The SYNCHRON LX20 Clinical Chemistry System is a fully automated, computer controlled, clinical chemistry analyzer intended for the in vitro quantitative measurement of a variety of analytes of clinical interest in biological fluids, such as, serum, plasma, urine, and cerebral spinal fluid (sample type is chemistry dependent).

Device Description

The LX20 Clinical Chemistry System is a fully automated, computer controlled, clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid (sample type is chemistry dependent). The analyzer operates in conjunction with reagents, calibrators, and controls designed for use with the system. The instrument features bar code identification of samples and reagents. It automatically dilutes samples and delivers them to the reaction cuvette along with readents and reaction constituents. The system analyzes up to 100 samples per run with up to 41 analytes per sample. Major hardware components include a reagent compartment, sample and reagent cranes, cartinge chemistry section, modular chemistry section, sample carousel and crane, hydropneumatics, electronics, and power supplies.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SYNCHRON LX™20 Clinical Chemistry System, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the SYNCHRON LX™20 Clinical Chemistry System appear to be defined by its substantial equivalence to existing predicate devices. This is demonstrated through method comparison and imprecision experiments, where the device's results are compared to those obtained from selected predicate methods. The performance is considered acceptable if it shows good correlation (high 'r' value, close to 1) and a slope close to 1 and intercept close to 0 in the method comparison studies, along with acceptable levels of imprecision (low %C.V.).

Table of Acceptance Criteria and Reported Device Performance:

Since specific acceptance thresholds for slope, intercept, r, SD, and %C.V. are not explicitly stated as numerical criteria in the document, I will infer them based on what would typically be considered good performance for substantial equivalence in clinical chemistry, and present the reported performance against general expectations.

Analyte	Acceptance Criteria (General Expectation)	Reported Device Performance (Method Comparison: Slope, Intercept, r)	Reported Device Performance (Within-run Imprecision: Mean, SD, %C.V., N)
Method Comparison	Slope close to 1.0 (e.g., 0.95-1.05)Intercept close to 0.0 (e.g., within ± a small absolute value)Correlation coefficient (r) > 0.97 (ideally > 0.99)	-	-
Albumin	-	0.970, 0.070, 0.997	Level 1: 2.21 g/dL, 0.04, 1.9%, 80Level 2: 4.81 g/dL, 0.03, 0.6%, 80
Creatinine	-	1.010, 0.04, 0.999	Level 1: 0.59 mg/dL, 0.07, 12.2%, 80Level 2: 8.24 mg/dL, 0.18, 2.1%, 80
Glucose	-	0.991, -0.250, 0.996	Level 1: 43.7 mg/dL, 1.3, 2.9%, 80Level 2: 397.1 mg/dL, 1.7, 0.4%, 80
Phosphorus	-	1.023, 0.27, 0.996	Level 1: 1.80 mg/dL, 0.04, 2.5%, 80Level 2: 7.04 mg/dL, 0.05, 0.7%, 80
Total Protein	-	0.962, -0.01, 0.993	Level 1: 3.54 g/dL, 0.06, 1.8%, 80Level 2: 7.52 g/dL, 0.05, 0.7%, 80
Urea Nitrogen	-	0.949, 1.13, 0.999	Level 1: 7.7 mg/dL, 0.4, 5.0%, 80Level 2: 58.7 mg/dL, 0.5, 0.9%, 80
Carbon Dioxide	-	1.015, -0.70, 0.992	Level 1: 10.58 mmol/L, 0.26, 2.5%, 80Level 2: 30.16 mmol/L, 0.29, 1.0%, 80
Calcium	-	0.990, -0.92, 0.998	Level 1: 7.5 mg/dL, 0.08, 1.1%, 80Level 2: 13.5 mg/dL, 0.11, 0.8%, 80
Chloride	-	0.974, 1.04, 0.997	Level 1: 81.11 mmol/L, 0.47, 0.6%, 80Level 2: 120.53 mmol/L, 0.84, 0.7%, 80
Potassium	-	1.008, -0.01, 0.999	Level 1: 2.4 mmol/L, 0.02, 0.9%, 80Level 2: 7.29 mmol/L, 0.04, 0.6%, 80
Sodium	-	1.028, -4.22, 0.993	Level 1: 111.1 mmol/L, 0.52, 0.5%, 80Level 2: 170.2 mmol/L, 1.01, 0.6%, 80
Benzodiazepine	Concordance = 100% agreement	Concordance = 100% agreement	Cutoff Calibrator: 293 mA/min, 2.4, 0.8%, 20High Control: 362 mA/min, 3.0, 0.8%, 20
Iron	-	0.976, 9.03, 0.997	Level 1: 51.2 ug/dL, 1.2, 2.4%, 80Level 2: 262.6, 2.2, 0.9%, 80
Magnesium	-	0.971, 0.09, 0.997	Level 1: 1.12 mg/dL, 0.03, 3.0%, 80Level 2: 3.63 mg/dL, 0.06, 1.5%, 80
Phenobarbital	-	0.976, 0.050, 0.992	Level 1: 9.32 ug/mL, 0.22, 2.3%, 80Level 2: 65.86 ug/mL, 1.42, 2.2%, 80
Uric Acid	-	0.977, -0.02, 0.999	Level 1: 2.42 mg/dL, 0.03, 1.1%, 80Level 2: 10.48 mg/dL, 0.05, 0.5%, 80
Lactate Dehydrogenase	-	1.018, 0.20, 0.999	Level 1: 49.9 IU/L, 1.6, 3.2%, 80Level 2: 363.5 IU/L, 3.4, 1.0%, 80
Imprecision	%C.V. generally below 5%, with some exceptions for very low concentrations or specific analytes	-	-

