AVL OPTI 1 PH/BLOOD GAS ANALYZER
Device Facts
| Record ID | K961161 |
|---|---|
| Device Name | AVL OPTI 1 PH/BLOOD GAS ANALYZER |
| Applicant | Avl Scientific Corp. |
| Product Code | CHL · Clinical Chemistry |
| Decision Date | Apr 26, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
Intended Use
The AVL OPTI 1 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO₂ and PO₂ in samples of whole blood in either a traditional blood gas or clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
Device Story
Microprocessor-based instrument measuring pH, PCO₂, and PO₂ in heparinized whole blood. Uses disposable, single-use cassettes containing three optical fluorescence sensors; cassette includes liquid buffer for calibration and waste containment. Instrument reads bar-coded calibration data from cassette; warms cassette to 37.0°C; performs calibration verification using internal precision gas cylinder. Modified to allow measurement of aqueous quality control product (OPTI-trol) prior to patient specimen analysis. Used in clinical labs or point-of-care settings by minimally qualified personnel. Output displayed on screen and printed via thermal printer; data interface via RS 232 C. Provides rapid blood gas analysis to support clinical decision-making.
Clinical Evidence
Three field studies compared the AVL OPTI 1 to IL 1312, AVL 995, and AVL OMNI analyzers using remnant patient whole blood specimens. Studies evaluated performance in both 'OPTI-trol' and 'Patient' modes. Results showed high correlation (r > 0.98) for pH, PCO₂, and PO₂ across all modes. Statistical analysis confirmed no significant difference (P<0.05) in mean values between measurement modes or compared to predicate devices. Bench testing included linearity and precision assessments, confirming performance consistency.
Technological Characteristics
Microprocessor-based fluorescence optode technology. Disposable single-use cassettes contain sensors, calibration buffer, and waste containment. Internal precision gas cylinder for calibration. Dimensions: 4.87 x 14.25 x 9.75 inches; Weight: 10 lb. Power: 100-240 VAC. Connectivity: RS 232 C interface (ASCII or ASTM). Measurement range: pH 6.9-7.7, PCO₂ 10-120 mmHg, PO₂ 20-500 mmHg. Sample size: 80 μL heparinized whole blood. Operating temperature: 37.0 ± 0.1 °C.
Indications for Use
Indicated for the measurement of pH, PCO₂, and PO₂ in heparinized whole blood samples. Intended for use in clinical laboratories or point-of-care settings by minimally qualified personnel.
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
- AVL OPTI 1 pH/Blood Gas Analyzer (K944089)
- AVL Model 995 pH / Blood Gas Analyzer (K895317)
- AVL COMPACT 2 pH / Blood Gas Analyzer (K942616)
Reference Devices
- IL Model 1312 pH/Blood Gas Analyzer
- AVL OMNI pH / Blood Gas / Electrolyte and tHb Analyzer
Related Devices
- K061730 — OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 · Osmetech, Inc. · Aug 4, 2006
- K200986 — OPTI® B-Lac Cassette · Opti Medical Systems, Inc. · Aug 2, 2021
- K160412 — GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) · Instrumentation Laboratory CO · Dec 14, 2016
- K240998 — ABL90 FLEX PLUS System · Radiometer Medicals Aps · Dec 13, 2024
Submission Summary (Full Text)
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APR 26 1996
A
K961161
510(k) Summary
(a) (1) Submitter's name, address
AVL Scientific Corporation
33 Mansell Court
Roswell, GA 30076
Contact Person
Randy Byrd
Quality Assurance Manager
(770) 587-4040 x 631
Date of preparation of this summary:
19 March 1996
(2) Device trade or proprietary name:
AVL OPTI 1 pH/Blood Gas Analyzer
Device common or usual name or classification name
pH / Blood Gas Analyzer
| Product Nomenclature | Classification Number | Class | Panel |
| --- | --- | --- | --- |
| BLOOD GASES / PH | 75 CHL | II | CHEMISTRY |
(3) Substantial Equivalence
Under 510(k) notification number K944089, AVL currently markets the AVL OPTI 1 pH/Blood Gas Analyzer.
Additionally, as in the former 510(k) submission, the AVL OPTI 1 is substantially equivalent to the AVL Model 995 pH / Blood Gas Analyzer [K895317] and AVL COMPACT 2 pH / Blood Gas Analyzer [K942616].
