BAYER ADVIA 1650 CHEMISTRY SYSTEM
Device Facts
| Record ID | K990346 |
|---|---|
| Device Name | BAYER ADVIA 1650 CHEMISTRY SYSTEM |
| Applicant | Bayer Corp. |
| Product Code | JGS · Clinical Chemistry |
| Decision Date | May 21, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1665 |
| Device Class | Class 2 |
Intended Use
The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes. The ADVIA 1650 is intended for use in conjunction with certain reagents to measure a variety of analytes contained in human fluids.
Device Story
Automated clinical chemistry analyzer; processes human serum, plasma, or urine samples. Performs photometric and immuno-turbidimetric assays; uses ion-selective electrodes for sodium and chloride measurements. Operates in random access, batch, or STAT modes; throughput up to 1200 photometric tests/hour and 450 electrolyte tests/hour. Used in clinical laboratory settings by trained technicians/pathologists. Provides quantitative analyte concentrations; results used by clinicians for diagnosis and monitoring of metabolic, renal, hepatic, and cardiac conditions. System automates sample handling and reagent mixing; provides rapid, high-volume testing to support clinical decision-making and patient management.
Clinical Evidence
Bench testing only. Performance validated through comparative studies against predicate devices using human serum, plasma, and urine samples. Metrics include imprecision (Total CV% typically <5%), correlation (R-values generally >0.95), and analytical range verification. Interference studies evaluated effects of bilirubin, hemoglobin, and lipids on analyte measurements. No clinical prospective/retrospective trials on patient outcomes were required for this analytical performance validation.
Technological Characteristics
Automated clinical chemistry analyzer; photometric and immuno-turbidimetric detection; potentiometric ion-selective electrodes for electrolytes. Throughput: 1200 photometric tests/hr, 450 electrolyte tests/hr. Sample types: serum, plasma, urine. Random access, batch, and STAT processing modes. System utilizes specific reagent kits for each analyte. Connectivity: automated laboratory system.
Indications for Use
Indicated for use by clinical laboratory professionals to measure various analytes in human serum, plasma, or urine for the diagnosis and monitoring of diseases including chronic inflammatory, collagen, liver, kidney, bone, and hepatobiliary disorders, myocardial infarction, pancreatitis, diabetes mellitus, hypoglycemia, coronary artery disease, gout, and electrolyte imbalances.
Regulatory Classification
Identification
A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Predicate Devices
- Technicon DAX (T01-1337-B3, T01-1814, T01-1750, T01-1476, T152-17, T01-1882, T01-1927, T01-1565, T11-1832, T01-1492-56, T01-1303, T01-2878, T01-3161, T01-1963, T01-2577, T01-1823)
- Beckman Synchron CX® (442775, 443794, 443355, 465145, 443325, 443315, 450124, 472095, 442785, 443350)
- Beckman Synchron CX7® (442775, 450214, 472095, 443794)
- DuPont Dimension (DF23A)
- Hitachi® (1040847, 1109774, 1447521, 1273582)
- Boehringer Mannheim on RA-XT (543004)
- Cobas Fara® (44031, 828475)
- Sigma RA1000 (565-1, 565-3)
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- K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2, 2014
- K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 · Vital Diagnostics (Manufacturing) Ptyltd · Dec 15, 2010
- K965240 — SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L · Beckman Instruments, Inc. · Mar 10, 1997
Submission Summary (Full Text)
{0}------------------------------------------------
1990346
# MAY 2 1
#### SUMMARY OF SAFETY AND EFFECTIVENESS
This section contains performance comparisons for 21 clinical methods. For each method, Advia 1650 was compared to a similar device (or devices) that was granted clearance of substantial equivalence. The table below lists the predicate devices and part numbers.
| | ADVIA 1650<br>Reagent Part # | Specimen<br>Type | Predicate Device<br>Name | Predicate Device<br>Reagent Part # |
|----------------------------|------------------------------|------------------|------------------------------|------------------------------------|
| Method | | | | |
| Albumin | B01-4121-01 | Serum | Technicon DAX® | T01-1337-B3 |
| Alkaline Phosphatase - AMP | B01-4134-01 | Serum | Technicon DAX® | T01-1814 |
| Amylase | B01-4136-01 | Serum | Beckman Synchron CX® | 442775 |
| | | Urine | Beckman Synchron CX7® | 442775 |
| Aspartate Aminotransferase | B01-4139-01 | Serum | Technicon DAX® | T01-1750 |
| | | Serum | Technicon DAX® | T01-1476 |
| Calcium | B01-4145-01 | Urine | DuPont Dimension | DF23A |
| | | Urine | Beckman Synchron CX3® | 450214, 472095 |
| | | Serum | Technicon DAX® | T152-17 |
| Chloride | B01-4171-01 | Serum | Beckman Synchron CX7® | 450214, 472095 |
| | | Urine | Beckman Synchron CX3/7® | 450214, 472095 |
| Creatine Kinase | B01-4137-01 | Serum | Technicon DAX® | T01-1882 |
| | | Serum | Beckman Synchron CX7® | 443794 |
| Creatinine, Jaffe | B01-4126-01 | Serum | Technicon DAX® | T01-1927 |
| | | Urine | Hitachi® | 1040847 |
