LogoFDA 510(k) Search
K Number
K990346
Device Name
BAYER ADVIA 1650 CHEMISTRY SYSTEM
Manufacturer
BAYER CORP.
Date Cleared
1999-05-21

(106 days)

Product Code
JGSCEMCGZJJE
Regulation Number
862.1665
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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.
More Information

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No
The description focuses on standard automated clinical chemistry analysis methods (photometry, immuno-turbidimetry, potentiometry with ion-selective electrodes) and does not mention any AI or ML components. The performance studies described are also standard for this type of device and do not indicate the use of AI/ML.

No

This device is an automated, clinical chemistry analyzer used to measure various analytes in human fluids for diagnostic purposes, not for treating a condition or disease.

Yes
The device is a "clinical chemistry analyzer" which runs tests on human fluids to measure various analytes, indicating its use in diagnosing conditions.

No

The device description clearly outlines hardware components such as a photometric analyzer, electrolyte portion, and ion-selective electrodes, indicating it is a physical system, not software-only.

Yes, based on the provided information, the ADVIA 1650 Chemistry System is an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for use "in conjunction with certain reagents to measure a variety of analytes contained in human fluids." This describes the core function of an IVD device – analyzing samples taken from the human body (in vitro) to provide diagnostic information.
  • Sample Types: The device analyzes "human serum, plasma, or urine," which are biological samples commonly used in in vitro diagnostic testing.
  • Measurement of Analytes: The device measures "a variety of analytes" and specifically mentions "sodium, and chloride concentrations," which are common clinical chemistry tests performed for diagnostic purposes.
  • Clinical Chemistry Analyzer: The device is described as a "clinical chemistry analyzer," which is a type of instrument specifically designed for performing in vitro diagnostic tests in a clinical laboratory setting.

The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JGS, CEM, CGZ, JJE

Device Description

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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The summary provides performance comparisons for 21 clinical methods, comparing the Advia 1650 to similar predicate devices. Each method details imprecision (total CV%) and correlation (Regression Equation, Syx, R, Sample Range) for various specimen types (Serum, Plasma, Urine) and comparison systems, along with analytical range and expected values. Interfering substances (Bilirubin, Hemoglobin, Lipids) and their effects on analyte concentration are also listed.

Here's a summary of the performance for each method:

1. Albumin Method (g/dL)

  • Imprecision (Advia 1650): Serum (Level 2.1: 2.4% CV; Level 3.4: 1.8% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=156): Y=0.86X+0.55, Syx=0.19, R=0.969, Sample Range=1.6-5.3.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=58): Y=0.96X+0.29, Syx=0.05, R=0.978, Sample Range=4.5-5.7.
  • Analytical Range: 1 to 6 g/dL.

2. Alkaline Phosphatase AMP Method (U/L)

  • Imprecision (Advia 1650): Serum (Level 69: 3.9% CV; Level 130: 3.1% CV).
  • Correlation:
    • Serum (TRYTN, vs. DAX, N=43): Y=1.03X-2.1, Syx=3.12, R=0.999, Sample Range=22-346.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=54): Y=1.06X+1.42, Syx=5.37, R=0.972, Sample Range=33-149.
  • Analytical Range: 0-1100 U/L.

3. Amylase Method (U/L)

  • Imprecision (Advia 1650): Serum (Level 60: 1.2% CV; Level 242: 1.3% CV; Level 322: 1.2% CV), Urine (Level 792: 7.2% CV).
  • Correlation:
    • Serum (MSK, vs. CX4, N=102): Y=0.72X+1.91, Syx=3.5, R=0.998, Sample Range=6-549.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=53): Y=1.08X+1.46, Syx=3.9, R=0.985, Sample Range=18-110.
    • Urine (MSK, vs. CX7, N=82): Y=0.75X+0.74, Syx=13.4, R=0.993, Sample Range=2-667.
  • Analytical Range: Serum/Plasma: 0 to 1500 U/L, Urine: 0 to 1500 U/L.

4. Aspartate Aminotransferase Method (U/L)

  • Imprecision (Advia 1650): Serum (Level 32: 3.9% CV; Level 146: 1.7% CV).
  • Correlation:
    • Serum (BERLIN, vs. DAX, N=111): Y=0.99X-6.3, Syx=3.63, R=0.999, Sample Range=9.8-607.2.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=54): Y=1.00X-2.9, Syx=3.01, R=0.954, Sample Range=16-85.
  • Analytical Range: 0-1000 U/L.

