ILAB 600 CLINICAL CHEMISTRY SYSTEM

K980757 · Instrumentation Laboratory CO · CGZ · Apr 21, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980757
• Device Name: ILAB 600 CLINICAL CHEMISTRY SYSTEM
• Applicant: Instrumentation Laboratory CO
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Apr 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

Intended Use

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

Device Story

ILab 600 is an automated, random-access clinical chemistry analyzer; utilizes photometry and potentiometry (ISE module) to measure analytes in physiological fluids (serum, plasma, urine, CSF). Operates in clinical laboratory settings; used by trained laboratory personnel. System processes samples to provide quantitative diagnostic results; results assist healthcare providers in clinical decision-making and patient diagnosis. Device features medium throughput (400 tests/hour) and Windows NT operating system. Benefits include automated, high-precision analysis of multiple clinical chemistry parameters.

Clinical Evidence

Bench testing only. Method comparison studies performed on serum, urine, and CSF samples comparing ILab 600 to ILab 900. Results showed high correlation (r values typically >0.98) and statistical similarity across a wide range of clinical chemistry analytes. Precision studies (n=60 per analyte) demonstrated acceptable within-run, among-run, and total %CV for all tested parameters.

Technological Characteristics

Automated random-access clinical chemistry analyzer. Analytical techniques: photometry and potentiometry (ISE). Throughput: 400 tests/hour. Optical path length: 5 mm. Reagent volume: 20-400 µL. Operating system: Windows NT. Connectivity: Standalone clinical chemistry system.

Indications for Use

Indicated for in vitro quantitation of analytes in serum, plasma, urine, and cerebrospinal fluid for medical diagnostic purposes.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Predicate Devices

• ILab 900/1800 Clinical Chemistry System (K932467)
• ILab 900/1800 Clinical Chemistry System - Urine Claims Added (K943595)
• IL Test Acid Phosphatase (K943366)
• IL Test CK-MB (K952646)
• IL Test Cholinesterase (K943367)
• IL Test Lipase (K952647)

Submission Summary (Full Text)

{0}------------------------------------------------

KL980757

## APR 2 | 1998

## SECTION 3

# ILab 600 Clinical Chemistry System - 510(k) SUMMARY (Summary of Safety and Effectiveness)

#### Submitted by:

Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] [phone] Fax:

#### Contact person:

Carol Marble Phone: [phone]

### Summary prepared:

February 26, 1998

#### Name of the device:

ILab 600 Clinical Chemistry System

### Classification name(s):

| CFR Ref. | Description | Class |
|----------|--------------------------------------------------------------------------------------------------------------------------------------|-------|
| 862.2300 | Colorimeter, photometer or spectrophotometer for clinical use<br>(75JJQ Colorimeter, photometer, spectrophotometer for clinical use) | I |
| 862.2500 | Enzyme analyzer for clinical use<br>(75JJI Analyzer, enzyme, for clinical use) | I |
| 862.1020 | Acid phosphatase (total or prostatic) test system | II |
| 862.1030 | Alanine amino transferase (ALT/SGPT) test system | I |
| 862.1035 | Albumin test system | II |
| 862.1050 | Alkaline phosphatase or isoenzymes test system | II |
| 862.1070 | Amylase test system | II |
| 862.1100 | Aspartate amino transferase (AST/SGOT) test system | II |
| 862.1110 | Bilirubin (total or direct) test system | II |
| 862.1145 | Calcium test system | II |
| 862.1150 | Calibrator | II |
| 862.1160 | Bicarbonate/carbon dioxide test system | II |
| 862.1170 | Chloride (total) test system | I |
| 862.1175 | Cholesterol | I |
| 862.1210 | Creatine test system | II |
| 862.1215 | Creatine phosphokinase/creatine kinase or isoenzymes test system | II |