| Creatinine, Enzymatic | B01-4127-01 | Serum | Technicon DAX® | T01-1927 |
| Bilirubin, Direct | B01-4123-01 | Serum | Technicon DAX® | T01-1565 |
| | | Serum | Hitachi® | 1109774 |
| Glucose - Hexokinase | B01-4129-01 | Serum | Technicon DAX® | T11-1832 |
| | | Urine | Hitachi® | 1447521 |
| Glucose - Oxidase | B01-4130-01 | Serum | Technicon DAX® | T01-1492-56 |
| | | Urine | Beckman Synchron CX3/7® | 443355 |
| HDL Cholesterol | B01-4125-01 | Serum | Boehringer Mannheim on RA-XT | 543004 |
| | | Serum | Technicon DAX® | T01-1303 |
| Inorganic Phosphorus | B01-4144-01 | Serum | Beckman Synchron CX7® | 465145 |
| | | Urine | Cobas Fara® | 44031 |
| Iron | B01-4147-01 | Serum | Technicon DAX® | 150-26E, 150-26F |
| | | Serum | Sigma RA1000 | 565-1, 565-3 |
| Magnesium | B01-4148-01 | Serum | Technicon DAX® | T01-2878 |
| | | Serum/Urine | Hitachi® | 1273582 |
| Potassium | B01-4171-01 | Serum | Technicon DAX® | T01-3161 |
| | | Urine | Beckman Synchron CX3® | 443325, 443315 |
| Sodium | B01-4171-01 | Serum | Technicon DAX® | T01-3161 |
| | | Urine | Beckman Synchron CX3® | 450124, 472095 |
| Bilirubin. Total | B01-4122-01 | Serum | Technicon DAX® | T01-1963 |
| | | Serum | Technicon DAX® | T01-2577 |
| Uric Acid | B01-4131-01 | Urine | Beckman Synchron CX7® | 442785 |
| | | Urine | Cobas Fara® | 828475 |
| Urea Nitrogen | B01-4132-01 | Serum | Technicon DAX® | T01-1823 |
| | | Urine | Beckman Synchron CX3/7® | 443350 |
Gabriel J. Muraca, Jr. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Ave. Tarrytown, NY 10591-5097
Date
{1}------------------------------------------------
## Albumin Method for the Bayer ADVIA 1650 (g/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure albumin concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of chronic inflammatory diseases, collagen diseases, and liver and kidney disorders.
#### Imprecision
Advia 1650
| Specimen<br>type | Level | Total<br>CV (%) |
|------------------|-------|-----------------|
| Serum | 2.1 | 2.4 |
| Serum | 3.4 | 1.8 |
| Technicon DAX | |
|---------------|--------------|
| Level | Total CV (%) |
| 2.2 | 3.3 |
| 3.4 | 2.5 |
| 4.8 | 2.0 |
# Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum: MSK | DAX | 156 | Y=0.86X+0.55 | 0.19 | 0.969 | 1.6-5.3 |
| Plasma(y), Serum(x) | ADVIA 1650 | 58 | Y=0.96X+0.29 | 0.05 | 0.978 | 4.5-5.7 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-----|
| Bilirubin | 25 | 4.2 | 0.0 | 0.0 |
| Hemoglobin | 500 | 3.7 | 0.3 | 8.1 |
| Lipids (Trig) | 500 | 4.1 | 0.3 | 7.3 |
## Analytical Range
1 to 6 g/dL
## Expected Values
3.4 - 4.8 g/dL
{2}------------------------------------------------
# 2. ALP-AMP
## SUMMARY OF SAFETY AND EFFECTIVENESS
#### Alkaline Phosphatase AMP Method for the Bayer ADVIA 1650 (U/L)
#### Intended Use
This in vitro diagnostic assay is intended to measure alkaline phosphatase activity in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used mainly in the diagnosis and treatment of hepatobiliary and bone disease.
#### Imprecision
Advia 1650
| Technicon DAX | |
|------------------------------------------------------------|--|
| Address to a status and and and and and and the collection | |
| | |
| Specimen<br>type | Level | Total<br>CV (%) |
|------------------|-------|-----------------|
| Serum | 69 | 3.9 |
| Serum | 130 | 3.1 |
| 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--|--|--|
| | Total | | | |
| Level | CV (%) | | | |
| 79 | 2.5 | | | |
| ાં ૪૯ | 2.2 | | | |
| 571 | 1.9 | | | |
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|----|---------------------|------|-------|--------------|
| Serum: TRYTN | DAX | 43 | $Y=1.03X-2.1$ | 3.12 | 0.999 | 22-346 |
| Plasma(y), Serum(x) | ADVIA 1650 | 54 | $Y=1.06X+1.42$ | 5.37 | 0.972 | 33-149 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 25 | 69.3 | 1.7 | 2.5 |
| Hemoglobin | 500 | 100.3 | -5.6 | -5.6 |
| Lipids (Trig) | 500 | 71.0 | 1.3 | 1.8 |
#### Analytical Range
0-1100 U/L
#### Expected Values
25 to 100 U/L
{3}------------------------------------------------
# 3. AMY
## SUMMARY OF SAFETY AND EFFECTIVENESS
## Amylase Method for the Bayer ADVIA 1650 (U/L)
#### Intended Use
This in vitro diagnostic assay is intended to measure amylase activity in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used primarily in the diagnosis and monitoring of acute pancreatitis (inflammation of the pancreas).
### Imprecision
Advia 1650
| Specimen<br>type | Level | Total<br>CV (%) |
|------------------|-------|-----------------|
| Serum | 60 | 1.2 |
| Serum | 242 | 1.3 |
| Serum | 322 | 1.2 |
| Urine | 792 | 7.2 |
#### Beckman CX7=Serum, Urine
Total
| | Level | CV (%) | |
|--|-------|--------|--|
| | 85.7 | 5.3 | |
| | 240 | 5.3 | |
| | 320 | 5.3 | |
| | 800 | 5.3 | |
### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum: MSK | CX4 | 102 | Y=0.72X+1.91 | 3.5 | 0.998 | 6-549 |
| Plasma(y), Serum(x) | ADVIA 1650 | 53 | Y=1.08X+1.46 | 3.9 | 0.985 | 18-110 |
| Urine: MSK | CX7 | 82 | Y=0.75X+0.74 | 13.4 | 0.993 | 2-667 |
Bias expected in serum and urine correlation when run against Beckman instrument due to the different substrates used in each instrument.