5. Calcium Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 5.9: 2.7% CV; Level 10.8: 2.9% CV; Level 12.0: 3.5% CV), Urine (Level 6.2: 2.4% CV; Level 21.2: 2.5% CV).
  • Correlation:
    • Serum (ARI, vs. DAX, N=100): Y=0.99X + 0.13, Syx=0.223, R=0.971, Sample Range=7.0-13.2.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=59): Y=0.94X + 0.82, Syx=0.094, R=0.963, Sample Range=9.0-10.8.
    • Urine (ARI, vs. Dimension, N=32): Y=1.2X - 2.25, Syx=0.165, R=0.999, Sample Range=3.7-14.5.
    • Urine (MSK, vs. CX3, N=63): Y=1.07X + 0.03, Syx=0.558, R=0.988, Sample Range=2.1-14.7.
  • Analytical Range: Serum/Plasma: 1 to 15 mg/dL, Urine: 1 to 15 mg/dL.

6. Chloride Method (mmol/L)

  • Imprecision (Advia 1650): Serum (Level 88.4: 1.6% CV; Level 111.8: 2.0% CV), Urine (Level 86.8: 1.7% CV; Level 290.4: 3.8% CV).
  • Correlation:
    • Serum (ARI, vs. CX7, N=115): Y=1.00X + 1.3, Syx=1.6, R=0.985, Sample Range=76-128.
    • Serum (MSK, vs. DAX, N=154): Y=0.98X + 3.3, Syx=2.2, R=0.914, Sample Range=86-122.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=69): Y=0.86X+15.9, Syx=1.20, R=0.944, Sample Range=102-118.
    • Urine (ARI, vs. CX7, N=76): Y=1.05X - 0.9, Syx=4.9, R=0.996, Sample Range=29-280.
  • Analytical Range: Serum/Plasma: 15 to 200 mmol/L, Urine: 15 to 400 mmol/L.

7. Creatine Phosphokinase Method (U/L)

  • Imprecision (Advia 1650): Serum (Level 139: 2.7% CV; Level 449: 3.0% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=151): Y=0.97X+1.19, Syx=3.3, R=0.999, Sample Range=6-700.
    • Serum (ARI, vs. CX7, N=145): Y=1.01X+0.8, Syx=6.50, R=1.000, Sample Range=13-1187.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=56): Y=1.05X-9.02, Syx=7.88, R=0.997, Sample Range=41-507.
  • Analytical Range: 0-1300 U/L.

8. Creatinine Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 1.8: 3.8% CV; Level 8.4: 3.7% CV), Urine (Level 84.6: 2.9% CV; Level 209.3: 4.0% CV).
  • Correlation:
    • Serum (BERLIN, vs. DAX, N=112): Y=0.92X+0.06, Syx=0.15, R=0.995, Sample Range=0.33-8.3.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=58): Y=1.02X+0.04, Syx=0.02, R=0.992, Sample Range=0.9-1.4.
    • Urine (BERLIN, vs. HITACHI, N=86): Y=1.13X+0.40, Syx=2.61, R=0.995, Sample Range=21-160.
  • Analytical Range: Serum/Plasma: 0 - 25 mg/dL, Urine: 17 - 160 mg/dL.

9. Creatinine-Enzymatic Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 0.9: 6.4% CV; Level 6.1: 2.3% CV; Level 9.5: 2.0% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=155): Y=0.99X-0.06, Syx=0.16, R=0.955, Sample Range=0.3-3.9.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=57): Y=0.96X+0.16, Syx=0.07, R=0.925, Sample Range=0.7-1.4.
  • Analytical Range: 0-30 mg/dL.

10. Direct Bilirubin Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 0.3: 4.6% CV; Level 1.6: 4.4% CV).
  • Correlation:
    • Serum (TRYTN, vs. DAX, N=145): Y=1.34X-0.10, Syx=0.18, R=0.994, Sample Range=0-6.12.
    • Serum (BERLIN, vs. HITACHI, N=92): Y=1.07X+0.06, Syx=0.14, R=0.997, Sample Range=0.02-9.26.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=49): Y=0.98X-0.01, Syx=0.02, R=0.988, Sample Range=0.1-0.6.
  • Analytical Range: 0 - 10 mg/dL.

