(51 days)
No
The summary describes a microprocessor-controlled analyzer using established technologies like ISE potentiometry and co-oximetry for quantitative measurements. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of various parameters in blood and expired gases, primarily for laboratory use to provide measured and calculated results, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the quantitative in vitro diagnostic determination" of various parameters in blood and expired gases. It further specifies that the results are used to "monitor electrolyte balance," which is a diagnostic purpose.
No
The device description explicitly states that the IL Synthesis is a "family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers," indicating it includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the device is for "quantitative in vitro diagnostic determination" of various analytes in whole blood and expired gases. This is the primary characteristic of an IVD.
- Device Description: The description refers to it as a "blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers," which are all types of devices used for in vitro diagnostic testing.
- Intended User/Care Setting: It is designed for "laboratory use," which is a typical setting for IVD devices.
The document clearly indicates that the device is intended to be used outside of the body to examine specimens (blood and expired gases) to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
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 (L 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 (C1-), 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 selectrode (ISE) petentiometry. 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 (O ct) oxygen binding capacity (O2 cap) and oxygen saturation (sO2m).
Product codes
75CHL, 75JF98, 75CGZ, 75LFR, 75CEM, 75JJE, 75JJQ, 91JKS, 81GKF, 81GKR, 81GHS, 81GLY
Device Description
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.
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
The IL Synthesis is designed for laboratory use to provide both measured and calculated results for blood gases, electrolytes, substrates, and co-oximeters on blood and gas samples.
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: Between-day imprecision study for Blood Gas using contrIL PLUS and HCT CHECK QC Material.
Sample Size: For pH, pCO2, pO2, Na, and K, 60 replicates on each of three IL Synthesis instruments (5 replicates/day for 12 days). For calcium, chloride, and glucose, 60 replicates on each of two IL Synthesis instruments (5 replicates/day for 12 days). For hematocrit, 12 replicates on each of 3 instruments (two levels of Hct CHECK run for 12 days).
Key Results: Imprecision (SD, %CV) measurements were reported across three levels for various parameters (pH, pCO2, pO2, Na, K, Ca, Cl, Glu, Hct) on multiple instruments. %CV values ranged from 0.07% to 4.01% for blood gas and electrolyte parameters and 0.80% to 1.39% for Hct.
Study Type: Between-day imprecision study for CO-OX using dye-based controls.
Sample Size: For each parameter (tHb, O₂Hb, COHb, MetHb), 15 replicates on each of three IL Synthesis instruments (5 replicates/day for 3 days).
Key Results: Imprecision (SD, %CV) measurements were reported across three levels for various CO-OX parameters (tHb, O₂Hb, COHb, MetHb) on multiple instruments. %CV values ranged from 0.00% to 5.42%.
Data Source: The data were collected during in-house studies.
Key Metrics
%CV (Coefficient of Variation) and SD (Standard Deviation) for quantitative measurements of pH, pCO2, pO2, Na, K, Ca, Cl, Glu, Hct, tHb, O₂Hb, COHb, MetHb.
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
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.
0
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 (617) 861-4182 fax (617) 861-4464
Contact Person:
Betty Lane phone (617) 861-4182
Summary Prepared:
September 20, 1996
Name of the device:
IL Synthesis™
Classification name(s):
| 75CHL | Electrode measurement, blood-gases (PCO2, PO2) and blood pH
862.1120 Blood-Gases (PCO2, PO2) and blood pH test system | Class II |
|--------|--------------------------------------------------------------------------------------------------------------------------|----------|
| 75JF98 | Electrode, ion specific, calcium
862.1145 Calcium test system | Class II |
| 75CGZ | Electrode, ion specific, chloride
862.1170 Chloride test system | Class II |
| 75LFR | Glucose dehydrogenase, glucose
862.1345 Glucose test system | Class II |
| 75CEM | Electrode, ion specific, potassium
862.1600 Potassium test system | Class II |
| | 862.1665 Sodium test system | Class II |
| Section 3 | IL Synthesis 510(k) | Page 1 of |
|---|---|---|
| ----------- | --------------------- | ----------- |
1
Classification name(s) (Cont.):
| 75JJE | Analyzer, chemistry (photometric. discrete), for clinical use
862.2160 Discrete photometric chemistry analyzer for clinical use | Class I |
|-------|---------------------------------------------------------------------------------------------------------------------------------------|----------|
| 75JJQ | Colorimeter, photometer, spectrophotometer for clinical use
862.2300 Colorimeter, photometer or spectrophotometer for clinical use | Class I |
| 91JKS | Spectral absorb, curve, oxyhemoglobin, carboxyhemoglobin,
carbon-monoxide
862.3220 Carbon monoxide test system | Class I |
| 81GKF | Instrument, hematocrit, automated
864.5600 Automated hematocrit instrument | Class II |
| 81GKR | System, hemoglobin, automated
864.5620 Automated hemoglobin system | Class II |
| 81GHS | Assay, carboxyhemoglobin
864.7425 Carboxyhemoglobin assay | Class II |
| 81GLY | Oximeter to measure hemoglobin
864.7500 Whole blood hemoglobin assays | Class II |
| | 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 |
2
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 (L 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 (C1-), 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 selectrode (ISE) petentiometry. 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 (O ct) 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-oximeters 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. L 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).
3
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 | |
| pCO2 | |||||||||||
| (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 | |
| pO2 | |||||||||||
| (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 | N/A | N/A | N/A | |
| 3 | 60 | 1.57 | 0.018 | 1.14 | 1.555 | 0.0146 | 0.94 | N/A | N/A | N/A | |
| 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 | N/A | N/A | N/A | 109.6 | 1.13 | 1.03 | |
| 3 | 60 | 137.1 | 0.73 | 0.53 | N/A | N/A | N/A | 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 | N/A | N/A | N/A | 84.75 | 3.24 | 3.83 | 86.56 | 1.09 | 1.26 | |
| 3 | 60 | N/A | N/A | N/A | 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 | 0.49 | 1.31 | 64.9 | 0.51 | 0.79 |
Between day imprecision results were generated by using three levels of Contrill Plus. For pH, pCO2, pO2, 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 Ca++, Cl-, and Glu.
4
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 |
| tHb | |||||||||||
| (mg/dL) | 2 | 15 | 13.78 | 0.65 | 4.68 | 13.82 | 0.35 | 2.55 | 13.52 | 0.18 | 1.33 |
| tHb | |||||||||||
| (mg/dL) | 3 | 15 | 17.69 | 0.91 | 5.12 | 17.86 | 0.55 | 3.10 | 17.15 | 0.12 | 0.70 |
| O₂Hb | |||||||||||
| (%) | 1 | 15 | 45.26 | 0.16 | 0.34 | 44.86 | 0.10 | 0.22 | 44.90 | 0.09 | 0.20 |
| O₂Hb | |||||||||||
| (%) | 2 | 15 | 93.56 | 0.08 | 0.08 | 93.54 | 0.08 | 0.08 | 93.66 | 0.08 | 0.08 |
| O₂Hb | |||||||||||
| (%) | 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 |
| COHb | |||||||||||
| (%) | 2 | 15 | 3.94 | 0.04 | 1.04 | 3.99 | 0.04 | 0.92 | 3.99 | 0.04 | 0.94 |
| COHb | |||||||||||
| (%) | 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 |
| MetHb | |||||||||||
| (%) | 2 | 15 | 1.99 | 0.04 | 1.84 | 1.88 | 0.06 | 3.07 | 1.78 | 0.09 | 4.79 |
| MetHb | |||||||||||
| (%) | 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.