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

Intended 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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K042291

### NOV 1 2 2004

#### 510(k) Summarv UniCel® DxC SYNCHRON® Clinical Systems

#### 1.0 Submitted By:

Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

August 23. 2004

#### 3.0 Device Name(s):

- 3.1 Proprietary Names UniCel® DxC 600 SYNCHRON® System UniCel® DxC 800 SYNCHRON® System
#### 3.2 Classification Name Discrete photometric chemistry analyzer for clinical use [862.2160]

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket # |
|-------------------------------------|----------------|------------------------|----------|
| UniCel® DxC 600<br>SYNCHRON® System | SYNCHRON LX®20 | Beckman Coulter, Inc.* | K965240, |
| UniCel® DxC 800<br>SYNCHRON® System | PRO Systems | | K011213 |

*Beckman Coulter, Inc., Brea, CA

#### 5.0 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.

#### 6.0 Intended 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).

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#### Comparison to Predicate(s): 7.0

| | Similarities | |
|--------------------------------------|----------------------------|-----------------------------------------------------------------------------------------------------|
| UniCel DxC<br>600 and 800<br>Systems | Intended Use | Same as Beckman Coulter<br>SYNCHRON LX PRO Systems |
| | Fundamental Technologies | |
| | Operational Environment | |
| | System Architecture | |
| | Optics/Reaction Subsystem | |
| | Sample Handling Subsystem | |
| | Chemistry Databases | |
| | Reagents and Consumables | |
| | Differences | |
| | Reagent Storage Capacity | LX: 30 cartridges<br>DxC 600/800: 59 cartridges |
| | Reagent Handling Subsystem | LX: Teflon coated high nickel steel probes<br>DxC 600/800: Extended length design |
| | Instrument Packaging | LX: 70 inch width<br>DxC 600: 62 inch width<br>DxC 600/800: New instrument skins |
| | Subsystem Designs | LX: Original<br>DxC 600/800: Modified Modular<br>Chemistry, Power, and Hydropneumatic<br>subsystems |
| | Electronics | LX: Original<br>DxC 600/800: New components to<br>address obsolescence issues |
| | Operator Interface | LX: Original<br>DxC 600/800: New key features |
| | Maintenance Procedures | LX: Chloride electrode resurfacing<br>DxC 600/800: Replaceable chloride<br>electrode tip |
| | Modular Chemistry Menu | LX: 11 chemistries<br>DxC 600: 6 chemistries |
| | Cartridge Chemistry Menu | LX: 83 chemistries<br>DxC 600/800: 86 chemistries |

#### Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision studies.

| Modular | N | Slope | Intercept | R | Cartridge | N | Slope | Intercept | R |
|---------|-----|-------|-----------|-------|--------------------------------|-----|-------|-----------|-------|
| Assays | | | | | Assays | | | | |
| 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 | | |

UniCel DxC 800 System vs. SYNCHRON LX20 PRO Serum Correlation Study

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| Chemistry | Control<br>Level | Mean | Within-run<br>SD | Within-run<br>%CV | Total<br>SD | Total<br>%CV |
|-----------|------------------|---------------|------------------|-------------------|-------------|--------------|
| NA | Low | 114.8 mmmol/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 |
| | 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 |

Unicel 800 System Estimated Serum Imprecision (N=80)

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.

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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two curved lines inside, resembling a stylized eye or a wave pattern. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked vertically, with "BECKMAN" on top and "COULTER" below. The text is in a bold, sans-serif font, and the entire logo is in black against a white background.

August 9, 2004

#### Software Development Statement of Compliance

The UniCell DxC 600/800 SYNCHRONR Systems Software Version 1.0 was developed in compliance with internal procedure 12-0101 Software Development: Description of the Software Development Process 9/16/2002. Each phase of this software process model, Planning, Requirements, Design, Implementation and Validation was completed, verified and documented. Documentation is stored in the Software Central Project File Section 4.

The specific application of Procedure 12-0101 to UniCelR DxC 600/800 SYNCHRONR Systems Software Version 1.0 is detailed in the Software Development Plan. The software was validated according to the Software Validation Plan. Discrepancies between expected performance and final outcomes were managed through the software change control process in compliance with section 4 of Procedure 12-0101. The software validation report is included as an addendum to the Software Validation Plan.

An independent review of the software development documentation and validation reports ensured that each phase was completed as planned and the resulting product meets the acceptance criteria.

Zulia noble

Gayle A. Nobbs Center Manager - Software Development Laboratory Systems and Routine Testing Platform Development

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized graphic of an abstract human figure, represented by three curved lines.

