UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

K042291 · Beckman Coulter, Inc. · CEM · Nov 12, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042291
• Device Name: UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
• Applicant: Beckman Coulter, Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Nov 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Indications for Use

The UniCel DxC SYNCHRON Systems are fully automated, computer-controlled clinical chemistry analyzers 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, or cerebrospinal fluid, (sample type is chemistry dependent). TPm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems Protein Calibrator, is intended for the quantitative determination of Total Protein concentration in human serum, plasma or cerebrospinal fluid (CSF). Total protein measurements are used in the diagnosis and treatment of diseases involving the liver, kidney or bone marrow, as well as other metabolic or nutritional disorders. TP reagent, when used in conjunction with UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Total Protein concentration in human serum or plasma. Total protein measurements are used in the diagnosis and treatment of diseases involving the liver, kidney or bone marrow, as well as other metabolic or nutritional disorders. ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of Potassium concentration in human serum, plasma or urine. Potassium measurements are used in the diagnosis and treatment of hypokalemia, hyperkalemia, renal failure, Addison's disease or other diseases involving electrolyte imbalance. PHOSm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and the SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of inorganic Phosphorus concentration in human serum, plasma or urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. LD reagent, when used in conjunction with SYNCHRON LX® Systems or UniCel® DxC 600/800 Systems, is intended for the quantitative determination of Lactate Dehydrogenase activity in human serum or plasma. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and acute metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. GLUCm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF). Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet cell carcinoma. CREm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. CREA reagent, when used in conjunction with UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, are intended for quantitative determination of Chloride concentration in human serum, plasma, urine or cerebrospinal fluid (CSF). Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. ALBm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems Protein Calibrator, is intended for the quantitative determination of Albumin concentration in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver and/or kidneys. ALB reagent, when used in conjunction with UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Albumin concentration in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver and/or kidneys. High Sensitivity CRPH reagent, when used in conjunction with SYNCHRON LX® PRO Systems, UniCel® DxC 600/800 Systems, and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry. Measurement of C-Reactive protein aids in the evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. PHE reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Drug Calibrator 1, is intended for the quantitative determination of Phenobarbital concentration in human serum or plasma. Phenobarbital is indicated for the treatment of status epilepticus, febrile seizures and seizure disorders (grand mal and psychomotor), except absence (petit mal) seizures. Phenobarbital therapy is monitored for suspected inadequate dose or toxicity. ISE Electrolyte Buffer reagent, ISE Electrolyte Reference reagent, CO2 Alkaline Buffer and CO2 Acid reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 3, are intended for quantitative determination of Carbon Dioxide concentration in human serum or plasma. Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, are intended for quantitative determination of Calcium concentration in human serum, plasma or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). MG reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Magnesium concentration in human serum, plasma or urine. Determination of magnesium is useful in assessing several diseases and conditions. High magnesium is associated with uremia, dehydration, diabetic acidosis, Addison's disease, and increased medicinal intake of magnesium, such as in the treatment of preeclampsia (hypertension induced by pregnancy). Low magnesium is associated with malabsorption syndrome, acute pancreatitis, hypoparathyroidism, chronic alcoholism and delirium tremens, chronic glomerulonephritis, aldosteronism, digitalis intoxication, and protracted I.V. feeding. ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of Sodium concentration in human serum, plasma or urine. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. URIC reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for quantitative determination of Uric Acid concentration in human serum, plasma, or urine. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. FE reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems FE/IBCT Calibrator Kit, is intended for the quantitative determination of Iron in human serum or heparinized plasma. Alterations in iron and total iron binding capacity levels result from changes in iron intake, absorption, storage, and release mechanisms. Such changes are indicative of a wide range of dysfunctions including anemias, nephrosis, cirrhosis and hepatitis. Both iron and total iron binding capacity measurements are important for definitive diagnosis because they are interrelated. Tietz has presented a summary of these relationships and the patterns of iron/total iron binding capacity associated with various disease states. BENZ reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems, and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of Benzodiazepine in human urine at a cutoff value of 200 ng/mL (oxazepam). The BENZ assay provides a rapid screening procedure for determining the presence of the analyte in urine. This test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used. Benzodiazepines are a class of central nervous system depressants that are used as sedatives and hypnotics. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, flurazepam, and nitrazepam. Measurements of benzodiazepines on the SYNCHRON® Systems are used in the diagnosis and treatment of benzodiazepine use and overdose, and in monitoring the presence of benzodiazepines to ensure appropriate therapy. BUNm or UREAm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems AQUA CAL 1, 2 and 3, is intended for the quantitative determination of Urea Nitrogen or Urea concentration in human serum, plasma or urine. The system can be configured to report results as either urea nitrogen in default units of mg/dL or urea in default units of mmol/L. Urea nitrogen or urea measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Story

UniCel DxC 600/800 are fully automated, random-access clinical chemistry analyzers for clinical labs. Systems process biological fluids (serum, plasma, urine, CSF) using spectrophotometric and ion-selective electrode (ISE) technologies. Input samples are bar-coded; system performs automated sampling, reagent handling, and reaction processing. Cartridge chemistry assays use endpoint or kinetic rate measurements; modular assays use ISE or photometric electrochemical methods. System calculates analyte concentrations via calibration curves (linear or non-linear) derived from calibrators. Output is quantitative or qualitative concentration/activity results. Healthcare providers use results for diagnosis and treatment monitoring of metabolic, renal, hepatic, and cardiac conditions, or drug therapy/abuse screening. Systems feature closed-tube sampling, obstruction detection, and dual-carousel reagent storage. Designed for high-throughput clinical environments; operated by laboratory technicians.

Clinical Evidence

Bench testing only. Performance validated per NCCLS guidelines (EP9-A, EP5-A, EP6, EP7-A, C28-A). Precision studies (N=80) demonstrated acceptable SD and %CV across low/high control levels. Linearity confirmed across reportable ranges. Method comparison against predicate showed high correlation (r > 0.99). Interference testing showed no significant interference for common substances (hemoglobin, bilirubin, lipemia).