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 25 | 68.3 | -1.6 | -2.3 |
| Hemoglobin | 500 | 174.3 | -2.3 | -1.3 |
| Lipids (Trig) | 500 | 66.3 | 1.4 | 2.1 |
## Analytical Range
| Serum/Plasma: | 0 to 1500 U/L (from reagent stability study) |
|---------------|----------------------------------------------|
| Urine | 0 to 1500 U/L (from reagent stability study) |
| Serum: | 20-104 U/L |
|--------|------------------|
| Urine: | 1-17 U/h (timed) |
{4}------------------------------------------------
## 4. AST
## SUMMARY OF SAFETY AND EFFECTIVENESS
## Aspartate Aminotransferase Method for the Bayer ADVIA 1650 (U/L)
#### Intended Use
This in vitro diagnostic assay is intended to measure aspartate aminotransferase activity in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used mainly to determine the progress and prognosis of patients with myocardial infarction and the diagnosis and monitoring of liver disease.
#### Imprecision
Advia 1650
| Specimen<br>type | Level | Total<br>CV (%) |
|------------------|-------|-----------------|
| Serum | 32 | 3.9 |
| Serum | 146 | 1.7 |
| Technicon DAX | |
|---------------|--------------|
| Level | Total CV (%) |
| 55 | 5.4 |
| 203 | 2.5 |
| 471 | 3.3 |
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison<br>System (X) | N | Regression<br>Equation | Syx | R | Sample<br>Range |
|----------------------|--------------------------|-----|------------------------|------|-------|-----------------|
| Serum: BERLIN | DAX | 111 | Y=0.99X-6.3 | 3.63 | 0.999 | 9.8-607.2 |
| Plasma(y), Serum (x) | ADVIA 1650 | 54 | Y=1.00X-2.9 | 3.01 | 0.954 | 16-85 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-------|
| Bilirubin | 25 | 31.0 | -3.7 | -11.9 |
| Hemoglobin | 500 | 74.7 | 18.6 | 24.9 |
| Lipids (Trig) | 500 | 29.7 | -4.4 | -14.8 |
Hemolyzed samples should not be used due to effect by RBC.
## Analytical Range
0-1000 U/L (from reagent stability study)
#### Expected Values
M: 15 - 40 U/L. F: 13 - 35 U/L.
{5}------------------------------------------------
## Calcium Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure calcium concentration in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
#### Imprecision
| Advia 1650 | | | Technicon DAX = Serum | | Dupont Dimension=Urine | |
|------------------|-------|-----------------|-----------------------|--------------|------------------------|--------------------|
| Specimen<br>type | Level | Total<br>CV (%) | Level | Total CV (%) | Level | Between Day CV (%) |
| Serum | 5.9 | 2.7 | 7.7 | 2.3 | 8.8 | 0.6 |
| Serum | 10.8 | 2.9 | 10.3 | 1.6 | 14.5 | 2.6 |
| Serum | 12.0 | 3.5 | 12.5 | 1.5 | | |
| Urine | 6.2 | 2.4 | | | | |
| Urine | 21.2 | 2.5 | | | | |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|-------|-------|--------------|
| Serum - ARI | DAX | 100 | Y=0.99X + 0.13 | 0.223 | 0.971 | 7.0 - 13.2 |
| Plasma(y), Serum(x) | ADVIA 1650 | 59 | Y=0.94X + 0.82 | 0.094 | 0.963 | 9.0 - 10.8 |
| Urine - ARI | Dimension | 32 | Y=1.2X - 2.25 | 0.165 | 0.999 | 3.7 - 14.5 |
| Urine - MSK | CX3 | 63 | Y=1.07X + 0.03 | 0.558 | 0.988 | 2.1 - 14.7 |
## Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-----|
| | | | conc. | % |
| Bilirubin | 25 | 8.0 | 0.0 | 0.0 |
| Hemoglobin | 500 | 8.8 | 0.2 | 2.3 |
| Lipids (Trig) | 500 | 8.0 | 0.3 | 3.8 |
# Analytical Range
| Serum/Plasma: | 1 to 15 mg/dL |
|---------------|---------------|
| Urine: | 1 to 15 mg/dL |
| Serum/Plasma: | 8.6 to 10.0 mg/dL |
|---------------|-------------------|
| Urine: | 100 to 300 mg/d |
{6}------------------------------------------------
## Chloride Method for the Bayer ADVIA 1650 (mmol/L)
#### Intended Use
This in vitro diagnostic assay is intended to measure chloride concentration in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used for their inferential value and are helpful in diagnosing disorders of acid-base and water balance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting, which can lower the serum chloride level.
