CALIBRATING MATERIAL, CALIBRATING STANDARDS
Device Facts
| Record ID | K033060 |
|---|---|
| Device Name | CALIBRATING MATERIAL, CALIBRATING STANDARDS |
| Applicant | Diamond Diagnostics, Inc. |
| Product Code | JIT · Clinical Chemistry |
| Decision Date | Mar 4, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Intended Use
These calibrators are intended to replace the original equipment manufacturer’s calibrators. Refer to Indications for Use for details. The fifteen Mission Diagnostic calibrator solutions appear in the table below, along with their intended use. PN Product Name Intended Use AV-BP1579D BG Calibrator Provide a second calibration point for the pH and pCO2electrodes on the AVL Compact 1 pH/Blood Gas Analyzer. CD-105670D Hct Slope Provide a second calibration point for the Hct sensor on the 348Analyzer. CD-471818D 634 Ca/pH Slope Standard To provide a second calibration point for the Ca & pH electrodeson the 634 Ca/pH Analyzer. CD-473606D 654 Lithium Slope Solution 2.50 mmol/L To provide a second calibration point for the Lithium electrodeon the 654 Na/K/Li Analyzer. CD-473692D pH Blood Gas Slope To provide a second calibration point for pH, pCO2, and pO2on 238 pH/Blood Gas Analyzer. RD-944015D Calibrating Solution 1, Btl# 9 To provide a calibration point for the Na+, K+, Ca++, Cl-, pH andglucose, lactate electrodes on Radiometer 605, 615, 625, EML100 & 105 Analyzers. RD-944030D Calibrating Solution 1, Btl# 3 To provide a calibration point for the Na+, K+, Ca++, Cl-, pH andglucose, lactate electrodes on Radiometer 605, 615, 625, EML100 & 105 Analyzers. RD-944031D Calibrating Solution 2, Btl# 4 To provide a second calibration point for the Na+, K+, Ca++, Cl-,and pH electrodes on Radiometer 555 Analyzer. BK-465908D Calibrator 1 Used in conjunction with Calibrator 2 and 3 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. BK-465909D Calibrator 2 Used in conjunction with Calibrator 1 and 3 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. BK-465910D Calibrator 3 Used in conjunction with Calibrator 1 and 2 to calibrate Na, K,Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX Delta, CX®CE, and CX9 ALX Systems. BK-443360D Calibration Standard 1 Used in conjunction with Calibration Standard 2 to calibrate Na,K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX3 and CX5 Systems. BK-443365D Calibration Standard 2 Used in conjunction with Calibration Standard 1 to calibrate Na,K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on BeckmanSynchron CX3 and CX5 Systems. BM-620427D ISE Standard High To provide a calibration point for Na+, K+ and Cl- electrodes onthe ISE module of Hitachi 7xx, 911, 912 and 917 Analyzers. BM-620428D ISE Standard Low To provide a calibration point for Na+, K+ and Cl- electrodes onthe ISE module of Hitachi 7xx, 911, 912 and 917 Analyzers.
Device Story
Mission Diagnostic Reagents are aqueous calibrating solutions containing salts; designed as direct replacements for OEM-specific calibrators. Used in clinical laboratory settings by technicians to calibrate automated analyzers (e.g., AVL, Radiometer, Beckman Synchron, Hitachi). Reagents provide known analyte concentrations to establish calibration points for electrodes; ensuring instrument accuracy for patient sample testing. Healthcare providers use analyzer outputs for diagnostic decision-making. Benefits include continued operation of existing clinical instrumentation using cost-effective, equivalent replacement reagents.
Clinical Evidence
No clinical data. Bench testing only. Value assignment performed by comparing recovery against OEM calibrator material or NIST standards. Stability studies (accelerated and real-time) conducted to verify concentration maintenance within specified tolerances over time.
