(63 days)
No
The description focuses on traditional sensor technology, microprocessor control for basic functions (display, printing, signal processing), and standard calibration procedures. There is no mention of AI, ML, or advanced algorithms for data interpretation or prediction.
No
The device is used to measure various blood parameters, which provides diagnostic information, but it does not directly treat or prevent a disease or condition.
Yes
The device measures blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium, and hematocrit in whole blood, which are all parameters used to diagnose or monitor medical conditions.
No
The device description clearly outlines hardware components including an analyzer, sensor cassette, calibration solution pack, power supply, and an aspiration stylus. While it utilizes microprocessor-controlled electronics (software), it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "measures blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium, and hematocrit in whole blood." These are measurements performed on biological samples (whole blood) outside of the body to provide information about a patient's health status.
- Device Description: The device description details how the system analyzes blood samples using sensors and calibration solutions. This process of analyzing biological samples is characteristic of IVD devices.
- Performance Studies: The document describes both non-clinical and clinical testing where the device's performance is compared to reference instruments and methodologies for measuring blood gases, electrolytes, and hematocrit. This type of testing is required for IVD devices to demonstrate their accuracy and reliability.
- Predicate Devices: The inclusion of predicate devices (other similar blood gas and electrolyte analyzers) further confirms that this device falls within the category of IVD instruments.
The definition of an In Vitro Diagnostic (IVD) device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The SenDx 100™ clearly fits this description by providing measurements from blood samples that are used for diagnostic purposes.
N/A
Intended Use / Indications for Use
The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is a portable, automated analyzer that measures blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium, and hematocrit in whole blood. The SenDx 100™ system is intended for use by trained technologists, nurses, physicians, and therapists. It can be used in laboratory, near patient or point-of-care settings.
The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood.
The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous whole blood samples.
Product codes
CHL, CGZ, CEM, JFP, JGS, GKF
Device Description
The SenDx 100™ system consists of the analyzer, a multi-use, disposable sensor cassette and a calibration solution pack. A bar code label containing lot and sensor-specific identifying parameters accompanies each new sensor cassette and calibration solution pack.
The SenDx 100™ line is available in two versions:
Model SD 100 B with modem
Model SD 100 IB without modem for international use
The SD100B is sold in the United States and is UL certified. The unit is battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Jerome Industries power supply model WSZ118M which requires 100 to 250 VAC, 50 to 60 Hertz with these units. It also has a modem.
The SD1001B is sold internationally and is certified by TUV Rheinland. This unit is also battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Advance Power Solutions power supply model AD-740U-1180 which requires 100 to 240 VAC, 50 to 60 Hertz with these units. This model is not equipped with a modem.
The SenDx 100™ analyzer utilizes microprocessor controlled electronics. The microprocessor controls the touch screen display, the analog electronics for processing sensor output, and the integral thermal printer. The printer provides a hard copy of the measured and calculated values. Samples are introduced into the analyzer via an aspiration stylus.
The SenDx 100™ sensor incorporates microelectrode technology for the measurement of blood oxygen (p()), carbon dioxide (pCO2), pHx, sodium (Na), potassium (K), chloride (Cl1), ionized calcium (iCat'), and hematocrit (Hct) in a multi-use, disposable cassette assembly.
The sensors are analogous to traditional electrode methodologies for the measurement of blood gases and electrolytes. A Clark cell for DO, measurement and potentiometric ion-selective electrodes for the measurement of pH, pCO, Na, K, Cl and iCa have been miniaturized for placement on a 1-3/8" x 3/8" sensing "chip". Hematocrit is measured by using conductivity.
The sensors are contained in a low volume flow-through cell. The sensor cassette contains reference electrodes for the potentiometric sensors and an integral temperature sensor and heating element for precise temperature control. Calibration and analysis are carried out at 37.0°C. The SenDx 100™ analyzer allows for patient temperature correction over the range of 12-45°C.
All SenDx 100™ sensor cassettes are 100% tested at the factory with multiple precision reference solutions.
Calibration of the system is accomplished using a calibration solution pack which contains two levels of precision tonometered electrolyte solutions packaged in gas tight disposable cartridges. Precise pH, blood gas, and electrolyte calibration values for each pack are provided on an attached calibration bar code label.
The SenDx 100TM performs two point calibrations at automatic intervals. Throughout the calibration and sample analysis phases, sensor signals are continuously monitored. If any abnormal conditions are detected, an error message is generated.