{1}------------------------------------------------

### Classification name(s) (Continued)

| CFR Ref. | Description | Class |
|----------|----------------------------------------------------------|-------|
| 862.1225 | Creatinine test system | II |
| 862.1345 | Glucose test system | I |
| 862.1360 | Gamma-glutamyl transpeptidase and isoenzymes test system | I |
| 862.1410 | Iron (non-heme) test system | I |
| 862.1440 | Lactate dehydrogenase test system | II |
| 862.1465 | Lipase test system | I |
| 862.1495 | Magnesium test system | I |
| 862.1580 | Phosphorus (inorganic) test system | I |
| 862.1600 | Potassium test system | II |
| 862.1635 | Total protein test system | II |
| 862.1660 | Quality control material (assayed and unassayed) | I |
| 862.1665 | Sodium test system | II |
| 862.1705 | Triglyceride test system | I |
| 862.1770 | Urea nitrogen test system | I |
| 862.1775 | Uric acid test system | I |
| 862.3240 | Cholinesterase test system | I |

### Identification of predicate device(s):

| K932467 | ILab 900/1800 Clinical Chemistry System |
|---------|--------------------------------------------------------------|
| K943595 | ILab 900/1800 Clinical Chemistry System - Urine Claims Added |
| K943366 | IL Test Acid Phosphatase |
| K952646 | IL Test CK-MB |
| K943367 | IL Test Cholinesterase |

- IL Test Lipase K952647
### Description of the device/intended use(s):

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

### Statement of how the Technological Characteristics of the Device compare to the Predicate Device:

The ILab 600 uses the same technology as the ILab 900 and is substantially equivalent in performance, intended use, safety and effectiveness. The ILab 900 maintain the same reagent temperature, use the same reagent formulations and the same applications (proportional volumes). The ISE module on the ILab 600 is also very similar to that of the ILab 900 (predicate device); the same electrodes and solutions are utilized as is the same type of reaction mechanism.

| Main differences: | ILab 600 | ILab 900 |
|-----------------------|-------------------------|-----------------------|
| • Throughput | Medium (400 tests/hour) | High (600 tests/hour) |
| • Optical Path Length | 5 mm | 6 mm |
| • Operating System | Windows NT | In-house Developed |
| • Reagent Volume | 20-400 µL | 50-600 µL |

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## Summary of performance data:

## Method Comparison Studies

In method comparison studies evaluating serum samples, the ILab 600 and the ILab 900 (predicate device) were shown to be statistically similar for the tests listed below.