Technological Characteristics
Liquid, ready-to-use aqueous salt solutions; tonometered with gas for blood gas analytes. Form factor: Vials. No energy source. Standalone use for instrument calibration. No software or algorithm involved.
Indications for Use
Indicated for in-vitro diagnostic use as calibrators for specific OEM pH, blood gas, and electrolyte analyzers to provide calibration points for various electrodes including Na+, K+, Cl-, Ca++, pH, pCO2, pO2, Hct, glucose, lactate, TCO2, BUN, and creatinine.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
- BG Calibrator (K943570)
- Hct Slope (K962021)
- 634 Slope Standard (K844188)
- 654 Lithium Slope Solution 2.50 mmol/L (K884769)
- pH Blood Gas Slope (K904188)
- Calibrating Solution 1, Btl# 9 (K954612)
- Calibrating Solution 1, Btl# 3 (K973367)
- Calibrator 2 (K942676)
- Calibration Standard 1 (K864236)
- ISE Standard High (K811194)
Related Devices
- K020894 — CALIBRATING MATERIAL, CAL-PAK, BUFFERS · Mission Diagnostics · Apr 29, 2002
- K013850 — STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE · Diamond Diagnostics, Inc. · Dec 21, 2001
- K031159 — CALIBRATING MATERIAL, CALIBRATING STANDARDS · Diamond Diagnostics, Inc. · Jun 25, 2003
- K020596 — CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS · Diamond Diagnostics, Inc. · Mar 23, 2002
Submission Summary (Full Text)
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| 510(k) Summary |
|--------------------------------------------|
| for Mission Diagnostic Reagents |
| on pH/Blood Gas &/or Electrolyte Analyzers |
| 1. Submitter's Name & Address | Mission Diagnostics<br>331 Fiske St<br>Holliston MA 01746<br>FAX: 508-429-0452 |
|-------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Linda Stundtner<br>QA/RA Manager<br>508-429-0450 |
| Establishment Registration Number: | 3003656721 |
|------------------------------------|---------------|
| Date of Preparation: | Dec. 29, 2003 |
2. Identification of the Device:
| Proprietary/Trade name: | Calibrating Material, Calibrating standards |
|-------------------------|-----------------------------------------------------------|
| Common or usual name | Calibrators for ISE and/or pH/Blood Gas automated systems |
| Classification name: | Calibrator, secondary |
| Device Classification | II |
21 CFR § 862.1150
Chemistry (75)
JIT
- Mission manufactures calibrators intended to serve as direct replacements to like named products . manufactured by Original Equipment Manufactures (OEM)
## 3. Predicate Device:
Panel:
Regulation Number:
Product Code:
- 4 2004
- Mission claims substantial equivalence to the OEM Calibrating Materials listed below: .
## Substantial Equivalence Table of Product PN's & Trade Names – Mission vs OEM
| # | Mission Diagnostics | | OEM* Equivalent | | | Cleared Date | PN | Description | Intended Use |
|----|---------------------|-------------------------------------------|------------------|---------------------------------------------|---------|--------------|------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Predicate Device | | | | AV-BP1579D | BG Calibrator | Provide a second calibration point for AVL Compact 1<br>pH/Blood Gas Analyzer. |
| 1 | AV-BP1579D | BG Calibrator | BP1579 | BG Calibrator | K943570 | 08-24-1994 | CD-105670D | Hct Slope | Provide a second calibration point for the Hct sensor on<br>the 348 Analyzer. |
| 2 | CD-105670D | Hct Slope | 105670 | Hct Slope | K962021 | 06-24-1996 | CD-471818D | 634 Ca/pH Slope Standard | To provide a second calibration point for the Ca & pH<br>electrodes on the 634 Ca/pH Analyzer. |