#### Imprecision
| Advia | 1650 |
|-------|------|
| | |
| Specimen<br>type | Level | Total<br>CV (%) |
|-------------------------|--------------|-----------------|
| Serum | 88.4 | 1.6 |
| Serum | 111.8 | 2.0 |
| Urine | 86.8 | 1.7 |
| Urine | 290.4 | 3.8 |
| Beckman CX7=Serum,Urine | | |
| Level | Total CV (%) | |
| 80 | 1.3 | |
| 118.8 | 1.1 | |
| 89.4 | 3.4 | |
| 250 | 1.5 | |
Technicon DAX=Serum
| Level | Total CV (%) |
|-------|--------------|
| 97 | 1.5 |
| 112 | 1.8 |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum - ARI | CX7 | 115 | $Y=1.00X + 1.3$ | 1.6 | 0.985 | 76 - 128 |
| Serum - MSK | DAX | 154 | $Y=0.98X + 3.3$ | 2.2 | 0.914 | 86 - 122 |
| Plasma(y), Serum(x) | ADVIA 1650 | 69 | $Y=0.86X+15.9$ | 1.20 | 0.944 | 102-118 |
| Urine - ARI | CX7 | 76 | $Y=1.05X - 0.9$ | 4.9 | 0.996 | 29 - 280 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-----|
| Bilirubin | 25 | 85.0 | 0.4 | 0.5 |
| Hemoglobin | 500 | 82.7 | 0.0 | 0.0 |
| Lipids (Trig) | 500 | 83.3 | 2.4 | 2.9 |
#### Analytical Range
| Serum/Plasma: | 15 to 200 mmol/L |
|---------------|------------------|
| Urine: | 15 to 400 mmol/L |
| Serum: | 98 - 107 mEq/L |
|--------|------------------|
| Urine: | 110 – 250 mmol/d |
{7}------------------------------------------------
# 7. СК
## SUMMARY OF SAFETY AND EFFECTIVENESS
## Creatine Phosphokinase Method for the Bayer ADVIA 1650 (U/L)
#### Intended Use
This in vitro diagnostic assay is intended to measure creatine kinase activity in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used mainly in the diagnosis and treatment of myocardial infarction and muscle diseases such as Duchenne progressive muscular dystrophy.
#### Imprecision
| Advia 1650 | Technicon DAX | Beckman CX7 | | | | |
|---------------|---------------|--------------|-------------|--------------|-------|--------------|
| Specimen type | Level | Total CV (%) | Level (U/L) | Total CV (%) | Level | Total CV (%) |
| Serum | 139 | 2.7 | 177 | 4.8 | 144 | 5.3 |
| Serum | 449 | 3.0 | 590 | 2.5 | 460 | 5.3 |
### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum: MSK | DAX | 151 | Y=0.97X+1.19 | 3.3 | 0.999 | 6-700 |
| Serum: ARI | CX7 | 145 | Y=1.01X+0.8 | 6.50 | 1.000 | 13-1187 |
| Plasma(y), Serum(x) | ADVIA 1650 | 56 | Y=1.05X-9.02 | 7.88 | 0.997 | 41-507 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 25 | 70.0 | 2.7 | 3.9 |
| Hemoglobin | 500 | 98.0 | 24.3 | 24.8 |
| Lipids (Trig) | 500 | 65.0 | 6.0 | 9.2 |
## Analytical Range
0-1300 U/L
#### Expected Values
M: 38 - 174 U/L. F: 26 - 140 U/L.
{8}------------------------------------------------
# 8. CREAT
## SUMMARY OF SAFETY AND EFFECTIVENESS
#### Creatinine Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure creatinine concentration in human serum, plasma and urine on the ADVIA® 1650 system. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
## Imprecision
| Advia 1650 | | | | Technicon DAX=Serum |
|------------|-------|-------|-------|---------------------|
| Specimen | | Total | | Total |
| type | Level | CV % | Level | CV (%) |
| Serum | 1.8 | 3.8 | 1.8 | 4.3 |
| Serum | 8.4 | 3.7 | 5.0 | 4.5 |
| Urine | 84.6 | 2.9 | 10.5 | 3.7 |
| Urine | 209.3 | 4.0 | | |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum: BERLIN | DAX | 112 | Y=0.92X+0.06 | 0.15 | 0.995 | 0.33-8.3 |
| Plasma(y), Serum(x) | ADVIA 1650 | 58 | Y=1.02X+0.04 | 0.02 | 0.992 | 0.9-1.4 |
| Urine: BERLIN | HITACHI | 86 | Y=1.13X+0.40 | 2.61 | 0.995 | 21-160 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect<br>conc. | Effect<br>% |
|--------------------------|--------------------------------------|------------------|-----------------|-------------|
| Bilirubin | 25 | 1.0 | -0.8 | -80.0 |
| Hemoglobin | 500 | 7.3 | 0.1 | 1.4 |
| Lipids (Trig) | 500 | 1.0 | 0.0 | 4.5 |
#### Analytical Range
Serum/Plasma: 0 - 25 mg/dL Urine: 17 - 160 mg/dL
| Serum: | M: 0.9 - 1.3 mg/dL |
|--------|---------------------|
| | F: 0.6 - 1.1 mg/dL. |
| Urine: | M: 14 - 26 |
| | F: 11 - 20 |
{9}------------------------------------------------
# 9. CREAT-E
## SUMMARY OF SAFETY AND EFFECTIVENESS
## Creatinine-Enzymatic Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure creatinine concentration in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
#### Imprecision
Advia 1650
| Technicon DAX | |
|---------------|--|
| | |
| Specimen<br>type | Level | Total CV (%) | Level | Total CV (%) |
|------------------|-------|--------------|-------|--------------|
| Serum | 0.9 | 6.4 | 1.8 | 4.3 |
| Serum | 6.1 | 2.3 | 5.0 | 4.5 |
| Serum | 9.5 | 2.0 | 10.5 | 3.7 |
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison<br>System (X) | N | Regression<br>Equation | Syx | R | Sample<br>Range |
|---------------------|--------------------------|-----|------------------------|------|-------|-----------------|
| Serum: MSK | DAX | 155 | $Y=0.99X-0.06$ | 0.16 | 0.955 | 0.3-3.9 |
| Plasma(y), Serum(x) | ADVIA 1650 | 57 | $Y=0.96X+0.16$ | 0.07 | 0.925 | 0.7-1.4 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|--------|
| Bilirubin | 25 | 0.7 | -0.2 | -28.6 |
| Hemoglobin | 500 | 7.8 | -0.1 | -1.3 |
| Lipids (Trig) | 500 | 0.7 | -1.2 | -171.4 |
### Analytical Range
0-30 mg/dL
#### Expected Values
M: 0.9 - 1.3 mg/dL, F: 0.6 - 1.1 mg/dL.
