IL SYNTHESIS

K963800 · Instrumentation Laboratory CO · CHL · Nov 13, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963800
• Device Name: IL SYNTHESIS
• Applicant: Instrumentation Laboratory CO
• Product Code: CHL · Clinical Chemistry
• Decision Date: Nov 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The IL Synthesis (hardware, software, and reagents) is for the quantitative in vitro diagnostic determination of pH, pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen), sodium (Na+), potassium (K+), calcium (Ca++), chloride (Cl-), glucose (Glu), and Hematocrit (conductivity) in whole blood or pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen) in expired gases by direct ion selective electrode (ISE) potentiometry. Sodium and potassium results are used to monitor electrolyte balance. Note that the number of electrodes is limited and any given instrument will only contain two of the three functions: calcium (Ca++), chloride (Cl-) and Glucose (Glu). The IL Synthesis (hardware, software, and reagents) also permits the quantitative in vitro diagnostic determination of five forms of hemoglobin in whole blood samples, total hemoglobin (tHb), oxyhemoglobin (%O₂Hb), carboxyhemoglobin (%COHb), methemoglobin (MetHb) and reduced hemoglobin, also called deoxyhemoglobin (%RHb) and will also calculate the following parameters: oxygen content of hemoglobin (O₂ct), oxygen binding capacity (O₂ cap), and oxygen saturation (sO₂m). The IL Synthesis is designed for laboratory use to provide both measured and calculated results for blood gases, electrolytes, substrates, and co-oximeter parameters on blood and gas samples.

Device Story

IL Synthesis is a fully automatic, microprocessor-controlled analyzer family; integrates blood gas, electrolyte, glucose, hematocrit, and co-oximeter modules. Inputs: whole blood or expired gas samples. Operation: direct ion selective electrode (ISE) potentiometry for electrolytes/gases; co-oximetry for hemoglobin fractions. Output: measured concentrations of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, hematocrit, and hemoglobin forms; calculated parameters include O₂ct, O₂ cap, and sO₂m. Used in clinical laboratories; operated by laboratory personnel. Healthcare providers use results to assess patient electrolyte balance and oxygenation status, informing clinical decisions regarding respiratory and metabolic management.

Clinical Evidence

Bench testing only. In-house studies evaluated between-day imprecision using three levels of ContrIL Plus and Hct CHECK QC materials, and dye-based controls for co-oximetry. Testing performed on three instruments (n=60 for blood gas/electrolytes; n=15 for co-oximetry). Results demonstrate consistent performance across parameters (pH, pCO2, pO2, Na, K, Ca, Cl, Glu, Hct, tHb, O2Hb, COHb, MetHb) with reported mean, SD, and %CV values.

Technological Characteristics

Fully automatic, microprocessor-controlled analyzer. Sensing: Ion Selective Electrode (ISE) potentiometry for electrolytes/gases; photometric/spectrophotometric analysis for co-oximetry. Measures pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, hematocrit (conductivity), and hemoglobin fractions. Modular configuration allows selection of two from Ca++, Cl-, and Glucose. Designed for laboratory use.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of pH, blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-), glucose, hematocrit, and hemoglobin fractions (tHb, O₂Hb, COHb, MetHb, RHb) in whole blood or expired gases for laboratory use to monitor electrolyte balance and oxygenation status.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• IL 1400 BGElectrolyte Analyzer (K890827/A)
• IL 1430 BGElectrolyte Analyzer (K935069/S2)
• IL BGGE Blood Gas with Glucose Analyzer (K955793)
• IL 682 CO-Oximeter (K945677/S2)
• Radiometer ICA2 Ionized Calcium Analyzer (K801848)

Submission Summary (Full Text)

{0}

NOV 13 1996
K963800

# SECTION 3
## IL Synthesis™ - 510(k) SUMMARY
### (Summary of Safety and Effectiveness)

## Submitted by:
Betty Lane
Director, Regulatory Affairs
Instrumentation Laboratory Company
113 Hartwell Avenue
Lexington, MA 02173
phone [phone]
fax [phone]