Blood analysis and the subsequent system calibration and flush take approximately 50-75 seconds. After analysis, pH, pCO2, pO2, Na, K+, Cl; iCa, and Hct measurement results are displayed on the analyzer touch screen. The measured values and derived values (HCO, BEb, BEecf, TCO3, SBC, Hb, and %02 Sat) are automatically printed.
The SenDx 100™ system can be interfaced via the RS232 serial data port with PC based or LIS/HIS data management systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained technologists, nurses, physicians, and therapists. It can be used in laboratory, near patient or point-of-care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
NON-CLINICAL TESTING
-
Linearity of Recovery:
- Study Design: Linearity of recovery for pCO2 and pO2 was assessed versus target recovery values employing blood tonometry. Linearity of recovery for pH, K, Na, Cl and iCa was assessed by selecting from the pooled whole blood data from five ranges evenly spread throughout the total range of measurement.
- Sample Size: Approximately 50 - 100 blood samples per range for pH, K, Na, Cl, iCa. Total sample sizes for each analyte: pH (333), pCO2 (384), pO2 (321), Na+ (465), K+ (475), Cl- (414), iCa++ (600), Hct (747).
- Data Source: Generated on-site at SenDx Medical, Inc.
- Annotation Protocol: Values independently verified against a Corning 850 Blood Gas and Electrolyte Analyzer (for pH, K, Na, Cl, iCa). Analysis used full linear regression.
- Key Results (Regression Slope, r, Intercept, Std Error Sy.x):
- pH: Slope 1.21, r 0.99, Intercept -1.56, Sy.x 0.017
- pCO2: Slope 1.00, r 0.99, Intercept 0.92, Sy.x 1.83
- pO2: Slope 1.01, r 1.00, Intercept 0.51, Sy.x 3.0
- Na+: Slope 1.09, r 0.99, Intercept -11.17, Sy.x 2.15
- K+: Slope 1.06, r 1.00, Intercept -0.18, Sy.x 0.13
- Cl-: Slope 1.03, r 0.99, Intercept 1.10, Sy.x 1.66
- iCa++: Slope 1.01, r 1.00, Intercept -0.04, Sy.x 0.04
- Hct: Slope 1.12, r 0.98, Intercept -2.42, Sy.x 1.69
-
Correlations:
- Study Design: Comparing the SenDx 100™ to a Corning 850 Blood Gas and Electrolyte Analyzer and a spun hematocrit (micro-centerfuge). Tonometered and spiked whole blood were tested.
- Sample Size: pH (472), pCO2 (413), pO2 (1677), Na+ (619), K+ (601), Cl- (619), iCa++ (621), Hct (1229).
- Data Source: Performed at SenDx Medical, Inc.
- Key Results (Regression Slope, r, Intercept, Std Error Sy.x):
- pH: Slope 1.23, r 0.99, Intercept -1.65, Sy.x 0.013
- pCO2: Slope 1.00, r 0.99, Intercept 0.49, Sy.x 1.62
- pO2: Slope 0.97, r 0.99, Intercept 3.81, Sy.x 5.56
- Na+: Slope 1.17, r 0.99, Intercept -24.22, Sy.x 2.11
- K+: Slope 1.02, r 1.00, Intercept 0.07, Sy.x 0.14
- Cl-: Slope 1.01, r 0.99, Intercept -0.10, Sy.x 1.54
- iCa++: Slope 1.33, r 0.99, Intercept -0.4, Sy.x 0.05
- Hct: Slope 1.12, r 0.95, Intercept -4.63, Sy.x 2.07
-
Precision:
- Study Design: In-house precision study using quality control materials (RNA Medical Qualidata levels 1, 2, 3 for blood gases/electrolytes; RNA Medical hematocrit levels low and high for hematocrit). Each level run in duplicate twice a day.
- Sample Size: Over a period of 15 days, utilizing multiple lots of sensor cassettes and calibration packs.
- Data Source: SenDx Medical, Inc.
- Key Results: Reported Mean, S.D., and %CV for pH, pCO2, pO2, Na+, K+, iCa++, Hct, Cl- at various levels. (Specific values are in the table).
CLINICAL TESTING
-
Hospital Stat Lab (Split Sample Testing):
- Study Design: Clinical studies comparing SenDx 100 system to Corning 865, Nova Stat Profile 5, Corning Co-oximeter and spun hematocrit (micro centrifuge) methodologies.