| 3 | CD-471818D | 634 Ca/pH Slope<br>Standard | 471818 | 634 Slope Standard<br>$2.50^{Ca}/6.84^{pH}$ | K844188 | 11-23-1988 | CD-473606D | 654 Lithium Slope Solution 2.50 mmol/L | To provide a second calibration point for the Lithium<br>electrode on the 654 Na/K/Li Analyzer. |
| 4 | CD-473606D | 654 Lithium Slope<br>Solution 2.50 mmol/L | 473606 | 654 Lithium Slope<br>Solution 2.50 mmol/L | K884769 | 01-17-1989 | CD-473692D | pH Blood Gas Slope | To provide a second calibration point for pH, pCO2, and<br>pO2 on 238 pH/Blood Gas Analyzer. |
| 5 | CD-473692D | pH Blood Gas Slope | 473692 | pH Blood Gas Slope | K904188 | 09-27-1990 | RD-944015D | Calibrating Solution 1, Btl# 9 | To provide a calibration point for the Na+, K+, Ca++, Cl-,<br>pH and glucose, lactate electrodes on Radiometer 605,<br>615, 625, EML 100 & 105 Analyzers. |
| 6 | RD-944015D | Calibrating Solution 1,<br>Bt # 9 | 944015 | Calibrating Solution 1,<br>Btl# 9 | K954612 | 11-09-1995 | RD-944030D | Calibrating Solution 1, Btl# 3 | To provide a calibration point for the Na+, K+, Ca++, Cl-,<br>pH and glucose, lactate electrodes on Radiometer 605,<br>615, 625, EML 100 & 105 Analyzers. |
| 7 | RD-944030D | Calibrating Solution 1,<br>Bt # 3 | 944030 | Calibrating Solution 1,<br>Btl# 3 | K973367 | 10-06-1997 | RD-944031D | Calibrating Solution 2, Btl# 4 | To provide a second calibration point for the Na+, K+,<br>Ca++, Cl-, and pH electrodes on Radiometer 555<br>Analyzer. |
| 8 | RD-944031D | Calibrating Solution 2,<br>Bt # 4 | 944031 | Calibrating Solution 2,<br>Btl# 4 | | | BK-465908D | Calibrator 1 | Used in conjunction with Calibrator 2 and 3 to calibrate<br>Na, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on<br>Beckman Synchron CX Delta, CX®CE, and CX9 ALX<br>Systems. |
| 9 | BK-465908D | Calibrator 1 | 465908 | Calibrator 1 | | | BK-465909D | Calibrator 2 | Used in conjunction with Calibrator 1 and 3 to calibrate<br>Na, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on<br>Beckman Synchron CX Delta, CX®CE, and CX9 ALX<br>Systems. |
| 10 | BK-465909D | Calibrator 2 | 465909 | Calibrator 2 | K942676 | 11-02-1994 | BK-465910D | Calibrator 3 | Used in conjunction with Calibrator 1 and 2 to calibrate<br>Na, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on<br>Beckman Synchron CX Delta, CX®CE, and CX9 ALX<br>Systems. |
| 11 | BK-465910D | Calibrator 3 | 465910 | Calibrator 3 | | | BK-443360D | Calibration Standard 1 | Used in conjunction with Calibration Standard 2 to<br>calibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, &<br>Creatinine on Beckman Synchron CX3 and CX5<br>Systems. |
| 12 | BK-443360D | Calibration Standard 1 | 443360 | Calibration Standard 1 | K864236 | 12-31-1986 | BK-443365D | Calibration Standard 2 | Used in conjunction with Calibration Standard 1 to<br>calibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, &<br>Creatinine on Beckman Synchron CX3 and CX5<br>Systems. |
| 13 | BK-443365D | Calibration Standard 2 | 443365 | Calibration Standard 2 | | | BM-620427D | ISE Standard High | To provide a calibration point for Na+, K+ and Cl-<br>electrodes on the ISE module of Hitachi 7xx, 911, 912<br>and 917 Analyzers. |
| 14 | BM-620427D | ISE Standard High | 620427 | ISE Standard High | K811194 | 05-27-1981 | BM-620428D | ISE Standard Low | To provide a calibration point for Na+, K+ and Cl-<br>electrodes on the ISE module of Hitachi 7xx, 911, 912<br>and 917 Analyzers. |
| 15 | BM-620428D | ISE Standard Low | 624028 | ISE Standard Low | | | | | |
* OEM = Original Equipment Manufacturer
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## 4. Device Description:
- The Calibrators for the OEM Instruments are aqueous reagents with salts (chemical constituents) . added to obtain desired analyte levels to provide the desired calibration.