| IL Test | Units | n | Range | Slope | Intercept | r |
|----------------------------|--------|-----|------------|-------|-----------|-------|
| Acid Phosp., Non-Prostatic | U/L | 97 | 0.3-27.6 | 0.867 | 0.38 | 0.986 |
| Acid Phosp., Total | U/L | 94 | 0.4-33.4 | 0.957 | 0.197 | 0.996 |
| Albumin | g/dL | 98 | 2.9-5.5 | 1.047 | -0.183 | 0.985 |
| Alkaline Phosphatase | U/L | 108 | 24-623 | 1.052 | 5.94 | 0.999 |
| ALT/GPT | U/L | 109 | 2-2557 | 1.006 | -1.4 | 0.999 |
| Amylase | U/L | 110 | 25-377 | 1.040 | 0.1 | 0.997 |
| AST/GOT | U/L | 115 | 14-2377 | 1.065 | 0.1 | 0.998 |
| Bilirubin, Direct | mg/dL | 100 | 0.03-15.19 | 0.989 | -0.029 | 0.999 |
| Bilirubin, Total | mg/dL | 99 | 0.02-26.52 | 0.955 | 0.034 | 0.999 |
| Calcium | mg/dL | 98 | 6.5-15.6 | 1.040 | -0.028 | 0.990 |
| Cholesterol | mg/dL | 117 | 40-944 | 1.005 | 2.334 | 0.997 |
| Cholinesterase | U/L | 107 | 2166-12692 | 1.002 | 195.4 | 0.990 |
| CK/CPK | U/L | 103 | 18-3759 | 0.933 | 6.72 | 0.998 |
| CK-MB | U/L | 110 | 0.6-237.2 | 1.003 | -1.4 | 0.997 |
| Creatinine | mg/dL | 99 | 0.8-7.1 | 1.029 | 0.147 | 0.998 |
| Glucose Hexokinase | mg/dL | 113 | 60-457 | 1.017 | 0.358 | 0.997 |
| Glucose Oxidase | mg/dL | 137 | 51-393 | 0.944 | 7.92 | 0.997 |
| γ-GT | U/L | 122 | 4-497 | 1.052 | 1.2 | 0.999 |
| Iron | µg/dL | 97 | 10-253 | 1.040 | 2.37 | 0.998 |
| LD-L/LDH-L | U/L | 95 | 45-404 | 0.997 | 3.56 | 0.992 |
| Lipase | U/L | 64 | 8-2719 | 0.972 | -1.7 | 0.999 |
| Magnesium | mg/dL | 103 | 1.60-8.24 | 0.988 | 0.01 | 0.994 |
| Phosphorus | mg/dL | 100 | 2.5-11.3 | 0.976 | 0.06 | 0.998 |
| TCO2 | mmol/L | 102 | 10-36 | 1.079 | -1.43 | 0.987 |
| Total Protein | g/dL | 98 | 4.6-8.8 | 0.966 | 0.16 | 0.992 |
| Triglycerides | mg/dL | 96 | 37-1039 | 0.978 | 1.414 | 0.999 |
| Urea Nitrogen | mg/dL | 119 | 7.0-68.0 | 1.007 | -0.015 | 0.998 |
| Uric Acid | mg/dL | 99 | 1.9-15.9 | 0.963 | 0.11 | 0.995 |
| ISE Chloride | mmol/L | 90 | 36.8-143.2 | 1.028 | -1.39 | 0.998 |
| ISE Potassium | mmol/L | 79 | 2.0-7.3 | 1.013 | -0.04 | 0.999 |
| ISE Sodium | mmol/L | 90 | 62.4-157.4 | 1.011 | 1.39 | 0.999 |
| IL Test | Units | n | Range | Slope | Intercept | r |
| Amylase | U/L | 65 | 26-6068 | 0.953 | -21 | 0.999 |
| Calcium | mg/dL | 70 | 20-92 | 0.923 | -0.07 | 0.995 |
| Creatinine | mg/dL | 59 | 49-263 | 1.065 | 4.2 | 0.992 |
| Glucose Hexokinase | mg/dL | 95 | 4-690 | 1.027 | 2.55 | 0.996 |
| Glucose Oxidase | mg/dL | 80 | 0-801 | 0.949 | 4.29 | 0.997 |
| Phosphorus | mg/dL | 60 | 36-161 | 0.953 | -2.3 | 0.980 |
| Urea Nitrogen | mg/dL | 58 | 200-1649 | 1.060 | 13.7 | 0.992 |
| Uric Acid | mg/dL | 70 | 9-91 | 0.989 | 1.84 | 0.997 |
| ISE Chloride | mmol/L | 50 | 73-249 | 1.042 | -5.74 | 0.998 |
| ISE Potassium | mmol/L | 49 | 19-85 | 1.083 | -1.3 | 0.999 |
| ISE Sodium | mmol/L | 49 | 73-194 | 1.000 | 5.36 | 0.999 |

{3}------------------------------------------------

### Method Comparison Studies (Continued)

In method comparison studies evaluating urine samples, the ILab 600 and the ILab 900 (predicate device) were shown to be statistically similar for the tests listed below.

In a method comparison study evaluating cerebrospinal fluid samples, the ILab 600 and the ILab 900 (predicate device) were shown to be statistically similar for the test shown below.

| IL Test | Units | n | Range | Slope | Intercept | r |
|-----------------|-------|----|----------|-------|-----------|-------|
| Glucose Oxidase | mg/dL | 20 | 40 - 226 | 0.932 | -0.117 | 1.000 |

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## Precision Studies

Two levels of serum samples (except IL Test Cholesterol which used three) were tested in triplicate I wo levels of berail banking to runs total, n=60) on an ILab 600 Clinical Chemistry System. The results are given below. and the same of the same of the same of the same of the states of the states and