{10}------------------------------------------------
## 10. DBILI
## SUMMARY OF SAFETY AND EFFECTIVENESS
#### Direct Bilirubin Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure direct bilirubin concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis of common bile duct obstruction caused by a stone and of patients with Dubin-Johnson syndrome.
> Total CV (%)
> > ** 5.7 2.3
#### Imprecision
Advia 1650
| Advia 1650 | | | Technicon DAX | |
|---------------|-------|--------------|---------------|--|
| Specimen type | Level | Total CV (%) | Level | |
| Serum | 0.3 | 4.6 | 0.2 | |
| Serum | 1.6 | 4.4 | 1.5 | |
| | | | 4.0 | |
** Value not significant when level approaches zero.
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison<br>System (X) | N | Regression Equation | Syx | R | Sample Range |
|-----------------------|--------------------------|-----|---------------------|------|-------|--------------|
| Serum - TRYTN | DAX | 145 | $Y=1.34X - 0.10$ | 0.18 | 0.994 | 0 - 6.12 |
| Serum - BERLIN | HITACHI | 92 | $Y=1.07X + 0.06$ | 0.14 | 0.997 | 0.02 - 9.26 |
| Plasma (y), Serum (x) | ADVIA 1650 | 49 | $Y=0.98X-0.01$ | 0.02 | 0.988 | 0.1 - 0.6 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|---|
| Hemoglobin | 200 | 0.3 | -0.6 | . |
| Hemoglobin | 500 | 0.3 | -1.5 | . |
| Lipids (Trig) | 500 | 0.2 | -0.5 | . |
#### Analytical Range
0 - 10 mg/dL (from reagent stability study)
### Expected Values
<0.2 mg/dL
{11}------------------------------------------------
# 11. GLU-HEX
## SUMMARY OF SAFETY AND EFFECTIVENESS
### Glucose-Hexokinase Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure glucose in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose.
#### Imprecision
| Advia 1650 | | | Technicon DAX=Serum | |
|---------------|-------|----------|---------------------|--------------|
| Specimen type | Level | Total CV | Level | Total CV (%) |
| Serum | 77 | 2.4 | 71 | 4.2 |
| Serum | 279 | 3.3 | 262 | 2.1 |
| Urine | 42 | 3.5 | 367 | 1.7 |
| Urine | 285 | 3.6 | | |
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|----------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum - BERLIN | DAX | 109 | Y= 1.05X - 2.8 | 5.42 | 0.995 | 19 - 262 |
| Urine - BERLIN | HITACHI | 81 | Y= 0.99X - 11.2 | 9.88 | 0.997 | 4 - 476 |
| Plasma (y) Serum (x) | ADVIA 1650 | 60 | Y= 1.03X - 6.6 | 9.00 | 0.986 | 36 - 384 |
#### Interfering Substances
| Analyte | Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect<br>conc. | Effect<br>% |
|---------|--------------------------|--------------------------------------|------------------|-----------------|-------------|
| GLU-HEX | Bilirubin | 10 | 95.5 | -8.2 | -8.6 |
| GLU-HEX | Bilirubin | 25 | 95.5 | -24.4 | -25.5 |
| GLU-HEX | Hemoglobin | 200 | 95.9 | -22.2 | -23.1 |
| GLU-HEX | Hemoglobin | 500 | 95.9 | -59.9 | -62.5 |
| GLU-HEX | Lipids (Trig) | 900 | 189.0 | 2.2 | 1.2 |
#### Analytical Range
| Serum/Plasma: | 0 - 700 mg/dL |
|---------------|---------------|
| Urine: | 0 - 700 mg/dL |
| Serum/Plasma | 74 – 106 mg/dL |
|--------------|----------------|
| Urine: | <0.5 g/day |
{12}------------------------------------------------
# 12. GLU-OX
#### SUMMARY OF SAFETY AND EFFECTIVENESS
## Glucose-Oxidase Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure glucose in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
#### Imprecision
| Advia | 1650 |
|-------|------|
|-------|------|
| Advia 1650 | | | Technicon DAX=Serum | |
|---------------|-------|--------------|---------------------|--------------|
| Specimen type | Level | Total CV (%) | Level | Total CV (%) |
| Serum | 77 | 1.5 | 74 | 2.1 |
| Serum | 294 | 1.4 | 293 | 1.5 |
| Urine | 48 | 1.5 | | |
| Urine | 277 | 1.4 | | |
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum: MSK | DAX | 155 | Y=0.98X-3.0 | 3.4 | 0.996 | 41-323 |
| Plasma(y), Serum(x) | ADVIA 1650 | 48 | Y=0.99X+2.9 | 2.21 | 0.999 | 60-381 |
| Urine: MSK | CX3 | 87 | Y=1.06X-1.2 | 4.8 | 0.989 | 0-249 |
#### Interfering Substances
| Analyte | Interfering<br>Substance | Interfering Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect<br>conc. | Effect<br>% |
|---------|--------------------------|-----------------------------------|------------------|-----------------|-------------|
| GLU-OX | Bilirubin | 10 | 91.9 | -3.5 | -3.8 |
| GLU-OX | Bilirubin | 25 | 91.9 | -13.6 | -14.8 |
| GLU-OX | Hemoglobin | 500 | 86.7 | 6.1 | 7.0 |
| GLU-OX | Lipids (Trig) | 900 | 187.0 | -5.8 | -3.1 |
#### Analytical Range
| Serum/Plasma: | 0 - 750 mg/dL |
|---------------|---------------|
| Urine: | 0 - 750 mg/dL |
| Serum: | 74 - 106 mg/dL |
|--------|----------------|
| Urine: | <0.5 g/day |
{13}------------------------------------------------
13. HDL
## SUMMARY OF SAFETY AND EFFECTIVENESS
## High Density Lipoprotein Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure HDL Cholesterol in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used in the risk assessment of coronary artery disease.
