SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
Device Facts
| Record ID | K965240 |
|---|---|
| Device Name | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L |
| Applicant | Beckman Instruments, Inc. |
| Product Code | JJE · Clinical Chemistry |
| Decision Date | Mar 10, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2160 |
| Device Class | Class 1 |
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 Story
Fully automated, computer-controlled clinical chemistry analyzer; processes serum, plasma, urine, and CSF samples. Input: biological fluid samples identified via barcode. Operation: automated sample/reagent dilution, delivery to reaction cuvettes, and analysis using 10-wavelength flash photometer (colorimetric/turbidometric) and conductimetric/oxygen rate electrodes. Output: quantitative analyte measurements. Used in clinical laboratory settings; operated by laboratory personnel. Enhances throughput and reagent capacity compared to predicate systems; features touch-screen interface. Provides rapid, high-volume diagnostic data to clinicians for patient assessment and therapeutic monitoring.
Clinical Evidence
Bench testing only. Method comparison studies performed against predicate methods for 17 analytes (e.g., Albumin, Glucose, Electrolytes, Drugs). Results show high correlation (r=0.992–0.999) and slopes near 1.0. Within-run imprecision evaluated with N=80 per analyte level, demonstrating low %C.V. (typically <3%). No clinical prospective/retrospective studies on human subjects reported.
Technological Characteristics
Fully automated discrete photometric chemistry analyzer. Features 10-wavelength flash photometer for colorimetric/turbidometric analysis and conductimetric/oxygen rate electrodes. Includes bar code identification, sample/reagent cranes, and modular chemistry sections. Connectivity via operator interface workstation. Software-controlled automation of dilution and reaction delivery.
Indications for Use
Indicated for in vitro quantitative measurement of analytes in biological fluids (serum, plasma, urine, CSF) for clinical chemistry, therapeutic drug monitoring, and other clinical diagnostics.
Regulatory Classification
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.
Predicate Devices
- SYNCHRON CX Systems (K950958)
- SYNCHRON Systems Albumin (K883181)
- SYNCHRON Systems Creatinine (K950958)
- SYNCHRON Systems Glucose (K950958)
- SYNCHRON Systems Phosphorus (K883181)
- SYNCHRON Systems Total Protein (K950958)
- SYNCHRON Systems Urea Nitrogen (K950958)
- SYNCHRON Systems Carbon Dioxide (K950958)
- SYNCHRON Systems Calcium (K950958)
- SYNCHRON Systems Chloride (K950958)
- SYNCHRON Systems Potassium (K950958)
- SYNCHRON Systems Sodium (K950958)
- SYNCHRON Systems Aqueous Cal (K942676)
- SYNCHRON Systems Protein Cal (K952676)
Related Devices
- K112412 — AU5800(R) CHEMISTRY ANALYZER · Beckman Coulter, Inc. · Dec 23, 2011
- K070704 — TRILOGY ANALYZER · Drew Scientific, Inc. · Jul 13, 2007
- K100853 — COBAS 8000 MODULAR SERIES ANALYZER · Roche Diagnostics Corp. · Sep 9, 2010
- K990346 — BAYER ADVIA 1650 CHEMISTRY SYSTEM · Bayer Corp. · May 21, 1999
- K022072 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS · Precision Systems, Inc. · Aug 23, 2002
Submission Summary (Full Text)
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200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • (714) 993-5321
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 system; 21 CFR §862.1580
- Total Protein test system; 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
file: b20sytm.sse
Beckman Instruments, Inc.
SSE1
bxx: 910-592-1260 • telex: 06-78413
{1}
Beckman Instruments Inc. Section 510(k) Notification
SYNCHRON LX™20 Clinical Chemistry Systems
Summary of Safety & Effectiveness
## 4.0 Predicate Device(s)
| 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 reagents 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, cartridge 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).
file: b20sytm.sse
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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 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 |
file: lx20sytm.sse
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Beckman Instruments Inc. Section 510(k) Notification
SYNCHRON LX™20 Clinical Chemistry Systems
Summary of Safety & Effectiveness
## 8.0 Summary of Performance Data
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 Dehydrogenase | 1.018 | 0.20 | 0.999 | LDL Reagent |
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 |
file: b20sytm.sse
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Beckman Instruments Inc. Section 510(k) Notification
SYNCHRON LX™20 Clinical Chemistry Systems
Summary of Safety & Effectiveness
Estimated Serum/Plasma Within-run Imprecision
(continued)
| 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 |
file: bz20sytm.sse
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Beckman Instruments Inc. Section 510(k) Notification
SYNCHRON LX™20 Clinical Chemistry Systems
Summary of Safety & Effectiveness
| Calibrator Material | Stability |
| --- | --- |
| AQUA CAL 1, 2, 3 | 18 months @ 2-8°C |
| Protein Calibrator | 18 months @ 2-8°C |
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.
file: b20sytm.sse
SSE6