(4) Description of the new device
The AVL OPTI 1 is a microprocessor-based instrument using optical fluorescence for the measurement of pH, PCO₂ and PO₂ in samples of whole blood. A disposable, single-use cassette containing three optical fluorescence sensors is packaged in a sealed, foil pouch which bears a bar coded label with calibration and identification information. Immediately prior to use, the bar coded calibration information is read into the instrument and the cassette positioned in the instrument for calibration verification prior to measurement using a liquid buffer contained within the cassette, and a precision calibration gas contained in a cylinder inside the OPTI 1.
In order to provide our customers with an additional level of security in the quality control of results obtained with the OPTI 1, AVL has modified the operation of the OPTI 1 to allow the measurement of a traditional, ampouled, aqueous quality control product prior to any measurement of a patient's blood specimen in the same cassette. In this way, the customer is provided the advantage to develop a quality control program for the OPTI 1 from a selection or combination of traditional and non-traditional methods which fulfills the real and perceived requirements under CLIA '88 and various laboratory accreditation organizations.
AVL SCIENTIFIC CORPORATION
33 Mansell Court • P.O.Box 337 • Roswell, GA USA 30076 • Phone: (770) 587-4040 • Fax: (770) 518-7033
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510(k) Summary
AVL OPTI 1 pH / Blood Gas Analyzer
## (5) Intended use of the device.
The AVL OPTI 1 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO₂ and PO₂ in samples of whole blood in either a traditional blood gas or clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
## (6) Technological characteristics of the device.
The OPTI 1 pH Blood Gas Analyzer uses fluorescence optode technology similar to that used in commercially available products since late 1983 and is unchanged in principle of operation from the originally submitted 510(k) for this device.
### Calibration
A disposable, single-use cassette contains all the elements needed for calibration, QC sample measurement, patient sample measurement and waste containment. After reading the calibration information specific to a cassette into the instrument by 'swiping' the cassette packaged through a convenient bar code reader, the cassette is placed into the measurement chamber. The analyzer warms the cassette to 37.0 ± 0.1 °C, and performs a calibration verification on the sensors for pH, pCO₂ and pO₂ by passing a precision calibration gas mixture across the optode sensors. The pH channel is calibrated with precision pH buffer solution contained in the cassette.
### Technical Specifications
#### Measured Values
| Parameter | Range | Display Resolution | units |
| --- | --- | --- | --- |
| pH | 6.9 to 7.7 | 0.001 | pH units |
| PCO₂ | 10 to 120 | 0.1 | mmHg |
| PO₂ | 20 to 500 | 0.1 | mmHg |
| Barometric Pressure | 300 to 800 | 0.1 | mmHg |
### Operating Conditions
- Minimum Sample Size: 80 μL
- Sample Type: heparinized whole blood
- Sample Application: syringe, capillary or AVL Microsampler
- Sample Input: automatic aspiration
- Ambient Temperature: 15 - 32 °C (59 - 90 °F)
- Relative Humidity: 5% to 95% (non-condensing)
- Type of Measurement: fluorescence
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510(k) Summary
AVL OPTI 1 pH / Blood Gas Analyzer
## Data Management
- Printout ... Built-in thermal printer
- Interface ... RS 232 C with selectable baud rate
- Format ... 8 bits, no parity, 1 stop bit, ASCII or ASTM (bi-directional)
## Electrical Supply
- Voltage ... 100 - 240 VAC (50-60 Hz)
- Power Consumption (max.) ... 110 VA
## Dimensions and Weight
- Height x width x depth ... 4.87 x 14.25 x 9.75 inches (12.5 x 36.2 x 24.8 cm)
- Weight ... 10 lb. (4.53 kg)
## (b) (1) Summary of nonclinical tests submitted with the premarket notification for the device.
In order to assess the effects of carry-over or memory between the measurement of OPTI-trol and a whole blood patient specimen, tonometered whole blood specimens were analyzed on a group of four (4) OPTI 1 instruments in both modes of operation: OPTI-trol and Patient. Each measurement of OPTI-trol was followed by a blood measurement in the same cassette, then a second measurement taken in the same instrument with a second cassette. This protocol was repeated to obtain 3 sets of measurement for each mode of operation for each of 5 levels of gas containing $\mathrm{CO}_{2}$ and $\mathrm{O}_{2}$, and then repeated for each of the three levels of OPTI-trol. No significant difference $(P < 0.05)$ was demonstrated between the measurement of the blood specimens in either of the measurement modes; or between any of the levels of OPTI-trol.