Public Health Service

NOV 1 2 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea, CA 92822-8000

k042291 Re: Trade/Device Name: UniCel® DxC 600 SYNCHRON® Clinical System UniCel® DxC 800 SYNCHRON® Clinical System Regulation Number: 21 CFR 862.1660 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM, CEK CEO, CFJ, CGA, CGX, CGZ, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JHB, JIY, JJE, JXM, LFP Dated: October 13, 2004 Received: October 15, 2004

Dear Ms. Tang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter natification. The FDA finding of substantial equivalence of your device to a legally prehand redicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, n "Jou citins on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Cornelius B. Lorks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

#### UniCel® DxC 600 SYNCHRON® Clinical System UniCel® DxC 800 SYNCHRON® Clinical System

Indications for Use:

The UniCel DxC SYNCHRON Systems are fully automated, computercontrolled 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).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042291

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510(k) Number (if known):

Device Name:

# SYNCHRON® Systems Total Protein (TP) Reagent

Indications for Use:

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.

X = Prescription Use_ (Part 21 CFR 801 Subpart D)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

AND/OR

Over-the-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alle & L's
Division Sign Off

Division Sign-Off

Office of In Vitro Diganos Device Evaluation and S

510(k) k042291

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510(k) Number (if known):

Device Name:

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

Indications for Use:

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.

Over-the-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device Evaluation and Safety

510/k) ..

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510(k) Number (if known):

Image /page/9/Picture/2 description: The image shows a solid black rectangle. The rectangle is wide and short. The background is white.

Device Name:

SYNCHRON® Systems Potassium (K) Assay

Indications for Use:

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when ISE Electrolyte Buner FougenvaHRON LX® Systems, UniCel® DxC 600/800 used in Conjunotion RQUA Systems AQUA CAL 1, 2 and 3, are intended for Systems and of Normono of Potassium concentration in human serum, plasma or urine.

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

AND/OR -Prescription Use __ × (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mette Salz?

Office of In Vitro Diagnostic Device Evaluation and Safety

51080 k042291

{10}------------------------------------------------

510(k) Number (if known):

**

Device Name:

### SYNCHRON® Systems Phosphorus (PHOSm) Reagent

Indications for Use:

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.

AND/OR -Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-the-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberts
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ision Sian-

Office of Iri Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

510/kj KOYa

{11}------------------------------------------------

510(k) Number (if known):

---

Device Name:

# SYNCHRON® Systems Lactate Dehydrogenase (LD) Reagent

Indications for Use:

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.

Over-the-Counter Use _ AND/OR AND/OR AND/OR X X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Allie to S
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Office of In Vitro Diagnostic Device Evaluation and Safety

53000 K0412291

{12}------------------------------------------------

510(k) Number (if known):

Image /page/12/Figure/2 description: The image is a solid black rectangle. The rectangle is oriented horizontally and takes up a significant portion of the frame. The black color is uniform throughout the shape, with no visible texture or variation in tone.

Device Name:

### SYNCHRON® Systems Glucose (GLUCm) Reagent

Indications for Use:

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.

Prescription Use AND/OR AND/OR AND/OR Over-the-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Office of In Vitro Diagnostic Device Evaluation and Safety

51000

{13}------------------------------------------------

510(k) Number (if known):

Image /page/13/Picture/2 description: The image shows a solid black shape against a white background. The shape is elongated and somewhat rectangular, with rounded edges. The black shape is opaque, and the white background is uniform. There are no other objects or details in the image.

Device Name:

SYNCHRON® Systems Creatinine (CREm) Reagent

Indications for Use:

CREm reagent, when used in conjunction with SYNCHRON LX® Systems, Chicin reagent, which desa 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 Orculinine incusarements and dialysis, and as a calculation basis for measuring other urine analytes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-the-Counter Use AND/OR AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Abuts
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Office of In Vitro Diagnostic Device Evaluation and Safen

5100 K

{14}------------------------------------------------

510(k) Number (if known):

Image /page/14/Picture/2 description: The image shows a thick black brush stroke. The stroke is horizontal and slightly curved. The stroke is thicker on the left side and thinner on the right side.

Device Name:

SYNCHRON® Systems Creatinine (CREA) Reagent

Indications for Use:

CREA reagent, when used in conjunction with UniCel® DxC 600/800 OnEA Tougent) Theorom® Systems Multi Calibrator, is intended for the Systems and Officent of Creatinine concentration in human serum, plasma or urine.