11. Glucose-Hexokinase Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 77: 2.4% CV; Level 279: 3.3% CV), Urine (Level 42: 3.5% CV; Level 285: 3.6% CV).
  • Correlation:
    • Serum (BERLIN, vs. DAX, N=109): Y=1.05X - 2.8, Syx=5.42, R=0.995, Sample Range=19-262.
    • Urine (BERLIN, vs. HITACHI, N=81): Y=0.99X - 11.2, Syx=9.88, R=0.997, Sample Range=4-476.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=60): Y=1.03X - 6.6, Syx=9.00, R=0.986, Sample Range=36-384.
  • Analytical Range: Serum/Plasma: 0 - 700 mg/dL, Urine: 0 - 700 mg/dL.

12. Glucose-Oxidase Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 77: 1.5% CV; Level 294: 1.4% CV), Urine (Level 48: 1.5% CV; Level 277: 1.4% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=155): Y=0.98X-3.0, Syx=3.4, R=0.996, Sample Range=41-323.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=48): Y=0.99X+2.9, Syx=2.21, R=0.999, Sample Range=60-381.
    • Urine (MSK, vs. CX3, N=87): Y=1.06X-1.2, Syx=4.8, R=0.989, Sample Range=0-249.
  • Analytical Range: Serum/Plasma: 0 - 750 mg/dL, Urine: 0 - 750 mg/dL.

13. High Density Lipoprotein Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 28: 3.8% CV; Level 53: 3.2% CV).
  • Correlation:
    • Serum (MSK, vs. RA-XT, N=121): Y=1.03X+3.91, Syx=2.5, R=0.987, Sample Range=12-94.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=79): Y=1.09X-1.9, Syx=4.50, R=0.960, Sample Range=26-98.
  • Analytical Range: 10-135 mg/dL.

14. Inorganic Phosphorus Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 3.0: 1.7% CV; Level 5.7: 2.6% CV; Level 7.7: 2.0% CV), Urine (Level 32.0: 1.6% CV; Level 170.6: 0.7% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=154): Y=0.93X+0.20, Syx=0.18, R=0.978, Sample Range=1.1-7.3.
    • Serum (ARI, vs. CX7, N=152): Y=1.01X+0.30, Syx=0.25, R=0.983, Sample Range=1.4-10.0.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=50): Y=0.98X-0.23, Syx=0.11, R=0.975, Sample Range=2.0-4.1.
    • Urine (MSK, vs. Cobas Fara, N=92): Y=1.02X-0.2, Syx=1.3, R=0.998, Sample Range=5-87.
  • Analytical Range: Serum/Plasma: 0 - 20 mg/dL, Urine: 5 - 100 mg/dL.

15. Iron Method (ug/dL)

  • Imprecision (Advia 1650): Serum (Level 64: 3.1% CV; Level 175: 2.6% CV; Level 295: 2.2% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=40): Y=0.88X + 4.5, Syx=4.8, R=0.997, Sample Range=6-253.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=57): Y=0.96X+15.5, Syx=6.9, R=0.978, Sample Range=40-186.
  • Analytical Range: 0 to 1000 µg/dL.

16. Magnesium Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 1.9: 2.3% CV; Level 3.4: 2.0% CV), Urine (Level 8.7: 11.9% CV).
  • Correlation:
    • Serum (TRYTN, vs. DAX, N=193): Y=0.91X + 0.10, Syx=0.131, R=0.973, Sample Range=0.9-5.3.
    • Serum (BERLIN, vs. HITACHI, N=112): Y=0.95X + 0.25, Syx=0.124, R=0.916, Sample Range=1.5-3.1.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=51): Y=0.97X + 0.02, Syx=0.032, R=0.963, Sample Range=1.6-2.1.
    • Urine (BERLIN, vs. HITACHI, N=97): Y=0.99X + 0.31, Syx=0.253, R=0.997, Sample Range=1.4-15.0.
  • Analytical Range: Serum/Plasma: 1.6 to 6 mg/dL, Urine: 1.6 to 25 mg/dL.