Whole blood samples were analyzed on four (4) OPTI 1 systems and on 1 AVL 995 after being tonometered at $37^{\circ}\mathrm{C}$ to various concentrations of $\mathrm{CO}_{2}$ and $\mathrm{O}_{2}$ concentrations certified to $0.03\%$ absolute by the manufacturer. The 995 was confirmed to have measurement of N.I.S.T. traceable pH buffer solutions (QUALIDATA, RNA Medical), at $6.841 \pm 0.005$, $7.100 \pm 0.005$, $7.383 \pm 0.005$ and $7.600 \pm 0.005$ each day prior to measurement of blood specimens.
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510(k) Summary
AVL OPTI 1 pH / Blood Gas Analyzer
| Parameter | Slope | Y-Intercept | Correlation Coefficient | Sy*x | Range |
| --- | --- | --- | --- | --- | --- |
| pH | | | | | |
| OPTI-trol Mode | 1.0081 | -0.046 | 0.9994 | 0.0067 | 7.0 - 7.6 |
| Patient Mode | 0.9905 | 0.076 | 0.9997 | 0.0047 | " |
| Total | 0.9993 | 0.015 | 0.9996 | 0.0051 | " |
| PCO2 | | | | | |
| OPTI-trol Mode | 0.9954 | +0.119 | 0.9998 | 0.6822 | 11-104 |
| Patient Mode | 1.0038 | -0.084 | 0.9998 | 0.6697 | " |
| Total | 0.9996 | +0.017 | 0.9998 | 0.6243 | " |
| PO2 | | | | | |
| OPTI-trol Mode | 0.9636 | 1.1497 | 0.99996 | 1.5635 | 21-515 |
| Patient Mode | 0.9704 | 0.8665 | 0.99994 | 1.8235 | " |
| Total | 0.9670 | 1.0081 | 0.99996 | 1.5773 | " |
Model equation for regression statistics is: [results of OPTI 1 Analyzer] = slope(m) [comparative method results] + intercept(b).
## (b) (2) Summary of clinical tests submitted with the premarket notification for the device.
Three field tests were conducted to demonstrate the correlation of the AVL OPTI 1 to legally marketed predicate devices in a clinical setting, operated by personnel trained to perform and report these analyses. Specimens analyzed in these tests were remnant from patient specimens collected for routing analysis on existing instrumentation. Measurement was accomplished in both modes of operation (OPTI-trol Mode and Patient Mode) on whole blood specimens for pH, PCO2 and PO2 in comparison to:
IL Model 1312 pH/Blood Gas Analyzer, AVL 995 pH / Blood Gas Analyzer and AVL OMNI pH / Blood Gas / Electrolyte and tHb Analyzer
In all evaluations, there was no difference in mean values (P<0.05) obtained on blood sample measurement performed with our without the prior analysis of OPTI-trol. The table below provides data representative of that collected in these field tests.
### Comparative Method: IL 1312 pH/Blood Gas Analyzer
| Parameter | Slope | Y-Intercept | Correlation Coefficient | Sy*x | n | Range |
| --- | --- | --- | --- | --- | --- | --- |
| pH | | | | | | |
| OPTI-trol Mode | 1.0174 | -0.1285 | 0.9869 | 0.0210 | 92 | 6.90 - 7.58 |
| Patient Mode | 1.0392 | -0.2924 | 0.9881 | 0.0181 | 92 | " |
| Total | 1.0304 | -0.2266 | 0.9908 | 0.0173 | 101 | " |
| PCO2 | | | | | | |
| OPTI-trol Mode | 1.0924 | -4.1204 | 0.9951 | 1.5905 | 92 | 23 - 110 |
| Patient Mode | 1.0806 | -2.9589 | 0.9930 | 1.7704 | 92 | " |
| Total | 1.0938 | -3.8301 | 0.9951 | 1.5302 | 101 | " |
| PO2 | | | | | | |
| OPTI-trol Mode | 0.9295 | 9.0345 | 0.9850 | 6.4536 | 92 | 30 - 271 |
| Patient Mode | 0.9590 | 4.7543 | 0.9918 | 5.1072 | 92 | " |
| Total | 0.9532 | 6.0512 | 0.9904 | 5.3436 | 101 | " |
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510(k) Summary
AVL OPTI 1 pH / Blood Gas Analyzer
(b) (3) Conclusions drawn from the clinical and nonclinical trials.
Analysis of the comparative measurement presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical and nonclinical trials demonstrates that the AVL OPTI 1, with the additional feature allowing the analysis of OPTI-trol quality control liquid prior to patient sample analysis, is safe and effective. There is no significant difference in the measurement values obtained on whole blood with the AVL OPTI 1 and those obtained with predicate devices in this study, with or without the analysis of OPTI-trol as a quality control specimen prior to patient sample analysis.
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