| IL Test | Serum<br>Sample | Mean | Within Run<br>%CV | Among Run<br>%CV | Among Day<br>%CV | Total<br>%CV |
|-------------------|-----------------|---------------|-------------------|------------------|------------------|--------------|
| Acid Phos., NP | Level 1 | 1.51 U/L | 8.51 | 3.24 | 7.01 | 11.49 |
| Acid Phos., NP | Level 2 | 1.75 U/L | 9.61 | 0.00 | 6.64 | 11.68 |
| Acid Phos., Total | Level 1 | 1.9 U/L | 5.78 | 0.00 | 7.89 | 9.78 |
| Acid Phos., Total | Level 2 | 2.5 U/L | 4.85 | 0.00 | 6.22 | 7.89 |
| Albumin | Level 1 | 2.4 g/dL | 1.69 | 0.38 | 0.44 | 1.79 |
| Albumin | Level 2 | 4.1 g/dL | 1.00 | 0.41 | 0.00 | 1.08 |
| Alk. Phosphatase | Level 1 | 43 U/L | 3.73 | 3.43 | 3.94 | 6.42 |
| Alk. Phosphatase | Level 2 | 187 U/L | 1.28 | 2.78 | 1.46 | 3.40 |
| ALT/GPT | Level 1 | 53 U/L | 0.91 | 0.87 | 0.00 | 1.26 |
| ALT/GPT | Level 2 | 101 U/L | 0.64 | 0.37 | 0.66 | 0.99 |
| Amylase | Level 1 | 45 U/L | 1.51 | 0.71 | 0.00 | 1.67 |
| Amylase | Level 2 | 149 U/L | 0.97 | 0.23 | 0.42 | 1.08 |
| AST/GOT | Level 1 | 25 U/L | 2.28 | 3.00 | 0.72 | 3.83 |
| AST/GOT | Level 2 | 52 U/L | 0.97 | 0.74 | 0.00 | 1.22 |
| Bilirubin, Direct | Level 1 | 0.18 mg/dL | 2.72 | 5.51 | 6.98 | 9.30 |
| Bilirubin, Direct | Level 2 | 2.12 mg/dL | 0.86 | 2.31 | 3.51 | 4.29 |
| Bilirubin, Total | Level 1 | 0.54 mg/dL | 2.62 | 4.70 | 3.94 | 6.72 |
| Bilirubin, Total | Level 2 | 3.70 mg/dL | 0.45 | 0.81 | 1.13 | 1.46 |
| Calcium | Level 1 | 9.0 mg/dL | 1.27 | 0.00 | 0.66 | 1.43 |
| Calcium | Level 2 | 13.6 mg/dL | 1.00 | 0.00 | 0.72 | 1.23 |
| Cholesterol | Level 1 | 94 mg/dL | 1.66 | 1.30 | 0.00 | 2.11 |
| Cholesterol | Level 2 | 175 mg/dL | 1.31 | 0.00 | 0.36 | 1.35 |
| Cholesterol | Level 3 | 207 mg/dL | 0.92 | 0.68 | 0.76 | 1.37 |
| Cholinesterase | Level 1 | 2399 U/L | 0.52 | 1.17 | 6.00 | 6.13 |
| Cholinesterase | Level 2 | 7078 U/L | 0.76 | 1.42 | 6.06 | 6.27 |
| CK/CPK | Level 1 | 109 U/L | 1.95 | 1.70 | 2.07 | 3.31 |
| CK/CPK | Level 2 | 368 U/L | 1.98 | 2.94 | 4.28 | 5.56 |
| CK-MB | Level 1 | 25.2 U/L | 2.74 | 7.38 | 4.44 | 9.04 |
| CK-MB | Level 2 | 99.2 U/L | 1.08 | 3.61 | 2.57 | 4.56 |
| Creatinine | Level 1 | 1.0 mg/dL | 4.53 | 0.00 | 1.51 | 4.70 |