Technological Characteristics

Random-access clinical chemistry analyzer; spectrophotometry and ion-selective electrode (ISE) technology. Features 10-wavelength flash photometer, 125-cuvette reaction wheel, and dual-carousel reagent storage (59 cartridges). Modular and cartridge-based chemistry. Connectivity via networked, multiprocessor control architecture. Automated sample handling with bar-code identification, cap piercing, and obstruction detection. Software-controlled calibration and quality control programs.

Indications for Use

Indicated for in vitro quantitative/qualitative determination of general chemistries, therapeutic drugs, and other clinical analytes in human serum, plasma, urine, or CSF. Patient population includes individuals requiring diagnosis/treatment monitoring for metabolic, renal, hepatic, cardiac, or nutritional disorders, electrolyte imbalances, or drug therapy/abuse screening.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

• SYNCHRON LX®20 (K965240)
• PRO Systems (K011213)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE AND INSTRUMENT TEMPLATE

A. 510(k) Number:
k042291

B. Purpose for Submission:
Beckman Coulter has determined the design for the DxC 600 and UniCel DxC 800 UniCel SYNCHRON Clinical Systems are significant enough to warrant a Premarket Notification. Modular and cartridge chemistries presented below are previously cleared test systems on the SYNCHRON platform and are presented to demonstrate instrument performance as a system not for assay specific clearance, with the exception of Cartridge Chemistry assays for ALB, CREA, and TP.

Cartridge Chemistry assays for ALB, CREA, and TP on the DxC platform utilize the existing, previously-cleared CX reagent formulations and assay parameters; however, because the assay analytical cycle and reaction subsystem designs differ between the SYNCHRON CX and SYNCHRON LX/UniCel DxC platforms, testing encompasses areas such as method comparison, imprecision, linearity, analytical sensitivity, interferences, reference ranges, and stability.

C. Analyte:
Total Protein, Potassium, Phosphorus (Inorganic), Lactate Dehydrogenase, Glucose, Creatinine, Chloride, Albumin, C-Reactive Protein Immunological, Phenobarbital, Bicarbonate/Carbon Dioxide, Calcium, Magnesium, Sodium, Uric Acid, Iron (non-heme), Benzodiazepine, Urea Nitrogen

D. Type of Test:
Semi-Quantitative for Benzodiazepine the all others are Quantitative.

E. Applicant:
BECKMAN COULTER, INC.

F. Proprietary and Established Names:
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1635 - Total protein test system.
21 CFR §862.1600 - Potassium test system.
21 CFR §862.1580 - Phosphorus (inorganic) test system.
21 CFR §862.1440 - Lactate dehydrogenase test system.
21 CFR §862.1345 - Glucose test system.

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21 CFR §862.1225 - Creatinine test system.
21 CFR §862.1170 - Chloride test system.
21 CFR §862.1035 - Albumin test system.
21 CFR §866.5270 - C-reactive protein immunological test system.
21 CFR §862.3660 - Phenobarbital test system.
21 CFR §862.1160 - Bicarbonate/carbon dioxide test system.
21 CFR §862.1145 - Calcium test system.
21 CFR §862.1495 - Magnesium test system.
21 CFR §862.1665 - Sodium test system.
21 CFR §862.1775 - Uric acid test system.
21 CFR §862.1410 - Iron (non-heme) test system.
21 CFR §862.2160 - Discrete Photometric Chemistry Analyzer for Clinical Use
21 CFR §862.3170 - Benzodiazepine test system.
21 CFR §862.1770 - Urea nitrogen test system.

2. Classification:
Class 2, 2, 1 reserved, 2, 2, 2, 2, 2, 2, 2, 2, 1 reserved, 2, 1 reserved, 1 reserved, 1, 2, and 2, respectively

3. Product Code:
CEK, CEM, CEO, CFJ, CGA, CGX, CGZ, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JHB, JIY, JJE, JXM and LFP, respectively

4. Panel:
Chemistry (75), Immunology (82) and Toxicology (91)

## H. Intended Use:

1. Indication(s) for use:

**Analyzers**
UniCel® DxC 600 SYNCHRON® Clinical System
UniCel® DxC 800 SYNCHRON® Clinical System

The UniCel DxC SYNCHRON Systems are fully automated, computer-controlled clinical chemistry analyzers 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, or cerebrospinal fluid, (sample type is chemistry dependent).

**Submitted Assays:**

**SYNCHRON® Systems Total Protein (TPm) Reagent**

TPm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems Protein Calibrator, is intended for the quantitative determination of Total Protein concentration in human serum, plasma or cerebrospinal fluid (CSF).

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Total protein measurements are used in the diagnosis and treatment of diseases involving the liver, kidney or bone marrow, as well as other metabolic or nutritional disorders.

## SYNCHRON® Systems Total Protein (TP) Reagent

TP reagent, when used in conjunction with UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Total Protein concentration in human serum or plasma.

Total protein measurements are used in the diagnosis and treatment of diseases involving the liver, kidney or bone marrow, as well as other metabolic or nutritional disorders.

## SYNCHRON® Systems Potassium (K) Assay

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of Potassium concentration in human serum, plasma or urine.

Potassium measurements are used in the diagnosis and treatment of hypokalemia, hyperkalemia, renal failure, Addison's disease or other diseases involving electrolyte imbalance.

## SYNCHRON® Systems Phosphorus (PHOSm) Reagent

PHOSm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and the SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of inorganic Phosphorus concentration in human serum, plasma or urine.

Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

## SYNCHRON® Systems Lactate Dehydrogenase (LD) Reagent

LD reagent, when used in conjunction with SYNCHRON LX® Systems or UniCel® DxC 600/800 Systems, is intended for the quantitative determination of Lactate Dehydrogenase activity in human serum or plasma.

Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and acute metastatic

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carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

## SYNCHRON® Systems Glucose (GLUCm) Reagent

GLUCm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

## SYNCHRON® Systems Creatinine (CREm) Reagent

CREm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

## SYNCHRON® Systems Creatinine (CREA) Reagent

CREA reagent, when used in conjunction with UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or urine.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

## SYNCHRON® Systems Chloride (CL) Assay

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, are intended for quantitative determination of Chloride concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).