## Contact Person:
Betty Lane
phone [phone]

## Summary Prepared:
September 20, 1996

## Name of the device:
IL Synthesis™

## Classification name(s):
| 75CHL | Electrode measurement, blood-gases (PCO2, PO2) and blood pH | Class II |
| --- | --- | --- |
| 862.1120 | Blood-Gases (PCO2, PO2) and blood pH test system | Class II |
| 75JFØP | Electrode, ion specific, calcium | Class II |
| 862.1145 | Calcium test system | Class II |
| 75CGZ | Electrode, ion specific, chloride | Class II |
| 862.1170 | Chloride test system | Class II |
| 75LFR | Glucose dehydrogenase, glucose | Class II |
| 862.1345 | Glucose test system | Class II |
| 75CEM | Electrode, ion specific, potassium | Class II |
| 862.1600 | Potassium test system | Class II |
| 862.1665 | Sodium test system | Class II |

Section 3 IL Synthesis 510(k) Page 1 of 5

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# Classification name(s) (Cont.):

| 75JJE | Analyzer, chemistry (photometric, discrete), for clinical use | Class I |
| --- | --- | --- |
| 862.2160 | Discrete photometric chemistry analyzer for clinical use | |
| 75JJQ | Colorimeter, photometer, spectrophotometer for clinical use | Class I |
| 862.2300 | Colorimeter, photometer or spectrophotometer for clinical use | |
| 91JKS | Spectral absorb, curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide | Class I |
| 862.3220 | Carbon monoxide test system | |
| 81GKF | Instrument, hematocrit, automated | Class II |
| 864.5600 | Automated hematocrit instrument | |
| 81GKR | System, hemoglobin, automated | Class II |
| 864.5620 | Automated hemoglobin system | |
| 81GHS | Assay, carboxyhemoglobin | Class II |
| 864.7425 | Carboxyhemoglobin assay | |
| 81GLY | Oximeter to measure hemoglobin | Class II |
| 864.7500 | Whole blood hemoglobin assays | |
| 862.1150 | Calibrator | Class II |
| 862.1660 | Quality control material (assayed and unassayed) | Class I |
| 864.8625 | Hematology quality control mixture | Class II |

# Identification of predicate device(s):

| IL 1400 BGElectrolyte Analyzer | K890827/A |
| --- | --- |
| IL 1430 BGElectrolyte Analyzer | K935069/S2 |
| IL BGGE Blood Gas with Glucose Analyzer | K955793 |
| IL 682 CO-Oximeter | K945677/S2 |
| Radiometer ICA2 Ionized Calcium Analyzer | K801848 |

Section 3
IL Synthesis 510(k)
Page 2 of 5

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# Description of the device/intended use(s):

The IL Synthesis is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers. Its technology combines that of the IL BGElectrolytes Analyzer (IL 1400/1430) and the IL BGGE Blood Gas with Glucose Analyzer (IL 1660) with an integrated co-oximeter module. The IL Synthesis will be available in several different configurations of blood gas, electrolytes, co-oximeter, and glucose.

The intended use, methodology, concentration levels, working range and analytical results of the IL Synthesis are substantially equivalent to the predicate devices: IL BGElectrolytes Analyzer (IL 1400/1430), IL BGGE Blood Gas with Glucose Analyzer (IL 1660) and the ICA2 Ionized Calcium Analyzer.

The IL Synthesis (hardware, software, and reagents) is for the quantitative *in vitro* diagnostic determination of pH, pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen), sodium (Na+), potassium (K+), calcium (Ca++), chloride (Cl-), glucose (Glu), and Hematocrit (conductivity) in whole blood or pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen) in expired gases by direct ion selective electrode (ISE) potentiometry. Sodium and potassium results are used to monitor electrolyte balance. Note that the number of electrodes is limited and any given instrument will only contain two of the three functions: calcium (Ca++), chloride (Cl-) and Glucose (Glu).

The IL Synthesis (hardware, software, and reagents) also permits the quantitative *in vitro* diagnostic determination of five forms of hemoglobin in whole blood samples, total hemoglobin (tHb), oxyhemoglobin (%O₂Hb), carboxyhemoglobin (%COHb), methemoglobin (MetHb) and reduced hemoglobin, also called deoxyhemoglobin (%RHb) and will also calculate the following parameters: oxygen content of hemoglobin (O₂ct), oxygen binding capacity (O₂ cap), and oxygen saturation (sO₂m).

The IL Synthesis is designed for laboratory use to provide both measured and calculated results for blood gases, electrolytes, substrates, and co-oximeter parameters on blood and gas samples.