- Sample Size: Over 400 split-samples evaluated at four clinical sites. Representative site performance shown with n for each analyte (pH: 120, pCO2: 114, pO2: 119, Na+: 120, K+: 120, iCa++: 118, Hct: 102).
- Data Source: Four different geographical sites.
- Reference Device: Corning 865 and CO-oximeter module.
- Key Results (Regression Slope, r, Intercept, Std Error Sy.x for representative site):
- pH: Slope 0.89, r 0.99, Intercept 0.841, Sy.x 0.013
- pCO2: Slope 0.84, r 0.99, Intercept 5.93, Sy.x 1.03
- pO2: Slope 1.02, r 1.00, Intercept -0.08, Sy.x 5.77
- Na+: Slope 0.98, r 0.89, Intercept 3.04, Sy.x 2.48
- K+: Slope 1.01, r 0.99, Intercept -0.15, Sy.x 0.07
- iCa++: Slope 0.85, r 0.94, Intercept 0.17, Sy.x 0.03
- Hct: Slope 1.11, r 0.93, Intercept -4.03, Sy.x 2.55
-
Hospital Operating Room Point-Of-Care (Split Sample Testing):
- Study Design: SenDx 100™ system subjected to operating room point-of-care use, operated by typical OR personnel.
- Sample Size: n for each analyte (pH: 112, pCO2: 106, pO2: 108, Na+: 112, K+: 112, iCa++: 97, Hct: 111) at a representative site.
- Data Source: Two different hospitals.
- Reference Device: Mallinckrodt Gem-Premier.
- Key Results (Regression Slope, r, Intercept, Std Error Sy.x for representative site):
- pH: Slope 0.78, r 0.99, Intercept 1.66, Sy.x 0.01
- pCO2: Slope 0.80, r 0.96, Intercept 4.96, Sy.x 1.56
- pO2: Slope 0.79, r 0.95, Intercept 54, Sy.x 28.5
- Na+: Slope 0.85, r 0.90, Intercept 17.1, Sy.x 1.98
- K+: Slope 1.06, r 0.98, Intercept -0.4, Sy.x 0.20
- iCa++: Slope 0.88, r 0.95, Intercept 0.12, Sy.x 0.06
- Hct: Slope 1.03, r 0.99, Intercept -2.35, Sy.x 1.85
-
Clinical Precision Study:
- Study Design: Precision studies using reference quality control materials for pH, blood gases, electrolytes and hematocrit. Each level run in duplicate twice a day.
- Sample Size: Conducted at four clinical sites over a five-day period.
- Reference Device: Corning 865 and Co-oximeter Module.
- Key Results: Summarized precision data for pH, pCO2, pO2, Na+, K+, iCa++, Hct across various levels, showing Mean, S.D., and %CV for Within Run, Within Day, Day to Day, and Site to Site (for three clinical sites). (Specific values are in the table).
Conclusion: The nonclinical and clinical data show that the performance of the SenDx 100™ system is equivalent or substantially equivalent to that of the predicate devices for measurement of pH, pO2, pCO2, Na+, K+, Cl-, iCa++ and hematocrit, and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not directly reported as sensitivity, specificity, PPV, NPV.
Performance is demonstrated through:
- Linearity of Recovery: Slope, correlation coefficient (r), intercept, and standard error of Sy.x.
- Correlations: Slope, correlation coefficient (r), intercept, and standard error of Sy.x.
- Precision: Mean, Standard Deviation (S.D.), and Coefficient of Variation (%CV).
Predicate Device(s)
K954482, K934907, K910305, K874832
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1170 Chloride test system.
(a)
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.(b)
Classification. Class II.
0
15973742
SenDx Medical, Inc. 1945 Palomar Oaks Way Carlsbad, California 92009 Phone: 760.930.6300 Fax: 760.930.6320
DEC - 3 1997
SenDx Medical, Inc. Company Name:
1945 Palomar Oaks Way Address: Carlsbad, California 92009
Phone: 760.930.6300
760.930.6320 Fax:
Contact Person: Ruben Chairez
Date: September 15, 1997
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510 (k) number is: ___________________
ు గ్రామం
నుండి
1
| A. Device Proprietary name: | SenDx 100 Blood Gas and Electrolyte Analysis System |
|---|---|
| B. Device common name: | Blood Gas and Electrolyte Analyzer |
| C. Device classification name: | |
| • 21 CFR 862.1120: | Blood gases (CO2, pO2) and blood pH test system Class II |
| • 21 CFR 862.1665 | Sodium test system Class II |
| • 21 CFR 862.1600 | Potassium test system Class II |
| • 21 CFR 862.1145 | Calcium test system Class II |
| • 21 CFR 862.1170 | Electrode, Ion-Specific, Chloride Class II |
| • 21 CFR 864.6400 | Hematocrit measuring device Class II |
ﺳﺴﺴﺴ
ਸੂਨੀ ਦੇ ਸੰਗ੍ਰਹਿ ਹੈ।
ਹਵਾਲੇ
..............................................................................................................................................................................