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Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

## SYNCHRON® Systems Albumin (ALBm) Reagent

ALBm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems Protein Calibrator, is intended for the quantitative determination of Albumin concentration in human serum or plasma.

Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver and/or kidneys.

## SYNCHRON® Systems Albumin (ALB) Reagent

ALB reagent, when used in conjunction with UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Albumin concentration in human serum or plasma.

Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver and/or kidneys.

## SYNCHRON® Systems High Sensitivity C-Reactive Protein (CRPH) Reagent

High Sensitivity CRPH reagent, when used in conjunction with SYNCHRON LX® PRO Systems, UniCel® DxC 600/800 Systems, and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry.

Measurement of C-Reactive protein aids in the evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases.

## SYNCHRON® Systems Phenobarbital (PHE) Reagent

PHE reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Drug Calibrator 1, is intended for the quantitative determination of Phenobarbital concentration in human serum or plasma.

Phenobarbital is indicated for the treatment of status epilepticus, febrile seizures and seizure disorders (grand mal and psychomotor), except absence (petit mal) seizures. Phenobarbital therapy is monitored for suspected inadequate dose or toxicity.

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# SYNCHRON® Systems Carbon Dioxide (CO2) Assay

ISE Electrolyte Buffer reagent, ISE Electrolyte Reference reagent, CO2 Alkaline Buffer and CO2 Acid reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 3, are intended for quantitative determination of Carbon Dioxide concentration in human serum or plasma.

Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

# SYNCHRON® Systems Calcium (CALC) Assay

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, are intended for quantitative determination of Calcium concentration in human serum, plasma or urine.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

# SYNCHRON® Systems Magnesium (MG) Reagent

MG reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Magnesium concentration in human serum, plasma or urine.

Determination of magnesium is useful in assessing several diseases and conditions. High magnesium is associated with uremia, dehydration, diabetic acidosis, Addison's disease, and increased medicinal intake of magnesium, such as in the treatment of preeclampsia (hypertension induced by pregnancy). Low magnesium is associated with malabsorption syndrome, acute pancreatitis, hypoparathyroidism, chronic alcoholism and delirium tremens, chronic glomerulonephritis, aldosteronism, digitalis intoxication, and protracted I.V. feeding.

# SYNCHRON® Systems Sodium (NA) Assay

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1, 2 and 3, are intended

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for the quantitative determination of Sodium concentration in human serum, plasma or urine.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

## SYNCHRON® Systems Uric Acid (URIC) Reagent

URIC reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for quantitative determination of Uric Acid concentration in human serum, plasma, or urine.

Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

## SYNCHRON® Systems Iron (FE) Reagent

FE reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems FE/IBCT Calibrator Kit, is intended for the quantitative determination of Iron in human serum or heparinized plasma.

Alterations in iron and total iron binding capacity levels result from changes in iron intake, absorption, storage, and release mechanisms. Such changes are indicative of a wide range of dysfunctions including anemias, nephrosis, cirrhosis and hepatitis. Both iron and total iron binding capacity measurements are important for definitive diagnosis because they are interrelated. Tietz has presented a summary of these relationships and the patterns of iron/total iron binding capacity associated with various disease states.

## SYNCHRON® Systems Benzodiazepine (BENZ) Reagent

BENZ reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems, and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of Benzodiazepine in human urine at a cutoff value of 200 ng/mL (oxazepam).

The BENZ assay provides a rapid screening procedure for determining the presence of the analyte in urine. This test provides only a preliminary

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analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.

Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Benzodiazepines are a class of central nervous system depressants that are used as sedatives and hypnotics. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, flurazepam, and nitrazepam. Measurements of benzodiazepines on the SYNCHRON® Systems are used in the diagnosis and treatment of benzodiazepine use and overdose, and in monitoring the presence of benzodiazepines to ensure appropriate therapy.

## SYNCHRON® Systems Urea Nitrogen (BUNm or UREAm) Reagent

BUNm or UREAm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems AQUA CAL 1, 2 and 3, is intended for the quantitative determination of Urea Nitrogen or Urea concentration in human serum, plasma or urine. The system can be configured to report results as either urea nitrogen in default units of $\mathrm{mg/dL}$ or urea in default units of mmol/L.

Urea nitrogen or urea measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

2. Special condition for use statement(s): Not Applicable
3. Special instrument Requirements: UniCel DxC 600 or 800 System

## I. Device Description:

The UniCel DxC 600 and 800 Systems are the next generation of clinical chemistry analyzers in Beckman Coulter's SYNCHRON instrument family. The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with SYNCHRON Systems. The DxC instruments feature bar code identification of samples and reagents, Closed Tube Sampling, Obstruction Detection and Correction, and a dual carousel reagent storage compartment with an onboard capacity of 59 cartridges. Major system components include sample and reagent handling systems, bar code readers, modular chemistry sections, cartridge chemistry systems, and reagent storage compartment, supported by power and hydropneumatic utilities.

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# J. Substantial Equivalence Information:

1. Predicate device name(s):
SYNCHRON LX®20 PRO Systems
Analytes: SYNCHRON Total Protein (TPm), SYNCHRON Total Protein (TP), SYNCHRON (ISE) Potassium, SYNCHRON Phosphorus (PHOSm), SYNCHRON LD Enzymes (LD), SYNCHRON Glucose (GLUCm), SYNCHRON Creatinine (CREA), SYNCHRON Creatinine (CREm), SYNCHRON (ISE) Chloride, SYNCHRON Albumin (ALB), SYNCHRON Albumin (ALBm), SYNCHRON High Sensitivity CRP (CRPH), SYNCHRON Phenobarbital (PHE), SYNCHRON (ISE) Carbon Dioxide, SYNCHRON (ISE) Calcium, SYNCHRON Magnesium (MG), SYNCHRON (ISE) Sodium, SYNCHRON Uric Acid (URIC), SYNCHRON Iron (FE), SYNCHRON Benzodiazepine (BENZ), SYNCHRON Urea Nitrogen (BUNm, UREAm),