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

The IL Synthesis uses the same technological characteristics as the predicate devices, IL BGElectrolytes Analyzer (IL 1400/1430), the BGGE Blood gas with Glucose Analyzer, and uses newer co-oximetry technology than the IL 682 CO-Oximeter. The IL Synthesis is substantially equivalent in performance, intended use, safety and effectiveness to the predicate devices: IL BGElectrolytes Analyzer (Cl), the IL BGGE Blood Gas with Glucose Analyzer (pH, pO2, pCO2, Na, K, Glu, Hct), Radiometer ICA2 Ionized Calcium Analyzer (Ca), and the IL 682 CO-Oximeter (co-ox).

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IL Synthesis 510(k)
Page 3 of 5

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Summary of performance data:
BLOOD GAS
BETWEEN DAY IMPRECISION
USING contrIL PLUS and HCT CHECK QC MATERIAL

| | | | INSTRUMENT 1 | | | INSTRUMENT 2 | | | INSTRUMENT 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Level | n | mean | SD | %CV | mean | SD | %CV | mean | SD | %CV |
| pH | 1 | 60 | 7.597 | 0.141 | 0.19 | 7.596 | 0.015 | 0.02 | 7.596 | 0.0146 | 0.19 |
| | 2 | 60 | 7.418 | 0.006 | 0.08 | 7.418 | 0.007 | 0.09 | 7.418 | 0.0056 | 0.08 |
| | 3 | 60 | 7.138 | 0.006 | 0.08 | 7.137 | 0.006 | 0.09 | 7.138 | 0.0053 | 0.07 |
| pCO_{2} (mmHg) | 1 | 60 | 20.63 | 0.32 | 1.57 | 20.54 | 0.37 | 1.81 | 19.75 | 0.30 | 1.53 |
| | 2 | 60 | 37.51 | 0.30 | 0.81 | 37.52 | 0.46 | 1.23 | 37.18 | 0.14 | 0.37 |
| | 3 | 60 | 64.21 | 0.83 | 1.29 | 65.30 | 0.58 | 0.89 | 66.25 | 0.37 | 0.56 |
| pO_{2} (mmHg) | 1 | 60 | 146.6 | 0.83 | 0.57 | 145.6 | 0.81 | 0.56 | 145.9 | 0.89 | 0.61 |
| | 2 | 60 | 88.4 | 1.51 | 1.84 | 87.0 | 1.37 | 1.58 | 87.2 | 1.21 | 1.39 |
| | 3 | 60 | 51.3 | 1.65 | 2.02 | 50.3 | 1.90 | 3.79 | 51.27 | 1.75 | 3.41 |
| Na (mmol/L) | 1 | 60 | 114.8 | 0.70 | 0.61 | 118.6 | 0.58 | 0.49 | 116.9 | 0.65 | 0.77 |
| | 2 | 60 | 137.0 | 0.85 | 0.62 | 140.8 | 0.92 | 0.65 | 138.5 | 0.67 | 0.48 |
| | 3 | 60 | 159.1 | 2.26 | 1.42 | 162.4 | 2.07 | 1.28 | 159.5 | 1.89 | 1.18 |
| K (mmol/L) | 1 | 60 | 2.58 | 0.027 | 1.05 | 2.55 | 0.052 | 2.05 | 2.59 | 0.0242 | 0.93 |
| | 2 | 60 | 4.38 | 0.060 | 1.37 | 4.35 | 0.052 | 1.20 | 4.40 | 0.0495 | 1.13 |
| | 3 | 60 | 6.09 | 0.099 | 1.62 | 6.13 | 0.139 | 2.27 | 6.11 | 0.0722 | 1.18 |
| Ca (mmol/L) | 1 | 60 | 0.625 | 0.011 | 1.82 | 0.628 | 0.0095 | 1.51 | N/A | N/A | N/A |
| | 2 | 60 | 1.03 | 0.029 | 2.84 | 1.025 | 0.0257 | 2.51 | | | |
| | 3 | 60 | 1.57 | 0.018 | 1.14 | 1.555 | 0.0146 | 0.94 | | | |
| Cl (mmol/L) | 1 | 60 | 85.8 | 3.44 | 4.01 | N/A | N/A | N/A | 86.9 | 3.48 | 3.50 |
| | 2 | 60 | 108.9 | 1.23 | 1.13 | | | | 109.6 | 1.13 | 1.03 |
| | 3 | 60 | 137.1 | 0.73 | 0.53 | | | | 137.0 | 0.79 | 0.58 |
| Gluc (mg/dL) | 1 | 60 | N/A | N/A | N/A | 59.67 | 1.72 | 2.88 | 62.08 | 1.10 | 1.31 |
| | 2 | 60 | | | | 84.75 | 3.24 | 3.83 | 86.56 | 1.09 | 1.26 |
| | 3 | 60 | | | | 237.2 | 8.62 | 3.63 | 216.2 | 8.03 | 3.72 |
| Hct (%) | Low | 12 | 36.1 | 0.29 | 0.80 | 37.7 | 0.49 | 1.31 | 36.8 | 0.39 | 1.06 |
| | High | 12 | 63.7 | 0.89 | 1.39 | 65.0 | 00.0 | 00.0 | 64.9 | 0.51 | 0.79 |