:
2
Statement of Substantial Equivalence
1
ﻟﺴﻴﺮ- ﺗﺮ
The SenDx 100 pH, Blood Gas and Electrolyte Analysis System is substantially equivalent to other blood gas, electrolyte and hematocrit measuring systems used with whole blood.
This 510(k) submission seeks clearance for modifications to the SenDx 100 line as embodied in the two models SD 100B and SD 100IB. These modifications include:
-
- Addition of chloride to the electrolyte panel.
-
- Modification to the Performance Characteristics section of the Operators Manual.
The SenDx 100 (Model SD100B and SD100IB) is substantially equivalent to other blood gas analyzers such as:
StatPal versions were previously submitted and cleared for marketing under 510(k) document Control numbers:
These three StatPal versions were found by FDA to be substantially equivalent to the Mallinckrodt® GEM@-STAT, among other instruments.
The SenDx 100 system was originally submitted and cleared for marketing under Document Control number K954482. This SenDx 100 system was also found by FDA to be substantially equivalent to the Mallinckrodt® GEM®-PREMIER among other instruments.
The SenDx 100 is substantially equivalent to other blood gas and electrolyte systems such as:
-
- The Ciba-Corning, Corning 865 Blood Gas and Electrolyte System 510(k) Document Control number K 934907.
-
- The Mallinckrodt® GEM®-PREMIER Blood Gas and Electrolyte Monitor, 510(k) Document Control number K 910305.
-
- The NOVA Biomedical, NOVA STAT Profile 5, 510(k) Document Control Number K874832.
3
Description
The SenDx 100™ system consists of the analyzer, a multi-use, disposable sensor cassette and a calibration solution pack. A bar code label containing lot and sensor-specific identifying parameters accompanies each new sensor cassette and calibration solution pack.
The SenDx 100™ line is available in two versions:
Model SD 100 B with modem Model SD 100 IB without modem for international use
The SD100B is sold in the United States and is UL certified. The unit is battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Jerome Industries power supply model WSZ118M which requires 100 to 250 VAC, 50 to 60 Hertz with these units. It also has a modem.
The SD1001B is sold internationally and is certified by TUV Rheinland. This unit is also battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Advance Power Solutions power supply model AD-740U-1180 which requires 100 to 240 VAC, 50 to 60 Hertz with these units. This model is not equipped with a modem.
The SenDx 100™ analyzer utilizes microprocessor controlled electronics. The microprocessor controls the touch screen display, the analog electronics for processing sensor output, and the integral thermal printer. The printer provides a hard copy of the measured and calculated values. Samples are introduced into the analyzer via an aspiration stylus.
The SenDx 100™ sensor incorporates microelectrode technology for the measurement of blood oxygen (p(), carbon dioxide (pCO2), pHx, sodium (Na*), potassium (K*), chloride (Cl1), ionized calcium (iCat'), and hematocrit (Hct) in a multi-use, disposable cassette assembly.
The sensors are analogous to traditional electrode methodologies for the measurement of blood gases and electrolytes. A Clark cell for DO, measurement and potentiometric ion-selective electrodes for the measurement of pH, pCO,, Na , K , Cl and iCa * have been miniaturized for placement on a 1-3/8" x 3/8" sensing "chip". Hematocrit is measured by using conductivity.
The sensors are contained in a low volume flow-through cell. The sensor cassette contains reference electrodes for the potentiometric sensors and an integral temperature sensor and heating element for precise temperature control. Calibration and analysis are carried out at 37.0°C. The SenDx 100™ analyzer allows for patient temperature correction over the range of 12-45°C.
All SenDx 100™ sensor cassettes are 100% tested at the factory with multiple precision reference solutions.
4
Calibration of the system is accomplished using a calibration solution pack which contains two levels of precision tonometered electrolyte solutions packaged in gas tight disposable cartridges. Precise pH, blood gas, and electrolyte calibration values for each pack are provided on an attached calibration bar code label.