2. Predicate K number(s):
Analyzers k965240, k011213
Analytes: k965240, k883181, k965240, k965240, k971333, k965240, k883181, k965240, k965240, k883181, k965240, k010597, k955644, k965240, k965240, k883967, k965240, k970919, k960485, k023048, k965240 respectively

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| • Intended Use
• Fundamental Technologies
• Operational Environment
• System Architecture
• Optics/Reaction Subsystem
• Sample Handling Subsystem
• Chemistry Databases
• Reagents and Consumables | | |
| Differences | | |
| Item | Device | Predicate |
| • Reagent Storage Capacity | DxC 600/800: 59 cartridges | LX: 30 cartridges |
| • Reagent Handling Subsystem | DxC 600/800: Extended length design | LX: Teflon coated high nickel steel probes |
| • Instrument Packaging | DxC 600: 62 inch | LX: 70 inch width |

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| • Subsystem Designs | width
DxC 600/800: New instrument skins | LX: Original |
| --- | --- | --- |
| • Electronics | DxC 600/800: Modified Modular Chemistry, Power, and Hydropneumatic subsystems | LX: Original |
| • Operator Interface | DxC 600/800: New components to address obsolescence issues | LX: Original |
| • Maintenance Procedures | DxC 600/800: New key features | LX: Original |
| • Modular Chemistry Menu | DxC 600/800: Replaceable chloride electrode tip | LX: Chloride electrode resurfacing |
| • Cartridge Chemistry Menu | DxC 600: 6 chemistries | LX: 11 chemistries |
| | DxC 600/800: 86 chemistries | LX: 83 chemistries |

K. Standard/Guidance Document Referenced (if applicable):
- NCCLS EP9-A - User Comparison of Quantitative Clinical Laboratory Methods Using Patient Samples
- NCCLS EP5-A - User Evaluation of Precision Performance of Clinical Chemistry NCCLS EP6 - A Evaluation of the Linearity of Quantitative Methods
- NCCLS EP7-A - Interference Testing in Clinical Chemistry
- NCCLS C28-A - How to Define and Determine Reference Intervals in the Clinical Laboratory

L. Test Principle:
Flow cell modules that use ion selective electrode (ISE) for NA, K, Cl, Ca and CO2 and photometric electrochemical technologies for specific analyte modular assays are TPm, PHOSm, GLUCm, CREm, ALBm and BUNm/UREAm. Cartridge Chemistry assays TP, LD, CREA, ALB, CRPH, PHE, MG, URIC and FE, BENZ utilize

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spectrophotometric techniques, two different measurements modes can be used: Endpoint measurement (equilibrium methods) and Rate measurements (kinetic methods).

**Test principles** in support of clearance of Cartridge Chemistry assays new to the UniCel DxC Systems:

**SYNCHRON Systems ALB assay** is based on a colorimetric, timed endpoint method. In the reaction, albumin combines with bromocresol purple (BCP) to form a colored product.

The chemical reaction scheme follows:

$$
\text{Albumin(sample)} + \text{BCP} \rightarrow \text{Albumin-BCP Complex}
$$

The SYNCHRON System automatically proportions the appropriate sample and reagent volumes into a cuvette. The ratio used is one part sample to 100 parts reagent. The system monitors the change in absorbance at 600 nanometers. This change in absorbance is directly proportional to the concentration of albumin in the sample and is used by the SYNCHRON System to calculate and express albumin concentration. The calculation is based upon a linear calibration curve generated from a single-level value-assigned calibrator.

**SYNCHRON Systems CREA assay** measures creatinine concentration by a modified rate Jaffé method. In the reaction, creatinine combines with picrate in an alkaline solution to form a creatinine-picrate complex.

The chemical reaction scheme follows:

Alkaline Solution

$$
\text{Creatinine(sample)} + \text{Picric acid} \rightarrow \text{Creatinine-picrate}
$$

The SYNCHRON System automatically proportions the appropriate sample and reagent volumes into a cuvette. The ratio used is one part sample to 11 parts reagent for serum, and one part sample to 73 parts reagent for urine. The system monitors the change in absorbance at 520 nanometers. This change in absorbance is directly proportional to the concentration of creatinine in the sample and is used by the SYNCHRON System to calculate and express creatinine concentration. The calculation is based upon a linear calibration curve generated from a single-level value-assigned calibrator.

**SYNCHRON Systems TP assay** is based on a colorimetric, timed endpoint method. In the reaction, the peptide bonds in the protein sample bind to cupric ions in an alkaline medium to form colored peptide/copper complexes. The chemical reaction scheme follows:

Alkali

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Protein(sample) + Cu2+ → Protein-Copper Complex

The SYNCHRON System automatically proportions the appropriate sample and reagent volumes into a cuvette. The ratio used is one part sample to 50 parts reagent. The system monitors the change in absorbance at 560 nanometers. This change in absorbance is directly proportional to the concentration of total protein in the sample and is used by the SYNCHRON System to calculate and express total protein concentration. The calculation is based upon a linear calibration curve generated from a single-level value-assigned calibrator.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Within-run and total precision studies were designed from NCCLS Guideline EP5-A