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The sample sizes are explicitly stated for the "Estimated Serum/Plasma Within-run Imprecision" for each analyte and level. For most analytes, the imprecision study used N=80 samples (likely runs or replicates) for each of two levels (Level 1 and Level 2). For Benzodiazepines, it was N=20 for each of the Cutoff Calibrator and High Control.
Data Provenance: The document does not specify the country of origin of the data. The studies described are performance validation studies for a new medical device, implying them to be prospective in nature, conducted to evaluate the device against established predicate methods. The samples were "Serum/Plasma" samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The concept of "ground truth" established by experts (like radiologists) is typically relevant for interpretative diagnostic tests, not for quantitative clinical chemistry analyzers. For this type of device, the "ground truth" or reference standard for comparison is the results obtained from the predicate device itself. Therefore, specific human experts were not explicitly used to establish a subjective "ground truth" for the test set in the way they would be for image interpretation. The predicate device's results are taken as the validated reference.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This concept of "adjudication" is also generally applied to subjective diagnostic evaluations where multiple human readers interpret data, and discrepancies need to be resolved. For a quantitative clinical chemistry analyzer, adjudication between human readers is not applicable. The comparison is objective, between the results of the new device and the predicate device.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses improvements in human performance with AI assistance and is irrelevant for a highly automated quantitative clinical chemistry analyzer. The device performs the measurements automatically without direct human interpretation of raw data in a way that would be "assisted" by AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, this entire study represents standalone performance. The SYNCHRON LX™20 Clinical Chemistry System is an automated analyzer, and the reported performance data (method comparison, imprecision) reflects the algorithm and hardware's ability to measure analytes independently. Human involvement is in operating the instrument and interpreting the final quantitative results, but the measurement itself is automated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the method comparison studies, the "ground truth" as a reference for comparison was the results obtained from the specified predicate devices. These predicate devices are already cleared for commercial distribution and their performance is established. For imprecision studies, the ground truth is statistical reliability of the device's own measurements.

8. The sample size for the training set

Not Applicable / Not Provided. Clinical chemistry analyzers like the SYNCHRON LX™20 typically do not rely on "training sets" in the way machine learning algorithms do. Their performance is based on established chemical reactions, photometric principles, and instrument design. Calibration is performed using specific calibrators (e.g., SYNCHRON LX™ AQUA CAL 1, 2, 3) which are part of routine operation, but this is distinct from an AI "training set." The document does not mention any machine learning or AI components that would require a dedicated training set.

9. How the ground truth for the training set was established

Not Applicable. As explained above, for this type of device, there is no "training set" in the context of AI/machine learning, and therefore no ground truth established for such a set.

