(80 days)
No
The summary describes a standard clinical chemistry analyzer with automated features for sample and reagent handling, but no mention of AI or ML for data analysis or interpretation.
No
The device is described as a clinical chemistry analyzer, which is used for in vitro determination of substances in biological fluids, not for direct therapeutic treatment of patients.
Yes
The device is a clinical chemistry analyzer intended for "in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids," which leads to a diagnosis.
No
The device description clearly outlines multiple hardware components including sample and reagent handling systems, bar code readers, modular chemistry sections, cartridge chemistry systems, and a reagent storage compartment. This indicates it is a physical instrument, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the systems are "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". The phrase "in vitro determination" is a key indicator of an IVD.
- Device Description: The description details a clinical chemistry analyzer that operates with reagents, calibrators, and controls to analyze biological fluids. This aligns with the typical function of an IVD device used in a laboratory setting.
- Performance Studies: The summary of performance studies mentions "method comparison and imprecision studies" and "Qualitative Drug Assay (urine): Agreement, +, -, %", which are standard types of studies performed to validate the performance of IVD devices.
- Predicate Device(s): The listed predicate devices are "SYNCHRON LX20 PRO Systems", which are also clinical chemistry analyzers and likely IVDs themselves. This further supports the classification of the UniCel DxC SYNCHRON Systems as an IVD.
N/A
Intended Use / 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).
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.
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.
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 disease, 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 disease, 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.
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 diseases primarily involving the liver and/or kidneys.
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 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, 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 petit mal. Its therapy is monitored for suspected inadequate dose or toxicity.
ISE Electrolyte Buffer reagent, ISE Electrolyte Reference reagent, CO2 Electrode 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 acid-base imbalance 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 the excess intake of magnesium, such as antacids, or magnesium induced by pregnancy). Low magnesium is associated with malabsorption syndrome, acute pancreatitis, hypoparathyroidism, chronic alcoholism and delirium tremens, chronic glomerulonephritis, protracted lactation, 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 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/TIBC 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, cellular and release mechanisms. Such changes are indicative of a wide range of dysfunctions including anemias, nephrosis, cirrhosis and hepatitis. Iron and total iron binding capacity measurements are important for definitive diagnosis because they are interrelated. Tietz has provided 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 and Controls, 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 Benzodiazepine in urine. This test provides only a preliminary analytical result; a positive, presumptive result by this assay should be confirmed by a generally accepted non-instrumental analytical 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 Benzodiazepines of clinical importance include chlordiazepoxide, diazepam, oxazepam, lorazepam, and flurazepam. Measurements of benzodiazepines in the SYNCHRON® Systems are assessed to ensure appropriate therapy.
BUNm or UREAm 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 Urea Nitrogen or Urea concentration in human serum, plasma or urine. The system can be configured to report results 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 renal and metabolic diseases.
Product codes
CEM, CEK, CEO, CFJ, CGA, CGX, CGZ, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JHB, JIY, JJE, JXM, LFP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision studies.
UniCel DxC 800 System vs. SYNCHRON LX20 PRO Serum Correlation Study
| 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 | Qualitative Drug Assay (urine) | ||||
| CREm | 137 | 1.037 | -0.01 | 1.000 | BENZ | + | - | Agreement | |
| GLUm | 199 | 1.006 | -0.11 | 1.000 | + | 43 | 0 | 100% | |
| PHOSm | 198 | 1.004 | 0.02 | 0.999 | - | 0 | 57 | ||
| TPm | 191 | 0.992 | 0.08 | 0.996 |
Unicel 800 System Estimated Serum Imprecision (N=80)
| Chemistry | Control Level | Mean | Within-run SD | Within-run %CV | Total SD | Total %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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1600 Potassium test system.
(a)
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.(b)
Classification. Class II.
0
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: (714) 961-3777 FAX: (714) 961-4123
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 | |||
| SYNCHRON® System | SYNCHRON LX®20 | Beckman Coulter, Inc.* | K965240, |
| UniCel® DxC 800 | |||
| 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).
1
Comparison to Predicate(s): 7.0
| Similarities | ||
|---|---|---|
| UniCel DxC | ||
| 600 and 800 | ||
| Systems | Intended Use | Same as Beckman Coulter |
| 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 | |
| DxC 600/800: 59 cartridges | ||
| Reagent Handling Subsystem | LX: Teflon coated high nickel steel probes | |
| DxC 600/800: Extended length design | ||
| Instrument Packaging | LX: 70 inch width | |
| DxC 600: 62 inch width | ||
| DxC 600/800: New instrument skins | ||
| Subsystem Designs | LX: Original | |
| DxC 600/800: Modified Modular | ||
| Chemistry, Power, and Hydropneumatic | ||
| subsystems | ||
| Electronics | LX: Original | |
| DxC 600/800: New components to | ||
| address obsolescence issues | ||
| Operator Interface | LX: Original | |
| DxC 600/800: New key features | ||
| Maintenance Procedures | LX: Chloride electrode resurfacing | |
| DxC 600/800: Replaceable chloride | ||
| electrode tip | ||
| Modular Chemistry Menu | LX: 11 chemistries | |
| DxC 600: 6 chemistries | ||
| Cartridge Chemistry Menu | LX: 83 chemistries | |
| 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
2
| Chemistry | Control
Level | Mean | Within-run
SD | Within-run
%CV | Total
SD | Total
%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.
3
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
4
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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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
6
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)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042291
7
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)
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510(k) K042291
8
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)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Device Evaluation and Safety
510/k) ..
9
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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alberts
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ision Sian-
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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)
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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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51000
13
510(k) Number (if known):
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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)
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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.
Division Sign-off
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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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
Division Sign Off
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
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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)
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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
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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)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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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)