Unicel 800 System Estimated Serum Imprecision (N=80) for test system precision

| Chemistry | Control Level | Mean | Within-run SD | Within-run %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- | --- |
| NA | Low | 114.8 mmol/L | 0.65 | 0.6 | 1.0 | 0.9 |
| | High | 155.6 mmol/L | 0.96 | 0.6 | 1.32 | 0.9 |
| K | Low | 2.39 mmol/L | 0.025 | 1.0 | 0.030 | 1.2 |
| | High | 7.30 mmol/L | 0.056 | 0.8 | 0.063 | 0.9 |
| CL | Low | 81.8 mmol/L | 0.77 | 0.9 | 1.00 | 1.2 |
| | High | 122.2 mmol/L | 0.92 | 0.8 | 1.20 | 1.0 |
| CO2 | Low | 12.2 mmol/L | 0.39 | 3.2 | 0.49 | 4.0 |
| | High | 31.5 mmol/L | 0.55 | 1.7 | 0.64 | 2.0 |
| CALC | Low | 7.5 mg/dL | 0.07 | 0.9 | 0.08 | 1.0 |
| | High | 13.6 mg/dL | 0.09 | 0.6 | 0.14 | 1.1 |
| ALBm | Low | 2.3 g/dL | 0.04 | 1.9 | 0.06 | 2.4 |
| | High | 5.1 g/dL | 0.05 | 1.0 | 0.06 | 1.1 |
| BUNm | Low | 6.8 mg/dL | 0.4 | 6.2 | 0.5 | 6.9 |
| | High | 61.4 mg/dL | 1.7 | 2.8 | 1.7 | 2.8 |
| CREm | Low | 0.5 mg/dL | 0.04 | 8.7 | 0.04 | 9.0 |
| | High | 7.9 mg/dL | 0.09 | 1.2 | 0.18 | 2.3 |
| GLUm | Low | 43.2 mg/dL | 1.17 | 2.7 | 1.51 | 3.5 |
| | High | 379.0 mg/dL | 2.11 | 0.6 | 4.88 | 1.3 |
| PHOSm | Low | 1.8 mg/dL | 0.04 | 1.9 | 0.05 | 2.7 |
| | High | 6.5 mg/dL | 0.06 | 1.0 | 0.11 | 1.7 |
| TPm | Low | 3.6 g/dL | 0.08 | 2.4 | 0.09 | 2.5 |
| | High | 7.8 g/dL | 0.08 | 1.0 | 0.10 | 1.2 |
| BENZ | Low | 413.1 mA/min | 2.35 | 0.6 | 3.61 | 0.9 |
| | High | 470.0 mA/min | 2.58 | 0.6 | 3.87 | 0.8 |
| CRPH | Low | 0.08 mg/dL | 0.004 | 5.3 | 0.004 | 5.3 |
| | High | 7.59 mg/dL | 0.135 | 1.8 | 0.153 | 2.0 |
| FE | Low | 65.0 μg/dL | 1.82 | 2.8 | 2.14 | 3.3 |
| | High | 260.6 μg/dL | 3.43 | 1.3 | 4.04 | 1.6 |
| LD | Low | 53 IU/L | 2.3 | 4.4 | 2.4 | 4.5 |
| | High | 383 IU/L | 4.1 | 1.1 | 6.5 | 1.7 |
| MG | Low | 1.2 mg/dL | 0.01 | 1.2 | 0.02 | 2.1 |

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| | High | 3.5 mg/dL | 0.05 | 1.6 | 0.07 | 2.0 |
| --- | --- | --- | --- | --- | --- | --- |
| PHE | Low | 9.3 µg/mL | 0.19 | 2.1 | 0.25 | 2.7 |
| | High | 67.7 µg/mL | 1.73 | 2.6 | 2.56 | 3.8 |
| URIC | Low | 2.5 mg/dL | 0.05 | 2.0 | 0.05 | 2.1 |
| | High | 11.0 mg/dL | 0.06 | 0.6 | 0.07 | 0.7 |

Data to support clearance of Cartridge Chemistry assays new to the UniCel DxC Systems:

ALB Imprecision Results UniCel DxC 600 System

| Sample | Mean (g/dL) | S.D. (g/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Within-Run Imprecision | | | | |
| Level 1 | 2.2 | 0.05 | 2.3 | 80 |
| Level 2 | 3.7 | 0.07 | 1.9 | 80 |
| Level 3 | 5.2 | 0.08 | 1.5 | 80 |
| Total Imprecision | | | | |
| Level 1 | 2.2 | 0.06 | 2.5 | 80 |
| Level 2 | 3.7 | 0.07 | 1.9 | 80 |
| Level 3 | 5.2 | 0.08 | 1.6 | 80 |

ALB Imprecision Results UniCel DxC 800 System

| Sample | Mean (g/dL) | S.D. (g/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Within-Run Imprecision | | | | |
| Level 1 | 2.2 | 0.04 | 1.9 | 80 |
| Level 2 | 3.7 | 0.07 | 1.8 | 80 |
| Level 3 | 5.1 | 0.08 | 1.6 | 80 |
| Total Imprecision | | | | |
| Level 1 | 2.2 | 0.05 | 2.1 | 80 |
| Level 2 | 3.7 | 0.07 | 1.9 | 80 |
| Level 3 | 5.1 | 0.08 | 1.6 | 80 |

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CREA Imprecision Results UniCel DxC 600 System

| Sample | Mean (mg/dL) | SD (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| SERUM SAMPLES | | | | |
| Within-Run Imprecision | | | | |
| Level Low | 0.6 | 0.05 | 9.4 | 80 |
| Level High | 7.2 | 0.06 | 0.9 | 80 |
| Total Imprecision | | | | |
| Level Low | 0.6 | 0.05 | 9.5 | 80 |
| Level High | 7.2 | 0.12 | 1.7 | 80 |
| URINE SAMPLES | | | | |
| Within-Run Imprecision | | | | |
| Level Low | 90.1 | 1.21 | 1.4 | 80 |
| Level High | 244.0 | 3.67 | 1.5 | 80 |
| Total Imprecision | | | | |
| Level Low | 90.1 | 1.70 | 1.9 | 80 |
| Level High | 244.0 | 4.22 | 1.7 | 80 |

CREA Imprecision Results UniCel DxC 800 System

| Sample | Mean (mg/dL) | SD (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| SERUM SAMPLES | | | | |
| Within-Run Imprecision | | | | |
| Level Low | 0.6 | 0.05 | 9.2 | 80 |
| Level High | 7.2 | 0.09 | 1.2 | 80 |
| Total Imprecision | | | | |
| Level Low | 0.6 | 0.05 | 9.4 | 80 |
| Level High | 7.2 | 0.16 | 2.2 | 80 |
| URINE SAMPLES | | | | |
| Within-Run Imprecision | | | | |
| Level Low | 86.1 | 1.18 | 1.4 | 80 |
| Level High | 233.4 | 3.12 | 1.3 | 80 |
| Total Imprecision | | | | |
| Level Low | 86.1 | 2.31 | 2.7 | 80 |
| Level High | 233.4 | 6.73 | 2.9 | 80 |