#### Imprecision
Advia 1650
RA-XT
| Specimen<br>type | Level | Total<br>CV (%) | Level | Between<br>Day CV (%) |
|------------------|-------|-----------------|-------|-----------------------|
| Serum | 28 | 3.8 | 15.5 | 5.1 |
| Serum | 53 | 3.2 | 52.3 | 1.9 |
# Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum: MSK | RA-XT | 121 | Y=1.03X+3.91 | 2.5 | 0.987 | 12-94 |
| Plasma(y), Serum(x) | ADVIA 1650 | 79 | Y=1.09X-1.9 | 4.50 | 0.960 | 26-98 |
#### Interfering Substances
| Interfering<br>Substance | Interfering Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|-----------------------------------|------------------|--------|-------|
| Bilirubin | 25 | 29.7 | -0.4 | -1.3 |
| Hemoglobin | 500 | 29.2 | -5.6 | -19.2 |
#### Analytical Range
10-135 mg/dL
#### Expected Values (years: mg/dL)
| Male, Ages 30 – 50: | 27.8 to 52.89 mg/dL |
|-----------------------|---------------------|
| Female, Ages 30 - 50: | 33.9 to 86.87 mg/dL |
{14}------------------------------------------------
## 14. IPHOS
### SUMMARY OF SAFETY AND EFFECTIVENESS
## Inorganic Phosphorus Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure inorganic phosphorus concentration in human serum, plasma and urine on the ADVIA® 1650 system. Such measurements are used in the diagnosis and treatment of kidney diseases, parathyroid gland disorders, and Vitamin D imbalance.
#### Imprecision
Advia 1650
| | | Technicon DAX=Serum |
|--|--|---------------------|
|--|--|---------------------|
Total CV (%) 3.0 2.3 2.1
| Specimen<br>type | Level | Total<br>CV (%) | Level |
|------------------|-------|-----------------|-------|
| Serum | 3.0 | 1.7 | 3.2 |
| Serum | 5.7 | 2.6 | 6.7 |
| Serum | 7.7 | 2.0 | 9.4 |
| Urine | 32.0 | 1.6 | |
| Urine | 170.6 | 0.7 | |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison<br>System (X) | N | Regression<br>Equation | Syx | R | Sample<br>Range |
|---------------------|--------------------------|-----|------------------------|------|-------|-----------------|
| Serum: MSK | DAX | 154 | Y=0.93X+0.20 | 0.18 | 0.978 | 1.1-7.3 |
| Serum: ARI | CX7 | 152 | Y=1.01X+0.30 | 0.25 | 0.983 | 1.4-10.0 |
| Plasma(y), Serum(x) | ADVIA 1650 | 50 | Y=0.98X-0.23 | 0.11 | 0.975 | 2.0-4.1 |
| Urine: MSK | Cobas Fara | 92 | Y=1.02X-0.2 | 1.3 | 0.998 | 5-87 |
#### Interfering Substances
| Analyte | Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | conc. | Effect<br>% |
|---------|--------------------------|--------------------------------------|------------------|-------|-------------|
| IPHOS | Bilirubin | 25 | 3.4 | 0.0 | -0.6 |
| IPHOS | Hemoglobin | 500 | 2.7 | 0.9 | 33.3 |
| IPHOS | Lipids (Trig) | 500 | 3.4 | -0.2 | -5.9 |
#### Analytical Range
Serum/Plasma: 0 - 20 mg/dL Urine: 5 - 100 mg/dL
#### Expected Values
2.7 - 4.5 mg/dL Serum: Urine: 0.4 - 1.3 g/d
{15}------------------------------------------------
## Iron Method for the Bayer ADVIA 1650 (ug/dL)
#### Intended Use
This in vitro diagnostic method is intended to measure iron concentration in human serum and plasma on an ADVIA® 1650 Chemistry System. Measurements are used in the diagnosis and treatment of iron deficiency anemias and hemochromatosis.
#### Imprecision
Advia 1650
Technicon DAX
| Specimen<br>type | Level | Total CV (%) | Level | Total CV (%) |
|------------------|-------|--------------|-------|--------------|
| Serum | 64 | 3.1 | 81 | 5.5 |
| Serum | 175 | 2.6 | 194 | 3.2 |
| Serum | 295 | 2.2 | 322 | 3.1 |
### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison<br>System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|--------------------------|----|---------------------|-----|-------|--------------|
| Serum - MSK | DAX | 40 | $Y=0.88X + 4.5$ | 4.8 | 0.997 | 6 - 253 |
| Plasma(y), Serum(x) | ADVIA 1650 | 57 | $Y=0.96X+15.5$ | 6.9 | 0.978 | 40 - 186 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-------|
| | | | conc. | % |
| Bilirubin | 25 | 111.6 | 1.9 | 1.7 |
| Hemoglobin | 500 | N/A | N/A | N/A |
| Lipids (Trig) | 500 | 107.9 | -11.1 | -10.3 |
## Analytical Range
0 to 1000 µg/dL
#### Expected Values
Males: 65 to 175 µg/dL Females: 50 to 170 µg/dL
{16}------------------------------------------------
## Magnesium Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure magnesium concentration in human serum. plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of hypermagnesemia and monitoring of patients receiving prolonged magnesium-free intravenous therapy.
