n	Predicate Method
SYNCHRON LXApolipoprotein A-1Reagent (ApoA)	1.022	-3.4	0.965	54	NWLRL*NephelometricProcedure
SYNCHRON LXApolipoprotein BReagent (ApoB)	1.006	1.7	0.991	54	NWLRL*NephelometricProcedure

NWLRL = Northwest Lipid Research Laboratories

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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

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Apolipoprotein B (ApoB
ever ·
evel 2			2.02
revel .*

Stability Study Results

Reagent	Product Claim
SYNCHRON LX Systems ApolipoproteinApoA and ApoB	24 month shelf-life14 day calibration stability30 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

Regulation Number and Section

§ 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.