SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L

• K Number: K965240
• Device Name: SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
• Manufacturer: BECKMAN INSTRUMENTS, INC.
• Date Cleared: 1997-03-10 ( 70 days)
• Product Code: JJE CDS CEK CEM CEO CGA CGX CGZ CIX JFL JFP JGS JIX
• Regulation Number: 862.2160

Intended Use

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.

Predicate Devices

K950958, K883181, K942676, K952676

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard automated clinical chemistry analyzer with computer control for sample handling and analysis. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The focus is on traditional analytical methods and system automation.

Therapeutic

No
This device is a clinical chemistry analyzer intended for in vitro diagnostic (IVD) quantitative measurement of analytes in biological fluids, not for direct therapeutic treatment of a patient.

Diagnostic

Yes
The device is described as a "clinical chemistry analyzer intended for the in vitro quantitative measurement of a variety of analytes of clinical interest in biological fluids" and its performance studies highlight "substantial equivalence to in vitro diagnostic test systems." This indicates its role in diagnosing diseases by analyzing biological samples.

SaMD (Software as a Medical Device)

No

The device description explicitly lists numerous hardware components, including a reagent compartment, sample and reagent cranes, cartinge chemistry section, modular chemistry section, sample carousel and crane, hydropneumatics, electronics, and power supplies. This indicates it is a physical system, not software only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "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..."

The term "in vitro" is a key indicator of an IVD device, meaning it is used to examine specimens taken from the human body. The description further clarifies that it measures analytes in biological fluids like serum, plasma, urine, and cerebral spinal fluid, which are all samples taken from the body for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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).

Product codes (comma separated list FDA assigned to the subject device)

Not Found

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.

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 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 Systems Predicate
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
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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" for metrics such as Slope, Intercept, r-value, and %C.V. Concordance = 100% agreement is reported for Benzodiazepine.

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.

K950958, K883181, K942676, K952676

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

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.

Summary

0

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: [phone] FAX: [phone]

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

1

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 Docket
Number |
|---------------------------|---------------------------------|----------------------|
| 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

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.

6.0 Intended Use

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).

2

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 and
operator interface work station as CX
Systems
Chemistry Databases	same reaction parameters as for
SYNCHRON Systems reagents
Optics and Measurement Types	10 wavelength flash photometer capable
of endpoint, rate colorimetric and
turbidometric analyses
Electrode Technology	both systems employ conductimetric and
oxygen rate electrodes
	Differences from SYNCHRON CX Systems
Operator Interface	LX20 has enhanced operator interface
including touch screen and/or pointing
device
Features	LX20 has enhanced throughput, reagent
capacity, and reaction cuvettes
Menu	LX20 has added Albumin and Phosphorus
to the high throughput (MC) portion of the
analyzer

3

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 Systems
Predicate |
|----------------|------------------------------|-----------|-------|-------------------------------|
| 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

4

Estimated Serum/Plasma Within-run Imprecision (continued)

5

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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.