Summary

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K965240

BECKMAN Summary of Safety & Effectiveness SYNCHRON LX™20 Clinical Chemistry System

1.0 Submitted By

Sheri Hall Manager, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd. W-337 Brea. California 92822-8000 Telephone: (714) 993-8916 FAX: (714) 961-4457

MAR 10 1997

2.0 Date Submitted

25 November 1996

3.0 Device Name(s)

3.1 Proprietary Names

SYNCHRON LX™20 Clinical Chemistry System SYNCHRON LX™ Albumin Reagent SYNCHRON LX™ Creatinine Picric Reagent SYNCHRON LX™ Creatinine Alkaline Reagent SYNCHRON LX™ Glucose Reagent SYNCHRON LX™ Phosphorus Molybdate Reagent SYNCHRON LX™ Phosphorus Diluent Reagent SYNCHRON LX™ Total Protein Reagent SYNCHRON LX™ Urea Nitrogen Reagent SYNCHRON LX™ CO2 Acid Reagent SYNCHRON LX™ CO2 Alkaline Buffer Reagent SYNCHRON LX™ ISE Reference Reagent SYNCHRON LX™ ISE Buffer Reagent SYNCHRON LX™ AQUA CAL 1, 2, 3 SYNCHRON LX™ Protein Calibrator

3.2 Classification Names

Discrete photometric chemistry analyzer for clinical use: 21 CFR §862.2160 Albumin test system; 21 CFR §862.1035 Creatinine test system: 21 CFR §862.1225 Glucose test system; 21 CFR §862.1345 Phosphorus test sytem: 21 CFR §862.1580 Total Protein test svstem: 21 CFR §862.1635 Urea Nitrogen test system: 21 CFR §862.1770 Carbon Dioxide test system: 21 CFR §862.1160 Calcium test system: 21 CFR §862.1145 Chloride test system; 21 CFR §862.1170 Potassium test system; 21 CFR §862.1600 Sodium test system: 21 CFR §862.1665 Calibrator; 21 CFR §862.1150

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Beckman Instruments Inc. Section 510(k) Notification SYNCHRON LX™20 Clinical Chemistry Systems Summary of Safety & Effectiveness

Predicate Device(s) 4.0

Candidate	Predicate	FDA DocketNumber
SYNCHRON LX20 System	SYNCHRON CX Systems	K950958
LX20 Albumin Assay	SYNCHRON Systems Albumin	K883181
LX20 Creatinine Assay	SYNCHRON Systems Creatinine	K950958
LX20 Glucose Assay	SYNCHRON Systems Glucose	K950958
LX20 Phosphorus Assay	SYNCHRON Systems Phosphorus	K883181
LX20 Total Protein Assay	SYNCHRON Systems Total Protein	K950958
LX20 Urea Nitrogen Assay	SYNCHRON Systems Urea Nitrogen	K950958
LX20 Carbon Dioxide Assay	SYNCHRON Systems Carbon Dioxide	K950958
LX20 Calcium Assay	SYNCHRON Systems Calcium	K950958
LX20 Chloride Assay	SYNCHRON Systems Chloride	K950958
LX20 Potassium Assay	SYNCHRON Systems Potassium	K950958
LX20 Sodium Assay	SYNCHRON Systems Sodium	K950958
LX AQUA CAL 1,2,3	SYNCHRON Systems Aqueous Cal	K942676
SYNCHRON Protein Cal	SYNCHRON Systems Protein Cal	K952676

5.0 Description

6.0 Intended Use

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Beckman Instruments Inc. Section 510(k) Notification SYNCHRON LX™20 Clinical Chemistry Systems Summary of Safety & Effectiveness

7.0 Comparison to Predicate(s)

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

	Similarities to SYNCHRON CX Systems
Hardware	separate chemistry analytical unit andoperator interface work station as CXSystems
Chemistry Databases	same reaction parameters as forSYNCHRON Systems reagents
Optics and Measurement Types	10 wavelength flash photometer capableof endpoint, rate colorimetric andturbidometric analyses
Electrode Technology	both systems employ conductimetric andoxygen rate electrodes
	Differences from SYNCHRON CX Systems
Operator Interface	LX20 has enhanced operator interfaceincluding touch screen and/or pointingdevice
Features	LX20 has enhanced throughput, reagentcapacity, and reaction cuvettes
Menu	LX20 has added Albumin and Phosphorusto the high throughput (MC) portion of theanalyzer

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Beckman Instruments Inc. Section 510(k) Notification SYNCHRON LX™20 Clinical Chemistry Systems Summary of Safety & Effectiveness

Summary of Performance Data 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to in vitro diagnostic test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision experiments that relate results obtained from the LX20 Clinical Chemistry System to selected predicate methods.