#### Imprecision
Advia 1650
| Specimen<br>type | Level | Total<br>CV (%) |
|------------------|-------|-----------------|
| Serum | 1.9 | 2.3 |
| Serum | 3.4 | 2.0 |
| Urine | 8.7 | 11.9 |
| Level | Total CV (%) |
|-------|--------------|
| 2.4 | 5.6 |
| 3.9 | 3.6 |
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison<br>System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|--------------------------|-----|---------------------|-------|-------|--------------|
| Serum - TRYTN | DAX | 193 | $Y=0.91X + 0.10$ | 0.131 | 0.973 | 0.9 - 5.3 |
| Serum - BERLIN | HITACHI | 112 | $Y=0.95X + 0.25$ | 0.124 | 0.916 | 1.5 - 3.1 |
| Plasma(y), Serum(x) | ADVIA 1650 | 51 | $Y=0.97X + 0.02$ | 0.032 | 0.963 | 1.6 - 2.1 |
| Urine - BERLIN | HITACHI | 97 | $Y=0.99X + 0.31$ | 0.253 | 0.997 | 1.4 - 15.0 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 25 | 2.6 | 0.4 | 14.0 |
| Hemoglobin | 500 | 2.7 | 0.2 | 7.4 |
| Lipids (Trig) | 500 | 1.8 | 1.0 | 55.6 |
#### Analytical Range
Serum/Plasma: 1.6 to 6 mg/dL Urine: 1.6 to 25 mg/dL
## Expected Values (values in Tietz converted to mg/dL)
| Serum/Plasma: | 1.6 – 2.6 mg/dL |
|---------------|-----------------|
| Urine: | 7.3 – 12.2 mg/d |
{17}------------------------------------------------
# 17. K
## SUMMARY OF SAFETY AND EFFECTIVENESS
### Potassium Method for the Bayer ADVIA 1650 (mmol/L)
#### Intended Use
This in vitro diagnostic assay is intended to measure potassium concentration in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used mainly to monitor electrolyte balance in the diagnosis and treatment of primary aldosteronism, metabolic alkalosis, diarrhea, severe vomiting, diuretic administration, diabetic ketoacidosis, and other diseases.
### Imprecision
| Advia 1650 | | Technicon DAX=Serum | | |
|---------------|-------|---------------------|-------|--------------|
| Specimen type | Level | Total CV (%) | Level | Total CV (%) |
| Serum | 3.0 | 3.0 | 3.4 | 1.6 |
| Serum | 6.4 | 2.7 | 7.5 | 1.7 |
| Urine | 28.5 | 6.1 | | |
| Urine | 102.9 | 4.8 | | |
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum - MSK | DAX | 156 | $Y=1.09X - 0.2$ | 0.08 | 0.995 | 2.2 - 8.1 |
| Plasma(y), Serum(x) | ADVIA 1650 | 49 | $Y=0.92X-0.01$ | 0.16 | 0.890 | 3.4 - 4.8 |
| Urine - MSK | CX3 | 99 | $Y=1.01X-0.2$ | 1.2 | 0.999 | 7 - 116 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-----|
| Bilirubin | 25 | 3.3 | 0.0 | 0.3 |
| Hemoglobin | 500 | N/A | N/A | N/A |
| Lipids (Trig) | 500 | 3.3 | 0.2 | 6.1 |
#### Analytical Range
| Serum/Plasma: | 1 to 10 mmol/L |
|---------------|-----------------|
| Urine: | 3 to 300 mmol/L |
| Serum: | 3.5 – 5.1 mmol/L |
|-----------------|------------------------------------|
| Plasma Males: | 3.5 – 4.5 mmol/L |
| Plasma Females: | 3.4 – 4.4 mmol/L |
| Urine: | 25 – 125 mmol/d (varies with diet) |
{18}------------------------------------------------
## Sodium Method for the Bayer ADVIA 1650 (mmol/L)
### Intended Use
This in vitro diagnostic assay is intended to measure sodium concentration in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used mainly in the diagnosis and treatment of gross changes in water and salt balance, aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, diabetic acidosis, severe diarrhea, or other diseases involving electrolyte imbalance.
### Imprecision
| Advia 1650 | | | Technicon DAX=Serum | | |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|---------------------|--------|--|
| Specimen | | Total | | Total | |
| type | Level | CV (%) | Level | CV (%) | |
| Serum | 119 | 1.7 | । । ર | 0.9 | |
| Serum | 143 | 1.8 | 141 | 0.9 | |
| Urine | ર્ભરે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે આવેલું એક ગામના લોકોનો મુખ્ય વ | 1.9 | ો ર્ણ્ | 1.2 | |
| Urine | 208 | 2.0 | | | |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|-----|---------------------|------|-------|--------------|
| Serum - MSK | DAX | 156 | Y=1.02X - 0.2 | 1.08 | 0.970 | 121 - 154 |
| Plasma(y), Serum(x) | ADVIA 1650 | 69 | Y=0.92X+11.6 | 1.45 | 0.964 | 139 - 156 |
| Urine - MSK | CX3 | 97 | Y=0.95X + 6.2 | 3 | 0.997 | 20 - 202 |
### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-----|
| Bilirubin | 25 | 122.8 | 0.0 | 0.0 |
| Hemoglobin | 500 | 128.7 | 2.3 | 1.8 |
| Lipids (Trig) | 500 | 117.3 | 3.1 | 2.6 |
### Analytical Range
| Serum/Plasma: | 100 to 200 mmol/L |
|---------------|-------------------|
| Urine: | 10 to 400 mmol/L |
| Serum/Plasma: | 136 – 145 mEq/L |
|---------------|-----------------|
| Urine: | 40 – 220 mmol/d |
{19}------------------------------------------------
## Total Bilirubin Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure total bilirubin concentration in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of hemolytic, biliary, and liver disorders, including hepatitis and cirrhosis.