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

Over-the-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/ORD (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert Lutz
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Office of In Vitro Diagnostic Device Evaluation and Safery

510/k

{15}------------------------------------------------

510(k) Number (if known):

Image /page/15/Picture/2 description: The image is a solid black rectangle. There are no discernible features or details within the image. The rectangle appears to be uniformly filled with black color. There is nothing else visible in the image.

Device Name:

SYNCHRON® Systems Chloride (CL) Assay

Indications for Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/OR Over-the-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Ville Dragmostic Device Evaluation היונ היונ

Page 1 of 1

51011 KO4229

{16}------------------------------------------------

510(k) Number (if known)

Device Name:

# SYNCHRON® Systems Albumin (ALB) Reagent

Indications for Use:

ALB reagent, when used in conjunction with UniCel® DxC 600/800 AEB Teagent, "Inter" asso Systems Multi Calibrator, is intended for the Systems and overmination of Albumin concentration in human serum or plasma.

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _ (21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberto S.
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Office of In Vitro Diagnostic Device Evaluation and Safery

5108k. k042291

{17}------------------------------------------------

510(k) Number (if known):

---

Device Name:

SYNCHRON® Systems Albumin (ALBm) Reagent

Indications for Use:

ALBm reagent, when used in conjunction with SYNCHRON LX® Systems, ALBH Teagent, when assu in c SYNCHRON® Systems Protein Calibrator, Unicel® DXC 800 Uystems and determination of Albumin concentration in human serum or plasma.

Albumin measurements are used in the diagnosis and treatment of Albumn - modelies primarily involving the liver and/or kidneys.

AND/OR -Over-the-Counter Use _ Prescription Use __ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberto S
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Office of In Vitro Diagnostic Device Evaluation and Safety

5300k k042291

{18}------------------------------------------------

510(k) Number (if known):

Device Name:

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

Indications for Use:

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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR AND/OR AND/OR Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert
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Office of In Vitro Diagnostic Device Evaluation and Safety

51000

{19}------------------------------------------------

510(k) Number (if known):

Image /page/19/Picture/2 description: The image shows a solid black shape against a white background. The shape is elongated and somewhat irregular, with a slightly curved top edge and a more jagged bottom edge. The black shape dominates the image, taking up a significant portion of the frame. There are no other discernible features or elements present in the image.

Device Name:

# SYNCHRON® Systems Phenobarbital (PHE) Reagent

Indications for Use:

PHE reagent, when used in conjunction with SYNCHRON LX® Systems, PHE reagent, when used in conjunetion who Systems Drug Calibrator Unicel® DXC 600/000 Systems and of Phenobarbitation of Phenobarbital concentration in human serum or plasma.

Phenobarbital is indicated for the treatment of status epilepticus, febrile Phenobarbital is indicated for the croand mal and psychomotor), except
seizures and seizure disorders (grand mall and psychomotor, manitared for seizures and seizure disorders (grand than atherapy is monitored for suspected inadequate dose or toxicity.

Over-the-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert S
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

51000

{20}------------------------------------------------

510(k) Number (if known):

Device Name:

# SYNCHRON® Systems Carbon Dioxide (CO2) Assay

Indications for Use:

ISE Electrolyte Buffer reagent, ISE Electrolyte Reference reagent, CO2 ISE Electrolyte 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 quantilative STNCHHON® Systems AGOT vide concentration in human serum or plasma.

Carbon dioxide measurements are used in the diagnosis and treatment of Carbon dioxide measurements as acra associated with changes in body acid-base balance.

Over-the-Counter Use AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberts S
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Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

KO4229 510/0

{21}------------------------------------------------

510(k) Number (if known)

Device Name:

### SYNCHRON® Systems Calcium (CALC) Assay

Indications for Use:

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, 13E Electrolyte Dunct Tougent and Coast and Concerns, UniCel® DxC when used in oonjanon 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 Oalchum incusations a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Over-the-Counter Use X X AND/OR AND/OR AND/ORD Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert S
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Sofery

53906 k042291

{22}------------------------------------------------

510(k) Number (if known):

Image /page/22/Picture/2 description: The image shows a solid black rectangle. The rectangle is wide and short. The rectangle is centered on a white background.

Device Name:

# SYNCHRON® Systems Magnesium (MG) Reagent

Indications for Use:

MG reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems Multi Calibrator, is intended for DXC 600/000 Systems and of Magnesium concentration in human serum, plasma or urine.