The SenDx 100TM performs two point calibrations at automatic intervals. Throughout the calibration and sample analysis phases, sensor signals are continuously monitored. If any abnormal conditions are detected, an error message is generated.
Blood analysis and the subsequent system calibration and flush take approximately 50-75 seconds. After analysis, pH, pCO2, pO2, Na', K+, Cl; iCa*, and Hct measurement results are displayed on the analyzer touch screen. The measured values and derived values (HCO), BEb, BEecf, TCO3, SBC, Hb, and %02 Sat) are automatically printed.
The SenDx 100™ system can be interfaced via the RS232 serial data port with PC based or LIS/HIS data management systems.
5
Intended Use
্রামের
The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is a portable, automated analyzer that measures blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium, and hematocrit in whole blood. The SenDx 100™ system is intended for use by trained technologists, nurses, physicians, and therapists. It can be used in laboratory, near patient or point-of-care settings.
6
510(k) Number (if known):
Device Name: SenDx 100™ pH, Blood Gas and Electrolyte Analysis System
Indications for Use:
The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood.
The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous whole blood samples.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUED ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
্রামের
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
7
Technological Characteristics
As described in a previous 510(k) (K922631/B) for StatPal II, the StatPal II and the Mallinckrodt® GEM® STAT are primarily intended for determination of arterial pH, pO2 and pCO2. Similarly, as described in the previous 510(k) (K954482) for the SenDx 100™ , this device intended to be used for determination of arterial or venous pH, pCO2, pO2, Na', K', ionized Ca* and hematocrit in whole blood. The present 510(k) submission adds chloride to the electrolyte panel of the SenDx 100™. The SenDx 100 is similar to the Mallinckrodte GEM®-PREMIER, Corning 850 & 865, and NOVA STAT Profile 5 in intended use, methods of application and principles of operation.
The methods of application involve trained medical personnel in a central lab, stat lab or critical care environment. The StatPal II, SenDx 100 and GEM®-PREMIER can also be used near the patient due to the portable nature of the devices. In each of these devices, the principles of operation are similar or the same:
| • polarographic
| (amperometric) | pO₂ measurement |
|---|---|
| • potentiometric | |
| measurement | pH, Na+, K+, Cl-, iCa++, and pCO₂ measurement |
| • conductance | Hematocrit measurement |
The SenDx 100 poses the same type of questions about safety and effectiveness of the equivalent devices.
8
NON-CLINICAL TESTING
Performance data was generated on-site at SenDx Medical, Inc. Comparisons were done with the following reference instruments:
- Corning 850 and spun hematocrit (micro centrifuge) o
Linearity of Recovery:
- SenDx Medical, Inc. a
Linearity of recovery for pCO, and pO, was assessed versus target recovery values employing blood tonometry. Linearity of recovery for pH, K', Na , Cl and iCa* was assessed by selecting from the pooled whole blood data from five ranges evenly spread throughout the total range of measurement. Each range consisted of approximately 50 - 100 blood samples. The values for these ranges were independently verified against a Corning 850 Blood Gas and Electrolyte Analyzer. The resulting data were analyzed using full linear regression analysis. Regression slope, intercept, and correlation coefficient are reported.
| Analyte | n | Slope | r | Intercept | Std Error
Sy.x |
|---------|-----|-------|------|-----------|-------------------|
| pH | 333 | 1.21 | 0.99 | -1.56 | 0.017 |
| pCO2 | 384 | 1.00 | 0.99 | 0.92 | 1.83 |
| pO2 | 321 | 1.01 | 1.00 | 0.51 | 3.0 |
| Na+ | 465 | 1.09 | 0.99 | -11.17 | 2.15 |
| K+ | 475 | 1.06 | 1.00 | -0.18 | 0.13 |
| Cl- | 414 | 1.03 | 0.99 | 1.10 | 1.66 |
| iCa++ | 600 | 1.01 | 1.00 | -0.04 | 0.04 |
| Hct | 747 | 1.12 | 0.98 | -2.42 | 1.69 |
Correlations:
: 大 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
- SenDx Medical, Inc. .
The study was performed at SenDx Medical, Inc. comparing the SenDx 100™ to a Corning 850 Blood Gas and Electrolyte Analyzer and a spun hematocrit (micro-centerfuge). Tonometered and spiked whole blood were tested in order to verify the accuracy of the SenDx 100™ system.