#### Imprecision
Advia 1650
| Advia 1650 | | | Technicon DAX | | |
|------------------|-------|-----------------|---------------|---|--|
| Specimen<br>type | Level | Total<br>CV (%) | Level | C | |
| Serum | 1.0 | 7.6 | 0.7 | | |
| Serum | 5.0 | 4.1 | 5.1 | | |
| Serum | 7.7 | 2.2 | 12.5 | | |
Total CV (%) le ** 2.3 2.2
** Value not significant when level approaches zero.
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison<br>System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------|--------------------------|-----|---------------------|-------|-------|--------------|
| Serum - MSK | DAX | 156 | $Y=1.10X+ 0.08$ | 0.194 | 0.999 | 0.1 - 29.5 |
| Serum/Plasma | ADVIA 1650 | 51 | $Y=0.94X+ 0.16$ | 0.071 | 0.954 | 0.3 - 1.4 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|--------|
| Hemoglobin | 200 | 0.9 | -0.5 | -61.6 |
| Hemoglobin | 500 | 0.9 | -1.1 | -122.1 |
| Lipids (Trig) | 500 | 0.9 | 0.5 | 55.6 |
## Analytical Range
0 to 30 mg/dL
#### Expected Values
0.3 to 1.2 mg/dL
{20}------------------------------------------------
## Uric Acid Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure uric acid concentration in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of renal failure, gout, and eclampsia.
## Imprecision
| Advia 1650 | | | Technicon DAX=Serum | | Beckman CX7=Urine | |
|---------------|-------|--------------|---------------------|--------|-------------------|--------|
| Specimen type | Level | Total CV (%) | | Total | | Total |
| Serum | 3.9 | 1.9 | Level | CV (%) | Level | CV (%) |
| Serum | 8.6 | 1.6 | 5.2 | 3.0 | 12 | 3 |
| Serum | 10.0 | 2.3 | 8.5 | 2.7 | 24 | 3 |
| Urine | 12.4 | 2.3 | 10.0 | 2.6 | | |
| Urine | 23.9 | 5.2 | | | | |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison<br>System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|--------------------------|-----|---------------------|-------|-------|--------------|
| Serum - MSK | DAX | 154 | Y=1.05X + 0.48 | 0.27 | 0.994 | 0.2 - 18.0 |
| Plasma(y), Serum(x) | ADVIA 1650 | 61 | Y=1.03X + 0.02 | 0.063 | 0.999 | 2.4 - 8.9 |
| Urine - ARI | CX7 | 30 | Y=1.03X - 0.5 | 3.06 | 0.989 | 8-91 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 25 | 4.5 | -0.2 | -4.2 |
| Hemoglobin | 500 | 6.2 | 0.2 | 3.2 |
| Lipids (Trig) | 500 | 4.3 | -0.4 | -9.3 |
#### Analytical Range
| Serum/Plasma: | 0 to 20 mg/dL |
|---------------|----------------|
| Urine: | 0 to 180 mg/dL |
| Males/Serum: | 3.5 to 7.2 mg/dL |
|----------------|------------------|
| Females/Serum: | 2.6 to 6.0 mg/dL |
| Urine: | 250 to 750 mg/dL |
{21}------------------------------------------------
# 21. UN
## SUMMARY OF SAFETY AND EFFECTIVENESS
## Urea Nitrogen Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure urea nitrogen (an end product of nitrogen metabolism) concentration in human serum, plasma and urine on a ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of kidney disease, urinary tract obstruction, and acute or chronic renal failure.
#### Imprecision
| Advia 1650 | | | Technicon DAX=Serum | | Beckman CX3=Urine | |
|------------------|-------|-------------|---------------------|--------------|-------------------|--------------|
| Specimen<br>type | Level | Total<br>CV | Level | Total CV (%) | Level | Total CV (%) |
| Serum | 18 | 2.4 | 21 | 3.5 | 460 | 7.5 |
| Serum | 50 | 2.2 | 59 | 1.8 | 620 | 7.5 |
| Serum | 86 | 1.7 | 102 | 1.7 | | |
| Urine | 461 | 4.6 | | | | |
| Urine | 618 | 2.3 | | | | |
#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|----|---------------------|------|-------|--------------|
| Serum - MSK | DAX | 34 | Y=1.12X - 0.8 | 1.01 | 0.997 | 8 - 64 |
| Plasma(y), Serum(x) | ADVIA 1650 | 54 | Y=1.0X - 0.2 | 0.22 | 0.997 | 7 - 22 |
| Urine - MSK | CX3 | 79 | Y=1.03X + 24.8 | 34.8 | 0.990 | 67 - 988 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 25 | 16.3 | -0.2 | -1.2 |
| Hemoglobin | 500 | 20.2 | -0.6 | -3.0 |
| Lipids (Trig) | 500 | 15.8 | 0.7 | 4.4 |
#### Analytical Range
| Serum/Plasma: | 5 to 150 mg/dL |
|---------------|------------------|
| Urine: | 35 to 1000 mg/dL |
#### Expected Values
6 to 20 mg/dL
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/22/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
MAY 21 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Gabriel J. Muraca, Jr. Manager Requlatory Affairs BAYER CORPORATION 511 Benedict Avenue Tarrytown, NY 10591-5097
Re: K990346
> Trade Name: Bayer ADVIA® 1650 Chemistry System Regulatory Class: II Product Code: JGS, CEM, CGZ, JJE Dated: April 21, 1999 Received: April 28, 1999
Dear Mr. Muraca:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Butman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 10
Page 1 of 1
510(k) Number (if known): K990346
#### Device Name: Bayer ADVIA® 1650 Chemistry System
Indications For Use:
The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes. The ADVIA 1650 is intended for use in conjunction with certain reagents to measure a variety of analytes contained in human fluids.
Jean Cooper
(Division Sign-Off)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use : (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