Between day imprecision results were generated by using three levels of ContrIL Plus. For pH, $\mathrm{pCO}_2$, $\mathrm{pO}_2$, Na and K, samples were run in replicates of 5 once a day for 12 days for a total of 60 replicates on each of three IL Synthesis instruments. For calcium, chloride and glucose, samples were run in replicates of 5 once a day for 12 days for a total of 60 replicates on each of two IL Synthesis instruments. For hematocrit, two levels of Hct CHECK were run for 12 days for a total of 12 replicates on each of 3 instruments. The data were collected during in-house studies.

N/A = Not available. The IL Synthesis can be configured with any two of $\mathrm{Ca}++$, Cl-, and Glu.

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IL Synthesis 510(k)
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Summary of performance data (continued):

CO-OX
BETWEEN DAY IMPRECISION
USING DYE-BASED CONTROLS

| | | | INSTRUMENT 1 | | | INSTRUMENT 2 | | | INSTRUMENT 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Parameter | Level | n | mean | SD | %CV | mean | SD | %CV | mean | SD | %CV |
| tHb (mg/dL) | 1 | 15 | 7.04 | 0.38 | 5.42 | 7.05 | 0.14 | 1.92 | 6.98 | 0.13 | 1.85 |
| | 2 | 15 | 13.78 | 0.65 | 4.68 | 13.82 | 0.35 | 2.55 | 13.52 | 0.18 | 1.33 |
| | 3 | 15 | 17.69 | 0.91 | 5.12 | 17.86 | 0.55 | 3.10 | 17.15 | 0.12 | 0.70 |
| O_{2}Hb (%) | 1 | 15 | 45.26 | 0.16 | 0.34 | 44.86 | 0.10 | 0.22 | 44.90 | 0.09 | 0.20 |
| | 2 | 15 | 93.56 | 0.08 | 0.08 | 93.54 | 0.08 | 0.08 | 93.66 | 0.08 | 0.08 |
| | 3 | 15 | 64.75 | 0.22 | 0.35 | 64.78 | 0.12 | 0.18 | 64.85 | 0.20 | 0.31 |
| COHb (%) | 1 | 15 | 53.73 | 0.15 | 0.28 | 54.15 | 0.08 | 0.14 | 54.13 | 0.09 | 0.18 |
| | 2 | 15 | 3.94 | 0.04 | 1.04 | 3.99 | 0.04 | 0.92 | 3.99 | 0.04 | 0.94 |
| | 3 | 15 | 34.71 | 0.22 | 0.63 | 34.72 | 0.09 | 0.27 | 34.70 | 0.20 | 0.57 |
| MetHb (%) | 1 | 15 | 0.50 | 0.00 | 0.00 | 0.473 | 0.04 | 8.62 | 0.413 | 0.04 | 8.83 |
| | 2 | 15 | 1.99 | 0.04 | 1.84 | 1.88 | 0.06 | 3.07 | 1.78 | 0.09 | 4.79 |
| | 3 | 15 | 0.50 | 0.00 | 0.00 | 0.50 | 0.00 | 0.00 | 0.46 | 0.04 | 9.72 |

Within run imprecision results were generated by using three levels of dye-based controls. For each parameter, samples were run in replicates of 5 once a day for 3 days for a total of 15 replicates on each of three IL Synthesis instruments. The data were collected during in-house studies.

Section 3
IL Synthesis 510(k)
Page 5 of 5