17. Potassium Method (mmol/L)

  • Imprecision (Advia 1650): Serum (Level 3.0: 3.0% CV; Level 6.4: 2.7% CV), Urine (Level 28.5: 6.1% CV; Level 102.9: 4.8% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=156): Y=1.09X - 0.2, Syx=0.08, R=0.995, Sample Range=2.2-8.1.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=49): Y=0.92X-0.01, Syx=0.16, R=0.890, Sample Range=3.4-4.8.
    • Urine (MSK, vs. CX3, N=99): Y=1.01X-0.2, Syx=1.2, R=0.999, Sample Range=7-116.
  • Analytical Range: Serum/Plasma: 1 to 10 mmol/L, Urine: 3 to 300 mmol/L.

18. Sodium Method (mmol/L)

  • Imprecision (Advia 1650): Serum (Level 119: 1.7% CV; Level 143: 1.8% CV), Urine (Level 135: 1.9% CV; Level 208: 2.0% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=156): Y=1.02X - 0.2, Syx=1.08, R=0.970, Sample Range=121-154.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=69): Y=0.92X+11.6, Syx=1.45, R=0.964, Sample Range=139-156.
    • Urine (MSK, vs. CX3, N=97): Y=0.95X + 6.2, Syx=3, R=0.997, Sample Range=20-202.
  • Analytical Range: Serum/Plasma: 100 to 200 mmol/L, Urine: 10 to 400 mmol/L.

19. Total Bilirubin Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 1.0: 7.6% CV; Level 5.0: 4.1% CV; Level 7.7: 2.2% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=156): Y=1.10X+0.08, Syx=0.194, R=0.999, Sample Range=0.1-29.5.
    • Serum/Plasma (vs. ADVIA 1650, N=51): Y=0.94X+0.16, Syx=0.071, R=0.954, Sample Range=0.3-1.4.
  • Analytical Range: 0 to 30 mg/dL.

20. Uric Acid Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 3.9: 1.9% CV; Level 8.6: 1.6% CV; Level 10.0: 2.3% CV), Urine (Level 12.4: 2.3% CV; Level 23.9: 5.2% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=154): Y=1.05X + 0.48, Syx=0.27, R=0.994, Sample Range=0.2-18.0.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=61): Y=1.03X + 0.02, Syx=0.063, R=0.999, Sample Range=2.4-8.9.
    • Urine (ARI, vs. CX7, N=30): Y=1.03X - 0.5, Syx=3.06, R=0.989, Sample Range=8-91.
  • Analytical Range: Serum/Plasma: 0 to 20 mg/dL, Urine: 0 to 180 mg/dL.

21. Urea Nitrogen Method (mg/dL)

  • Imprecision (Advia 1650): Serum (Level 18: 2.4% CV; Level 50: 2.2% CV; Level 86: 1.7% CV), Urine (Level 461: 4.6% CV; Level 618: 2.3% CV).
  • Correlation:
    • Serum (MSK, vs. DAX, N=34): Y=1.12X - 0.8, Syx=1.01, R=0.997, Sample Range=8-64.
    • Plasma(y), Serum(x) (vs. ADVIA 1650, N=54): Y=1.0X - 0.2, Syx=0.22, R=0.997, Sample Range=7-22.
    • Urine (MSK, vs. CX3, N=79): Y=1.03X + 24.8, Syx=34.8, R=0.990, Sample Range=67-988.
  • Analytical Range: Serum/Plasma: 5 to 150 mg/dL, Urine: 35 to 1000 mg/dL.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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§ 862.1665 Sodium test system.

(a)
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.(b)
Classification. Class II.

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
Reagent Part # | Specimen
Type | Predicate Device
Name | Predicate Device
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
type | Level | Total
CV (%) |
|------------------|-------|-----------------|
| Serum | 2.1 | 2.4 |
| Serum | 3.4 | 1.8 |

Technicon DAX
LevelTotal CV (%)
2.23.3
3.42.5
4.82.0

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: MSKDAX156Y=0.86X+0.550.190.9691.6-5.3
Plasma(y), Serum(x)ADVIA 165058Y=0.96X+0.290.050.9784.5-5.7

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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
type | Level | Total
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
LevelCV (%)
792.5
ાં ૪૯2.2
5711.9

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: TRYTNDAX43$Y=1.03X-2.1$3.120.99922-346
Plasma(y), Serum(x)ADVIA 165054$Y=1.06X+1.42$5.370.97233-149