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TP Imprecision Results UniCel DxC 600 System

| Sample | Mean (g/dL) | S.D. (g/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Within-Run Imprecision | | | | |
| Level 1 | 3.9 | 0.09 | 2.2 | 80 |
| Level 2 | 6.1 | 0.11 | 1.8 | 80 |
| Level 3 | 8.3 | 0.15 | 1.8 | 80 |
| Total Imprecision | | | | |
| Level 1 | 3.9 | 0.12 | 3.0 | 80 |
| Level 2 | 6.1 | 0.16 | 2.6 | 80 |
| Level 3 | 8.3 | 0.21 | 2.6 | 80 |

TP Imprecision Results UniCel DxC 800 System

| Sample | Mean (g/dL) | S.D. (g/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Within-Run Imprecision | | | | |
| Level 1 | 3.9 | 0.05 | 1.3 | 80 |
| Level 2 | 6.1 | 0.09 | 1.5 | 80 |
| Level 3 | 8.3 | 0.10 | 1.2 | 80 |
| Total Imprecision | | | | |
| Level 1 | 3.9 | 0.08 | 2.0 | 80 |
| Level 2 | 6.1 | 0.12 | 1.9 | 80 |
| Level 3 | 8.3 | 0.13 | 1.6 | 80 |

b. Linearity/assay reportable range:
Data to support clearance of Cartridge Chemistry assays new to the UniCel DxC Systems:

Linearity (analytical range) studies were designed using the NCCLS Guideline EP6-P

ALB Linearity

| SYNCHRON System | Sample Type | Measuring Range (mg/dL) | Linear Regression Analysis | Assessment |
| --- | --- | --- | --- | --- |
| DxC 600 | Serum/Plasma | 1.0 – 7.0 | Y = 1.030X – 0.12 | Linear |
| DxC 800 | | | Y = 1.029X – 0.12 | Linear |

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CREA Linearity

| SYNCHRON System | Sample Type | Measuring Range (mg/dL) | Linear Regression Analysis | Assessment |
| --- | --- | --- | --- | --- |
| DxC 600 | Serum/Plasma | 1.0 – 12.0 | Y = 1.008X – 0.05 | Linear |
| DxC 800 | | | Y = 1.003X + 0.03 | Linear |
| DxC 600 | Urine | 10 - 120 | Y = 0.981X + 4.99 | Linear |
| DxC 800 | | | Y = 0.991X + 3.32 | Linear |

TP Linearity

| SYNCHRON System | Sample Type | Measuring Range (g/dL) | Linear Regression Analysis | Assessment |
| --- | --- | --- | --- | --- |
| DxC 600 | Serum/Plasma | 3.0 – 12.0 | Y = 1.006X + 0.07 | Linear |
| DxC 800 | | | Y = 1.004X + 0.02 | Linear |

c. Traceability (controls, calibrators, or method):
Not Applicable subject of previously cleared submissions

d. Detection limit:
Data to support clearance of Cartridge Chemistry assays new to the UniCel DxC Systems:

Sensitivity is defined as the lowest measurable concentration that can be distinguished from zero with 95% confidence. The claimed sensitivity for serum albumin determination for the ALB assay is 1.0 g/dL, for the CREA assay is 1.0 mg/dL and for the TP assay is 3.0 g/dL.

e. Analytical specificity:
Interference Testing NCCLS EP7-P Data to support clearance of Cartridge Chemistry assays new to the UniCel DxC Systems:

ALB Serum Interferences

| Substance | Source | Level Tested | Observed Effect^{a} |
| --- | --- | --- | --- |
| Hemoglobin | RBC Hemolysate | 500 mg/dL | NSI^{b} |
| Bilirubin | Porcine | 30 mg/dL | NSI |
| Lipemia | Human | +4 (visual) | NSI |

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## CREA Serum Interferences

| Substance | Source | Level Tested | Observed Effect^{a} |
| --- | --- | --- | --- |
| Hemoglobin | RBC Hemolysate | 500 mg/dL | NSI^{b} |
| Bilirubin | Porcine | 15.0 mg/dL | NSI |
| | | 22.5 mg/dL | -0.5 mg/dL |
| Lipemia | Human | +4 (visual) | NSI |
| Acetoacetate | Lithium salt | 20 mg/dL | NSI |
| Pyruvate | Pyruvic acid | 10 mg/dL | NSI |
| Methyl Dopa | Methyl dopa HCl | 5 mg/dL | NSI |
| Gentisic Acid | 2,5-dihydroxybenzoic acid | 50 mg/dL | NSI |
| Cephalothin | 7-[2-thienylacetamido]-cephalosporanic acid sodium salt | 100 mg/dL | NSI |
| Cefotaxime | Sodium salt | 50 mg/dL | NSI |
| Cefoxitin | Sodium salt | 12.5 mg/dL | NSI |
| | | 25.0 mg/dL | +0.7 mg/dL |
| Cephalosporin | Zinc salt | 10 mg/dL | NSI |

## TP Serum Interferences

| Substance | Source | Level Tested | Observed Effect^{a} |
| --- | --- | --- | --- |
| Hemoglobin | RBC Hemolysate | 500 mg/dL | NSI^{b} |
| Bilirubin | Porcine | 30 mg/dL | NSI |
| Lipemia | Human | 4+ (visual) | NSI |
| Dextran | Dextran 40 | 7,500 mg/dL | NSI |
| Fluorescein | NA^{c} | 25 mg/L | -1.8 g/dL |
| Methyl Dopa | Methyl dopa HCl | 5.0 mg/dL | NSI |
| Sulfasalazine (Azulfidine) | NA | 7.5 mg/dL | -2.4 g/dL |

a Plus (+) or minus (-) signs in this column signify positive or negative interference.
b NSI = No Significant Interference (within ± 0.4 g/dL or 4% for ALB and CREA and within ± 0.6 g/dL or 6% for TP)

## f. Assay cut-off:

The qualitative determination of Benzodiazepine in human urine has a cutoff value of 200 ng/mL (oxazepam).