#### Intended Use: .
- For each Calibrator included in this submission, the calibrator is intended for use on equivalent . OEM Instruments, i.e. predicate device and are necessary for the continued operation and use of the instruments.
- For each Calibrator included in this submission, Mission uses a similar composition, description and . packaging as that used by the OEM in its products, as shown in the packaging section of this submission.
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## 5. Performance Characteristics:
See table below for Summary.
| PN | Description | Performance Data collected: | Results: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| CD-105670D | Hct Slope | Precision and correlation data are collected per: SOP23-01-02 Performance Study Protocol for 510(k) Submission with the following modifications: Testing was conducted over 7 days, 2 runs each, Mission and OEM, per day. The 348 Hct sensor was sloped with the OEM Hct slope and Hct QC samples were measured in duplicate. The Hct Sensor was calibrated and Hct QC samples were measured in duplicate – this equaled 1 run, n= 4 per QC sample. 2 runs were completed each day, n=8 per QC sample. The 348 Hct sensor was sloped with the Mission Hct slope and Hct QC samples were measured in duplicate. The Hct Sensor was calibrated and Hct QC samples were measured in duplicate - this equaled 1 run, n= 4 per QC sample. 2 runs were completed each day, n=8 per QC sample. Hct Slope is an ampuled product used to provide a slope point for the Hct sensor. Other required reagents to run the 348 instrument remained constant throughout testing. | Summary of QC Recovery and Precision for 348 Hct Slope CD-105670D<br>Summary of QC Data Analyte Level N Mean Sd Min Max %CV %Hct QC - A 56 26 0.6 24 27 2.2 QC - B 56 48 0.8 45 49 1.6 OEM %Hct QC - A 48 27 0.3 26 27 1.0 QC - B 48 49 0.6 48 50 1.2 Recoveries of individual QC observations when 348 Hct sensor sloped with Mission Hct Slope vs OEM Hct Slope were compared by least squares regression. The following statistics were obtained:<br>Mission = 0.999 x Corning - 0.818<br>Range = 26 & 48 %Hct; $r^2$ = 0.997; df = 95; n = 96; S(y.x) = 0.58 %Hct<br>Mission Hct Slope performed equally to the OEM Hct Slope. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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| PN | Description | Performance Data collected: | Results: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| CD-471818D | 634 Ca/pH Slope Standard | Precision and correlation data are collected per:<br>SOP23-01-02 Performance Study Protocol for 510(k) Submission with the following modifications:<br>Serum samples were spiked or diluted to yield Ca samples ranging from 0.37-4.57 mmol/L. 5 replicates of a serum sample and 1 replicate of each of 3 levels of QC were tested in a calibrated run. Samples were tested over a three-day period. All samples and QC's were tested in calibrated runs where Mission 634 Ca/pH Slope was used for the slope point and in calibrated runs where the OEM 634 Slope Standard was used for the slope point. The 634 Ca/pH Slope Standard is an ampuled product used to provide a slope