Serum/Plasma Sample Method Comparison Study Results LX20 Clinical Chemistry System vs Selected Predicate Methods

Analyte	Slope	Intercept	r	SYNCHRON SystemsPredicate
Albumin	0.970	0.070	0.997	Albumin Reagent
Creatinine	1.010	0.04	0.999	Creatinine Reagents
Glucose	0.991	-0.250	0.996	Glucose Reagent
Phosphorus	1.023	0.27	0.996	Phosphorus Reagents
Total Protein	0.962	-0.01	0.993	Total Protein Reagent
Urea Nitrogen	0.949	1.13	0.999	Urea Nitrogen Reagent
Carbon Dioxide	1.015	-0.70	0.992	Carbon Dioxide Reagents
Calcium	0.990	-0.92	0.998	Calcium Reagents
Chloride	0.974	1.04	0.997	Chloride Reagents
Potassium	1.008	-0.01	0.999	Potassium Reagents
Sodium	1.028	-4.22	0.993	Sodium Reagents
Benzodiazepine	Concordance = 100% agreement			Benzodiazepine Reagent
Iron	0.976	9.03	0.997	Iron Reagent
Magnesium	0.971	0.09	0.997	Magnesium Reagent
Phenobarbital	0.976	0.050	0.992	Phenobarbital Reagent
Uric Acid	0.977	-0.02	0.999	Uric Acid Reagent
Lactate	1.018	0.20	0.999	LDL Reagent
Dehydrogenase

Estimated Serum/Plasma Within-run Imprecision

Material	Mean	SD	%C.V.	N
Albumin Reagent
Level 1	2.21 g/dL	0.04	1.9	80
Level 2	4.81 g/dL	0.03	0.6	80
Creatinine Reagent
Level 1	0.59 mg/dL	0.07	12.2	80
Level 2	8.24 mg/dL	0.18	2.1	80
Glucose Reagent
Level 1	43.7 mg/dL	1.3	2.9	80
Level 2	397.1 mg/dL	1.7	0.4	80
Phosphorus Reagent
Level 1	1.80 mg/dL	0.04	2.5	80
Level 2	7.04 mg/dL	0.05	0.7	80
Material	Mean	SD	%C.V.	N
Total Protein
Level 1	3.54 g/dL	0.06	1.8	80
Level 2	7.52 g/dL	0.05	0.7	80
Urea Nitrogen Reagent
Level 1	7.7 mg/dL	0.4	5.0	80
Level 2	58.7 mg/dL	0.5	0.9	80
Calcium
Level 1	7.5 mg/dL	0.08	1.1	80
Level 2	13.5 mg/dL	0.11	0.8	80
Carbon Dioxide
Level 1	10.58 mmol/L	0.26	2.5	80
Level 2	30.16 mmol/L	0.29	1.0	80
Chloride
Level 1	81.11 mmol/L	0.47	0.6	80
Level 2	120.53 mmol/L	0.84	0.7	80
Potassium
Level 1	2.4 mmol/L	0.02	0.9	80
Level 2	7.29 mmol/L	0.04	0.6	80
Sodium
Level 1	111.1 mmol/L	0.52	0.5	80
Level 2	170.2 mmol/L	1.01	0.6	80
Benzodiazepines
Cutoff Calibrator	293 mA/min	2.4	0.8	20
High Control	362 mA/min	3.0	0.8	20
Iron
Level 1	51.2 ug/dL	1.2	2.4	80
Level 2	262.6	2.2	0.9	80
Magnesium
Level 1	1.12 mg/dL	0.03	3.0	80
Level 2	3.63 mg/dL	0.06	1.5	80
Phenobarbital
Level 1	9.32 ug/mL	0.22	2.3	80
Level 2	65.86 ug/mL	1.42	2.2	80
Uric Acid
Level 1	2.42 mg/dL	0.03	1.1	80
Level 2	10.48 mg/dL	0.05	0.5	80
Lactate Dehydrogenase
Level 1	49.9 IU/L	1.6	3.2	80
Level 2	363.5 IU/L	3.4	1.0	80

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Estimated Serum/Plasma Within-run Imprecision (continued)

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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.

Regulation Number and Section

§ 862.2160 Discrete photometric chemistry analyzer for clinical use.

(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.