9
| Analyte | n | Slope | r | Intercept | Std Error
Sy.x |
|---------|------|-------|------|-----------|-------------------|
| pH | 472 | 1.23 | 0.99 | -1.65 | 0.013 |
| pCO₂ | 413 | 1.00 | 0.99 | 0.49 | 1.62 |
| pO₂ | 1677 | 0.97 | 0.99 | 3.81 | 5.56 |
| Na⁺ | 619 | 1.17 | 0.99 | -24.22 | 2.11 |
| K⁺ | 601 | 1.02 | 1.00 | 0.07 | 0.14 |
| Cl⁻ | 619 | 1.01 | 0.99 | -0.10 | 1.54 |
| iCa⁺⁺ | 621 | 1.33 | 0.99 | -0.4 | 0.05 |
| Hct | 1229 | 1.12 | 0.95 | -4.63 | 2.07 |
Precision
- SenDx Medical, Inc. g
An in-house precision study using quality control materials was performed over a period of 15 days. This study utilized multiple lots of sensor cassettes and calibration packs.
RNA Medical Qualidata levels 1, 2, 3 were used for blood gases and electrolytes, and RNA Medical hematocrit levels low and high were used for hematocrit. Each level was run in duplicate twice a day.
| SenDx 100™ | Mean | S. D. | %CV | Mean | S. D. | %CV | ||
|---|---|---|---|---|---|---|---|---|
| pH | $pCO_2$ | |||||||
| (mmHg) | ||||||||
| Level 1 | 7.177 | 0.006 | 0.089 | 67.5 | 2.1 | 3.1 | ||
| Level 2 | 7.416 | 0.003 | 0.047 | 45.0 | 0.7 | 1.7 | ||
| Level 3 | 7.612 | 0.006 | 0.073 | 24.7 | 0.7 | 2.8 | ||
| $pO_2$ | ||||||||
| (mmHg) | $Na^+$ | |||||||
| (mmol/L) | ||||||||
| Level 1 | 71.4 | 3.0 | 4.3 | 107.6 | 0.7 | 0.6 | ||
| Level 2 | 109.5 | 2.0 | 1.9 | 130.1 | 0.5 | 0.4 | ||
| Level 3 | 146.0 | 1.5 | 1.0 | 157.4 | 0.6 | 0.4 | ||
| $K^+$ | ||||||||
| (mmol/L) | $iCa^{++}$ | |||||||
| (mmol/L) | ||||||||
| Level 1 | 1.85 | 0.02 | 1.30 | 1.55 | 0.02 | 1.32 | ||
| Level 2 | 4.39 | 0.03 | 0.78 | 1.19 | 0.01 | 0.97 | ||
| Level 3 | 6.46 | 0.06 | 0.92 | 0.54 | 0.01 | 2.03 | ||
| Hct | ||||||||
| (%) | Cl | |||||||
| (mmol/L) | ||||||||
| Low | 35.0 | 0.3 | 0.7 | |||||
| High | 58.2 | 0.5 | 0.8 | Level 1 | 74.0 | 1.1 | 1.5 | |
| Level 2 | 94.0 | 0.5 | 0.6 | |||||
| Level 3 | 127.0 | 1.0 | 0.8 |
10
CLINICAL TESTING
Clinical studies were conducted of the SenDx 100™ system at four different geographical sites. This study involved four different SenDx 100™ analyzers, and multiple lots of sensor cassettes and calibrant solution packs. These clinical studies included split sample testing of over 50 samples per site and precision testing with QC control samples.
Hospital Stat Lab �
Clinical studies comparing the SenDx 100 system to the Corning 865, Nova Stat Profile 5, Corning Co-oximeter and spun hematocrit (micro centrifuge) methodologies have been conducted by evaluating over 400 split-samples at four clinical sites. Shown below is the performance of a representative site:
| Analyte | n | Slope | r | Intercept | Std Error Sy.x |
|---|---|---|---|---|---|
| pH | 120 | 0.89 | 0.99 | 0.841 | 0.013 |
| pCO2 | 114 | 0.84 | 0.99 | 5.93 | 1.03 |
| pO2 | 119 | 1.02 | 1.00 | -0.08 | 5.77 |
| Na+ | 120 | 0.98 | 0.89 | 3.04 | 2.48 |
| K+ | 120 | 1.01 | 0.99 | -0.15 | 0.07 |
| iCa++ | 118 | 0.85 | 0.94 | 0.17 | 0.03 |
| Hct | 102 | 1.11 | 0.93 | -4.03 | 2.55 |
Reference Device: Corning 865 and CO-oximeter module
Hospital Operating Room Point-Of-Care .