| Creatinine | Level 2 | 4.3 mg/dL | 1.29 | 0.25 | 0.81 | 1.54 |
| Glu. Hexokinase | Level 1 | 83 mg/dL | 0.87 | 0.20 | 0.28 | 0.93 |
| Glu. Hexokinase | Level 2 | 263 mg/dL | 0.72 | 0.37 | 0.00 | 0.81 |
| Glucose Oxidase | Level 1 | 73 mg/dL | 1.31 | 0.00 | 0.75 | 1.51 |
| Glucose Oxidase | Level 2 | 248 mg/dL | 0.75 | 0.44 | 0.34 | 0.94 |
| γ-GT | Level 1 | 19 U/L | 1.53 | 1.05 | 0.97 | 2.09 |
| γ-GT | Level 2 | 123 U/L | 0.93 | 0.41 | 0.24 | 1.05 |
| Iron | Level 1 | 129 µg/dL | 0.71 | 0.00 | 0.57 | 0.91 |
| Iron | Level 2 | 193 µg/dL | 0.75 | 0.40 | 0.85 | 1.20 |
| LD-L/LDH-L | Level 1 | 141 U/L | 1.67 | 0.86 | 1.69 | 2.53 |
| LD-L/LDH-L | Level 2 | 442 U/L | 1.79 | 0.66 | 1.25 | 2.28 |
| | Serum | | Within Run | Among Run | Among Day | Total |
| IL Test | Sample | Mean | %CV | %CV | %CV | %CV |
| | Level 1 | 19 U/L | 9.48 | 0.00 | 5.06 | 10.74 |
| Lipase | Level 2 | 352 U/L | 0.84 | 0.00 | 2.18 | 2.34 |
| | Level 1 | 1.86 mg/dL | 1.15 | 3.40 | 0.00 | 3.58 |
| Magnesium | Level 2 | 5.06 mg/dL | 0.90 | 2.23 | 2.04 | 3.16 |
| | Level 1 | 3.45 mg/dL | 1.45 | 0.00 | 0.61 | 1.57 |
| Phosphorus | Level 2 | 6.44 mg/dL | 0.98 | 0.53 | 0.00 | 1.12 |
| | Level 1 | 14.92 mmol/L | 3.12 | 0.00 | 3.30 | 4.54 |
| TCO2 | Level 2 | 30.80 mmol/L | 1.26 | 0.87 | 2.10 | 2.60 |
| | Level 1 | 3.8 g/dL | 1.13 | 0.00 | 0.44 | 1.21 |
| Total Protein | Level 2 | 6.9 g/dL | 0.98 | 0.00 | 0.38 | 1.05 |
| | Level 1 | 64 mg/dL | 1.48 | 2.61 | 3.18 | 4.37 |
| Triglycerides | Level 2 | 197 mg/dL | 0.77 | 0.91 | 1.66 | 2.04 |
| | Level 1 | 15.7 mg/dL | 1.05 | 2.15 | 5.30 | 5.82 |
| Urea Nitrogen | Level 2 | 53.6 mg/dL | 0.79 | 1.59 | 4.26 | 4.62 |
| | Level 1 | 3.3 mg/dL | 1.17 | 3.37 | 0.48 | 3.60 |
| Uric Acid | Level 2 | 7.9 mg/dL | 0.77 | 1.53 | 0.57 | 1.80 |
| | Level 1 | 83.00 mmol/L | 0.69 | 1.26 | 0.24 | 1.45 |
| ISE Chloride | Level 2 | 108.67 mmol/L | 0.46 | 0.58 | 0.00 | 0.74 |
| | Level 1 | 4.18 mmol/L | 1.16 | 0.00 | 0.52 | 1.27 |
| ISE Potassium | Level 2 | 7.20 mmol/L | 0.41 | 0.69 | 0.77 | 1.11 |
| | Level 1 | 130 mmol/L | 0.70 | 0.38 | 0.50 | 0.94 |
| ISE Sodium | Level 2 | 150 mmol/L | 0.53 | 0.20 | 0.36 | 0.67 |