point for Ca & pH on the 634. Other required reagents to run the 634 instrument remained constant throughout testing. | Table of QC Data for 634 Ca/pH Slope CD-471818D & OEM<br>Summary QC Data for Ca and pH - with Mission 634 Slope Analyte Level N Mean Sd Min Max %CV pH 1 12 7.11 0.04 7.05 7.18 0.62 2 12 7.41 0.02 7.37 7.45 0.33 3 12 7.60 0.01 7.58 7.62 0.18 Ca 1 12 2.13 0.03 2.08 2.15 1.32 2 12 1.07 0.01 1.06 1.08 0.62 3 12 0.56 0.01 0.55 0.56 1.50 Summary QC Data for Ca and pH - with Corning 634 Slope Analyte Level N Mean Sd Min Max %CV pH 1 12 7.18 0.05 7.08 7.22 0.67 2 12 7.41 0.04 7.36 7.50 0.54 3 12 7.58 0.02 7.57 7.63 0.21 Ca 1 12 2.10 0.03 2.08 2.15 1.24 2 12 1.08 0.01 1.06 1.09 0.84 3 12 0.57 0.01 0.55 0.59 1.90 Recoveries of individual serum observations were compared by least squares regression.<br>The following statistics were obtained:<br>Mission = 1.018 x Corning - 0.019<br>Range = 0.37 to 4.57 mmol/L; r² = 0.998; df = 68; n = 69; S(y.x) = 0.05 mmol/L<br>Recoveries of individual QC observations when 634 calibrated with Mission 634 Ca/pH Slope Standard vs OEM 634 Slope Standard were compared by least squares regression.<br>The following statistics were obtained:<br>For Ca<br>Mission = 1.028 x Corning - 0.031<br>Range = 0.55 - 2.18; r² = 0.998; df = 32 n = 33; S(y.x) = 0.02 mmol/L Ca<br>For pH<br>Mission = 1.045 x Corning - 0.36<br>Range = 7.05 - 7.62; r² = 0.937; df = 32; n = 33; S(y.x) = 0.05<br>Mission 634 Ca/pH Slope performed equally to the OEM 634 Slope Standard. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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| PN | Description | Performance Data collected: | Results: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|------------|-------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| CD-473606D | 654 Lithium<br>Slope Solution | Precision and correlation data are collected per: | Table of QC Data for 654 Li Slope CD-473606D & OEM<br>Summary of QC Data with Mission 654 Li Slope Standard Analyte Level N Mean Sd Min Max %CV Na 1 20 119 0.6 118 120 0.5 2 20 141 0.6 140 142 0.4 3 20 165 0.7 164 167 0.4 K 1 20 2.09 0.03 2.00 2.14 1.59 2 20 4.26 0.05 4.10 4.34 1.09 3 20 6.71 0.09 6.40 6.83 1.36 Li 1 20 0.33 0.02 0.29 0.38 6.8 2 20 1.14 0.05 1.06 1.22 4.3 3 20 2.17 0.09 2.01 2.28 4.0 Summary of QC Data with OEM 654 Li Slope Standard Analyte Level N Mean Sd Min Max %CV Na 1 20 119 0.6 118 120 0.5 2 20 141 0.6 140 142 0.4 3 20 166 0.5 165 166 0.3 K 1 20 2.10 0.02 2.05 2.13 1.04 2 20 4.26 0.03 4.20 4.32 0.76 3 20 6.72 0.08 6.59 6.90 1.17 Li 1 20 0.38 0.02 0.34 0.42 5.2 2 20 1.14 0.04 1.09 1.19 3.1 3 20 2.10 0.06 2.02 2.18 2.7 Recoveries of individual serum observations were compared by least squares regression.