The SenDx 100™ system was subjected to operating room point-of-care use and at two different hospitals, operated by typical OR personnel. Shown below is the performance of a representative site:
| Analvte | n | Slope | r | Intercept | Std Error
Sy.x |
|---------|-----|-------|------|-----------|-------------------|
| pH | 112 | 0.78 | 0.99 | 1.66 | 0.01 |
| pCO2 | 106 | 0.80 | 0.96 | 4.96 | 1.56 |
| pO2 | 108 | 0.79 | 0.95 | 54 | 28.5 |
| Na+ | 112 | 0.85 | 0.90 | 17.1 | 1.98 |
| K+ | 112 | 1.06 | 0.98 | -0.4 | 0.20 |
| iCa++ | 97 | 0.88 | 0.95 | 0.12 | 0.06 |
| Hct | 111 | 1.03 | 0.99 | -2.35 | 1.85 |
Reference Device: Mallinckrodt Gem-Premier
11
Hospital Stat Lab �
Precision studies of the SenDx 100™ were conducted at four clinical sites over a five-day period. Reference quality control materials for pH, blood gases, electrolytes and hematocrit were tested. Each level was run in duplicate twice a day. Shown below are summarized precision data collected from these clinical sites:
Reference Device: Corning 865 and Co-oximeter Module
| | Mean | Level 1
S. D. | % CV | Mean | Level 2
S. D. | % CV | Mean | Level 3
S. D. | % CV |
|----------------------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | 6 3 3 3 | | ,在此次 | الموالي الموالي | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ |
| DE EXP
Within Run | 7.188 | ,一起,
0.001 | 이 기자 10
0.020 | 7.416 | 0.007 | 0.010 | 7.599 | 0.002 | 0.028 |
| Within Day | 7.188 | 0.001 | 0.013 | 7.416 | 0.001 | 0.017 | 7.601 | 0.003 | 0.035 |
| Day to Day | 7.193 | 0.003 | 0.046 | 7.423 | 0.004 | 0.029 | 7.607 | 0.005 | 0.072 |
| Site to Site* | 7.192 | 0.007 | 0.100 | 7.422 | 0.008 | 0.102 | 7.602 | 0.006 | 0.075 |
| pCO2 . | | | | Shop The | | | ર્વારા તા | 的一个人 | |
| Within Run | 67.7 | 0.354 | 0.523 | Production of the
46.8 | 0.000 | 0.000 | 想的一个感情
24.1 | 0.354 | 1.470 |
| Within Day | 67.9 | 0.374 | 0.551 | 47.0 | 0.238 | 0.507 | 23.9 | 0.263 | 1.099 |
| Day to Day | 67.6 | 0.642 | 0.952 | 46.0 | 1.015 | 2.216 | 23.9 | 0.760 | 3.332 |
| Site to Site* | 66.4 | 1.883 | 2.835 | 44.5 | 1.098 | 2.470 | 23.3 | 0.385 | 1.653 |
| po2 po2 | 사 | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | | | | , | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | |
| Within Run | 68.5 | 0.636 | 0.930 | 106.8 | 1.061 | 0.994 | 144.5 | 0.071 | 0.049 |
| Within Day | 68.2 | 1.049 | 1.538 | 106.5 | 0.707 | 0.664 | 144.4 | 0.419 | 0.290 |
| Day to Day | 68.0 | 1.433 | 1.937 | 106.2 | 0.953 | 0.877 | 143.6 | 0.789 | 0.543 |
| Site to Site* | 68.2 | 2.502 | 3.667 | 107.4 | 1.328 | 1.236 | 143.1 | 2.546 | 1.779 |
| 1 Naje J | | 1. Sales of the | ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ | , | 儿的母婴儿 | | 이러한 이름이 있 | | a ka |
| Within Run | 108.1 | 0.141 | 0.131 | 129.8 | 0.071 | 0.054 | 157.4 | 0.424 | 0.270 |
| Within Day | 108.0 | 0.263 | 0.244 | 129.8 | 0.141 | 0.109 | 157.1 | 0.432 | 0.275 |
| Day to Day | 108.0 | 0.455 | 0.421 | 129.7 | 0.234 | 0.180 | 156.5 | 0.454 | 0.290 |
| Site to Site* | 107.4 | 2.133 | 1.987 | 129.2 | 1.452 | 1.124 | 156.2 | 1.176 | 0.753 |
| AK K | રે રું | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق | | an de la p | | | ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ |
| Within Run | 1.80 | 0.028 | 1.571 | 4.37 | 0.028 | 0.647 | 6.50 | 0.007 | 0.109 |
| Within Day | 1.80 | 0.017 | 0.950 | 4.38 | 0.030 | 0.681 | 6.48 | 0.021 | 0.318 |
| Day to Day | 1.81 | 0.013 | 0.716 | 4.37 | 0.015 | 0.347 | 6.46 | 0.031 | 0.477 |
| Site to Site* | 1.81 | 0.019 | 1.055 | 4.35 | 0.036 | 0.822 | 6.43 | 0.047 | 0.728 |
| PriCattle | | のお得な | ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ | | 14.08 | | ,但是 | | |
| Within Run | 1.56 | 0.042 | 2.720 | 1.17 | 0.000 | 0.000 | 0.49 | 0.000 | 0.000 |