{5}------------------------------------------------

## Precision Studies (Continued)

Two levels of urine samples were tested in triplicate twice a day for 10 days (20 runs total, n=60) on an ILab 600 Clinical Chemistry System. The results are given below.

| IL Test | Urine<br>Sample | Mean | Within Run<br>%CV | Among Run<br>%CV | Among Day<br>%CV | Total<br>%CV |
|-----------------|-----------------|-------------|-------------------|------------------|------------------|--------------|
| Amylase | Level 1 | 139.0 U/L | 1.89 | 1.20 | 1.26 | 2.56 |
| Amylase | Level 2 | 410.0 U/L | 1.49 | 1.00 | 1.10 | 2.02 |
| Calcium | Level 1 | 3.9 mg/dL | 2.58 | 0.00 | 2.19 | 3.18 |
| Calcium | Level 2 | 5.9 mg/dL | 1.67 | 1.32 | 1.50 | 2.50 |
| Creatinine | Level 1 | 71.6 mg/dL | 1.40 | 0.00 | 1.58 | 2.11 |
| Creatinine | Level 2 | 108.0 mg/dL | 1.11 | 0.00 | 1.33 | 1.73 |
| Glu. Hexokinase | Level 1 | 63.0 mg/dL | 1.78 | 1.82 | 2.28 | 3.41 |
| Glu. Hexokinase | Level 2 | 223.0 mg/dL | 1.88 | 0.00 | 1.28 | 2.28 |
| Glucose Oxidase | Level 1 | 56.0 mg/dL | 1.38 | 1.18 | 1.85 | 2.60 |
| Glucose Oxidase | Level 2 | 201.0 mg/dL | 1.32 | 1.14 | 0.76 | 1.91 |
| Phosphorus | Level 1 | 41.5 mg/dL | 2.20 | 0.92 | 0.00 | 2.38 |
| Phosphorus | Level 2 | 59.0 mg/dL | 1.77 | 0.00 | 1.41 | 2.26 |
| Urea Nitrogen | Level 1 | 493.0 mg/dL | 1.49 | 0.00 | 0.78 | 1.68 |
| Urea Nitrogen | Level 2 | 964.0 mg/dL | 1.17 | 0.43 | 0.87 | 1.52 |
| Uric Acid | Level 1 | 16.2 mg/dL | 2.75 | 0.00 | 5.69 | 6.32 |
| Uric Acid | Level 2 | 28.5 mg/dL | 1.92 | 0.00 | 2.36 | 3.05 |

Section 3

" مستعمانية"

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

{6}------------------------------------------------

# Precision Studies (Continued)

| IL Test | Urine<br>Sample | Mean | Within Run<br>%CV | Among Run<br>%CV | Among Day<br>%CV | Total<br>%CV |
|---------------|-----------------|--------------|-------------------|------------------|------------------|--------------|
| ISE Chloride | Level 1 | 105.0 mmol/L | 0.35 | 0.84 | 0.19 | 0.93 |
| ISE Chloride | Level 2 | 203.0 mmol/L | 0.44 | 0.55 | 0.75 | 1.03 |
| ISE Potassium | Level 1 | 25.8 mmol/L | 0.26 | 0.54 | 1.69 | 1.79 |
| ISE Potassium | Level 2 | 70.0 mmol/L | 0.44 | 1.02 | 2.42 | 2.66 |
| ISE Sodium | Level 1 | 95.0 mmol/L | 0.38 | 0.43 | 0.97 | 1.13 |
| ISE Sodium | Level 2 | 166.0 mmol/L | 0.37 | 0.20 | 0.50 | 0.65 |

Two levels of cerebrospinal fluid samples were tested in triplicate twice a day for 5 days (10 runs total, n=30) using IL Test Glucose Oxidase on an ILab 600 Clinical Chemistry System. The results are given below.

| IL Test | CSF<br>Sample | Mean | Within Run<br>%CV | Among Run<br>%CV | Among Day<br>%CV | Total<br>%CV |
|-----------------|---------------|------------|-------------------|------------------|------------------|--------------|
| | Level 1 | 45.5 mg/dL | 1.50 | 0.47 | 0.00 | 1.49 |
| Glucose Oxidase | Level 2 | 90.3 mg/dL | 0.77 | 0.46 | 0.45 | 0.98 |

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 21 1998

Carol Marble . Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue 02173-3190 Lexington, Massachusetts

Re : K980757 ILab™ 600 Clinical Chemistry System Requlatory Class: II CGZ, CEK, CEM, CFJ, CFR, CGA, CGS, CGX, Product Code: CIC, CIG, CIT, CIX, CJE, CKB, DIH, JFJ, JGJ, JGS, JIX, JJW, JJX, JJY, KHS Dated: February 26, 1998 February 27, 1998 Received:

Dear Ms. Marble:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification 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.

{8}------------------------------------------------

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact. the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" a

Sincerely yours,
Steven Litman

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

{9}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): k980757

Device Name: ILab 600 Clinical Chemistry System

### Indications for Use:

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) |
|---------------|-----------------------------------------|
| | Division of Clinical Laboratory Devices |
| 510(k) Number | K980757 |

| Prescription Use<br>(Per 21 CFR 801.019) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

Section 2
ILab 600 510(k)
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