<br>Scatter plot of individual observations are below. The following statistics were obtained:<br>Mission = 1.050 x Corning - 0.075<br>Range = 0.28 to 2.95 mmol/L; $r^2$ = 0.998; df = 27; n = 28; S(y.x) = 0.04 mmol/L Li<br>Mission 654 Li Slope Standard performed equally to the OEM 654 Li Slope Standard | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 2.50 mmol/L | | SOP23-01-02 Performance Study Protocol for 510(k) Submission with the followingmodifications: Serum samples were spiked or diluted to yield Li samples ranging from 0.28 - 2.95 mmol/L. 5 replicates of a serum sample and 1 replicate of each of 3 levels of QC were tested in a calibrated run. Samples were tested over a four-day period. All samples and QC's were tested in calibrated runs where Mission 654 Li Slope was used for the slope point and in calibrated runs where the OEM 654 Li Slope Standard was used for the slope point. The 654 Li Slope Standard is an ampuled product used to provide a slope point for Li on the 654. Other required reagents to run the 654 instrument remained constant throughout testing. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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| PN | Description | Performance Data collected: | Results: | | | | | | | |
|------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----|------|------|------|------|------|
| CD-473692D | pH Blood Gas Slope | Precision and correlation data are collected per:<br>SOP23-01-02 Performance Study Protocol for 510(k) Submission with the following modifications:<br>• Testing was conducted over 5 days, 2 runs each, Mission and OEM, per day.<br>• The 238 was calibrated then sloped with Mission pH/Blood Gas Slope. 3 levels of QC were tested: QC 1, QC2, QC3, QC3, QC2, QC1 – a new ampule tested for each sample. The 238 was calibrated and 3 levels of QC tested as before. This equaled 1 run, n= 4 for each QC level. 2 runs were completed each day, n=8 per OC sample.<br>• The 238 was calibrated and then sloped with the OEM pH/Blood Gas Slope. 3 levels of QC were tested: QC 1, QC2, QC3, QC3, QC2, QC1 - a new ampule tested for each sample. The 238 was calibrated and 3 levels of QC tested as before. This equaled 1 run, n= 4 for each QC level. 2 runs were completed each day, n=8 per QC sample.<br>The pH/Blood Gas Slope is an ampuled product used to provide a slope point for pH, pCO2, pO2 on the 238. Other required reagents to run the 238 instrument remained constant throughout testing. | Table of QC Data for 238 Slope CD-473692D vs OEM<br>Summary of QC Data – with Mission 238 Slope | | | | | | | |
| | | | Analyte | Level | N | Mean | Sd | Min | Max | %CV |
| | | | pH | 1 | 36 | 7.05 | 0.01 | 7.02 | 7.08 | 0.02 |
| | | | | 2 | 38 | 7.33 | 0.02 | 7.30 | 7.38 | 0.25 |
| | | | | 3 | 40 | 7.55 | 0.02 | 7.50 | 7.60 | 0.30 |
| | | | pCO2 | 1 | 36 | 95 | 2.1 | 92 | 99 | 2.2 |
| | | | | 2 | 38 | 47 | 1.5 | 44 | 50 | 2.1 |
| | | | | 3 | 40 | 22 | 0.6 | 21 | 23 | 2.6 |
| | | | pO2 | 1 | 36 | 73 | 1.2 | 71 | 76 | 1.6 |
| | | | | 2 | 38 | 113 | 4.1 | 106 | 121 | 3.7 |
| | | | | 3 | 40 | 133 | 3.6 | 128 | 142 | 2.7 |
| | | | Summary of QC Data – with OEM 238 Slope | | | | | | | |
| | | | Analyte | Level | N | Mean | Sd | Min | Max | %CV |
| | | | pH | 1 | 37 | 7.06 | 0.02 | 7.02 | 7.11 | 0.24 |
| | | | | 2 | 40 | 7.33 | 0.02 | 7.29 | 7.36 | 0.23 |
| | | | | 3 | 39 | 7.54 | 0.02 | 7.49 | 7.57 | 0.26 |
| | | | pCO2 | 1 | 37 | 90 | 2.1 | 87 | 94 | 2.4 |
| | | | | 2 | 40 | 46 | 1.3 | 44 | 49 | 2.8 |
| | | | | 3 | 39 | 22 | 0.7 | 21 | 23 | 3.0 |
| | | | pO2 | 1 | 37 | 73 | 1.3 | 70 | 75 | 1.8 |
| | |…