## 2. Comparison studies:

a. Method comparison with predicate device:

Method comparison experiments were designed using NCCLS Procedure EP9-A and employed Deming regression analysis to assess the data.

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UniCel DxC 800 System vs. SYNCHRON LX20 PRO Serum
Correlation Study for test system equivalence

| Modular Assays | N | Slope | Intercept | R | Cartridge Assays | N | Slope | Intercept | R |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| NA | 164 | 0.987 | 1.99 | 0.996 | CRPH | 94 | 1.024 | -0.03 | 0.999 |
| K | 161 | 0.993 | 0.07 | 0.998 | FE | 141 | 1.002 | -0.16 | 1.000 |
| CL | 194 | 1.005 | -0.86 | 0.997 | LD | 181 | 1.005 | 5.54 | 0.999 |
| CO2 | 219 | 1.043 | -1.05 | 0.994 | MG | 175 | 0.969 | 0.04 | 0.999 |
| CAL | 184 | 1.007 | -0.03 | 0.999 | PHE | 91 | 0.981 | 0.02 | 0.998 |
| ALBm | 158 | 0.990 | 0.05 | 1.000 | URIC | 112 | 1.017 | -0.08 | 1.000 |
| BUNm | 111 | 0.985 | 0.31 | 1.000 | | | | | |
| CREm | 137 | 1.037 | -0.01 | 1.000 | Qualitative Drug Assay (urine) | | | | |
| GLUm | 199 | 1.006 | -0.11 | 1.000 | BENZ | + | - | Agreement | |
| PHOSm | 198 | 1.004 | 0.02 | 0.999 | + | 43 | 0 | 100% | |
| TPm | 191 | 0.992 | 0.08 | 0.996 | - | 0 | 57 | | |

Data to support clearance of Cartridge Chemistry assays new to the UniCel DxC Systems:

| Candidate | Platform | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- | --- |
| ALB Reagent | DxC 600 | 0.978 | -0.07 | 0.995 | 150 | Beckman Coulter SYNCHRON CX Systems ALB Assay |
| | DxC 800 | 0.960 | 0.00 | 0.996 | 152 | |
| CREA Reagent | DxC 600 | 0.949 | 0.03 | 1.000 | 169 | Beckman Coulter SYNCHRON CX |
| | DxC 800 | 0.962 | 0.03 | 1.000 | 150 | Systems CREA Assay |
| Urine | | | | | | |
| CREA Reagent | DxC 600 | 1.031 | 2.6 | 0.999 | 73 | Beckman Coulter SYNCHRON CX |
| | DxC 800 | 1.002 | 3.7 | 0.999 | 75 | Systems CREA Assay |
| TP Reagent | DxC 600 | 0.991 | -0.04 | 0.997 | 163 | Beckman Coulter SYNCHRON CX |
| | DxC 800 | 0.971 | 0.10 | 0.996 | 170 | Systems TP Assay |

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b. Matrix comparison:
Serum versus plasma studies were performed to substantiate the use of anticoagulants:

ALB Anticoagulant Study Summary

| System | Anticoagulant | Level of Anticoagulant Tested | Deming Regression Analysis |
| --- | --- | --- | --- |
| DxC 600 | Lithium Heparin | 14 units/mL | Y = 0.979X + 0.13; r = 0.996 |
| | Sodium Heparin | 14 units/mL | Y = 0.990X + 0.06; r = 0.994 |
| | EDTA | 1.5 mg/mL | Y = 0.922X + 0.12; r = 0.995 |
| DxC 800 | Lithium Heparin | 14 units/mL | Y = 1.006X - 0.01; r = 0.996 |
| | Sodium Heparin | 14 units/mL | Y = 0.988X + 0.08; r = 0.994 |
| | EDTA | 1.5 mg/mL | Y = 0.923X + 0.11; r = 0.995 |

CREA Anticoagulant Study Summary

| System | Anticoagulant | Level of Anticoagulant Tested | Deming Regression Analysis |
| --- | --- | --- | --- |
| DxC 600 | Lithium Heparin | 14 units/mL | Y = 0.985X + 0.02; r = 0.999 |
| | Sodium Heparin | 14 units/mL | Y = 1.006X - 0.02; r = 0.999 |
| | EDTA | 1.5 mg/mL | Y = 0.953X + 0.03; r = 0.999 |
| DxC 800 | Lithium Heparin | 14 units/mL | Y = 1.020X - 0.03; r = 0.999 |
| | Sodium Heparin | 14 units/mL | Y = 1.005X + 0.01; r = 0.996 |
| | EDTA | 1.5 mg/mL | Y = 0.956X + 0.03; r = 0.999 |

TP Anticoagulant Study Summary

| System | Anticoagulant | Level of Anticoagulant Tested | Deming Regression Analysis |
| --- | --- | --- | --- |
| DxC 600 | Lithium Heparin | 14 units/mL | Y = 0.923X + 0.75; r = 0.989 |
| | Sodium Heparin | 14 units/mL | Y = 0.945X + 0.65; r = 0.984 |
| DxC 800 | Lithium Heparin | 14 units/mL | Y = 0.962X + 0.47; r = 0.991 |
| | Sodium Heparin | 14 units/mL | Y = 0.960X + 0.52; r = 0.989 |

3. Clinical studies:
a. Clinical sensitivity: Not Applicable
b. Clinical specificity: Not Applicable

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c. Other clinical supportive data (when a and b are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Confirmatory studies were designed in accordance with NCCLS Document C28-A. Data to support clearance of Cartridge Chemistry assays new to the UniCel DxC Systems:

ALB Reference Interval

| Sample Type | SYNCHRON ALB Assay | REFERENCE INTERVAL |
| --- | --- | --- |
| Serum/Plasma | CX | 3.5 – 5.0 g/dL |
| | DxC 600/800 | 3.5 – 5.0 g/dL |