| Within Day | 1.55 | 0.029 | 1.856 | 1.16 | 0.015 | 1.290 | 0.50 | 0.006 | 1.166 |
| Day to Day | 1.55 | 0.019 | 1.236 | 1.16 | 0.009 | 0.763 | 0.50 | 0.004 | 0.714 |
| Site to Site* | 1.52 | 0.045 | 2.959 | 1.15 | 0.021 | 1.841 | 0.49 | 0.008 | 1.681 |
| Hotel Hotel | :: | | | - 北海 | | , | | | |
| Within Run | 35.4 | 0.212 | 0.600 | 58.7 | 0.071 | 0.121 | | | |
| Within Day | 35.4 | 0.173 | 0.490 | 58.7 | 0.141 | 0.241 | | | |
| Day to Day | 34.8 | 0.425 | 1.220 | 57.8 | 0.722 | 1.249 | | | |
| Site to Site* | 34.2 | 0.546 | 1.594 | 57.3 | 0.797 | 1.391 | | | |
SUMMARY OF PRECISION STUDY
- For three clinical sites.
12
CONCLUSION FROM NONCLINICAL AND CLINICAL TESTING
From the nonclinical data we conclude that the performance of the SenDx 100™ system is equivalent to that of the Mallinckrodt GEM-PREMIER, Corning 865 and spun hematocrit for measurement of pH, pO2, pCO2, Na*, K*, Cli, iCa** and hematocrit.
From the clinical study data we conclude that the performance of the SenDx 100™ system is substantially equivalent to that of the predicate devices routinely employed at the clinical sites, for measurement of pH, pO3, pCO2, Na K*, iCa* and hematocrit. From these nonclinical and clinical studies we conclude that the performance of the SenDx 100™ system is substantially equivalent to that of the predicate devices routinely employed at several clinical sites.
These data adequately show that the SenDx 100™ system is safe and effective for its intended use in the laboratory or point-of-care. The data shows the SenDx 100™ system can be used at clinical sites for equivalent performance to the predicate devices routinely in use.
R. Chans
Signature of applicant
Sept. 29, 1997
Date
Date
13
Image /page/13/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health. The seal is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 3 1997
Ruben Chairez, Ph.D. . Vice President, Regulatory Affairs/Quality Assurance SenDx Medical, Inc. 1945 Palomar Oaks Way Carlsbad, California 92009
Re : K973742 SenDx 100 pH, Blood Gas and Electrolyte Analysis System Regulatory Class: II CHL, CGZ, CEM, JFP, JGS, GKF Product Code: Dated: September 23, 1997 Received: October 1, 1997
Dear Dr. Chairez:
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, Drug, 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 requirements for annual registration, listing of devices, qood 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 requlations 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 requlation may result in regulatory action. In addition, FDA may publish further announcements 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.
14
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 (770) 488-7655.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
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
15
510(k) PRE-MARKET NOTIFICATION 510(k) PRE-MARKET NOTIFICATION
SenDx 100 pH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
Ka73742
510(k) Number (if known):
SenDx 100™ pH, Blood Gas and Electrolyte Analysis System Device Name:
Indications for Use:
The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is The SellDX 100 - p11, D100 Gar ara Love Story Corporation, potassium, chloride, ionized calcium and hematocrit in whole blood.
The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care The SellDX 100" System can oo abou in the tas binn the tass of electrolytes and hematocrit in arterial or venous whole blood samples.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUED ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Clinical Laboratory Devices |
| 510(k) Number | K973742 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)