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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
type | Level | Total
CV (%) |
|------------------|-------|-----------------|
| Serum | 60 | 1.2 |
| Serum | 242 | 1.3 |
| Serum | 322 | 1.2 |
| Urine | 792 | 7.2 |

Beckman CX7=Serum, Urine

Total

LevelCV (%)
85.75.3
2405.3
3205.3
8005.3

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: MSKCX4102Y=0.72X+1.913.50.9986-549
Plasma(y), Serum(x)ADVIA 165053Y=1.08X+1.463.90.98518-110
Urine: MSKCX782Y=0.75X+0.7413.40.9932-667

Bias expected in serum and urine correlation when run against Beckman instrument due to the different substrates used in each instrument.

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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)
Urine0 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
type | Level | Total
CV (%) |
|------------------|-------|-----------------|
| Serum | 32 | 3.9 |
| Serum | 146 | 1.7 |

Technicon DAX
LevelTotal CV (%)
555.4
2032.5
4713.3

Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen type: Site | Comparison
System (X) | N | Regression
Equation | Syx | R | Sample
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
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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 1650Technicon DAX = SerumDupont Dimension=Urine
Specimen
typeLevelTotal
CV (%)LevelTotal CV (%)LevelBetween Day CV (%)
Serum5.92.77.72.38.80.6
Serum10.82.910.31.614.52.6
Serum12.03.512.51.5
Urine6.22.4
Urine21.22.5

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen typeComparison System (X)NRegression EquationSyxRSample Range
Serum - ARIDAX100Y=0.99X + 0.130.2230.9717.0 - 13.2
Plasma(y), Serum(x)ADVIA 165059Y=0.94X + 0.820.0940.9639.0 - 10.8
Urine - ARIDimension32Y=1.2X - 2.250.1650.9993.7 - 14.5
Urine - MSKCX363Y=1.07X + 0.030.5580.9882.1 - 14.7

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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

Advia1650

| Specimen
type | Level | Total
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

LevelTotal CV (%)
971.5
1121.8

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen typeComparison System (X)NRegression EquationSyxRSample Range
Serum - ARICX7115$Y=1.00X + 1.3$1.60.98576 - 128
Serum - MSKDAX154$Y=0.98X + 3.3$2.20.91486 - 122
Plasma(y), Serum(x)ADVIA 165069$Y=0.86X+15.9$1.200.944102-118
Urine - ARICX776$Y=1.05X - 0.9$4.90.99629 - 280

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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 1650Technicon DAXBeckman CX7
Specimen typeLevelTotal CV (%)Level (U/L)Total CV (%)LevelTotal CV (%)
Serum1392.71774.81445.3
Serum4493.05902.54605.3

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: MSKDAX151Y=0.97X+1.193.30.9996-700
Serum: ARICX7145Y=1.01X+0.86.501.00013-1187
Plasma(y), Serum(x)ADVIA 165056Y=1.05X-9.027.880.99741-507

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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 1650Technicon DAX=Serum
SpecimenTotalTotal
typeLevelCV %LevelCV (%)
Serum1.83.81.84.3
Serum8.43.75.04.5
Urine84.62.910.53.7
Urine209.34.0

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: BERLINDAX112Y=0.92X+0.060.150.9950.33-8.3
Plasma(y), Serum(x)ADVIA 165058Y=1.02X+0.040.020.9920.9-1.4
Urine: BERLINHITACHI86Y=1.13X+0.402.610.99521-160

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect
conc. | Effect
% |
|--------------------------|--------------------------------------|------------------|-----------------|-------------|
| 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

typeLevelTotal CV (%)LevelTotal CV (%)
Serum0.96.41.84.3
Serum6.12.35.04.5
Serum9.52.010.53.7

Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen type: Site | Comparison
System (X) | N | Regression
Equation | Syx | R | Sample
Range |
|---------------------|--------------------------|-----|------------------------|------|-------|-----------------|
| Serum: MSK | DAX | 155 | $Y=0.99X-0.06$ | 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
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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 1650Technicon DAX
Specimen typeLevelTotal CV (%)Level
Serum0.34.60.2
Serum1.64.41.5
4.0

** Value not significant when level approaches zero.

Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen type | Comparison
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
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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

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.

23

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

24

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)