CREA Reference Interval Summary

| Sample Type | SYNCHRON CREA Assay | REFERENCE INTERVAL |
| --- | --- | --- |
| Serum/Plasma | CX | 0.6 – 1.3 mg/dL |
| | DxC 600/800 | 0.6 – 1.3 mg/dL |
| Urine | CX | 11 – 26 mg/kg/24 hours |
| | DxC 600/800 | 11 – 26 mg/kg/24 hours |

TP Reference Interval Summary

| Sample Type | SYNCHRON TP Assay | REFERENCE INTERVAL |
| --- | --- | --- |
| Serum/Plasma | CX | 6.5 – 8.1 g/dL |
| | DxC 600/800 | 6.5 – 8.1 g/dL |

N. Instrument Name:
UniCel® DxC 600 SYNCHRON® Clinical System
UniCel® DxC 800 SYNCHRON® Clinical System

O. System Descriptions:

1. Modes of Operation:
The UniCel DxC 600 and 800 Systems are self-contained random access general clinical chemistry analyzer systems, utilizing Spectrophotometry and Electrochemistry technology. The Chemistry Analytical Unit and Computer Console are integrated to comprise two major analytical components and eight major functional subsystems controlled via distributed, networked, multiprocessor control architecture. There is an Optics/Reaction Subsystem of 10 wavelength flash photometer for cartridge chemistry methodologies and 125-cuvette reaction wheel; optional near-infrared module for large particle immunoassays.

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2. Software:

FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes ☐ X or No ☐

3. Sample Identification:

Bar-Code

4. Specimen Sampling and Handling:

Standard components (probes, mixers, wash cups, racks, shuttle, bar code readers) plus Cap Piercing and Obstruction Detection assemblies.

5. Assay Types:

Flow cell modules use ion selective electrode (ISE) and photometric electrochemical technologies for specific analyte modular assays. Cartridge Chemistry assays utilize spectrophotometric techniques, two different measurements modes can be used: Endpoint measurement (equilibrium methods) and Rate measurements (kinetic methods).

6. Reaction Types:

| Reaction Type | Description |
| --- | --- |
| Upgoing | Absorbance increases as reaction progresses. |
| Downgoing | Absorbance decreases as reaction progresses. |
| Endpoint | Reaction comes to completion before the absorbance measurements are taken and is expressed as absorbance (A). |
| Rate | Reaction is in progress when the absorbance measurements are taken and is expressed as a rate (delta A/minute). |
| Blanked | Sample/reagent or reagent measurement is subtracted from the reaction measurement. The difference is used in the calculation for sample recovery using either delta absorbance or delta rate. |
| Non-blanked | Only the measurement taken during the reaction is used in the calculation for sample recovery. |
| Non-triggered | The reaction is initiated by the addition of sample to the cuvette that already has all the reagents needed for the reaction to take place. |
| Triggered | The reaction is initiated by a reagent component added to the cuvette after sample addition. |
| Double Triggered | The reaction scheme call for 2 reagent additions to take place after the sample is added to the cuvette. |

7. Calibration:

System calibration is accomplished by testing a single analyte concentration which is contained in a specific calibrator. Calibration determines the relationship between measured reaction responses and known concentrations.

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Calibration factors are derived from this relationship. These factors are used to convert the reaction responses to final concentration results.

System calibration adjustment is accomplished when the DxC reads a reagent lot specific parameter card that contains the calibration curve fit parameter. Calibrator and diskette can then be loaded to run the calibration and update the calibration information for patient sample and control value determinations.

Calibration chemistries include endpoint, first order rate, nonlinear, and qualitative cutoff reactions. Zero-order rate chemistries include enzymes which use extinction coefficients (of coenzymes or chromophore, of either substrate or end product), and require no routine calibration. Enzyme verification can be performed on some of the enzymes to conform to International Federation of Clinical Chemistry (IFCC) guidelines at 37°C.

Some calibrators are primary standards with values that do not change from lot-to-lot. Other serum-based calibrators require value assignment. These calibrators come packaged with a diskette containing the lot-specific data. A calibration sequence uses from one to six levels of calibrators. The number of calibrators used is chemistry dependent.

Calibration of endpoint and first-order rate chemistries uses either a single-level calibrator or a two-level calibrator kit. Each analyte in the calibrator solution has a known concentration value. For most calibrated cartridge chemistries with a linear response, the system will set calibration factors based on four calibrator replicates per calibrator level. The system discards the high and the low replicates and uses the remaining two values as the usable calibrator replicates. Other chemistries may require calibration based on two calibrator replicates per calibrator level, where no replicates will be discarded. The average value of the calibrator replicates is used to determine the calibration factor.

Many drug and specific protein assays are non-linear chemistries. For these assays with non-linear responses, the calibration curves may exhibit a logarithmic or other non-linear relationship. Curve fitting interpolation techniques are employed to construct these calibration curves. Multi-point chemistry calibration consists of five or six different levels of calibrators. These chemistries set calibration based upon single replicates of each calibrator level.

The qualitative drugs of abuse testing (DAT) assays require three levels of calibrators. The calibration measures the response separation between calibrators to measure reagent integrity; the calibration factor generated is non-functional for sample result calculation. The cutoff value for each DAT chemistry represents the mean reaction rate of the low calibrators. The reaction rate of the samples is compared to the reaction rate of the low (cutoff) calibrator and reported out as POSITIVE or NEGATIVE.

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Enzyme verification is used as a means of adjusting enzyme chemistry results to report IFCC equivalent values. Verification is similar to calibration except that normalization factors are applied to the sample result in the form of a slope and offset adjustment, whereas calibration factors would be applied to the reaction response.

Modular chemistries are calibrated using two to three levels of calibrator (chemistry dependent). Four replicates per level are assayed. As with the cartridge chemistries, data from the two middle replicates of each level is used to set the system response. Error checks are performed on the two middle replicates to verify successful calibration.

8. Quality Control:
Has a built in quality control program

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "L. Performance Characteristics" Section Of The SE Determination Decision Summary:
Not Applicable

Q. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.