Determination of magnesium is useful in assessing several diseases and Determination of magnesium is associated with uremia, dehydration, diabetic conditions. "Thgh magnesian" is "doosenated" intake of magnesium, such acroosis, Addison's diocuse, and the the marting induced by pregnancy). Low magnesium is associated with malabsorption syndrome, acute pancreatitis, hypoparathyroidism, chronic alcoholism and delirium tremens, chronic hypoparathyroldish, onromo-acontention, and protracted l.V. feeding.

Over-the-Counter Use _ AND/OR AND/OR AND/OR AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD A Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert S
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Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

5100

{23}------------------------------------------------

510(k) Number (if known):

Device Name:

### SYNCHRON® Systems Sodium (NA) Assay

Indications for Use:

ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when ISE Electronyto Baner FougHRON LX® Systems, UniCel® DxC 600/800 ased in Johnstich The Systems AQUA CAL 1, 2 and 3, are intended for Systems and of Henrination of Sodium concentration in human serum, plasma or urine.

Sodium measurements are used in the diagnosis and treatment of Souran modeles insipidus, adrenal hypertension, Addison's alidoster onliners, "than inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Over-the-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

<Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albetz S

---

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5309: k0422

{24}------------------------------------------------

510(k) Number (if known):

Image /page/24/Picture/2 description: The image shows a silhouette of two train cars. The train cars are connected to each other. The train cars are dark and the background is white.

Device Name:

# SYNCHRON® Systems Uric Acid (URIC) Reagent

Indications for Use:

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 One acrd including increabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Over-the-Counter Use _ AND/OR AND/OR AND/ORD Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mate Salz
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Office at in Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

6092291

{25}------------------------------------------------

510(k) Number (if known):

Image /page/25/Picture/2 description: The image is a black rectangle. It is a simple, solid shape with no discernible features or details. The rectangle is uniformly black, with no variations in color or texture. There is nothing else visible in the image.

Device Name:

### SYNCHRON® Systems Iron (FE) Reagent

Indications for Use:

FE reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® FE feagent, when used in oonjanenen was 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 Anterations in from and tellar and release mechanisms. Such changes are iroli intake, absorphon, oterage, dysfunctions including anemias, nephrosis, mulcative of a Wide Yango of and total iron binding capacity measurements cirriosis and ficpatitive diagnosis because they are interrelated. Tietz has are important for donnary of these relationships and the patterns of iron/total iron binding capacity associated with various disease states.

Over-the-Counter Use __ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

KO42291 5101

{26}------------------------------------------------

510(k) Number (if known):

-

Device Name:

SYNCHRON® Systems Benzodiazepine (BENZ) Reagent

Indications for Use:

BENZ reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC
enting States of the Concess of Archives of Abuse, Tosting, (DAT), Urin BENZ Feagent, when used in Conjunton than of Pennsodiaroping in human 600/800 Systems, and STNCTHON® Oystems Drago 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 BENZ assay provides a rapid sereching processionalytical result; a positive, positive, positive, positive, positive, positive, positive, positive, positive, positive, pos the analyte in urine. This lest provides only a provinces generally accepted nonresult by this assay Should Bo January Boging (TCC), gas chromatography (TCC), 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 Clinical consideration when preliminary positive results are used.

Benzodiazepines are a class of central nervous system depressants that are used as Benzodiazepines are a Class of Central nervous of Stonings include chlordiazepoxide, Sedatives and Tryphotics. The Benzonials of Measurements of benzodiazepines diazepani, Oxazepan, hardzepain, and in the diagnosis and treatment of benzodiazepine on the STNCHHON® Systems are assessme of benzodiazepines to ensure appropriate therapy.

× Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _ (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Allen & G
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DIVISION SIO2

Page 1 of 1

Office of In Vir. Leaguesti. Device Evaluation and Salar

53095 k042291

{27}------------------------------------------------

510(k) Number (if known):

**10.1002/adma.201806631**

Device Name:

SYNCHRON® Systems Urea Nitrogen (BUNm or UREAm) Reagent

Indications for Use:

BUNm or UREAm reagent, when used in conjunction with SYNCHRON LX®
CALL CAL BUNM or UREAM reagent, when assum systems and SYNCHRON® Systems AQUA CAL
Systems, UniCel® DxC 800 Systems and SYNCHRON® Systems AQUA CAL Systems, Unicel® DXO 600 Oystems and C letermination of Urea Nitrogen or T, Z and S, Is Intended for the quarnitulity student or urine. The system can be Orea concentration in haman octains, present 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 Orca "hitrogo-netain renal and metabolic diseases.

Over-the-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR A (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert Sutz
Division Sign-off

Office of In this Diagnostic Device Evaluation and Safety

Page 1 of 1

KO4229 110%